FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredients are: gelatin (E441), glycerin (E422), sorbitol (E420), mannitol (E421), sorbitan, yellow iron oxide (E172), titanium dioxide (E171), purified water, macrogol 400 (E1521), sorbitan monooleate (E494), polysorbate 80 (E433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E1520), carmine (E120), brilliant blue FCF (E133) and ammonium hydroxide (E527).
Croatian: • Drugi sastojci su: želatina (E441), glicerin (E422), sorbitol (E420), manitol (E421), sorbitan, žuti željezov oksid (E172), titanijev dioksid (E171), pročišćena voda, makrogol 400 (E1521), sorbitanoleat (E494), polisorbat 80 (E433), etilni alkohol, izopropilni alkohol, poli(vinilacetatftalat), propilenglikol (E1520), carmine (E120), brilliant blue fcf (E133) i amonijev hidroksid (E527).
English: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Croatian: Vyndaqel je indiciran za terapiju transtiretinske amiloidoze u odraslih bolesnika s 1. stadijem simptomatske polineuropatije kako bi se odgodilo oštećenje perifernih živaca.
English: No dosage adjustment is required for patients with renal or mild and moderate hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega ili blagim i umjerenim oštećenjem jetre.
English: Capsule shell
Croatian: Meka kapsula
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: - non-steroidal anti-inflammatory drugs - diuretic medicines (e.g. furosemide, bumetanide) - anti-cancer medicines (e.g. methotrexate, imatinib) - statins (e.g. rosuvastatin) - anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine,
Croatian: - nesteroidne protuupalne lijekove - diuretičke lijekove (npr. furosemid, bumetanid) - lijekove protiv raka (npr. metotreksat, imatinib) - statine (npr. rosuvastatin) - antivirusne lijekove (npr. oseltamivir, tenofovir, ganciklovir, adefovir, cidofovir, lamivudin,
English: In vitro studies with tafamidis meglumine suggest that it is unlikely tafamidis meglumine will cause drug interactions at clinically relevant concentrations with substrates of UDP glucuronosyltransferase (UGT), P-gp transporters, or organic anion-transporting polypeptide transporters (OATP1B1 and 1B3).
Croatian: In vitro ispitivanja s tafamidismegluminom ukazuju da nije vjerojatno da će tafamidismeglumin uzrokovati interakcije lijekova pri klinički značajnim koncentracijama sa supstratima UDPglukuronoziltransferaze (UGT), transportera P-glikoproteina ili polipeptidnih transportera organskih aniona (OATP1B1 i 1B3).
English: If you stop taking Vyndaqel
Croatian: Ako prestanete uzimati Vyndaqel
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measure: Description
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Within the frequency group, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane prema opadajućoj ozbiljnosti.
English: • Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel.
Croatian: • Žene koje mogu zatrudnjeti moraju koristiti kontracepciju za vrijeme uzimanja Vyndaqela i moraju nastaviti koristiti kontracepciju tijekom jednog mjeseca nakon prestanka liječenja Vyndaqelom.
English: What Vyndaqel contains
Croatian: Što Vyndaqel sadrži
English: The capsule contains sorbitol (E420).
Croatian: Kapsula sadrži sorbitol (E420).
English: Tafamidis meglumine should not be used during breast-feeding.
Croatian: Тafamidismeglumin se ne bi trebao primjenjivati tijekom dojenja.
English: Macrogol 400 (E1521) Sorbitan monooleate (E494) Polysorbate 80 (E433)
Croatian: Sadržaj kapsule makrogol 400 (E1521) sorbitanoleat (E494) polisorbat 80 (E433)
English: The NOAEL for viability and growth in the F1 generation offspring following maternal treatment during pregnancy and lactation with tafamidis was 5 mg/kg (HED=0.8 mg/kg), a dose approximately 4.6-times the recommended dose.
Croatian: Doza bez zapaženog štetnog učinka na održivost na životu i rast potomstva F1 generacije nakon liječenja ženke tafamidisom tijekom trudnoće i laktacije bila je 5 mg/kg (HED=0,8 mg/kg), što je doza približno 4,6 puta veća od preporučene doze.
English: PFIZER ΕΛΛΑΣ Α.Ε.
Croatian: PFIZER ΕΛΛΑΣ A.E.,
English: Diarrhoea Upper abdominal pain
Croatian: Poremećaji probavnog sustava proljev bol u gornjem dijelu abdomena
English: A supra-therapeutic, single, 400 mg oral dose of tafamidis solution in healthy volunteers demonstrated no prolongation of the QTc interval.
Croatian: Jednokratna peroralna doza od 400 mg otopine tafamidisa, koja je veća od terapijske doze, u zdravih dobrovoljaca nije pokazala produljenje QTc-intervala.
English: Adverse reactions reported from the clinical programme in the tabular listing below reflect the rates at which they occurred in the Phase 3, double-blind, placebo-controlled study (Fx-005).
Croatian: Nuspojave navedene u tabličnom prikazu u nastavku odražavaju stope pojavljivanja u dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze III (Fx-005).
English: TTR amyloid polyneuropathy is a multi-faceted, progressive, axonal degenerative neuropathy characterized by sensory, motor and autonomic impairment.
Croatian: TTR amiloidna polineuropatija progresivna je degenerativna neuropatija aksona sa šarolikom kliničkom slikom, čije su značajke oštećenje senzoričkih, motoričkih i autonomnih živaca.
English: Health care professionals are asked to report any suspected adverse reactions.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu za ovaj lijek.
English: • The existence and scope of the Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program and the details how to report pregnancies in women who are being treated with Vyndaqel.
Croatian: Tafamidis Enhanced Surveillance for Pregnancy Outcomes - TESPO) i informacije o tome kako prijaviti trudnoću u žena koje se liječe Vyndaqelom.
English: If you take more Vyndaqel than you should
Croatian: Ako uzmete više Vyndaqela nego što ste trebali
English: Vyndaqel contains sorbitol (E420).
Croatian: Vyndaqel sadrži sorbitol (E420).
English: In a developmental toxicity study in rabbits, a slight increase in skeletal malformations and variations, abortions in few females, and reduction in foetal weights were observed at an AUC0-24 ratio of 3.2-fold, based on the human AUC at steady state.
Croatian: U ispitivanju razvojne toksičnosti u kunića, blago povećanje malformacija i varijacija kostura, pobačaji u malog broja ženki i smanjenje fetalne tjelesne težine opaženi su pri 3,2 puta većem AUC0-24 omjeru, na temelju AUC-a u ljudi pri ravnotežnoj koncentraciji.
English: Vyndaqel contains the active substance tafamidis.
Croatian: Vyndaqel sadrži djelatnu tvar tafamidis.
English: Likewise, tafamidis meglumine inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 µM and IC50=2.36 µM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine).
Croatian: Tafamidismeglumin ujedno inhibira transportere unosa, OAT1 i OAT3 (transportere organskih aniona) uz IC50 = 2,9 µM odnosno IC50 = 2,36 µM te može pri klinički značajnim koncentracijama uzrokovati interakcije lijekova sa supstratima tih transportera (npr. nesteroidni protuupalni lijekovi, bumetanid, furosemid, lamivudin, metotreksat, oseltamivir, tenofovir, ganciklovir, adefovir, cidofovir, zidovudin, zalcitabin).
English: • That physicians are encouraged to enter patients in the Transthyretin Amyloidosis Outcome Survey (THAOS) and provided with details how to enroll patients into this international disease registry
Croatian: Transthyretin Amyloidosis Outcome Survey - THAOS) te će dobiti detaljne informacije kako uključiti bolesnike u ovaj međunarodni registar bolesti.
English: There is no relevant use of tafamidis in the paediatric population.
Croatian: Nema relevantne primjene tafamidisa u pedijatrijskoj populaciji za navedenu indikaciju.
English: In the rat peri- and post-natal development study with tafamidis, decreased pup survival and reduced pup weights were noted following maternal treatment during pregnancy and lactation at doses of 15 and 30 mg/kg.
Croatian: U perinatalnom i postnatalnom ispitivanju tafamidisa u štakora, smanjeno preživljenje i smanjena tjelesna težina potomstva zabilježeni su nakon liječenja ženke tijekom trudnoće i laktacije dozama od 15 i 30 mg/kg.
English: Each soft capsule contains no more than 44 mg of sorbitol (E420).
Croatian: Jedna meka kapsula sadrži najviše 44 mg sorbitola (E420).
English: How to take Vyndaqel
Croatian: Kako uzimati Vyndaqel
English: The exposure to tafamidis in patients with severe hepatic impairment is unknown.
Croatian: Nije poznata izloženost tafamidisu u bolesnika s teškim oštećenjem jetre.
English: What Vyndaqel is and what it is used for
Croatian: Što je Vyndaqel i za što se koristi
English: If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible.
Croatian: U slučaju da nakon uzimanja doze nastupi povraćanje, a u povraćenom se sadržaju nađe cjelovita kapsula Vyndaqela, treba primijeniti dodatnu dozu Vyndaqela, ako je to moguće.
English: Excipients with known effect
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom
English: 4.5 Interaction with other medicinal products and other forms of interaction In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
Croatian: U kliničkom ispitivanju u zdravih dobrovoljaca tafamidismeglumin nije inducirao niti inhibirao enzim citokroma P450 CYP3A4.
English: What you need to know before you take Vyndaqel 3.
Croatian: Što morate znati prije nego počnete uzimati Vyndaqel
English: Annual Reassessment
Croatian: Godišnja procjena
English: 11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Results of once-daily dosing with tafamidis meglumine 20 mg for 14 days demonstrated that steadystate was achieved by Day 14.
Croatian: Rezultati doziranja tafamidismeglumina jedanput na dan u dozi od 20 mg tijekom 14 dana pokazali su da se stanje dinamičke ravnoteže postiglo do 14. dana.
English: 13 BATCH NUMBER
Croatian: 13. BROJ SERIJE
English: Following daily administration of a 20 mg dose of tafamidis meglumine for 14 days in healthy subjects, mean steady-state half-life was 59 h and mean total clearance was 0.42 l/h.
Croatian: Nakon svakodnevne primjene tafamidismeglumina u dozi od 20 mg tijekom 14 dana u zdravih ispitanika, prosječni poluvijek u stanju dinamičke ravnoteže iznosio je 59 sati a prosječni je ukupni klirens bio 0,42 l/h.
English: The recommended dose is one capsule (20 mg Tafamidis meglumine) of Vyndaqel once a day.
Croatian: Preporučena doza je jedna kapsula (20 mg tafamidismeglumina) Vyndaqela jedanput na dan.
English: Treatment should be initiated by and remain under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy.
Croatian: Terapiju treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s transtiretinskom amiloidnom polineuropatijom.
English: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis meglumine, and for one month after stopping treatment, due to the prolonged half life.
Croatian: Žene reproduktivne dobi moraju koristiti kontracepciju tijekom liječenja tafamidismegluminom i do mjesec dana nakon prestanka liječenja, zbog dugog poluvijeka ovog lijeka.
English: 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHTAND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Croatian: Na temelju farmakodinamičkog i farmakokinetičkog profila, smatra se da tafamidismeglumin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: 1 NAME OF MEDICINAL PRODUCT
Croatian: NAZIV LIJEKA
English: There are no data on the use of tafamidis meglumine in pregnant women.
Croatian: Nema podataka o primjeni tafamidismeglumina u trudnica.
English: The inhibition of transthyretin tetramer dissociation forms the rationale for the use of tafamidis to slow disease progression.
Croatian: Opravdanost primjene tafamidisa je inhibicija razdvajanja tetramera transtiretina kako bi se usporilo napredovanje bolesti.
English: 30 x 1 soft capsules.
Croatian: 30x1 mekih kapsula.
English: If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual.
Croatian: Ako se u povraćenom sadržaju ne nađe kapsula, nije potrebna dodatna doza i Vyndaqel se nastavlja uzimati sljedećeg dana prema uobičajenom rasporedu doziranja.
English: The capsule may be taken with or without food Instructions for opening the blisters
Croatian: Kapsula se može uzeti s hranom ili bez nje.
English: • Peel back the paper at the curved arrow to expose the aluminium foil.
Croatian: • odlijepite papir kod zakrivljene strelice kako biste otkrili aluminijsku foliju.
English: Vyndaqel 20 mg soft capsules
Croatian: Vyndaqel 20 mg meke kapsule
English: However, in vitro tafamidis meglumine inhibits the efflux transporter BCRP (breast cancer resistant protein) with IC50=1.16 µM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib).
Croatian: Breast Cancer Resistance Protein, protein koji uzrokuje rezistenciju raka dojke na lijekove) uz IC50 = 1,16 µM i može pri klinički značajnim koncentracijama uzrokovati interakcije lijekova sa supstratima tog transportera (npr. metotreksat, rosuvastatin, imatinib).
English: The dissociation of the transthyretin tetramer to monomers is the rate limiting step in the pathogenesis of TTR amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Croatian: Razdvajanje transtiretinskih tetramera u monomere korak je koji ograničava brzinu patogeneze TTR amiloidne polineuropatije, još poznate pod nazivom TTR obiteljska amiloidna polineuropatija (TTRFAP).
English: Soft capsule Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red.
Croatian: Žuta, neprozirna, duguljasta (približno 21 mm) kapsula s oznakom “VYN 20” otisnutom crvenom tintom.
English: Vyndaqel 20 mg soft capsules tafamidis meglumine
Croatian: Vyndaqel 20 mg meke kapsule tafamidismeglumin
English: 4 PHARMACEUTICAL FORM AND CONTENTS
Croatian: OBLIK I SADRŽAJ
English: Pack of 30 x 1 soft capsules - WITH BLUE BOX
Croatian: Pakiranje od 30x1 mekih kapsula - S PLAVIM OKVIROM
English: Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Croatian: Veličine pakiranja: pakiranje od 30x1 mekih kapsula i višestruko pakiranje koje sadrži 90 (3 pakiranja od 30x1) mekih kapsula.
English: If you forget to take Vyndaqel
Croatian: Ako ste zaboravili uzeti Vyndaqel
English: Vyndaqel is a medicine which treats a disease called Transthyretin (TTR) amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Croatian: Vyndaqel je lijek kojim se liječi transtiretinska (TTR) amiloidna polineuropatija, bolest još poznata pod nazivom TTR obiteljska amiloidna polineuropatija (TTR-FAP).
English: NA=Not applicable
Croatian: NP = nije primjenjivo.
English: Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) imprinted with “VYN 20” in red.
Croatian: Vyndaqel meke kapsule su žute boje, neprozirne, duguljaste (približno 21 mm) s oznakom “VYN 20” otisnutom crvenom tintom.
English: There is no explicit evidence of biliary excretion of tafamidis in humans.
Croatian: Nema jasnog dokaza da se tafamidis u ljudi izlučuje putem žuči.
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) In the pre-specified ITT NIS-LL Responder analysis, patients who discontinued prior to the 18-month time point due to liver transplantation were categorized as non-responders.
Croatian: TQOL promjena od početne srednje vrijednosti najmanjih kvadrata (SE) Razlika u srednjoj vrijednosti najmanjih kvadrata (SE) 95% CI razlike (p-vrijednost) U unaprijed određenoj analizi bolesnika planiranih za liječenje koji su prema ljestvici NIS-LL odgovorili na liječenje, bolesnici koji su prekinuli ispitivanje prije isteka 18 mjeseci zbog presađivanja jetre svrstani su u kategoriju bolesnika bez odgovora.
English: 30 x 1 soft capsules
Croatian: 30x1 mekih kapsula
English: The primary outcome measures were the Neuropathy Impairment Score of the Lower Limb (NIS-LL - a physician assessment of the neurologic exam of the lower limbs) and the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN - a patient reported outcome, total quality of life score [TQOL]).
Croatian: Norfolk Quality of Life - Diabetic Neuropathy [Norfolk QOL-DN], što je ishod prema procjeni samog bolesnika, ukupni broj bodova za kvalitetu života (engl. total quality of life score [TQOL])).
English: Multipack: 90 (3 packs of 30 x 1) soft capsules.
Croatian: Višestruko pakiranje: 90 (3 pakiranja od 30x1) mekih kapsula.
English: Vyndaqel is for oral use.
Croatian: Vyndaqel je namijenjen za primjenu kroz usta.
English: Tafamidis meglumine should be added to the standard of care for the treatment of the transthyretin familial amyloid polyneuropathy (TTR-FAP) patient.
Croatian: Tafamidismeglumin treba dodati standardnoj njezi u liječenju bolesnika s transtiretinskom obiteljskom amiloidnom polineuropatijom (engl. transthyretin familial amyloid polyneuropathy, TTR-FAP).
English: (CYPRUS BRANCH), Τηλ: +357 22 817690
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Pfizer Innovations AB Τηλ: +357 22 817690
English: Following 18 months of treatment, more tafamidis meglumine-treated patients were NIS-LL Responders (change of less than 2 points on NIS-LL) Outcomes for the pre-specified analyses of the primary endpoints are provided in the following table:
Croatian: Nakon 18 mjeseci terapije, više je bolesnika liječenih tafamidismegluminom imalo terapijski odgovor mjereno ljestvicom NIS-LL (promjena za manje od 2 boda na ljestvici NIS-LL).
English: Pfizer Croatia d.o.o.
Croatian: Pfizer Polska Sp. z o.o.,
English: 5 METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: • Stomach ache or abdominal pain
Croatian: • bol u želucu ili trbuhu
English: Pack of 30 - for multipack of 90 (3 packs of 30 x 1) soft capsules - WITHOUT BLUE BOX
Croatian: Pakiranje od 30 - za višestruko pakiranje od 90 (3 pakiranja od 30x1) mekih kapsula - BEZ PLAVOG OKVIRA
English: Gelatin (E441) Glycerin (E422) Yellow iron oxide (E172) Sorbitan
Croatian: Ovojnica kapsule želatina (E441) glicerin (E422) željezov oksid, žuti (E172) sorbitan sorbitol (E420) manitol (E421) titanijev dioksid (E171) pročišćena voda
English: • Tear off one individual blister from the blister card along the perforated line.
Croatian: • uzduž perforirane linije blistera odvojite jedan pojedinačni dio blistera s jednom kapsulom.
English: België/Belgique/Belgien Pfizer S.A. / N.V.
Croatian: Pfizer S.A. / N.V.
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) Pre-specified Efficacy Evaluable Analysis
Croatian: Odgovorili prema ljestvici NIS-LL (% bolesnika) Razlika (Vyndaqel minus Placebo) 95% CI razlike (p-vrijednost)
English: Multipack of 90 (3 packs of 30 x 1) soft capsules - WITH BLUE BOX
Croatian: Višestruko pakiranje od 90 (3 pakiranja od 30x1) mekih kapsula - S PLAVIM OKVIROM
English: Each capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis.
Croatian: Jedna kapsula sadrži 20 mg tafamidismeglumina što odgovara 12,2 mg tafamidisa.
English: Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.
Croatian: Jedna meka kapsula sadrži 20 mg mikroniziranog tafamidismeglumina što odgovara 12,2 mg tafamidisa.
English: Danmark Pfizer ApS Tlf: +45 44 20 11 00
Croatian: Tlf: +45 44 20 11 00
English: Secondary Endpoints Changes from Baseline to Month 18 LSMean (Standard Error) (Intentto-Treat Population) (Study Fx-005) Placebo N=61
Croatian: Sekundarne mjere ishoda promjene srednje vrijednosti najmanjih kvadrata (standardna pogreška, engl. SE) od početnih vrijednosti do vrijednosti nakon 18 mjeseci (populacija s namjerom liječenja) (Ispitivanje Fx-005)
English: Perforated unit dose blisters of 10 x 20 mg Vyndaqel soft capsules
Croatian: Perforirani blister s jediničnim dozama s 10 mekih kapsula koje sadrže po 20 mg Vyndaqela
English: 2 STATEMENT OF ACTIVE SUBSTANCES
Croatian: POPIS POMOĆNIH TVARI
English: Each soft capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis
Croatian: Jedna meka kapsula sadrži 20 mg tafamidismeglumina što odgovara 12,2 mg tafamidisa.
English: 12 MARKETING AUTHORISATION NUMBER(S)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: INNER CARTON
Croatian: UNUTARNJA KUTIJA
English: 9 SPECIAL STORAGE CONDITIONS
Croatian: POSEBNE MJERE ČUVANJA
English: United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
Croatian: Tel: +44 (0)1304 616161
English: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
Croatian: farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
English: Brilliant Blue FCF (E133) Ammonium hydroxide (E527) 28%
Croatian: Tinta za označivanje (Opacode ljubičasta) etilni alkohol izopropilni alkohol pročišćena voda makrogol 400 (E1521) poli(vinilacetatftalat) propilenglikol (E1520) carmine (E120) brilliant Blue FCF (E133) amonijev hidroksid (E527) 28%
English: 4.4 Special warnings and precautions for use Women of childbearing potential should use appropriate contraception when taking tafamidis meglumine and continue to use appropriate contraception for 1-month after stopping treatment with tafamidis meglumine (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom uzimanja tafamidismeglumina i do mjesec dana nakon prestanka liječenja tafamidismegluminom (vidjeti dio
English: 2 NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: What you need to know before you take Vyndaqel Do not take Vyndaqel
Croatian: Što je Vyndaqel i za što se koristi Što morate znati prije nego počnete uzimati Vyndaqel Kako uzimati Vyndaqel
English: Pfizer Innovations AB Tel: +46 (0)8 550 520 00
Croatian: Tel: +46 (0)8 550 520 00
English: Luxembourg/Luxemburg Pfizer S.A.
Croatian: Pfizer Luxembourg SARL
English: Pfizer Healthcare Ireland Tel: +353 1800 633 363 (toll free) Tel: +44 (0)1304 616161
Croatian: Tel: +353 1800 633 363 (toll free)
English: 5 PHARMACOLOGIC PROPERTIES
Croatian: FARMAKOLOŠKA SVOJSTVA
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/11/717/001
Croatian: EU/1/11/717/001 EU/1/11/717/002
English: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
Croatian: Pfizer Croatia d.o.o. Tel: + 385 1 3908 777
English: NA
Croatian: Co.
English: 14 GENERAL CLASSIFICATION FOR SUPPLY
Croatian: 14. NAČIN IZDAVANJA LIJEKA