FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
English: Pregabalin Mylan Pharma 225 mg hard capsules EU/1/15/998/040
Croatian: Pregabalin Mylan Pharma 225 mg tvrde kapsule EU/1/15/998/040
English: Teл.
Croatian: C.
English: Table 1.
Croatian: PRILOG III.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Croatian: Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula, perforiranim blister pakiranjima koja sadrže 14 x 1, 56 x 1, 100 x 1 kapsulu i bocama koje sadrže 200 kapsula.
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Croatian: Rijetko edem pluća, stezanje u grlu Poremećaji probavnog sustava Često povraćanje, mučnina, konstipacija, proljev, flatulencija, distenzija abdomena, suha usta
English: Pregabalin Mylan Pharma 300 mg hard capsules EU/1/15/998/045
Croatian: Pregabalin Mylan Pharma 300 mg tvrde kapsule EU/1/15/998/045
English: Pregabalin Mylan Pharma 100 mg hard capsule
Croatian: Pregabalin Mylan Pharma 100 mg tvrde kapsule
English: Pregabalin Mylan Pharma 75 mg hard capsules The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 75 mg tvrde kapsule želatinozna kapsula tvrde ovojnice sa svjetloružičastom neprozirnom kapicom i svjetloružičastim neprozirnim tijelom napunjena bjeličastim prahom.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 200 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 200 mg tvrde kapsule pregabalin
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 100 mg
English: Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules.
Croatian: Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula i perforiranim blister pakiranjima koja sadrže 56 x 1, 100 x 1 kapsulu.
English: Discontinuation of pregabalin
Croatian: Prekid primjene pregabalina
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 300 mg
English: Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 Table 1).
Croatian: U bolesnika čija je bubrežna funkcija oslabljena zbog starije dobi možda će biti potrebno smanjiti dozu pregabalina (vidjeti dio 4.2, Tablica 1).
English: Pregabalin Mylan Pharma 300 mg hard capsules The 300 mg capsule are No. 0, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 300 mg želatinozna kapsula tvrde boje sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
English: Pregabalin Mylan Pharma 200 mg hard capsules The 200 mg capsule are No. 1, light peach opaque cap and light peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 200 mg tvrde kapsule želatinozna kapsula sa svjetloružičastom neprozirnom kapicom i svjetloružičastim neprozirnim tijelom napunjena bjeličastim prahom.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 100 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 100 mg tvrde kapsule pregabalin
English: Pregabalin Mylan Pharma 50 mg hard capsules EU/1/15/998/009
Croatian: Pregabalin Mylan Pharma 50 mg tvrde kapsule EU/1/15/998/009
English: Pregabalin Mylan Pharma 150 mg hard capsules EU/1/15/998/028
Croatian: Pregabalin Mylan Pharma 150 mg tvrde kapsule EU/1/15/998/028
English: Pregabalin Mylan Pharma 150 mg hard capsules The 150 mg capsule are No. 2, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 150 mg tvrde kapsule želatinozna kapsula tvrde ovojnice sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 300 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 300 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 150 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 150 mg tvrde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 225 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 225 mg tvrde kapsule Pregabalin
English: The capsule is axially printed with MYLAN over PB200 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB200 crnom tintom na kapici i tijelu.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 50 mg pregabalina.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Croatian: Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula, perforiranim blister pakiranjima koja sadrže 56 x 1, 100 x 1 kapsulu i bocama koje sadrže 200 kapsula.
English: PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules.
Croatian: PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 84 x 1 i 100 x 1 tvrdu kapsulu.
English: The capsule is axially printed with MYLAN over PB225 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB225 crnom tintom na kapici i tijelu.
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules.
Croatian: Dostupan je u blister pakiranjima koja sadrže 14, 21, 56, 84, 100 kapsula i perforiranim blister pakiranjima koja sadrže 84 x 1, 100 x 1 kapsulu.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg pregabalin.
Croatian: TVARI Jedna tvrda kapsula sadrži 100 mg pregabalina.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Croatian: 14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 56 x 1 tvrda kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: Pregabalin Mylan Pharma 25 mg hard capsules EU/1/15/998/001
Croatian: Pregabalin Mylan Pharma 25 mg tvrde kapsule EU/1/15/998/001
English: Pregabalin Mylan Pharma 25 mg hard capsule
Croatian: Pregabalin Mylan Pharma 25 mg tvrde kapsule
English: The capsule is axially printed with MYLAN over PB150 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB150 crnom tintom na kapici i tijelu.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Croatian: 14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 25 mg
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard capsules.
Croatian: PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 56 x 1, 84 x 1 i 100 x 1 tvrdu kapsulu.
English: Pregabalin Mylan Pharma 50 mg hard capsule
Croatian: Pregabalin Mylan Pharma 50 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 75 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 75 mg tvrde kapsule pregabalin
English: Pregabalin Mylan Pharma 225 mg hard capsules The 225 mg capsule are No. 1, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 225 mg tvrde kapsule želatinozna kapsula s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
English: • Increased fluid in the abdomen
Croatian: • nakupljanje tekućine u trbuhu
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules.
Croatian: PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 14 x 1, 56 x 1 i 100 x 1 tvrdu kapsulu.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 50 mg
English: The capsule is axially printed with MYLAN over PB75 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB75 crnom tintom na kapici i tijelu.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 50 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 50 mg tvrde kapsule pregabalin
English: How to take Pregabalin Mylan Pharma 4.
Croatian: Kako uzimati Pregabalin Mylan Pharma 4. Moguće nuspojave
English: No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Croatian: Tvrda želatinozna kapsula br. 4 sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsule.
Croatian: PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 56 x 1 i 100 x 1 tvrdu kapsulu.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 200 tvrdih kapsula 14 x 1 tvrda kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: Date of last renewal: DDMMYY
Croatian: Datum posljednje obnove odobrenja:
English: 14 hard capsules 56 hard capsules 100 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: The capsule is axially printed with MYLAN over PB50 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB50 crnom tintom na kapici i tijelu.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 200 tvrdih kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 25 mg hard capsules pregabalin
Croatian: NAZIV LIJEKA Pregabalin Mylan Pharma 25 mg tvrde kapsule pregabalin
English: The capsule is axially printed with MYLAN over PB100 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB100 crnom tintom na kapici i tijelu.
English: Pregabalin Mylan Pharma 50 mg hard capsules PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Croatian: PVC/PVDC-Al blister pakiranja koja sadrže 14, 21, 56, 84 i 100 tvrdih kapsula.
English: The capsule is axially printed with MYLAN over PB25 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN iznad PB25 crnom tintom na kapici i tijelu.
English: Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Croatian: Tvrda želatinozna kapsula br. 0 sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
English: • Weight gain
Croatian: • otežano gutanje
English: Lot
Croatian: U
English: Hypersensitivity Angioedema, allergic reaction
Croatian: Rijetko angioedem, alergijska reakcija Poremećaji metabolizma i prehrane Često pojačan tek
English: Pregabalin Mylan Pharma 100 mg hard capsules The 100 mg capsule are No. 3, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Croatian: Pregabalin Mylan Pharma 100 mg tvrde kapsule želatinozna kapsula tvrde ovojnice s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
English: The capsule is axially printed with MYLAN over PB300 in black ink on cap and body.
Croatian: Na kapsuli je poprečno otisnuto MYLAN i PB300 crnom tintom na kapici i tijelu.
English: Pregabalin Mylan Pharma 100 mg hard capsules PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules.
Croatian: PVC/PVDC-Al blister pakiranja koja sadrže 21, 84 i 100 tvrdih kapsula.
English: България Майлан ЕООД
Croatian: Mylan bvba/sprl
English: Management
Croatian: Zbrinjavanje
English: Date of latest renewal: 13 November 2013
Croatian: Datum posljednje obnove: 13. studenoga 2013.
English: Take your dose at around the same time every day.
Croatian: Uzmite dozu svakoga dana približno u isto vrijeme.
English: This concern applies especially to patients:
Croatian: To se osobito odnosi na bolesnike:
English: • Sudden difficulty in walking or loss of balance or co-ordination.
Croatian: • iznenadne poteškoće pri hodanju ili gubitak ravnoteže ili koordinacije
English: There is no difference in exposure among Chinese, Japanese, and Korean subjects.
Croatian: Nema razlike u izloženosti između kineskih, japanskih i korejskih ispitanika.
English: For further information please refer to section 5.1.
Croatian: Za dodatne informacije molimo vidjeti dio 5.1.
English: The educational material should include:
Croatian: Edukacijski materijal mora sadržavati:
English: TTP is a serious condition and requires prompt treatment.
Croatian: TTP je ozbiljna bolest koja zahtijeva hitno liječenje.
English: Hazard Ratio (HR) (95% CI)
Croatian: Omjer hazarda (HR) (95% CI)
English: Active pathological bleeding.
Croatian: Aktivno patološko krvarenje.
English: What Efient looks like and contents of the pack
Croatian: Kako Efient izgleda i sadržaj pakiranja
English: If you miss your scheduled daily dose, take Efient when you remember.
Croatian: Ako ste propustili predviđenu dnevnu dozu, uzmite Efient kad se sjetite.
English: Patients may be counted in more than one row.
Croatian: Bolesnici mogu biti uključeni u više od jednog retka.
English: - The other ingredients are:
Croatian: Drugi sastojci su:
English: • Emphasis that:
Croatian: • Mora se naglasiti da:
English: These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient').
Croatian: To mogu biti znakovi teške alergijske reakcije (vidjeti dio 2 'Što morate znati prije nego počnete uzimati Efient').
English: The format and means of dissemination, of this material should be discussed with the appropriate learned societies.
Croatian: O formatu i načinu podjele tog materijala treba raspraviti s odgovarajućim stručnim društvima.
English: • Sudden confusion, difficulty speaking or understanding others.
Croatian: • iznenadnu smetenost, otežano govorenje ili razumijevanje drugih osoba
English: b Other standard therapies were used as appropriate.
Croatian: b Drugi standardni lijekovi primjenjivali su se po potrebi.
English: Tell your doctor if you are taking morphine or other opioids (used to treat severe pain).
Croatian: Obavijestite svog liječnika ako uzimate morfin ili druge opioide (koji se koriste za liječenje jake boli).
English: Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher.
Croatian: Nemojte prestati uzimati Efient bez savjetovanja s liječnikom; ako prerano prestanete uzimati Efient, rizik od srčanog udara može biti povećan.
English: If this has happened to you, tell your doctor immediately.
Croatian: Ako se to dogodi, odmah obavijestite svog liječnika.
English: Talk to your doctor before taking Efient.
Croatian: Obratite se svom liječniku prije nego uzmete Efient.
English: • If you have an increased risk of bleeding such as: - age of 75 years or older.
Croatian: • Ako imate povećan rizik krvarenja, primjerice: - ako imate 75 ili više godina.
English: No dose adjustment is recommended based on ethnicity alone.
Croatian: Ne preporučuje se prilagođavati dozu samo s obzirom na etničko podrijetlo.
English: Mechanism of action / Pharmacodynamic effects
Croatian: Mehanizam djelovanja / Farmakodinamički učinci
English: It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient.
Croatian: Važno je da obavijestite svog liječnika, stomatologa i ljekarnika da uzimate Efient.
English: Store in the original package in order to protect from air and moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od zraka i vlage.
English: 85276 Pfaffenhofen Germany
Croatian: 85276 Pfaffenhofen
English: 81379 Munich
Croatian: 81379 München
English: Pharmacokinetics in special Populations
Croatian: Farmakokinetika u posebnim populacijama
English: Inhibitors of CYP3A:
Croatian: Inhibitori CYP3A:
English: Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Croatian: Primjena bilo kojeg tienopiridina unutar 5 dana prije uključenja u ispitivanje bio je kriterij za isključenje.
English: • Sudden dizziness or sudden severe headache with no known cause.
Croatian: • iznenadnu omaglicu ili iznenadnu jaku glavobolju bez jasnog uzroka
English: • Small red bruises on the skin (ecchymoses)
Croatian: • male crvene modrice na koži (ekhimoze)
English: The study failed to meet any of the primary or secondary endpoints.
Croatian: Ispitivanje nije postiglo nijednu od primarnih ni sekundarnih mjera ishoda.
English: You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Croatian: Efient smijete uzimati samo nakon što ste s liječnikom razgovarali o mogućoj koristi liječenja i mogućim rizicima za Vaše nerođeno dijete.
English: The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
Croatian: Rezultati rasprave i po potrebi materijal moraju biti usuglašeni s nacionalnom nadležnim tijelom i moraju biti dostupni prije stavljanja lijeka na tržište u svakoj državi članici.
English: The usual dose of Efient is 10 mg per day.
Croatian: Uobičajena doza lijeka Efient je 10 mg na dan.
English: Children and adolescents Efient should not be used in children and adolescents below 18 years of age.
Croatian: Efient se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: Body weight:
Croatian: Tjelesna težina:
English: The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age.
Croatian: U populaciji bolesnika bilo je 92% bijelaca, 26% žena i 39% osoba u dobi od ≥ 65 godina.
English: It is particularly important to tell your doctor if you are being treated with:
Croatian: Posebno je važno da obavijestite liječnika ako se liječite:
English: • While you are taking Efient:
Croatian: • Dok uzimate Efient:
English: Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient.
Croatian: Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate Efient.
English: 81366 Munich
Croatian: 81366 München
English: What you need to know before you take Efient
Croatian: Što morate znati prije nego počnete uzimati Efient
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Croatian: Ta bi interakcija mogla biti povezana sa smanjenim gastrointestinalnim motilitetom te bi mogla vrijediti i za druge opioide.
English: The benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study.
Croatian: Korist od primjene prasugrela vidjela se već u prva 3 dana i trajala je do kraja ispitivanja.
English: • Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body.
Croatian: • iznenadnu utrnulost ili slabost u ruci, nozi ili na licu, osobito ako je zahvaćena samo jedna strana tijela
English: Excipient(s) with known effect
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom
English: Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
Croatian: Vaš liječnik može zatražiti da privremeno prestanete uzimati Efient zbog povećanog rizika od krvarenja.
English: Therefore, platelets are essential to help stop bleeding.
Croatian: Zato su trombociti neophodni za zaustavljanje krvarenja.
English: The safety and efficacy of Efient in children below age 18 has not been established.
Croatian: Sigurnost i djelotvornost lijeka Efient u djece mlađe od 18 godina nisu ustanovljene.
English: You may take Efient with or without food.
Croatian: Efient možete uzimati s hranom ili bez nje.
English: Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Croatian: Bolesnike treba upozoriti da obavijeste liječnika ili stomatologa da uzimaju prasugrel prije planiranja bilo kojeg kirurškog zahvata i prije početka uzimanja bilo kojeg novog lijeka.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban hazard za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i toksičnosti vezane za reprodukciju.
English: Frequencies are defined as follows:
Croatian: Učestalost je definirana kako slijedi:
English: Because animal reproduction studies are not always predictive of a human response, Efient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Croatian: Budući da se iz ispitivanja reprodukcije na životinjama ne može uvijek predvidjeti odgovor u ljudi, Efient se tijekom trudnoće smije primjenjivati samo ako moguća korist za majku opravdava mogući rizik za plod.
English: If you take more Efient than you should
Croatian: Ako uzmete više Efient tableta nego što ste trebali
English: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Croatian: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Španjolska
English: These patients may have an increased bleeding risk.
Croatian: Ovi bolesnici mogu imati povećan rizik od krvarenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 February 2009
Croatian: Datum provog odobrenja: 25. veljače 2009.
English: Platelets are very small cell particles that circulate in the blood.
Croatian: Trombociti (krvne pločice) su vrlo male stanice koje cirkuliraju u krvi.
English: In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study.
Croatian: U fazi III kliničkog ispitivanja je u 437 bolesnika tijekom ispitivanja učinjen CABG.
English: • If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Efient.
Croatian: • Ako ste imali alergijske reakcije (reakcije preosjetljivosti) na klopidogrel ili bilo koji drugi antitrombocitni lijek, molimo obavijestite o tome svog liječnika prije početka liječenja lijekom Efient.
English: CABG-related bleeding
Croatian: Krvarenje vezano uz CABG