natgillin/translations-raw huggingface dataset:
Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. t
Prašek in suspenzija za pripravo suspenzije za injiciranje Komponente cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw- HBV) so v tekočem stanju in sicer v obliki motne bele suspenzije. eā
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. uc rod
Komponenta cepiva proti boleznim, ki jih povzroča Haemophilus influenzae tipa b (HIB) je v liofiliziranem stanju in sicer v obliki belega praška. av
4.1 Therapeutic indications lP
4. 1 Terapevtske indikacije nim
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 type b and for booster immunisation of young children during the second year of life. na
Cepivo Quintanrix je indicirano za osnovno cepljenje otrok (med prvim letom življenja) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivnim boleznim, ki jih povzroča Haemophilus influenzae tipa b ter za obnovitveno cepljenje otrok med drugim letom življenja. ilo
4.2 Posology and method of administration i dic
4. 2 Odmerjanje in način uporabe rav
Posology
Odmerjanje Zd
Me
Osnovno cepljenje:
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
Shema osnovnega cepljenja je sestavljena iz treh odmerkov po 0, 5 ml, ki se jih v skladu z uradnimi lokalnimi priporočili daje v prvih šestih mesecih življenja.
The first dose can be administered at 6 weeks of age.
Presledek med danimi odmerki mora biti vsaj 4 tedne.
2-4-6 months, 3-4-5 months and 6-10-14 weeks.
Otrok lahko prejme prvi odmerek cepiva pri 6 tednih starosti.
2 Quintanrix can be given to children who have received hepatitis B vaccine at birth.
2 S cepivom Quintanrix se lahko cepi otroke, ki so ob rojstvu prejeli cepivo proti hepatitisu B.
ed Booster vaccination:
t me Obnovitveno cepljenje:
After the completion of the primary series, a booster should be administered preferably before the
Po končanem osnovnem cepljenju je potrebno opraviti obnovitveno cepljenje, po možnosti pred
ris end of the second year of life.
pro dopolnjenim drugim letom starosti.
tho Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting.
Če je sestava cepiva Quintanrix v skladu z uradnimi priporočili za obnovitveno cepljenje, se cepivo Quintanrix lahko uporablja za obnovitev odziva na DTP, HBV in HIB antigene.
au Method of administration
za Način uporabe
r ge 4.3 Contraindications
nja 4. 3 Kontraindikacije
Hypersensitivity to the active substances or to any of the excipients. lon Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Preobčutljivost za aktivne sestavine ali katero koli pomožno snov cepiva. lje Uporaba cepiva Quintanrix je kontraindicirana, če je otrok prebolel encefalopatijo neznanega vzroka, vo ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti oslovskemu kašlju.
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines. no
V takšnih primerih je potrebno cepljenje nadaljevati le s cepivi proti davici, tetanusu, hepatitisu B in HIB. do
The presence of a minor infection, such as a cold, is not a contraindication for vaccination. t uc
Blage okužbe, npr. prehlad niso kontraindikacija za cepljenje. eā
4.4 Special warnings and special precautions for use rod
4. 4 Posebna opozorila in previdnostni ukrepi av
As with all injectable vaccines, appropriate medical treatment and supervision should always be lP
Tako kot pri vseh cepivih, ki se jih injiciramora biti vedno na voljo možnost takojšnjega ustreznega nim
readily available in case of a rare anaphylactic event following the administration of the vaccine.
zdravljenja, saj v redkih primerih cepljenju lahko sledi anafilaksijska reakcija.
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give na
Če je znano, da se je v določenem času po prejemu cepiva Quintanrix pojavil kateri koli izmed naslednjih neželenih učinkov, je potrebno odločitev o dajanju nadaljnjih odmerkov cepiva s vsebnostjo ilo
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. i dic
komponente proti oslovskemu kašlju temeljito pretehtati: • Zvišana telesna temperatura ≥ 40, 0 ºC v 48 urah, ki ji ni možno pripisati drugega vzroka. • Kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda) v 48 urah. rav
• Persistent crying lasting ≥ 3 hours, occurring within 48 hours. • Convulsions with or without fever, occurring within 3 days.
• Stalen, neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah. • Krči z zvišano telesno temperaturo ali brez nje, ki so se pojavili v 3 dneh.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
V nekaterih okoliščinah, npr. v primeru visoke incidence oslovskega kašlja, lahko pričakovana korist Zd
Me
cepljenja prevlada nad možnim tveganjem.
3 The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
3 Cepivo ne bo preprečilo okužb z drugimi patogeni, ki lahko prizadenejo jetra, npr. okužbe z virusom hepatitisa A, virusom hepatitisa C in virusom hepatitisa E.
The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.
HIB komponenta cepiva ščiti le pred boleznimi zaradi tipa b, ne pa pred boleznimi zaradi drugih kapsularnih serotipov Haemophilusa influenzae, prav tako ne ščiti pred meningitisom zaradi drugih
Vaccinees with a history of
t povzročiteljev.
ris febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
me Vročinski krči v anamnezi ali konvulzije oziroma sindrom nenadne smrti dojenčka (SIDS - Sudden Infant Death Syndrome) v družinski anamnezi ne predstavljajo kontraindikacije za uporabo cepiva
tho HIV infection is not considered as a contraindication.
pro Quintanrix.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Otroke, ki jih cepimo in imajo vročinske krče v anamnezi, je potrebno skrbno nadzirati, saj se takšni neželeni dogodki lahko pojavijo v 2 do 3 dneh po cepljenju.
Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be
Možno je, da pri bolnikih z imunosupresivnim zdravljenjem po cepljenju ni dosežen pričakovani imunski odziv.
au observed within 1-2 weeks following vaccination.
za Ker se kapsularni polisaharidni antigen izloča z urinom, so rezultati testov za odkrivanje antigena v urinu od 1 do 2 tednov po cepljenju lahko pozitivni.
Antipyretic treatment should be initiated according to local treatment guidelines.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti. do
r ge 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. lon As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. no
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.5 Interaction with other medicinal products and other forms of interaction
Pogosta praksa pri cepljenju otrok je, da se jih ob enkratnem obisku cepi z različnimi cepivi za eā
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session. t uc
injiciranje, ki se jih injicira na ločenih mestih.
Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
Skopi podatki kažejo, da antigeni peroralnega polio cepiva (OPV – oral polio vaccine) ne motijo av
Although no data are available on the immune response to the Bacille-Calmette- rod
imunskega odziva na cepivo proti ošpicam, mumpsu in rdečkam (MMR – Measles- Mumps- Rubella).
Guérin (BCG) antigen, no interference is expected.
Glede imunskega odziva na antigen BCG (Bacille- Calmette- Guérin) sicer ni podatkov, vendar pa se oviranje imunskega odziva na cepivo MMR ne pričakuje. nim
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. lP
Pri bolnikih z imunosupresivnim zdravljenjem ali bolnikih z imunsko pomanjkljivostjo se lahko pričakuje, tako kot tudi pri drugih cepivih, da dosežen imunski odziv ne bo zadosten.
As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used na
Ker cepivo Quintanrix ni predvideno za uporabo pri odraslih, podatki o varnosti uporabe cepiva med nosečnostjo ali dojenjem niso na voljo. rav
4.7 Effects on ability to drive and use machines i dic
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Not relevant.
Zd
4.8 Undesirable effects Me
4. 8 Neželeni učinki
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
V večih kliničnih raziskavah je bilo s cepivom Quintanrix osnovno cepljenih približno 1. 340 zdravih otrok, starejših od 6 tednov.
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.
Pojavile so se pri približno 50% apliciranih odmerkov.
4 Adverse reactions are listed below.
Neželene reakcije so navedene v nadaljevanju.
Frequencies are reported as:
t Pogostnost je prikazana kot:
(> 1/ 10) (> 1/ 100, < 1/ 10)
(> 1/ 10) (> 1/ 100, < 1/ 10) (> 1/ 1. 000, < 1/ 100)
Rare:
pro Redki:
(> 1/ 1,000 ,< 1/100) (> 1/10 ,000, < 1/1,000) (< 1/ 10,000) including isolated reports
(> 1/ 10. 000, < 1/ 1. 000) (< 1/ 10. 000), vključno s posameznimi primeri
ris Psychiatric disorders: very common: irritability
zelo pogosti: razdražljivost
tho Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
za Bolezni živčevja: zelo pogosti: zaspanost redki: kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda), konvulzije
au Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
nja Bolezni dihal, prsnega koša in mediastinalnega prostora: redki: bronhitis, kašelj lje Bolezni prebavil: zelo pogosti: izguba apetita vo redki: bruhanje
r ge Gastrointestinal disorders: very common: loss of appetite rare: vomiting lon 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) no
zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37, 5 ºC; rektalna ≥ 38 ºC) pogosti: induracija, zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39, 5 ºC) eā
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
Obnovitveni odmerek je, tako kot pri drugih cepivih, povezan s povečano pojavnostjo blažjih neželenih dogodkov, kot so povišana telesna temperatura in lokalne reakcije. av
Adverse reactions reported after booster vaccination are listed below. uc
Neželene reakcije o katerih so poročali po obnovitvenem cepljenju so navedene v nadaljevanju.
Psychiatric disorders rod
Psihiatrične motnje: nim
very common: irritability
zelo pogosti: razdražljivost
Nervous system disorders: very common: drowsiness lP
Bolezni živčevja: zelo pogosti: zaspanost ilo
Gastrointestinal disorders: very common: loss of appetite na
Bolezni prebavil: zelo pogosti: izguba apetita rav
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
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37, 5 ºC; rektalna ≥ 38 ºC) pogosti: zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39, 5 ºC) Zd
uncommon: induration
občasni: induracija
Me
Po cepljenju s cepivi, ki so vsebovala komponento DTP, komponento proti hepatitisu B in komponento HIB, so zelo redko poročali o alergijskih reakcijah, kar velja tudi za anafilaktoidne reakcije in urtikarijo.
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.
5 Med postmarketinškimi študijami drugih cepiv s vsebnostjo komponente proti hepatitisu B, so zelo redko poročali o serumski bolezni podobnem stanju in trombocitopeniji.
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).
To cepivo vsebuje kot konzervans tiomersal (organska živosrebrova spojina) in tako je možen pojav preobčutljivostnih reakcij (glejte poglavje 4. 3).
5 Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
t Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte
4.9 Overdose
me poglavje 4. 4).
ed 5.
za 5.
ris Pharmaco-therapeutic group:
Farmakoterapevtska skupina:
5.1 Pharmacodynamic properties
nja 5. 1 Farmakodinamične lastnosti
Results from different
Imunski odziv po osnovnem cepljenju s tremi odmerki cepiva je bil ovrednoten s petimi raziskavami: pri 297 otrocih, ki so bili cepljeni po shemi 6., 10. in 14 teden starosti, pri 685 otrocih, ki so bili lje cepljeni po shemi 2., 4. in 6. mesec starosti in pri 107 otrocih, ki so bili cepljeni po shemi 3., 4. in 5. mesec starosti.
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.
Rezultati različnih študij kažejo, da je, gledano v celoti, en mesec po zaključku vo osnovnega cepljenja imelo 95, 5% oseb titer protiteles proti davici ≥ 0, 1 i. e. / ml.
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
En mesec po zaključku osnovnega cepljenja je imelo > 99% otrok titer proti- PRP ≥ 0, 15 µg/ ml in 97, 3% otrok titer protiteles proti- HBs do
r mIU/ ml was 97.3%.
≥ 10 i. e. / l.
More than 99% of subjects were considered to have responded to the pertussis
Ocenjeno je bilo, da se je več kot 99% oseb odzvalo na komponento cepiva proti oslovskemu kašlju, kar je definirano kot pojav protiteles pri osebah, ki so bile v izhodišču seronegativne (npr. osebe s titrom pred cepljenjem < 15 ELU/ ml) ali osebah, ki so bile zaradi maternalnih protiteles v izhodišču seropozitivne, po cepljenju pa imajo vsaj enak titer kot pred eā
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.
cepljenjem.
Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs.
Serozaščita in odstotek odziva na cepivo je bil pri vseh treh uporabljenih shemah podoben, izjema so av
to the small sample size:
bila le protitelesa proti- HBs.
months schedule N = 672
Shema 2., 4., 6. mesec N = 672
months schedule N = 107
Shema 3., 4., 5. mesec N = 107
rod
98, 9% ilo
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
Rezultati pilotne študije so pokazali, da je rav
diphtheria, tetanus, HBs and PRP at levels considered to be protective.
protitelesa proti davici, tetanusu, HBs in PRP v vrednostih, ki se smatrajo za zaščitne imelo še > 80% od 63 otrok, ki so bili osnovno cepljeni po shemi 6., 10., 14 teden.
Forty-one percent had antibodies to pertussis.
41% otrok je imelo protitelesa proti oslovskemu kašlju.
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
Vendar pa podatki iz kliničnih raziskav kažejo, da dajanje obnovitvenega odmerka Zd
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as i
cepiva Quintanrix v drugem letu življenja povzroči več kot 10- kratni porast srednjega titra protiteles proti vsem komponentam cepiva glede na vrednosti pred obnovitvenim cepljenjem.
hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. dic
Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po imunizaciji s cepivom Quintanrix pričakuje tudi preventiva hepatitisa D.
Me
6 Navedba smiselno ni potrebna.
6 6.
t me 6.
6.1 List of excipients
pro 6. 1 Seznam pomožnih snovi
Lactose
Komponenta HIB v liofiliziranem stanju: laktoza
Thiomersal
za Komponenta DTPw- HBV v tekočem stanju: tiomersal natrijev klorid voda za injiciranje
ris Sodium chloride Water for injections.
nja Za adjuvanse glejte poglavje 2.
tho For adjuvants, see section 2.
6. 2
au In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti se rekonstituirano cepivo Quintanrix ne sme mešati z vo drugimi zdravili.
6.3 Shelf life
6. 3 Rok uporabnosti do
r ge 3 years.
3 leta
However the stability has been lon demonstrated for 8 hours at 25°C after reconstitution.
Po rekonstituciji je bila sicer eā
6.4 Special precautions for storage no
6. 4 Posebna navodila za shranjevanje av
Do not freeze. t
Ne zamrzujte. nim
Store in the original package in order to protect from light. uc
Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
6.5 Nature and contents of container rod
6. 5 Vrsta ovojnine in vsebina ilo
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
0, 5 ml suspenzije v viali (steklo tipa I) za 1 odmerek z zamaškom (butilna guma) v naslednjih velikostih pakiranja: rav
- pack size of 1 vial of powder plus 1 vial of suspension
- 1 viala s praškom in 1 viala s suspenzijo
- pack size of 100 vials of powder plus 100 vials of suspension
- 100 vial s praškom in 100 vial s suspenzijo
Not all pack sizes may be marketed. na
Možno je, da na trgu ni vseh navedenih pakiranj.
6.6 Instructions for use and handling i dic
6. 6 Navodila za pripravo in ravnanje z zdravilom
Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component.
Med shranjevanjem se lahko pri komponenti DTPw- HBV pojavi bela usedlina in bister supernatant.
The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white Me
7 Komponento DTPw- HBV je potrebno dobro pretresti, da nastane homogena motna bela suspenzija, potrebno pa jo je tudi vizualno preveriti glede morebitne prisotnosti tujih delcev in/ ali neobičajnega fizikalnega izgleda.
suspension and should be inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Cepivo se rekonstituira tako, da se vsebina viale s komponento DTPw- HBV odvzame z brizgo in se
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Po dodajanju komponente DTPw- HBV komponenti
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.
Rekonstituirano cepivo je homogena motna bela suspenzija.
After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until
pro Pred aplikacijo cepiva je potrebno odstraniti in zavreči iglo, ki je bila uporabljena pri rekonstituciji ter jo nadomestiti z novo.
ris GlaxoSmithKline Biologicals s. a.
za GlaxoSmithKline Biologicals s. a.
tho 8.
nja 8.
au EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET lje EU/ 1/ 04/ 301/ 001 EU/ 1/ 04/ 301/ 002 vo
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET do
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA av nim ilo rav Zd
See section 6.5 for the number of doses per vial.
0, 40 miligrama Al 3+ adsorbiran na aluminijev fosfat 3 pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae lje Vsebnik vsebuje več odmerkov.
For excipients, see section 6.1. no
Za število odmerkov v viali glejte poglavje 6. 5. vo Za pomožne snovi glejte poglavje 6. 1. do
Powder and suspension for suspension for injection t
Prašek in suspenzija za pripravo suspenzije za injiciranje eā
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid uc
Komponente cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw- HBV) so v tekočem stanju in sicer v obliki motne bele suspenzije.
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. rod
Komponenta cepiva proti boleznim, ki jih povzroča Haemophilus influenzae tipa b (HIB) je v av
CLINICAL PARTICULARS lP
KLINIČNI PODATKI nim
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
Cepivo Quintanrix je indicirano za osnovno cepljenje otrok (med prvim letom življenja) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivnim boleznim, ki jih povzroča Haemophilus ilo
type b and for booster immunisation of young children during the second year of life.
influenzae tipa b ter za obnovitveno cepljenje otrok med drugim letom življenja.
The use of Quintanrix should be determined on the basis of official recommendations. i dic
Cepivo Quintanrix je potrebno uporabljati na osnovi uradnih priporočil. rav
Posology Me
Odmerjanje Zd
The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
Presledek med danimi odmerki mora biti vsaj 4 tedne.
The following schedules have been studied in
Med kliničnim
9 clinical trials:
9 preskušanjem so bile opravljene študije z naslednjimi shemami:
2-4-6 months, 3-4-5 months and 6-10-14 weeks.
2., 4., 6. mesec; 3., 4., 5. mesec in 6., 10., 14. teden.
The immunoprophylactic measures for hepatitis B should not be modified for children born to
V primeru, da je mati novorojenčka nosilka virusa hepatitisa B, se ukrepov imunoprofilakse proti
ed hepatitis B virus carrying mothers.
t hepatitisu B ne sme spreminjati.
This may require separate administration of hepatitis B vaccine and should follow official recommendations.
me B, biti pa morajo v skladu z uradnimi priporočili.
ris Booster vaccination:
Obnovitveno cepljenje: