natgillin/translations-raw huggingface dataset:
Respiratory system disorders:
Bolezni kože in priveskov: angioedem / rdečica / srbečica / izpuščaj / urtikarija.
Dyspnoea or Stridor inspiratory.
Žilne bolezni: rdečica.
5 Skin and appendages disorders:
5 reakcija.
Bacterial and viral vaccines, combined, ATC code:
Oznaka ATC:
The acellular pertussis components (pertussis toxin:
Necelične komponente proti oslovskemu kašlju (pertusis toksin:
PT and filamentous haemagglutinin:
PT in filamentozni hemaglutinin:
FHA) are extracted from Bordetella pertussis cultures then separately purified.
FHA) so ekstrahirane iz kultur bakterije Bordetella pertussis in ločeno prečiščene.
This vaccine contains the purified capsular polysaccharide (polyribosyl ribitol phosphate:
To cepivo vsebuje prečiščen kapsularni polisaharid (poliribozilribitol fosfat:
PRP) of Haemophilus influenzae type b conjugated to tetanus toxoid.
PRP) bakterije Haemophilus influenzae tipa b, ki je konjugiran na tetanusni toksoid.
This vaccine induces specific humoral antibodies against HBsAg (anti-HBs) and against diphtheria and tetanus toxoids (anti-D and anti-T).
To cepivo sproži nastanek specifičnih humoralnih protiteles proti HBsAg (proti- HBs), proti davičnemu toksoidu (proti- D) in tetanusnemu toksoidu (proti- T).
Development of anti-HBs titre equal to or greater than 10 mIU/ ml and of anti-D and anti-T equal to or greater than 0.01 IU/ ml measured 1-2 months after the third injection correlates with protection against hepatitis B infection and against diphtheria and tetanus respectively.
Razvoj titra proti- HBs ne manj kot 10 mIU/ ml po 1- 2 mesecih po tretjem odmerku cepiva korelira z zaščito proti okužbi z virusom hepatitisa B, razvoj titrov proti- D oz. proti- T na manj kot 0, 01 i. e. / ml v istem času pa korelira z zaščito proti davici in tetanusu.
Immune response after primary vaccination In the pivotal clinical study, all infants (100%) developed a seroprotective antibody level (equal to or greater than 0.01 IU/ ml) to both diphtheria and tetanus antigens one month after completion of the primary series.
Imunski odziv po primarnem cepljenju V ključni klinični študiji so vsi dojenčki (100%) razvili zaščitno raven protiteles (ne manj kot 0, 01 i. e. / ml) tako proti antigenom davice in antigenom tetanusa en mesec po zaključku programa primarnega cepljenja.
For pertussis, 91.8% and 90.5% of infants achieved a four-fold rise in PT and FHA antibody titres respectively.
Proti oslovskemu kašlju je 91, 8% dojenčkov razvilo štirikratno povečanje titra protiteles proti PT, 90, 5% pa enako povečanje protiteles proti FHA.
6 96.6% of infants; the geometric mean titres (GMTs) were diminished compared to the control group.
Zaščitne ravni proti- HBs (ne manj kot 10 mi. e. / ml) so bile dosežene pri 96, 6% dojenčkov; titri geometričnega povprečja (GMT) so bili zmanjšani v primerjavi s kontrolno skupino.
Anti-poliovirus titres above the threshold of 5 (reciprocal of dilution in seroneutralisation) against poliovirus types 1, 2 and 3 were developed in 100% of infants and these were considered protected against poliomyelitis.
Titri protiteles proti poliovirusom tipa 1, 2 in 3 nad vrednostjo praga 5 (recipročno redčenje pri seronevtralizaciji) so se razvili pri 100% dojenčkov in zanje se smatra, da so zaščiteni proti otroški ohromelosti.
After primary vaccination, 93.7% of infants had an anti-PRP titre equal to or greater than 0.15 µg/ ml; the GMTs were diminished compared to the control group (2.06 µg/ ml versus 3.69 µg/ ml).
Po primarnem cepljenju je imelo 93, 7% dojenčkov titer proti- PRP enak ali večji kot 0, 15 µg/ ml; GMT so bile zmanjšani v primerjavi s kontrolno skupino (2, 06 µg/ ml napram 3, 69 µg/ ml).
Immune response after booster injection In the pivotal clinical study where toddlers received HEXAVAC as a booster dose after having been primed with HEXAVAC, antibody titres equal to or greater than 0.1 IU/ ml were achieved by all toddlers to tetanus and by 98.8% to diphtheria.
Imunski odziv po obnovitvenem odmerku V ključni klinični študiji, kjer so malčki prejeli HEXAVAC kot obnovitveni odmerek po primarnem cepljenju s HEXAVAC- om, so titer najmanj 0, 1 IU/ ml dosegli vsi malčki proti tetanusu in 98, 8% malčkov proti davici.
A mean 7.4 and 4.3-fold rise in antibody titres to PT and FHA respectively was achieved and all toddlers developed protective antibody titres against poliovirus types 1, 2 and 3.
Malčki so v povprečju razvili 7, 4- kratno povečanje titra protiteles proti PT in 4, 3- kratno povečanje titra proti FHA.
Just before the booster injection anti-PRP GMTs were 0.40 µg/ ml and 0.64 µg/ ml for HEXAVAC and for the control group respectively.
Vsi so razvili zaščitne titre protiteles proti poliovirusom tipov 1, 2 in 3.
After booster, GMTs increased to 16.7 µg/ ml and 23.0 µg/ ml in each group respectively, indicating a strong anamnestic response.
Tik pred obnovitvenim odmerkom so bili GMT proti- PRP 0, 40 µg/ ml v skupini HEXAVAC in 0, 64 µg/ ml v kontrolni skupini.
Anti- PRP titres equal to or greater than 0.15 µg/ ml and equal to or greater than 1 µg/ ml were achieved in 100% and 96.6% of toddlers respectively.
Titre proti- PRP najmanj 0, 15 µg/ ml je doseglo 100% malčkov, titre najmanj 1 µg/ ml pa 96, 6% malčkov.
Following the booster dose, 96.6% of toddlers developed anti-HBs titres equal to or greater than 10 mIU/ ml.
Po obnovitvenem odmerku je 96, 6% malčkov razvilo titre proti - HBs najmanj 10 mIU/ ml.
A mean 20.5-fold rise in antibody titres to HBs was observed after the booster dose.
Po obnovitvenem odmerku je bilo opaženo v povprečju 20, 5- kratno povečanje titrov protiteles proti HBs.
7 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl) with attached needle - pack of 1, 10, 25 and 50.
V pakiranjih po 1, 10, 25 in 50.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl) without needle - pack of 1, 10, 25 and 50.
V pakiranjih po 1, 10, 25 in 50.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl), with 1 or 2 separate needles - pack of 1 and 10.
V pakiranjih po 1 in 10.
6.6 Instructions for use and handling
7 6. 6 Navodila za pripravo in ravnanje z zdravilom
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA( E) V REGISTRU ZDRAVIL SKUPNOSTI
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE( UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substances
Ime in naslov izdelovalca biološke zdravilne učinkovine( učinkovin)
For the other components:
Za druge komponente:
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EEC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti hemofilusu tipa b( konjugirano).
STATEMENT OF ACTIVE SUBSTANCE(S)
En 0, 5 mililitrski odmerek adsorbiranega cepiva vsebuje:
1 adjuvanted dose (0.5 ml) contains:
Prečiščen davični toksoid...................................................................... ≥20 i. e.
Purified diphtheria toxoid...................................................................... .≥ 20 IU Purified tetanus toxoid........................................................................... .≥ 40 IU Purified pertussis toxoid........................................................................ .25 µg Purified pertussis filamentous haemagglutinin....................................... 25 µg Hepatitis B surface antigen..................................................................... 5.0 µg Inactivated type 1 poliovirus.................................................................. 40 D units Inactivated type 2 poliovirus.................................................................. 8 D units Inactivated type 3 poliovirus.................................................................. 32 D units Haemophilus influenzae type b conjugated to tetanus toxoid............... ..12 µg
Prečiščen toksoid bordetele pertusis....................................................... 25 µg Prečiščen filamentozni hemaglutinin bordetele pertusis......................... 25 µg Površinski antigen virusa hepatitisa B.................................................... 5, 0 µg Inaktiviran poliovirus tipa 1.................................................................... 40 enot D Inaktiviran poliovirus tipa 2.................................................................... 8 enot D Inaktiviran poliovirus tipa 3.................................................................... 32 enot D Haemophilus influenzae tipa b konjugiran na tetanusni toksoid............ 12 µg
1 single dose 0.5 ml pre-filled syringe with attached needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION
POSTOPEK IN (ČE JE POTREBNO) POT( I) UPORABE ZDRAVILA
Store at 2 °C – 8 °C (in a refrigerator) Do not freeze
Shranjujte pri temperaturi med 2°C – 8 °C (v hladilniku).
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju( acelularno), otroški ohromelosti( inaktivirano), hepatitisu B- rekombinantno in proti hemofilusu tipa b( konjugirano).
1 adjuvanted dose (0.5 ml) contains:
Prečiščen tetanusni toksoid..................................................................... ≥40 i. e.
1 single dose 0.5 ml pre-filled syringe without needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
1 single dose 0.5 ml pre-filled syringe with 1 separate needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
1 single dose 0.5 ml pre-filled syringe with 2 separate needles Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju( acelularno), otroški ohromelosti (inaktivirano), hepatitisu B( rekombinantno) in proti hemofilusu tipa b( konjugirano).
10 single doses 0.5 ml pre-filled syringes with attached needle.
10 posameznih odmerkov po 0, 5 ml v napolnjenih injekcijskih brizgah z iglo.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
1 adjuvanted dose (0.5 ml) contains:
Prečiščen toksoid tetanusa...................................................................... ≥40 i. e.
Purified diphtheria toxoid...................................................................... .≥ 20 IU Purified tetanus toxoid........................................................................... .≥ 40 IU Purified pertussis toxoid........................................................................ .25 µg Purified pertussis filamentous haemagglutinin....................................... 25 µg Hepatitis B surface antigen..................................................................... 5.0 µg Inactivated type 1 poliovirus.................................................................. 40 D units Inactivated type 2 poliovirus.................................................................. 8 D units Inactivated type 3 poliovirus.................................................................. 32 D units Haemophilus influenzae type b conjugated to tetanus toxoid............... ..12 µg
Prečiščen toksoid pertusisa..................................................................... 25 µg Prečiščen filamentozni hemaglutinin pertusisa....................................... 25 µg Površinski antigen virusa hepatitisa B.................................................... 5, 0 µg Inaktiviran poliovirus tipa 1.................................................................... 40 enot D Inaktiviran poliovirus tipa 2.................................................................... 8 enot D Inaktiviran poliovirus tipa 3.................................................................... 32 enot D Haemophilus influenzae tipa b konjugiran na tetanusni toksoid............ 12 µg
10 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 10
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z 1 priloženo iglo - Pakiranje po 10
STATEMENT OF ACTIVE SUBSTANCE(S)
Vsak 0, 5 mililitrski odmerek adsorbiranega cepiva vsebuje:
10 single doses 0.5 ml pre-filled syringes with 1 separate needle (for each syringe).
10 posameznih odmerkov po 0, 5 ml v napolnjenih injekcijskih brizgah z 1 priloženo iglo (za vsako injekcijsko brizgo).
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
HEXAVAC - single dose pre-filled syringe with 2 separate needles - Pack of 10
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi z 2 priloženima iglama - Pakiranje po 10
10 single doses 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) Suspension for injection in pre-filled syringe
10 posameznih odmerkov po 0, 5 ml v napolnjenih injekcijskih brizgah z 2 priloženima iglama (za vsako injekcijsko brizgo).
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
25 single doses 0.5 ml pre-filled syringes with attached needle.
25 posameznih odmerkov po 0, 5 ml v napolnjenih injekcijskih brizgah z iglo.
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
25 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
50 single doses 0.5 ml pre-filled syringes with attached needle.
50 posameznih odmerkov po 0, 5 ml v napolnjenih injekcijskih brizgah z iglo.
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
HEXAVAC - single dose pre-filled syringe without needle - Pack of 50
HEXAVAC - enkratni odmerek v napolnjeni injekcijski brizgi brez igle - Pakiranje po 50
50 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
36 PODATKI, KI OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN (ČE JE POTREBNO) POT( I) UPORABE ZDRAVILA
Store at 2 °C – 8 °C Do not freeze Shake well before use
Shranjujte pri temperaturi med 2°C – 8 °C Ne zamrzujte Pred uporabo dobro pretresti
38 PACKAGE LEAFLET
38 NAVODILO ZA UPORABO
- This vaccine has been prescribed for your child and you should not pass it on to others.
- Cepivo je bilo predpisano za vašega otroka in ga ne smete dajati drugim.
Storing HEXAVAC 6.
Shranjevanje HEXAVAC- a 6.
HEXAVAC suspension for injection in pre-filled syringe Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted.
HEXAVAC Suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B( rekombinantno) in proti hemofilusu tipa b( konjugirano).
32 units † Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 12 micrograms conjugated to tetanus toxoid (24 micrograms) for one adjuvanted dose of 0.5 ml
32 enot † Polisaharid Haemophilus influenzae tipa b (poliribozilribitol fosfat) 12 mikrogramov, konjugiran na toksoid tetanusa (24 mikrogramov) na en 0, 5 mililitrski odmerek z adjuvansom
* As lower confidence limit (p = 0.95). ** Surface antigen of hepatitis B virus produced from recombinant strain 2150-2-3 of the yeast Saccharomyces cerevisiae. ^ Quantity of antigen in the final bulk product, according to W. H. O.
* Spodnja meja intervala zaupanja (p = 0, 95). ** Površinski antigen virusa hepatitisa B proizvaja rekombinantni sev 2150- 2- 3 kvasovke Saccharomyces cerevisiae. ^ Količina antigena v končnem proizvodu po W. H. O.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon Izdelovalec:
HEXAVAC is an injectable vaccine in a 0.5 ml single dose syringe.
HEXAVAC je cepivo za injiciranje v injekcijski brizgi z enkratnim odmerkom 0, 5 ml.
HEXAVAC is indicated to help protect your child against diphtheria, tetanus, pertussis, poliomyelitis, infection of the liver caused by all known subtypes of hepatitis B virus and invasive disease (infection of brain and spinal cord tissues, infection of the blood, etc.) caused by Haemophilus influenzae type b (Hib) bacterium in children 8 weeks to 18 months of age.
HEXAVAC je namenjen zaščiti vašega otroka proti davici, tetanusu, oslovskemu kašlju, otroški ohromelosti, okužbi jeter, ki jo povzročajo vsi znani podtipi virusa hepatitisa B in proti invazivni
39 HEXAVAC is available in packs of 1, 10, 25 and 50 with or without neddles.
HEXAVAC je na voljo v pakiranjih po 1, 10, 25 in 50 z ali brez igel.
Do not use HEXAVAC:
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI HEXAVAC Ne uporabite HEXAVAC:
- if your child is allergic to any component of the vaccine.
- če je vaš otrok alergičen na katerokoli sestavino cepiva.
- in case of newborns, adolescents or adults.
- če gre za novorojenčka, mladostnika ali odraslo osebo.
- if your child has fever or other illness, particularly a cough, cold or flu (vaccination should be
- če ima vaš otrok vročino ali drugo obolenje, predvsem kašelj, prehlad ali gripo (cepljenje naj se
delayed).
prestavi).
- if your infant has suffered brain damage (encephalopathy) following a previous dose of a whole
- če je vaš dojenček utrpel možganske poškodbe (encefalopatijo) po prejšnjem odmerku celičnega
cell or acellular pertussis vaccine.
ali neceličnega cepiva proti oslovskemu kašlju.
- if your child has an hypersensitivity to neomycin, streptomycin and polymyxin B, due to the use
- če je vaš otrok preobčutljiv za neomicin, streptomicin in polimiksin B, ker so bile te snovi
of these substances during production.
uporabljene med proizvodnjo.
- if your child has a thrombocytopenia or a bleeding disorder since bleeding may occur following
- če ima vaš otrok trombocitopenijo ali motnjo krvavitve, saj se lahko v teh primerih razvije
an intramuscular administration to these subjects.
krvavitev kot posledica intramuskularnega dajanja.
- if any of the following events are known to have occurred in temporal relation to receipt of the
- če se je pojavil katerikoli od naslednjih znakov v časovni povezavi s cepljenjem (Skrbno je
vaccine (The decision to give further doses of pertussis-containing vaccines to your child should be carefully considered if any of the following events are known to have occurred following the administration of the vaccine):
Temperatura ≥ 40, 0 °C v 48 urah brez drugega vzroka.
- if your child has any present or past medical problems or allergies, including allergic reactions
- če ima vaš otrok zdravstvene težave z alergijami trenutno ali jih je imel kadarkoli v preteklosti,
after any dose of HEXAVAC.
vključno z alergijskimi reakcijami po kateremkoli odmerku HEXAVAC- a.
- if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should
- če ste mati pozitivni za površinski antigen virusa hepatitisa B (HBsAg), bi moral vaš otrok ob
receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
rojstvu prejeti imunoglobulin proti virusu hepatitisa B (HBIG) in rekombinantno cepivo proti hepatitisu B, nato pa dokončati zaporedje cepljenj proti hepatitisu B.
HEXAVAC should not be used as the birth dose or subsequent doses during the first year of life for children born to HbsAg-positive mothers.
HEXAVAC naj se ne uporablja za odmerek ob rojstvu ali za kasnejše odmerke v prvem letu življenja pri otrocih mater pozitivnih za HBsAg.
- because as with other similar vaccines, cases of Haemophilus b disease may occur in the week
- ker se lahko (kot pri drugih podobnih cepivih) pojavi bolezen, ki jo povzroča bakterija
after vaccination prior to the onset of the protective effects of the vaccine.
Haemophilus b v tednu po cepljenju (preden se začnejo zaščitni učinki cepiva).
- because hepatitis B infection can go undetected for a long period of time, it is possible that an
- ker lahko okužba z virusom hepatitisa B poteka nezaznavno dolgo časa, je možno, da je oseba
individual may already be infected at the time the vaccine is given.
že okužena v času cepljenja.
Using other vaccines There are currently not sufficient data available regarding immune response of the concomitant administration of HEXAVAC with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed).
Uporaba drugih zdravil Trenutno ni na voljo dovolj podatkov o imunskem odzivu pri sočasnem cepljenju s HEXAVAC- om in PREVENAR- jem (adsorbirano pnevmokokno polisaharidno konjugirano cepivo).
However, when HEXAVAC was co-administered in clinical studies the rate of febrile reactions was higher compared to that occurring following administration of hexavalent vaccines alone.
Vendar je bila v kliničnih poskusih sočasnega dajanja HEXAVAC- a stopnja febrilnih reakcij višja kot pri cepljenju samo s heksavalentnimi cepivi.
If your child is due to be vaccinated with HEXAVAC and other vaccines simultaneously, please ask your doctor for further information.
Če naj bi se vaš otrok sočasno cepil s HEXAVAC- om in drugim cepivom, se posvetujte z zdravnikom.
The primary vaccination schedule consists of two or three doses of 0.5 ml administered within the first year of life according to the official recommendations.
Med odmerki naj bo najmanj enomesečni presledek: npr.
After a primary vaccination with 2 doses of HEXAVAC (e. g 3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e. g.
3. in 5. mesec) obnovitveno cepljenje izvesti med 11. in 13. mesecem življenja; po primarnem cepljenju s 3 odmerki HEXAVAC- a (npr.