natgillin/translations-raw huggingface dataset:
På grund af risikoen for alvorlige bivirkninger af TRISENOX hos børn, der ammes, må du ikke amme, så længe du får TRISENOX.
Because of the potential for serious side-effects in nursing infants from TRISENOX, do not breast-feed while on TRISENOX.
Det er uvist, om TRISENOX påvirker arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
The effect of TRISENOX on your ability to drive is not known.
Hvis du mærker ubehag eller føler dig utilpas efter en TRISENOX behandling, skal du vente, indtil symptomerne forsvinder, før du kører bil, motorcykel eller cykel eller arbejder med værktøj eller maskiner.
If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
Vigtig information om nogle af de øvrige indholdsstoffer i TRISENOX
Important information about some of the ingredients of TRISENOX
TRISENOX indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige ” natriumfri ”.
Trisenox contains less than 1 mmol sodium (23 mg) per dose i.e. essentially ‘sodium-free’.
SÅDAN SKAL DU BRUGE TRISENOX
HOW TO USE TRISENOX
Din læge vil fortynde TRISENOX med 100 til 250 ml glucoseinjektionsvæske 50 mg/ ml( 5%) eller natriumchloridinjektionsvæske 9 mg/ ml (0, 9%).
Your doctor will dilute TRISENOX with 100 to 250 ml of glucose 50 mg/ml (5%) injection, or sodium chloride 9 mg/ml (0.9%) injection.
Din læge vil give TRISENOX ved infusion gennem en slange ind i en blodåre i løbet af 1- 2 timer, men infusionen kan vare længere, hvis der optræder bivirkninger som rødmen og svimmelhed.
Your doctor will infuse TRISENOX through a tube into a blood vessel over 1-2 hours, but the infusion may last longer if side-effects like flushing and dizziness occur.
Din læge vil give dig TRISENOX én gang om dagen som en enkelt infusion hver dag.
Your doctor will give you TRISENOX once every day as a single infusion each day.
I løbet af din første behandlingscyklus vil du blive behandlet hver dag i op til 50 dage, eller indtil din læge bestemmer, at din sygdom er i bedring.
In your first treatment cycle, you may be treated every day up to 50 days at most, or until your doctor determines that your disease is better.
Hvis din sygdom reagerer positivt på TRISENOX, vil du få yderligere en behandlingscyklus på 25 doser; én infusion hver hverdag i 5 uger.
If your disease responds to TRISENOX, you will be given a second treatment cycle of 25 doses, one infusion every weekday for 5 weeks.
23 Hver TRISENOX- ampul må kun bruges én gang og indeholder ingen konserveringsmidler.
Each TRISENOX ampoule must be used only once and does not contain any preservatives.
Ubrugte portioner af hver ampul skal bortskaffes korrekt.
Unused portions of each ampoule must be discarded properly.
Ubrugte portioner må ikke gemmes til senere brug.
23 Do not save any unused portions for later use.
TRISENOX må ikke blandes med eller gives som infusion gennem samme slange som andrelægemidler.
TRISENOX must not be mixed with, or infused through the same tube with other medicinal products.
Mens du er i behandling med TRISENOX, kan du opleve nogle af følgende reaktioner:
Like all medicines, TRISENOX can have side effects.
Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 behandlede): • Træthed (mathed), øget blodsukker, kortåndethed, hoste, hovedpine.
While on treatment with TRISENOX, you may experience some of the following reactions: common side effects (greater than or equal to 1 in 100 but less than 1 in 10): fatigue (weariness), increased blood sugar, shortness of breath, cough, headache. uncommon side effects (greater than or equal to 1 in 1000 but less than 1 in 100): increased white blood cell count, Herpes zoster, pneumonia, sepsis, anaemia, dehydration, confusion, blurry vision, cardiac failure, hypotension, pneumonitis, chills, renal failure, increased weight, nausea, vomiting, diarrhoea, stomach ache, oedema (water retention), rash or itching, change in your heart rhythm or dizziness.
Hyppighed ukendt: • Nedsat antal blodceller, et syndrom med feber, sammen med vejrtrækningsbesvær, hoste og brystsmerter.
Frequency unknown: decreased blood cell counts, a syndrome including fever, together with difficulty in breathing, coughing and chest pain.
Hvis du oplever disse symptomer, skal du straks kontakte din læge.
If you experience these symptoms, you should inform your doctor immediately.
Andre bivirkninger, som ikke er nævnt ovenfor, kan også forekomme hos nogle patienter.
Other side effects not mentioned above may also occur in some patients.
Hvis du oplever åndenød, feber, pludselig vægtforøgelse, besvimelse, ophobning af væske eller palpitationer (kraftig hjertebanken, du kan mærke i brystet), skal du straks kontakte din læge.
Tell your doctor immediately if you experience shortness of breath, fever, sudden weight gain, water retention, fainting or palpitations (strong heartbeat you can feel in your chest).
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
OPBEVARING
HOW TO STORE TRISENOX
Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
Do not use after the expiry date stated on the ampoule label.
24 Må ikke nedfryses
After dilution, if not used immediately, in-use storage times and conditions before use are the responsibility of your doctor and would normally not be longer than 24 hours at 2ºC – 8ºC, unless dilution has taken place in a sterile environment.
Brug ikke TRISENOX, hvis der er fremmede partikler eller misfarvning i det.
Do not use TRISENOX if you notice foreign particulate matter or if discolouration is present.
TRISENOXindeholder:
What TRISENOX contains
- Aktivt stof: arsentrioxid 1 mg/ ml.
- The active substance is arsenic trioxide 1 mg/ml
- Øvrige indholdsstoffer: natriumhydroxid, saltsyre og vand til injektionsvæsker.
- The other ingredients are sodium hydroxide, hydrochloric acid and water for injections
TRISENOX er et koncentrat til opløsning til infusion.
TRISENOX is supplied in glass ampoules
TRISENOX leveres i glasampuller som en koncentreret, steril, klar, farveløs, vandig opløsning, der klargøres og fortyndes på hospitalet og gives som en infusion i en blodåre.
as a concentrated, sterile, clear, colourless, aqueous solution that is prepared and diluted at the hospital
Indehaver af markedsføringstilladelsen:
- Marketing Authorisation Holder:
Cephalon Europe, 5 Rue Charles Martigny, 94700 Maisons Alfort, Frankrig
Cephalon Europe, 5 Rue Charles Martigny, 94700 Maisons Alfort, FRANCE
Fremstiller:
- Manufacturer:
Denne indlægsseddel blev senest godkendt den {dato}
This leaflet was last approved in {MM/YYYY}
TRISENOX er godkendt under ” særlige omstændigheder ”.
This medicine has been authorised under “Exceptional Circumstances”.
Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for TRISENOX, fordi det drejer sig om en sjælden sygdom.
This means that because of the rarity of this disease, it has been impossible to get complete information on this medicine.
Det Europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende TRISENOX og denne indlægsseddel vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Der er også links til websites om sjældne sygdomme, og hvordan de behandles.
Detailed information on this medicine is available on the EMEA web site:http://www.emea.europa.eu There are also links to other websites about rare diseases and treatments.
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Tilberedning af TRISENOX
Preparation of TRISENOX
ASEPTISK TEKNIK SKAL NØJE OVERHOLDES UNDER HELE HÅNDTERINGEN AF TRISENOX, DA DET IKKE INDEHOLDER NOGEN KONSERVERINGSMIDLER.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT.
25 TRISENOX skal fortyndes med 100 til 250 ml 50 mg/ ml (5%) glucoseinjektionsvæske, eller 9 mg/ ml (0, 9%) natriumchloridinjektionsvæske umiddelbart efter udtrækning fra ampullen.
TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) injection or sodium chloride 9 mg/ml (0.9%) injection immediately after withdrawal from the ampoule.
TRISENOX skal indgives intravenøst over 1- 2 timer.
TRISENOX must be administered intravenously over 1-2 hours.
Hvis det ikke anvendes umiddelbart, vil anvendelsesholdbarheden og - forholdene være at betragte som brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2- 8°C, medmindre fortynding har fundet sted under kontrollerede og aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Ikke anvendte lægemidler, eventuelle genstande, der kommer i kontakt hermed samt affald heraf bør destrueres i henhold til lokale retningslinjer.
25 Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Den indeholder difteri - og stivkrampetoksoider (kemisk svækkede toksiner), inaktiverede (dræbte) Bordetella pertussis (kighostebakterie) og dele af hepatitis B- virus som aktive stoffer.
It contains toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough) and parts of the hepatitis B virus as active substances.
Tritanrix HepB anvendes til at vaccinere spædbørn fra seks- ugers- alderen mod difteri, stivkrampe, kighoste og hepatitis B.
Tritanrix HepB is used to vaccinate infants from six weeks of age against diphtheria, tetanus, pertussis (whooping cough) and hepatitis B.
Hvis der ikke er givet nogen vaccine mod hepatitis B ved fødslen, kan Tritanrix HepB gives allerede ved otte- ugers- alderen.
If a vaccine against hepatitis B has not been given at birth, Tritanrix HepB can be given as early as eight weeks of age.
I områder, hvor hepatitis B er almindeligt forekommende, bør der fortsat vaccineres mod hepatitis B ved fødslen, og vaccination med Tritanrix HepB kan indledes i seks- ugers- alderen.
In areas where hepatitis B is common, vaccination against hepatitis B at birth should be continued as normal, with Tritanrix HepB started at six weeks of age.
Tritanrix HepB indeholder små mængder af: • toksoider fra den bakterie, der fremkalder difteri og stivkrampe, • dræbte, hele B. pertussis, der er den bakterie, der fremkalder kighoste, • overfladeantigen, dvs. proteiner fra overfladen, fra hepatitis B- virussen.
Tritanrix HepB contains small amounts of: • toxoids from the bacteria that cause diphtheria and tetanus; • killed whole B. pertussis, the bacterium that causes pertussis; • ‘ surface antigen’ (proteins from the surface) of the hepatitis B virus.
Når et spædbarn bliver vaccineret, opfatter immunsystemet delene fra bakterierne og viraene i vaccinen som fremmede og danner antistoffer mod dem.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses contained in the vaccine as ‘ foreign’ and makes antibodies against them.
Dette bidrager til at beskytte mod de sygdomme, som disse bakterier og vira kan fremkalde.
The vaccine is ‘ adsorbed’.
De fik alle vaccinen.
Tritanrix HepB has been studied in six studies involving a total of 872 infants aged between seven and 20 weeks, all of whom received the vaccine.
Undersøgelserne viste, at udviklingen af beskyttende niveauer af antistoffer mod difteri, stivkrampe og hepatitis B forekom hos mindst 98% af spædbørnene.
The studies showed that the production of protective levels of antibodies against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants.
Mindst 92% af spædbørnene udviklede beskyttende niveauer af antistoffer mod kighoste.
At least 92% developed protective levels of antibodies against pertussis.
Yderligere undersøgelser viste, at det var hensigtsmæssigt at indlede vaccinationen i seks- ugers - alderen, og at det var nødvendigt med en boosterdosis i det andet leveår for at vedligeholde beskyttelsen.
The additional studies showed that starting vaccination at six weeks was adequate, and that a booster dose is needed in the second year of life in order to maintain protection.
Den bør heller ikke anvendes til spædbørn, der har haft en overfølsomhedsreaktion, efter de har fået en vaccine mod difteri, stivkrampe, kighoste eller hepatitis B.
It should also not be used in infants who have had an allergic reaction after being given diphtheria, tetanus, pertussis or hepatitis B vaccines.
Vaccination med Tritanrix HepB skal udskydes hos spædbørn med pludseligt opstået, alvorlig feber, og den bør ikke gives, hvis barnet har haft hjernelidelsen encefalopati af ukendte årsager inden for syv dage efter en tidligere vaccination med en vaccine, der indeholder en kighostebakterie.
Tritanrix HepB should be postponed in infants with a severe sudden fever, and it should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tritanrix HepB er større end risiciene ved Tritanrix HepB ved aktiv immunisering mod difteri, stivkrampe, kighoste og hepatitis B hos spædbørn fra seks uger og opefter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB’ s benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tritanrix HepB til GlaxoSmithKline Biologicals s. a. den 19. juli 1996.
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s. a. for Tritanrix HepB on 19 July 1996.
EU/ 1/ 96/ 014/ 001 Tritanrix HepB
EU/ 1/ 96/ 014/ 001
U/ 1/ 96/ 014/ 002 Tritanrix HepB
EU/ 1/ 96/ 014/ 002
EU/ 1/ 96/ 014/ 003 Tritanrix HepB
EU/ 1/ 96/ 014/ 003
1 1 dosis (0. 5 ml) indeholder:
1 1 dose (0.5 ml) contains:
Diphtheria toxoid * Tetanus toxoid * Inaktiv Bordetella pertussis stamme ** ≥ 4
Diphtheria toxoid* Tetanus toxoid*
≥ 30 IU ≥ 60 IU IU
≥ 30 IU ≥ 60 IU
Hepatitis B virus overflade Antigen rekombinant ** (S protein) ***
Inactivated Bordetella pertussis strain** ≥ 4 IU Hepatitis B virus surface Antigen recombinant** (S protein)*** 10 micrograms * adsorbed on aluminium oxide hydrated ** adsorbed on aluminium phosphate *** produced on genetically-engineered yeast
** adsorberet på aluminium fosfat Total:
0.26 milligrams Al3+ Total:
0. 37 milligram Al3+ *** fremstillet af genetisk modificerede gær celler (Saccharomyces cerevisiae)
0.37 milligrams Al3+ cells (Saccharomyces cerevisiae)
Tritanrix HepB, injektion, suspension, Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B (rDNA) (HBV) vaccine (adsorberet)
Tritanrix HepB, suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Difteritoxoid1 Tetanustoxoid1 Bordetella pertussis (inaktiveret) 2 Hepatitis B virus overflade antigen 2, 3
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen 2,3 1
1 Adsorberet til aluminiumhydroxid, hydreret 2 Adsorberet til aluminiumphosphat
Adsorbed on aluminium hydroxide, hydrated
0, 26 milligram Al3+ 0, 37 milligram Al3+
0.26 milligrams Al3+
3 Produceret på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA- teknologi
Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Tritanrix HepB er indiceret til aktiv immunisering mod difteri, tetanus, pertussis og hepatitis B (HBV) hos børn fra 6 uger og opefter (Se afsnit 4. 2).
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2).
Den anbefalede dosis er 0, 5 ml.
The recommended dose is 0.5 ml.
Når Tritanrix HepB gives som et 6- 10- 14- ugers program, anbefales det at administrere en dosis HBV - vaccine ved fødslen for at forbedre beskyttelsen.
When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.
2 Boostervaccination:
2 Booster vaccination:
Det anbefales at administrere vaccinen subkutant hos patienter med thrombocytopeni eller blødningsforstyrrelser (se afsnit 4. 4.)
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered subcutaneously (see section 4.4).
Under disse omstændigheder bør vaccinations- programmet fortsætte med DT og HBV vacciner.
In these circumstances the vaccination course should be continued with DT and HBV vaccines.
Temperatur på ≥ 40, 0 °C indenfor 48 timer, hvilket ikke skyldes anden identificerbar årsag.
Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Kollaps eller shock- lignende tilstand (hypotonisk- hyporesponsiv episode) indenfor 48 timer.
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
3 HIV infektion betragtes ikke som en kontraindikation for difteri, tetanus, pertussis og HBV vaccination.
3 HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Det er muligt, at den forventede immunologiske reaktion ikke kan opnås efter vaccination af immunosupprimerede patienter, f. eks. patienter i immunosuppressiv terapi.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e. g. patients on immunosuppressive therapy.
(se afsnit 6. 2)
In some clinical studies, Tritanrix HepB was used to reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response to any of the antigens was observed as compared to the responses observed following administration of the vaccines at separate sites (see section 6.2).
• Kliniske undersøgelser
• Clinical trials:
4 Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 og < 1/ 10) Ikke almindelig (≥ 1/ 1000 og < 1/ 100) Sjælden (≥ 1/ 10. 000 og < 1/ 1000) Meget sjælden (< 1/ 10. 000) Ikke kendte (kan ikke bedømmes udfra de tilgængelige data)
4 Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000) Not known (cannot be estimated from the available data)
Døsighed
Nervous system disorders: very common: drowsiness
Respiratoriske forstyrrelser
Respiratory, thoracic and mediastinal disorders: common: bronchitis uncommon: respiratory disorder
Gastro- intestinale symptomer, som opkast og diaré
Gastro-intestinal disorders: very common: feeding problems common: gastro-intestinal symptoms such as vomiting and diarrhoea
Pneumoni
Infections and infestations: common: otitis media, pharyngitis uncommon: pneumonia
Feber, hævelse, smerte og rødme
General disorders and administration site conditions: very common: fever, swelling, pain and redness
Allergisk reaktion herunder anafylaktisk og anafylaktisk- lignende reaktion, samt serumsyge- lignende sygdom.
Immune system disorders: very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease
Usædvanlig gråd, irritabilitet
Psychiatric disorders: very common: unusual crying, irritability
I et prospektivt sammenlignende studie, som sammenholdt administration af kombineret DTPw- HBV med samtidig og separat administration af DTPw og HBV, fandtes højere incidens af smerte, rødme, hævelse og feber i den gruppe, der modtog den kombinerede vaccine.
5 In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
(Separate)
(separate)
checklisten
N° of symptom checklists
Total Alvorlig *
Total Severe*
Total > 2 cm
Total > 2cm
30, 9 10, 9
30.9 10.9
21, 5 3, 4
21.5 3.4
4, 5 0, 6
4.5 0.6
Feber ≥ 38°C Feber > 39, 5°C
Fever > 38°C Fever > 39.5° C
35, 0 0
35.0 0.0
* Rapporteret af forældre som en bivirkning, der påvirkede barnets daglige aktiviteter.
* reported by the parents as adversely affecting the child’ s daily activities
For begge vacciner galdt det, at majoriteten af reaktionerne var af kort varighed.
For both vaccination groups, the majority of the reactions were short lasting.
• Post marketing overvågning:
• Post marketing surveillance:
Kollaps eller shok- lignende tilstand (hypotonic- hyporesponsive episode)
Collapse or shock-like state (hypotonic-hyporesponsive episode)
Nervestystemet:
Nervous system disorders:
4. 3).
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Farmakoterapeutisk klassifikation:
6 Pharmaco-therapeutic group:
6 D og T toxoiderne er fremstillet ud fra toxiner fra kulturer af Corynebacterium diphtheriae og Clostridium tetani ved formalininaktivering ved hjælp af etableret teknologi.
The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
Overfladeantigenet af HBV (HBsAg) er fremstillet v. h. a. dyrkning af gensplejsede gærceller (Saccharomyces cerevisiae), som bærer genet, der koder for det vigtigste overfladeantigen af HBV.
The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.
Dette HBsAg udtrykt i gærceller er oprenset ved flere fysisk- kemiske trin.
This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
HBsAg´et samles spontant uden kemisk behandling til sfæriske partikler med en gennemsnitlig diameter på 20 nm.
The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
Disse indeholder ikke- glycosyleret HBsAg polypeptid og en lipidmatrix, der hovedsagligt består af phospholipider.
Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.
Fire forskellige programmer er blevet undersøgt (6- 10- 14- ugers; 2- 4- 6- måneders; 3- 4- 5- måneders og 3- 4½- 6- måneders) i overensstemmelse med rutine- vaccinationspraksis i forskellige lande med tre doser administreret inden for de første seks levemåneder.
Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first six months of life.
Procentdel af personer med antistoftiter ≥ den fastsatte grænseværdi (assay cut- off) 1 måned efter vaccination med Tritanrix HepB:
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Tritanrix HepB:
6- 10- 14- ugers
6-10-14 weeks%
2- 4- 6- måneders; 3- 4- 5 - måneders og 3- 4½- 6 - måneders
2-4-6 months; 3-4-5 months and 3-4½-6 months%
Anti- B.
Anti-B.
Pertussis (vaccinerespons) ††
Pertussis (vaccine response) ††
Procentdel af personer, der vurderes at have responderet på Bordetella pertussis - antigenet
* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres ≥ 10 mIU/ ml † cut-off accepted as indicative of protection †† vaccine response:% of subjects considered to have responded to the Bordetella pertussis antigen
6. 1 Hjælpestoffer
7 6.1 List of excipients