FrancophonIA/ELRC3.0 huggingface dataset:
English: Local reactions at injection site: transient soreness, erythema, induration
Slovenian: Lokalne reakcije na mestu vboda: prehodna občutljivost, eritem, zatrdelost
English: PROCOMVAX has been generally well tolerated in clinical trials.
Slovenian: V kliničnih raziskavah so otroci PROCOMVAX praviloma dobro prenašali.
English: Anti-PRP Responses to PROCOMVAX in Infants
Slovenian: Odziv anti-PRP na cepivo PROCOMVAX pri dojenčkih
English: At 12 to 15 months of age, PROCOMVAX may be given simultaneously with Merck MMR (Measles, Mumps, and Rubella Virus Vaccine Live), or OPV or with a booster dose of diphtheria, tetanus, acellular pertussis vaccine (DTaP) at 15 months of age in children who received the primary series of DTP.
Slovenian: Od 12. do 15. meseca starosti se PROCOMVAX lahko daje sočasno z Merckovim cepivom MMR (cepivo proti ošpicam, mumpsu in rdečkam (živ virus)) in z OPV; sočasno se zdravilo daje z obnovitvenim odmerkom cepiva DTaP (cepivo proti davici, tetanusu in brezcelično cepivo proti oslovskemu kašlju) pri 15. mesecih starosti pri otrocih, ki so dobili osnovni niz cepljenja z DTP.
English: 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
Slovenian: 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
English: Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered PROCOMVAX on the schedule of 2, 4, and 12 -15 months of age.
Slovenian: Otroci, ki dobijo odmerek cepiva proti hepatitisu B ob rojstvu ali kmalu po njem, lahko dobijo PROCOMVAX po shemi pri 2., 4. in od 12. do 15. meseca starosti.
English: 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.
Slovenian: Preostalih 1816 dojenčkov je bilo vključenih v raziskave, v katerih so PROCOMVAX dobivali sočasno bodisi s preiskovanim polisaharidno-beljakovinskim konjugiranim cepivom proti pnevmokokom ali s preiskovanim pripravkom cepiva proti davici, tetanusu, oslovskemu kašlju in inaktiviranim poliovirusnim cepivom).
English: - if your child has bleeding disorders such as haemophilia or thrombocytopenia , special precautions should be taken against the risk of haematoma following injection.
Slovenian: - če ima vaš otrok motnje strjevanja krvi kot sta hemofilija ali trombocitopenija, je treba za preprečitev podpludbe po injiciranju uporabiti posebne previdnostne ukrepe.
English: As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.
Slovenian: Kot je opisano pri polisaharidnem cepivu proti hemofilusu b in drugem konjugiranem cepivu proti hemofilusu b, se lahko v tednu po cepljenju, to je še pred nastopom zaščitnega učinka cepiv, pojavijo
English: PROCOMVAX will not protect against invasive disease caused by Haemophilus influenzae other than type b or against invasive disease (such as meningitis or sepsis) caused by other microorganisms.
Slovenian: PROCOMVAX ne varuje pred invazivno boleznijo, ki jo povzročajo ostali tipi Haemophilusa influenzae, razen tipa b, in tudi ne pred invazivno boleznijo (npr. meningitisom ali sepso), ki jo
English: Skin Pain at the injection site
Slovenian: Koža Bula na mestu vboda
English: If you forget to take PROCOMVAX: Your doctor will decide when to give the missed dose.
Slovenian: Vaš zdravnik bo odločil, kdaj dati izpuščeni odmerek.
English: Side effects include injection-site reactions such as pain, soreness, redness, and swelling.
Slovenian: Med neželenimi učinki se pojavljajo reakcije na mestu vboda, kot so bolečina, občutljivost, pordelost in oteklost.
English: Because of a long incubation period for Hepatitis B, it is possible for unrecognised infection to be present at the time the vaccine is given.
Slovenian: Inkubacijska doba hepatitisa B je dolga, zato je v času cepljenja lahko prisotna neodkrita okužba.
English: Other side effects that may occur rarely and be serious include seizure, febrile seizure, allergic reactions, allergic swelling (angioedema) and certain severe types of rash, injection site nodule.
Slovenian: Redko pa se lahko pojavijo še naslednji resni neželeni učinki: napad krčev, vročinski krči, preobčutljivost, alergijska oteklina (angioedem) in določeni resni tipi izpuščajov; bula na mestu vboda.
English: Efficacy of whole cell or acellular pertussis vaccines when given concomitantly with PROCOMVAX has not been established in field trials.
Slovenian: Učinkovitost polnoceličnega oz. brezceličnega cepiva proti oslovskemu kašlju ob sočasni uporabi s cepivom PROCOMVAX v terenskih raziskavah ni bila ugotovljena.
English: In infants with bleeding disorders such as haemophilia or thrombocytopenia, special precautions should be taken against the risk of haematoma following the injection.
Slovenian: Pri dojenčkih z motnjami hemostaze, kot sta hemofilija ali trombocitopenija, je treba za preprečitev hematomov po injiciranju uporabiti posebne previdnostne ukrepe.
English: In addition, a variety of adverse effects have been reported with marketed use of either Merck PRPOMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age.
Slovenian: Poleg tega so bili med obdobjem tržne uporabe Merckovih cepiv PRP - OMPC oz. (rekombinantnega) cepiva proti hepatitisu B pri dojenčkih in otrocih do 71. meseca starosti zabeležni različni neželeni učinki.
English: 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.
Slovenian: V teh študijah je bil pri 1503 dojenčkih podatek za anti-HBs na voljo po prvih dveh odmerkih, pri 1309 pa po tretjem odmerku.
English: 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.
Slovenian: Po 2. odmerku se je pri 95 % do 99 % dojenčkih razvila raven antiPRP > 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.
English: Merck Sharp & Dohme (Middle East) Limited.
Slovenian: Merck Sharp & Dohme (Middle East) Ltd Τηλ.
English: 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.
Slovenian: Trajanje zaščitnega učinka za hepatitis B pri zdravih cepljenih osebah trenutno ni znano.
English: In 6 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 2528 infants, approximately 2 months of age, who had not previously received any Hib vaccine.
Slovenian: V 6 kliničnih preskušanjih v obdobju med 1992 in 2000 je cepivo PROCOMVAX dobilo 2528 dojenčkov, starih približno 2 meseca, ki še niso bili cepljeni z nobenim cepivom proti Hib.
English: 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.
Slovenian: Poleg tega omejeno število izsledkov o imunogenosti iz odprte, kontrolirane raziskave kaže, da se PROCOMVAX lahko uporabi sočasno z DTaP (Diphtheria, Tetanus, and acellular
English: 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.
Slovenian: V teh študijah je bil pri 2121 dojenčkih podatek za anti-PRP na voljo po prvih dveh odmerkih, pri 1768 pa po tretjem odmerku.
English: 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,
Slovenian: 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.
English: Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine
Slovenian: Odziv anti-HBs na PROCOMVAX pri dojenčkih, ki še niso bili cepljeni s cepivom proti hepatitisu B
English: 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.
Slovenian: V teh študijah je bil pri 618 dojenčkih podatek za anti-HBs na voljo po prvih dveh odmerkih, pri 461 pa po tretjem odmerku.
English: Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg
Slovenian: Poliribozilribitolfosfat (PRP) Haemophilusa influenzae tipa b kot PRP - OMPC
English: PROCOMVAX has been administered simultaneously with the primary series of DTaP and enhanced inactivated poliovirus vaccine (IPV) to a limited number of infants.
Slovenian: Pri omejenem številu dojenčkov so PROCOMVAX uporabili sočasno z osnovnim nizom DTaP in okrepljenim inaktiviranim cepivom proti poliovirusu (IPV).
English: These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Slovenian: Ti dojenčki so cepivo PROCOMVAX dobili v starosti 2, 4, in 12-15 mesecev.
English: BEFORE YOU USE PROCOMVAX
Slovenian: KAJ MORATE VEDETI PRED CEPLJENJEM Z ZDRAVILOM PROCOMVAX
English: Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine
Slovenian: Odziv anti-HBs na cepiv PROCOMVAX pri dojenčkih, ki so že bili cepljeni s cepivom proti hepatitisu
English: Nervous System Seizure, febrile seizure
Slovenian: Napadi krčev, vročinski krči
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
English: PROCOMVAX is indicated to help protect your child against invasive disease caused by Haemophilus influenzae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against infection of the liver caused by all known subtypes of hepatitis B virus.
Slovenian: PROCOMVAX je namenjen zaščiti vašega otroka pred invazivno boleznijo, ki jo povzroča bakterija Haemophilus influenzae tipa b (okužba možganov in hrbtenjače, okužba krvi idr.
English: Infants born of HBsAg negative mothers should be vaccinated with three 0.5 ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Slovenian: Dojenčke HBsAg negativnih mater je treba cepiti s tremi 0,5 ml odmerki cepiva PROCOMVAX, najbolje pri 2., 4. in od 12. do 15. meseca starosti.
English: 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.
Slovenian: 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.
English: It has been recommended that immunisation should be delayed during the course of an acute febrile illness.
Slovenian: Med potekom akutne vročinske bolezni je imunizacijo priporočljivo odložiti.
English: Formulation contains amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride.
Slovenian: Cepivo vsebuje amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0,9 % natrijevem kloridu.
English: - in infants younger than 6 weeks of age - if your child has fever (vaccination should be delayed).
Slovenian: - če je vaš otrok alergičen na katerokoli sestavino cepiva, - pri dojenčkih, mlajših od 6 tednov, - pri otrocih, ki imajo zvišano telesno temperaturo (cepljenje je treba prestaviti), - pri dojenčkih, rojenih HBsAg pozitivnim materam.
English: Neisseria meningitidis OMPC (outer membrane protein complex
Slovenian: OMPC (outer membrane protein complex - beljakovinski kompleks zunanje membrane) Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B)
English: Shake well before withdrawal and use.
Slovenian: Preden cepivo izvlečete in uporabite, dobro pretresite.
English: None of the serious adverse experiences was judged by the study investigator to be related to this vaccine.
Slovenian: Po presoji zdravnika raziskovalca noben resen neželen pojav ni bil povezan s tem
English: - as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine.
Slovenian: - tako kot pri drugih podobnih cepivih se lahko v tednu po cepljenju, torej še pred začetkom zaščitnih učinkov cepiva, pojavijo primeri bolezni zaradi okužbe s hemofilusom b. - ker lahko okužba s hepatitisom B dolgo ostane neopažena, se lahko zgodi, da je oseba v času cepljenja že okužena.
English: All vaccines can be administered to infants with minor illnesses such as diarrhoea or mild upper-respiratory infection.
Slovenian: Dojenčki z blažjimi boleznimi, kot sta diareja ali blaga okužba zgornjih dihal, lahko dobijo vsa cepiva.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Slovenian: Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
English: Among the 2,993 children given PROCOMVAX, 33 had serious adverse experiences within 14 days of vaccination.
Slovenian: V 14 dneh po cepljenju je resne neželene pojave doživelo 33 od 2993 otrok, ki so dobili PROCOMVAX.
English: Parenteral medicinal products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.
Slovenian: Kadar koli raztopina in vsebnik to dopuščata, je treba parenteralna zdravila pred uporabo pregledati, da ne vsebujejo tujih delcev in niso
English: Rarely : anaphylaxis, angioedema, urticaria, erythema multiforme.
Slovenian: Redko: anafilaksa, angioedem, urtikarija, multiformni eritem Živčevje
English: - if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Slovenian: - če je otrokova mati pozitivna na površinski antigen hepatitisa B, mora dojenček dobiti imunoglobulin proti hepatitisu B (HBIG) in rekombinantno cepivo proti hepatitisu B ob rojstvu ter opraviti celoten niz cepljenj proti hepatitisu B. 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.
English: 125 µg of the B11 strain of Neisseria meningitidis subgroup B) Adsorbed hepatitis B surface antigen produced in recombinant yeast cells
Slovenian: Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B) Adsorbiran površinski antigen hepatitisa B, pridobljen v rekombinantnih celicah kvasovk
English: Posology
Slovenian: SERIJE
English: Excipients: Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9 % sodium chloride
Slovenian: Pomožne snovi: amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0,9 % natrijevem kloridu.
English: 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.
Slovenian: 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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Poliribozilribitolfosfat (PRP) Haemophilusa influenzae tipa b kot PRP - OMPC
English: 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.
Slovenian: 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.
English: The other ingredients are: amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Slovenian: Pomožne snovi so amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0,9 % natrijevem
English: 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.
Slovenian: 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. Ti dojenčki so cepivo PROCOMVAX prejeli v starosti 2-3, 4-5 in 12-15 mesecev.
English: Pharmacotherapeutic group : anti infectious, ATC code : 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.
Slovenian: Oznaka ATC: J07CA PROCOMVAX je sterilno dvovalentno cepivo iz antigenskih sestavin, ki se uporabljajo za pripravo Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B. 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.
English: Post-dose 3, 92 % to 99 % of infants developed >1.0 µg/ml of anti-PRP, a level associated with longterm protection against invasive Hib disease, and the GMTs ranged from 7.7 µg/ml to 14.0 µg/ml.
Slovenian: Po 3. odmerku se je pri 92 % do 99 % dojenčkih razvila raven antiPRP > 1,0 µg/ml - to je raven povezana s dolgotrajno zaščito proti invazivni bolezni Hib, GMT pa je
English: 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.
Slovenian: 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. Ti dojenčki so cepivo PROCOMVAX dobili v starosti 2, 4, in 12 - 15 mesecev.
English: 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.
Slovenian: Večina otrok je DTP in OPV dobila sočasno s prvima odmerkoma cepiva PROCOMVAX ali Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B. 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. 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.
English: 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.
Slovenian: 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
English: Name and address of the manufacturer of the biological active substances
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK
English: 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.
Slovenian: 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. 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.
English: - elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like symptoms, serum sickness, thrombocytopenia - dizziness, headache, paresthesia - nausea, vomiting, diarrhea, abdominal pain - arthralgia, myalgia - rash, pruritus, - hypotension, syncope - paralysis (Bell's palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis including transverse myelitis), encephalitis, optical neuritis.
Slovenian: - zvišanje jetrnih encimov, utrujenost, zvišana telesna temperatura, splošno slabo počutje, gripi podobni simptomi, bronhospazmu podobni simptomi, serumska bolezen, trombocitopenija;
English: In this leaflet: What PROCOMVAX is and what it is used for
Slovenian: Navodilo vsebuje: Kaj je zdravilo PROCOMVAX in za kaj ga uporabljamo Kaj morate vedeti pred cepljenjem z zdravilom PROCOMVAX
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose = 0.5 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Slovenian: PROCOMVAX suspenzija za injiciranje konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) in rekombinantno cepivo proti hepatitisu B
English: Merck Hepatitis B (Recombinant) Vaccine Common reactions
Slovenian: Rekombinantno Merckovo cepivo proti hepatitisu B
English: Suspension for injection in vial.
Slovenian: NALEPKA NA VIALI
English: Intramuscular use.
Slovenian: - Navodilo shranite.
English: PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
Slovenian: Pri takšnih bolnikih je mogoče, da cepivo ne prepreči hepatitisa B. Uporaba drugih cepivPROCOMVAX se lahko daje hkrati z osnovnim nizom cepiva proti davici, tetanusu in oslovskemu kašlju (DTP) in peroralnega cepiva proti poliovirusu (OPV).
English: 6.6 Instructions for use and handling
Slovenian: 6.3 Rok uporabnosti
English: For Haemophilus B conjugate and Hepatitis B surface antigen:
Slovenian: Ime in naslov izdelovalca bioloških zdravilnih učinkovin Za konjugirani antigen hemofilusa B in površinski antigen hepatitisa B: Merck & Co. Inc.
English: The active substances are:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi med 2°C in 8°C (v hladilniku).
English: DATE OF REVISION OF THE TEXT
Slovenian: FARMACEVTSKI PODATKI