Prac-tic

Glavna informacija

  • Trgovački naziv:
  • Prac-tic
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Prac-tic
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • psi
  • Područje terapije:
  • Ektoparazitici za topikalnu primjenu
  • Terapijske indikacije:
  • Liječenje i prevencija zaraze buha (Ctenocephalides canis i C. felis) kod pasa. Učinkovitost prema novim infestacijama buha traje najmanje 4 tjedna. Liječenje i sprječavanje zaraze krpeljima (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) kod pasa. Učinkovitost protiv krpelja sprema u roku od 4 tjedana.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/000103
  • Datum autorizacije:
  • 18-12-2006
  • EMEA koda:
  • EMEA/V/C/000103
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP ZA

Prac-tic spot-on otopina za pse

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

SERIJE U PROMET, AKO JE RAZLIČITO

Nositelj odobrenja za stavljanje u promet:

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

VELIKA BRITANIJA

Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet:

Elanco France S.A.S.

Usine de Huningue

26, rue de la Chapelle

F-68330 Huningue Cedex

Francuska

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

Prac-tic 56,25 mg spot-on otopina za vrlo male pse

Prac-tic 137,5 mg spot-on otopina za male pse

Prac-tic 275 mg spot-on otopina za pse srednje veličine

Prac-tic 625 mg spot-on otopina za velike pse

Piriprol

3.

KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH

SASTOJAKA

Jedan ml sadrži 125 mg piriprola kao bezbojne do žute, bistre otopine za vanjsku primjenu na koži.

Jedna pipeta sadrži:

Jedinična

doza

Piriprol

Prac-tic za vrlo male pse

0,45 ml

56,25 mg

Prac-tic za male pse

1,1 ml

137,5 mg

Prac-tic za pse srednje veličine

2,2 ml

275 mg

Prac-tic za velike pse

5,0 ml

625 mg

Otopina također sadrži 0,1 % butilhidroksitoluena (E321).

4.

INDIKACIJE

Liječenje i prevencija infestacije buhama (Ctenocephalides canis i C. felis).

Liječenje i prevencija infestacije krpeljima (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis,

Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum).

Liječenje i prevencija infestacije buhama: Prac-tic djelotvoran je protiv novih infestacija buhama uz

minimalno trajanje od četiri tjedna.

Liječenje i prevencija infestacije krpeljima: Prac-tic je djelotvoran protiv krpelja tijekom 4 tjedna.

5.

KONTRAINDIKACIJE

Nemojte upotrebljavati u pasa mlađih od osam tjedana ili s tjelesnom težinom manjom od 2 kg.

Nemojte

upotrebljavati

slučaju

poznate

preosjetljivosti

skupinu

fenilpirazola

bilo

koju

pomoćnu tvar.

Nemojte upotrebljavati na bolesnim životinjama ili na životinjama koje se oporavljaju od bolesti.

Ovaj veterinarsko-medicinski proizvod posebno je razvijen za pse.

Nemojte koristiti na mačkama jer može doći do predoziranja.

Nemojte koristiti na kunićima.

6.

NUSPOJAVE

Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP,

molimo obavijestite svog veterinara.

U vrlo rijetkim prilikama zabilježene su sljedeće nuspojave:

- reakcije na mjestu primjene i kožne reakcije: pruritus (svrbež), promjene na dlaci, dermatitis (upala

kože), eritem (crvenilo kože), alopecija (gubitak dlake), promjena boje i masni izgled dlake;

- neurološke reakcije: ataksija (manjak koordinacije) i konvulzije;

- sustavne reakcije: letargija (omamljenost);

- reakcije u probavnom sustavu: emeza (povraćanje) i proljev.

Ti znakovi obično su prolazni i nestaju unutar 24 sata nakon primjene; ako njihovo povlačenje potraje

duže, obratite se svom veterinaru.

Kratko razdoblje hipersalivacije (slinjenje) može se pojaviti ako životinja liže mjesto primjene odmah

nakon liječenja. To nije znak intoksikacije i nestaje unutar nekoliko minuta bez liječenja. Ispravna

primjena smanjiti će lizanje mjesta primjene.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

- vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana)

- česte (više od 1 ali manje od 10 životinja na 100 životinja)

- manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)

- rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja)

- vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)

7.

CILJNE VRSTE ŽIVOTINJA

Pas.

8.

DOZIRANJE

ZA

SVAKU

CILJNU

VRSTU

ŽIVOTINJA,

NAČIN

I

PUT(EVI)

PRIMJENE

Spot-on uporaba za vanjsku primjenu na koži psa.

Tablica doziranja

Preporučena minimalna doza je 12,5 mg piriprola po kg tjelesne težine, što je jednako 0,1 ml spot-on

otopine po kg tjelesne težine.

Raspon težine

psa

Veličina pipete

koja će se

koristiti

Jedna pipeta od

12,5 %-tne

(volumnog udjela)

otopine (ml)

sadrži

Piriprol

(mg/kg tjelesne

težine)

2 - 4,5 kg

Vrlo mali pas

0,45

12,5 - 28,1

> 4,5 - 11 kg

Mali pas

12,5 - 30,6

> 11 - 22 kg

Srednji pas

12,5 - 25,0

> 22 - 50 kg

Veliki pas

12,5 - 28,4

Teži od 50 kg

Upotrijebite odgovarajuću kombinaciju pipeta za postizanje

točne doze.

Unutar svakog raspona težine cijeli sadržaj pipete ispravne veličine treba nanijeti na psećoj koži.

Liječenje i prevencija buha

Piriprol ubija buhe unutar 24 sata nakon primjene. Jedna primjena sprječava infestaciju buhama

tijekom četiri tjedna.

Liječenje i prevencija krpelja

Piriprol ubija krpelje unutar 48 sata nakon primjene. Jedna primjena djelotvorna je protiv krpelja

tijekom 4 tjedna.

9.

SAVJETI ZA ISPRAVNU PRIMJENU

Samo za primjenu na koži.

Izvadite jednu pipetu iz pakovanja. Držite je u uspravnom položaju. Lagano lupite na uski dio pipete

kako biste se uvjerili da je sadržaj unutar tijela pipete. Odvojite vrh pipete duž označene linije.

Razdvojite dlaku na leđima životinje između lopatica sve dok ne ugledate kožu. Položite vrh pipete na

kožu i stisnite blago pipetu nekoliko puta na jednom ili dva mjesta kako biste ispraznili sadržaj pipete

na kožu. Pobrinite se da se proizvod zadrži na koži. Primijenite pipetu od 5 ml na 2 - 3 mjesta niz

liniju leđa velikih pasa kako bi se spriječilo curenje.

Pse treba točno izvagati prije primjene lijeka kako bi se osiguralo da se koristi ispravna veličina

pipete.

10.

KARENCIJA

Nije primjenjivo.

11.

POSEBNE MJERE PRI ČUVANJU

Čuvati izvan pogleda i dosega djece.

Ne koristite poslije isteka roka valjanosti naznačenog na pipeti poslije „EXP“.

Čuvati pipete u originalnom pakovanju sve dok nisu spremne za upotrebu, radi zaštite od svjetlosti.

Nemojte čuvati pri temperaturi iznad 25°C.

12.

POSEBNO(A) UPOZORENJE(A)

Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na

životinjama:

Osobe s poznatom preosjetljivošću na skupinu fenilpirazola ili bilo koju pomoćnu tvar trebaju

izbjegavati doticaj s proizvodom.

Izbjegavajte dodirivati sadržaja pipete prstima. Operite ruke nakon uporabe sapunom i isperite

proizvod koji je bio u doticaju s vašom kožom. Ako proizvod slučajno dođe u vaše oči, pažljivo ih

isperite vodom. Ako nadraženost oka potraje, potražite savjet liječnika i pokažite mu uputu ili etiketu

o veterinarsko-medicinskom proizvodu.

Ako dođete u doticaj s proizvodom možete osjetiti obamrlost i nadraženost kože i sluznice, ali ta

stanja obično se povlače spontano.

Ako vi ili netko drugi slučajno proguta ovaj proizvod, odmah potražite savjet liječnika i pokažite mu

ovu uputu ili etiketu.

Nemojte pušiti, jesti niti piti dok rukujete proizvodom.

Treba izbjegavati doticaj s liječenim psima kao mjeru predostrožnosti, a djeci se ne smije dozvoliti da

se igraju s liječenim psima sve dok mjesto primjene proizvoda ne bude suho. Stoga se preporučuje

liječiti pse uvečer. Nedavno liječenim psima ne smije se dozvoliti da spavaju u istom krevetu s

vlasnicima, posebice s djecom.

Ovaj veterinarsko-medicinski proizvod namijenjen je za iskorjenjivanje krpelja i odraslih buha.

Potrebno je liječiti sve pse u kućanstvu u isto vrijeme.

Posebne mjere opreza prilikom primjene na životinjama:

Nakon liječenja, krpelji će otpasti s psa unutar 24 do 48 sati nakon doticaja sa životinjom; no,

pojedinačni krpelji mogu ostati na životinji. Zbog tog se razloga ne smije u potpunosti isključiti

prijenos zaraznih bolesti putem krpelja.

slučaju teške

infestacije

prije liječenja,

okoliš u kojem borave

treba

očistiti

od prašine

usisivačem i tretirati odgovarajućim insekticidom.

Primijenite samo na površinu kože, na neoštećenu kožu.

Ovaj proizvod je za kožnu primjenu samo na psima, nemojte ga stavljati u pseća usta. Vodite računa

da izbjegnete doticaj veterinarsko-medicinskog proizvoda s očima vašeg psa.

Obratite se veterinaru ako namjeravate koristiti proizvod na psima istovremeno s drugim proizvodima

ili lijekovima.

Nemojte davati proizvod na usta ili na bilo koji drugi način jer to može uzrokovati predoziranje.

Neškodljivost proizvoda nije utvrđena u rasplodnih pasa niti u gravidnih ili kuja u laktaciji. Ako

postoji sumnja na gravidnost kuje ili ako kuja doji psiće ili ako želite liječiti rasplodne pse obratite se

svom veterinaru za savjet prije primjene.

Predoziranje (simptomi, hitni postupci, antidoti):

Blagi neurološki znakovi poput blage nekoordinacije i nestabilnosti pokreta uočeni su kod nekih

životinja koje su liječene jednom mjesečno. Ti znakovi iščezavaju unutar tri sata nakon primjene.

Kod jednog na osam pasa uočene su sljedeće prolazne nuspojave: tremor (drhtavica), ataksija (manjak

koordinacije), dahtanje i konvulzije. Ti znakovi iščezavaju unutar 18 sati nakon primjene.

Nakon pojedinačnog predoziranja uočene su sljedeće nuspojave: povraćanje, anoreksija (gubitak

apetita), smanjena tjelesna težina, tremori mišića, napadaji, nestabilnost, otežano disanje. Svi znakovi

povlače se unutar 48 sati osim gubitka apetita.

Predoziranje veterinarsko-medicinskim proizvodom može uzrokovati ljepljiv i zamršeni izgled dlake

na mjestu liječenje do 24 sata.

U slučaju predoziranja obratite se svom veterinaru.

Primijenite dozu na područje koje vaš pas ne može lizati i ne dozvolite svom psu ili drugoj

životinji da ližu jedno drugi nakon liječenja.

Pse nemojte kupati niti šamponirati 48 sati prije liječenja. Uranjanje vašeg psa u vodu ili šamponiranje

unutar 24 sata nakon liječenja može smanjiti djelotvornosti veterinarsko-medicinskog proizvoda. Ako

želite okupati svog psa, ostavite barem jedan dan između liječenja i šamponiranja.

Prilikom primjene proizvoda pokušajte izbjeći močenje dlake jer će to uzrokovati ljepljiv i zamršen

izgled dlake. No, ako se to dogodi, proći će unutar 24 sata nakon primjene.

Otapalo u proizvodu Prac-tic može bojati određene materijale uključujući kožu, tkanine, plastiku i

obrađene površine. Omogućite da se mjesto primjene osuši prije nego dozvolite kontakt životinje s

takvim materijalima.

13.

POSEBNE

MJERE

OPREZA

PRILIKOM

ODLAGANJA

NEUPOTREBLJENOG

PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA

Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom

tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.

Prac-tic ne treba odlagati u otvorene vode jer to može biti opasno za ribe i druge vodene organizme.

Lijekovi se ne smiju odlagati u otpadne vode ili kućni otpad.

Te mjere pomažu u zaštiti okoliša.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici

Europske agencije za lijekove http://www.ema.europa.eu/.

15.

OSTALE INFORMACIJE

Odrasle buhe ugibaju prije nesenja jajašca tijekom najmanje četiri tjedna nakon liječenja. S obzirom

da Prac-tic potpuno eliminira nastanak jajašca, prekida se životni ciklus buhe.

Kartonska kutija sadrži 1, 2 ili 10 blistera, od kojih svaki sadrži tri pipete.

Ne moraju sve veličine pakovanja biti u prometu.

Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte nositelja

odobrenja za stavljanje u promet.

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

10-9-2018

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

On September 19, 2018, the FDA will host the third of a three-part eSubmitter webinar series. This session will provide a platform to answer any remaining questions participants may have after attending or viewing the first two webinars on the use of CVM’s electronic submission tool, eSubmitter.

FDA - U.S. Food and Drug Administration

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

7-8-2018

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

August 6, 2018: Nurse Practitioner Sentenced for Illegally Prescribing Drugs at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

6-7-2018

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

FDA - U.S. Food and Drug Administration

14-6-2018

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

FDA issued draft guidance to help animal food facilities needing a supply-chain program meet those requirements under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule.

FDA - U.S. Food and Drug Administration

7-6-2018

Minister Bruno Bruins (Sport) opent Special Olympics 2018

Minister Bruno Bruins (Sport) opent Special Olympics 2018

Dit weekend worden in de Achterhoek de Special Olympics Nationale Spelen gehouden. Meer dan 2000 sporters met een verstandelijke beperking gaan de strijd aan in 20 takken van sport. Sportminister Bruno Bruins zal de Spelen vrijdagavond officieel openen tijdens een feestelijke ceremonie in Stadion de Vijverberg in Doetinchem. Bruno Bruins: ‘Sporten is gezond en vooral leuk. Ik vind het belangrijk dat iedereen kan sporten en er lol aan beleeft. Dat is ook een belangrijk onderdeel van het sportakkoord dat i...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-5-2018

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

Danish Medicines Agency

29-9-2017

New practice for follow-up information on adverse reaction reports

New practice for follow-up information on adverse reaction reports

The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.

Danish Medicines Agency

13-2-2017

New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.

Danish Medicines Agency

1-10-2015

New practice for MIAs

New practice for MIAs

As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that all manufacturing activities will be listed on the authorisation.

Danish Medicines Agency

17-4-2015

EMA's new assessment of the HPV vaccine: The benefits outweigh the risks

EMA's new assessment of the HPV vaccine: The benefits outweigh the risks

A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance experts have made a new assessment of the vaccine and still consider it to be safe.

Danish Medicines Agency

31-3-2015

New guidelines on good distribution practice for APIs

New guidelines on good distribution practice for APIs

The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.

Danish Medicines Agency

9-3-2015

Wholesale Distribution Authorisations and GDP certificates can now be transferred to EudraGMDP

Wholesale Distribution Authorisations and GDP certificates can now be transferred to EudraGMDP

We can now transfer Wholesale Distribution Authorisations and Good Distribution Practice certificates to EudraGMDP, a Community database in the EU.

Danish Medicines Agency

18-9-2018

 PRAC advice template

PRAC advice template

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

5-9-2018

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medical devices on Sept. 9th

FDA - U.S. Food and Drug Administration

3-9-2018

Agenda:  Agenda - PRAC draft agenda of meeting 3-6 September 2018

Agenda: Agenda - PRAC draft agenda of meeting 3-6 September 2018

Europe - EMA - European Medicines Agency

3-9-2018

TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)

TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)

New TIWGG meeting summaries now available

Therapeutic Goods Administration - Australia

29-8-2018

Prac-Tic (Elanco GmbH)

Prac-Tic (Elanco GmbH)

Prac-Tic (Active substance: pyriprole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5784 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000103/T/0025

Europe -DG Health and Food Safety

23-8-2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

MMDR implementation, SME Assist, GMP reforms, medicinal cannabis and international cooperation

Therapeutic Goods Administration - Australia

21-8-2018

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits  http://bit.ly/2ifnt2O  #ContactLensHealthWeekpic.twitter.com/ZBZAAtbrVr

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits http://bit.ly/2ifnt2O  #ContactLensHealthWeekpic.twitter.com/ZBZAAtbrVr

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits http://bit.ly/2ifnt2O  #ContactLensHealthWeek pic.twitter.com/ZBZAAtbrVr

FDA - U.S. Food and Drug Administration

14-8-2018

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting.  We look forward to continuing discussions around increasing medical device options for children today.  #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevice pic.twitter.com/7cXPFfvfif

FDA - U.S. Food and Drug Administration

10-8-2018

 Minutes of the PRAC meeting 11-14 June 2018

Minutes of the PRAC meeting 11-14 June 2018

Europe - EMA - European Medicines Agency

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

9-7-2018

Agenda:  Agenda - PRAC draft agenda of meeting 9-12 July 2018

Agenda: Agenda - PRAC draft agenda of meeting 9-12 July 2018

Europe - EMA - European Medicines Agency

9-7-2018

 Minutes of the PRAC meeting 14-17 May 2018

Minutes of the PRAC meeting 14-17 May 2018

Europe - EMA - European Medicines Agency

29-6-2018

TGA presentation: ARCS  webinar, 22 June 2018

TGA presentation: ARCS webinar, 22 June 2018

An overview of the expectations and best practices for structuring and formatting data in module 1.3 for submissions in the eCTD format using the Australian specifications version 3.1

Therapeutic Goods Administration - Australia

28-6-2018

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonthpic.twitter.com/ZpJ0aas1N4

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonthpic.twitter.com/ZpJ0aas1N4

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonth pic.twitter.com/ZpJ0aas1N4

FDA - U.S. Food and Drug Administration

11-6-2018

 Minutes of the PRAC meeting 9-12 Apil 2018

Minutes of the PRAC meeting 9-12 Apil 2018

Europe - EMA - European Medicines Agency

11-6-2018

 Minutes of the PRAC meeting 9-12 April 2018

Minutes of the PRAC meeting 9-12 April 2018

Europe - EMA - European Medicines Agency

11-6-2018

Agenda:  Agenda - PRAC draft agenda of meeting 11-14 June 2018

Agenda: Agenda - PRAC draft agenda of meeting 11-14 June 2018

Europe - EMA - European Medicines Agency

24-5-2018

Inaugural Industry Forum on Good Manufacturing Practice (GMP)

Inaugural Industry Forum on Good Manufacturing Practice (GMP)

Registrations for the 2018 GMP Forum closing on Wednesday 30 May 2018

Therapeutic Goods Administration - Australia

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Medicine labels: Guidance on TGO 91 and TGO 92

Medicine labels: Guidance on TGO 91 and TGO 92

The guidance for medicine labels has been updated to improve clarity for sponsors. It also includes new best practice on latex labelling.

Therapeutic Goods Administration - Australia

14-5-2018

Agenda:  Agenda - PRAC draft agenda of meeting 14-17 May 2018

Agenda: Agenda - PRAC draft agenda of meeting 14-17 May 2018

Europe - EMA - European Medicines Agency

8-5-2018

 Minutes of the PRAC meeting 5-8 March 2018

Minutes of the PRAC meeting 5-8 March 2018

Europe - EMA - European Medicines Agency