Co-Cazaprol

Glavna informacija

  • Trgovački naziv:
  • Co-Cazaprol 5 mg/12,5 mg filmom obložene tablete
  • Doziranje:
  • 5 mg + 12,5 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 5 mg cilazaprila u obliku cilazapril hidrata i 12,5 mg hidroklorotiazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka - farma d.o.o., Zagreb, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Cazaprol 5 mg/12,5 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Urbroj: 381-12-01/30-14-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-823696008
  • Datum autorizacije:
  • 22-09-2014
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

UPUTA O LIJEKU: Informacija za bolesnika

Co-Cazaprol 5 mg/12,5 mg filmom obložene tablete

cilazapril/hidroklorotiazid

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Co-Cazaprol i za što se koristi

Što morate znati prije nego počnete uzimati Co-Cazaprol

Kako uzimati Co-Cazaprol

Moguće nuspojave

Kako čuvati Co-Cazaprol

Sadržaj pakiranja i druge informacije

1.

ŠTO JE CO-CAZAPROL I ZA ŠTO SE KORISTI

Co-Cazaprol je kombinacija dva lijeka, pod nazivom cilazapril i hidroklorotiazid.

Co-Cazaprol se koristi za liječenje visokog krvnog tlaka. Obje djelatne tvari djeluju zajednički kako bi

snizile Vaš krvni tlak. Koriste se zajedno kada je liječenje jednom od djelatnih tvari nedovoljno.

Cilazapril pripada skupini lijekova pod nazivom ‘ACE inhibitori’ (inhibitori angiotenzin

konvertirajućeg enzima). On djeluje tako da opušta i širi krvne žile. To pomaže u snižavanju krvnog

tlaka. Također olakšava srcu pumpanje krvi po tijelu.

Hidroklorotiazid pripada skupini lijekova pod nazivom ‘tiazidni diuretici’ ili ‘tablete za mokrenje’.

Djeluje tako što povećava stvaranje tekućine (mokraće). To snižava krvni tlak.

2.

ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI CO-CAZAPROL

Nemojte uzimati Co-Cazaprol

ako ste alergični (preosjetljivi) na cilazapril, hidroklorotiazid ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6.).

ako ste alergični (preosjetljivi) na lijekove slične Co-Cazaprolu, kao što su drugi ACE

inhibitori, drugi tiazidni diuretici ili sulfonamidi.

ako ste nakon uzimanja drugih lijekova iz skupine ACE inhibitora imali ozbiljnu nuspojavu pod

nazivom angioedem, nasljedni angioedem ili angioedem nepoznatog uzroka. Znakovi

angioedema uključuju oticanje lica, usana, usta ili jezika.

ako imate teške poteškoće s bubrezima (klirens kreatinina manji od 30 ml/min) ili anuriju

(nemogućnost m

okrenja).

ako ste trudni više od 3 mjeseca (Također je bolje izbjegavati Co-Cazaprol u ranoj trudnoći -

pogledajte dijelove “Trudnoća” i “Dojenje”).

Ako se nešto od gore navedenog odnosi na Vas, nemojte uzimati Co-Cazaprol. Ako niste sigurni, prije

uzimanja Co-Cazaprola posavjetujte se sa svojim liječnikom ili ljekarnikom.

Upozorenja i mjere opreza

Obratite se svom liječniku

ili ljekarniku prije nego uzmete Co-Cazaprol:

ako imate poteškoća sa srcem. Co-Cazaprol nije prikladan za osobe s određenim vrstama

H A L M E D

22 - 09 - 2014

O D O B R E N O

poteškoća sa srcem.

ako ste imali moždani udar ili imate problema s opskrbom mozga krvlju.

ako imate teške poteškoće s jetrom ili ako razvijete žuticu.

ako imate poteškoća s bubrezima ili s opskrbom bubrega krvlju koji se naziva stenoza bubrežne

arterije.

ako idete na dijalizu bubrega.

ako ste nedavno povraćali ili imali proljev.

ako ste na dijeti kojom kontrolirate koliko soli (natrija) unosite.

ako imate u planu tretman za smanjenje alergijske reakcije na ubode pčela ili osa

(desenzibilizacija).

ako planirate ići na operaciju (uključujući operativni zahvat na zubu). To je zbog toga što neki

anestetici mogu sniziti Vaš krvni tlak te on može postati prenizak.

ako Vam se nakupila tekućina u trbuhu (ascites).

ako imate šećernu bolest.

ako imate kolagenu bolest krvnih žila.

ako ste podvrgnuti LDL aferezi s dekstran sulfatom.

ako imate giht.

ako imate porfiriju.

Ako se nešto od gore navedenog odnosi na Vas ili ako niste sigurni, prije uzimanja Co-Cazaprola

posavjetujte se sa svojim liječnikom ili ljekarnikom.

Morate obavijestiti svog liječnika ako mislite da ste (ili možda ostanete) trudni. Co-Cazaprol se ne

preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni duže od 3 mjeseca, jer može ozbiljno

naštetiti Vašem djetetu ako se koristi u toj fazi (pogledajte dijelove “Trudnoća” i “Dojenje”).

Primjena u djece i adolescenata

Co-Cazaprol se ne preporučuje za primjenu u djece i adolescenata u dobi mlađoj od 18 godina.

Drugi lijekovi i Co-Cazaprol

Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje

druge lijekove. To uključuje i lijekove dobivene bez recepta

i biljne lijekove. Razlog tom

e je što Co-

Cazaprol može utjecati na djelovanje nekih lijekova. Također neki drugi lijekovi mogu utjecati na

djelovanje Co-Cazaprola.

Posebno, obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:

Bilo koji lijek za liječenje visokog krvnog tlaka.

Lijekove pod nazivom ‘nesteroidni antiinflamatorni (protuupalni) lijekovi’ (NSAID). Oni

uključuju acetilsalicilnu kiselinu, indometacin i ibuprofen.

Inzulin ili druge lijekove za liječenje šećerne bolesti.

Litij (koristi se za liječenje depresije).

Steroidne lijekove (kao što su hidrokortizon, prednizolon i deksametazon) ili druge lijekove koji

suprimiraju (potiskuju) imunološki sustav.

Nadomjeske kalija (uključujući i zamjene za sol) ili diuretike koji štede kalij.

Antagoniste aldosterona.

Simpatomimetike.

Anestetike, narkotike.

Tricikličke antidepresive, antipsihotike.

Spojeve zlata (koriste se za liječenje reumatoidnog artritisa).

Lijekove za liječenje zatajenja srca ili abnormalnosti rada srca.

Nadomjeske kalcija i vitamin D.

Kolestiramin/kolestipol (koriste se za smanjenje količine masnoće u Vašoj krvi).

Antikolinergike.

Citotoksične lijekove (npr. metotreksat, ciklofosfamid).

Ciklosporine (sprječavaju odbacivanje organa nakon transplantacije).

Kontrastna sredstva koja sadrže jod (daju se bolesnicima prije određenih vrsta RTG pretraga).

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O D O B R E N O

Co-Cazaprol s hranom i pićem

Co-Cazaprol se može uzimati sa ili bez hrane.

Obavijestite svojeg liječnika ili ljekarnika ako uzimate dodatke prehrani koji sadrže kalij.

Trudnoća, dojenje i plodnost

Trudnoća

Morate obavijestiti svog liječnika ako mislite da ste (ili možda ostanete) trudni. Liječnik će Vam

obično savjetovati da prestanete uzimati Co-Cazaprol prije nego ostanete trudni ili čim saznate da ste

trudni te će Vam savjetovati da uzmete drugi lijek umjesto Co-Cazaprola. Co-Cazaprol se ne

preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni duže od 3 mjeseca, jer može ozbiljno

naštetiti Vašem djetetu ako se koristi nakon trećeg mjeseca trudnoće.

Dojenje

Obavijestite svog liječnika ako dojite ili počinjete dojiti. Co-Cazaprol se ne preporučuje

majkama koje doje te Vaš liječnik može za Vas odabrati drugu terapiju ako želite dojiti, osobito ako je

Vaše dijete tek rođeno ili je rođeno prerano.

Upravljanje vozilima i strojevima

Pri uzimanju Co-Cazaprola možete osjetiti omaglicu. Ona će se najvjerojatnije pojaviti kad prvi put

počinjete liječenje. Ako osjetite omaglicu nemojte upravljati vozilima ili koristiti bilo kakve alate ili

strojeve.

Co-Cazaprol sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

3.

KAKO UZIMATI CO-CAZAPROL

Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Uobičajena doza za odrasle je 1 tableta dnevno.

Uzimanje ovog lijeka

Progutajte svaku tabletu s čašo

m vode.

Nije važno u koje doba dana uzimate Co-Cazaprol. Međutim, uzimajte ga uvijek približno u isto

vrijeme.

Co-Cazaprol se može uzimati prije ili nakon obroka.

Nemojte drobiti ili žvakati tablete.

Ako uzmete više Co-Cazaprola nego što ste trebali

Ako ste uzeli više Co-Cazaprola nego ste trebali ili je netko drugi uzeo Vašu Co-Cazaprol tabletu,

obratite se svom liječniku ili odmah otiđite u bolnicu. Sa sobom ponesite pakiranje lijeka. Mogu se

pojaviti sljedeći učinci: osjećaj omaglice ili ošamućenosti, plitko disanje, hladna znojna koža,

nemogućnost pomicanja ili govora te usporeni ili nepravilni otkucaji srca.

Ako ste zaboravili uzeti Co-Cazaprol

Ako ste zaboravili uzeti dozu, preskočite propuštenu dozu. Zatim uzmite sljedeću dozu prema

rasporedu.

Nemojte uzeti dvostruku dozu (dvije doze u istom trenutku) kako biste nadoknadili

zaboravljenu dozu.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.

H A L M E D

22 - 09 - 2014

O D O B R E N O

4.

MOGUĆE NUSPOJAVE

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave

iako se one neće javiti kod svakoga.

Teške reakcije

Ako imate tešku reakciju nazvanu angioedem, prestanite uzimati Co-Cazaprol i odmah se obratite

liječniku. Znakovi mogu obuhvaćati:

Iznenadno oticanje lica, grla, usana ili usta. To može otežati disanje ili gutanje.

Poteškoće s krvi zabilježene kod primjene ACE inhibitora i tiazidnih diuretika uključuju:

Smanjen broj crvenih krvnih stanica (anemija). Znakovi uključuju osjećaj umora, blijedu kožu,

brze ili nepravilne otkucaje srca (palpitacije - osjećaj lupanja srca) i osjećaj nedostatka zraka.

Smanjen broj svih vrsta bijelih krvnih stanica. Znakovi uključuju povećan broj infekcija, na

primjer u Vašim ustima, desnima, grlu i plućima.

Smanjen broj trombocita (krvnih pločica) u krvi. Znakovi uključuju lakše dobivanje modrica i

krvarenje iz nosa.

Ostale moguće nuspojave

Česte

(zahvaćaju manje od 1 na 10 osoba)

Osjećaj omaglice

Kašalj

Mučnina

Osjećaj umora

Glavobolja

Manje česte

(zahvaćaju manje od 1 na 100 osoba)

Nizak krvni tlak. Zbog njega možete osjećati slabost, omaglicu ili ošamućenost te može dovesti

do zamagljenog vida i nesvjestice. Prekomjerno snižavanje krvnog tlaka, u određenih bolesnika,

može povećati mogućnost od srčanog ili

moždanog udara.

Ubrzan srčani puls

Osjećaj slabosti

Bol u prsnom košu

Poteškoće s disanjem, uključujući nedostatak zraka i stezanje u prsnom košu

Curenje iz nosa ili začepljen nos i kihanje (rinitis)

Suha ili otečena usta

Gubitak apetita

Promjene u osjetu okusa

Proljev i povraćanje

Kožni osip (koji može biti težak)

Grčevi mišića ili bolovi u mišićima i zglobovima

Impotencija

Znojenje više nego uobičajeno

Crvenilo uz osjećaj vrućine

Poteškoće sa spavanjem

Krvne pretrage pokazuju smanjenje broja crvenih krvnih stanica, bijelih krvnih stanica ili

trombocita (anemija, neutropenija, agranulocitoza i trombocitopenija)

Krvne pretrage pokazuju abnormalne razine elektrolita (natrija, kalija, klorida, magnezija,

kalcija, bikarbonata) ili povišene razine glukoze, urata, kolesterola i triglicerida

Oblik teške alergijske reakcije (anafilaksa)

Cerebralna ishemija, prolazni ishemijski napadaj, ishemijski moždani udar (može se javiti ako

krvni tlak postane prenizak)

Infarkt miokarda (može se javiti ako krvni tlak postane prenizak)

Nepravilni ot

kucaji srca

Intersticijska bolest pluća

Poremećaj sličan sistemskom lupusu eritematozusu

H A L M E D

22 - 09 - 2014

O D O B R E N O

Bockanje i trnci ili obamrlost u rukama ili nogama

Piskanje (pri disanju)

Osjećaj punoće ili pulsirajuća bol iza nosa, obraza i očiju (sinusitis)

Bolnost jezika

Pankreatitis (upala gušterače). Znakovi uključuju jaku bol u trbuhu koja se širi prema leđima.

Promjene u načinu rada jetre ili bubrega (vidljive u pretragama krvi i mokraće)

Poteškoće s jetrom kao što je hepatitis (upala jetre) ili oštećenje jetre

Teške kožne reakcije koje obuhvaćaju stvaranje mjehurića ili ljuštenje kože

Pojačana osjetljivost na svjetlo

Gubitak kose (koji može biti privremen)

Klimanje ili odvajanje nokta iz svog ležišta

Povećanje dojki kod muškaraca

Depresija

Smetenost

Suhoća očiju

Poremećaj vida kod kojeg se stvari čine žute.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava:

Agencija za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju

Roberta Frangeša Mihanovića 9

10 000 Zagreb

Republika Hrvatska

Fax: + 385 (0)1 4884 119

Website: www.halmed.hr

e-mail: nuspojave@halmed.hr

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

KAKO ČUVATI CO-CAZAPROL

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE

Što Co-Cazaprol sadrži

Djelatne tvari su cilazapril i hidroklorotiazid. Svaka tableta sadrži 5 mg cilazaprila u obliku

cilazapril hidrata i 12,5 mg hidroklorotiazida.

Pomoćne tvari su: laktoza hidrat; hipromeloza; kukuruzni škrob; talk; natrijev stearilfumarat;

titanijev dioksid (E171); željezov oksid, crveni (E172).

Kako Co-Cazaprol izgleda i sadržaj pakiranja

Ružičaste, ovalne, bikonveksne, filmom obložene tablete.

H A L M E D

22 - 09 - 2014

O D O B R E N O

Co-Cazaprol je dostupan u blisterima po 10 filmom obloženih tableta, a svaka kutija sadrži ukupno 30

i 60 filmom obloženih tableta.

Nositelj odobrenja za stavljanje u promet lijeka i proizvođač

KRKA - FARMA d.o.o., Radnička cesta 48,

10000 Zagreb, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u rujnu, 2014.

H A L M E D

22 - 09 - 2014

O D O B R E N O

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Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

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

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

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

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety