natgillin/translations-raw huggingface dataset:
andre vacciner, er boosterdosis potentielt associeret med en øget forekomst af mindre alvorlige bivirkninger såsom feber og lokale reaktioner. læ
As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions. t
Bivirkninger rapporteret efter booster vaccination er opstillet herunder.
Adverse reactions reported after booster vaccination are listed below. uc
Psykiske sygdomme ke
Psychiatric disorders rod
Meget almindelig: irritabilitet ik
very common: irritability
Meget almindelig: døsighed er
Nervous system disorders: very common: drowsiness lP
Meget almindelig: appetitløshed t dle
Gastrointestinal disorders: very common: loss of appetite na
Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37. 5 °C; rektalt ≥ 38 °C) Almindelig: feber (axillær > 39 °C; rektalt > 39. 5 °C) mi
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) i dic
Usædvanlig: induration ge
uncommon: induration
Dette medicinalprodukt indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel, og derfor er det muligt at overfølsomhedsreaktioner opstår( se afsnit 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).
4. 4)
5 Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
a lg 5.
ed 5.
Farmakoterapeutisk gruppe:
ris Pharmaco-therapeutic group:
Bakterielle og virale vacciner, kombinerede, ATC kode JO7CA10
Bacterial and viral vaccines combined, ATC code JO7CA10
s 5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties
297
tho The immune response after a three-dose primary vaccination course was evaluated in five trials:
ret spædbørn blev undersøgt efter vaccination ved 6, 10 og 14 ugers alder, 685 efter vaccination ved 2, 4, og 6 måneders alder og 107 efter vaccination ved 3, 4 og 5 måneders alderen.
297 infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4, and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age.
Resultater fra forskellige studier viser at overordnet havde 95, 5% og 99% af individerne anti- difteri og anti -
Results from different
ise stivkrampe titre ≥0. 1 IU/ ml én måned efter afslutningen på det primære vaccinationsprogram.
au studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ ml one month after completion of the primary vaccination course.
På dette tidspunkt, var procentdelen af spædbørn med anti- PRP titre ≥ 0. 15 µg/ ml, > 99% og procentdelen med anti- HB titre ≥ 10 mIU/ ml var 97, 3%.
At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ ml was > 99% and the percentage with anti-HBs titres ≥ 10
Mere end 99% af individerne havde
More than 99% of subjects were considered to have responded to the pertussis
tor responderet på kighostekomponenten i vaccinen, hvilket var defineret som forekomsten af antistoffer hos initialt seronegative individer (dvs. individer med præ- vaccinationstitre < 15 ELU/ ml) eller en
ge component of the vaccine, which was defined as the appearance of antibodies in initially seronegative subjects (i. e. subjects with pre-vaccination titres < 15 ELU/ ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternally- lon derived antibodies.
Serobeskyttelse og vaccine respons hyppigheder var ens for de tre programmer der blev anvendt, ere med undtagelse af anti- HB’ erne.
Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs.
Serobeskyttelseshyppighederne for anti- HB’ erne (≥ 10 mlU/ ml), observeret ved 6, 10, 14 ugers programmet, var lavere som vist i tabellen herunder, men det er sandsynligvis ikke klinisk relevant pga. den lille prøvestørrelse: ng
The seroprotection rates for anti-HBs (≥ 10 mlU/ ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due no
2, 4, 6 måneders program
to the small sample size:
3, 4, 5 måneders program læ
2, 4, 6
6, 10, 14 måneders program
months schedule N = 672
N=672
uc
N=107
t
N=97
3, 4, 5
Resultater fra et ik
Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses.
pilotforsøg viste, at for 63 spædbørn, vaccineret i overensstemmelse med et 6, 10, 14 ugers program, havde > 80% stadig antistoffer mod difteri, stivkrampe, HB’ er og PRP ved niveauer der betragtes er
Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to lP
som værende beskyttende.
diphtheria, tetanus, HBs and PRP at levels considered to be protective.
41% havde antistoffer mod kighoste.
Forty-one percent had antibodies to pertussis.
Data fra kliniske studier viser at Quintanrix, når den gives som en boosterdosis i andet leveår, inducerer en mere end 10- foldig øgning i gennemsnitlige antistoftitre i forhold til præbooster niveauer for alle vaccine komponenter. t
Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect na
Det kan forventes at hepatitis D også vil forebygges ved immunisering med Quintanrix da hepatitis D dle
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as i
(forårsaget af delta komponenten) ikke forekommer i fravær af hepatitis B infektion.
hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. dic
5. 2 Farmakokinetiske egenskaber mi
5.2 Pharmacokinetic properties
Ikke relevant. ge
Me
5. 3 Prækliniske sikkerhedsdata Læ
5.3 Preclinical safety data
6 Frysetørret HIB komponent:
Lyophilised HIB component:
Flydende DTPw- HBV komponent:
ed Liquid DTPw-HBV component:
Thiomersal Natriumklorid
Thiomersal
a lg Vand til injektionsvæske.
ris Sodium chloride Water for injections.
Vedrørende adjuvans, se afsnit 2.
tho For adjuvants, see section 2.
s 6. 2 Uforligeligheder
6.2 Incompatibilities
til I fravær af forligelighedsstudier, må den rekonstituerede Quintanrix vaccine ikke blandes med andre
au In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
ret lægemidler.
6.3 Shelf life
ise 3 år.
r ge 3 years.
tor Efter rekonstitution, anbefales det at injicere vaccinen med det samme.
After reconstitution, it is recommended to inject the vaccine promptly.
Stabiliteten er dog demonstreret for 8 timer ved + 25oC efter rekonstitution.
However the stability has been lon demonstrated for 8 hours at 25°C after reconstitution.
6. 4 Særlige opbevaringsforhold au Opbevares i køleskab (2°C – 8°C) ere
Store in a refrigerator (2°C – 8°C)
Må ikke fryses. ng
Do not freeze. t
Opbevares i den originale emballage for beskyttelse mod lys.
Store in the original package in order to protect from light. uc
6. 5 Emballage (art og indhold) læ
6.5 Nature and contents of container rod
0, 5 ml suspension i et hætteglas (type I glas) til 1 dosis med en prop (butylgummi) ke
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: lP
- pakkestørrelse med 1 hætteglas med pulver plus 1 hætteglas med suspension.
- pack size of 1 vial of powder plus 1 vial of suspension
- pakkestørrelse med 100 hætteglas med pulver plus 100 hætteglas med suspension
- pack size of 100 vials of powder plus 100 vials of suspension
Ikke alle pakkestørrelser er nødvendigvis markedsført. er
Not all pack sizes may be marketed. na
6. 6 Eventuelle instruktioner vedrørende anvendelse og håndtering t dle
6.6 Instructions for use and handling i dic
Dette er ikke et tegn på nedbrydning. mi
This does not constitute a sign of deterioration.
Ubrugt vaccine samt affald ge
The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white Me
heraf skal bortskaffes i overensstemmelse med lokale krav
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Vaccinen rekonstitueres ved at opsuge indholdet af hætteglasset indeholdende DTPw HBV Læ
The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder.
komponenten vha. en sprøjte og tilsætte det til hætteglasset indeholdende HIB pulveret.
7 the powder is completely dissolved.
Fjern og smid nålen, brugt til rekonstitution, væk og erstat den med en anden nål til administration af vaccinen.
After reconstitution, the vaccine should be injected promptly.
7 7.
ed 7.
Rue de l' Institut 89 B- 1330 Rixensart, Belgium
Rue de l'Institut 89 B-1330 Rixensart, Belgium
a lg 8.
tho 8.
til EU/ 1/ 04/ 301/ 002
au EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002
ret 9.
r ge 9.
ise 17/ 02/ 2005
17/ 02/ 2005 lon 10.
au ere ng læ
uc
Difteri, stivkrampe, kighoste (hel celle), hepatitis B (rDNA) og Hæmofilus type b konjugeret vaccine (adsorberet).
Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
til Difteri toxoid1
tho Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2 Hepatitis B surface antigen (rDNA) 2, 3
mindst 30 International Units
not less than 30 International Units not less than 60 International Units not less than 4 International Units 10 micrograms
ret Stivkrampe toxoid1 Inaktiveret Bordetella kighoste 2 Hepatitis B overflade antigen (rDNA) 2, 3
au Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
mindst 60 International Units mindst 4 International Units 10 mikrogram
2.5 micrograms
ise Hæmofilus influenzae type b polysakkarid (polyribosylribitolfosfat) 2
conjugated to tetanus toxoid as a carrier
2. 5 mikrogram
5-10 micrograms
0. 26 milligram Al3+
0.26 milligrams Al3+
adsorberet til aluminiumfosfat
ge adsorbed on aluminium hydroxide, hydrated 2 3
au
adsorbed on aluminium phosphate
Fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi. ere Dette er en flerdosis beholder.
produced in Saccharomyces cerevisae cells by recombinant DNA technology lon This is a multidose container.
Se afsnit 6. 5 for antal doser pr. hætteglas.
See section 6.5 for the number of doses per vial.
Hjælpestoffer er anført under pkt.
For excipients, see section 6.1. no
LÆGEMIDDELFORM læ
PHARMACEUTICAL FORM
Pulver og væske til suspension til injektion Den flydende difteri, stivkrampe, kighoste (hel celle), hepatitis B (DTPw HBV) komponent er en uklar ke
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid uc
hvid suspension.
white suspension.
Den frysetørrede Haemophilus influenzae type b (HIB) komponent er et hvidt pulver. ik
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. rod
KLINISKE OPLYSNINGER er
CLINICAL PARTICULARS lP
4. 1 Terapeutiske indikationer t
4.1 Therapeutic indications
Quintanrix er indiceret til primær immunisering af spædbørn (under første leveår) mod difteri, dle
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae na
stivkrampe, kighoste og angribende sygdom forårsaget af Haemophilus influenzae type b, og til booster immunisering af småbørn under 2. leveår. mi
type b and for booster immunisation of young children during the second year of life.
Brug af Quintanrix bør besluttes på basis af officielle anbefalinger. ge
The use of Quintanrix should be determined on the basis of official recommendations. i dic
Dosering Læ
Posology Me
Følgende
9 clinical trials:
De immunoprofylaktiske målinger for hepatitis B skal ikke modificeres til børn født af hepatitis B
The immunoprophylactic measures for hepatitis B should not be modified for children born to
a lg virus bærende mødre.
ed hepatitis B virus carrying mothers.
Dette kan kræve separat administration af hepatitis B vaccine og bør følge lokale officielle
This may require separate administration of hepatitis B vaccine and should follow official recommendations.
s anbefalinger.
ris Booster vaccination:
til Booster vaccination:
After the completion of the primary series, a booster should be administered preferably before the
ret Efter afslutningen af de primære vaccinationer, skal en booster gives og helst før slutningen af 2. leveår.
tho end of the second year of life.
ise Quintanrix kan bruges til at booste responset overfor DTP, HBV og HIB antigener, hvis dens komposition er i overensstemmelse med officielle anbefalinger for boosting.
au accordance with official recommendations for boosting.
tor Indgivelsesmåde
Method of administration
4. 3 Kontraindikationer au Quintanrix er til dyb intramuskulær injektion, anterolateralt på låret ere
r ge Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Overfølsomhed over for de aktive substanser eller over for et eller flere af hjælpestofferne. ng
4.3 Contraindications lon Hypersensitivity to the active substances or to any of the excipients.
Quintanrix er kontraindiceret hvis barnet har haft encephalopati med ukendt ætiologi, der er opstået inden for 7 dage efter tidligere vaccination med vaccine indeholdende kighoste.
occurring within 7 days following previous vaccination with pertussis containing vaccine.
Under disse omstændigheder skal vaccinationsprogrammet fortsættes med difteri, stivkrampe, hepatitis B og HIB læ
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines. t
Som med andre vacciner, skal administration af Quintanrix udsættes hos individer med akut alvorlig ke
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering uc
febril sygdom.
from acute severe febrile illness.
Tilstedeværelsen af en mindre infektion, som forkølelse, er ikke en kontraindikation for vaccination. ik
The presence of a minor infection, such as a cold, is not a contraindication for vaccination. rod
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen er
4.4 Special warnings and special precautions for use
Inden vaccination skal der være overblik over anamnesen (specielt med hensyn til tidligere vaccination og mulig forekomst af bivirkninger). t dle
previous vaccination and possible occurrence of undesirable events).
Som for alle injicerbare vacciner skal passende medicinsk behandling og tilsyn altid være umiddelbart til rådighed i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. na
Af denne årsag skal den vaccinerede person forblive under medicinsk tilsyn i mindst 30 mi
For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
minutter. ge
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give i dic
Hvis nogle af de følgende forhold opstår i tidsmæssig relation til modtagelsen af Quintanrix, skal beslutningen, om at give efterfølgende doser af en vaccine indeholdende kighoste komponenten, overvejes nøje:
subsequent doses of a vaccine containing the pertussis component should be carefully considered: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
• Temperatur på ≥ 40. 0 °C inden for 48 timer, som ikke skyldes en anden infektion. • Kollaps eller shock- lignende tilstand (hypotonisk- hyporesponsiv episode) inden for 48 timer. • Vedholdende gråd der varer ≥ 3 timer, og opstår inden for 48 timer. • Kramper med eller uden feber, der opstår inden for 3 dage.
• Convulsions with or without fever, occurring within 3 days.
10 Quintanrix skal administreres med forsigtighed til personer med trombocytopeni eller en blødningslidelse, da blødning kan opstå efter en intramuskulær administration hos disse personer.
A
En fin nål kan anvendes til vaccinationen og et fast tryk på administrationsstedet (uden at gnide) i mindst 2 minutter efter administration.
10 fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
a lg Vaccinen vil ikke forebygge infektion forårsaget af andre patogener der vides at inficere leveren såsom hepatitis A, hepatitis C og hepatitis E virus.
ed hepatitis A, hepatitis C and hepatitis E virus.
s HIB komponenten i vaccinen beskytter ikke mod sygdomme som skyldes type b af Haemophilus influenzae eller mod meningitis forårsaget af andre organismer.
ris than type b of Haemophilus influenzae or against meningitis caused by other organisms.
til En anamnese med feberkramper, en famileanamnese med kramper eller Sudden Infant Death
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome
ret Syndrome (SIDS) er ikke en kontraindikation for brug af Quintanrix.
tho (SIDS) do not constitute a contraindication for the use of Quintanrix.
ise HIV infektion betragtes ikke som en kontraindikation.
au HIV infection is not considered as a contraindication.
tor Da kapsel polysakkarid antigenet udskilles i urinen kan der observeres en positiv urin antigen test inden for 1- 2 uger efter vaccination.
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be
Andre tests skal udføres for at bekræfte HIB infektionen i denne periode. au Antipyretisk behandling skal initieres i overensstemmelse med lokale behandlingsguidelines. ere
Other tests should be performed in order to confirm HIB infection during this period.
Den potentielle risiko for apnø og behov for respiratorisk overvågning i 48- 72 timer bør overvejes ved primære immuniseringprogrammer til meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og ng
Antipyretic treatment should be initiated according to local treatment guidelines. lon The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. no
Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller læ
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. t
4. 5 Interaktion med andre lægemidler og andre former for interaktion ke
4.5 Interaction with other medicinal products and other forms of interaction uc
I pædiatri vaccination er det normal praksis, at co- administrere forskellige injicerbare vacciner på ik
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate rod
separate injektionssteder, under samme konsultation.
injection sites, during the same session.
Begrænsede data viser, at der ikke er interferens med responset til mæslinger fåresyge røde hunde er
Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
Selvom der ikke er data tilgængelige på immunresponset overfor Bacille- Calmette- Guérin (BCG) t
Although no data are available on the immune response to the Bacille-Calmette- lP
antigenet, forventes der ikke interferens. dle
Guérin (BCG) antigen, no interference is expected.
Som med andre vacciner kan det forventes at et tilstrækkeligt respons måske ikke opnås hos patienter der modtager immunosuppressiv behandling eller patienter med nedsat immunforsvar. mi
As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency. na
4. 6 Graviditet og amning ge
4.6 Pregnancy and lactation i dic
Læ
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
11 Quintanrix blev administreret til cirka 1, 340 raske spædbørn fra 6 ugers alderen som et primært vaccinationsprogram i adskillelige kliniske studier.
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
50% af den administrerede dosis.
11 In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
a lg Bivirkninger er opstillet herunder.
Adverse reactions are listed below.
s Hyppigheder er rapporteret som:
ed Frequencies are reported as:
til Almindelig Usædvanlig
Rare:
(> 1/ 100, < 1/ 10) (> 1/ 1, 000, < 1/ 100)
(> 1/ 100 ,< 1/10) (> 1/1 ,000, < 1/100) (> 1/10,000, < 1/ 1,000)
ret Sjælden Meget sjælden
tho Very rare:
(> 1/ 10, 000, < 1/ 1, 000) (< 1/ 10, 000) inklusiv enkeltstående rapporter.
(< 1/ 10,000) including isolated reports
Meget almindelig: irritabilitet
Psychiatric disorders: very common: irritability
tor Sygdomme i nervesystemet:
au Nervous system disorders: very common: drowsiness
Sjælden: bronchitis, hoste ere
r rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
Almene lidelser og reaktioner på indgivelsesstedet: læ
ge Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing lon Gastrointestinal disorders: very common: loss of appetite rare: vomiting no
Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37. 5 °C; rektalt ≥ 38 °C) Almindelig: induration, feber (axillær > 39 °C; rektalt > 39. 5 °C) ke
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) t uc
Som det er vist med andre vacciner, er boosterdosis potentielt associeret med en øget forekomst af mindre alvorlige ik
As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions. rod
Psykiske lidelser: t
Psychiatric disorders lP
Meget almindelig: irritabilitet dle
very common: irritability
Meget almindelig: døsighed mi
Nervous system disorders: very common: drowsiness na
Gastrointestinale sygdomme: ge
Gastrointestinal disorders: very common: loss of appetite i dic
Meget almindelig: appetitløshed
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) Me
Læ
uncommon: induration
12 Under post marketing studier med andre vacciner indeholdende hepatitis B, blev serum syge lignende sygdom og trombocytopeni rapporteret meget sjældent.
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.
Dette medicinalprodukt indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel derfor er det muligt at overfølsomhedsreaktioner kan opstå (se afsnit 4. 3).
12 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).
4. 4)
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
4. 9 Overdosering
ed 4.9 Overdose
s Ingen tilfælde af overdosering er blevet rapporteret.
No case of overdose has been reported.
til ret 5.
ris 5.