natgillin/translations-raw huggingface dataset:
- If you have further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2° C - 8° C).
Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Od teh so jih 1110 spremljali glede resnih in ne resnih neželenih pojavov.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
For paediatric use only.
Cepivo je le za pediatrično uporabo.
All three doses must be administered to complete the vaccination regimen.
Za dokončanje sheme cepljenja je treba dati vse tri odmerke.
Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
Infants with moderate or severe febrile illness should only be vaccinated as soon as they have recovered from the acute phase of the illness.
Dojenčke z zmerno ali hudo vročinsko boleznijo se lahko cepi, takoj ko okrevajo po akutni fazi bolezni.
If the recommended schedule cannot be followed exactly, the interval between the first two doses should be approximately two months and the interval between the second and third dose should be as close as possible to eight to eleven months.
Če priporočene sheme ni mogoče natančno upoštevati, mora biti presledek med prvima odmerkoma približno dva meseca, presledek med drugim in tretjim odmerkom pa čim bliže osmim do enajstim mesecem.
Potential Adverse Effects
Možni neželeni učinki
Children not vaccinated according to recommended schedule Vaccination schedules for children not vaccinated according to the recommended schedule should be considered on an individual basis.
Otroci, ki niso bili cepljeni po priporočeni shemi Shemo cepljenja za otroke, ki niso bili cepljeni po priporočeni shemi, je treba določiti individualno.
The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.
Zaščitna učinkovitost sestavin cepiva PROCOMVAX je bila ugotovljena v terenskih preskušanjih z monovalentnima cepivoma.
Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.
Od teh dojenčkov jih je bilo 1177 vključenih v klinične raziskave, v katerih je večina dobila PROCOMVAX sočasno z drugimi odobrenimi pediatričnimi cepivi.
Take special care with PROCOMVAX:
Bodite posebno pozorni pri uporabi zdravila PROCOMVAX:
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.
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.
In addition, tell your doctor if your child experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series.
Poleg tega svojemu zdravniku povejte, če otrok po katerem koli odmerku cepiva doživi simptome, ki nakazujejo alergijsko reakcijo.
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
PROCOMVAX je cepivo za injiciranje v 0,5 ml enoodmerni viali.
No serious vaccine-related side effects were reported.
Zabeležili niso nobenih resnih neželenih učinkov, povezanih s cepivom.
Like all medicines, PROCOMVAX can have side effects.
Kot vsa zdravila ima lahko tudi zdravilo PROCOMVAX neželene učinke.
0.5 ml suspension in vial (type I flint glass).
0,5 ml suspenzije v viali (kremenovo steklo tipa 1).
Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Izdelovalec: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Nizozemska.
Immune response data are satisfactory for PROCOMVAX but are currently unavailable for DTaP.
Izsledki o imunskem odzivu so za PROCOMVAX zadovoljivi, za DTaP pa jih trenutno še ni na voljo.
In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or other medicinal products in the same syringe.
Zaradi pomanjkanja raziskav kompatibilnosti cepiva ne smemo mešati v isti brizgi z drugimi cepivi ali drugimi zdravili.
Do not inject intravenously, intradermally, or subcutaneously
Ne injicirajte intravensko, intradermalno ali subkutano.
Individuals who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.
Osebe, pri katerih se po injiciranju pojavijo simptomi, ki nakazujejo preobčutljivost, ne smejo več dobiti injekcij tega cepiva.
1 WHAT PROCOMVAX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PROCOMVAX IN ZA KAJ GA UPORABLJAMO
After thorough agitation, PROCOMVAX is a slightly opaque, white suspension.
Dobro pretreseni PROCOMVAX je rahlo motna, bela suspenzija.
PROCOMVAX must not be mixed with other vaccines in the same syringe.
Cepiva PROCOMVAX se ne sme mešati z drugimi cepivi v isti brizgi.
PROCOMVAX - single dose in vial - Pack of 1
ŠKATLA PROCOMVAX - enoodmerna viala - pakiranje po 1
PROCOMVAX must be injected into the muscle of the thigh.
PROCOMVAX je treba injicirati v mišico na stegnu.
As for any vaccine, adequate treatment provisions, including adrenaline, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Tako kot velja za vsa cepiva, mora biti za takojšnjo uporabo na voljo ustrezna oprema, vključno z adrenalinom, če bi se pojavila anafilaktična ali anafilaktoidna reakcija.
PROCOMVAX will not prevent hepatitis caused by other viruses known to infect the liver.
PROCOMVAX ne prepreči hepatitisa, povzročenega z drugimi virusi, ki okužijo jetra.
Since PROCOMVAX has not been studied in persons who have malignancies or are otherwise immunocompromised, the extent of the immune response in such persons is unknown.
Delovanje cepiva PROCOMVAX ni raziskano pri osebah z malignomi in pri osebah, ki so drugače imunsko oslabele, zato stopnja imunskega odziva pri takšnih ljudeh ni znana.
The vaccine should be used as supplied; no reconstitution is necessary.
6.6 Navodila za pripravo in ravnanje z zdravilom Cepivo je treba uporabiti, kot je dobavljeno; rekonstitucija ni potrebna.
PROCOMVAX may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.
Mogoče je, da PROCOMVAX ne povzroči nastanka zaščitne vrednosti protiteles takoj po cepljenju; prav tako je mogoče, da zaščitnega odziva protiteles ne povzroči pri vseh prejemnikih cepiva.
No increase in the frequency or severity of adverse events was seen with subsequent doses.
Po nadaljnjih odmerkih niso opažali večje pogostnosti ali izrazitosti neželenih učinkov.
PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.
PROCOMVAX je indiciran za cepljenje proti invazivni bolezni, ki jo povzroča Haemophilus influenzae tipa b, in proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, in sicer pri otrocih, starih od 6 tednov do 15 mesecev.
In clinical trials involving the administration of 7,350 doses of PROCOMVAX to 2,993 healthy infants 6 weeks to 15 months of age, PROCOMVAX was generally well tolerated.
V kliničnih raziskavah 7350 odmerkov cepiva PROCOMVAX, danih 2993 zdravim dojenčkom, starim od 6 tednov do 15 mesecev, so dojenčki PROCOMVAX na splošno dobro prenašali.
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT(I) UPORABE
Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 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).
Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying.
Med drugimi neželenimi učinki so razdražljivost, zaspanost, zvišana telesna temperatura, driska, bruhanje, izguba teka, okužba srednjega ušesa in jok z nenavadno visokim glasom.
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.
V eni od teh raziskav, ki je bila randomizirana in multicentrična, so 882 dojenčkov v razmerju 3:1 razvrstili tako, da so prejemali PROCOMVAX ali pa Merckovo konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) (cepivo Merck PRP - OMPC) in Merckovo (rekombinantno) cepivo proti hepatitisu B. 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.
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.
MANUFACTURER'S BATCH NUMBER Batch
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
The vaccine may not prevent hepatitis B in such patients.
Pri takšnih bolnikih se lahko zgodi, da cepivo ne prepreči hepatitisa B.
Local reactions at injection site: transient soreness, erythema, induration
Lokalne reakcije na mestu vboda: prehodna občutljivost, eritem, zatrdelost
PROCOMVAX has been generally well tolerated in clinical trials.
V kliničnih raziskavah so otroci PROCOMVAX praviloma dobro prenašali.
Anti-PRP Responses to PROCOMVAX in Infants
Odziv anti-PRP na cepivo PROCOMVAX pri dojenčkih
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.
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.
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
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.
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.
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.
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).
- if your child has bleeding disorders such as haemophilia or thrombocytopenia , special precautions should be taken against the risk of haematoma following injection.
- če ima vaš otrok motnje strjevanja krvi kot sta hemofilija ali trombocitopenija, je treba za preprečitev podpludbe po injiciranju uporabiti posebne previdnostne ukrepe.
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.
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
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.
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
Skin Pain at the injection site
Koža Bula na mestu vboda
If you forget to take PROCOMVAX: Your doctor will decide when to give the missed dose.
Vaš zdravnik bo odločil, kdaj dati izpuščeni odmerek.
Side effects include injection-site reactions such as pain, soreness, redness, and swelling.
Med neželenimi učinki se pojavljajo reakcije na mestu vboda, kot so bolečina, občutljivost, pordelost in oteklost.
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.
Inkubacijska doba hepatitisa B je dolga, zato je v času cepljenja lahko prisotna neodkrita okužba.
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.
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.
Efficacy of whole cell or acellular pertussis vaccines when given concomitantly with PROCOMVAX has not been established in field trials.
Učinkovitost polnoceličnega oz. brezceličnega cepiva proti oslovskemu kašlju ob sočasni uporabi s cepivom PROCOMVAX v terenskih raziskavah ni bila ugotovljena.
In infants with bleeding disorders such as haemophilia or thrombocytopenia, special precautions should be taken against the risk of haematoma following the injection.
Pri dojenčkih z motnjami hemostaze, kot sta hemofilija ali trombocitopenija, je treba za preprečitev hematomov po injiciranju uporabiti posebne previdnostne ukrepe.
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.
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.
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, 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 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.
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.
Trajanje zaščitnega učinka za hepatitis B pri zdravih cepljenih osebah trenutno ni znano.
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.
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.
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.
Poleg tega omejeno število izsledkov o imunogenosti iz odprte, kontrolirane raziskave kaže, da se PROCOMVAX lahko uporabi sočasno z DTaP (Diphtheria, Tetanus, and acellular
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.
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.
Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine
Odziv anti-HBs na PROCOMVAX pri dojenčkih, ki še niso bili cepljeni s cepivom proti hepatitisu B
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.
Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg
Poliribozilribitolfosfat (PRP) Haemophilusa influenzae tipa b kot PRP - OMPC
PROCOMVAX has been administered simultaneously with the primary series of DTaP and enhanced inactivated poliovirus vaccine (IPV) to a limited number of infants.
Pri omejenem številu dojenčkov so PROCOMVAX uporabili sočasno z osnovnim nizom DTaP in okrepljenim inaktiviranim cepivom proti poliovirusu (IPV).
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.
BEFORE YOU USE PROCOMVAX
KAJ MORATE VEDETI PRED CEPLJENJEM Z ZDRAVILOM PROCOMVAX
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
Nervous System Seizure, febrile seizure
Napadi krčev, vročinski krči
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
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.
PROCOMVAX je namenjen zaščiti vašega otroka pred invazivno boleznijo, ki jo povzroča bakterija Haemophilus influenzae tipa b (okužba možganov in hrbtenjače, okužba krvi idr.
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.
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.
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.
It has been recommended that immunisation should be delayed during the course of an acute febrile illness.
Med potekom akutne vročinske bolezni je imunizacijo priporočljivo odložiti.
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.
- in infants younger than 6 weeks of age - if your child has fever (vaccination should be delayed).
- 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.
Neisseria meningitidis OMPC (outer membrane protein complex
OMPC (outer membrane protein complex - beljakovinski kompleks zunanje membrane) Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B)
Shake well before withdrawal and use.
Preden cepivo izvlečete in uporabite, dobro pretresite.
None of the serious adverse experiences was judged by the study investigator to be related to this vaccine.
Po presoji zdravnika raziskovalca noben resen neželen pojav ni bil povezan s tem
- 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.
- 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.
All vaccines can be administered to infants with minor illnesses such as diarrhoea or mild upper-respiratory infection.
Dojenčki z blažjimi boleznimi, kot sta diareja ali blaga okužba zgornjih dihal, lahko dobijo vsa cepiva.
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.
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.