ProZinc

Glavna informacija

  • Trgovački naziv:
  • ProZinc
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • ProZinc
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • mačke
  • Područje terapije:
  • Inzulini i analozi za ubrizgavanje, intermedijarni inzulin (humani)
  • Terapijske indikacije:
  • Za liječenje dijabetes melitusa kod mačaka radi postizanja smanjenja hiperglikemije i poboljšanja povezanih kliničkih znakova.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/002634
  • Datum autorizacije:
  • 12-07-2013
  • EMEA koda:
  • EMEA/V/C/002634
  • Zadnje ažuriranje:
  • 24-02-2018

Izvješće o ocjeni javnog

EMA/300817/2013

EMEA/V/C/002634

Sažetak Europskoga javnog izvješća o procjeni (EPAR)

ProZinc

Ljudski inzulin

Ovaj dokument je sažetak Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.

Cilj mu je objasniti kako procjena, koju Odbor za veterinarsko- medicinske proizvode (CVMP) provodi

na temelju zaprimljene dokumentacije, dovodi do preporuka o uvjetima korištenja.

Ovaj dokument ne može zamijeniti osobni razgovor s vašim veterinarom. Ako vam je potrebno više

informacija o zdravstvenom stanju ili liječenju vaše životinje, obratite se svom veterinaru. Ako želite

više informacija na temelju preporuka Odbora za veterinarsko- medicinske proizvode (CVMP),

pročitajte znanstvenu raspravu (ista je dio Europskoga javnog izvješća o procjeni veterinarsko-

medicinskog proizvoda (EPAR)).

Što je ProZinc?

ProZinc jest veterinarsko-medicinski proizvod koji sadrži djelatnu tvar ljudski inzulin. Dostupan je kao

suspenzija za injekciju (40 IU/ml).

Za što se ProZinc koristi?

ProZinc koristi se za liječenje dijabetesa u mačaka. VMP se primjenjuje potkožnom injekcijom dva puta

na dan istovremeno s jelom ili nakon obroka. Ispravna se doza utvrđuje individualno za svaku mačku

ovisno o masi i potrebama da se doza prilagodi ovisno o odgovoru na liječenje.

Na koji način ProZinc djeluje?

Dijabetes je bolest, pri kojoj gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi

(šećera) i/ili ako tijelo ne može učinkovito upotrijebiti inzulin. To može rezultirati povišenim razinama

glukoze u krvi i povezanim kliničkim znakovima, poput poliurije (povećanje u volumenu urina),

polidipsije (povećanje u unosu vode) i gubitka tjelesne mase. ProZinc jest inzulin kojem su dodani

protamin i cink da bi se tvorili kristali. Oni se apsorbiraju sporije nakon injekcije i potrebno im je više

vremena od prirodno proizvedenog inzulina da dosegnu svoj cilj u tijelu. To znači da VMP ima dulje

djelovanje. ProZinc djeluje na isti način kao prirodno proizveden inzulin, te pomaže glukozi da iz krvi

uđe u stanice. Kontrolirajući razinu glukoze u krvi, smanjuju se simptomi i komplikacije dijabetesa.

+44 (0)20

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

Djelatni sastojak VMP-a ProZinc, ljudski inzulin (rDNA), proizvodi se metodom koja je poznata kao

„tehnologija rekombinantne DNK“: VMP proizvodi se od stanica kvasca, u koje se ugrađuje gen

(segment DNK-a), uslijed čega stanice kvasca mogu proizvoditi inzulin.

Kako se ProZinc ispitivao?

ProZinc je ispitan u terenskom ispitivanju, kojim je obuhvaćeno 176 mačaka s dijabetesom različite

starosti i različitih pasmina. Glavna mjera djelotvornosti bilo je poboljšanje kontrole dijabetesa 6

tjedana nakon početka liječenja, što je utvrđeno poboljšanjem izmjerenih vrijednosti šećera u krvi i

najmanje jednog od tri klinička znaka: tjelesne mase, poliurije i polidipsije.

Koje koristi ProZinc su utvrđene tijekom ispitivanja?

Ispitivanje je dokazalo da su nakon 6 tjedana liječenja prosječne razine šećera u krvi smanjene te da

su klinički znakovi poboljšani, primjerice prosječna tjelesna masa je povećana. Na temelju glavnog

mjerenja djelotvornosti, liječenje 116 od 139 mačaka (84%) smatrano je uspješnim.

Koji su rizici povezani s VMP-om ProZinc?

Najčešća nuspojava tijekom liječenja VMP-om ProZinc (koja se može javiti u više od 1 na 10 životinja)

jest hipoglikemija (niske razine glukoze u krvi), što može rezultirati znakovima poput gladi, tjeskobe,

nestabilnog kretanja, trzanje mišića, posrtanja ili gubljenja tla pod stražnjim nogama te

dezorijentacije. Ovi hipoglikemijski događaji su općenito blage prirode.

ProZinc ne smije se koristiti u mačaka, koje su hiperosjetljive (alergične) na inzulin ili bilo koji drugi

sastojak.

Cjelokupan popis nuspojava i ograničenja za uporabu VMP-a ProZinc dostupan je u uputi o VMP-u.

Koje su mjere opreza za osobu koja primjenjuje veterinarsko-medicinski

proizvod ili dolazi u kontakt sa životinjom?

Ukoliko se netko nehotično samoinjicira ovim veterinarsko-medicinskim proizvodom, ta osoba treba

odmah potražiti hitnu medicinsku pomoć i sa sobom ponesite uputu o VMP.

Zašto je ProZinc odobren?

CVMP zaključio je da koristi VMP-a ProZinc nadmašuju rizike za odobrene indikacije i preporučio je da

se odobrenje za stavljanje VMP-a u promet dodijeli VMP-u ProZinc. Omjer koristi i rizika dostupan je u

modulu znanstvene rasprave ovog EPAR.

Druge informacije o VMP-u ProZinc:

Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske

unije za VMP ProZinc dana 12/07/2013. Informacije o tome je li za ovaj proizvod potreban veterinarski

recept možete naći na etiketi/vanjskom dijelu pakiranja.

Sažetak je posljednji put dopunjen u svibnju 2013.

ProZinc

EMA/300817/2013

Stranica 2/2

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP:

ProZinc 40 IU/ml suspenzija za injekcije za mačke

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 i proizvođač odgovoran za puštanje serije u promet:

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim/Rhein

NJEMAČKA

Proizvođač odgovoran za puštanje serije u promet:

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324

24106 Kiel

NJEMAČKA

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

ProZinc 40 IU/ml suspenzija za injekciju za mačke

Ljudski inzulin

3.

KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH

SASTOJAKA

Jedan ml sadrži:

Djelatna tvar:

Ljudski inzulin*

40 IU u obliku protamin-cink inzulina

Jedna međunarodna jedinica (IU) odgovara količini od 0,0347 mg ljudskog inzulina.

*proizvedeno tehnologijom rekombinantne DNK

Pomoćne tvari:

protamin-sulfat

0,466 mg

cinkov oksid

0,088 mg

fenol

2,5 mg

Mutna, bijela, vodena suspenzija.

4.

INDIKACIJA(E)

Za liječenje dijabetesa melitusa u mačaka, kako bi se smanjila hiperglikemija i postiglo poboljšanje

popratnih kliničkih znakova.

5.

KONTRAINDIKACIJE

Ne primjenjivati za akutnu kontrolu dijabetičke ketoacidoze.

Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.

6.

NUSPOJAVE

Hipoglikemijske reakcije su vrlo često zabilježene (13% (23 od 176) liječenih mačaka) u ispitivanju

neškodljivosti i djelotvornosti. Te reakcije su uglavnom bile blaže prirode. Klinički znakovi mogu

uključivati glad, tjeskobu, nestabilno kretanje, trzanje mišića, posrtanje ili gubljenje tla pod stražnjim

nogama te dezorijentaciju.

Ako se ovo dogodi, nužno je odmah dati otopinu glukoze i/ili hranu.

Davanje inzulina bi privremeno trebalo obustaviti, a sljedeću dozu inzulina prilagoditi na odgovarajući

način.

Lokalne reakcije na mjestu davanja injekcije bile su zabilježene vrlo rijetko te su se povukle bez

prekida terapije.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

- vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) )

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

- manje česte (više od 1 ali manje od 10 životinja na 1000 tretiranih životinja)

- rijetke (više od 1 ali manje od 10 životinja na 10 000 tretiranih životinja)

- vrlo rijetke (manje od 1 životinje na 10 000 tretiranih životinja, uključujući izolirane slučajeve).

Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da

veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.

7.

CILJNE VRSTE ŽIVOTINJA

Mačke

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)

PRIMJENE

Potkožna primjena.

Doziranje:

Početna preporučena doza iznosi od 0,2 do 0,4 IU/kg tjelesne mase svakih 12 sati. Mačkama koje su

prethodno liječene inzulinom može biti prikladnija viša početna doza do 0,7 IU/kg tjelesne mase.

Veterinar bi trebao u odgovarajućim vremenskim razmacima procjenjivati mačku te prilagođavati

protokol liječenja, na primjer dozu i režim doziranja, sve dok se ne postigne odgovarajuća kontrola

glikemije.

Svaku prilagodbu doze (tj. povećanje doze) trebalo bi u pravilu provoditi nakon nekoliko dana (npr.

nakon 1 tjedna) jer potpuno djelovanje inzulina zahtijeva fazu uravnoteženja. Prilagodbe doze

inzulina, ako su potrebne, obično treba provoditi unutar vrijednosti od 0,5 do 1 IU po injekciji. Doza

se može smanjiti za 50% ili više ako se opazi hipoglikemija ili u slučaju sumnje na Somogyijev učinak

(povratna hiperglikemija).

Kad se postigne odgovarajuća kontrola glikemije, valja redovito kontrolirati glukozu u krvi (npr. svaka

3 do 4 mjeseca ili češće) i možda će biti potrebne daljnje prilagodbe doze inzulina.

Mačke mogu razviti dijabetičku remisiju, pri čemu tijelo ponovno uspostavlja proizvodnju vlastitog

inzulina te se dozu inzulina treba prilagoditi ili obustaviti.

Način primjene:

Ovaj veterinarsko-medicinski proizvod treba primjenjivati potkožnom injekcijom dvaput na dan.

9.

SAVJETI ZA ISPRAVNU PRIMJENU

Mora se koristiti štrcaljka U-40.

Suspenziju treba izmiješati laganim okretanjem bočice prije izvlačenja svake doze iz bočice.

Posebno valja pripaziti na preciznost doziranja.

Dozu treba davati istovremeno s jelom ili neposredno poslije jela.

Izbjegavati unošenje kontaminanata za vrijeme primjene.

Nakon što se bočica lagano provalja suspenzija je mutna i bijela.

Bijeli prsten je ponekad vidljiv na grliću nekih bočica, ali to ne utječe na kvalitetu proizvoda.

U inzulinskim suspenzijama se mogu pojaviti nakupine, odnosno grudice: nemojte upotrijebiti

proizvod ukoliko su nakupine vidljive i nakon što ste bočicu provaljali.

10.

KARENCIJA(E)

Nije primjenjivo.

11.

POSEBNE MJERE PRI ČUVANJU

Čuvati izvan pogleda i dosega djece.

Za neiskorištene i probušene bočice:

Čuvati uspravno u hladnjaku (2

C – 8

Ne zamrzavati.

Držati bočicu u vanjskom kartonu radi zaštite od svjetla.

Rok valjanosti poslije prvog otvaranja spremnika: 60 dana.

Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i

bočici poslije EXP.

12.

POSEBNO(A) UPOZORENJE(A)

Posebna upozorenja za svaku od ciljnih vrsta životinja:

Vrlo stresni događaji, istovremeno liječenje gestagenima i kortikosteroidima ili druge popratne bolesti

(npr. infekcijske ili upalne ili endokrine bolesti), mogu utjecati na djelotvornost inzulina te bi stoga

trebalo prilagoditi dozu inzulina.

Posebne mjere opreza prilikom primjene na životinjama:

U slučaju remisije dijabetičkog stanja, vjerojatno će biti potrebno prilagoditi dozu ili prekinuti terapiju

inzulinom.

Mačke mogu razviti dijabetičku remisiju, pri čemu tijelo mačke ponovno uspostavlja proizvodnju

vlastitog inzulina.

Nakon što se odredi dnevna doza inzulina, preporučuje se redovito praćenje glukoze.

Liječenje inzulinom može izazvati hipoglikemiju, za kliničke znakove i odgovarajuću terapiju vidjeti

odjeljak niže "Predoziranje".

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

životinjama:

Nehotično samoinjiciranje može izazvati kliničke znakove hipoglikemije, a u senzibiliziranih osoba

postoji i mala mogućnost za alergijsku reakciju.

U slučaju da se nehotice samoinjicira, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP-u.

Graviditet i laktacija:

Neškodljivost i djelotvornost ProZinc-a nije utvrđena za vrijeme parenja, graviditeta i laktacije

mačaka.

Primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.

U pravilu, potrebe za inzulinom za vrijeme graviditeta i laktacije mogu biti različite zbog promjena u

metaboličkom stanju. Stoga se preporučuje strogo praćenje razine glukoze i veterinarski nadzor.

Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:

Promjene u potrebama za inzulinom mogu biti posljedica primjene tvari koje mijenjaju podnošljivost

glukoze (npr. kortikosteroidi i gestageni). Potrebno je pratiti koncentracije glukoze kako bi se u skladu

s tim prilagodila doza. Slično tomu, prehrana s visokim sadržajem proteina ili niskim sadržajem

ugljikohidrata može utjecati na potrebe za inzulinom (npr. smanjiti dozu inzulina).

Predoziranje (simptomi, hitni postupci, antidoti):

Predoziranje inzulinom može imati za posljedicu hipoglikemiju; u tom je slučaju nužno odmah dati

otopinu glukoze i/ili hranu. Klinički znakovi mogu uključivati glad, sve veću tjeskobu, nestabilno

kretanje, trzanje mišića, posrtanje ili gubljenje tla pod stražnjim nogama te dezorijentaciju.

Davanje inzulina privremeno treba obustaviti, a sljedeću dozu inzulina prilagoditi na odgovarajući

način.

Vlasniku se preporučuje da u kućanstvu drži proizvode koji sadrže glukozu (npr. med, gel na bazi

dekstroze).

Glavne inkompatibilnosti:

U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod se ne smije miješati s

drugim veterinarsko-medicinskim proizvodima.

13.

POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENOG PROIZVODA

ILI OTPADNIH MATERIJALA, AKO IH IMA

Veterinarsko medicinski proizvodi se ne smiju odlagati u otvorene vode ili kućni otpad. Pitajte vašeg

veterinara kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni. 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

Pakiranje s jednom bočicom od prozirnog stakla zapremnine 10ml. Bočica je zatvorena čepom od

butilne gume i sigurnosnim plastičnim "flip-off" poklopcem.

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

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

Xylitol and Your Dog: Danger, Paws Off

This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

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

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Tresiba (Novo Nordisk A/S)

Tresiba (Novo Nordisk A/S)

Tresiba (Active substance: Insulin degludec) - Centralised - Yearly update - Commission Decision (2018)6244 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

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

17-9-2018

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

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

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency