FrancophonIA/ELRC3.0 huggingface dataset:
English: Among the 7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months (range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 30 days (range: 4 days to 8.6 months).
Croatian: Među 7 bolesnika s imunološki uzrokovanim proljevom ili kolitisom medijan vremena do nastupa iznosio je 3,8 mjeseci (raspon: 15 dana do 6,0 mjeseci), dok je medijan trajanja imunološki uzrokovanog proljeva ili kolitisa iznosio 30 dana (raspon: 4 dana do 8,6 mjeseci).
English: Other immune-related adverse reactions
Croatian: Druge imunološki uzrokovane nuspojave
English: • diarrhoea (loose stools).
Croatian: • proljev (meka stolica)
English: • If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant: while you are being treated with LIBTAYO and for at least 4 months after the last dose.
Croatian: • Ako možete zatrudnjeti, morate koristiti učinkovitu metodu kontracepcije da biste izbjegli trudnoću:
English: It is unknown whether cemiplimab is secreted in human milk.
Croatian: Nije poznato izlučuje li se cemiplimab u majčino mlijeko.
English: Severitya
Croatian: Nuspojava
English: • Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat, such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding.
Croatian: vrućica, umor ili slabost, smetenost, poteškoće s pamćenjem ili pospanost, napadaji, halucinacije (kada čujete glasove ili vidite stvari kojih nema), promjene vida, bol u oku ili crvenilo oka, izrazita mišićna slabost, promjene srčanog ritma poput ubrzanih otkucaja srca ili osjećaja preskakanja ili lupanja srca te modrice na koži ili krvarenje
English: Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions.
Croatian: Imunološki uzrokovane kožne nuspojave javile su se u 12 (2,0%) od 591 bolesnika liječenog cemiplimabom, uključujući 6 (1,0%) bolesnika s imunološki uzrokovanim kožnim nuspojavama 3. stupnja.
English: Dosing delay or discontinuation may be required based on individual safety and tolerability.
Croatian: Ovisno o sigurnosti i podnošljivosti lijeka u pojedinog bolesnika, možda će biti potrebno odgoditi ili prekinuti primjenu lijeka.
English: Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis
Croatian: Imunološki uzrokovane nuspojave (vidjeti dio 4.4)
English: severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual.
Croatian: • jetrene tegobe (hepatitis) kao što su žuta boja kože ili bjeloočnica, jaka mučnina ili povraćanje, bol na desnoj strani trbuha (abdomena), pospanost, tamna mokraća (boje čaja), veća sklonost krvarenju ili nastanku modrica nego inače i manji osjećaj gladi nego inače
English: Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Croatian: Bolesnike treba zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
English: Immune-related adverse reactions can occur with cemiplimab.
Croatian: Kod primjene cemiplimaba mogu se javiti imunološki uzrokovane nuspojave.
English: Storage of diluted solution
Croatian: Čuvanje razrijeđene otopine
English: Skin adverse reactions
Croatian: Kožne nuspojave
English: Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Croatian: Početna doza od 2 - 4 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje
English: Sanofi S.p.A. Tel: 800.536 389
Croatian: Tel: 800.536 389
English: Immune-related diarrhoea or colitis occurred in 7 (1.2%) of 591 patients receiving cemiplimab including 2 (0.3%) with Grade 3 immune-related diarrhoea or colitis.
Croatian: Imunološki uzrokovan proljev ili kolitis javio se u 7 (1,2%) od 591 bolesnika liječenog cemiplimabom, uključujući 2 (0,3%) bolesnika s imunološki uzrokovanim proljevom ili kolitisom 3. stupnja.
English: Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism.
Croatian: Hipertireoza se javila u 11 (1,9%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s hipertireozom 3. stupnja.
English: Dose modification
Croatian: Prilagodbe doze
English: Tel: +39 02 39394275
Croatian: Sanofi S.p.A Tel: +39 02 39394275
English: Diarrhoea is a composite term that includes diarrhoea and colitis.
Croatian: e Proljev je skupni pojam koji obuhvaća proljev i kolitis.
English: Each vial contains 350 mg of cemiplimab in 7 ml.
Croatian: Jedna bočica sadrži 350 mg cemiplimaba u 7 ml.
English: Resume LIBTAYO if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Croatian: Nastaviti primjenu lijeka LIBTAYO ako se hipofizitis poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan ili ako je bolesnikovo stanje inače klinički stabilno
English: Endocrine disorders Hypothyroidism
Croatian: Poremećaji štitnjače (hipotireoza/hipertireoza)
English: Resolution had occurred in 6 (50%) of 12 patients at the time of data cut-off.
Croatian: Do trenutka prekida prikupljanja podataka kožne su se nuspojave povukle u 6 (50%) od 12 bolesnika.
English: 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Croatian: Mora se primjenjivati intravenskom infuzijom u trajanju od 30 minuta, kroz intravensku liniju sa sterilnim, nepirogenim ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličine pora od 0,2 do 5 mikrometara).
English: Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Croatian: Početna doza od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje
English: Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan hipofizitis (vidjeti dio 4.8).
English: Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažena je insuficijencija nadbubrežne žlijezde (vidjeti dio 4.8).
English: • Kidney problems (nephritis and kidney failure)
Croatian: • bubrežne tegobe (nefritis i zatajivanje bubrega)
English: Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažene su imunološki uzrokovane endokrinopatije, definirane kao endokrinopatije koje su se javile tijekom liječenja i nisu imale jasnu drugu etiologiju (vidjeti dio 4.8).
English: Duration of response (DOR)
Croatian: Trajanje odgovora a
English: • inflammation of the liver
Croatian: • upala jetre
English: Infusion-related reactions
Croatian: Reakcije na infuziju
English: Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis.
Croatian: Imunološki uzrokovan nefritis javio se u 3 (0,5%) od 591 bolesnika liječenog cemiplimabom, uključujući 2 (0,3%) bolesnika s imunološki uzrokovanim nefritisom 3. stupnja.
English: Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Croatian: Šećerna bolest tipa 1 dovela je do trajnog prekida liječenja cemiplimabom u 1 (0,2%) od 591 bolesnika.
English: Stomatitis
Croatian: Doziranje
English: • inflammation of the mouth
Croatian: • upala bubrega
English: Eye disorders Keratitis
Croatian: Poremećaji oka keratitis manje često
English: IV
Croatian: ND
English: Once prepared, administer the diluted solution immediately.
Croatian: Razrijeđenu otopinu treba primijeniti odmah nakon pripreme.
English: Tel: +40 (0) 21 317 31 36
Croatian: Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
English: Among
Croatian: Međutim,
English: Immune-related diarrhoea or colitis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Croatian: Imunološki uzrokovan proljev ili kolitis doveo je do trajnog prekida liječenja cemiplimabom u 1 (0,2%) od 591 bolesnika.
English: Immune-related nephritis
Croatian: Imunološki uzrokovan nefritis
English: Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma insuficijencije nadbubrežne žlijezde tijekom i nakon liječenja te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
English: Patients with suspected pneumonitis should be evaluated with radiographic imaging as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids.
Croatian: U bolesnika u kojih se sumnja na pneumonitis treba provesti radiografsko oslikavanje, kada je to indicirano na temelju kliničke ocjene, te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
English: Immune-related skin adverse reactions led to permanent discontinuation of cemiplimab in 2 (0.3%) of 591 patients.
Croatian: Imunološki uzrokovane kožne nuspojave dovele su do trajnog prekida liječenja cemiplimabom u 2 (0,3%) od 591 bolesnika.
English: Resume LIBTAYO if other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Croatian: Nastaviti primjenu lijeka LIBTAYO ako se druga imunološki uzrokovana nuspojava poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan
English: Immune-related nephritis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Croatian: Imunološki uzrokovan nefritis doveo je do trajnog prekida liječenja cemiplimabom u 1 (0,2%) od 591 bolesnika.
English: shaking or fever, itching or rash, flushing or swollen face, being short of breath or wheezing, feeling dizzy or feel like passing out and back or neck pain.
Croatian: • reakcije na infuziju (koje ponekad mogu biti teške ili opasne po život) kao što su zimica, drhtanje ili vrućica, svrbež ili osip, navale crvenila ili oticanje lica, nedostatak zraka ili piskanje pri disanju, omaglica ili nesvjestica te bol u leđima ili vratu
English: e.
Croatian: a.
English: • eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light • inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs
Croatian: • upala živaca koja uzrokuje trnce, utrnulost, slabost ili žareću bol u rukama ili nogama
English: Resume LIBTAYO if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper
Croatian: Početna doza od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje Nastaviti primjenu lijeka LIBTAYO ako se hepatitis poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan ili ako se AST ili ALT vrate na početnu vrijednost nakon dovršenog smanjenja doze kortikosteroida
English: How you are given LIBTAYO 4.
Croatian: Kako ćete primati LIBTAYO
English: Immune-related skin adverse reactions
Croatian: Imunološki uzrokovane kožne nuspojave
English: Similar exposures to cemiplimab are achieved with the doses of 350 mg every 3 weeks and 3 mg/kg every 2 weeks.
Croatian: I uz dozu od 350 mg svaka 3 tjedna i uz dozu od 3 mg/kg svaka 2 tjedna postiže se slična izloženost cemiplimabu.
English: Patients should be monitored for signs and symptoms of hypophysitis and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma hipofizitisa te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
English: Adrenal insufficiency occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 adrenal insufficiency.
Croatian: Insuficijencija nadbubrežne žlijezde javila se u 3 (0,5%) od 591 bolesnika liječenog cemiplimabom, uključujući 1 (0,2%) bolesnika s insuficijencijom nadbubrežne žlijezde 3. stupnja.
English: Nephritis
Croatian: Nefritis
English: Immune-related pneumonitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan pneumonitis, uključujući i slučajeve sa smrtnim ishodom, definiran kao pneumonitis koji je zahtijevao primjenu kortikosteroida i nije imao jasnu drugu etiologiju (vidjeti dio 4.8).
English: Each vial contains 350 mg of cemiplimab in 7 ml of solution.
Croatian: Jedna bočica sadrži 350 mg cemiplimaba u 7 ml otopine.
English: Immune-related hepatitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan hepatitis, uključujući i slučajeve sa smrtnim ishodom, definiran kao hepatitis koji je zahtijevao primjenu kortikosteroida i nije imao jasnu drugu etiologiju, (vidjeti dio 4.8).
English: Patients should be monitored for signs and symptoms of immune-related adverse reactions and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma imunološki uzrokovanih nuspojava te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom kortikosteroida (vidjeti dio 4.2).
English: Fatigue has been reported following treatment with cemiplimab (see section 4.8).
Croatian: Nakon primjene cemiplimaba prijavljen je umor (vidjeti dio 4.8).
English: Immune-related nephritis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan nefritis, definiran kao nefritis koji je zahtijevao primjenu kortikosteroida i nije imao jasnu drugu etiologiju (vidjeti dio 4.8).
English: Immune-related diarrhoea or colitis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Croatian: U bolesnika koji su primali cemiplimab opažen je imunološki uzrokovan proljev ili kolitis, definiran kao proljev ili kolitis koji je zahtijevao primjenu kortikosteroida i nije imao jasnu drugu etiologiju (vidjeti dio 4.8).
English: • Visually inspect the medicinal product for particulate matter and discoloration prior to administration.
Croatian: • Prije primjene vizualno pregledajte lijek kako biste utvrdili sadrži li strane čestice i je li promijenio boju.
English: Patients should be monitored for signs and symptoms of diarrhoea or colitis and managed with cemiplimab treatment modifications, anti-diarrhoeal agents, and corticosteroids (see section 4.2).
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma proljeva ili kolitisa te ih zbrinuti prilagodbom liječenja cemiplimabom i primjenom antidijaroika i kortikosteroida (vidjeti dio 4.2).
English: Adrenal insufficiency
Croatian: Insuficijencija nadbubrežne žlijezde
English: Thyroid disorders (Hypothyroidism/Hyperthyroidism) Immune-related thyroid disorders have been observed in patients receiving cemiplimab.
Croatian: U bolesnika koji su primali cemiplimab opaženi su imunološki uzrokovani poremećaji štitnjače.
English: PD-L2.
Croatian: PRILOG II.
English: • joint pain, swelling, polyarthritis and joint effusion
Croatian: • bol u zglobovima, oticanje zglobova, poliartritis i izljev u zglob
English: Polysorbate 80
Croatian: L-prolin polisorbat 80 voda za injekcije
English: Central nervous system inflammation Uncommon Neuropathy peripheral c
Croatian: Guillain-Barréov sindrom manje često upala u središnjem živčanom sustavu manje često periferna neuropatija c manje često miastenija gravis manje često
English: Resume LIBTAYO if adrenal insufficiency improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Croatian: Početna doza od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje Nastaviti primjenu lijeka LIBTAYO ako se insuficijencija nadbubrežne žlijezde poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan ili ako je bolesnikovo stanje inače klinički stabilno
English: ICR
Croatian: k
English: Immune-related adverse reactions
Croatian: Imunološki uzrokovane nuspojave
English: Warnings and precautions Talk to your doctor or nurse before you are given LIBTAYO if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije nego primite LIBTAYO:
English: Resume LIBTAYO if skin reaction or other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Croatian: Odmah uvesti simptomatsko liječenje, koje uključuje početnu dozu od 1 - 2 mg/kg prednizona ili ekvivalenta na dan, koja se zatim postupno smanjuje Nastaviti primjenu lijeka LIBTAYO ako se kožna reakcija ili druga imunološki uzrokovana nuspojava poboljša do 0. - 1. stupnja i ostane na toj razini nakon smanjenja doze kortikosteroida na ≤ 10 mg prednizona ili ekvivalenta na dan
English: Resume LIBTAYO when diabetes mellitus returns to Grade 0 to 1 or is otherwise clinically stable
Croatian: Uvesti liječenje antihiperglikemicima sukladno kliničkoj indikaciji Nastaviti primjenu lijeka LIBTAYO kada se šećerna bolest vrati na 0. - 1. stupanj ili ako je bolesnikovo stanje inače klinički stabilno
English: Immune-related colitis
Croatian: Imunološki uzrokovan kolitis
English: Immediate packaging
Croatian: Veličina pakovanja
English: 200 mg Concentrate for solution for infusion
Croatian: 200 mg Koncentrat za otopinu za infuziju
English: 1.33 ml (150 mg/ml)
Croatian: Intravenska primjena bočica (staklena) 1,33 ml (150 mg/ml)
English: United Kingdom Teva United Kingdom Limted
Croatian: Teva United Kingdom Limted
English: Moll de Barcelona s/n World Trade Centre Edifici Est 6ª planta 08039 Barcelona Spain
Croatian: Moll de Barcelona s/n World Trade Centre Edifici Est 6ª planta 08039 Barcelona
English: Nicosia, CY-1060
Croatian: Nicosia, CY-1060 Cyprus
English: United Kingdom Crescent Pharma Limited Units 3 & 4
Croatian: Crescent Pharma Limited Units 3 & 4
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Croatian: Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
English: Luxembourg Eurogenerics s.a. Heizel Esplanade B22
Croatian: Luksemburg Eurogenerics s.a. Heizel Esplanade B22
English: United Kingdom Generics (United Kingdom) Limited
Croatian: Generics (United Kingdom) Limited
English: Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov România
Croatian: Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov Romania
English: Luxembourg Hexal AG Industriestr.
Croatian: Luksemburg Hexal AG Industriestr.
English: Czech Republic Hexal AG Industriestrasse 25
Croatian: Češka Republika Hexal AG Industriestrasse 25
English: Station Close, Potters Bar Hertfordshire EN6 1TL
Croatian: Station Close, Potters Bar Hertfordshire EN6 1TL United Kingdom
English: Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland
Croatian: Finska sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland
English: Str. Logofăt Tăutu, nr. 99 sector 3, Bucureşti 031212 Romania
Croatian: Logofăt Tăutu, nr. 99 sector 3, Bucureşti 031212 Romania
English: Luxembourg Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles
Croatian: Luksemburg Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles
English: Abbott Products GmbH Perfektastraße 84A 1230 Wien
Croatian: Products GmbH Perfektastraße 84A 1230 Wien
English: Sopharma PLC 16 Iliensko Shosse Str. Sofia
Croatian: Sopharma PLC 16 Iliensko Shosse Str.
English: S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca 400632 România
Croatian: S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca 400632 Romania
English: 08019 Barcelona Spain
Croatian: 08019 Barcelona
English: 82102 Bratislava
Croatian: 82102 Bratislava Slovakia
English: 0.526% w/v
Croatian: 0,526% m/v
English: Polhampton Lane, Overton Hampshire RG25 3ED
Croatian: Polhampton Lane, Overton Hampshire RG25 3ED United Kingdom
English: 0.5% w/v
Croatian: 0,5% m/v
English: United Kingdom Chelonia Healthcare Limited
Croatian: Chelonia Healthcare Limited
English: Luxembourg Sanofi-Aventis Belgium Culliganlaan 1 C
Croatian: Luksemburg Sanofi-Aventis Belgium Culliganlaan 1 C
English: Hampden Park, Eastbourne East Sussex BN22 9AG United Kingdom
Croatian: Brampton Road Hampden Park, Eastbourne East Sussex BN22 9AG United Kingdom
English: United Kingdom Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ United Kingdom
Croatian: Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ United Kingdom
English: Laboratoire Renaudin Z A. Errobi
Croatian: Laboratoire Renaudin Z A.
English: Czech Republic Teva Pharmaceuticals CR, s.r.o.
Croatian: Češka Republika Teva Pharmaceuticals CR, s.r.o.
English: United Kingdom Actavis UK Limited Whiddon Valley
Croatian: Actavis UK Limited Whiddon Valley Barnstaple
English: 1000 Ljubljana
Croatian: 1000 Ljubljana Slovenia
English: Luxembourg Ratiopharm GMBH Arzneimittel
Croatian: Luksemburg Ratiopharm GMBH Arzneimittel
English: Accord Healthcare B.V. De Waterman 15 A 4891 TL Rijsbergen The Netherlands
Croatian: De Waterman 15 A 4891 TL Rijsbergen The Netherlands
English: United Kingdom Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin
Croatian: Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin Ireland
English: Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park Co. Dublin
Croatian: Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park Co.
English: ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 România
Croatian: Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 Romania
English: S.C. LAROPHARM S.R.L.
Croatian: S.C. LAROPHARM S.R.L. Şos.
English: spa Via Scandicci, 37 50143 Firenze Italy
Croatian: F.I.R.M.A. spa Via Scandicci, 37 50143 Firenze Italy
English: Slovak Republic TEVA Pharmaceuticals Slovakia s.r.o.
Croatian: TEVA Pharmaceuticals Slovakia s.r.o.
English: Alkaloid-INT d.o.o.
Croatian: Alkaloid-INT d.o.o. Ljubljana
English: 20 mg/spray
Croatian: 20 mg/sprej
English: Luxembourg Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1
Croatian: Luksemburg Dolorgiet Gmbh&Co Otto-von-Guericke-Str.
English: Capsule, soft
Croatian: Kapsula, meka
English: Concentrate for solution for infusion
Croatian: Koncentrat za otopinu za infuziju
English: United Kingdom Metwest Pharmaceuticals Limited
Croatian: Metwest Pharmaceuticals Limited
English: 10 mg/spray
Croatian: 10 mg/sprej
English: United Kingdom Rosemont Pharmaceuticals Limited
Croatian: Rosemont Pharmaceuticals Limited