FrancophonIA/ELRC3.0 huggingface dataset:
English: A 52-week, single arm extension study to the placebo-controlled and “switch” studies described above was conducted to characterise the long term safety and efficacy of Parsabiv in 891 SHPT patients with CKD on haemodialysis.
Slovenian: Podaljšana študija je imela eno samo skupino in je bila izvedena za ugotavljanje dolgoročne varnosti in učinkovitosti zdravila Parsabiv pri 891 bolnikih s KLB in SHPT na hemodializi.
English: No body weight, gender, age, or race-related pharmacokinetic differences have been observed in adult patients studied.
Slovenian: Pri proučenih odraslih bolnikih niso opazili nobenih farmakokinetičnih razlik, ki bi bile povezane s telesno maso, spolom, starostjo ali raso.
English: The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target.
Slovenian: Zdravilo Parsabiv je treba titrirati tako, da so odmerki individualno prilagojeni med 2,5 mg in 15 mg. Odmerek je mogoče povečevati v korakih po 2,5 mg ali 5 mg, vendar ne pogosteje kot na 4 tedne, do največjega odmerka 15 mg 3-krat na teden, tako da je dosežena želena ciljna koncentracija paratiroidnega hormona (PTH).
English: If the patient's last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥ 8.3 mg/dL (2.08 mmol/L).
Slovenian: Če je bil bolnikov nazadnje uporabljeni odmerek 2,5 mg, se lahko zdravilo Parsabiv ponovno uvede v odmerku 2,5 mg, če je PTH > 300 pg/ml (31,8 pmol/l), najnovejši izvid cCa v serumu pred dializo pa ≥ 8,3 mg/dl (2,08 mmol/l).
English: The expected pharmacological effect of decreased PTH and calcium in blood were observed in animal studies at clinical exposure levels.
Slovenian: V študijah na živalih so ob klinični ravni izpostavljenosti opažali pričakovani farmakološki učinek, znižanje PTH in kalcija v krvi.
English: Each vial contains 2 mL solution for injection.
Slovenian: Ena viala vsebuje 2 ml raztopine za injiciranje.
English: In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small glands in the neck).
Slovenian: Pri sekundarnem hiperparatiroidizmu obščitnične žleze (štiri majhne žleze v vratu) izdelujejo preveč hormona PTH. "Sekundarni" pomeni, da hiperparatiroidizem povzroča neka druga bolezen, npr. bolezen ledvic.
English: Each vial contains 1 mL solution for injection.
Slovenian: Ena viala vsebuje 1 ml raztopine za injiciranje.
English: Hypocalcaemia1, 5
Slovenian: Pogosti hipokalciemija1, 5 hiperkaliemija2 hipofosfatemija
English: • Vomiting
Slovenian: • Bruhanje
English: Mean (SE) baseline PTH concentrations across the 2 studies were 846.9 (21.8) pg/mL, and 835.9 (21.0) pg/mL for the Parsabiv and placebo groups, respectively with approximately 21% of subjects enrolling across both studies having baseline PTH > 1,000 pg/mL.
Slovenian: Povprečna (std. napaka) izhodiščna koncentracija PTH v teh 2 študijah je bila 846,9 (21,8) pg/ml med bolniki, ki so prejemali zdravilo Parsabiv, in 835,9 (21,0) pg/ml med bolniki, ki so prejemali placebo.
English: Nausea Vomiting Diarrhoea
Slovenian: Adinamična kostna bolezen
English: The primary endpoint was non-inferiority for the proportion of patients who achieved > 30% reduction from baseline in mean PTH during the EAP (weeks 20 to 27).
Slovenian: Primarni opazovani dogodek je bila neinferiornost glede deleža bolnikov, ki so med OOU (20. do 27. teden) dosegli > 30 % znižanje povprečnega PTH v primerjavi z izhodiščem.
English: Metabolism and nutrition disorders Very common
Slovenian: Presnovne in prehranske motnje
English: Serum calcium levels should be monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see section 4.2), which may be associated with reductions in serum calcium levels.
Slovenian: Bolnikom z anamnezo kongestivnega srčnega popuščanja je treba med zdravljenjem z zdravilom Parsabiv, ki ga lahko spremlja znižana koncentracija kalcija v serumu, skrbno kontrolirati koncentracijo kalcija v serumu (glejte poglavje 4.2).
English: Switch from cinacalcet to Parsabiv
Slovenian: Prehod s cinakalceta na zdravilo Parsabiv
English: Parsabiv decreased PTH regardless of baseline PTH, duration of dialysis, and whether or not patients were receiving vitamin D sterols.
Slovenian: Zdravilo Parsabiv je znižalo PTH ne glede na izhodiščni PTH ali trajanje dialize in ne glede na to, ali so bolniki prejemali sterole vitamina D ali ne. Bolniki, ki so imeli ob presejanju nižjo koncentracijo PTH, so imeli večjo verjetnost, da med OOU dosežejo PTH ≤ 300 pg/ml.
English: The pharmacokinetics of etelcalcetide was characterised in CKD patients receiving haemodialysis.
Slovenian: Farmakokinetiko etelkalcetida so opredelili pri bolnikih s KLB, zdravljenih s hemodializo.
English: Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia (see section 4.2).
Slovenian: Ker etelkalcetid znižuje kalcij v serumu, je treba bolnikom naročiti, naj poiščejo zdravniško pomoč, če se jim pojavijo simptomi hipokalciemije.
English: Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection etelcalcetide
Slovenian: Parsabiv 2,5 mg raztopina za injiciranje Parsabiv 5 mg raztopina za injiciranje Parsabiv 10 mg raztopina za injiciranje etelkalcetid
English: ATC code: H05BX04
Slovenian: Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija, paratiroideo zavirajoče učinkovine, oznaka ATC: H05BX04
English: No specific pharmacokinetic studies of etelcalcetide have been conducted in patients with mild to severe kidney impairment.
Slovenian: Pri bolnikih z blago do hudo okvaro ledvic niso izvedli specifičnih farmakokinetičnih študij etelkalcetida.
English: Mean percent change during the EAP, % (SE)
Slovenian: Povprečni odstotek spremembe med OOU, % (std. napaka)
English: Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL).
Slovenian: Zdravilo Parsabiv 2,5 mg raztopina za injiciranje: ena viala vsebuje 2,5 mg etelkalcetida v 0,5 ml raztopine (5 mg/ml).
English: Single doses up to 60 mg and multiple doses up to 22.5 mg 3 times a week at the end of dialysis in patients receiving haemodialysis were safely administered in clinical trials.
Slovenian: V kliničnih preskušanjih so pri bolnikih, zdravljenih s hemodializo, varno uporabili enkratne odmerke do 60 mg in večkratne odmerke od 22,5 mg 3-krat na teden ob koncu dialize.
English: Parsabiv (N = 255)
Slovenian: Zdravilo Parsabiv (n = 255)
English: Tell your doctor if you are breast-feeding or plan to do so.
Slovenian: Zdravniku morate povedati, če dojite ali če nameravate dojiti.
English: Parsabiv (N = 254)
Slovenian: Zdravilo Parsabiv (n = 254)
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection
Slovenian: Parsabiv 2,5 mg raztopina za injiciranje Parsabiv 5 mg raztopina za injiciranje Parsabiv 10 mg raztopina za injiciranje
English: Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be associated with significant reductions in serum calcium levels.
Slovenian: Bistveno znižanje koncentracije kalcija v serumu lahko spremljajo zmanjšana zmogljivost miokarda, hipotenzija in kongestivno srčno popuščanje.
English: Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL).
Slovenian: Zdravilo Parsabiv 5 mg raztopina za injiciranje: ena viala vsebuje 5 mg etelkalcetida v 1 ml raztopine (5 mg/ml).
English: The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Slovenian: Glavni regulator izločanja PTH so receptorji, ki zaznavajo kalcij, na površini glavnih celic obščitnic.
English: Etelcalcetide is intended for CKD patients receiving haemodialysis.
Slovenian: Etelkalcetid je namenjen bolnikom s KLB, zdravljenih s hemodializo.
English: Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).
Slovenian: Zdravilo Parsabiv 10 mg raztopina za injiciranje: ena viala vsebuje 10 mg etelkalcetida v 2 ml raztopine (5 mg/ml).
English: Parsabiv 10 mg solution for injection
Slovenian: Parsabiv 10 mg raztopina za injiciranje
English: If you start to get numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immediately.
Slovenian: Zdravniku morate nemudoma povedati, če se vam začnejo pojavljati omrtvičenost ali mravljinčenje okrog ust ali v udih, bolečine ali krči v mišicah, ali napadi krčev (konvulzije).
English: Parsabiv 2.5 mg solution for injection
Slovenian: Parsabiv 2,5 mg raztopina za injiciranje
English: Serum calcium levels should be closely monitored in patients with a history of a convulsion disorder while being treated with Parsabiv.
Slovenian: Bolnikom z anamnezo konvulzivnih motenj je treba med zdravljenjem z zdravilom Parsabiv skrbno kontrolirati koncentracijo kalcija v serumu.
English: Succinic acid
Slovenian: Jantarna kislina
English: Adverse reactions from controlled clinical studies and post-marketing experience
Slovenian: Neželeni učinki iz kontroliranih kliničnih študij in iz obdobja trženja zdravila Organski sistem po MedDRA Kategorija pogostnosti Neželeni učinki Bolezni imunskega sistema
English: How to store Parsabiv
Slovenian: Shranjevanje zdravila Parsabiv
English: Parsabiv 5 mg solution for injection
Slovenian: Parsabiv 5 mg raztopina za injiciranje
English: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution.
Slovenian: Parsabiv 10 mg raztopina za injiciranje Ena viala vsebuje 10 mg etelkalcetida (v obliki klorida) v 2 ml raztopine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 2,5 mg etelkalcetida (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 2.5 mg solution for injection etelcalcetide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Parsabiv 2,5 mg raztopina za injiciranje etelkalcetid i.v.
English: The threshold for seizures may be lowered by significant reductions in serum calcium levels.
Slovenian: Bistveno znižanje koncentracije kalcija v serumu lahko zniža prag za konvulzije.
English: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution.
Slovenian: Parsabiv 5 mg raztopina za injiciranje Ena viala vsebuje 5 mg etelkalcetida (v obliki klorida) v 1 ml raztopine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 10 mg etelkalcetida (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide
Slovenian: Parsabiv 10 mg raztopina za injiciranje etelkalcetid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 10 mg solution for injection etelcalcetide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Parsabiv 10 mg raztopina za injiciranje etelkalcetid i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 5 mg solution for injection etelcalcetide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Parsabiv 5 mg raztopina za injiciranje etelkalcetid i.v.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 5 mg etelkalcetida (v obliki klorida).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide
Slovenian: Parsabiv 5 mg raztopina za injiciranje etelkalcetid
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide
Slovenian: Parsabiv 2,5 mg raztopina za injiciranje etelkalcetid
English: Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Parsabiv 2,5 mg raztopina za injiciranje Ena viala vsebuje 2,5 mg etelkalcetida (v obliki klorida) v 0,5 ml raztopine.
English: Reductions in serum calcium associated with tremoring,
Slovenian: Ob klinični ravni izpostavljenosti so opažali znižanje kalcija v serumu s spremljajočim tremorjem, konvulzijami in s stresom povezanimi spremembami.
English: Single use only
Slovenian: Način uporabe
English: Very common
Slovenian: Pogosti mialgija
English: *PFU: plaque forming units
Slovenian: *PFU: enote, ki tvorijo plak
English: Parenteral use
Slovenian: parenteralna uporaba
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
Slovenian: Romunija GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
English: 1495-131 Algés Portugal
Slovenian: 1495-131 Algés
English: United Kingdom Sanofi Pasteur MSD Limited Mallards Reach
Slovenian: Velika Britanija Sanofi Pasteur MSD Limited Mallards Reach
English: 2031 BN Haarlem
Slovenian: 2031 BN Haarlem The Netherlands
English: United Kingdom SmithKline Beecham plc 980 Great West Road
Slovenian: Velika Britanija SmithKline Beecham plc 980 Great West Road
English: The Netherlands GlaxoSmithKline B.V Huis ter Heideweg 62
Slovenian: Nizozemska GlaxoSmithKline B.V Huis ter Heideweg 62
English: Slovak Republic Merck Sharp & Dohme B.V Waarderweg 39
Slovenian: Merck Sharp & Dohme B.V Waarderweg 39
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France
Slovenian: GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France
English: GSK d.o.o Cvetkova ulica 29 1000 Ljubljana Slovenia
Slovenian: Slovenija GSK d.o.o Cvetkova ulica 29
English: Subcutaneous use , Intramascular use
Slovenian: subkutalna uporaba, intramuskularna uporaba
English: Merck Sharp & Dohme B.V. Waardeweg 39, 2031 BN Haarlem The Netherlands
Slovenian: Waardeweg 39, 2031 BN Haarlem The Netherlands
English: Merck Sharp & Dohme OÜ A.H. Tammsaare tee 47 Tallinn 11316
Slovenian: Tammsaare tee 47 Tallinn 11316
English: Na Pankráci 17/1685
Slovenian: Na Pankráci 17/1685 140 21 Prague 4
English: Priorix-Tetra injectieflacon/amp ul, poeder en oplosmiddel voor oplossing voor injectie
Slovenian: Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie parenteralna uporaba
English: Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer
Slovenian: Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung
English: PRIORIX TETRA one dose (0.5 ml) contains:
Slovenian: Po pripravi cepiva 1 odmerek (0,5 ml) vsebuje:
English: Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie
Slovenian: Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie parenteralna uporaba
English: Mumps virus Jeryl Lynn strain (live, attenuated) - 5 x 10
Slovenian: Virus mumpsa, sev Jeryl Lynn (živ, oslabljen) - 5 x 103.0 CCID50
English: Measles virus Schwartz strain (live, attenuated) - not less than 10
Slovenian: Virus ošpic, sev Schwartz (živ, oslabljen) - ne manj kot 103
English: Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 10
Slovenian: Živ, oslabljen virus mumpsa (RIT 4385, pridobljen iz seva Jeryl Lynn) - ne manj kot
English: one dose (0.5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 x 10 TCID50
Slovenian: Virus mumpsa (sev Jeryl Lynn - nivo B)ne manj kot 20 x 10
English: Live attenuated varicella-zoster virus (Oka strain) 103.3 PFU*
Slovenian: Živ, oslabljen virus varicella-zoster (sev Oka) 103.3 PFU
English: Varivax one dose (0.5 ml) contains: varicella virus (zoster vivo) - 1350 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: Virus noric (zoster, živ) - 1350 PFU*
English: Powder for suspension for injection
Slovenian: Prašek za razopino za injeciranje
English: Priorix-Tetrapowder and solvent for solution for injection in a pre-filled syringe
Slovenian: Priorix-Tetrapowder and solvent for solution for injection in a prefilled syringe
English: strain, derived from Jeryl Lynn strain)not less than 103.7 CCID50
Slovenian: Virus mumpsa (sev Jeryl Lynn) - ne manj kot 5 x 103.7 CCID50
English: one dose (0.5 ml) contains: not less than 103.0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 x 103.0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103.0 CCID50 of the rubella virus strain
Slovenian: 1 odmerek (0,5 ml) vsebuje: virus ošpic Edmonston 749D (živ, oslabljen)103.0 CCID50Virus mumpsa Jeryl Lynn (živ, oslabljen) - 5 x 103.0 CCID50Virus rdečk Wistar RA 27/3 (živ, oslabljen) - 103.0 CCID50
English: Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 x 10
Slovenian: Virus mumpsa, sev URABE AM-9 (živ, oslabljen) - ne manj kot 5 x 103.0 CCID50
English: Varicella Virus OKA/Merck Strain - not less than 1350 PFU*
Slovenian: Virus noric, sev OKA/Merck - ne manj kot 1350 PFU*
English: Priorix-Tetra powder and solvent for solution for injection in prefilled syringe
Slovenian: Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe
English: Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Slovenian: Cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
English: Czech Republic GlaxoSmithKline, s.r.o.
Slovenian: GlaxoSmithKline, s.r.o.
English: Varicella virus OKA/Merck strain (live, attenuated) not less than 1350 PFU*
Slovenian: Virus noric (sev Oka / Merck) (živ, oslabljen) - ne manj kot 1350 PFU*
English: Czech Republic GlaxoSmithKline Biologicals S.A.
Slovenian: Češka republika GlaxoSmithKline Biologicals S.A.
English: one dose (0.5 ml) contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1350 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: Virus noric (Oka / Merck): ne manj kot 1350 PFU*
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50 Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Slovenian: Virus ošpic - ne manj kot 103.0 CCID50 Virus mumpsa - ne manj kot 103.7 CCID50 Virus rdečk - ne manj kot 103.0 CCID50 Virus noric - ne manj kot 103.3 PFU*
English: Live attenuated measles virus (Schwarz strain) -not less than 103.0 CCID50
Slovenian: Virus ošpic (živ, oslabljen) - ne manj kot 103.0 CCID50
English: Luxembourg GlaxoSmithKline Biologicals S.A.
Slovenian: Luksemburg GlaxoSmithKline Biologicals S.A.
English: RUBEATEN BERNA Rubella virus live (Strain Wistar RA 27/3) - not less than 10
Slovenian: RUBEATEN BERNA Virus rdečk živ (sev RA 27/3) - ne manj kot 103.0 CCID50
English: Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Slovenian: Cepivo proti ošpicam, mumpsu in rdečkam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
English: one dose (0.5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1350 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus noric (sev Oka / Merck), ki ni manj od 1350 PFU*
English: Varivax one dose (0.5 ml) contains: Varicella virus (Oka/Merck strain) ≥ 1350 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: Virus noric (sev Oka / Merck) 1350 PFU*
English: Varicella virus, live attenuated, Oka/Merck strain ≥ 1350 PFU*
Slovenian: Živ, oslabljen virus noric,sev Oka / Merck ≥ 1350 PFU*
English: Priorix injection one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Slovenian: Priorix injection 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
English: Live attenuated varicella virus (OKA strain) - not less than 103.3 PFU*
Slovenian: Živ, oslabljen virus varicella zoster (Oka sev) - ne manj kot 103.3 PFU*
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50
Slovenian: Živ, oslabljen virus rdečk (sev Wistar RA 27/3) - ne manj kot 103.0 CCID50
English: Measles vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Slovenian: Cepiva proti ošpicam (živo) z dovoljenjem za promet v Evropski uniji Država članica(EU/EEA)
English: Priorix-Tetra lag one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Slovenian: Priorix-Tetra lag 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
English: one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (OKa strain) - not less than 103.3 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus varicella zoster (sev Oka) - ne manj kot 103.3 PFU*
English: one dose (0,5 ml) contains : Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU*
Slovenian: 1 odmerek (0,5 ml) vsebuje: živ, oslabljen virus varicella zoster (sev Oka) - ne manj kot 103.3 PFU*
English: Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Slovenian: Živ, oslabljen virus varicella zoster(sev OKA): ne manj kot 103.3 PFU*
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 10
Slovenian: Virus rdečk sev Wistar RA 27/3 (živ, oslabljen) - 103.0 CCID50
English: Belgium GlaxoSmithKline Biologicals S.A.
Slovenian: Romunija GlaxoSmithKline Biologicals S.A.
English: Varicella virus strain Oka/Merck (live, attenuated) ≥1350 PFU*
Slovenian: Virus noric sev Oka / Merck (živ, oslabljen) ≥ 1350 PFU*
English: Rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Slovenian: Cepivo proti noricam (živo) z dovoljenjem za promet v Evropski uniji Država članica(EU/EEA)
English: PRIORIX TETRA one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Slovenian: PRIORIX TETRA 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
English: Varicella virus Oka/Merck strain (live, attenuated)≥1350 PFU*
Slovenian: Virus noric sev Oka / Merck (živ, oslabljen) ≥ 1350 PFU *
English: PRIORIX-TETRA one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Slovenian: PRIORIX-TETRA 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
English: Varivax one dose (0.5 ml) contains: not less than 1350 PFU* of the live attenuated varicella virus (OKA.Merck strain)
Slovenian: 1 odmerek (0,5 ml) vsebuje: Ne manj kot 2 x 103.0 PFU* virusa varicellazoster
English: Varicella virus Oka/Merck strain (live, attenuated) 1350 PFU*
Slovenian: Virus noric sev Oka / Merck (živ, oslabljen) 1350 PFU*
English: Powder and solvent for solution for injection, suspension
Slovenian: Prašek in vehikel za raztopino za injiciranje, suspenzija
English: CCID50 of the measles virus Enders-Edmonston strain, not less than 12500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 10 CCID50of the Wistar RA 27/3 rubella virus strains
Slovenian: Virus mumpsa - ne manj kot 12500 CCID50 in Virus rdečk - ne manj kot 103.0CCID50
English: Measles and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Slovenian: Cepivo proti ošpicam in rdečkam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
English: What measures are being taken to ensure the safe and effective use of Granpidam?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Granpidam?
English: It is not intended to provide practical advice on how to use Granpidam.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.