Fludeoxyglucose "OUH"
Primær information
- Handelsnavn:
- Fludeoxyglucose "OUH" 400 MBq-316 GBq/htgl injektionsvæske, opløsning
- Aktiv bestanddel:
- Fludeoxyglucose (18-F)
- Tilgængelig fra:
- Odense Universitetshospital
- ATC-kode:
- V09IX04
- INN (International Name):
- Fludeoxyglucose (18-F)
- Dosering:
- 400 MBq-316 GBq/htgl
- Lægemiddelform:
- injektionsvæske, opløsning
- Brugt til:
- Mennesker
- Medicin typen:
- Allopatiske stof
Dokumenter
- for den brede offentlighed:
- Indlægsseddel
-
- for sundhedspersonale:
- Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.
Anmode informationsbrochure for sundhedspersonale.
Lokation
- Fås i:
-
Danmark
- Sprog:
- dansk
Andre oplysninger
Status
- Kilde:
- Lægemiddelstyrelsen - Danish Medicines Agency
- Autorisation status:
- Markedsført
- Autorisationsnummer:
- 02235
- Sidste ændring:
- 22-02-2018
Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
Indlægsseddel: Information til brugeren
Fludeoxyglucose ”OUH”, 400 MBq – 316 GBq, Injektionsvæske
F]-Fludeoxyglucose, Ph. Eur.
Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder
vigtige oplysninger.
Gem indlægssedlen. Du kan få brug for at læse den igen.
Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som
ikke er nævnt her.
Oversigt over indlægssedlen
Virkning og anvendelse
Det skal du vide, før du begynder at bruge Fludeoxyglucose ”OUH”.
Sådan skal du bruge Fludeoxyglucose ”OUH”
Bivirkninger
Opbevaring
Pakningsstørrelser og yderligere oplysninger
1.
Virkning og anvendelse
Fludeoxyglucose
”OUH”
bruges
PET-undersøgelser,
hvor
metabolismen
organer
væv
ønske
undersøgt. Det kan f. eks være i forbindelse med diagnosticering, stadieinddeling og behandlingskontrol ved
kræftsygdom.
Fludeoxyglucose ”OUH” indgives ved intravenøs injektion i henhold til normale injektionsprocedurer for
radioaktive lægemidler. Dit aktivitetsniveau, i perioden lige efter injektion, har beydning for hvordan stoffet
fordels i kroppen. Normalt anbefales det at du skal hvile i 45 – 60 minutter inden skanningen foretages.
Sundhedspersonalet instruerer dig nærmere herom.
2.
Det skal du vide før du begynder at bruge Fludeoxyglucose ”OUH”.
Brug ikke Fludeoxyglucose ”OUH”:
hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer angivet i punkt 6.
Særlige advarsler og forsigtighedsregler vedrørende brugen
Fludeoxyglucose ”OUH” må kun udleveres til og anvendes af godkendte brugere af radioaktive lægemidler.
Præparatet må først tages i brug når der ligger en skriftlig frigivelse fra producenten.
Som for øvrige
radioaktive
lægemidler bør udbyttet
undersøgelsen vægtes
risikoen
forventede strålingsdosis. Hos patienter med nedsat nyrefunktion og hos børn må der forventes en højere
effektiv dosis per administreret aktivitetsmængde end hos normale voksne. Se senere afsnit om dosimetri.
Fludeoxyglucose ”OUH” må kun gives som intravenøs injektion. Præparatet er stærkt radioaktivt og skal
håndteres under hensyntagen til normale principper for strålebeskyttelse. Da gammastrålingen fra præparatet
er meget gennemtrængende, skal der benyttes blybeholdere med mindst 30 mm vægtykkelse.
Under dosis optræk og indgift bør der tages forholdsregler, der kan nedbringe den lokale strålingsdosis til
eksempelvis hænder.
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
Efter
injektionen
udgør
patienten
eventuel
urin
(f.eks
opsamlet
urinpose)
ikke
ubetydelig
strålingskilde og det undersøgende personale bør være instrueret i hvorledes tid, afstand og afskærmning kan
nedbringe den resulterende dosis. Også strålingsdosis til pårørende og medpatienter bør tages i betragtning.
Ved injektionen skal det sikres, at denne finder sted i venen og ikke subkutant eller paravenøst, da dette vil
medføre uhensigtsmæssig stor lokal stråledosis og kompromittere billeddannelsen ved injektionsstedet.
Patientforberedelsen er meget vigtig for udbyttet og kvaliteten af undersøgelsen. Faktorer der påvirker
blodsukkeret har stor betydning. Patienten skal faste 6 timer op til injektion. FDG bør normalt kun gives til
fastende personer, da FDG konkurrerer med glukose om optagelse i cellerne. Patienten må dog gerne drikke
kaffe/te uden sukker/sødetabletter/mælk. Specielle forholdsregler bør tages før administration til patienter
med diabetes mellitus, hvor det er vigtigt at sikre, at patienter hverken udvikler hypo- eller hyperglycæmi.
Interaktion med andre lægemidler og andre former for interaktion
Mange lægemidler, herunder lægemidler der påvirker blodsukkeret, kan påvirke fordelingen og dermed
undersøgelsesresultatet. PET undersøgelsen og skanningsresultatet må bedømmes under hensyntagen hertil.
Brug af anden medicin sammen med Fludeoxyglucose ”OUH”
Fortæl altid sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig. Dette gælder også
medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
Graviditet og amning
Hvis det er nødvendigt at give radioaktive lægemidler til en kvinde i den fødedygtige alder, skal det altid
oplyses, om patienten er gravid. Ved en udebleven menstruation må kvinden betragtes som værende gravid,
og undersøgelsen må kun gennemføres, hvis en akut foretaget graviditetstest er negativ. Generelt bør PET-
undersøgelser så vidt muligt gennemføres i første halvdel af menstruationscyklus. Stråledosis bør holdes så
lavt
muligt
under
hensyntagen
opnåelse
søgte
kliniske
information.
Andre
undersøgelsesmetoder, der ikke medfører strålebelastning, bør overvejes såsom ultralyd eller MR.
Undersøgelser på gravide foretaget med radioaktive stoffer medfører en strålingsdosis til fosteret. Kun
afgørende vigtige undersøgelser bør udføres under svangerskabet, og kun når hensynet til det forventede
udbytte overstiger risikoen, som undersøgelsen påfører moder og foster. I så tilfælde bør evt. gennemførelse
af undersøgelsen konfereres forinden mellem ansvarlig nuklearmedicinsk læge, ansvarlig fysiker, ansvarlig
henvisende kliniker og Statens Institut for Strålebeskyttelse.
Der er ingen ammepause, men det anbefales (ICRP), at kvinder der ammer, begrænser kontakten til barnet til
så lidt som muligt de første 12 timer efter injektion, for at undgå at udsætte barnet for ekstern stråling fra
moderen. Det anbefales ligeledes at amme umiddelbart inden injektionen, for at gøre tiden fra injektion til
næste amning så lang som muligt.
Trafik- og arbejdssikkerhed
Fludeoxyglucose ”OUH” påvirker ikke evnen til at føre motorkøretøjer.
3.
Sådan skal du bruge Fludeoxyglucose ”OUH”
Brug altid Fludeoxyglucose ”OUH” nøjagtigt efter sundhedspersonalets anvisning. Er du i tvivl, så spørg
sundhedspersonalet.
Dosering Voksne:
Dosering til voksne: 100-600 MBq afhængig af skanner og undersøgelsestype.
Dosering til børn
Dosering
børn:
MBq/kg
legemsvægt
hjerneskanning
MBq/kg
legemsvægt
helkropsskanning.
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
Aktiviteten af den aktuelle patientdosis skal kontrolleres i dosiskalibrator inden administration.
Produktet indgives ved intravenøs injektion i henhold til normale injektionsprocedurer for radioaktive
lægemidler.
Hvis du har fået en for stor dosis Fludeoxyglucose ”OUH”
En væsentlig (flerfold) overskridelse af den anbefalede dosisindgift vil både medføre en øget strålingsdosis
til patient og personale, og kompromittere billeddannelsen grundet dødtids- og linearitetsproblemer. Hvis
overdosering har fundet sted, kan dosis til blærevæggen nedsættes gennem øget væskeindtagelse og hyppig
vandladning.
Spørg sundhedspersonalet, hvis der er noget, du er i tvivl om.
4.
Bivirkninger
Dette lægemiddel kan som al anden medicin give bivirkninger, men på nuværende tidspunkt findes der ingen
kendte bivirkninger.
Hvis der opstår bivirkninger skal du kontakte din læge. Bivirkninger skal indberettes til indehaveren af
markedsføringstilladelsen (se sidst i denne indlægsseddel) og/eller til Sundhedsstyrelsen.
Du eller dine pårørende kan selv indberette bivirkninger direkte til sundhedsstyrelsen. Du finder skema og
vejledning på Sundhedsstyrelsens netsted: www.meldenbivirkning.dk. Du kan også indberette via mail,
almindeligt brev eller telefonisk ved at rekvirere et indberetningsskema.
5.
Opbevaring
Opbevaring
Præparatet skal indgives inden 10 timer efter fremstillingen (EOS). Udløbstidspunktet er angivet på etiket.
Præparatet må ikke opbevares over 25
C. Præparatet er stærkt radioaktivt og skal opbevaret i det oprindelige
hætteglas i en egnet blybeholder med mindst 30 mm vægtykkelse.
Emballage
Produktet
udleveres
hætteglas
lukket
septum
kapsel.
Hætteglasset
indeholder
angivne
aktivitetsmængde på referencetidspunktet i et volumen på op til 30 ml.
Hætteglasset leveres i særlig blybeholder (35 mm vægtykkelse) placeret i formstøbte skumindlæg i en
transportspand af plastic (Type A forsendelse). Blybeholder, skumindlæg og transportspand skal returneres
til producenten og genanvendes.
Bortskaffelse
Præparatet og hætteglasset bør af hensyn til den intense stråling så vidt muligt håndteres i den oprindelige
blybeholder og bag egnet ekstern blyafskærmning. Bemærk, at alle nødvendige oplysninger om aktivitet,
kalibreringstidspunkt og volumen findes på den ydre etikette. Den enkelte dosis udtages gennem septum,
som desinficeres inden hvert anbrud. Hver patientdosis skal måles i dosiskalibrator inden indgift.
Produktet kan fortyndes med isoton natriumklorid opløsning til injektion (0,9%), der også kan benyttes til
efterskyl af injektionsvejen.
Præparatets aktive indholdsstof forsvinder fuldstændigt ved fysisk henfald inden for en periode af ca. 1 døgn.
Indenfor denne periode skal stoffet behandles i overensstemmelse med reglerne for transport af radioaktive
stoffer og håndtering af åbne radioaktive kilder. Efter det radioaktive henfald udgør det aktive indholdsstof
ingen miljøbelastende risiko og det henfaldne præparat kan bortskaffes i lighed med andre medicinrester.
Blybeholdere returneres og genanvendes.
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
6.
Pakningsstørrelser og yderligere oplysninger
Fludeoxyglucose ”OUH”, 400 MBq – 316 GBq, Injektionsvæske indeholder:
Aktivt stof : [
F]-Fludeoxyglucose
Øvrige indholdsstoffer:
Phosphatbuffer
Vand
Ethanol (0.4%)
Indehaver af markedsføringstilladelsen og fremstiller
Odense Universitetshospital
PET & Cyklotronenheden, Nuklearmedicinsk Afdeling
Sdr. Boulevard 29
Tlf. 6541 2980
Fax. 65906192
Email: ouh@rsyd.dk
Kontakt vedr. Markedsføringstilladelsen og produktion
QP: Signe Inglev
Email: Signe.Inglev@rsyd.dk
Indberetning af bivirkninger:
QPPV Henrik Petersen
Email: Henrik.petersen@rsyd.dk
Denne indlægsseddel blev senest ændret 11/2015
-----------------------------------------------------------------------------------------------------------------------------------
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
Følgende organfordeling er beskrevet af Mejia et al i J Nucl Med 1991, 32, 699 – 706:
Organ
% af indgiven dosis
Hjerne
6,9%
Hjerte
3,3%
Nyrer
1,3%
Lever
4,4%
Lunger
0,9%
Ovarier
0,01%
Pancreas
0,3%
Knoglemarv
1,7%
Milt
0,4%
Testes
0,04%
Blæreindhold
6,3%
Resten af kroppen
74,4%
I alt
99,95%
Prækliniske sikkerhedsdata
Ingen bivirkninger ud over stråledosis (se nedenfor).
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
Dosimetri
Nedenstående tabel
ICRP publikation 80
viser den beregnede absorberde
dosis per administreret
aktivitetsmængde (mSv/MBq) for Fludeoxyglukose (18 F):
T½=
109,77
Absorbed
dose
unit
activity
administered
(mGy/MBq)
Organ
Adult
15 years
10 yesrs
5 years
1 year
Adrenal glands
0.012
0.015
0.024
0.038
0.072
Bladder wall
0.16
0.21
0.28
0.32
0.59
Bone surfaces
0.011
0.014
0.022
0.035
0.066
Brain
0.028
0.028
0.030
0.034
0.048
Breasts
0.0086
0.011
0.018
0.029
0.056
Bile duct
0.012
0.015
0.023
0.035
0.066
Inte4stinal wall
0.011
0.014
0.022
0.036
0.068
Small intestine
0.013
0.017
0.027
0.041
0.077
Colon
0.013
0.017
0.027
0.040
0.074
ULI wall
0.012
0.016
0.025
0.039
0.072
LLI wall
0.015
0.019
0.029
0.042
0.076
Heart
0.062
0.081
0.12
0.20
0.35
Kidney
0.021
0.025
0.036
0.054
0.096
Lier
0.011
0.014
0.022
0.037
0.070
Lungs
0.010
0.014
0.021
0.034
0.065
Muscles
0.011
0.014
0.021
0.034
0.065
Oesophagus
0.011
0.015
0.022
0.035
0.068
Ovaries
0.015
0.020
0.030
0.044
0.082
Pancreas
0.012
0.016
0.025
0.040
0.076
Bone marrow
0.011
0.014
0.022
0.032
0.061
Skin
0.0080
0.010
0.016
0.027
0.052
Spleen
.0.011
0.014
0.022
0.036
0.069
Testes
0.012
0.016
0.026
0.038
0.073
Thymus
0.011
0.015
0.022
0.035
0.068
Thyroid
0.010
0.013
0.021
0.035
0.068
Uterus
0.021
0.026
0.039
0.055
0.10
Other organs
0.011
0.014
0.022
0.034
0.063
Effective dose
(mSV/MBq)
0.019
0.025
0.036
0.050
0.095
Annals of the ICRP, ICRP Publication 80
Radiation Dose to Patients from Radiopharmaceuticals, Addendum 2 to ICRP Publication 53, Also includes
Addendum 1 to ICRP Publication 72, Editor J. Valentin. Den effektive dosis fra indgift af 400 MBq til en
typisk normal voksen er cirka 7,6 mSv. Ved denne aktivitetsmængde er absorberet dosis til de kritiske
organer blære, hjerte og hjerne henholdsvis 64 mGy, 25 mGy og 11 mGy.
Farmakologiske Oplysninger
Terapeutisk klassifikation
Præparatet er et diagnostisk radiofarmakon. ATC-kode V09IX04.
Odense Universitetshospital, PET & Cyklotronenheden. Revisionsdato 11/2015
Farmakodynamiske egenskaber
fremstilles
dispenseres
under
stort
carrierfri
betingelser,
maksimale
mængde
administreret FDG (aktiv og inaktiv) er meget lille (under 10 mg) sammenlignet med den samlede mængde
glukose der metaboliseres på et givet tidspunkt. Præparatet har derfor ingen primære eller sekundære
farmakodynamiske egenskaber. Gentagen administration bør kun ske efter overvejelse af den samlede
strålingsdosis
Farmakokinetiske egenskaber
Fludeoxyglukose (18F) er en glukose analog, som ophobes i alle celler der udnytter glukose som energikilde.
Stoffet ophobes i tumorer med højt glukose forbrug. Aktivitetskoncentrationen i det vaskulære system efter
intravenøs
injektion
følger
biexponentiel
kurve
fordelingstid
cirka
minut
eliminationstid på 12 minutter. Vævenes optag af Fludeoxyglukose (18 F) beror på en række vævsspecifikke
transportsystemer, hvoraf nogle er insulin-afhængige. Vævsoptagelsen kan derfor påvirkes af fødeindtag,
ernæringstilstand
eventuel
sukkersyge.
patienter
diabetes
mellitus
nedsat
optag
Fludeoxyglukose (18 F), der skyldes ændret vævsfordeling og ændret glukosestofskifte. Fludeoxyglukose
(18 F) transporteres over cellemembranen som glukose, men gennemgår kun det første trin i glykolysen, som
resulterer i dannelsen af Fludeoxyglukose (18 F)-6-fosfat, som forbliver fanget intracellulært i flere timer,
fordi defosforyleringen forårsaget af intracellulære fosfataser er langsom. Hos normale raske personer
fordeles Fludeoxyglukose (18 F) i hele kroppen, og optages særligt i hjernen og hjertet, og i mindre grad
også i lunger og lever. Udskillelsen sker primært gennem nyrene, idet ca 20% af aktiviteten kan forventes i
urinen indenfor 2 timer fra injektionen. Bindingen til selve nyreparenkymet er svag, men de samlede urinveje
indeholder megen aktivitet p.g.a. urinudskillelsen. Fludeoxyglukose (18 F) passerer blod-hjerne barrieren.
Cirka 7 % af den injicerede aktivitet akkumuleres i hjernen indenfor en periode af 80-100 minutter fra
indgift. Epileptiske foci udviser nedsat optag i perioderne uden kramper. Cirka 3% af aktiviteten optages af
myokardiet indenfor de første 40 minutter. Fordelingen i det normale hjerte er nogenlunde homogen, idet der
dog er beskrevet op til 15% regional forskel for septum. Under og efter reversibel myokardieiskæmi ses en
øget optagelse af Fludeoxyglukose (18 F) i de berørte områder. Ca. 0.3 % af aktiviteten går til pancreas, og
0.9 - 2.4 % akkumuleres i lungerne. Fludeoxyglukose (18 F) bindes også til øjets muskler, til pharynx og til
tarmen. Binding til muskelvæv kan ses efter nylig fysisk anstrengelse umiddelbart inden undersøgelsen eller
følge
muskelaktivitet
fordelings-
undersøgelsesforløbet.
Depoter
brunt
fedt
optager
Fludeoxyglukose (18 F).
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31-1-2019

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States
January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States
FDA - U.S. Food and Drug Administration
25-1-2019

Mrs. Grissom’s Salads Issues a Voluntary Recall
For immediate release- January 18,2019 – Nashville, TN – Mrs. Grissom’s Salads is voluntarily recalling a single days production of Mrs. Grissom’s SELECT Old Fashioned Pimento Cheese because of a labeling issue. Product produced on December 13, 2018 may have been packaged incorrectly, with the correct Pimento Cheese label on top lid, but a Chicken salad label on the container. The Pimento Cheese may contain allergens not listed on the products ingredient label, Specifically Milk.
FDA - U.S. Food and Drug Administration
19-1-2019

Data sources on animal diseases: Country Card of Poland
Published on: Fri, 18 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops
Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-1-2019

Data sources on animal diseases: Country Card of Belgium
Published on: Fri, 18 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...
Europe - EFSA - European Food Safety Authority EFSA Journal
15-1-2019

Specialized Bicycle Components Canada, Inc. recalls select Specialized-Branded Bicycles with Steerer Tube Collars
The steerer tube collar on the affected products may crack if exposed to corrosion which may cause the rider to loose control, posing fall and injury hazards. As of December 18, 2018, the company has not received any reports of incidents in Canada, and no report of injuries.
Health Canada
14-1-2019

Meer orgaan- en weefseltransplantaties in 2018
In 2018 zijn in Nederland 815 orgaantransplantaties geweest en ruim 4000 patiënten geholpen met gedoneerd weefsel. Dit is een stijging van respectievelijk 15 en 18% in vergelijking met het jaar ervoor. Deze positieve jaarcijfers zijn gepubliceerd door de Nederlandse Transplantatie Stichting (NTS).
Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport
4-1-2019

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds
Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.
FDA - U.S. Food and Drug Administration
19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower
Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...
FDA - U.S. Food and Drug Administration
19-12-2018

Pest categorisation of Phyllosticta solitaria
Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking
Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-12-2018

Pest categorisation of Grapholita prunivora
Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...
Europe - EFSA - European Food Safety Authority EFSA Journal
18-2-2019

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)
EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1362 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003732
Europe -DG Health and Food Safety
18-2-2019

Jardiance (Boehringer Ingelheim International GmbH)
Jardiance (Active substance: Empagliflozin) - Centralised - Renewal - Commission Decision (2019)1427 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2677/R/40
Europe -DG Health and Food Safety
18-2-2019

Fotivda (EUSA Pharma (Netherlands) B.V.)
Fotivda (Active substance: tivozanib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1435 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4131/T/05
Europe -DG Health and Food Safety
18-2-2019

Aripiprazole Mylan Pharma (Mylan S.A.S.)
Aripiprazole Mylan Pharma (Active substance: aripiprazole) - Centralised - Yearly update - Commission Decision (2019)1438 of Mon, 18 Feb 2019
Europe -DG Health and Food Safety
18-2-2019

Modigraf (Astellas Pharma Europe B.V.)
Modigraf (Active substance: Tacrolimus) - PSUSA - Modification - Commission Decision (2019)1426 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/954/PSUSA/2839/201803
Europe -DG Health and Food Safety
18-2-2019

Zirabev (Pfizer Europe MA EEIG)
Zirabev (Active substance: bevacizumab) - Centralised - Authorisation - Commission Decision (2019)1424 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4697
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)
EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)
EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1363 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003788
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/2011 (Kyowa Kirin Holdings B.V.)
EU/3/18/2011 (Active substance: Burosumab) - Transfer of orphan designation - Commission Decision (2019)1344 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003746
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/2099 (Celgene Europe B.V.)
EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Transfer of orphan designation - Commission Decision (2019)1351 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003330
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/2018 (Celgene Europe B.V.)
EU/3/18/2018 (Active substance: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor) - Transfer of orphan designation - Commission Decision (2019)1350 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003327
Europe -DG Health and Food Safety
14-2-2019

EU/3/18/2012 (IDEA Innovative Drug European Associates (Ireland) Limited)
EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Transfer of orphan designation - Commission Decision (2019)1356 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003115
Europe -DG Health and Food Safety
11-2-2019

Manufacture of sterile radiopharmaceuticals labelled with fluorine-18
Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13
Therapeutic Goods Administration - Australia
5-2-2019

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised
Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised
Europe - EMA - European Medicines Agency
1-2-2019

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised
Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised
Europe - EMA - European Medicines Agency
17-1-2019

EU/3/18/2129 (Amicus Therapeutics UK Ltd)
EU/3/18/2129 (Active substance: Miglustat) - Orphan designation - Commission Decision (2019)225 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002050
Europe -DG Health and Food Safety
17-1-2019

Hemangiol (Pierre Fabre Dermatologie)
Hemangiol (Active substance: propranolol) - Centralised - Renewal - Commission Decision (2019)273 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2621/R/18
Europe -DG Health and Food Safety
16-1-2019

EU/3/18/2132 (Silence Therapeutics GmbH)
EU/3/18/2132 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2019)226 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001845
Europe -DG Health and Food Safety
16-1-2019

EU/3/18/2125 (Isabelle Ramirez)
EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)
EU/3/18/2133 (Active substance: Vinorelbine tartrate) - Orphan designation - Commission Decision (2019)227 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001988
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2131 (UCB Biopharma SPRL)
EU/3/18/2131 (Active substance: Rozanolixizumab) - Orphan designation - Commission Decision (2019)240 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002029
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)
EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2128 (Thiogenesis Therapeutics S.A.R.L)
EU/3/18/2128 (Active substance: Mercaptamine-pantetheine disulfide) - Orphan designation - Commission Decision (2019)224 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002209
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2127 (Therapicon Srl)
EU/3/18/2127 (Active substance: Melatonin) - Orphan designation - Commission Decision (2019)223 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001921
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)
EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592
Europe -DG Health and Food Safety
15-1-2019

EU/3/18/2124 (IntraBio Ltd)
EU/3/18/2124 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2019)220 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001741
Europe -DG Health and Food Safety
15-1-2019

Vizamyl (GE Healthcare AS)
Vizamyl (Active substance: flutemetamol (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)201 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2557/T/18
Europe -DG Health and Food Safety
7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019
Therapeutic Goods Administration - Australia
7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019
Therapeutic Goods Administration - Australia
7-1-2019

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
We seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019
Therapeutic Goods Administration - Australia
4-1-2019

GMP clearance guidance update - Version 18.1
Updated version of GMP clearance guidance (Version 18.1)
Therapeutic Goods Administration - Australia
4-1-2019

GMP clearance guidance
Updated version of GMP clearance guidance (Version 18.1)
Therapeutic Goods Administration - Australia
19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/
On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383 #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe
FDA - U.S. Food and Drug Administration
19-12-2018

EU/3/18/2122 (Genzyme Europe B.V.)
EU/3/18/2122 (Active substance: Venglustat) - Orphan designation - Commission Decision (2018)9037 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/148/18
Europe -DG Health and Food Safety
19-12-2018

EU/3/18/2120 (Takeda Pharma A/S)
EU/3/18/2120 (Active substance: Pevonedistat) - Orphan designation - Commission Decision (2018)9035 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/18
Europe -DG Health and Food Safety
19-12-2018

EU/3/18/1987 (Richardson Associates Regulatory Affairs Ltd)
EU/3/18/1987 (Active substance: Vocimagene amiretrorepvec) - Transfer of orphan designation - Commission Decision (2018)9006 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002643
Europe -DG Health and Food Safety
19-12-2018

EU/3/18/1978 (Richardson Associates Regulatory Affairs Ltd)
EU/3/18/1978 (Active substance: Flucytosine) - Transfer of orphan designation - Commission Decision (2018)9005 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002608
Europe -DG Health and Food Safety
19-12-2018

Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018
The TGA has published its Self-Assessment Report for 2017-18
Therapeutic Goods Administration - Australia
18-12-2018

EU/3/18/2123 (IQVIA RDS Ireland Limited)
EU/3/18/2123 (Active substance: 6,8-bis(benzylthio)octanoic acid) - Orphan designation - Commission Decision (2018)9038 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/18
Europe -DG Health and Food Safety
18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)
EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18
Europe -DG Health and Food Safety
18-12-2018

EU/3/18/2119 (Celgene Europe B.V.)
EU/3/18/2119 (Active substance: Marizomib) - Orphan designation - Commission Decision (2018)9034 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/161/18
Europe -DG Health and Food Safety
18-12-2018

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)
EU/3/18/2118 (Active substance: Lonafarnib) - Orphan designation - Commission Decision (2018)9033 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/159/18
Europe -DG Health and Food Safety
18-12-2018

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)
EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18
Europe -DG Health and Food Safety