OVULATION TEST

Informazioni principali

  • Nome commerciale:
  • OVULATION TEST
  • Confezione:
  • Scatola da 6 test
  • Tipo di ricetta:
  • Libera vendita
  • Utilizzare per:
  • Animali
  • Tipo di medicina:
  • Dispositivo medico

Documenti

Localizzazione

  • Disponibile in:
  • OVULATION TEST
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Cani
  • Area terapeutica:
  • Tutti gli altri prodotti non terapeutici
  • Indicazioni terapeutiche:
  • Diagnosi rapida per il dosaggio semi quantitativo del livello di progesterone sierico o plasmatico.
  • Dettagli prodotto:
  • Posologia: Lasciare tutti i reagenti a temperatura ambiente per 2 ore prima di eseguire il test. Utilizzare solo siero o plasma, mai sangue intero. Il siero non deve essere emolizzato o lipemico. Il campione deve essere limpido.

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Numero dell'autorizzazione:
  • 939742767
  • Ultimo aggiornamento:
  • 14-08-2017

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Ovulation

®

test

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 1

Français ......................................... P

English ........................................... P

Espanioles ...................................... P 12

Italiano ........................................... P 16

Português ....................................... P 20

Protocole opératoire....................... P 23

Operating procedure

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 2

USAGE IN VITRO UNIQUEMENT

FRANÇAIS

L'Ovulation Test est un test ELISA semi-quantitatif rapide sur membrane à lecture visuelle

pour déterminer le taux de progestérone dans le plasma ou le sérum chez la chienne. Ce

dosage vous aide à préciser le moment de l'ovulation et donc à prévoir la date de saillie ou

d'insémination de la chienne. L'Ovulation Test est un excellent complément du frottis

vaginal pour suivre l'évolution des chaleurs dans le temps.

D

ÉTERMINATION DE LA PÉRIODE FERTILE CHEZ LA CHIENNE

Les signes visuels des chaleurs (congestion vulvaire, écoulements vaginaux, attraction du

mâle) ne sont que des indications approximatives qui ne suffisent pas à déterminer le

moment optimal de la saillie chez la chienne. Une grande variabilité individuelle complique

d'autant plus les prévisions d'insémination. Le frottis vaginal est donc indispensable pour

confirmer les phases de pro-oestrus et d'œstrus.

Le pic de LH (Hormone Lutéinisante) précède toujours l'ovulation. Si on considère ce

moment pour déterminer le Jour 0, on peut prévoir l'ovulation dans les 2 jours. La matura-

tion des ovocytes dure en moyenne 2 à 3 jours après l'ovulation. Les ovocytes sont fécon-

dables pendant 48 à 72 heures après maturation. Ainsi la période fertile se situe 5 à 6 jours

après le pic LH. L'augmentation de la progestérone peut atteindre (selon les publications et

les techniques de dosage) les taux de 6 à 8 ng/ml au moment de l'ovulation.

Comme le montre le graphique page 23, ci-dessous, les taux de progestérone sont bas avant

l'ovulation (entre 0 et 1 ng/ml, test couleur bleu vif). Lorsque la progestérone commence à

augmenter, la couleur du test change du bleu vif au bleu clair, ceci correspondant au jour

du pic LH (Jour 0). La progestérone continue à augmenter les jours suivants, et la couleur du

test devient bleu pâle, puis blanche.

La gestation n'est possible qu'en présence d'ovocytes fécondables (2 jours en moyenne après

l'ovulation) et de spermatozoïdes vivants (5 jours en moyenne). 20% des chiennes ovulent

"en dehors" de la période comprise entre le 10ème et le 14ème jour des chaleurs. Selon C.

DUMON (1) seuls 2 examens associés, frottis vaginal et dosage de la progestérone, permet-

tent de programmer saillie ou insémination et d'obtenir 95 % de succès ainsi qu'une

augmentation de la prolificité.

INTERETS

PRINCIPE

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 3

A

UTRES INTÉRÊTS DE L

'

OVULATION TEST

Détermination du moment de la mise-bas:

Lorsqu'elle est associée aux prodromes (température corporelle, présence de lait blanc,

suivi échographique) une valeur de progestérone inférieure à 1 ng/ml indique que la mise-

bas aura lieu dans les 24 à 48 heures.

Autres intérêts:

- Exploration des troubles de la fertilité: chaleurs silencieuses, chaleurs anovulatoires.

- Prévention des risques d'avortements par insuffisance lutéale en adaptant la supplémen-

tation médicamenteuse.

A

UTRES INTÉRÊTS

: B

OVINE

, E

QUINE

- contrôler le début de la gestation

- vérifier l'efficacité des traitements à base de progestagènes ou de progestatifs.

Kit pour 6 tests

- 6 coupelles tests

- 1 flacon SUBSTRAT A

réf OV6

- 1 flacon SOLUTION DE LAVAGE 1

- 1 flacon SUBSTRAT B

- 1 flacon SOLUTION DE LAVAGE 2

- 1 flacon conjugué

- 1 flacon pour le mélange des substrats

- 6 pipettes à usage unique

- 1 nuancier coloré.

Stable 14 mois à partir de la date de fabrication. Conserver à 2-8 °C

La date de péremption est indiquée sur l'étiquette du kit.

Q

UAND TESTER

?

Vérifier l'exactitude du stade de pro-oestrus à l'aide d'un frottis vaginal. Le frottis vaginal

vous aide à identifier l'approche du pic LH et ainsi de commencer à évaluer le taux de

progestérone.

Un à deux tests sont généralement suffisants en sachant que l'ovulation se produit vers le

2ème jour après le pic LH (entre le 10ème et le 14ème jour après le début des chaleurs).

La fréquence de réalisation de l'Ovulation Test sera évaluée pour chaque cas en fonction

du stade des chaleurs, et des antécédents connus de l’animal.

RECOMMANDATIONS

STABILITÉ – CONSERVATION

PRÉSENTATION

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 4

P

RELEVEMENTS

Prélever le sang dans un tube traité (à l' héparine ou EDTA) ou dans un tube sec (sang total).

Ne pas utiliser de tube de prélèvement à gel de séparation. Ne pas utiliser de sang total.

Immédiatement après la prise de sang, homogénéiser les échantillons en retournant les

tubes plusieurs fois. Centrifuger l'échantillon de sang ou laisser coaguler le sang total sur

tube sec à température ambiante, séparer le sérum ou le plasma dans un tube propre.

L'échantillon ne doit être ni hémolysé, ni lipémique (il doit être limpide).

Inscrire le nom de l'animal et la date du prélèvement sur le tube.

Il est possible de conserver le sérum ou le plasma plusieurs jours au réfrigérateur (2-8°C).

Pour un stockage plus long, l'échantillon doit être congelé.

P

RECAUTIONS DE MANIPULATION

Conserver le coffret en entier au réfrigérateur lorsqu'il n'est pas utilisé. Ne pas congeler.

Re-sceller toujours hermétiquement le sachet des coupelles après en avoir retiré une.

Ne pas échanger les réactifs ou coupelles entre différents coffrets.

Avant de commencer le test, laisser les échantillons et les réactifs revenir à température

ambiante (2h). Il est possible de laisser le kit à température ambiante toute la journée.

Le temps des étapes 1,3 et 7 est très important.

1 Au moyen d'une pipette, ajouter 8 gouttes de sérum ou de plasma au centre de la

coupelle.

Attendre 2 minute.

2 Ajouter 4 gouttes de Solution de Lavage 1 au centre de la coupelle.

Attendre que le liquide soit totalement absorbé.

Répéter 1 fois ce lavage.

3 Ajouter 3 gouttes de conjugué (flacon à capuchon rouge) au centre de la coupelle.

Attendre 1 minute.

4 Remplir la coupelle avec la Solution de Lavage 2 jusqu'à la limite inférieure du bord de

la coupelle, soit environ 20 gouttes.

Attendre que le liquide soit totalement absorbé.

5 Préparer un substrat frais dans le flacon pour le mélange des substrats (étiquette bleue):

PROTOCOLE OPERATOIRE (schéma p. 23)

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 5

ajouter une mesure de chaque substrat A et B (flacons à capuchons noirs) en remplissant

chaque compte-gouttes jusqu'au trait noir. Bien agiter.

Il est déconseillé de préparer le substrat à l'avance car il se détériore après 30 minutes.

6 Ajouter 4 gouttes de substrat fraîchement préparé au centre de la coupelle.

Après 30 minutes, jeter toute solution inutilisée de substrat (flacon de mélange à étiquette

bleue). Conserver ce flacon vidé pour les tests ultérieurs.

7 Attendre 9 minutes pour lire le résultat

Lire et enregistrer le résultat à l'aide du nuancier coloré.

Les couleurs du test correspondent aux niveaux de progestérone. Le nuancier coloré inclus

dans le coffret est un guide lors de l'observation des changements de couleurs des tests

réalisés.

Le tableau ci-dessous est un guide de suivis des chaleurs chez la chienne.

Couleurs

Concentration

Recommandations *

Progestérone

0 à 1 ng/ml

Niveau de base de la progestérone

Bleu vif

Effectuer un nouveau test dans 2 jours.

1 à 2,5 ng/ml

Pic LH

Bleu clair

Effectuer un nouveau test dans les 2 jours.

2,5 à 8 ng/ml

Début de la maturation des ovules

Bleu pâle

Saillir ou inséminer avec du sperme frais dans 1 et 3 jours

Avec du sperme congelé inséminer dans 1, 3 et 5 jours

> 8 ng/ml

Saillir ou inséminer immédiatement.

Blanc

Attention, vous pouvez vous trouver en fin de période fertile.

* Ces recommandations constituent un guide, aucune méthode de diagnostic ne pouvant

prétendre être précise à 100%. Ainsi, le vétérinaire devra toujours tenir compte de l’historique

et de l’examen clinique et/ou échographique de la chienne pour prendre une décision.

Ce test a pour but d’aider le vétérinaire praticien dans son choix thérapeutique. Cette décision

est prise sous sa responsabilité. Bio Véto Test ne peut être tenu responsable des conséquences

liées à une mauvaise utilisation ou une mauvaise interprétation des résultats donnés par ce test.

INTERPRÉTATION DES RÉSULTATS

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 6

USE IN VITRO ONLY

ENGLISH

The Ovulation Test is a rapid semi quantitative ELISA test on membrane with a visual

reading for the determination of progesterone level in plasma or serum of dogs. It allows

essentially to determine the ovulation and therefore to forecast the date of insemination or

covering. Ovulation Test is an ideal complementary tool to vaginal smear examination

during the heat follow up.

D

ETERMINATION OF THE FERTILE PERIOD

:

The visible signs of heat and breeding time (such as vulval swelling, vaginal discharge, or

flagging) are only an approximate indication of time of ovulation. These signs can vary by

more than one week. The vaginal smear examination is necessary to confirm the oestrus or

pro-oestrus stages.

The Luteinizing Hormone or LH triggers the ovulation. The day when LH increases is cal-

led Day 0. The ovulation occurs 2 days after. After ovulation, the ovocytes take 2-3 days to

mature, and the mature ovules are alive for 48 to 72 hours. Therefore, the most fertile

period for the bitch is 5-6 days after the LH peak.

According to the figure p23, the progesterone levels are low before the ovulation time

(between 0 to 1 ng/ml, test bright blue). When the progesterone begins to increase, the

color of the test changes from bright blue to light blue, corresponding to peak LH (day 0).

Then the progesterone continues to increase the following days and the test color becomes

faint blue, then white.

The pregnancy is only possible with mature ovules (2 days after ovulation) and with alive

sperm (5 days +/- 2). 20% of dog shows ovulation outside the period between the 10th and

14th days of heat. According to C. DUMONT (1) only two associated examinations,

vaginal smears and detection of progesterone level, allow to schedule insemination or

covering and to reach 95% of success with an increasing of prolificity.

A

NOTHER INTEREST FOR DOGS

Determination of the whelping date :

When it is used in conjunction with all other available information such as drop of rectal

temperature, white milk, ultrasound examination and others, level of progesterone lower

than 1 ng/ml indicates a readiness for delivery within 24 hours or 48 hours.

INTEREST

PRINCIPLE

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 7

Another interests :

- Follow up of fertility treatment

- Preventing abortion due to luteal insufficiency by controlling the effect of adapted

treatment.

A

NOTHER INTEREST FOR

B

OVINE

, E

QUINE

:

- Early pregnancy status

- Efficiency of progestagenes or progestative treatment

6 tests / kit:

6 unitary test cups

1 vial of SUBSTRATE A

6 transfer pipettes

1 vial of SUBSTRATE B

1 vial of WASH SOLUTION 1

1 vial of Substrate Mixing Bottle

1 vial of WASH SOLUTION 2

1 vial of Conjugate

1 colour guide

1 pack insert

Store at 2-8°C. DO NOT FREEZE

Shelf Life : 14 months from the manufacturing date written on the box

W

HEN TO TEST

:

Generally 1 or 2 tests are enough if the first day of the appearance of pro-estrus is known

(vaginal bleeding). The vaginal cytology can be used like a guide in order to identify the

approach of LH peak and then to determine the progesterone level.

For particular cases, like infertility problem or non-regular cycle, it is recommended to tests

starting from the 4th day during pro-estrus and to continue until insemination by testing

every 2 days.

S

AMPLING

:

·Collect the blood sample into an EDTA or Heparin coated tube or in a dry tube. Do not

use tube with serum separator gel. Do not use whole blood.

·Immediately after collection, invert the tube many times to mix it. Spin the blood down

with a centrifuge or let the blood clot by staying at room temperature (2 hour) and pour the

serum into a clean glass tube.

Do not use hemolysed or lipemic serum.

If the sample is not immediately used, store the sample at the fridge (2-8°C). For a long

RECOMMENDATION

STABILITY – STORAGE

PRESENTATION

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 8

storage, the serum or plasma should be frozen.

Label the sample.

P

RECAUTIONS OF USE

:

Always reseal the plastic bag after removing a test cup.

Do not exchange the test cups or the reagents from one box to another

Take the kit out from the refrigerator at least 2 hours before using a test, in order to allow

the reagents to come at room temperature. It is also possible to leave the kit a room

temperature along the day.

Timing the steps 1,3 and 7 is very important.

1 With a transfer pipette, add 8 drops of sample to the center of the cup.

Wait 2 minutes.

2 Add 4 drops of Wash solution 1.

Wait for the liquid to drain completely into the cup.

Repeat this step 1 time.

3 Add 3 drops of conjugate (red cap bottle) to the center of the cup.

Wait 1 minute.

4 Fill the cup to the top of inner line with the Wash solution 2, for about 20 drops.

Wait for the liquid to drain completely into cup.

5 Prepare a fresh substrate solution using the empty mixing bottle (blue label bottle): add

one volume of each substrate A and substrate B bottles by filling their droppers up to the

line. Homogenize by shaking the freshly prepared substrate.

6 Add 4 drops of the freshly prepared substrate bottle (blue label bottle) to the center of

the cup.

Discard any unused freshly prepared substrate solution after 30 minutes as it becomes

rapidly unstable.

7 Wait 9 minutes. Read and record the result, with the help of the colour guide.

PROCEDURE (fig. p. 23)

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 9

The colour result is corresponding to the level of progesterone. Use the enclosed colour

guide for evaluating and recording the result.

The following table is a guide of interpretation for the follow up of the fertile period in dog

female

Color

Progesterone

Interpretation*

Level

0 to 1 ng / ml

Baseline progesterone level.

Bright Blue

Test again every 2 days until getting a light blue colour result.

1 to 2,5 ng / ml

LH peak

Light Blue

Test again every 2 days in case of suspected cycle troubles.

2,5 to 8 ng / ml

The eggs begin to ripen after ovulation.

Faint Blue

Mate or inseminate in 1 and 3 days (and 5 days with frozen

semen).

> 8 ng / ml

Mate or Inseminate immediately.

White

Caution: may be the fertile period is ended.

* The recommended actions above are a guideline, as no test is 100% accurate in all times

and under all conditions. Therefore, the veterinarian should interpret all test result in light

of the patient’s clinical and/or ultrasonic examination, and historical information.

This kit is intendet to help the practitioner in the choice of treatment. This is the veterinarian’s

prerogative

responsibility. Bio

Veto

Test

held

responsible

consequences of misuse or misinterpretation of the results given by the test.

INTERPRETATION OF RESULTS

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 10

PARA USO IN VITRO

ESPANOL

BVT Ovulation Test es un procedimiento semi-cuantitativo rápido que se basa en la

técnica ELISA en membrana. Mediante la lectura visual se puede determinar el nivel de

progesterona en plasma o suero de perros, gatos, bovinos y equinos. El Ovulation Test está

indicado fundamentalmente para determinar la ovulación y consecuentemente el momen-

to indicado para la inseminación o apareamiento.

D

ETERMINACIÓN DEL PERÍODO FÉRTIL EN PERRAS

Los signos visibles del estro (hinchazón de la vulva, fin de la descarga vaginal) son sólo

indicadores aproximados del momento de la ovulación. Estos signos pueden variar en más

de una semana en relación con el momento de la ovulación.

La ovulación se produce por efecto de la hormona luteinizante (LH). El día en que la LH

aumenta es el día 0. La ovulación tiene lugar 2 días después de este pico de LH. Después

de producida la ovulación, los ovocitos necesitan de 2 a 3 días para madurar, y los óvulos

maduros viven de 48 a 72 horas. Por lo tanto, el período de mayor fertilidad en la perra

será en los días 5 y 6 después del aumento de la LH. El aumento en los niveles de proges-

terona corresponden con el pico de LH, por lo tanto su dosaje nos permitirá precisar el

momento de la ovulación con relativa exactitud.Tal cómo lo muestra el gráfico página 24,

los niveles de progesterona son bajos antes de la ovulación (entre 0 y 1 ng/ml,test de color

azul brillante). Cuando la progesterona comienza a aumentar, el color del test cambia del

azul brillante al azul claro, y esto corresponde al día del pico de LH (día 0). La proges-

terona sigue aumentando los días siguientes, y el color del test se vuelve azul pálido, luego

blanco.

La preñez solo será posible si los óvulos están maduros (2 días después de la ovulación) y

el esperma viable (5 días ± 2). En el 20 % de las perras la ovulación se produce fuera del

período comprendido entre los días 10 y 14 a partir del inicio del celo.

El primer día del celo no es preciso y la aceptación del macho no coincide necesariamente

con el período fértil. De acuerdo con C.Dumont (1) únicamente dos determinaciones aso-

ciadas : frotis vaginal y test de progesterona, sirven para programar la inseminación y

obtener un 95 % de éxito con un aumento de la prolificidad.

O

TROS USOS DEL

BVT

OVULATION TEST

Detección de ciclos sin ovulación:

la progesterona queda baja

Detección de cuerpos lúteos quísticos: la progeterona queda alta

RECOMENDACIONES DE USO

PRINCIPIO

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 11

Detección de la ovulación en perras que presentan celos silenciosos

Determinación de la fecha de parto:

La disminución del nivel sérico de progesterona a

niveles inferiores a 1 ng/ml, en una perra cuyo período de gestación está llegando al fin,

nos indica que el parto ocurrirá en 24 a 48 horas. De acuerdo a C.Dumont (1) y

A.Fontbonne (2), la determinación del nivel de progesterona, aumenta las posibilidades de

éxito en una cesárea. (mayor posibilidad de supervivencia).

ratamientos con progestágenos:

El BVT Ovulation Test sólo detecta la progesterona de

origen natural y permite entonces seguir la eficacia de un tratamiento con progestágenos.

Uso en gatas:

El BVT Ovulation Test puede ser utilizado en gatas para confirmar un

aumento en el nivel de progesterona, inducido por el contacto con un macho o por la

presencia de quistes de ovario.

Vacas, yeguas:

El BVT Ovulation Test puede ser utilizado para monitorear el ciclo de la

progesterona y controlar la eficacia de tratamientos que incluyan prostaglandinas o

progestágenos. También se puede utilizar para confirmar la preñez.

6 test / kit:

6 pocillos individuales

1 vial de SUSTRATO A

6 pipetas desechables

1 vial de SUSTRATO B

1 vial de SOLUCIÓN DE LAVADO 1

1 vial para la mezcla de sustratos

1 vial de SOLUCIÓN DE LAVADO 2

1 vial de conjugado

1 guía de colores

1 inserto

Conservar en el refrigerador (2-8°C). NO CONGELAR

El kit es estable durante 14 meses a partir de la fecha de fabricación. La fecha de caducidad

figura en la caja del kit.

Los pocillos que no se utilicen deben conservarse en la bolsa cerrada.

C

UANDO UTILIZARLO

?

Uno o dos tests son generalmente suficientes, si tenemos en cuenta que la fecha de

ovulación (día 2) se produce en general entre los días 11 y 13 a partir del inicio del proestro

(secreción vaginal).

La citología vaginal puede ser utilizada como una guía para poder saber la proximidad del

pico de LH y entonces comenzar a utilizar el test de progesterona.

Para casos particulares (problemas de fertilidad, etc.) es recomendable estimar el nivel de

progesterona a partir del 4º día de proestro, y continuar hasta la inseminación.

RECOMENDACIONES

ESTABILIDAD CONSERVACIÓN

PRESENTACIÓN

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 12

N

O UTILICE SANGRE ENTERA

El tiempo en los pasos 1, 3 y 7 es muy importante.

No mezcle componentes de distintos lotes.

Si desea realizar un control de calidad del kit puede realizar los pasos del 2 al 7. El resul-

tado debe ser azul brillante.

M

UESTRAS

Obtenga las muestras de sangre en tubos con EDTA o heparina, o en tubos secos.

Inmediatamente después de la obtención, invierta el tubo varias veces para mezclar.

Obtenga la muestra por centrifugación o dejando el tubo en reposo durante 1/2 - 1 hora y

coloque el suero en un tubo de vidrio limpio.

Si la muestra no es analizada inmediatamente, consérvela en el frigorífico.

Para la conservación durante un largo período se debe congelar.

Etiquete la muestra con el nombre, fecha y día del ciclo.

No utilice sangre entera.

Saque el kit del refrigerador por lo menos 2 horas antes de utilizarlo para que alcance la

temperatura ambiente. Es posible dejar el kit a temperatura ambiento durante la noche.

NO UTILICE SANGRE ENTERA

1

Con una pipeta de transferencia agregue 8 gotas de muestra en el centro del pocillo.

Espere 2 (dos) minutos. El tiempo en este paso es muy importante.

2

Agregue 4 gotas de solución de lavado al pocillo. Espere a que el líquido sea absorbido

completamente por el pocillo. Repita este paso 1 vez

3

Agregue 3 gotas de conjugato del vial rojo en el centro del pocillo. Espere 1 (un)

minuto. El tiempo en este paso es muy importante.

4

Llene

el

pocillo hasta

tope

línea

interior

con

solución

de

lavado

2,

aproximadamente 20 gotas. Espere a que el líquido sea absorbido completamente por

el pocillo.

5

Prepare la solución de sustrato en el vial vacío con la etiqueta azul, mezclando

1 gotero (hasta la marca) de cada uno de los viales de sustrato (A y B). Mezcle por

agitación. *

6

Agregue 4 gotas de sustrato fresco (vial con la etiqueta azul) en el centro del pocillo.*

7

Espere 9 minutos, lea el resultado y regístrelo con la guía de colores.

(azul brillante = C1; azul claro = C2; azul pálido = C3; blanco=C4).

* Atención: Después de 30 minutos de preparado el sustrato deberá ser desechado, y se

debe preservar el vial vacío para nuevos tests.

PROCEDIMENTO (fig. p. 23)

PRECAUCIÓN

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 13

El color resultante se corresponde con los niveles de progesterona. Utilice la carta de colo-

res como una guía para evaluar los resultados.

Color

Nivel de

Interpretación*

Progesterona

0 a 1 ng / ml

Nivel basal de progesterona.

Azul

Vuelva a ensayar a los 2 días.

brillante

1 a 2,5 ng / ml

Pico de LH.

Azul claro

Vuelva a ensayar a los 2 días.

2,5 a 8 ng / ml

Los óvulos están madurando.

Azul pálido

Insemine o cubra en 1 y 3 días.

Si va a utilizar semen congelado, insemine en 1, 3 y 5 días.

> 8 ng / ml

Insemine o cubra inmdiatamente.

Blanco

Atención, es posible que se encuentre al final del período fértil.

* Las acciones recomendadas anteriormente son sólo una guía, ya que ningún ensayo es

100% preciso todo el tiempo y en todas las condiciones. Por lo tanto, el veterinario debe-

rá interpretar el resultado tomando en cuenta la exploración clínica y el historial del

paciente.

El ensayo tiene como finalidad ayudar al veterinario en el determinación del nivel de pro-

gesterona. El diagnóstic definitivo es una prerrogativa y responsabilidad del profesional

actuante. Bio Veto Test no se puede responsabilizar de las consecuencias del mal uso o

error en la interpretación de los resultatos obtenidos con el ensayo.

INTERPRETACIÓN DE LOS RESULTADOS

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 14

RISERVATO ALL'UTILIZZO IN VITRO

ITALIANO

Ovulation test è un test ELISA semiquantitativo rapido su membrana a lettura visuale per la

determinazione dei livelli di progesterone nel plasma o nel siero di cane. L'Ovulation test

permette soprattutto di precisare il momento dell'ovulazione e quindi di programmare la

data del salto o dell'inseminazione della cagna.

D

ETERMINAZIONE DEL PERIODO DI FERTILITÀ

I segni visivi dei calori e del momento della riproduzione (rigonfiamento vulvare, termine

delle perdite vaginali) sono solo una indicazione approssimativa del momento dell'ovu-

lazione. Questi stessi segni possono variare di una o più settimane. Il segno più affidabile

di ovulazione è l'improvviso aumento dell'ormone luteinizzante (LH) che fa partire

l'ovulazione. Il giorno in cui aumenta LH è detto giorno 0. L'ovulazione avviene due giorni

dopo questo picco di LH. Dopo l'ovulazione, gli ovuli maturano in 2-3 giorni e gli ovuli

maturi vivono per 48-72 ore. Quindi il periodo più fertile per la cagna è 5-6 giorni dopo

l'aumento di LH. L'aumento del progesterone corrisponde al picco di LH, che è quello che

permette di identificare con precisione l'ovulazione. Come mostra il grafico pagina 24, i

tassi di progesterone sono bassi prima dell'ovulazione (tra 0 e 1 ng/ml; il test mostra un col-

ore blu intenso). Quando il progesterone comincia ad aumentare, il colore del test vira dal

blu intenso al blu chiaro, che corrisponde al picco di LH (giorno 0). Il progesterone

continua ad aumentare i giorni successivi ed il colore del test diventa blu pallido e poi

bianco. La gestazione è possibile sono in presenza di un ovulo fecondabile (2 giorni dopo

l'ovulazione) e di spermatozoi vivi (5 giorni + 2). Il 20% delle cagne ovula fuori dal peri-

odo compreso tra il 10° e il 14° giorno di calore. Il primo giorno del calore non è preciso

e l'accettazione del maschio non è automaticamente sovrapponibile al periodo di fecon-

dità. Secondo C. Dumon (1) solo due esami associati, striscio vaginale e dosaggio del

progesterone, permettono di programmare il salto o l'inseminazione e di ottenere il 95%

di successo oltre ad un aumento della prolificità.

INTERESSE

PRINCIPIO

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 15

A

LTRI INTERESSI DELL

OVULATION TEST

Determinazione del momento del parto

La caduta del progesterone ad un tasso inferiore a 1 ng/ml, associata ai segni (temperatura

corporea, presenza di latte bianco, seguimento ecografico), in una cagna quasi a termine

indica che il parto avverrà entro 24-48 ore.

Altri interessi :

- Esplorazione della fertilità : calori silenti, cicli non ovulatori.

- Prevenzione dei rischi di fallimento causati da un insufficienza luteale adattando il trat-

tramento medica.

Altri interessi : Bovini, Cavalli :

- Controllo del inizio della gestazione.

- Controllo dell’ efficacia dei trattamenti con progestinici.

Kit per 6 tests

6 cilindri test

1 flacone SUBSTRATO A

Rèf. OV6 -

1 flacone SOLUZIONE DI LAVAGGIO 1

1 flacone SUBSTRATO B

1 flacone SOLUZIONE DI LAVAGGIO 2

1 flacone di conjugato

1 flacone per mescolare i substrati

1 legenda dei colori di

6 pipette monouso

riferimento

Conservazione in frigorifero (2-8 °C). Stabile 14 mesi a partire dalla data di fabbricazione.

La data di scadenza è indicata sull'etichetta del kit.

Richiudere sempre la confezione dopo aver preso un test.

Q

UANDO TESTARE

- Normalmente sono sufficienti da uno a due tests per stabilire che l'ovulazione (giorno 2)

avverrà dall'11° al 13° giorno dopo l'inizio del pro-estro caratterizzato dalla comparsa

delle prime perdite. La citologia vaginale può essere usata come guida per identificare l'ap-

proccio al picco di LH così come per cominciare a valutare il progesterone.

PRECAUZIONI

STABILITÀ E CONSERVAZIONE

PRESENTAZIONE

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 16

- Per tutti i casi particolari (problemi di fertilità, inseminazioni importanti, ...) si consiglia

di valutare il tasso a partire dal 4° giorno di pro-estro e di continuare fino all'inseminazione

con un test ogni due giorni.

A

LTRE RACCOMANDAZIONI

- Conservare la confezione in frigorifero fino al momento dell'utilizzo. Non congelare.

- NON USARE SANGUE INTERO

- Richiudere ogni voltala confezione dopo aver preso un test.

- Sono importanti i tempi delle tappe 1, 3 e 7.

- Non cambiare mai i reattivi o i cilindri-tests di confezioni diverse.

Se volete fare un controllo della procedura, eseguite solo le tappe da 2 a 7 senza

aggiungere il campione. Il colore ottenuto deve essere blu intenso.

Prelevare il sangue e metterlo in una provetta con anticoagulante (eparina o EDTA) o in

una provetta secca (sangue intero). Immediatamente dopo il prelievo, omogeneizzare il

campione ruotando la provetta più volte. Centrifugare il campione di sangue o lasciare

coagulare il sangue intero nella provetta a secco a temperatura ambiente, separare il siero

o il plasma in una provetta apposta. Scrivere il nome dell'animale e la data del prelievo

sulla provetta. È possibile conservare il siero o il plasma più giorni in frigorifero. Per uno

stoccaggio più lungo, il campione deve essere congelato. Non usare sangue intero.

Prima di iniziare il test, portare a temperatura ambiente il campione e i reagenti (2 ore). Si

può anche lasciare il kit a temperatura ambiente per una giornata.

1

Con l'aiuto della pipetta, aggiungere 8 gocce di siero o plasma al centro della coppa-

test. ASPETTARE 2 MINUTI.

2

Aggiungere 4 gocce di soluzione di lavaggio 1 al centro della coppa-test; aspettare che

il liquido sia totalmente assorbito.

Ripetere un altro lavaggio.

3

Aggiungere al centro della coppa-test 3 gocce di conjugato del flacone con il tappo

rosso. ASPETTARE 1 MINUTO.

È importante rispettare i tempi indicati.

4

Riempire la coppa-test con la soluzione di lavaggio 2 fino al limite inferiore (più o meno

20 gocce). Aspettare che il liquido sia completamente assorbito.

5

Preparare il substrato fresco nel flacone vuoto con l’etichetta blu mescolando una

misura (riempire fino al livello nero) di ognuno dei substrati A e B (flacone con tappo

nero).

PROTOCOLLO OPERATIVO (fig. p. 23)

CAMPIONI

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 17

Agitare bene. Si sconsiglia di preparare il substrato prima perché si deteriora in

30 minuti.

6

Aggiungere infine 4 gocce di questa soluzione appena preparata al centro del test.

Dopo 30 minuti, buttare la soluzione preparata nel flacone di mescolamento con

l’etichetta blu.

Conservare il flacone per successivi tests.

7

ASPETTARE 9 MINUTI. Leggere e registrare il risultato con l'aiuto della legenda dei

colori (blu intenso = C1; blu chiaro = C2; blu pallido = C3; bianco = C4).

I colori del test corrispondono ai livelli di progesterone. Il diagramma dei colori incluso è

una guida per l'osservazione dei cambiamenti di colore.

Colori

Concentrazione

Raccomandazioni*

Progesterone

C1 Blu

0-1 ng/ml

Livello base di progesterone; eseguire un nuovo test fra 2

giorni.

1-2,5 ng/ml

Picco di LH.

Blu Chiaro

eseguire un nuovo test fra 2 giorni.

2,5-8 ng/ml

Inizio di maturazione degli ovuli; salto o

Blu Pallido

inseminazione

sperma

fresco

dopo

giorni;

con sperma congelato inseminare dopo 1, 3 e 5 gg.

C4 bianco

> 8 ng/ml

Salto o inseminazione immediata; attenzione

perché potreste anche essere alla fine del periodo fertile.

* Queste raccomandazioni constituiscono una guida. Nessuno metodo di diagnosi può

pretendere di essere precisa al 100%. Quindi, il veterinario dovrà tenere sempre conto del

cronostoria e dell’esame clinico dell’animale prima di prendere una decisione.

Questo test ha lo scopo di aiutare il veterinario nella determinazione dei livelli di proges-

terone. La diagnosi finale e al responsabilità resta però comunque sempre del veterinario

che esercita. Bio Veto Test non può essere tenuta responsabile delle conseguenze legate ad

una errato utilizzo o di una mal interpretazione deil risultati dati dal test stesso.

INTERPRETAZIONE DEI RISULTATI

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 18

SÓ PARA USO IN VITRO

PORTUGUES

O Ovulation Test é um teste do tipo ELISA rápido e semiqualitativo em membrana para a

determinação dos níveis de progesterona em soro ou plasma em cães e gatos. Permite

essencialmente predeterminar o momento da ovulação, e assim prever a data ideal para o

acasalamento ou a inseminação. Pode igualmente ser utilizado, para determinar os níveis

de progesterona na vaca e na égua (protocolos enviados a pedido).

D

ETERMINAÇÃO DO PERÍODO FÉRTIL

:

Os sinais visuais do cio e da receptividade para acasalamento tais como (edema vulvar, fim

do corrimento vaginal) são unicamente aproximativos como indicadores do momento da

ovulação. Estes sinais podem diferir entre eles mais de uma semana.

O sinal

mais

fiavel

iminencia

ovulação,

súbito

aumento

hormona

luteinizante(LH). O dia em que a LH atinge o pico é chamado dia 0. A ovulação ocorre 2

dias depois. Após a ovulação, os oocitos amadurecem em 2-3 dias, e os ovulos maduros

permanecem viáveis durante 48-72 horas. Assim, o período mais fértil para a cadela

situase entre os 5-6 dias após o pico da LH.

Como se pode verificar no gráfico P24, os niveis de progesterona são baixos antes da ovu-

lação (entre 0 e 1 ng/ml, teste com a coloração azul vivo). Logo que a progesterona

começa a aumentar, a coloração do teste muda do azul vivo para o azul claro, o que

corresponde no dia do pico LH (dia 0). Nos dias seguintes a progesterona continua a

aumentar e a coloração do teste torna-se azul pálido e depois branca.

A gravidez só é possivel na presença de ovulos maduros (2 dias após a ovulação) e de

esperma viável (5 dias +/- 2). 20% das cadelas ovulam fora do período compreendido entre

o 10º e o 14º dias do cio. O primeiro dia do cio não é constantea a receptividade ao macho

nem sempre coincide com o período fértil. Segundo C. DUMONT (1) só a associação de

dois exames, esfregaço vaginal e doseamento da progesterona,

permitem programar a

inseminação ou o acasalamento garantindo uma taxa de sucesso de 95%, com o respec-

OBJETIVOS

FUNDAMENTO

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 19

tivo aumento da prolificidade.

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 20

O

UTROS OBJECTIVOS PARA O

O

VULATION

T

EST

:

Detecção de quistos lúteos: o nível de progesterona permanece alto.

Detecção de ciclos anovulatórios: a progesterona permanece baixa.

Detecção de ovulação em cadelas com cios silenciosos.

Determinação do momento do parto ou da decisão cirurgica em caso de cesariana:

queda da progesterona para um valôr inferior a 1 ng/ml numa cadela a termo, é indicativo

de que o parto terá inicio nas 24 a 48 H seguintes. .

Segundo

DUMONT

FONTBONNE

determinação

níveis

progesterona aumenta a percentagem de viabilidade dos fetos nascidos de cesariana.

ratamentos de fertilidade:

O Ovulation Test detecta unicamente a progesterona natural.

Permite por isso seguir a eficácia de um tratamento por progestagéneos

Determinação do momento da I.V.G.: O nível de progesterona deve estar inferior a 2ng/ml.

Ovulation Test permite o acompanhamento de um tratamento, nomeadamente com

prostaglandinas.

Na gata: Ovulation Test pode ser utilizado para confirmar o contacto com um macho ou a

presença de quistos ováricos o nível de progesterona estará aumentado).

Kit / 6 testes:

6 cupulas de teste

1 frasco SUBSTRATO A

Ref: OV6

6 pipêtas individuais

1 frasco SUBSTRATO B

1 frasco SOLUÇÃO LAVAGEM 1

1 frasco de mistura de substratos A+B

1 frasco SOLUÇÃO LAVAGEM 2

1 frasco de Enzima conjugado

1 guia colorido

1 literatura de instruções

Armazenar entre (2-8°C). NÃO CONGELAR.

Validade: 14 meses após a data de fabrico

(marcada sobre o Kit). Mantenha sempre o saco herméticamente fechado após remover

cada cupúla de teste.

Q

UANDO TESTAR

:

Geralmente 1 ou 2 testes são suficientes desde que se conheça o primeiro dia do

pro-estro (corrimento vaginal). A citologia vaginal pode ser usada como um guia de forma

a identificar a proximidade do pico de LH e só então executar o Ovulation Test.

Casos

particulares

como

problemas

infertilidade

ciclos

irregulares,

recomenda-se testar desde o 4º dia do pro-estro e continuar até á inseminação testando

cada 2 dias.

RECOMENDAÇÕES

ESTABILIDADE – ARMAZENAMENTO

APRESENTAÇÃO

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 21

A

TENÇÃO

NÃO USAR SANGUE TOTAL.

É muito importante respeitar o tempo de execução das etapas 1, 3 e 7

Não permutar os componentes entre diferentes kits.

É possivel efectuar um Controlo de Qualidade executando unicamente as etapas 2 a 7

(sem adicionar a amostra). O resultado deverá sêr de cor Azul Vivo.

Recolha o sangue num tubo com EDTA/ Heparina ou num tubo seco e limpo.

Imediatamente após a recolha, inverta o tubo várias vezes para homogenização.

Centrifugue o sangue (EDTA/Heparina) ou deixe formar o coágulo á temperatura ambiente

(1 hora) seguidamente transfira o soro para um tubo de vidro limpo.

Se a amostra não for imediatamente testada, armazene-a no frigorifico (até 3 ou 4 dias).

Para períodos superiores de armazenamento, o soro ou o plasma deve ser congelado.

Identifique a amostra de forma visivel.

Antes de iniciar o teste, deixe a amostra e os diferentes componentes atingir a temperatura

ambiente (2h). È possivel guardar os componentes do kit á temperatura ambiente durante o dia.

NÃO USE SANGUE TOTAL

1 Com auxilio de uma pipêta, adicione 8 gotas da amostra no centro da cupula.

AGUARDE 2 (dois) MINUTOS.

Este intervalo de tempo é importante.

2

ADICIONE 4 (quatro) gotas da Solução de Lavagem 1.

Aguarde até que o liquido seja completamente absorvido pela almofada. Repita esta

etapa mais uma vez.

3

ADICIONE 3 (três) gotas do conjugato frasco de tampa vermelha no centro da cupúla

e AGUARDE 1 (um) MINUTO. Este intervalo de tempo é importante.

4

Encha a cupúla até ao limite inferior com a Solução de Lavagem 2 (20 gotas do frasco).

AGUARDE até que o liquido seja completamente absorvido.

5

Prepare uma solução de Substrato fresca no frasco misturador com o rótulo azul usan-

do para esse fim o doseador (cheio até á linha negra) com respectivamente o Substrato

A e o Substrato B. De seguida agite bem a mistura. Não preparar antecipadamente.

6

ADICIONE 4 (quatro) gotas da solução fresca de substrato A+B (rótulo azul)

centro da cupúla*.

7

AGUARDE 9 (nove) MINUTOS.

Leia e registe o resultado (comparativamente com a

escala colorimétrica fornecida no teste):

PROTOCOLO DE UTILIZAÇÃO (fig. p. 23)

RECOLHA DA AMOSTRA

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 22

Azul vivo = C1 Azul claro = C2 Azul pálido = C3 Branco = C4

* Atenção: Após 30 minutos, deitar fora a solução preparada e não utilizada no frasco de

tampa azul. Este frasco depois de seco e limpo servirá na preparação de outros testes.

A coloração resultante corresponde ao nível de progesterona. Utilize o guia incluso para

avaliar e registar os resultadosd

C

OLORAÇÃO

NÍVEL DE

INTERPRETAÇÃO

*

PROGESTERONA

0 a 1 ng / ml

Nível basal de progesterona.

Azul Vivo

Testar de novo cada 2 dias,até obter um resultado de cor

Azul Claro.

1 a 2,5 ng / ml

Pico de LH

Azul Claro

Acasalar ou inseminar no 3º e 5º dias seguintes (e tmbem

no 7º caso se utilize semen congelado).

Perante suspeita de ciclos irregulares, testar novamente

cada 2 dias.

2,5 a 8 ng / ml

Os ovulos começam a amadurecer após a ovulação.

Azul Pálido

Acasalar ou inseminar no 1º e 3º (e 5 dias com semen

congelado) dias que se seguem.

> 8 ng / ml

Acasalar ou inseminar imediatamente.

Branco

Atenção: talvez o período fértil já tenha terminado.

Estas recomendações constituem ùnicamente um guia, sabendo que nenhum método de dia-

gnóstico é 100% preciso. Deste modo, recomenda-se que o médico veterinário no momen-

to de tomar uma decisão, para além do resultado do teste de diagnóstico, tome sempre em

linha de conta a anamnése assim como o exame clinico do animal.

Este teste tem como objectivo auxiliar o ‘médico veterinário no determinação dos níveis de

progesterona. O diagnóstico final será sempre uma prerogativa e uma responsabilidade

exclusiva do médico veterinário. A Bio Vetot Test descarta toda e qualquer responsabilidade

pelas consequências inerentes a uma utilização indevida ou a uma deficiente interpretaçã

deverá ter sempre em linha de conta a história clinica da cadela.

(1) C. DUMONT : "Vaginal smears and progesterone levels : practical applications" 1

ères

journées

CNVSPA-SNGTV - Joué les Tours France 3-5 Juin 1994.

(2) A. FONTBONNE : "Use of progesterone level determination in bitch". Les indispensables de l'ani-

mal de compagnie - Reproduction du chat et du chien 1992, Editions PMCAC Paris 17, 53-58

(3) TAINTURIER (D.), CHOQUART (V.), FIENI (F.), BRUYAS (J.F.) et BATTUT (I. ) : Le suivi de la gesta-

tion chez la chienne. Rec. Med. Vet. 1998, 174, 3/4, 77-83.

BIBLIOGRAPHIES

INTERPRETAÇÃO DOS RESULTADOS

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 23

ovulation TEST vrac Haut 150 25/10/07 17:12 Page 24

8

Serum / Plasma

4

+

4

Solution 1

3

Enzyme

20

Solution 2

Substrat A

+ Substrat B

4

Substrat A + B

Attendre

Aspettare

Wait

Aguarde

Espere

9 mn

1 mn

2 mn

PROTOCOLE OPERATOIRE

7

Initial rise in

Progesterone

LH Peak

Ovulation

Days to

Breed

Days before/after the day of the LH Peak

Light blue

Bright blue

White

Faint blue

Progestérone

ng/ml

Pro-Estrus

Estrus

-8 -6 -4 -2 0 2 4 6 8

9 + days

9 days

1

2

3

4

5

6

ovulation TEST vrac Haut 150 25/10/07 17:13 Page 25

réf. : X PROTO M OV6 V5

BIO VETO TEST

285, AVENUE DE ROME

83500 LA SEYNE SUR MER - FRANCE

TEL. +33 (0)4 94 10 58 94 - FAX +33 (0)4 94 10 58 90

W E B

w w w. b v t . f r -

M A I L

b v t @ b v t . f r

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FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.

FDA - U.S. Food and Drug Administration

20-12-2018

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

FDA - U.S. Food and Drug Administration

20-12-2018

Health Canada releases test results of certain sartan drugs

Health Canada releases test results of certain sartan drugs

Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.

Health Canada

16-12-2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the ...

FDA - U.S. Food and Drug Administration

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Bonify recalls 2 lots of dried cannabis products

Bonify recalls 2 lots of dried cannabis products

The recalled product may not meet some of the microbial and chemical contaminant limits as specified by the Good Production Practices requirements of the Cannabis Regulations.Documentation confirming test results could not be matched to the lot specific numbers.

Health Canada

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA - U.S. Food and Drug Administration

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

Health Canada’s sampling and evaluation program has determined that the toys do not meet the Canadian safety requirements for toys. Additionally, the fish toy released small parts during testing, which could pose as a choking hazard for young children.

Health Canada

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA - U.S. Food and Drug Administration

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Roche Diagnostics to Replace CoaguChek® XS PT Test Strips

Roche Diagnostics to Replace CoaguChek® XS PT Test Strips

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.

FDA - U.S. Food and Drug Administration

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later

Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later

Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

16-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials

FDA - U.S. Food and Drug Administration

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA - U.S. Food and Drug Administration

9-11-2018

Medical Devices Safety Update, Volume 6, Number 6, November 2018

Medical Devices Safety Update, Volume 6, Number 6, November 2018

Standards minimise risk of misconnections; eltrombopag interference with test results; amniotic fluid tests

Therapeutic Goods Administration - Australia

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA - U.S. Food and Drug Administration

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Urgent: Curry Spice Recall

Urgent: Curry Spice Recall

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

FDA - U.S. Food and Drug Administration

24-10-2018

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA - U.S. Food and Drug Administration

23-10-2018

Shimano North America recalls Lazer Bicycle Helmets

Shimano North America recalls Lazer Bicycle Helmets

The recalled helmets do not meet the CPSC standard for the "Dynamic Roll Off" test. The helmet may come off on impact posing a head injury to the user.

Health Canada

18-10-2018

CTG recalls Friction Powered School Bus

CTG recalls Friction Powered School Bus

Health Canada's sampling and evaluation program has determined that the school bus toy does not meet Canadian safety requirements for toys. Specifically, the school bus released small parts during testing, which are a choking hazard for young children.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

FDA - U.S. Food and Drug Administration

22-8-2018

King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

King Bio is voluntarily recalling the below products to the consumer level. A small percentage of our products produced between 08/01/2017 and 04/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below

FDA - U.S. Food and Drug Administration

15-1-2019

Ongoing stability testing for listed and complementary medicines

Ongoing stability testing for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

5-12-2018

Updates to the Database of TGA laboratory testing results

Updates to the Database of TGA laboratory testing results

New release of results published

Therapeutic Goods Administration - Australia

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

26-11-2018

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

FDA - U.S. Food and Drug Administration

26-11-2018

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understa

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understa

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

FDA - U.S. Food and Drug Administration

6-11-2018

November is #DiabetesAwarenessMonth  #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4 

FDA - U.S. Food and Drug Administration

2-11-2018

.@US_FDA  issues a class I recall: Roche Diagnostics recalls CoaguChek  XS PT Test  Strips due to inaccurate INR test results. Find out more:  https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency