natgillin/translations-raw huggingface dataset:
Selvom symptomer på meningitis, som nakkesmerter/ stivhed eller photophobia er set som følge af administration af andre MenC konjugerede vacciner, er der ingen tegn på, at MenC konjugerede vacciner fremkalder meningitis.
Although symptoms of meningism such as neck pain/ stiffness or photophobia have been reported following administration of other MenC conjugate vaccines, there is no evidence that MenC conjugate vaccines cause meningitis.
10 Da Hib- kapslet polysaccharid antigen udskilles i urinen, kan en positiv urin- antigen- test ses i 1- 2 uger efter vaccination.
Since Hib capsular polysaccharide antigen is excreted in the urine, a positive urine antigen test can be observed within 1-2 weeks following vaccination.
Andre diagnostiske test, som ikke baseres på måling af kapslet antigen i urinen, bør anvendes til bestemmelse af Hib- infektioner i denne periode.
Other diagnostic tests, not based on the detection of the capsular antigen in urine, should be used to confirm Hib disease during this period.
Forskellige forsøg med godkendte, konjugerede monovalente meningokokker gruppe C- vacciner, som er administreret sammen med kombinationsvacciner indeholdende difteri -, tetanus - og acellulær pertussiskomponenter (med og uden inaktiveret polio virus, hepatitis B overflade antigen eller konjugeret Hib [f. eks.
In various studies with licensed monovalent meningococcal group C conjugate vaccines, concomitant administration with combinations containing diphtheria, tetanus and acellular pertussis components (with or without inactivated polio viruses, hepatitis B surface antigen or Hib conjugate [e. g.
DTPa- HBV- IPV- Hib *]), har vist at give lavere geometriske gennemsnitstitre (GMT) for serumbakerielt antistof (SBA) sammenlignet med separat administration eller administration i kombination med helcellepertussis- vaccine.
DTPa- HBV-IPV-Hib*]), has been shown to result in lower serum bactericidal antibody (SBA) geometric mean titres (GMT) compared to separate administrations or to co-administration with whole cell pertussis vaccines.
Forholdene til opnåelse af SBA- titer på mindst 1: 8 påvirkes ikke.
The proportions reaching SBA titres of at least 1:8 are not affected.
I kliniske forsøg med de primære vaccinationsprogrammer blev Menitorix administreret samtidig (på hver sit lår) med en DTPa- HBV- IPV vaccine.
In clinical trials of primary vaccination series, Menitorix was administered concomitantly (into opposite thighs) with a DTPa-HBV-IPV vaccine.
Responset for alle samtidigt administrerede antigener var tilfredstillende og sammenlignelige med det opnåede respons i kontrolgrupperne, som fik DTPa - HBV- IPV- Hib * samtidig med en konjugeret MenC- vaccine (MenCC) eller DTPa- HBV- IPV * samtidig med en Hib konjugeret vaccine og ingen MenCC.
Responses to all the co-administered antigens were satisfactory and were similar to those achieved in control groups that received DTPa-HBV-IPV-Hib* concomitantly with a MenC conjugate vaccine (MenCC) or DTPa-HBV-IPV* concomitantly with a Hib conjugate vaccine and no MenCC.
Immunresponset for Hib og MenC komponenterne i Menitorix er kun vurderet i kliniske forsøg med primær vaccination med samtidig administration af DTPa- IPV * eller DTPa- HBV- IPV * vacciner.
The immune response to the Hib and MenC components of Menitorix was only assessed in primary vaccination clinical studies that employed co-administration with DTPa-IPV* or DTPa-HBV-IPV* vaccines.
Resultaterne blev sammenlignet med de syv pneumokok serotyper, som blev opnået i en gruppe, som modtog DTPa- HBV- IPV * samtidig med Hib (konjugeret til tetanustoksin) og en godkendt, konjugeret pneumokoksaccharid- vaccine.
In a trial of primary vaccination, concomitant administration of an investigational vaccine containing the same amount of conjugated Hib and MenC saccharides as in Menitorix with DTPa-HBV-IPV* and a licensed pneumococcal saccharide conjugated vaccine (the three injections were made into anatomically distant sites) gave similar immune responses to the seven pneumococcal serotypes as achieved in a group that received DTPa-HBV-IPV* concomitantly with Hib (conjugated to tetanus toxoid) and a licensed pneumococcal saccharide conjugated vaccine.
Interferens er dog ikke at forvente.
There are no data on concomitant use of Menitorix with whole cell pertussis and oral poliomyelitis vaccines, however, no interference is expected.
I et forsøg med boostervaccination mod Hib og MenC, blev Menitorix administreret samtidig (på hver sit lår) med 1. dosis af en kombineret mæslinge -, fåresyge - og røde hunde - (MFR) vaccine.
In a trial of booster vaccination against Hib and MenC, Menitorix was administered concomitantly (into opposite thighs) with a first dose of combined measles, mumps and rubella (MMR) vaccine.
4. 8 og 5. 1)
See sections 4.8 and 5.1.
* GlaxoSmithKline kombinationsvaccine.
*GlaxoSmithKline combination vaccine
Samtidig med, at Menitorix blev administreret i et 3- dosis - primærvaccinationsprogram, blev en DTPa- HBV- IPV * vaccine (N = 796) eller en DTPa- IPV vaccine * (N = 375) også givet.
When Menitorix was administered as a 3-dose primary vaccination course, a DTPa- HBV-IPV* vaccine (N=796) or a DTPa-IPV vaccine* (N=375) was administered concomitantly.
I to kliniske forsøg (N = 578), blev Menitorix administreret samtidig med en mæslinge -, fåresyge - og røde- hunde- vaccine (MFR).
In two clinical trials (N=578), Menitorix was administered concomitantly with Measles, Mumps, Rubella (MMR) vaccine.
I det ene af disse forsøg var hyppigheden af bivirkninger, observeret for personer (N = 102), som modtog Menitorix samtidig med MFR * vaccine sammenlignelig med dem, som blev observeret i den gruppe, som kun modtog MFR- vaccine (N = 91), eller som kun modtog Menitorix (N = 104) (se pkt.
In one of these trials, the incidences of adverse reactions observed in subjects (N=102) who received Menitorix concomitantly with MMR* were similar to those observed in the group who received MMR alone (N=91) or Menitorix alone (N=104).
4. 5 og 5. 1)
(See sections 4.5 and 5.1)
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til, < 1/ 10) Ikke almindelig (≥ 1/ 1. 000 til, < 1/ 100) Sjælden (≥ 1/ 10. 000 til, < 1/ 1. 000) Meget sjælden (≥ 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data) I hver frekvensgruppe er bivirkningerne listet med faldende alvorlighed.
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)
Gråd
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Sløvhed
Psychiatric disorders: very common: irritability uncommon: crying
Mave- tarmkanalen Meget almindelig:
Nervous system disorders: very common: drowsiness
Udslæt
Gastrointestinal disorders: very common: appetite lost uncommon: diarrhoea, vomiting
Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
Skin and subcutaneous tissue disorders: uncommon: dermatitis atopic rare: rash
• Post- marketing
General disorders and administration site conditions: very common: fever (rectal ≥ 38°C), swelling, pain, rednesscommon: injection site reaction uncommon: fever (rectal > 39.5°C), malaise 12 • Post-marketing experience
Følgende bivirkninger er set efter administration af Menitorix:
The following adverse events have been reported after administration of Menitorix:
Allergiske reaktioner (inklusive nældefeber og anafylaktiske reaktioner), lymfeknudesvulst, svimmelhed, feberkramper, hypotoni, hovedpine.
Allergic reactions (including urticaria and anaphylactoid reactions), lymphadenopathy, dizziness, febrile seizures, hypotonia, headache.
12 Følgende er ikke set i forbindelse med administration af Menitorix, men er ofte set ved almindelig brug af godkendte konjugerede meningokok gruppe C- vacciner:
The following have not been reported in association with administration of Menitorix but have occurred very rarely during routine use of licensed meningococcal group C conjugate vaccines:
Alvorlige hudreaktioner, kollaps eller shocktilstand, besvimelsesanfald, kramper hos personer, som i forvejen lider af krampeanfald, hypoæstesi, paræstesi, tilbagefald af nefrotisk syndrom, artralgi, petecchie og/ eller purpura.
Severe skin reactions, collapse or shock-like state (hypotonic-hyporesponsiveness episode), faints, seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia, relapse of nephrotic syndrome, arthralgia, petechiae and/ or purpura.
Farmakoterapeutisk klassifikation: bakteriel vaccine, ATC- kode:
Pharmacotherapeutic group: bacterial vaccines ATC code:
2, 3, 4 måneder eller 2, 4, 6 måneder.
Clinical trials have evaluated the antibody responses at one month after two doses and after completion of a 3-dose primary vaccination course of Menitorix (co-administered with DTPa-HBV- IPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
Procentdelen af børn med antistoftitre ≥ ” assay cut off ” en måned efter primærvaccination med Menitorix givet samtidig med en DTPa- IPV * - eller DTPa- HBV- IPV * - vaccine var følgende:
Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
2- 3- 4- måneders program
2-3-4 month schedule
efter to doser N = 93
After two doses N=93
Efter tre doser N = 330 †
After three doses N=330†
rSBA- MenC ≥ 1: 8 N = antal børn
Anti-PRP rSBA-MenC ≥ 1:8
≥ 1 mikrogram/ ml GMC (mikrogram/ ml) ≥ 1: 32 ≥ 1: 128 GMT med tilgængelige resultater
≥ 0.15 micrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
76, 3% 3, 40 100, 0% 98, 9% 98, 9% 679, 6
96.8% 76.3% 3.40 100.0% 98.9% 98.9% 679.6
97, 3% 11, 18 98, 8% 97, 9% 92, 4% 685, 5
100.0% 97.3% 11.18 98.8% 97.9% 92.4% 685.5
% = procentdel af børn med en titer lig med eller over “ the cut- off ” PRP = polyribosylribitolphosphat rSBA- MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer † = børn ≤ 18 uger ved tredje dosis af Menitorix
N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre
2- 4- 6- måneders program
13 † = subjects ≤ 18 weeks of age at time of third Menitorix dose
efter to doser N = 111
Antibody
efter tre doser N = 111
2-4-6 month schedule
Anti- PRP
After two doses N=111
≥ 0, 15 mikrogram/ ml
After three doses N=111
≥ 1 mikrogram/ ml GMC (mikrogram/ ml) ≥ 1: 32 ≥ 1: 128 GMT med tilgængelige resultater
≥ 0.15 lmicrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
74, 8% 3, 26 100, 0% 100, 0% 96, 4% 847, 2
96.4% 74.8% 3.26 100.0% 100.0% 96.4% 847.2
97, 3% 12, 84 100, 0% 100, 0% 99, 1% 2467, 1
100.0% 97.3% 12.84 100.0% 100.0% 99.1% 2467.1
% = procentdel af børn med en titer lig med eller over ” the cut- off ” PRP = polyribosylribitolphosphat rSBA- MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer
N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre
Vedholdende antistof er eftervist for Hib i tre klinsiske forsøg (N = 217), hvor 98, 2% af børnene havde en anti- PRP- koncentration på ≥ 0, 15 mikrogram/ ml ved 11- 18- måneders alderen, det vil sige 7 - 14 måneder efter afslutningen af 3- dosis- primærprogrammet med Menitorix.
Antibody persistence has been demonstrated for Hib in three clinical trials (N=217) with 98.2% of subjects having an anti-PRP concentration of ≥ 0.15 microgramsml at 11-18 months of age i. e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
I tre kliniske forsøg (N = 209) havde 92, 3% af børnene en SBA- MenC titer ≥ 1/ 8 ved 11- 18 - måneders alderen, det vil sige 7- 14 måneder efter afslutningen af 3- dosis- primærprogrammet med Menitorix.
In three clinical trials (N=209), 92.3% of subjects had an SBA-MenC titre ≥ 1/ 8 at 11– 18 months of age, i. e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
Alle børn responderede immunologisk på en dosis på 10 µg ukonjugeret gruppe C meninggococ polysaccharid med 33 gange forøgelse i SBA- titer, hvilket demonstrerer immun - memory- inducering ved det primære vaccinationsprogram.
All subjects responded immunologically to a challenge dose of 10 µg of unconjugated group C meningococcal polysaccharide with a thirty-three-fold increase in SBA titres demonstrating the immune memory induced by the primary vaccination course.
Procentdelen af børn med en antistoftitre ≥ ” assay cut- off ” en måned efter boostervaccination med Menitorix administreret alene eller samtidig med en DTPa- HBV- IPV * - vaccine var følgende:
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:
Børn eksponeret med 3 doser af Menitorix * N = 123
Subjects primed with 3
Børn eksponeret med 2 doser af NeisVac- C ** N = 167
Subjects primed with 2 doses
Børn eksponeret med 3 doser af Meningitec ** eller Menjugate ** N = 96
of Meningitec** or Menjugate** N=96
Anti- PRP- antistoffer ≥ 0, 15 mikrogram/ ml
≥ 0.15 micrograms/ ml
≥1 mikrogram/ ml
≥ 1 micrograms/ ml
98, 8%
98.8%
99, 0%
99.0%
GMC (mikrogram/ ml) rSBA- MenC
GMC (micrograms/ ml) rSBA-MenC
56, 72
56.72
77, 15
77.15
30, 27
30.27
≥ 1: 8 ≥ 1: 32 ≥ 1: 128 GMT
≥ 1:8 ≥ 1:32 ≥ 1:128 GMT
100, 0% 100, 0% 99, 2% 4172, 5
100.0% 100.0% 99.2% 4172.5
99, 4% 99, 4% 99, 4% 11710, 5
99.4% 99.4% 99.4% 11710.5
N = antal børn med tilgængelige resultater PRP = polyribosylribitolphosphat rSBA- MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer% = procentdel af børn med en titer lig med eller over “ the cut- off ” * = samtidig administration med DTPa- HBV- IPV ** = samtidig administration med DTPa- Hib- TT vacciner
14 rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines
Procentdelen af børn med en antistoftitre ≥ ” assay cut- off ” en måned efter boostervaccination med Menitorix administreret samtidig med en mæslinge- fåresyge- røde- hunde- vaccine (MFR) * var følgende:
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
Børn eksponeret med 3 doser af Menitorix * N = 349
Subjects primed with 3 doses of Menitorix* N= 349
Børn eksponeret med 3 doser af godkendt Meningitec ** eller Menjugate ** N = 96
Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
14 ≥ 0, 15 mikrogram/ ml
Anti-PRP antibodies ≥ 0.15 micrograms/ ml
≥ 1 mikrogram/ ml GMC (mikrogram/ ml)
≥ 1 micrograms/ ml
100% 93, 19
100%
100% 44, 27
100%
97. 9% 37, 17
97.9%
rSBA- MenC ≥ 1: 8 ≥ 1: 32 ≥ 1: 128 GMT
≥ 1:8 ≥ 1:32 ≥ 1:128 GMT
99, 1% 98, 8% 97, 7% 2193, 7
99.1% 98.8% 97.7% 2193.7
N = antal børn med tilgængelige resultater PRP = polyribosylribitolphosphat rSBA- MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer% = procentdel af børn med en titer lig med eller over “ the cut- off ” * = samtidig administration med DTPa- IPV vacciner ** = samtidig administration med DTPa- Hib- TT vacciner
N= number of subjects with available results PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-IPV vaccines **= co-administered with DTPa-Hib-TT containing vaccines
Antistofniveauet blev målt 18 måneder efter administration af Menitorix boosterdosis hos 14- månder gamle børn, som tidligere var blevet eksponeret for enten Menitorix ved 2 -, 4 - og 6- måneders alderen eller NeisVac- C ved 2 -, 4- måneders alderen (og en DTPa/ Hib vaccine ved 2 -, 4 -, 6- måneders alderen).
Antibody levels have been measured at 18 months after the administration of a booster dose of Menitorix at age 14 Months to subjects who had been primed in infancy with either Menitorix at 2, 4 and 6 months of age or with NeisVac-C at 2, 4 months of age (and a DTPa/ Hib containing vaccine at 2, 4, 6 months of age).
Der findes resultater for SBA- MenC fra 177 børn og for anti- PRP fra 178 børn.
SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
I alt havde 92, 7% af de 177 børn en SBA- MenC titre på mindst 1: 8, og 99, 4% af de 178 børn havde en anti- PRP - antistofkoncentration på mindst 0, 15 mikrogram/ ml.
Overall, 92.7% of 177 subjects had SBA-MenC titres of at least 1:8 and 99.4% of the 178 subjects had anti-PRP antibody concentrations of at least 0.15 µg/ ml.
I den gruppe, som blev eksponeret med Menitorix både som primærvaccination og boostervaccination, havde 49/ 56 (87, 5%) en SBA- MenC titer på mindst 1: 8, og 56/ 56 (100%) havde en antistofkoncentration på mindst 0, 15 mikrogram/ ml.
In the Menitorix primed and boosted group 49/ 56 (87.5%) of the subjects had SBA-MenC titers of at least 1:8 and 56/ 56 (100%) had anti-PRP antibody concentrations of at least 0.15 µg/ ml.
I den gruppe, som blev eksponeret med NeisVac- C som primærvaccination, havde 115/ 121 (95%) en SBA - MenC titer på mindst 1: 8 og 121/ 122 (99, 2%) havde en anti- PRP- antistofkoncentration på mindst 0, 15 mikrogram/ ml.
In the group primed with NeisVac-C 115/ 121 (95%) had SBA-MenC titers of at least 1:8 and 121/ 122 (99.2%) had anti-PRP antibody concentrations of at least 0.15 µg/ ml.
Der var ingen signifikant forskel mellem de to gruppers andelen af en SBA - MenC- titer på mindst 1: 8 eller en anti- PRP- antistofkoncentrationer på mindst 0, 15 mikrogram/ ml.
There were no significant differences between the two groups in the proportions with SBA-MenC titers of at least 1:8 or anti-PRP antibody concentrations of at least 0.15 µg/ ml.
Et estimat af vaccine- effektiviteten fra rutineimmuniseringsprogrammet i UK (som anvender forskellige kvantiteter af tre konjugerede meningokok gruppe C- vacciner), der dækker perioden fra introduktionen i slutningen af 1999 til marts 2004, har vist behovet for en boosterdosis efter det primære program (tre doser administreret ved 2, 3, og 4 måneder).
Within one year of completion of
Inden for et år efter afslutningen af det primære program var vaccineeffektiviteten hos spædbørnskohorten estimeret til 93% (95% konfidensinterval 67- 99%).
15 the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
90% eller derover.
Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.
15 6. 1 Hjælpestoffer
6.1 List of excipients
Efter rekonstitution bør vaccinen straks injiceres eller opbevares i køleskab (2 °C – 8 °C).
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C – 8°C).
Opbevares i den originale yderpakning for at beskytte mod lys.
Do not freeze Store in the original package in order to protect from light.
6. 5 Emballagetype og pakningsstørrelser
16 6.5 Nature and contents of container
Pulver i hætteglas (type I- glas) med en prop (butyl- gummi), 0, 5 ml solvens i fyldt injektionssprøjte (type I- glas) med en stempelprop (butyl- gummi) med eller uden separate kanyler i følgende pakningsstørrelser:
Powder in a vial (type I glass) with a stopper (butyl rubber), 0.5 ml of solvent in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) with or without separate needles in the following pack sizes:
- 1 hætteglas med pulver og 1 fyldt injektionssprøjte med solvens, med eller uden 2 separate
- pack size of 1 vial of powder plus 1 pre-filled syringe of solvent with 2 separate needles or
kanyler.
without needles
- 10 hætteglas med pulver og 10 fyldte injektionssprøjter med solvens, med eller uden 2 separate
- pack size of 10 vials of powder plus 10 pre-filled syringes of solvent with 2 separate needles or
Den rekonstituerede vaccine skal undersøges visuelt for partikler og/ eller variation i fysiske forhold inden administration.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Injicer hele indholdet af hætteglasset.
The reconstituted vaccine is a clear and colourless solution. Inject the entire contents of the vial.
[Se Bilag I – Udfyldes nationalt]
[See Annex I – To be completed nationally]
Menitorix, og associerede navne (se Bilag I) pulver og solvens til injektionsvæske, opløsning Konjugeret Haemophilus type b - og Meningokok gruppe C- vaccine [Se Bilag I – Udfyldes nationalt]
Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I – To be completed nationally]
Efter rekonstitution indeholder hver dosis (0, 5 ml):
After reconstitution, 1 dose (0.5 ml) contains:
Pulver og solvens til injektionsvæske, opløsning 1 hætteglas:
Powder and solvent for solution for injection 1 vial:
Pulver 1 fyldt injektionssprøjte:
Powder 1 pre-filled syringe:
Solvens 1 dosis (0, 5 ml)
Solvent 1 dose (0.5 ml)
Solvens 2 kanyler 1 dosis (0, 5 ml)
Solvent 2 needles 1 dose (0.5 ml)
10 hætteglas:
10 vials:
Pulver 10 fyldte injektionssprøjter:
Powder 10 pre-filled syringes:
Solvens 10 x 1 dosis (0, 5 ml)
Solvent 10 x 1 dose (0.5 ml)
Solvens 20 kanyler 10 x 1 dosis (0, 5 ml)
Solvent 20 Needles 10 x 1 dose (0.5 ml)
19 Intramuskulær anvendelse Læs indlægssedlen inden brug Omrystes før brug
METHOD AND ROUTE(S) OF ADMINISTRATION
GlaxoSmithKline Pharma A/ S Nykær 68 2605 Brøndby
[See Annex I – To be completed nationally]
FREMSTILLERENS BATCHNUMMER
MARKETING AUTHORISATION NUMBER(S)
Lot [Udfyldes nationalt]
[To be completed nationally]
GENEREL KLASSIFIKATION FOR UDLEVERING
BATCH NUMBER
Receptpligtigt lægemiddel.
LOT:
20 15.
20 14.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
GENERAL CLASSIFICATION FOR SUPPLY
21 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
Menitorix, og associerede navne (se Bilag I) solvens til injektionsvæske, opløsning [Se Bilag I – Udfyldes nationalt] i. m.
Menitorix and associated names (see Annex I) solvent for solution for injection [See Annex I – To be completed nationally] I. M.
22 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Menitorix, og associerede navne (se Bilag I) pulver til injektionsvæske, opløsning Konjugeret Haemophilus type b - og Meningokok gruppe C- vaccine [Se Bilag I – Udfyldes nationalt] i. m.
Menitorix and associated names (See Annex I) powder for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I – To be completed nationally] I. M.
24 INDLÆGSSEDDEL INFORMATION TIL BRUGEREN
INFORMATION FOR THE USER
Menitorix, pulver og solvens til injektionsvæske, opløsning [Se Bilag I – Udfyldes nationalt]
Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I – To be completed nationally]