natgillin/translations-raw huggingface dataset:
- a prospective blinded household contact study performed in Germany (3, 4, 5 months schedule).
Na podlagi podatkov zbranih po drugem obisku v gospodinjstvih, v katerih so imeli primer značilnega oslovskega kašlja, je bila učinkovitost zaščite, ki jo je nudilo cepivo 88, 7 -%.
Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%.
- raziskavi učinkovitosti, sponzorirani s strani NIH (zdravstvena zavarovalnica), ki je bila izvedena v
- a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule.
Italiji (cepljenje pri 2, 4 in 6 mesecih).
was found to be 84%.
Učinkovitost cepiva je bila 84 -%.
This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
Vendar pa podatki kažejo tudi, da pri cepljenju po shemi (3- 5- 12 mesec) zaščita proti oslovskemu kašlju v starosti od 7 do 8 let lahko oslabi, kar kaže, da je pri otrocih, ki so bili cepljeni po tej shemi, v starosti od 5 do 7 let upravičeno cepljenje še z drugim obnovitvenim odmerkom cepiva.
Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of Infanrix hexa.
Zaščitna protitelesa proti hepatitisu B so dokazano prisotna vsaj še 3, 5 leta pri več kot 90% otrok, ki dobijo štiri odmerke Infanrix hexa.
8 The effectiveness of the Hib component of Infanrix hexa has been, and continues to be, investigated via an extensive post-marketing surveillance study conducted in Germany.
Obširna študija postmarketinškega spremljanja učinkovitosti komponente cepiva Infanrix hexa proti Hib poteka v Nemčiji.
Over a five year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 90.4% for a full primary series and 100% for a booster dose (irrespective of priming).
Po petih letih spremljanja je bila učinkovitost komponent proti Hib dveh šestvalentnih cepiv, od katerih je bilo eno Infanrix hexa, po popolnem osnovnem cepljenju 90, 4%, po cepljenju z obnovitvenim odmerkom pa 100% (neodvisno od osnovnega cepljenja).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredients.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Lactose anhydrous
Prašek Hib: brezvodna laktoza
Sodium chloride (NaCl) Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Suspenzija DTPa- HBV- IPV: natrijev klorid (NaCl) medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine voda za injekcije
6.4 Special precautions for storage
9 6. 4 Posebna navodila za shranjevanje
0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
0, 5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom iz butilne gume.
Pack sizes of 1, 10, 20 and 50 with or without needles.
Pakiranja po 1, 10, 20 in 50 napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami ali brez njih.
9 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
Pred uporabo je treba brizgo s cepivom dobro pretresti, da dobimo homogeno, motno belo suspenzijo.
The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Preveriti morate videz suspenzije DTPa- HBV- IPV glede morebitne prisotnosti tujih delcev in/ ali neobičajnega fizikalnega videza cepiva.
The vaccine is reconstituted by adding the contents of the syringe to the vial containing the Hib powder.
Cepivo rekonstituiramo z dodajanjem vsebine injekcijske brizge viali, ki vsebuje prašek s Hib - komponento.
After the addition of the DTPa-HBV-IPV vaccine to the powder, the mixture should be well shaken until the powder is completely dissolved.
Po dodatku DTPa- HBV- IPV cepiva prašku, mešanico dobro pretresemo, da se prašek popolnoma raztopi.
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone.
Rekonstituirano cepivo je na videz bolj motna suspenzija kot sama tekoča komponenta.
This is normal and does not impair the performance of the vaccine.
To je normalno in ne vpliva na delovanje cepiva.
In the event of other variation being observed, discard the vaccine.
Če je cepivo videti drugače, ga zavrzite.
MARKETING AUTHORISATION NUMBER(S
ŠTEVILKE DOVOLJENJ ZA PROMET
Date of first authorisation:
10 Datum pridobitve dovoljenja za promet:
23 October 2000 Date of latest renewal:
23. oktober 2000 Datum zadnjega podaljšanja dovoljenja za promet:
23 October 2005
23. oktober 2005
type 1 (Mahoney strain) 4 type 2 (MEF-1 strain) 4 type 3 (Saukett strain) 4
tip 1 (sev Mahoney) 4 tip 2 (sev MEF- 1) 4 tip 3 (sev Saukett) 4
conjugated to tetanus toxoid as carrier protein 1
vezan na tetanusni toksoid kot nosilni protein 4 namnožen v celicah VERO 1
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO4) 4 propagated in VERO cells
pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae 3 adsorbiran na aluminijev fosfat (AlPO4)
4.2 Posology and method of administration
12 4. 2 Odmerjanje in način uporabe
11 The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months).
Osnovno shemo cepljenja setavljajo trije odmerki po 0, 5 ml (npr.
Infanrix hexa is contraindicated if the infant has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Uporaba Infanrixa hexa je kontraindicirana, če je otrok prebolel encefalopatijo neznanega vzroka, ki se je pojavila v sedmih dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti oslovskemu kašlju.
4.4 Special warnings and precautions for use
13 4. 4 Posebna opozorila in previdnostni ukrepi
12 Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
Kolaps ali šoku podobno stanje (hipotonične, slabo odzivne epizode) v 48 urah po cepljenju.
Infanrix hexa should under no circumstances be administered intravascularly or intradermally.
Infanrixa hexa v nobenem primeru ne dajemo intravaskularno ali intradermalno.
Limited data in 169 premature infants indicate that Infanrix hexa can be given to premature children.
14 Omejeni podatki pri 169 nedonošenčkih kažejo, da nedonošeni otroci lahko dobijo cepivao Infanrix hexa.
13 There are insufficient data with regard to the efficacy and safety of simultaneous administration of Infanrix hexa and Measles-Mumps-Rubella vaccine to allow any recommendation to be made.
O učinkovitosti in varnosti sočasnega dajanja Infanrixa hexa in cepiva proti ošpicam, mumpsu in rdečkam ni dovolj podatkov, da bi bilo mogoče dati kakšna priporočila.
As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy, an adequate response may not be achieved.
Kot pri drugih cepivih lahko tudi pri tem pričakujete, da pri bolnikih ki prejemajo imunosupresivno terapijo ne bo dosežen zadosten odziv na cepljenje.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Kot pri DTPa- cepivu in kombiniranih cepivih, ki vsebujejo DTPa, so poročali o povečanem pojavu lokalnih reakcij in zvišane telesne temperature po aplikaciji obnovitvenega odmerka cepiva Infanrix hexa v primerjavi z osnovnim cepljenjem
Frequencies per dose are defined as follows:
15 Pogostnost na odmerek je definirana kot sledi:
Nervous system disorders:
Občasni: zaspanost
Uncommon: somnolence Very rare: convulsions (with or without fever)
Zelo redki: konvulzije (z zvišano telesno temperaturo ali brez nje)
Respiratory, thoracic and mediastinal disorders Uncommon: cough
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni: kašelj
14 Gastrointestinal disorders:
Bolezni prebavil:
Very common: crying abnormal, irritability, restlessness Common: nervousness
Zelo pogosti: neobičajen jok, razdražljivost, vznemirjenost Pogosti:,, živčnost
Apnoea [see section 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)]
Apneja [glejte poglavje 4. 4 glede apneje pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti)].
Skin and subcutaneous tissue disorders Angioedema
Bolezni kože in podkožja Angioedem
Swelling of the entire injected limb*, extensive swelling reactions, injection site mass, injection site vesicles
Oteklinaokončine v katero je bilo cepivo injicirano *, obsežna oteklina, masa na mestu injiciranja, mehurčki na mestu injiciranja
Immune system disorders Anaphylactic reactions, anaphylactoid reactions (including urticaria), allergic reactions (including pruritus)
16 Anafilaktične reakcije, anafilaktoidne reakcije (vključno z urtikarijo), alergijske reakcije (vključno s srbenjem)
98.0
% 98, 0
100.0
% 100, 0
99.8
% 99, 8
Anti-PRP (0.15 μ g/ ml) † N = number of subjects
17 Anti- PRP (0, 15 μg/ ml) † n = število preiskovancev
16 Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Infanrix hexa
Odstotek preiskovancev, ki so imeli titre protiteles ≥ mejno vrednostjo preizkusa en mesec po obnovitvenem cepljenju z Infanrix hexa
Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.
Pri dolgotrajnem spremljanju cepiv na Švedskem se je izkazalo, da so brezcelična cepiva proti oslovskemu kašlju učinkovita, če so bili otroci osnovno cepljeni po shemi 3. in 5. mesec starosti ter so
However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule.
18 prejeli obnovitveni odmerek pri približno 12 mesecih starosti.
17 The effectiveness of the Hib component of Infanrix hexa has been, and continues to be, investigated via an extensive post-marketing surveillance study conducted in Germany.
Obširna študija postmarketinškega spremljanja učinkovitosti komponente cepiva Infanrix hexa proti Hib poteka v Nemčiji.
Powder in a vial (type I glass) with Bioset® with a stopper (butyl).
Prašek v viali (steklo tipa I) z Bioset® in zamaškom iz butilne gume.
0.5 ml of suspension in pre-filled syringe (type I glass) with plunger stoppers (butyl).
0, 5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom iz butilne gume.
18 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
It is good clinical practice to only inject a vaccine when it has reached room temperature.
Dobra klinična praksa zahteva injiciranje cepiva, ko se le- to ogreje na sobno temperaturo.
In addition, a vial at room temperature ensures sufficient elasticity of the rubber closure to minimise any coring of rubber particles.
Samo pri sobni temperaturi lahko zagotovimo zadostno elastičnost gumijastih zapork, da bi kar se da zmanjšali možnost luščenja gumijastih delcev.
To achieve this, the vial should be kept at room temperature (25 ± 3 °C) for at least five minutes before connecting the syringe and reconstituting the vaccine.
Da dosežemo ta pogoj, moramo hraniti vialo pri sobni temperaturi (25 + 3 °C) vsaj 5 minut, preden jo spojimo z injekcijsko brizgo in rekonstituiramo cepivo.
For reconstitution, twist and remove the plastic cover from the Bioset® and remove the cap from the syringe.
Za rekonstitucijo cepiva odstranite plastični pokrov Bioseta in odstranite pokrovček z injekcijske brizge.
Before connecting the syringe onto the Bioset®, make sure the two containers are aligned (see Picture 1).
Preden namestite injekcijsko brizgo na Bioset, se prepričajte, da sta oba vsebnika poravnana v isti liniji (glejte sliko 1).
Connect the syringe onto the Bioset® by twisting it.
Injekcijsko brizgo namestite na Bioset tako, da jo zavrtite.
Push downwards until syringe“ clicks” into position.
Potisnite jo navzdol, dokler brizga ne leže v pravi položaj (ko zaslišite “ klik ”).
Inject the contents of the syringe into the vial.
Vbrizgajte vsebino injekcijske brizge v vialo.
Mix thoroughly until the Hib powder is completely dissolved.
Mešanico dobro pretresite, da se prašek (Hib) popolnoma raztopi.
Aspirate the reconstituted vaccine back into the syringe.
Potegnite rekonstituirano cepivo nazaj v injekcijsko brizgo.
Unscrew the syringe from Bioset® and affix a needle for vaccine administration.
Odvijte brizgo z Bioseta in pritrdite iglo za injiciranje cepiva.
EU/ 1/ 00/ 152/ 009 EU/ 1/ 00/ 152/ 010 EU/ 1/ 00/ 152/ 011 EU/ 1/ 00/ 152/ 012 EU/ 1/ 00/ 152/ 013 EU/ 1/ 00/ 152/ 014 19 EU/ 1/ 00/ 152/ 015 EU/ 1/ 00/ 152/ 016 EU/ 1/ 00/ 152/ 017 EU/ 1/ 00/ 152/ 018
20 EU/ 1/ 00/ 152/ 009 EU/ 1/ 00/ 152/ 010 EU/ 1/ 00/ 152/ 011 EU/ 1/ 00/ 152/ 012 EU/ 1/ 00/ 152/ 013 EU/ 1/ 00/ 152/ 014 EU/ 1/ 00/ 152/ 015 EU/ 1/ 00/ 152/ 016 EU/ 1/ 00/ 152/ 017 EU/ 1/ 00/ 152/ 018
21 A.
21 DODATEK II
Rue de l’ Institut 89, 1330 Rixensart Belgium
Rue de l’ Institut 89, 1330 Rixensart Belgija
76, D-35041 Marburg Germany
76, D- 35041 Marburg Nemčija
The holder of marketing authorisation will continue to submit annual PSURs.
Imetnik dovoljenja za promet bo redno predajal letna poročila o neželenih učinkih zdravila.
23 A.
23 DODATEK III
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 VIALS AND 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 VIALS AND 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES 20 VIALS AND 20 PRE-FILLED SYRINGES WITH 40 NEEDLES 50 VIALS AND 50 PRE-FILLED SYRINGES WITH 100 NEEDLES
25 PODATKI NA ZUNANJI OVOJNINI 1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 20 VIAL IN 20 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 50 VIAL IN 50 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI 20 VIAL IN 20 NAPOLNJENIH INJEKCIJSKIH BRIZG S 40 IGLAMI 50 VIAL IN 50 NAPOLNJENIH INJEKCIJSKIH BRIZG S 100 IGLAMI
Infanrix hexa – Powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed)
Infanrix hexa – prašek in suspenzija za suspenzijo za injiciranje Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu tipa b (konjugirano) (Hib)
After reconstitution, 1 dose (0.5 ml):
1 odmerek (0, 5 ml) po rekonstituciji: davični toksoid1 tetanusni toksoid
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
1
≥ 30 IU ≥ 40 IU
≥ 30 i. e. ≥ 40 i. e.
(Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1) Hepatitis B surface antigen2 Poliovirus (inactivated) type 1, 2, 3 Haemophilus type b polysaccharide (polyribosylribitol phosphate) 2
poliovirus (inaktivirani) tip 1, 2, 3 polisaharid hemofilusa tipa b (poliribozilribitol- fosfat) 2
25, 25, 8 micrograms 10 micrograms 40, 8, 32 DU 10 micrograms
40, 8, 32 D- antigenskih enot 10 mikrogramov
20-40 micrograms
20 - 40 mikrogramov
adsorbed on Al(OH)3 2
adsorbiran na Al( OH) 3 2
adsorbed on AlPO4
adsorbiran na AlPO4
Lactose anhydrous Sodium chloride Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
brezvodna laktoza natrijev klorid medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine voda za injekcije
Powder and suspension for suspension for injection Vial: powder Pre-filled syringe: suspension
prašek in suspenzija za suspenzijo za injiciranje viala: prašek napolnjena injekcijska brizga: suspenzija
1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
1 viala in 1 napolnjena injekcijska brizga 1 odmerek (0, 5 ml)
10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 vial in 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0, 5 ml)
25 20 vials and 20 pre-filled syringes 20 x 1 dose (0.5 ml)
26 20 vial in 20 napolnjenih injekcijskih brizg 20 x 1 odmerek (0, 5 ml)
50 vials and 50 pre-filled syringes 50 x 1 dose (0.5 ml)
50 vial in 50 napolnjenih injekcijskih brizg 50 x 1 odmerek (0, 5 ml)
1 vial and 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 viala in 1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0, 5 ml)
10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 vial in 10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0, 5 ml)
20 vials and 20 pre-filled syringes + 40 needles 20 x 1 dose (0.5 ml)
20 vial in 20 napolnjenih injekcijskih brizg + 40 igel 20 x 1 odmerek (0, 5 ml)
50 vials and 50 pre-filled syringes + 100 needles 50 x 1 dose (0.5 ml)
50 vial in 50 napolnjenih injekcijskih brizg + 100 igel 50 x 1 odmerek (0, 5 ml)
Read the package leaflet before use Intramuscular use Shake before use
Pred uporabo preberite priloženo navodilo za intramuskularno uporabo Pred uporabo pretresite
EXPIRY DATE
DATUM IZTEKA ROKA UPORABNOSTO ZDRAVILA
MM/ YYYY
Uporabno do:
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Shranjujte v hladilniku Ne zamrzujte Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo
26 Rue de l’ Institut 89 B-1330 Rixensart, Belgium
27 Rue de l’ Institut 89 B- 1330 Rixensart, Belgija
EU/ 1/ 00/ 152/ 001 - 1 vial and 1 pre-filled syringe without needle EU/ 1/ 00/ 152/ 002 - 10 vials and 10 pre-filled syringes without needles EU/ 1/ 00/ 152/ 003 - 20 vials and 20 pre-filled syringes without needles EU/ 1/ 00/ 152/ 004 - 50 vials and 50 pre-filled syringes without needles EU/ 1/ 00/ 152/ 005 - 1 vial and 1 pre-filled syringe with 2 needles EU/ 1/ 00/ 152/ 006 - 10 vials and 10 pre-filled syringes with 20 needles EU/ 1/ 00/ 152/ 007 - 20 vials and 20 pre-filled syringes with 40 needles EU/ 1/ 00/ 152/ 008 - 50 vials and 50 pre-filled syringes with 100 needles
EU/ 1/ 00/ 152/ 001 - 1 viala in 1 napolnjena injekcijska brizga brez igle EU/ 1/ 00/ 152/ 002 - 10 vial in 10 napolnjenih injekcijskih brizg brez igel EU/ 1/ 00/ 152/ 003 - 20 vial in 20 napolnjenih injekcijskih brizg brez igel EU/ 1/ 00/ 152/ 004 - 50 vial in 50 napolnjenih injekcijskih brizg brez igel EU/ 1/ 00/ 152/ 005 - 1 viala in 1 napolnjena injekcijska brizga z 2 iglama EU/ 1/ 00/ 152/ 006 - 10 vial in 10 napolnjenih injekcijskih brizg z 20 iglami EU/ 1/ 00/ 152/ 007 - 20 vial in 20 napolnjenih injekcijskih brizg s 40 iglami EU/ 1/ 00/ 152/ 008 - 50 vial in 50 napolnjenih injekcijskih brizg s 100 iglami
LOT:
Serija:
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 VIALS WITH BIOSET® AND 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 VIALS WITH BIOSET® AND 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 VIALS WITH BIOSET® AND 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 VIALS WITH BIOSET® AND 50 PRE-FILLED SYRINGES WITH 50 NEEDLES 1 VIAL WITH BIOSET® AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS WITH BIOSET® AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
28 PODATKI NA ZUNANJI OVOJNINI 1 VIALA Z BIOSETOM IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 VIAL Z BIOSETOM® IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 20 VIAL Z BIOSETOM® IN 20 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 50 VIAL Z BIOSETOM® IN 50 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 VIALA Z BIOSETOM® IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 IGLO 10 VIAL Z BIOSETOM® IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 20 VIAL Z BIOSETOM® IN 20 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI 50 VIAL Z BIOSETOM® IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 1 VIALA Z BIOSETOM® IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 VIAL Z BIOSETOM®IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI
Infanrix hexa – Powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed)
Infanrix hexa – prašek in suspenzija za suspenzijo za injiciranje Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV), otroški ohromelosti (inaktivirano) (IPV) in hemofilusu tipa b (konjugirano) (Hib)
Diphtheria toxoid1 Tetanus toxoid1 Pertussis antigens
1 odmerek (0, 5 ml) po rekonstituciji: davični toksoid1 tetanusni toksoid1 antigeni bordetele pertusis
Powder and suspension for suspension for injection Vial with Bioset® Cap: powder Pre-filled syringe: suspension 1 vial with bioset® and 1 pre-filled syringe 1 dose (0.5 ml)
prašek in suspenzija za suspenzijo za injiciranje viala z Bioset® zaporko: prašek napolnjena injekcijska brizga: suspenzija 1 viala z biosetom® in 1 napolnjena injekcijska brizga
10 vials with bioset® and 10 pre-filled syringes
29 1 odmerek (0, 5 ml)
28 10 x 1 dose (0.5 ml)
10 vial z biosetom® in 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0, 5 ml)
20 vials with bioset® and 20 pre-filled syringes 20 x 1 dose (0.5 ml)
20 vial z biosetom® in 20 napolnjenih injekcijskih brizg 20 x 1 odmerek (0, 5 ml)
50 vials with bioset® and 50 pre-filled syringes 50 x 1 dose (0.5 ml)
50 vial z biosetom® in 50 napolnjenih injekcijskih brizg 50 x 1 odmerek (0, 5 ml)
1 vial with bioset® and 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
1 viala z biosetom®in 1 napolnjena injekcijska brizga + 1 igla 1 odmerek (0, 5 ml)
10 vials with bioset® and 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 vial z biosetom® in 10 napolnjenih injekcijskih brizg + 10 igel 10 x 1 odmerek (0, 5 ml)
20 vials with bioset® and 20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
20 vial z biosetom® in 20 napolnjenih injekcijskih brizg + 20 igel 20 x 1 odmerek (0, 5 ml)
50 vials with bioset® and 50 pre-filled syringes + 50 needles 50 x 1 dose (0.5 ml)
50 vial z biosetom® in 50 napolnjenih injekcijskih brizg + 50 igel 50 x 1 odmerek (0, 5 ml)
1 vial with bioset® and 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 viala z biosetom® in 1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0, 5 ml)
10 vials with bioset® and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 vial z biosetom® in 10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0, 5 ml)
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
30 Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo