natgillin/translations-raw huggingface dataset:
3 Immunogenicitetsresultater fra åbne kliniske afprøvninger viser at PROCOMVAX kan administreres samtidig med DTP (Difteri, Tetanus og helcelle Pertussis vaccine), OPV (Oral Poliomyelitis vaccine), IPV (inaktiveret poliomyelitis vaccine) og Merck M- M- R (levende mæslinge- parotitis- rubella vaccine) ved at anvende separate sprøjter og på forskellige injektionssteder for de injicerbare vacciner.
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,
Desuden viser begrænsede immunogenicitets- resultater fra en åben, kontrolleret klinisk afprøvning at PROCOMVAX kan administreres samtidig med DTaP (Difteri, Tetanus og acellulær Pertussis vaccine) ved at anvende separate sprøjter og på forskellige injektionssteder for de injicerbare vacciner.
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.
Af disse blev 1110 monitoreret med henblik på både alvorlige og ikke- alvorlige bivirkninger.
Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Afprøvningerne blev overvåget med henblik på alvorlige bivirkninger.
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.
Børnene blev monitoreret daglig i 5 dage efter hver injektion med henblik på lokale og systemiske reaktioner.
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.
De fleste børn modtog DTP og OPV samtidig med de 2 første doser PROCOMVAX eller Merck PRP- OMPC vaccine eller Merck Hepatitis B (rekombinant) vaccine.
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.
For alle 3 doser PROCOMVAX fandtes ikke nogen væsentlige forskelle i hyppigheden af bivirkninger mellem PROCOMVAX og de monovalente vacciner Merck PRP- OMPC vaccine og Merck Hepatitis B (rekombinant) vaccine.
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.
Smerte/ ømhed, erytem, hævelse/ induration på injektionsstedet; feber (> 38, 3 ºC rektalt), anoreksi, opkastning, diaré; irritabilitet, døsighed, gråd inkl. usædvanlig højrøstet gråd, langvarig gråd (> 4 timer), og gråd ikke specificeret på anden vis; mellemørebetændelse.
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.
PROCOMVAX Overfølsomhed I sjældne tilfælde: anafylaksi, angioødem, urticaria, erythema multiforme.
PROCOMVAX Hypersensitivity Rarely: anaphylaxis, angioedema, urticaria, erythema multiforme.
4 Nervesystemet Krampeanfald, feberkramper
Nervous System Seizure, febrile seizure
Luftveje, thorax og mediastinum Apnø hos præmature spædbørn (≤ 28 gestationsuge) (se afsnit 4. 4)
4 Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Hud Knude på injektionsstedet.
Potential Adverse Effects
Eventuelle bivirkninger Desuden er der rapporteret en del forskellige bivirkninger ved anvendelse af enten Merck PRP- OMPC vaccine eller Merck Hepatitis B (rekombinant) vaccine efter markedsføring hos spædbørn og børn i alderen op til 71 måneder.
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.
Flydende Merck PRP- OMPC vaccine
Liquid Merck PRP-OMPC Vaccine
Hæmatologiske/ Lymfevej Lymfadenopati
Haematologic/ Lymphatic Lymphadenopathy
Hud Smerte på injektionsstedet
Skin Pain at the injection site
Merck Hepatitis B (rekombinant) vaccine Hyppige reaktioner
Merck Hepatitis B (Recombinant) Vaccine Common reactions
Forbigående ømhed, erytem og induration
Local reactions at injection site: transient soreness, erythema, induration
Sjældne reaktioner
Rare
- Forhøjelse af leverenzymværdien, træthed, feber, utilpashed, influenza- lignende symptomer,
- elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like
bronchospasmelignende symptomer, serumsyge, trombocytopeni
symptoms, serum sickness, thrombocytopenia
- Svimmelhed, hovedpine, parastæsier
- dizziness, headache, paresthesia
- Kvalme, opkastning, diaré, abdominalsmerter
- nausea, vomiting, diarrhea, abdominal pain
- Arthralgia, myalgia
- arthralgia, myalgia
- Hududslæt, kløe
- rash, pruritus,
- Hypotension, synkope
- hypotension, syncope
- Paralyse (Bell' s paralyse), neuropati, neuritis (inklusive Guillain Barré syndrom), myelitis
- paralysis (Bell’ s palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis
(inklusive myelitis transversa), encephalitis, optisk neuritis
including transverse myelitis), encephalitis, optical neuritis.
- Lymfadenopati.
- lymphadenopathy.
Farmakoterapeutisk klassifikation: vaccine, ATC kode:
Pharmacotherapeutic group: anti infectious, ATC code:
J07CA PROCOMVAX er en steril bivalent vaccine fremstillet af de antigen- komponenter, der indgår i Merck PRP- OMPC vaccine og Merck Hepatitis B (rekombinant) vaccine.
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.
Disse komponenter består af Haemophilus influenzae type b kapselpolysaccharider (PRP), som kovalent bindes til et ydermembran proteinkonjugat (OMPC) af Neisseria meningitidis og til hepatitis B overflade- antigen (HBsAg) som er fremstillet på basis af rekombinant gærkultur.
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.
5 Den beskyttende virkning fra de enkelte komponenter i PROCOMVAX er blevet etableret ved afprøvning i praksis udført med de monovalente vacciner.
The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.
Anti- HBs- respons på PROCOMVAX hos spædbørn, som ikke tidligere er vaccineret med hepatitis B - vaccine
5 Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine
I 4 kliniske undersøgelser der blev gennemført mellem 1992 og 2000 blev PROCOMVAX givet til 1809 spædbørn, der var cirka 2 måneder gamle, og som ikke tidligere havde fået nogen hepatitis B - vaccine.
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.
Disse spædbørn fik nominelt PROCOMVAX ved 2, 4 og 12- 15- måneders alderen.
These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Hos 1309 af spædbørnene var der tilgængelige anti- HBs- resultater efter den tredje dosis PROCOMVAX.
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.
Efter 2. dosis udviklede 77- 96% af spædbørnene et beskyttende antistofniveau af anti- HBs (≥ 10 mIE/ ml) og med GMT i området fra 30 mIE/ ml til 190 mIE/ ml.
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.
Efter 3. dosis udviklede 96- 100% af spædbørnene et beskyttende antistofniveau af anti- HBs og med GMT i området fra 897 mIE/ ml til 4467 mIE/ 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.
Anti- HBs- respons på PROCOMVAX hos spædbørn, som tidligere er blevet vaccineret med hepatitis B - vaccine
Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine
I 4 kliniske undersøgelser der blev gennemført mellem 1992 og 2000 blev PROCOMVAX givet til 722 spædbørn, der var cirka 2 måneder gamle, og som tidligere havde fået en enkelt dosis hepatitis B - vaccine ved fødslen.
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.
Disse spædbørn fik nominelt PROCOMVAX ved 2- 3, 4- 5 og 12- 15- måneders alderen.
These infants nominally received PROCOMVAX at 2-3, 4-5, and 12-15 months of age
Hos 461 af spædbørnene var der tilgængelige anti- HBs- resultater efter den tredje dosis PROCOMVAX.
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.
Efter 2. dosis udviklede 93- 100% af spædbørnene et beskyttende antistofniveau af anti- HBs (≥ 10 mIE/ ml) og med GMT i området fra 125 mIE/ ml til 417 mIE/ ml.
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.
Efter 3. dosis udviklede 98- 100% af spædbørnene et beskyttende antistofniveau af anti- HBs og med GMT i området fra 1509 mIE/ ml til 3913 mIE/ 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.
Varigheden af den beskyttende virkning over for hepatitis B i raske vaccinerede personer kendes ikke på nuværende tidspunkt, og behovet for en rutinemæssig boosterdosis med hepatitis B- indeholdende vacciner er endnu ikke defineret.
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.
Anti- PRP- respons på PROCOMVAX hos spædbørn
Anti-PRP Responses to PROCOMVAX in Infants
I 6 kliniske undersøgelser der blev gennemført mellem 1992 og 2000 blev PROCOMVAX givet til 2528 spædbørn, cirka 2 måneder gamle, som ikke tidligere havde fået nogen Hib- vaccine.
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.
I disse undersøgelser havde 2121 spædbørn anti- PRP- resultater tilgængelige efter de første 2 doser af PROCOMVAX, og 1768 havde anti- PRP- resultater tilgængelige efter den tredje dosis PROCOMVAX.
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.
Efter 2. dosis udviklede 95- 99% af spædbørnene > 0, 15 µg/ ml anti- PRP.
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.
Efter 3. dosis udviklede 92- 99% af spædbørnene > 1, 0 µg/ ml anti- PRP.
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.
6 Ikke relevant.
Not applicable.
Formuleringen indeholder amorft aluminiumhydroxyfosfatsulfat og natriumborat i 0, 9% natriumklorid.
6 Formulation contains amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride.
0, 5 ml suspension i hætteglas (type I flintglas).
0.5 ml suspension in vial (type I flint glass).
6. 6 Eventuelle instruktioner vedrørende anvendelse, håndtering samt bortskaffelse
6.6 Instructions for use and handling
Ingen opløsning er påkrævet.
The vaccine should be used as supplied; no reconstitution is necessary.
8, rue Jonas Salk F - 69007 LYON
8, rue Jonas Salk F - 69007 LYON
07/ 05/ 1999 Dato for seneste fornyelse af markedsføringstilladelsen:
07/ 05/ 1999 Date of latest renewal:
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES
Til Haemophilus B- konjugat og Hepatitis- B- overfladeantigen:
For Haemophilus B conjugate and Hepatitis B surface antigen:
Sumneytown Pike West Point Pennsylvania 19486 USA
Sumneytown Pike West Point Pennsylvania 19486 USA
Box 581, 2003 PC Haarlem Olanda
Box 581, 2003 PC Haarlem The Netherlands
Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/ 83/ EØF vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium beregnet hertil.
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.
ETIKETTERING
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
Haemophilus b- konjugat (meningokok proteinkonjugat) og Hepatitis B - (rekombinant) vaccine
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) Vaccine.
7, 5 µg PRP fra Haemophilus influenzae type b som PRP- OMPC 125 µg Neisseria meningitidis OMPC 5, 0 µg hepatitis B- overflade- antigen fremstillet i rekombinante gærceller
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
Amorft aluminiumhydroxyfosfatsulfat og natriumborat i 0, 9% natriumklorid
Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
1 éndosis 0, 5 ml hætteglas.
1 single dose 0.5 ml in vial.
ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
METHOD AND,, ROUTE(S) OF ADMINISTRATION
Sanofi Pasteur MSD SNC 8, rue Jonas Salk F - 69007 Lyon
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon
PROCOMVAX Intramuskulær anvendelse
PROCOMVAX
16 INDLÆGSSEDDEL
15 PACKAGE LEAFLET
Hvad PROCOMVAX er, og hvad det anvendes til 2.
What PROCOMVAX is and what it is used for 2.
Hvad De skal gøre, før De begynder at tage PROCOMVAX 3.
Before you use PROCOMVAX 3.
Hvordan De anvender PROCOMVAX 4.
How to use PROCOMVAX 4.
Hvilke mulige bivirkninger PROCOMVAX har 5.
Possible side effects 5.
Hvordan De opbevarer PROCOMVAX 6.
Storing PROCOMVAX 6.
Haemophilus b- konjugat (meningokok proteinkonjugat) og Hepatitis B (rekombinant) vaccine.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine.
De øvrige indholdsstoffer er amorft aluminiumhydroxyfosfatsulfat og natriumborat i 0, 9% natriumklorid.
The other ingredients are: amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon
Fremstiller:
Manufactured by:
Merck, Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, Olanda
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
PROCOMVAX er en injicerbar vaccine, der fås i et enkeltdosis hætteglas (0, 5 ml).
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
PROCOMVAX er beregnet som en hjælp til at beskytte Deres barn mod invasive sygdomme forårsaget af Haemophilus influenzae type b (infektion i hjerne - og rygmarvsvæv, infektioner i blodet, osv.) og imod leverinfektioner forårsaget af alle kendte undertyper af hepatitis B- virus.
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.
De bør ikke anvende PROCOMVAX:
Do not use PROCOMVAX:
- Hvis Deres barn allergisk over for nogle af indholdsstofferne i vaccinen.
- if your child is allergic to any component of the vaccine.
- Hos spædbørn i alderen under 6 uger.
- in infants younger than 6 weeks of age
- Hvis Deres barn har feber (vaccination bør udsættes).
- if your child has fever (vaccination should be delayed).
- Hos spædbørn født af HBsAg- positive mødre.
- in infants born to HBsAg positive mothers.
17 Vær særlig forsigtig med at anvende PROCOMVAX:
16 Take special care with PROCOMVAX:
- Hos spædbørn med blødningsforstyrrelser som hæmofili eller trombocytopeni bør der træffes
- if your child has bleeding disorders such as haemophilia or thrombocytopenia, special
særlige forholdsregler mod risikoen for hæmatom efter injektion.
precautions should be taken against the risk of haematoma following injection.
- Spædbørn født af HBsAg- positive mødre bør få hepatitis B- immunglobulin samt Hepatitis B -
- if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should
vaccine (rekombinant) ved fødslen, og derefter fuldføre et vaccinationsprogram mod hepatitis B.
receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Det er ikke undersøgt, hvordan PROCOMVAX efterfølgende administreres til at fuldføre et vaccinationsprogram mod hepatitis B hos spædbørn født af HBsAg- positive mødre, som ved fødslen fik hepatitis B- immunglobulin eller spædbørn født af mødre, hvis HBsAg- status er ukendt.
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.
- Som ved lignende vacciner, kan der muligvis opstå tilfælde af Haemophilus b- infektion i ugen
- as with other similar vaccines, cases of Haemophilus b disease may occur in the week after
efter vaccination, inden vaccinens beskyttelse indtræder.
vaccination prior to the onset of the protective effects of the vaccine.
- Da hepatitis B- infektion kan være til stede i længere tid uden at blive diagnosticeret, kan en
- because hepatitis B infection can go undetected for a long period of time, it is possible that an
person være inficeret allerede på vaccinationstidspunktet.
individual may already be infected at the time the vaccine is given.
PROCOMVAX kan administreres samtidig med primærimmuniseringen omfattende difteri- tetanus - pertussis vaccine (DTP) og oral poliovaccine (OPV).
PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
I alderen 12 til 15 måneder kan barnet samtidig vaccineres med PROCOMVAX og Merck MMR (levende mæslinge- parotitis- rubella vaccine) eller OPV, eller ved 15 måneders alderen med en boosterdosis difteri- tetanus- acellulær pertussis- vaccine (DTaP) til børn som har fået primærimmunisering med DTP.
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.
HVORDAN DE ANVENDER PROCOMVAX
HOW TO USE PROCOMVAX
Spædbørn født af HBsAg- negative mødre bør vaccineres med tre doser PROCOMVAX à 0, 5 ml, helst i alderen 2, 4 og 12- 15 måneder.
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.
2 måneder mellem 1. og 2. dosis, og intervallet mellem 2. og 3. dosis bør ligge så tæt som muligt på 8 til 11 måneder.
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.
Alle 3 doser skal administreres for at fuldføre vaccinations - programmet.
All three doses must be administered to complete the vaccination regimen.
Børn, som ikke er vaccineret ifølge det anbefalede vaccinationsprogram Vaccinationsprogrammer for børn, som ikke er vaccineret ifølge det anbefalede vaccinations- program, bør afpasses individuelt.
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.
HVILKE MULIGE BIVIRKNINGER PROCOMVAX HAR
POSSIBLE SIDE EFFECTS
Bivirkninger omfatter lokale reaktioner på injektionsstedet som f. eks. smerte, ømhed, rødme og hævelse.
Side effects include injection-site reactions such as pain, soreness, redness, and swelling.
18 irritabilitet, døsighed, feber, diaré, opkastning, nedsat appetit, mellemørebetændelse og usædvanlig højrøstet gråd.
Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying.
HVORDAN DE OPBEVARER PROCOMVAX
STORING PROCOMVAX
Opbevares i køleskab (2°C – 8°C) Må ikke nedfryses Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
Do not use after the expiry date stated on the label.
България Мерк Шарп и Доум България ЕООД тел. + 359 2 819 3740
България Мерк Шарп и Доум България ЕООД тел. + 359 2 819 3740
Nederland SANOFI PASTEUR MSD Tel: +31 23 567 9600
Nederland SANOFI PASTEUR MSD Tel: +31 23 567 9600
Norge SANOFI PASTEUR MSD Tlf: +47 67505020
Norge SANOFI PASTEUR MSD Tlf: +47 67505020
Portugal Sanofi Pasteur MSD, SA Tel: +351 21 470 45 50
Portugal Sanofi Pasteur MSD, SA Tel: +351 21 470 45 50
Τηλ: +357 22866700
Τηλ: +357 22866700
Den godkendte indikation for Procomvax er vaccination af spædbørn i alderen 6 uger til 15 måneder mod invasive infektioner forårsaget af Haemophilus influenzae type b samt infektioner forårsaget af alle kendte subtyper af hepatitis B- virus.
The approved indication of Procomvax is 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.
De aktive stoffer i Procomvax er polyribosylribitolphosphat (PRP) oprenset fra Haemophilus influenzae, der er kemisk bundet til ydermembran proteinkomplekset (OMPC) af Neisseria meningitidis og til hepatitis B overfladeantigenet (HBsAg) af hepatitis B - virusset, som er fremstillet på basis af en rekombinant gærstamme.
The active substances of Procomvax consist of polyribosylribitol phosphate (PRP) purified from Haemophilus influenzae and chemically coupled to the outer membrane protein complex (OMPC) of Neisseria meningitidis, and the hepatitis B surface antigen (HBsAg) of the hepatitis B virus, derived from a recombinant strain of yeast.