natgillin/translations-raw huggingface dataset:
As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
3 Pri dojenčku ali otroku z novonastalo hudo nevrološko boleznijo ali napredovanjem takšne bolezni je treba tveganje in korist cepljenja s cepivom Tritanrix HepB ali odložitve cepljenja natančno pretehtati, tako kot velja za vsa cepiva.
3 HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Okužba s HIV ni kontraindikacija za cepljenje proti davici, tetanusu, oslovskemu kašlju in HBV.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e. g. patients on immunosuppressive therapy.
Cepljenje pri bolnikih z oslabljenim imunskim odzivom, npr. pri bolnikih z imunosupresivnim zdravljenjem, lahko ne vzbudi pričakovanega odziva.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri osnovnem cepljenju veliko prezgodaj rojenih nedonošenčkov (rojenih pred ali v 28. tednu nosečnosti), še posebej tistih z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 - do 72- urnem spremljanju pljučnega delovanja.
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).
V nekaterih kliničnih študijah so Tritanrix HepB uporabili za rekonstitucijo liofiliziranega cepiva Hib (Hiberix); v primerjavi z odzivi po dajanju cepiv na različna mesta ni bil opažen medsebojni vpliv v imunskem odzivu na katerega od antigenov (glejte poglavje 6. 2).
• Clinical trials:
• Klinična preskušanja:
General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.
4 V nadaljevanju so navedene splošne reakcije, ki se lahko pojavijo v časovni povezavi s cepljenjem s cepivom Tritanrix HepB.
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)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100 do < 1/ 10) Občasni (≥ 1/ 1. 000 do < 1/ 100) Redki ((≥ 1/ 10. 000 do < 1/ 1. 000) Zelo redki (< 1/ 10. 000) Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Gastro-intestinal disorders: very common: feeding problems common: gastro-intestinal symptoms such as vomiting and diarrhoea
Bolezni prebavil: zelo pogosti: težave pri hranjenju pogosti: gastrointestinalni simptomi, kot sta bruhanje in driska
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.
Tako so v skupini, ki je prejela kombinirano cepivo, poročali o večji incidenci bolečine, rdečine, otekline in vročine.
Total Severe*
skupno huda *
Redness
Rdečina
Total > 2cm
skupno > 2 cm
Swelling
Oteklina
Fever > 38°C Fever > 39.5° C
Zvišana telesna temperatura ≥ 38 °C Zvišana telesna temperatura > 39, 5 °C
* reported by the parents as adversely affecting the child’ s daily activities
* poročila staršev o vplivu na dnevno aktivnost otroka
For both vaccination groups, the majority of the reactions were short lasting.
Pri obeh skupinah je bila večina reakcij po cepljenju kratkotrajnih.
• Post marketing surveillance:
• Postmarketinško spremljanje cepiva:
Collapse or shock-like state (hypotonic-hyporesponsive episode)
Bolezni živčevja: kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda)
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Bolezni dihal, prsnega koša in mediastinalnega prostora: apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4. 4).
Thrombocytopenia
Bolezni krvi in limfatičnega sistema: trombocitopenija
Convulsions
Bolezni živčevja: konvulzije
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 tiomersal (organska živosrebrova spojina) kot konzervans, zato je možen pojav preobčutljivostnih reakcij (glejte poglavje 4. 3).
6 Pharmaco-therapeutic group:
Farmakoterapevtska skupina:
This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
Ta v kvasovkah izražen HBsAg je prečiščen z različnimi fizikalno- kemičnimi postopki.
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.
Glede na rutinsko prakso cepljenja v različnih državah so bile raziskane štiri različne sheme z dajanjem treh odmerkov v prvih šestih mesecih starosti (6- 10- 14 tednov, 2- 4- 6 mesecev; 3- 4 - 5 mesecev in 3- 41/ 2- 6 mesecev).
For each component of the vaccine, the following immune responses have been documented one month after completion of the primary vaccination schedule.
Za vsako komponento cepiva so bili en mesec po zaključku osnovne sheme cepljenja dokazani naslednji imunski odzivi:
6-10-14 weeks%
6- 10- 14 tednov%
2-4-6 months; 3-4-5 months and 3-4½-6 months%
mesecev; 3- 4- 5 mesecev in 3- 4½- 6 mesecev%
Anti-diphtheria (0.1 IU/ ml) †
Protitelesa proti davici (0, 1 i. e. / ml) †
Anti-tetanus (0.1 IU/ ml) †
Protitelesa proti tetanusu (0, 1 i. e. / ml) †
Pertussis (vaccine response) ††
Protitelesa proti B. pertussis (odziv na cepivo) ††
Anti-HBs (10 mIU/ ml) †
Protitelesa proti HBs (10 mi. e. / ml) †
* 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
* v podskupini dojenčkov, ki niso prejeli cepiva proti hepatitisu B ob rojstvu, jih je 89, 9% imelo titer protiteles proti HBs ≥ 10 mi. e. / ml † mejna vrednost velja kot kazalec zaščite †† odziv na cepivo:% oseb, za katere smatramo, da so se odzvali na Bordetella pertussis antigen
7 6.1 List of excipients
6. 1 Seznam pomožnih snovi
Thiomersal Sodium chloride Water for injections
tiomersal natrijev klorid voda za injekcije
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Cepiva ne smemo mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6. 6.
0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl) – pack size of 1.
0, 5 ml suspenzije v viali (steklo tipa I) s potopnim zamaškom (butilna guma) – velikost pakiranja 1.
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Pred aplikacijo morate cepivo dobro pretresti, da nastane homogena motna bela suspenzija, in ga vizualno preveriti glede morebitne prisotnosti tujih delcev in/ ali spremenjenega fizičnega izgleda.
19 July 1996.
Datum pridobitve dovoljenja za promet:
19 July 2006.
19. julij 1996 Datum zadnjega podaljšanja dovoljenja za promet: 19. julij 2006
Tritanrix HepB, suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB suspenzija za injiciranje, večodmerna adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju - celotna celica (Pw) in hepatitisu B - rekombinantno (HBV)
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3 1
davični toksoid1 tetanusni toksoid1 Bordetella pertussis (inaktivirana) 2 površinski antigen virusa hepatitisa B2, 3 1
See section 6.5 for the number of doses per vial.
Glede števila odmerkov v eni viali glejte poglavje 6. 5.
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.
10 Pri dajanju cepiva Tritanrix HepB v skladu s shemo 6- 10- 14 tednov priporočamo odmerek cepiva HBV ob rojstvu, da bi tako izboljšali zaščito.
10 In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified.
Pri novorojenčkih mater, ki so znane nosilke HBV, se ukrepov imunoprofilakse proti hepatitisu B ne sme spreminjati.
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered subcutaneously (see section 4.4.).
Priporočljivo je, da se pri bolnikih s trombocitopenijo ali z motnjami hemostaze cepivo aplicira subkutano (glejte poglavje 4. 4).
As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
11 Pri dojenčku ali otroku z novonastalo hudo nevrološko boleznijo ali napredovanjem takšne bolezni je treba tveganje in korist cepljenja s cepivom Tritanrix HepB ali odložitve cepljenja natančno pretehtati, tako kot velja za vsa cepiva.
11 A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
Febrilne konvulzije v anamnezi ter konvulzije, SIDS (sindrom nenadne smrti dojenčka) in neželena reakcija po cepljenju s Tritanrix HepB v družinski anamnezi ne predstavljajo kontraindikacije.
(see section 6.2.).
V nekaterih kliničnih študijah so Tritanrix HepB uporabili za rekonstitucijo liofiliziranega cepiva Hib (Hiberix); v primerjavi z odzivi po dajanju cepiv na različna mesta ni bil opažen medsebojni vpliv v imunskem odzivu na katerega od antigenov (glejte poglavje 6. 2).
12 General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.
12 V nadaljevanju so navedene splošne reakcije, ki se lahko pojavijo v časovni povezavi s cepljenjem s cepivom Tritanrix HepB.
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) 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)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100 do < 1/ 10) Občasni (≥ 1/ 1. 000 do < 1/ 100) Redki ((≥ 1/ 10. 000 do < 1/ 1. 000) Zelo redki (< 1/ 10. 000) Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
13 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.
Tako so v skupini, ki je prejela kombinirano cepivo, poročali o večji incidenci bolečine, rdečine, otekline in vročine.
Redness Total > 2cm Swelling Total > 2cm
skupno > 2 cm
38.9 9.1 30.9 10.9
Oteklina
27.1 3.4 21.5 3.4
skupno > 2 cm
5.1 0.6 4.5 0.6
30, 9 10, 9
Collapse or shock-like state (hypotonic-hyporesponsive episode).
Bolezni živčevja: kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda)
14 Pharmaco-therapeutic group:
Farmakoterapevtska skupina:
15 6.1 List of excipients
6. 1 Seznam pomožnih snovi
PSUR:
Periodična poročila o varnosti (PSUR):
The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2 years basis.
Imetnik dovoljenja za promet z zdravilom bo periodična poročila o varnosti še naprej predajal vsaki 2 leti.
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL
21 PODATKI NA ZUNANJI OVOJNINI ENOODMERNA VIALA
Tritanrix HepB – Suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB – suspenzija za injiciranje adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju - celotna celica (Pw) in hepatitisu B – rekombinantno (HBV)
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3 1
1 odmerek (0, 5 ml): davični toksoid1 tetanusni toksoid1 Bordetella pertussis (inaktivirana) 2 površinski antigen virusa hepatitisa B2, 3 1
≥ 30 IU ≥ 60 IU ≥ 4 IU 10 µg
≥ 30 i. e. ≥ 60 i. e. ≥ 4 i. e.
0.37 mg Al3+
10 μg
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
0, 26 mg Al3+ adsorbiran na hidratirani aluminijev hidroksid 2 0, 37 mg Al3+ adsorbiran na aluminijev fosfat 3 pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae)
1 vial 1 dose (0.5 ml)
suspenzija za injiciranje 1 viala 1 odmerek (0, 5 ml)
Read the package leaflet before use intramuscular use Shake before use
Intramuskularna uporaba.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
LOT:
Serija
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH ENOODMERNA VIALA
Tritanrix HepB – Suspension for injection DTPw-HBV vaccine I. M.
Tritanrix HepB – suspenzija za injiciranje DTPw- HBV cepivo i. m.
LOT:
Lot
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL
24 PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA
Suspension for injection 1 vial 2 doses (1 ml)
suspenzija za injiciranje 1 viala 2 odmerka (1 ml)
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL
26 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VEČODMERNA VIALA
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL
27 PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA
Suspension for injection 1 vial 10 doses (5 ml)
suspenzija za injiciranje 1 viala 10 odmerkov (5 ml)
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL
29 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VEČODMERNA VIALA
Tritanrix HepB suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB suspenzija za injiciranje adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju - celotna celica (Pw) in hepatitisu B – rekombinantno (HBV)
What Tritanrix HepB is and what it is used for 2.
Kaj je cepivo Tritanrix HepB in za kaj ga uporabljamo 2.
Before your child receives Tritanrix HepB 3.
Kaj morate vedeti preden bo vaš otrok prejel cepivo Tritanrix HepB 3.
How Tritanrix HepB is given 4.
Kako se cepivo Tritanrix HepB uporablja 4.
How to store Tritanrix HepB 6.
Shranjevanje cepiva Tritanrix HepB 6.
Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and hepatitis B.
Tritanrix HepB je cepivo, ki se ga uporablja pri otrocih za preprečevanje štirih bolezni: davice, tetanusa (mrtvičnega krča), oslovskega kašlja (pertusisa) in hepatitisa B.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Cepivo deluje tako, da telo spodbudi k proizvajanju lastne zaščite (protiteles) proti tem boleznim.
Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Bakterije, povzročiteljice tetanusa, vstopajo v telo preko vreznin, opraskanin ali ran na koži.
Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/ dung or wood splinters.
K okužbi so še posebej nagnjene rane, kot so opekline, zlomi, globoke rane ali rane, onesnažene z zemljo, s prahom, konjskim gnojilom/ iztrebki ali z lesenimi ivermi.
• Pertussis (Whooping cough):
• Oslovski kašelj (pertusis):
The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Oslovski kašelj je zelo nalezljiva bolezen, ki prizadene dihalne poti in povzroča močne napade kašlja, ki lahko ovirajo normalno dihanje.
The coughing is often accompanied by a “ whooping” sound, hence the common name “ whooping cough”.
Kašelj pogosto spremlja zvok, podoben riganju, zato se bolezen tudi imenuje oslovski kašelj.
The cough may last for 1-2 months or longer.
Kašelj lahko traja 1– 2 meseca ali dlje.
It causes the liver to become inflamed and swollen.
Povzročitelj hepatitisa B je virus hepatitisa B, ki povzroči vnetje in oteklino jeter.
BEFORE YOUR CHILD RECEIVES TRITANRIX HepB
KAJ MORATE VEDETI PREDEN BO VAŠ OTROK PREJEL CEPIVO TRITANRIX HepB
Tritanrix HepB should not be given:
Vaš otrok cepiva Tritanrix HepB ne sme prejeti:
32 • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
• če je predhodno imel kakršnokoli alergijsko reakcijo na cepivo Tritanrix HepB ali na katerokoli sestavino v tem cepivu.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough) or hepatitis B diseases. • if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease. • if your child has a severe infection with a high temperature (over 38°C).
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika. • če je predhodno imel alergijsko reakcijo na katerokoli cepivo proti davici, tetanusu, oslovskemu kašlju (pertusisu) ali hepatitisu B. • če je imel težave z živčevjem v 7 dneh po predhodnem cepljenju s cepivom proti oslovskemu kašlju (pertusisu). • če ima hudo okužbo z visoko vročino (nad 38 ºC).
• if your child has experienced any health problems after previous administration of a vaccine. • if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• če je vaš otrok po predhodnem cepljenju imel kakršnekoli zdravstvene težave. • če je po predhodnem prejemu Tritanrix HepB ali drugega cepiva proti oslovskemu kašlju (pertusisu) vaš otrok imel kakršnekoli težave, še posebej: ♦ visoko vročino (nad 40 ºC) v 48 urah po cepljenju, ♦ kolaps ali šoku podobno stanje v 48 urah po cepljenju, ♦ če je v 48 urah po cepljenju vztrajno jokal 3 ure ali dlje, ♦ epileptične napade/ krče z zvišano telesno temperaturo ali brez v 3 dneh po cepljenju; • če ima vaš otrok nediagnosticirano ali napredujočo bolezen možganov ali neurejeno epilepsijo.
After control of the disease the vaccine should be administered • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this
Cepivo je treba uporabiti po ureditvi bolezni. • če ima vaš otrok težave s krvavitvami ali hitrim pojavom modric; • če je vaš otrok nagnjen k epileptičnim napadom/ krčem zaradi vročine ali pa se je to pojavljalo v družini.
Using other medicines or vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Zdravnika obvestite tudi, če je vaš otrok pred kratkim bil cepljen s katerimkoli drugim cepivom.
HOW TRITANRIX HepB IS GIVEN
KAKO SE CEPIVO TRITANRIX HepB UPORABLJA
The vaccine should never be given into a vein.
33 Cepivo se ne sme dajati v žilo.
33 Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Med kliničnimi preskušanji cepiva Tritanrix HepB so se pojavili naslednji neželeni učinki:
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine): • pain or discomfort at the injection site • redness or swelling at the injection site • fever (more than 38°C) • drowsiness, irritability, unusual crying • feeding problems
♦ Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 odmerkov cepiva): • bolečina ali neugodje na mestu vboda • rdečina ali oteklina na mestu vboda • zvišana telesna temperatura (višja od 38 °C) • zaspanost, razdražljivost, neobičajen jok • težave s hranjenjem
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): • infection of the middle ear • bronchitis • sore throat and discomfort when swallowing • gastrointestinal symptoms such as vomiting and diarrhoea
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od 100 odmerkov cepiva): • vnetje srednjega ušesa • bronhitis • vnetje žrela in težave pri požiranju • prebavni simptomi, kot sta bruhanje in driska
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • pneumonia (serious lung infection) • respiratory disorder
♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100, vendar več kot 1 od 1. 000 odmerkov cepiva): • pljučnica (hujše vnetje pljuč) • težave z dihanjem
♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine): • allergic reactions, including anaphylactic and anaphylactoid reactions.
♦ Zelo redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10. 000 odmerkov cepiva): • alergijske reakcije, vključno z anafilaksijskimi in anafilaktoidnimi reakcijami.
Such reactions may occur before leaving the doctor’ s surgery.
Te reakcije se lahko pojavijo še preden zapustite ambulanto.
However, you should seek immediate treatment in any event. • serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes)
V vsakem primeru morate nemudoma poiskati zdravniško pomoč. • serumski bolezni podobno stanje (preobčutljivostna reakcija po dajanju tujega seruma s simptomi, kot so zvišana telesna temperatura, otekline, kožni izpuščaj, povečanje bezgavk).
• collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days after vaccination • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
• v 2 do 3 dneh po cepljenju so poročali o pojavu kolapsa ali obdobij nezavesti ali motenj zavedanja. • pri zelo prezgodaj rojenih dojenčkih (tj. rojenih 28. teden gestacije ali prej) se lahko od 2 do 3 dni po cepljenju pojavljajo daljši presledki med dihi, kot je normalno.
Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B virus.
Cepivo Tritanrix HepB vsebuje komponento proti hepatitisu B in tako zagotavlja zaščito pred boleznijo, ki jo povzroča virus hepatitisa B.
The following undesirable events have occurred very rarely following the administration of hepatitis B containing vaccines: ♦ seizures or fits ♦ bleeding or bruising more easily than normal
Po dajanju cepiv z vsebnostjo komponente proti hepatitisu B so se zelo redko pojavljali naslednji neželeni učinki: ♦ epileptični napadi ali krči; ♦ krvavitve ali neobičajno hiter pojav modric.