natgillin/translations-raw huggingface dataset:
Pack size of 1, 10 0.5 ml of suspension in pre-filled syringe (Type I glass) with 2 separate needles with a plunger stopper (chlorobutyl).
Velikost pakiranja:
Pack size of 1, 10 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Francija
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA 1.
HBVAXPRO 10 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogramov/ ml Suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
En 1 ml odmerek vsebuje: rekombinantni površinski antigen virusa hepatitisa B (HBsAg) *............. 10, 00 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 50 miligrama Al+)
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in adults and adolescents (16 years of age and older) considered at risk of exposure to hepatitis B virus.
Cepivo je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri odraslih in mladostnikih (starih vsaj 16 let), ki jih ogroža okužba s tem virusom.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Pričakujemo lahko, da cepljenje s HBVAXPRO prepreči tudi hepatitis D, ker se ta tip hepatitisa, ki ga povzroča agens delta, pojavi le sočasno z okužbo z virusom hepatitisa B.
Posology Adults and adolescents (16 years of age and older):
Odmerjanje Odrasli in mladostniki (stari vsaj 16 let):
1 dose (10 µg) of 1 ml at each injection is intended for use.
1 odmerek (10 µg) z 1 ml na injekcijo.
16 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2 in 12 mesecev: tri injekcije v presledku enega meseca, četrti odmerek je treba dati po 12 mesecih.
Special dosage recommendations for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle):
Posebna priporočila za odmerjanje po znani ali domnevni izpostavljenosti virusu hepatitisa B (npr. vbod z okuženo iglo):
- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24
- Čim prej po izpostavljenosti (v 24 urah) je treba uporabiti imunoglobulin proti hepatitisu B.
simultaneously with hepatitis B immunoglobulin, but at a separate injection site.
imunoglobulinom proti hepatitisu B, vendar na drugo vbodno mesto.
17 Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.
Izjemoma je cepivo mogoče dati subkutano pri bolnikih s trombocitopenijo ali z motnjami hemostaze.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Opazili so več dejavnikov, ki zmanjšujejo imunski odziv na cepivo proti hepatitisu B.
These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases.
Ti dejavniki vključujejo starost, moški spol, debelost, kajenje, način uporabe in nekatere obstoječe kronične bolezni.
Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO.
Pozornost je potrebna pri serološkem testiranju tistih oseb, pri katerih obstaja tveganje, da ne bi dosegli ustrezne serološke zaščite po končanem popolnem cepljenju s HBVAXPRO.
For the hepatitis B virus surface antigen (HBsAg) no clinical data on exposed pregnancies are available.
Kliničnih podatkov o izpostavljenosti površinskemu antigenu virusa hepatitisa B (HBsAg) med nosečnostjo ni.
However, as with all inactivated viral vaccines, one does not expect harm for the foetus.
Toda tako kot pri vseh inaktiviranih virusnih cepivih ni pričakovati škodljivih vplivov na plod.
Utilisation during pregnancy requires that the potential benefit justifies the potential risk to the foetus.
Med nosečnostjo se sme cepivo uporabiti le, če možne koristi upravičujejo možno tveganje za plod.
Caution should be exercised when prescribing to pregnant women.
Pri nosečnicah je treba cepivo uporabljati previdno.
The effect on breastfed infants of the administration of this vaccine has not been assessed; no contraindication has been established.
Vpliv uporabe tega cepiva na dojene dojenčke ni raziskan; kontraindikacije niso bile dokazane.
18 No studies on the effects on the ability to drive and use machines have been performed.
Raziskav o vplivu na sposobnost vožnje in upravljanja s stroji niso opravili.
However, some of the rare effects mentioned under "Undesirable effects" may affect the ability to drive or operate machinery.
Vendar lahko nekateri redki učinki, navedeni v poglavju Neželeni učinki, vplivajo na sposobnost vožnje in upravljanja s stroji.
Immune system disorders Very rare (< 1/ 10,000) Serum sickness, anaphylaxis, polyarteritis nodosa
Bolezni krvi in limfatičnega sistema Zelo redke (< 1/ 10. 000) trombocitopenija, limfadenopatija Bolezni imunskega sistema Zelo redke (< 1/ 10. 000) serumska bolezen, anafilaksa, nodozni poliarteritis
Respiratory, thoracic and mediastinal diosrders Very rare (< 1/ 10,000) Bronchospasm-like symptoms
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redke (< 1/ 10. 000) bronhospazmu podobni simptomi
Musculoskeleta, connective tissue and bone disorders Very rare (< 1/ 10,000) Arthralgia, arthritis, myalgia, pain in extremity
Bolezni kosti, sklepov, mišic in vezivnega tkiva Zelo redke (< 1/ 10. 000) artralgija, artritis, mialgija, bolečine v okončinah
Development of an antibody titre against hepatitis B (anti-HBsAg) equal to or greater than 10 IU/ l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.
Titer protiteles proti hepatitisu B (anti- HBsAg), ki, izmerjen 1 do 2 meseca po zadnji injekciji, znaša vsaj 10 i. e. / l, korelira z zaščito pred okužbo z virusom hepatitisa B.
In two trials conducted in older adolescents and adults, 95.6-97.5% of vaccinees developed a protective level of antibodies, with geometric mean titres in these trials ranging from 535 – 793 IU/ l.
V dveh preskušanjih pri starejših mladostnikih in odraslih se je pri 95, 6- 97, 5% cepljenih osebah razvila zaščitna raven protiteles z geometričnim povprečjem titra 535- 793 i. e. / l.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’ s recombinant hepatitis B vaccine in healthy adults.
Poleg tega so pri zdravih odraslih dokazali obstoj s cepivom sproženega imunskega spomina za površinski antigen virusa hepatitisa B (HBsAg) z anamnestičnim odzivom protiteles na obnovitveni odmerek prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B.
1 ml of suspension in vial (Type I glass).
1 ml suspenzije v viali (steklo tipa 1).
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Francija
HBVAXPRO 10 micrograms/ ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogramov/ ml Suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
En 1 ml odmerek vsebuje: rekombinantni površinski antigen virusa hepatitisa B (HBsAg) *............. 10, 00 mikrogramov
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 50 miligrama Al+)
23 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2 in 12 mesecev: tri injekcije v presledku enega meseca, četrti odmerek je treba dati po 12 mesecih.
When persons who do not respond to the primary vaccine series are revaccinated, 15-25% produce an adequate antibody response after one additional dose and 30-50% after three additional doses.
Po vnovičnem cepljenju oseb, ki se ne odzovejo na primarno cepljenje, se ustrezen odziv protiteles po enem dodatnem odmerku razvije pri 15 – 25% ljudeh, po treh dodatnih odmerkih pa pri 30 – 50%.
Special dosage recommendations for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle):
Posebna priporočila za odmerjanje po znani ali domnevni izpostavljenosti virusu hepatitisa B (npr. vbod z okuženo iglo)
simultaneously with hepatitis B immunoglobulin but at a separate injection site.
imunoglobulinom proti hepatitisu B, vendar na drugo vbodno mesto. -
- Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if
serološko testiranje in, če je potrebno, nadaljne odmerke cepiva (t. j.
necessary, (i. e according to the serologic status of the patient) for short and long term protection.
glede na serološko stanje bolnika) za kratkotrajno in dolgotrajno zaščito.
- In the case of unvaccinated or incompletely vaccinates individuals, additional doses should be given
- Necepljene ali nepopolno cepljene osebe morajo dobiti dodatne odmerke po priporočeni
as in the recommended immunisation schedules.
imunizacijski shemi.
24 Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.
Izjemoma je cepivo mogoče dati subkutano pri bolnikih s trombocitopenijo ali z motnjami hemostaze.
The effect on breast-fed infants of the administration of this vaccine has not been assessed; no contraindication has been established.
Vpliv uporabe tega cepiva na dojene dojenčke ni raziskan; kontraindikacije niso bile dokazane.
25 No studies on the effects on the ability to drive and use machines have been performed.
Raziskav o vplivu na sposobnost vožnje in upravljanja s stroji niso opravili.
Nervous system disorders Very rare (< 1/ 10,000) Paresthesia, paralysis (Bell's palsy), peripheral neuropathies (polyradiculoneuritis, facial paralysis), neuritis (including Guillain Barre Syndrome, optical neuritis, myelitis including transverse myelitis), encephalitis, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis, multiple sclerosis, seizure, headache, dizziness, syncope
Bolezni živčevja Zelo redke (< 1/ 10. 000) parestezije, paraliza (Bellova paraliza), periferne nevropatije, (poliradikulonevritis, paraliza obraza), nevritis (vključno z Guillain- Barréjevim sindromom, optičnim nevritisom, mielitisom, vključno s transverznim mielitisom), encefalitis, demielinizirajoča bolezen osrednjega živčevja, poslabšanje multiple skleroze, multipla skleroza, konvulzije, glavobol
Respiratory, thoracic and mediastinal disorders Very rare (< 1/ 10,000) Bronchospasm-like symptoms
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redke (< 1/ 10. 000) bronhospazmu podobni simptomi
Pharmacotherapeutic group: anti-infectious, ATC code:
Farmakoterapevtska skupina: virusna cepiva, znaka ATC:
Although the duration of the protective effect of a previous formulation of Merck’ s recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.
Trajanje zaščitnega učinka prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B pri zdravih cepljencih sicer ni znano, toda med 5 - do 9- letnim spremljanjem približno 3000 zelo ogroženih preiskovancev, ki so dobili podobno iz plazme pridobljeno cepivo, niso odkrili primerov klinično očitnega hepatitisa B.
1 ml of suspension in pre-filled syringe (Type I glass) without needle with a plunger stopper (chlorobutyl).
Velikost pakiranja:
Pack size of 1, 10 1 ml of suspension in pre-filled syringe (Type I glass) with 1 separate needle with a plunger stopper (chlorobutyl).
Velikost pakiranja:
Pack size of 1, 10 1 ml of suspension in pre-filled syringe (Type I glass) with 2 separate needles with a plunger stopper (chlorobutyl).
Velikost pakiranja:
Before use, the vaccine should be well shaken.
Pred uporabo je treba cepivo dobro pretresti, da nastane rahlo motna bela suspenzija.
27/ 04/ 2001 Date of latest renewal:
27. 04. 2001
HBVAXPRO 40 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 40 mikrogramov/ ml Suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
En 1 ml odmerek vsebuje: rekombinantni površinski antigen virusa hepatitisa B (HBsAg) *............. 40, 00 mikrogramov
40.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 50 miligrama Al+)
This vaccine is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Cepivo je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri odraslih bolnikih, ki so pred ali na dializi.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Pričakujemo lahko, da cepljenje s HBVAXPRO prepreči tudi hepatitis D, ker se ta hepatitis, ki ga povzroča agens delta, pojavi le sočasno z okužbo z virusom hepatitisa B.
Posology Predialysis and dialysis adult patients:
Odmerjanje Odrasli bolniki pred ali na dializi:
1 dose (40 µg) of 1 ml at each injection is intended for use.
1 odmerek (40 µg) z 1 ml na injekcijo.
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) after primary series is less than 10 IU/ l.
O obnovitvenem odmerku je treba razmisliti pri tistih cepljenih osebah, pri katerih je raven protiteles proti površinskemu antigenu virusa hepatitisa B (anti- HBsAg) po začetnih serijah pod 10 i. e. / l.
30 In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
V skladu s standardno zdravniško prakso za cepljenje proti hepatitisu B je pri bolnikih na hemodializi potrebno redno testiranje protiteles.
A booster dose should be given when antibody levels decline below 10 IU/ l.
Obnovitveni odmerek je potreben, če raven protiteles pade pod 10 i. e. / l.
Method of administration This vaccine should be administered intramuscularly.
Način uporabe Cepivo je za intramuskularno uporabo.
No studies on the effects on the ability to drive and use machines have been performed.
Raziskav o vplivu na sposobnost vožnje in upravljanja s stroji niso opravili.
32 Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000) Rash, alopecia, pruritus, urticaria, erythema multiforme, angioedema, eczema
Bolezni kože in podkožja Zelo redke (< 1/ 10. 000) izpuščaj, alopecija, pruritus, urtikarija, multiformni eritem, angioedem, ekcem
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10) Local reactions (injection site): transient soreness, erythema, induration Very rare (< 1/ 10,000) Fatigue, fever, malaise, influenza-like symptoms
Splošne težave in spremembe na mestu aplikacije Pogoste (> 1/ 100, < 1/ 10) lokalne reakcije (na mestu aplikacije): prehodna občutljivost, eritem, induracija Zelo redke (< 1/ 10. 000) utrujenost,, zvišana telesna temperatura, splošno slabo počutje, gripi podobni simptomi
33 Reduced risk of Hepatocellular Carcinoma Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Zmanjšanje tveganja za karcinom jetrnih celic Karcinom jetrnih celic je resen zaplet okužbe z virusom hepatitisa B.
Sodium chloride Borax Water for injections.
natrijev klorid boraks voda za injekcije 6. 2 Inkompatibilnosti
6.3 Shelf life
6. 3 Rok uporabnosti 3 leta
1 ml of suspension in vial (Type I glass) - Pack size of 1
1.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Francija
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA DODATEK II
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE AND
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MERCK & Co., Inc.
Inc.
Sumneytown Pike West POINT, Pennsylvania 19486 USA
Sumneytoxn Pike West Point Pensilvanija 19486 ZDA
MERCK Manufacturing Division Haarlem Waaderweg 39, P. O.
Merck Sharp & Dohme B. V.
Box 581 2031 BN, 20030 PC Haarlem The Netherlands
Waarderweg 39, 2003 PC Haarlem Nizozemska
The marketing authorisation holder will continue to submit periodic safety update reports on a 1- year cycle.
Imetnik dovoljenja za promet z zdravilom bo periodična poročila o varnosti še naprej predajal enkrat letno.
37 ANNEX III
DODATEK III
LABELLING AND PACKAGE LEAFLET
OZNAČEVANJE IN NAVODILO ZA UPORABO A.
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE PODATKI NA ZUNAJI OVOJNINI
HBVAXPRO 5 micrograms/ 0.5 ml - single dose vial - Pack of 1, 10
HBVAXPRO 5 mikrogramov/ 0, 5 ml – enoodmerna viala - pakiranje po 1, 10
1 dose (0.5 ml) contains:
En 0, 5 ml odmerek vsebuje:
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Rekombinantni površinski antigen virusa hapatitisa B (HBsAg) *..................
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
5, 00 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 25 miligrama Al+)
* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)
* pridobljen iz rekombinantnega seva kvasovke Saccharomyces cerevisae (sev 2150- 2- 3)
Sodium chloride, borax and water for injections.
Natrijev klorid, boraks in voda za injekcije
Suspension for injection 1 single dose 0.5 ml vial 10 single doses 0.5 ml vials
Suspenzija za injiciranje 1 enoodmerna 0, 5 ml viala 10 enoodmernih 0, 5 ml vial
Shake well before use.
Pred uporabo dobro pretresite!
9.
EXP 9.
EU/ 1/ 01/ 183/ 001 1 vial EU/ 1/ 01/ 183/ 018 10 vials
EU/ 1/ 01/ 183/ 001 1 viala EU/ 1/ 01/ 183/ 018 10 vial
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODATKI V BRAILLOVI PISAVI PODATKI NA ZUNAJI OVOJNINI
HBVAXPRO 5 micrograms/ 0.5 ml - single dose vial + syringe with needle - Pack of 1
HBVAXPRO 5 mikrogramov/ 0, 5 ml – enoodmerna viala + brizga z iglo - pakiranje po 1
Suspension for injection 1 single dose 0.5 ml vial 1 sterile injection syringe with needle.
Susupenzija za injiciranje 1 enoodmerna 0, 5 ml viala 1 sterilna injekcijska brizga z iglo
43 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODATKI V BRAILLOVI PISAVI PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
HBVAXPRO 5 µg/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 µg/ 0, 5 ml Suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
IM use
IM uporaba
Shake well before use
Pred uporabo dobro pretresite!
SANOFI PASTEUR MSD SNC
SANOFI PASTEUR MSD SNC PODATKI NA ZUNAJI OVOJNINI
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe without needle - Pack of 1, 10, 20, 50
HBVAXPRO 5 mikrogramov/ 0, 5 ml – enoodmerna napolnjena injekcijska brizga brez igle - pakiranje po 1, 10, 20, 50
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
5, 00 mikrogramov, adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 25 miligrama Al+)
Suspension for injection 1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle
Suspenzija za injiciranje 1 enoodmerna 0, 5 ml napolnjena injekcijska brizga brez igle 10 enoodmernih 0, 5 ml napolnjenih injekcijskih brizg brez igel 20 enoodmernih 0, 5 ml napolnjenih injekcijskih brizg brez igel 50 enoodmernih 0, 5 ml napolnjenih injekcijskih brizg brez igel
EU/ 1/ 01/ 183/ 004 1 pre-filled syringe EU/ 1/ 01/ 183/ 005 10 pre-filled syringes EU/ 1/ 01/ 183/ 020 20 pre-filled syringes EU/ 1/ 01/ 183/ 021 50 pre-filled syringes
EU/ 1/ 01/ 183/ 004 1 napolnjena injekcijska brizga EU/ 1/ 01/ 183/ 005 10 napolnjenih injekcijskih brizg EU/ 1/ 01/ 183/ 020 20 napolnjenih injekcijskih brizg EU/ 1/ 01/ 183/ 021 50 napolnjenih injekcijskih brizg
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10
PODATKI V BRAILLOVI PISAVI PODATKI NA ZUNAJI OVOJNINI HBVAXPRO 5 mikrogramov/ 0, 5 ml – enoodmerna napolnjena injekcijska brizga z 1 priloženo iglo - pakiranje po 1, 10
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogramov/ 0, 5 ml Suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rDNA) za otroke in mladostnike
Suspension for injection 1 single dose 0.5 ml pre-filled syringe with 1 separate needle 10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe)
Suspenzija za injiciranje 1 enoodmerna 0, 5 ml napolnjena injekcijska brizga z 1 priloženo iglo 10 enoodmernih 0, 5 ml napolnjenih injekcijskih brizg z 1 priloženo iglo (za vsako injekcijsko brizgo)
EU/ 1/ 01/ 183/ 022 1 pre-filled syringe EU/ 1/ 01/ 183/ 023 10 pre-filled syringes
EU/ 1/ 01/ 183/ 022 1 napolnjena injekcijska brizga EU/ 1/ 01/ 183/ 023 10 napolnjenih injekcijskih brizg
HBVAXPRO 5 micrograms/ 0.5 ml - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10
PODATKI V BRAILLOVI PISAVI PODATKI NA ZUNAJI OVOJNINI HBVAXPRO 5 mikrogramov/ 0, 5 ml – enoodmerna napolnjena injekcijska brizga z 2 priloženima iglama - pakiranje po 1, 10
Suspension for injection 1 single dose 0.5 ml pre-filled syringe with 2 separate needles 10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)
Suspenzija za injiciranje 1 enoodmerna 0, 5 ml napolnjena injekcijska brizga z 2 priloženima iglama 10 enoodmernih 0, 5 ml napolnjenih injekcijskih brizg z 2 priloženima iglama (za vsako injekcijsko brizgo)
EU/ 1/ 01/ 183/ 024 1 pre-filled syringe EU/ 1/ 01/ 183/ 025 10 pre-filled syringes
EU/ 1/ 01/ 183/ 024 1 napolnjena injekcijska brizga EU/ 1/ 01/ 183/ 025 10 napolnjenih injekcijskih brizg
HBVAXPRO 5 micrograms/ 0.5 ml
PODATKI V BRAILLOVI PISAVI PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH HBVAXPRO 5 mikrogramov/ 0, 5 ml
SANOFI PASTEUR MSD SNC
SANOFI PASTEUR MSD SNC PODATKI NA ZUNAJI OVOJNINI HBVAXPRO 10 mikrogramov/ ml – enoodmerna viala - pakiranje po 1, 10
HBVAXPRO 10 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogramov/ ml, Suspenzija za injiciranje Cepivo proti hepatitisu B (rDNA)
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10, 00 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 50 miligrama Al+)
10 single dose 1 ml vials.
Suspenzija za injiciranje 1 enoodmerna 1 ml viala 10 enoodmernih 1 ml vial
EU/ 1/ 01/ 183/ 007 1 vial EU/ 1/ 01/ 183/ 008 10 vials
EU/ 1/ 01/ 183/ 007 1 viala EU/ 1/ 01/ 183/ 008 10 vial
HBVAXPRO 10 micrograms/ ml
PODATKI V BRAILLOVI PISAVI PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH HBVAXPRO 10 mikrogramov/ ml
HBVAXPRO 10 µg/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 µg/ ml, Suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
SANOFI PASTEUR MSD SNC
DRUGI PODATKI
HBVAXPRO 10 micrograms/ ml - single dose pre-filled syringe without needle - Pack of 1, 10
SANOFI PASTEUR MSD SNC PODATKI NA ZUNAJI OVOJNINI HBVAXPRO 10 mikrogramov/ ml – enoodmerna napolnjena injekcijska brizga brez igle - pakiranje po 1, 10