natgillin/translations-raw huggingface dataset:
k. Fatigue is a composite term that includes fatigue and asthenia. 
k. Utrujenost je sestavljen izraz, ki vključuje utrujenost in astenijo.
LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles 
Zdravilo LIBTAYO je bistra do rahlo opalescentna ter brezbarvna do bledo rumena raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
LIBTAYO 350 mg concentrate for solution for infusion. 
LIBTAYO 350 mg koncentrat za raztopino za infundiranje
• Visually inspect medicinal product for particulate matter and discoloration prior to administration. 
• Zdravilo pred dajanjem preglejte glede delcev ali obarvanja.
• infusion-related reactions 
• z infundiranjem povezane reakcije
Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hypothyroidism. 
Hipotiroidizem se je pojavil pri 42 (7,1 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom s hipotiroidizmom 3. stopnje.
Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term 
Preglednica 2: Seznam neželenih učinkov pri bolnikih, zdravljenih s cemiplimabom, v preglednici
Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 11 (1.9%) of 591 patients. 
Imunsko pogojeni pnevmonitis je povzročil trajno prenehanje uporabe cemiplimaba pri 11 (1,9 %) od 591 bolnikov.
Encephalitis 
Encefalitis
Animal reproduction studies have not been conducted with cemiplimab. 
S cemiplimabom niso izvedli študij o vplivu na sposobnost razmnoževanja pri živalih.
Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeni hipofizitis (glejte poglavje 4.8).
Each vial contains 350 mg of cemiplimab in 7 ml. 
Ena viala vsebuje 350 mg cemiplimaba v 7 ml.
Immune-related hepatitis occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 5, 1 (0.2%) patient with Grade 4, and 9 (1.5%) patients with Grade 3 immune-related hepatitis. 
Imunsko pogojeni hepatitis se je pojavil pri 11 (1,9 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom z imunsko pogojenim hepatitisom 5. stopnje, 1 (0,2 %) 4. stopnje in 9 (1,5 %) 3. stopnje.
Immune-related nephritis 
Imunsko pogojeni nefritis
Hrvatska sanofi-aventis Croatia d.o.o. 
România sanofi-aventis Croatia d.o.o.
• diarrhoea (loose stools). 
• driska (redko blato)
Dose modification 
Prilagoditve odmerka
6 months 
6.3 Rok uporabnosti
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. 
• Težave z jetri (hepatitis), na primer porumenelost kože ali očesnih beločnic, huda slabost (siljenje na bruhanje) ali bruhanje, bolečine na desni strani trebuha, zaspanost, temen urin (takšne barve kot čaj), večjo nagnjenost k podplutbam ali krvavitvam kot po navadi in manjši občutek lakote kot po navadi.
Skin and subcutaneous skin disorders Rashg 
Bolezni kože in podkožja Izpuščajg
The infusion should be stopped and cemiplimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions (see section 4.2). 
V primeru hudih (3. stopnja) ali življenjsko nevarnih (4. stopnja) z infundiranjem povezanih reakcij je treba infundiranje končati in zdravljenje s cemiplimabom trajno prenehati (glejte poglavje 4.2).
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. 
Imunsko pogojeni neželeni učinki na kožo so se pojavili pri 12 (2,0 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno s 6 (1,0 %) bolniki z imunsko pogojenimi kožnimi neželenimi učinki 3. stopnje.
22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22). 
Med 22 bolniki z napredovalim PCKK in PD-L1 < 1 % je bil ORR po oceni neodvisnega centralnega pregleda
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) 
2. stopnja, ki traja več kot 1 teden, 3. stopnja ali sum na StevensJohnsonov sindrom (SJS) ali toksično epidermalno nekrolizo (TEN)
Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism. 
Hipertiroidizem se je pojavil pri 11 (1,9 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom s hipertiroidizmom 3. stopnje.
Specific metabolism studies were not conducted because cemiplimab is a protein. 
Cemiplimab je beljakovina, zato specifičnih študij presnove niso izvedli.
How to store LIBTAYO 
Shranjevanje zdravila LIBTAYO
No patient discontinued cemiplimab due to hyperthyroidism. 
Zaradi hipertiroidizma ni cemiplimaba prenehal uporabljati noben bolnik.
Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali nadledvično insuficienco (glejte poglavje 4.8).
Eye disorders Keratitis 
Očesne bolezni Keratitis
Cemiplimab should be interrupted or the rate of infusion slowed for mild or moderate infusion-related reactions. 
V primeru blagih do zmernih z infundiranjem povezanih reakcij je treba infundiranje cemiplimaba prekiniti ali hitrost infundiranja upočasniti.
Skin adverse reactions 
Kožni neželeni učinki
Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and skin reaction. 
generaliziran izpuščaj, bulozni dermatitis, medikamentozno erupcijo, eritem, pemfigoid, psoriazo,
Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2). 
Bolnike je treba voditi s prilagoditvami zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis. 
Imunsko pogojeni nefritis se je pojavil pri 3 (0,5 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma z imunsko pogojenim nefritisom 3. stopnje.
Once prepared, administer the diluted solution immediately. 
Ko je razredčena raztopina pripravljena, jo nemudoma uporabite.
Interrupt or slow rate of infusion 
Prekinite infundiranje ali zmanjšajte hitrost infundiranja
LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles. 
Zdravilo LIBTAYO je bistra do rahlo opalescentna ter brezbarvna do bledorumena raztopina, ki lahko vsebuje prosojne ali bele delce v sledovih.
Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper 
Začetni odmerek od 2 do 4 mg/kg/dan prednizona (ali enakovredno) in nato postopno zmanjšanje odmerka
Similar exposures to cemiplimab are achieved with the doses of 350 mg every 3 weeks and 3 mg/kg every 2 weeks. 
Z odmerkoma 350 mg na 3 tedne in 3 mg/kg na 2 tedna je bila dosežena podobna izpostavljenost cemiplimabu.
Fatigue has been reported following treatment with cemiplimab (see section 4.8). 
Po zdravljenju s cemiplimabom so poročali o utrujenosti (glejte poglavje 4.8).
Cemiplimab should be withheld and anti-hyperglycaemics or insulin should be administered in patients with severe or life-threatening (Grade ≥ 3) hyperglycaemia. 
Pri bolnikih s hudo ali smrtno nevarno (≥ 3. stopnja) hiperglikemijo je treba zdravljenje s cemiplimabom prekiniti in uporabiti antihiperglikemična zdravila ali insulin.
Immune-related hepatitis led to permanent discontinuation of cemiplimab in 5 (0.8%) of 591 patients. 
Zaradi imunsko pogojenega hepatitisa je trajno prenehalo uporabljati cemiplimab 5 (0,8 %) od 591 bolnikov.
Immune-related adverse reactions can occur with cemiplimab. 
Med uporabo cemiplimaba se lahko pojavijo imunsko pogojeni neželeni učinki.
• joint pain, swelling, polyarthritis and joint effusion 
• bolečine v sklepih, oteklost sklepov, poliartritis in izliv v sklepih
Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojene endokrinopatije, opredeljene kot med zdravljenjem nastale endokrinopatije brez jasne alternativne etiologije (glejte poglavje 4.8).
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. 
Imunsko pogojena driska ali kolitis sta se pojavila pri 7 (1,2 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 2 (0,3 %) bolnikoma, ki sta imela imunsko drisko ali kolitis 3. stopnje.
Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients. 
Sladkorna bolezen tipa 1 je povzročila trajno prenehanje uporabe cemiplimaba pri 1 (0,2 %) od 591 bolnikov.
Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 1 (0.2%) patient with Grade 3 infusion-related reaction. 
Z infundiranjem povezane reakcije so se pojavile pri 54 (9,1 %) od 591 bolnikov, ki so prejemali cemiplimab, vključno z 1 (0,2 %) bolnikom z reakcijo 3. stopnje.
Thyroiditis 
Tiroiditis
Infusion-related reaction 
Z infundiranjem povezane reakcije
LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody. 
Kaj je zdravilo LIBTAYO in za kaj ga uporabljamo Zdravilo LIBTAYO je zdravilo proti raku, ki vsebuje učinkovino cemiplimab.
Patients with suspected pneumonitis should be evaluated with radiographic imaging as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids. 
Bolnike, pri katerih obstaja sum na pnevmonitis, je treba oceniti z radiološkim slikanjem, kot je indicirano glede na klinično oceno, ter jih nadalje voditi s prilagoditvijo zdravljenja s cemiplimabom ter s kortikosteroidi (glejte poglavje 4.2).
No dose adjustment of LIBTAYO is recommended for patients with renal impairment. 
Bolnikom z okvaro ledvic odmerka zdravila LIBTAYO ni treba prilagoditi.
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper 
Začetni odmerek od 1 do 2 mg/kg/dan prednizona (ali enakovredno) in nato postopno zmanjšanje odmerka
• Gut problems (colitis) 
• težave s črevesom (kolitis),
Immune system disorders Infusion-related reaction 
Bolezni imunskega sistema Z infundiranjem povezane reakcije Pogosti Sjögrenov sindrom
Severitya 
Izrazitosta
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 
Nadaljujte uporabo zdravila LIBTAYO, če se hepatitis izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno, ali če se AST ali ALT po dokončanem postopnem zmanjšanju odmerka kortikosteroida vrne na izhodiščno vrednost
Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis 
Imunsko pogojeni neželeni učinki (glejte poglavje 4.4)
Diarrhoea is a composite term that includes diarrhoea and colitis. 
Driska je sestavljen izraz, ki vključuje drisko in kolitis.
Each vial contains 350 mg of cemiplimab in 7 ml of solution. 
Ena viala vsebuje 350 mg cemiplimaba v 7 ml raztopine.
Do not shake the solution. 
Raztopine ne stresajte.
No patient discontinued cemiplimab due to hypothyroidism. 
Zaradi hipotiroidizma ni cemiplimaba prenehal uporabljati noben bolnik.
Patients should be monitored for signs and symptoms of hypophysitis and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2). 
Bolnike je treba spremljati glede znakov in simptomov hipofizitisa in jih voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
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 
Nadaljujte uporabo zdravila LIBTAYO, če se nadledvična insuficienca izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno ali je sicer klinično stabilna
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 
Nadaljujte uporabo zdravila LIBTAYO, če se hipofizitis izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno ali je sicer klinično stabilen
Immune-related skin adverse reactions led to permanent discontinuation of cemiplimab in 2 (0.3%) of 591 patients. 
Imunsko pogojeni neželeni učinki na kožo so povzročili trajno prenehanje uporabe cemiplimaba pri 2 (0,3 %) od 591 bolnikov.
Look out for these side effects while you are having LIBTAYO. 
Medtem ko prejemate zdravilo LIBTAYO, bodite pozorni na te neželene učinke.
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). 
Bolnike je treba spremljati glede znakov in simptomov driske ali kolitisa ter jih voditi s prilagoditvijo zdravljenja s cemiplimabom, z antidiaroičnimi zdravili in kortikosteroidi (glejte poglavje 4.2).
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). 
Bolnike je treba spremljati glede znakov in simptomov imunsko pogojenih neželenih učinkov in jih voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
Uncommon General disorders and administration site conditions Fatigue k 
Občasni Splošne težave in spremembe na mestu aplikacije Utrujenostk
Immune-related diarrhoea or colitis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients. 
Imunsko pogojena driska ali kolitis sta povzročila trajno prenehanje uporabe cemiplimaba pri 1 (0,2 %) od 591 bolnikov.
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). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeni pnevmonitis, opredeljen s potrebo po uporabi kortikosteroidov in brez jasne alternativne etiologije, vključno s primeri s smrtnim izidom (glejte poglavje 4.8).
Severe and fatal immune-related adverse reactions have been observed with cemiplimab (see section 4.8). 
Med uporabo cemiplimaba so opažali hude imunsko pogojene neželene učinke, tudi s smrtnim izidom (glejte poglavje 4.8).
Fertility 
Artritisj
• 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 
• vnetje živcev, ki povzroči mravljinčenje, omrtvičenost, šibkost ali pekoče bolečine v rokah ali nogah
Hepatobiliary disorders Hepatitis f 
Bolezni jeter, žolčnika in žolčevodov Hepatitisf
Immune-related nephritis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients. 
Imunsko pogojeni nefritis je povzročil trajno prenehanje uporabe cemiplimaba pri 1 (0,2 %) od 591 bolnikov.
Immune-related skin adverse reactions 
Imunsko pogojeni neželeni učinki na kožo
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). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeni hepatitis, opredeljen s potrebo po uporabi kortikosteroidov in brez jasne alternativne etiologije, vključno s primeri s smrtnim izidom (glejte poglavje 4.8).
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 
Nadaljujte uporabo zdravila LIBTAYO, če se kožna reakcija ali drugi imunsko pogojeni neželeni učinki izboljšajo in ostanejo na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno
Thyroid disorders (Hypothyroidism/Hyperthyroidism) Immune-related thyroid disorders have been observed in patients receiving cemiplimab. 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojene ščitnične motnje.
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). 
Bolnike je treba med zdravljenjem in po njem spremljati glede znakov in simptomov nadledvične insuficience in jih voditi s prilagoditvijo zdravljenja s cemiplimabom in s kortikosteroidi (glejte poglavje 4.2).
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. 
• Reakcije povezane z infundiranjem (včasih so lahko hude ali življenjsko nevarne), na primer mrzlico, tresenje ali zvišano telesno temperaturo, srbenje ali izpuščaj, zardevanje ali oteklost obraza, kratko sapo ali piskajoče dihanje, omotičnost ali občutek omedlevice ter bolečine v hrbtu ali vratu.
Pericarditis 
Perikarditis
Or 
ali
One ml of concentrate contains 50 mg of cemiplimab. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter koncentrata vsebuje 50 mg cemiplimaba.
LIBTAYO. 
ZMN
No patient discontinued cemiplimab due to adrenal insufficiency. 
Zaradi nadledvične insuficience ni cemiplimaba prenehal uporabljati noben bolnik.
LIBTAYO has not been studied in patients with moderate or severe hepatic impairment. 
Pri bolnikih z zmerno ali hudo okvaro jeter zdravilo LIBTAYO ni raziskano.
Resume LIBTAYO if pneumonitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent 
Nadaljujte uporabo zdravila LIBTAYO, če se pnevmonitis izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno
LIBTAYO 350 mg sterile concentrate cemiplimab 
IME ZDRAVILA IN POT(I) UPORABE LIBTAYO 350 mg sterilen koncentrat cemiplimab i.v.
No dose adjustment is recommended for patients with mild hepatic impairment. 
Bolnikom z okvaro jeter odmerka ni treba prilagoditi.
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 
Nadaljujte uporabo zdravila LIBTAYO, če se drugi imunsko pogojeni neželeni učinki izboljšajo in ostanejo na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno
ICR 
NCP
• inflammation of the liver 
• vnetje ledvic
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). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeno drisko ali kolitis, opredeljena s potrebo po uporabi kortikosteroidov in brez jasne alternativne etiologije (glejte poglavje 4.8).
Resume LIBTAYO if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent 
Nadaljujte uporabo zdravila LIBTAYO, če se kožna reakcija izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno
Gastrointestinal disorders Diarrhoea e 
Srčne bolezni Miokarditisd
Progression free survival (PFS) 
Preživetje brez napredovanja bolezni (PFS)a, c 6 mesecev 12 mesecev
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). 
Pri bolnikih, ki so prejemali cemiplimab, so opažali imunsko pogojeni nefritis, opredeljen s potrebo po uporabi kortikosteroidov in brez jasne alternativne etiologije (glejte poglavje 4.8).
ORR 
Hrvatska
• Infusion-related reactions 
• z infundiranjem povezane reakcije,
Resume LIBTAYO if nephritis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent 
Nadaljujte uporabo zdravila LIBTAYO, če se nefritis izboljša in ostane na 0. ali 1. stopnji po postopnem zmanjšanju odmerka kortikosteroida na ≤ 10 mg/dan prednizona ali enakovredno
Cardiac disorders Myocarditis d 
c Vključuje avtoimunski miokarditis in miokarditis.
Resume LIBTAYO when diabetes mellitus returns to Grade 0 to 1 or is otherwise clinically stable 
Uvedite zdravljenje z antihiperglikemičnimi zdravili, kot je klinično indicirano Nadaljujte uporabo zdravila LIBTAYO, ko se sladkorna bolezen vrne na 0. ali 1. stopnjo ali je sicer klinično stabilna
Resume LIBTAYO when hypothyroidism returns to Grade 0 to 1 or is otherwise clinically stable 
Uvedite nadomeščanje ščitničnih hormonov, kot je klinično indicirano Nadaljujte uporabo zdravila LIBTAYO, ko se hipotiroidizem vrne na 0. ali 1. stopnjo ali je sicer klinično stabilen
Immediate packaging 
Pot uporabe Stična ovojnina Velikost pakiranja
1.33 ml (150 mg/ml) 
200 mg Koncentrat za raztopino za infundiranje intravenska uporaba viala (steklena) 1,33 ml (150 mg/ml)
Intravenous use vial (glass) 
Pot uporabe Stična ovojnina
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 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V
United Kingdom Teva United Kingdom Limted 
Velika Britanija Teva United Kingdom Limted
United Kingdom Ennogen Limited 78 York Street 
Velika Britanija Ennogen Limited 78 York Street
Empreendimento Lagoas Park 
Lagoas Park
United Kingdom Actavis UK Limited Whiddon Valley 
Velika Britanija Actavis UK Limited Whiddon Valley
United Kingdom Amdipharm plc Regency House 
Velika Britanija Amdipharm plc Regency House
Labesfal - Laboratórios Almiro, S.A. 
Portugalska Labesfal - Laboratórios Almiro, S.A.
United Kingdom Accord Healthcare Ltd Sage House 
Velika Britanija Accord Healthcare Ltd Sage House
Laboratório MedinfarProdutos Farmacêuticos, S.A. l Ribeiro de Pavia, 1 - 1ºVenda Nova 2700-547 Amadora Portugal 
Portugalska Laboratório MedinfarProdutos Farmacêuticos, S.A. l Ribeiro de Pavia, 11º - Venda Nova 2700547 Amadora Portugal
United Kingdom Chelonia Healthcare Limited 
Velika Britanija Chelonia Healthcare Limited
United Kingdom Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin 
Velika Britanija Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin
83-200 Starogard Gdański Poland 
83-200 Starogard
Laboratório MedinfarProdutos Farmacêuticos, S.A. 
Portugalska Laboratório MedinfarProdutos Farmacêuticos, S.A.
Zona Industrial do Lagedo 3465-157 Santiago de Besteiros 
3465-157 Santiago de Besteiros
176 74 Kalithea - Athens Greece 
176 74 KalitheaAthens
Capsule, soft 
kapsula, mehka
Meda Pharma France 25, boulevard de l'Amiral Bruix 
Meda Pharma France 25, boulevard de l'Amiral Bruix 75016 Paris France
1 - 1 - Venda Nova 2700-547 Amadora Portugal 
2700-547 Amadora
ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 România 
S.C. ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti
Hampden Park, Eastbourne East Sussex BN22 9AG United Kingdom 
East Sussex BN22 9AG United Kingdom
United Kingdom Hameln Pharmaceuticals Limited 
Velika Britanija Hameln Pharmaceuticals Limited
Miles Gray Road, Basildon Essex SS14 3AF 
Miles Gray Road, Basildon
Primperan for adults suppository 20mg 
Primperan for adults suppository 20mg svečka rektalna uporaba