natgillin/translations-raw huggingface dataset:
--------------------------------------------------------------------------------------------------------------------------- ------- The following information is intended for medical or healthcare professionals only:
------------------------------------------------------------------------------------------------------------------------------ Naslednje informacije so namenjene samo zdravstvenemu osebju:
It contains proteins from Haemophilus influenzae type b (‘ Hib’, a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Kot zdravilno učinkovino vsebuje beljakovine Haemophilus influenzae tipa b („ Hib “ je bakterija, ki lahko povzroči meningitis) in dele virusa hepatitisa B.
PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘ invasive’ disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
Zdravilo PROCOMVAX se uporablja za cepljenje dojenčkov, starih od šest tednov do 15 mesecev, proti invazivni bolezni, ki jo povzroča Hib (npr. bakterijski meningitis), in proti okužbi z virusom hepatitisa B.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „ naučijo “, kako naj se brani pred boleznimi.
PROCOMVAX contains small amounts of: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of the bacterium Neisseria meningitidis); • surface antigen (proteins from the surface) of the hepatitis B virus.
Zdravilo PROCOMVAX vsebuje majhno količino: • iz Hib prečiščene beljakovine, vezane na nosilec (beljakovino, prečiščeno iz zunanje ovojnice bakterije Neisseria meningitidis); • površinski antigen (beljakovine s površine) virusa hepatitisa B.
These are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Te beljakovine so pridobljene z metodo, imenovano „ tehnologija rekombinantne DNA “, pri kateri kvasovka prejeme gen (DNA), s katerim lahko tvori te beljakovine.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Ko dojenček prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot „ tujke “ in proti njim razvije protitelesa.
The active substances are ‘ adsorbed’, meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘ adjuvant’ (a compound containing aluminium) to stimulate a better response.
Zdravilni učinkovini sta „ adsorbirani “, kar pomeni, da sta vezani na površino aluminijeve spojine, cepivo pa vsebuje „ adjuvans “ (spojino, ki vsebuje aluminij), ki spodbudi boljši odziv.
PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
Zdravilo PROCOMVAX je kombinacija komponent, ki so v raznih cepivih v Evropski uniji (EU) na voljo že vrsto let. Kako je bilo zdravilo PROCOMVAX raziskano?
The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
Z glavno študijo so pokazali tudi, da zdravilo PROCOMVAX zagotavlja ustrezno stopnjo zaščite proti virusu hepatitisa B.
This conclusion was confirmed with the results from seven additional studies supplied by the company.
Ta zaključek so potrdili tudi rezultati sedmih dodatnih študij, ki jih je predložilo podjetje.
The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX’ s benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila PROCOMVAX pri cepljenju proti invazivni bolezni, ki jo povzroča Hib, ter proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, pri otrocih, starih od 6 tednov do 15 mesecev, večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S. N. C. for PROCOMVAX on 7 May 1999.
Evropska komisija je dovoljenje za promet z zdravilom PROCOMVAX, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD S. N. C. dne 7. maja 1999.
Strength 1
Jakost 1
1 Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC -7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B) Adsorbed hepatitis B surface antigen produced in recombinant yeast cells(Saccharomyces cerevisiae) - 5.0 µg
OMPC (outer membrane protein complex - beljakovinski kompleks zunanje membrane)
- 125 µg
125 µg
PROCOMVAX suspension for injection Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
PROCOMVAX suspenzija za injiciranje konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) in rekombinantno cepivo proti hepatitisu B
Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC
Poliribozilribitolfosfat (PRP) Haemophilusa influenzae tipa b kot PRP - OMPC
Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B)
OMPC (outer membrane protein complex - beljakovinski kompleks zunanje membrane)
Adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)
(Saccharomyces cerevisiae)
For excipent, see section 6.1.
Za pomožne snovi glejte poglavje 6. 1.
Posology Infants born of HBsAg negative mothers should be vaccinated with three 0.5ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Odmerjanje Dojenčke HBsAg negativnih mater je treba cepiti s tremi 0, 5 ml odmerki cepiva PROCOMVAX; najbolje je to storiti pri 2., 4. in od 12. do 15. meseca starosti.
Method of administration FOR INTRAMUSCULAR ADMINISTRATION Do not inject intravenously, intradermally, or subcutaneously
Način uporabe ZA INTRAMUSKULARNO UPORABO Ne injicirajte intravensko, intradermalno ali subkutano.
2 4.3 Contraindications
4. 3 Kontraindikacije
Because of the potential for immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen) PROCOMVAX is not recommended for use in infants younger than 6 weeks of age.
2 Zaradi možnosti imunske tolerance (okvarjene zmožnosti za odziv na poznejši stik z antigenom PRP) uporaba cepiva PROCOMVAX ni priporočljiva pri otrocih, mlajših od 6 tednov.
Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Dojenčki HBsAg pozitivnih mater morajo ob rojstvu dobiti imunoglobulin proti hepatitisu B in (rekombinantno) cepivo proti hepatitisu B ter opraviti celoten niz cepljenj proti hepatitisu B.
The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.
Nadaljnja uporaba cepiva PROCOMVAX za dokončanje niza cepljenj proti hepatitisu B pri dojenčkih HBsAg pozitivnih mater, ki so dobili HBIG, in pri dojenčkih mater z neznanim statusom ni raziskana.
Immunogenicity results from open-labeled studies indicate that PROCOMVAX can be administered concomitantly with DTP (Diphtheria, Tetanus and whole cell Pertussis vaccine), OPV (Oral Poliomyelitis vaccine), IPV (inactivated poliomyelitis vaccine) and Merck MMR (Measles, Mumps,
Izsledki o imunogenosti iz odprtih raziskav kažejo, da se PROCOMVAX lahko uporablja sočasno s cepivi DTP (Diphtheria, Tetanus and whole cell Pertussis vaccine - davica, tetanus in polno celično cepivo proti oslovskemu kašlju), OPV (Oral Poliomyelitis vaccine - peroralno cepivo proti poliomielitisu), IPV (inactivated poliomyelitis vaccine - inaktivirano cepivo proti poliomielitisu) in Merckovim cepivom MMR (Measles, Mumps, and Rubella Virus Vaccine Live - cepivo proti ošpicam, mumpsu in živo cepivo proti virusu rdečk), če se cepivo za injiciranje daje na drugo mesto in z drugo brizgo.
Additionally, limited immunogenicity results from an open-labeled, controlled study indicate that PROCOMVAX may be administered concomitantly with DTaP (Diphtheria, Tetanus, and acellular Pertussis vaccine), using separate sites and syringes for injectable vaccines.
3 Pertussis vaccine - cepivo proti davici, tetanusu in brezcelično cepivo proti oslovskemu kašlju), če se cepivo za injiciranje daje na drugo mesto in z drugo brizgo.
The remaining 1,816 infants were involved in trials where PROCOMVAX was administered concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated poliovirus vaccine and were under surveillance for serious adverse experiences.
Te so nadzorovali glede resnih neželenih pojavov.
In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
Otroke so cepili v starosti 2., 4. in od 12. do 15. meseca in jih glede lokalnih reakcij in sistemskih težav spremljali pet dni po vsaki injekciji.
Most children received DTP and OPV concomitantly with the first two doses of PROCOMVAX or Merck PRP-OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine.
Večina otrok je DTP in OPV dobila sočasno s prvima odmerkoma cepiva PROCOMVAX ali Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B.
Across all three doses of PROCOMVAX, there were no significant differences in the frequency of adverse experiences between PROCOMVAX and the monovalent vaccines Merck PRP- OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
Pri vseh treh odmerkih cepiva PROCOMVAX se pogostnost neželenih pojavov ni pomembno razlikovala med cepivom PROCOMVAX ter monovalentnima Merckovima cepivoma PRP - OMPC in rekombinantnim cepivom proti hepatitisu B.
However, the frequency of irritability was statistically higher after all three injections of PROCOMVAX combined and after the first injection of PROCOMVAX compared to the monovalent vaccines.
Vendar pa je bila pogostnost razdražljivosti po vseh treh injekcijah cepiva PROCOMVAX skupaj in po prvi injekciji cepiva PROCOMVAX v primerjavi z monovalentnima cepivoma statistično večja.
The following local reactions and systemic complaints were reported in ≥ 1.0% of children within five days after any injection of PROCOMVAX: pain/ soreness, erythema, swelling/ induration at the injection site; fever (> 38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying (> 4hrs), and crying not otherwise specified; otitis media.
V petih dneh po kateri koli injekciji cepiva PROCOMVAX so pri ≥ 1, 0% otrok opisali naslednje lokalne reakcije in sistemske težave: bolečine/ občutljivost, eritem, oteklost/ zatrdelost na mestu vboda; zvišano telesno temperaturo (> 38, 3°C, rektalni ekvivalent); anoreksijo, bruhanje, drisko; razdražljivost, zaspanost, jok (vključno z jokom z nenavadno visokim glasom), dolgotrajen jok (> 4 ure) in ne drugače opredeljen jok; otitis media.
Post marketing Experience
Izkušnje po začetku trženja
PROCOMVAX Hypersensitivity Rarely: anaphylaxis, angioedema, urticaria, erythema multiforme.
PROCOMVAX Preobčutljivost Redko: anafilaksa, angioedem, urtikarija, multiformni eritem
Nervous System Seizure, febrile seizure
Živčevje Napadi krčev, vročinski krči
4 Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
4 Bolezni dihal, prsnega koša in mediastinalnega prostora Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4. 4).
Skin Injection site nodule
Koža Bula na mestu vboda
Potential Adverse Effects
Možni neželeni učinki Poleg tega so bili med obdobjem tržne uporabe Merckovih cepiv PRP - OMPC oz.
In addition, a variety of adverse effects have been reported with marketed use of either Merck PRP- OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age.
(rekombinantnega) cepiva proti hepatitisu B pri dojenčkih in otrocih do 71. meseca starosti zabeležni različni neželeni učinki.
Liquid Merck PRP-OMPC Vaccine
Tekoče Merckovo cepivo PRP – OMPC
Haematologic/ Lymphatic Lymphadenopathy
Hematološki/ limfatični Limfadenopatija
Skin Pain at the injection site
Koža Bolečine na mestu vboda
Merck Hepatitis B (Recombinant) Vaccine Common reactions
Rekombinantno Merckovo cepivo proti hepatitisu B Pogoste reakcije
- elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like
- zvišanje jetrnih encimov, utrujenost, zvišana telesna temperatura, splošno slabo počutje, gripi
symptoms, serum sickness, thrombocytopenia
podobni simptomi, bronhospazmu podobni simptomi, serumska bolezen, trombocitopenija;
- dizziness, headache, paresthesia
- omotica, glavobol, parestezija;
- nausea, vomiting, diarrhea, abdominal pain
- navzeja, bruhanje, driska, bolečine v trebuhu;
- arthralgia, myalgia
- artralgija, mialgija;
- rash, pruritus,
- izpuščaj, pruritus;
- hypotension, syncope
- hipotenzija, sinkopa;
- paralysis (Bell’ s palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis
- paraliza (Bellova paraliza), nevropatija, nevritis (vključno z Guillain- Barréjevim sindromom,
including transverse myelitis), encephalitis, optical neuritis.
mielitis, vključno s transverznim mielitisom), encefalitis, optični nevritis;
- lymphadenopathy.
- limfadenopatija.
Pharmacotherapeutic group: anti infectious, ATC code:
Oznaka ATC:
J07CA PROCOMVAX is a sterile bivalent vaccine made of the antigenic components used in producing Merck PRP-OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
J07CA PROCOMVAX je sterilno dvovalentno cepivo iz antigenskih sestavin, ki se uporabljajo za pripravo Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B.
These components are the Haemophilus influenzae type b capsular polysaccharide (PRP) that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.
Ti sestavini sta kapsulni polisaharid (PRP) Haemophilusa influenzae tipa b, kovalentno vezan na beljakovinski kompleks zunanje membrane (OMPC) Neisserie meningitidis, ter površinski antigen hepatitisa B (HBsAg) iz rekombinantnih kultur kvasovk.
5 Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine
5 Odziv anti- HBs na PROCOMVAX pri dojenčkih, ki še niso bili cepljeni s cepivom proti hepatitisu B
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 1809 infants, approximately 2 months of age, who had not previously received any hepatitis B vaccine.
V 4 kliničnih preskušanjih v obdobju med 1992 in 2000 je cepivo PROCOMVAX dobilo 1809 dojenčkov, starih približno 2 meseca, ki prej še niso bili cepljeni s cepivom proti hepatitisu B.
These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Ti dojenčki so cepivo PROCOMVAX dobili v starosti 2, 4, in 12 - 15 mesecev.
In these studies, 1503 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 1309 had anti-HBs results available following the third dose of PROCOMVAX.
V teh študijah je bil pri 1503 dojenčkih podatek za anti- HBs na voljo po prvih dveh odmerkih, pri 1309 pa po tretjem odmerku.
Post-dose 2, 77% to 96% of infants developed a protective level of anti-HBs (≥ 10 mIU/ ml) and the GMTs ranged from 30 mIU/ ml to 190 mIU/ ml.
Po 2. odmerku se je zaščitna raven anti- HBs (≥ 10 mi. e. / ml) razvila pri 77% do 96% dojenčkov, GMT (geometrično povprečje titrov) pa je bil od 30 mi. e. / ml do 190 mi. e. / ml.
Post-dose 3, 96% to 100% of infants developed a protective level of anti-HBs and the GMTs ranged from 897 mIU/ ml to 4467 mIU/ ml.
Po 3. odmerku se je zaščitna raven anti- HBs razvila pri 96% do 100% dojenčkih, GMT pa je bil od 897 mi. e/ ml do 4467 mi. e/ ml.
Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine
Odziv anti- HBs na cepiv PROCOMVAX pri dojenčkih, ki so že bili cepljeni s cepivom proti hepatitisu B
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 722 infants, approximately 2 months of age, who had previously received a single dose of hepatitis B vaccine at birth.
V 4 kliničnih preskušanjih v obdobju med 1992 in 2000 je cepivo PROCOMVAX dobilo 722 dojenčkov, starih približno 2 meseca, ki so ob rojstvu že dobili en odmerek cepiva proti hepatitisu B.
These infants nominally received PROCOMVAX at 2-3, 4-5, and 12-15 months of age
Ti dojenčki so cepivo PROCOMVAX prejeli v starosti 2- 3, 4- 5 in 12- 15 mesecev.
In these studies, 618 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 461 had anti-HBs results available following the third dose of PROCOMVAX.
V teh študijah je bil pri 618 dojenčkih podatek za anti- HBs na voljo po prvih dveh odmerkih, pri 461 pa po tretjem odmerku.
Post-dose 2, 93% to 100% of infants developed a protective level of anti-HBs (≥ 10 mIU/ ml) and the GMTs ranged from 125 mIU/ ml to 417 mIU/ ml.
Po 2. odmerku se je zaščitna raven anti- HBs (≥ 10 mi. e. / ml) razvila pri 93% do 100% dojenčkov, GMT pa je bil od 125 mi. e. / ml do 417 mi. e. / ml.
Post-dose 3, 98% to 100% of infants developed a protective level of anti-HBs and the GMTs ranged from 1509 mIU/ ml to 3913 mIU/ ml.
Po 3. odmerku se je zaščitna raven anti- HBs razvila pri 98% do 100% dojenčkov, GMT pa je bil od 1509 mi. e/ ml do 3913 mi. e/ ml.
The duration of the protective effect for hepatitis B in healthy vaccinees is unknown at present and the need for a routine booster dose with hepatitis B-containing vaccines is not yet defined.
Potreba po rutinskem obnovitvenem odmerku s cepivom proti hepatitisu B ni določena.
Anti-PRP Responses to PROCOMVAX in Infants
Odziv anti- PRP na cepivo PROCOMVAX pri dojenčkih
These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Ti dojenčki so cepivo PROCOMVAX dobili v starosti 2, 4, in 12- 15 mesecev.
In these studies, 2121 infants had anti-PRP results available following the first 2 doses of PROCOMVAX and 1768 had anti-PRP results available following the third dose of PROCOMVAX.
V teh študijah je bil pri 2121 dojenčkih podatek za anti- PRP na voljo po prvih dveh odmerkih, pri 1768 pa po tretjem odmerku.
Post-dose 2, 95% to 99% of infants developed > 0.15 µg/ ml of anti-PRP, a level associated with short-term protection against invasive Hib disease, and the GMTs ranged from 2.5 µg/ ml to 4.3 µg/ ml.
Po 2. odmerku se je pri 95% do 99% dojenčkih razvila raven anti - PRP > 0, 15 µg/ ml – to je raven povezana s kratkotrajno zaščito proti invazivni bolezni Hib, GMT pa je bil od 2, 5 µg/ ml do 4, 3 µg/ ml.
Post-dose 3, 92% to 99% of infants developed > 1.0 µg/ ml of anti-PRP, a level associated with long- term protection against invasive Hib disease, and the GMTs ranged from 7.7 µg/ ml to 14.0 µg/ ml.
Po 3. odmerku se je pri 92% do 99% dojenčkih razvila raven anti - PRP > 1, 0 µg/ ml – to je raven povezana s dolgotrajno zaščito proti invazivni bolezni Hib, GMT pa je bil od 7, 7 µg/ ml do 14 µg/ ml.
6 Formulation contains amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride.
Cepivo vsebuje amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0, 9% natrijevem kloridu.
6.2 Incompatibilities
6 6. 2 Inkompatibilnosti
0.5 ml suspension in vial (type I flint glass).
6. 5 Vrsta ovojnine in vsebina
07/ 05/ 1999 Date of latest renewal:
07/ 05/ 1999 Datum zadnjega podaljšanja:
Sumneytown Pike West Point Pennsylvania 19486 USA
Sumneytoxn Pike West Point Pensilvanija 19486 ZDA
Name and address of the manufacturer responsible for batch release
Pozitivno inšpekcijsko poročilo je izdalo Ministrie van Volksgezondheid, Welzjin en Sport, Inspectie voor de gezondheidszorg, Postbus 5850, 2280 HW Rijswijk, Nizozemska, dne 17. 11. 1998.
(Merck Manufacturing Division) Waarderweg 39, 2031 BN, P. O.
Waarderweg 39 2031 BN, P. O.
Box 581, 2003 PC Haarlem The Netherlands
Box 581 2003 PC Haarlem Nizozemska
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Dovoljenje za promet je izdalo Ministrie van Volksgezondheid, Welzjin en Sport, Inspectie voor de gezondheidszorg, Postbus 5850, 2280 HW Rijswijk, Nizozemska, dne 27. 1. 1998.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EEC, the official batch release will be undertaken by a state laboratory or a laboratory disignated for that purpose.
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) Vaccine.
PROCOMVAX suspenzija za injiciranje Konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) in rekombinantno cepivo proti hepatitisu B
1 dose (0.5 ml) contains:
En odmerek (0, 5 ml) vsebuje:
7.5 µg of PRP from Haemophilus influenzae type b as PRP-OMPC 125 µg of Neisseria meningitidis OMPC 5.0 µg of hepatitis B surface antigen produced in recombinant yeast cells
7, 5 µg PRP Haemophilusa influenzae tipa b kot PRP- OMPC 125 µg OMPC (beljakovinski kompleks zunanje membrane) Neisserie meningitidis 5, 0 µg adsorbiranega površinskega antigena hepatitisa B, pridobljenega v rekombinantnih celicah kvasovk
Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Pomožne snovi: amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0, 9% natrijevem kloridu.
Suspension for injection in vial.
Ena enoodmerna 0, 5 ml viala Suspenzija za injiciranje v viali
METHOD AND,, ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 LYON
What PROCOMVAX is and what it is used for 2.
Kaj je zdravilo PROCOMVAX in za kaj ga uporabljamo 2.
Before you use PROCOMVAX 3.
Kaj morate vedeti pred cepljenjem z zdravilom PROCOMVAX 3.
How to use PROCOMVAX 4.
Kako uporabljati zdravilo PROCOMVAX 4.
Storing PROCOMVAX 6.
Shranjevanje zdravila PROCOMVAX 6.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine.
PROCOMVAX suspenzija za injiciranje v viali konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) in rekombinantno cepivo proti hepatitisu B
125 µg
OMPC 125 µg Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B)
Adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)
Adsorbiran površinski antigen hepatitisa B, pridobljen v rekombinantnih celicah kvasovk (Saccharomyces cerevisiae)
The other ingredients are: amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Pomožne snovi so amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0, 9% natrijevem kloridu.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon Izdelovalec:
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, Nizozemska.
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
PROCOMVAX je cepivo za injiciranje v 0, 5 ml enoodmerni viali.