natgillin/translations-raw huggingface dataset:
• If you are hypersensitive (allergic) to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds, • If you are pregnant, • If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
• če ste preobčutljivi za (alergični) na etilen- diamin- tetrametilen- fosfonsko kislino (EDTMP) ali fosfonatom podobne sestavine, • če ste noseči, • če ste se v zadnjih 6 tednih zdravili s kemoterapijo ali zunanjim obsevanjem polovice telesa.
Take special care with QUADRAMET:
Bodite posebno pozorni pri uporabi zdravila QUADRAMET:
QUADRAMET is not recommended for use in children below 18 years of age.
Uporaba zdravila QUADRAMET pri otrocih pod 18 let ni priporočljiva.
During 6 hours following the injection of QUADRAMET, your physician will encourage you to drink and void as often as possible.
V šestih urah po injekciji QUADRAMETa vam bo zdravnik svetoval, da kar se da veliko pijete in pogosto odvajajte vodo.
18 In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours.
V primeru urinske inkontinence ali urinske zapore vam bodo za 6 ur vstavili urinski kateter.
If your renal function is decreased, the amount of product will be adapted.
18 Če je zmogljivost vaših ledvic zmanjšana, bodo temu primerno prilagodili količino zdravila.
QUADRAMET must not be administered to pregnant women.
QUADRAMET se ne sme dajati nosečnicam.
If QUADRAMET administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Če je uporaba zdravila QUADRAMET pri ženskah v obdobju dojenja nujna, je treba z dojenjem prenehati.
HOW TO TAKE QUADRAMET
KAKO JEMATI ZDRAVILO QUADRAMET
Your doctor will want to carry out a special scan before administering QUADRAMET to ascertain whether you are likely to benefit from QUADRAMET.
Preden vam bo dal QUADRAMET, bo vaš zdravnik želel opraviti posebno slikanje, da ugotovi, če vam zdravljenje s QUADRAMETom lahko koristi.
One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of QUADRAMET per kilogram of body weight is to be injected.
Injicira se enkratni odmerek 37 MBq (Becquerel je enota za merjenje radioaktivnosti) QUADRAMETa na kilogram telesne mase.
If you have the impression that the effect of QUADRAMET is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila QUADRAMET premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Method and route of administration
Način uporabe in vrsta aplikacije
QUADRAMET is to be administered by slow injection into a vein.
QUADRAMET se injicira počasi v veno.
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following QUADRAMET injection).
Oddelek za nuklearno medicino vam bo dovoljeno zapustiti po opravljeni kontroli sevanja (običajno v 6 urah po prejemu injekcije QUADRAMETa).
If you take more QUADRAMET than you should
Če ste uporabili večji odmerek zdravila QUADRAMET, kot bi smeli
QUADRAMET being supplied as a single-dose vial, an accidental overdose is unlikely to occur.
Glede na to, da je QUADRAMET na razpolago v enoodmernih vialah, naključno preveliko odmerjanje ni verjetno.
Like all medicines, QUADRAMET can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo QUADRAMET neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The undesirable effects due to QUADRAMET administration are linked with a decrease of red and white blood cells, and platelets.
Neželeni učinki pri uporabi QUADRAMETa so povezani z zmanjšanjem števila rdečih in belih krvnih telesc ter trombocitov.
This is the reason why your blood counts will be monitored strictly for a few weeks following QUADRAMET injection.
To je tudi razlog, zakaj bodo nekaj tednov po injekciji QUADRAMETa skrbno spremljali vašo krvno sliko.
You may exceptionally feel a slight increase in bone pain a few days after QUADRAMET injection.
Izjemoma se lahko zgodi, da boste nekaj dni po injekciji QUADRAMETa občutili močnejše bolečine v kosteh.
HOW TO STORE QUADRAMET
SHRANJEVANJE ZDRAVILA QUADRAMET
Do not use QUADRAMET after the expiry date which is stated on the label.
Zdravila QUADRAMET ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
QUADRAMET expires 1 day from the activity reference time stated on the label.
Zdravilu QUADRAMET izteče rok uporabnosti 1 dan po referenčnem datumu za aktivnost, ki je naveden na ovojnini.
Store at – 10°C to – 20°C in a freezer in its original packaging.
Shranjujte v zamrzovalniku pri temperaturi – 10 °C do – 20 °C v originalni ovojnini.
QUADRAMET should be used within 6 hours of thawing.
QUADRAMET je treba uporabiti v 6 urah po odmrznjenju.
What QUADRAMET contains The active substance is samarium [153Sm] lexidronam pentasodium.
Zdravilna učinkovina je [153Sm] samarij- leksidronam, pentanatrijeva sol.
Each ml of solution contains 1.3 GBq Samarium [153Sm] lexidronam pentasodium at the reference date (corresponding to 20-46 µg/ ml of samarium per vial).
En ml raztopine vsebuje 1, 3 GBq [153Sm] samarij- leksidronam, pentanatrijeve soli, na referenčni datum (ustreza 20 – 46 µg/ ml samarija na vialo)
The other ingredients are Total EDTMP (as EDTMP. H2O), calcium-EDTMP sodium salt (as Ca),
Pomožne snovi so skupni EDTMP (v obliki EDTMP. H2O), kalcij- EDTMP natrijeva sol (v obliki Ca), skupni natrij (kot Na), voda za injekcije
What QUADRAMET looks like and contents of the pack QUADRAMET is a solution for injection.
Izgled zdravila QUADRAMET in vsebina pakiranja QUADRAMET je raztopina za injiciranje.
This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/ natural rubber stopper and aluminium flip-off overseal.
Zdravilo je bistra, brezbarvna do svetlo jantarna raztopina, ki je v 15- ml brezbarvni viali iz stekla tipa I po Evropski farmakopeji, zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz naravne gume in aluminijasto zaščitno zaporko.
Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Ena viala vsebuje 1, 5 ml (2 GBq na referenčni datum) do 3, 1 ml (4 GBq na referenčni datum) raztopine za injiciranje.
CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette cedex France
CIS bio international Boîte Postale 32 F- 91192 Gif- sur- Yvette cedex Francija
The leaflet was last approved on ().
Navodilo je bilo odobreno ().
For detailed information refer to the Summary of Product Characteristics of QUADRAMET.
Podrobne podatke najdete v Povzetku glavnih značilnosti zdravila QUADRAMET.
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
NAVODILA ZA UPORABO, ROKOVANJE IN ODLAGANJE
Read directions for use thoroughly before starting the preparation procedure.
Preden se lotite postopka priprave, skrbno preberite navodila.
All procedures should be conducted using aseptic techniques and standard precautions for handling radionuclides.
Pri vseh postopkih morate uporabljati aseptične postopke in upoštevati standardne previdnostne ukrepe za rokovanje z radioizotopi.
Radiopharmaceuticals should only be used by qualified personnel with the appropriate government authorisation for the use and handling of radionuclides.
Radiofarmake sme uporabljati le strokovno usposobljeno osebje z ustreznim pooblastilom vladne ustanove za uporabo in rokovanje z radioizotopi.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Prejemanje, uporaba in dajanje radiofarmakov lahko poteka le v določenih kliničnih ustanovah, poseg pa smejo izvajati le za to pooblaščene osebe.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licences of the local competent official organisations.
Prevzem, shranjevanje, uporaba, premeščanje in odlaganje radiofarmakov mora potekati v skladu s predpisi in ustreznimi dovoljenji odgovornih lokalnih uradnih organizacij.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical requirements.
21 Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji kot tudi farmacevtske zahteve.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Upoštevati mora ustrezne previdnostne ukrepe za zagotavljanje aseptičnosti, ki so v skladu z Dobro proizvodno prakso za zdravila.
21 The activity should be measured by a dose calibrator immediately before administration.
Radioaktivnost morate izmeriti z radionuklidnim kalibratorjem neposredno pred aplikacijo.
Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.
Pred aplikacijo QUADRAMETa morate verificirati odmerek in identificirati bolnika.
Usual precautions regarding sterility and radioprotection should be respected.
Upoštevati morate ustaljene previdnostne ukrepe glede sterilnosti in zaščite pred sevanjem.
He will be released when exposure rates comply with the limits prescribed by the regulations in force.
Bolnik/ bolnica bo odpuščen/ a, ko bo stopnja sevanja v mejah, ki jih predpisuje veljavna zakonodaja.
Radioactive waste must be disposed of in conformity with the relevant national and international regulations.
Radioaktivne odpadke je treba odlagati v skladu z veljavnimi nacionalnimi in mednarodnimi predpisi.
tho This document is a summary of the European Public Assessment Report (EPAR).
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi
au reach their recommendations on how to use the medicine.
za katerih je oblikoval priporočila glede uporabe zdravila.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
nja želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
What is Quintanrix? ge lon Quintanrix is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
lje Kaj je zdravilo Quintanrix?
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and polysaccharides (sugars) from the bacterium no
Zdravilo Quintanrix je cepivo, ki je na voljo kot prašek in suspenzija, iz katerih se pripravi suspenzija za injiciranje.
Haemophilus influenzae type b (‘ Hib’, a bacterium that causes meningitis).
Cepivo vsebuje naslednje zdravilne učinkovine: toksoida (kemijsko oslabljena toksina) vo iz bakterij, ki povzročata davico in tetanus, inaktivirano (uničeno) bakterijo Bordetella pertussis (bakterijo, ki povzroča oslovski kašelj), dele virusa hepatitisa B in polisaharide (sladkorje) iz bakterije Haemophilus influenzae tipa b („ Hib “, bakterije, ki povzroča meningitis). do
Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis t
Cepivo Quintanrix se uporablja za cepljenje otrok, mlajših od enega leta, proti davici, tetanusu, eā
It uc
oslovskemu kašlju, hepatitisu B in „ invazivnim “ boleznim, ki jih povzroča Hib (kot je bakterijski meningitis).
is also used as a booster immunisation of young children during the second year of life.
Uporablja se tudi za obnovitveno cepljenje otrok med drugim letom življenja.
The medicine can only be obtained with a prescription. rod
Cepivo se dobi samo na recept. av
The recommended vaccination schedule for Quintanrix is three doses, given at intervals of at least four weeks within the first six months of life.
Priporočena shema cepljenja za cepivo Quintanrix je sestavljena iz treh odmerkov, ki se jih daje v nim
vaccine is given by deep injection into a muscle, preferably the thigh.
Cepivo se daje z globokim injiciranjem v mišico, najboljše v stegno.
Quintanrix can also be used to boost previous vaccinations against diphtheria, tetanus and na
Cepivo Quintanrix se lahko uporablja za obnovitev odziva na ilo
pertussis, against hepatitis B or against Hib, when it should be given at least six months after the last dose of the first vaccination course.
V tem primeru se mora uporabiti najmanj šest mesecev po zadnjem odmerku osnovnega cepljenja.
Quintanrix can be given to children who received a hepatitis B vaccine at birth. i dic
Cepivo Quintanrix se lahko daje otrokom, ki so prejeli cepivo proti hepatitisu B ob rojstvu. rav
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „ naučijo “ obrambe pred boleznimi.
• toxoids from the bacteria that cause diphtheria and tetanus; • killed whole B. pertussis; • polysaccharides extracted from the ‘ capsules’ that surround the bacterium Hib - the polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine; 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
• toksoidov iz bakterij, ki povzročata davico in tetanus, • uničene cele bakterije B. pertussis, • polisaharide iz kapsule, ki obdaja bakterijo Hib - polisaharidi so kemijsko vezani (konjugirani) na tetanusni toksoid, ki deluje kot nosilna beljakovina, saj to izboljša odziv na cepivo, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. • ‘ surface antigen’ (proteins from the surface) of the hepatitis B virus.
Reproduction is authorised provided the source is acknowledged. • „ površinski antigen “ (beljakovino površine) virusa hepatitisa B.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Ko otroka cepimo, imunski sistem prepozna dele bakterij in virusa kot „ tuje “ in izdela protitelesa, usmerjena proti njim.
This means that the active substances are fixed on aluminium compounds,
t znano kot „ tehnologija rekombinantne DNK “, pri kateri kvasovka prejme gen (DNK), s katerim lahko
ed to stimulate a better immune response.
me tvori beljakovine.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Zdravilne učinkovine v cepivu Quintanrix so bile na voljo v Evropski uniji (EU) že več let v drugih cepivih: učinkovine proti davici, tetanusu, oslovskemu kašlju in hepatitisu B so bile na voljo v cepivu
ris The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
Te zdravilne učinkovine so bile še pred tem na voljo tudi v drugih cepivih.
The
Tudi sestavina proti Hib je bila na voljo v drugih cepivih.
tho Hib component has also been available in other vaccines.
Kako je bilo zdravilo Quintanrix raziskano?
How has Quintanrix been studied?
Učinke cepiva Quintanrix so preučevali v petih glavnih študijah, v katere je bilo vključenih več kot
au The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
V treh študijah so učinke cepiva Quintanrix primerjali z učinki kombinacije cepiva Tritanrix HepB in cepiva proti Hib.
In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months
V četrti študiji so primerjali učinke cepiva Quintanrix, uporabljenega pri
The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318
nja šestih, 10 in 14 tednih starosti pri 318 dojenčkih, ki so prejeli cepivo proti hepatitisu B ob rojstvu ali pa ne.
In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after lon the final vaccination.
V vseh študijah je bilo glavno merilo učinkovitosti nastanek lje zaščitnih ravni protiteles po opravljenem končnem cepljenju.
Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Kakšne koristi je zdravilo Quintanrix izkazalo med študijami? vo Cepivo Quintanrix je enako učinkovito spodbudilo nastanek zaščitnih ravni protiteles kot ločeni cepivi.
Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, no
Predhodno cepljenje do
There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
proti hepatitisu B ni vplivalo na učinkovitost cepiva Quintanrix.
The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after t uc
Študija obnovitvenega cepljenja je pokazala, da je cepivo Quintanrix enako učinkovito kot dve ločeni cepivi, saj je imelo 42 dni po obnovitvenem cepljenju od 92 do 100% otrok zaščitne ravni protiteles. eā
What is the risk associated with Quintanrix? rod
Kakšna tveganja so povezana z zdravilom Quintanrix?
The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
Najpogostejši neželeni učinki cepiva Quintanrix (opaženi pri več kot 1 od 10 odmerkov cepiva) so razdražljivost, zaspanost, izguba apetita, bolečine, pordelost, otekanje in zvišana telesna temperatura. av
Quintanrix should not be used in people who may be hypersensitive (allergic) to any of the active lP
Cepiva Quintanrix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine ali katerokoli drugo sestavino cepiva.
It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
encefalopatijo (bolezen možganov) neznanega vzroka v sedmih dneh po prejšnjem cepljenju s cepivom proti oslovskemu kašlju.
Quintanrix should be postponed in people with a severe sudden fever. na
Cepljenje s cepivom Quintanrix je treba odložiti pri osebah s hudo, nenadno zvišano telesno temperaturo.
Their breathing should be monitored for up to three days after vaccination. i dic
Pri teh otrocih je treba dihanje spremljati ilo
Why has Quintanrix been approved?
Zakaj je bilo zdravilo Quintanrix odobreno? rav
The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix’ s benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster Me
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Quintanrix večje od z njim povezanih tveganj primarnega cepljenja dojenčkov (med prvim letom starosti) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivni bolezni, ki jo povzroči Hib, in tveganj Zd
immunisation of young children during the second year of life.
obnovitvenega cepljenja majhnih otrok med drugim letom starosti.
The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s. a. on 21 October 2004.
Evropska komisija je dovoljenje za promet s cepivom Quintanrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 21. oktobra 2004.
2/ 3 The full EPAR for Quintanrix can be found here.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Quintanrix je na voljo tukaj.
ed ris tho aur ge lon
t me pro za nja lje vo do eā av nim ilo rav Zd
EU number
et om EU številka
Invented namStrength Pharmaceutical
Izmišljeno ime Jakost
Route of
Farmacevtska oblika
Packaging
Način uporabe zdravila
Form
Vsebina
EU/ 1/ 4/ 301/ 001
r EU/ 1/ 4/ 301/ 001
th
Prašek in
suspension for
Intramuskularno
(glass);
prašek: viala (steklo)
1
1 viala + 1 viala
suspension: vial (glass)
p suspenzija: viala suspenzija za (steklo) suspenzijo za
r EU/ 1/ 4/ 301/ 002
za injiciranje -- 1 EU/ 1/ 4/ 301/ 002
Powder and
Prašek in
ge
ja
suspension for suspension for
suspenzija za
(glass); suspension: vial
suspenzija: viala
n
en
injection
suspenzijo za injiciranje
lo EU/ 1/ 4/ 301/ 003
lj -- 1 EU/ 1/ 4/ 301/ 003
Powder and suspension for
Prašek in
powder: vial (glass);
prašek: viala (steklo)
o
vo
suspension: vial
suspenzija za suspenzijo za
(glass)
suspenzija: viala (steklo)
EU/ 1/ 4/ 301/ 004
do injiciranje EU/ 1/ 4/ 301/ 004
Powder and
Prašek in suspenzija za
powder: vial
prašek: viala (steklo) suspenzija: viala
(glass); suspension: vial
ā (steklo) suspenzijo za
injection
e injiciranje
r EU/ 1/ 4/ 301/ 005
v -- 1 EU/ 1/ 4/ 301/ 005
(glass); suspension: vial
a suspenzija: viala suspenzija za (steklo) suspenzijo za
injection
im injiciranje
--1 ic in 1 dose (0.5 ml) contains:
n o il -- 1 1 odmerek (0, 5 ml) vsebuje:
≥ 30 IU ≥ 60 IU
v ≥ 30 mednarodnih enot; Davični toksoid *
M Inactivated Bordetella pertussis strain**
ra ≥ 60 mednarodnih enot; Tetanusni toksoid * ≥ 4 mednarodne enote; Inakivirana bakterija Bordetella pertussis **
10 micrograms
d Rekombinantni površinski antigen virusa hepatitisa B ** (S protein) *** 10 mikrogramov
1/ 2 ed Haemophilus influenzae type b polysaccharide
Z Polisaharid bakterije Haemophilus influenzae tipa b (poliribozilribitol fosfat) 2
is (polyribosylribitol phosphate) 2
1/ 2 et konjugiran na tetanusni toksoid kot nosilec
5-10 micrograms
5 – 10 mikrogramov
* adsorbed on aluminium hydroxide hydrated Total:
om adsorbiran na aluminijev hidroksid Skupno:
0.26 milligrams Al3+
0. 26 milligrama Al3+ *
th ** adsorbed on aluminium phosphate Total:
r Skupno:
0.40 milligrams Al3+
0, 40 milligrama Al3+ ** adsorbiran na aluminijev fosfat
au *** produced in Saccharomyces cerevisiae cells by recombinant DNA technology
p 3 *** pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae
r n ge o lo tn uc r od a lP ic in M ed 2/ 2
za a nj lje vo do ā e v a im n o il v ra d Z 2/ 2
ed ris tho r au ANNEX Ige lon SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
t me pro za nja lje DODATEK I vo POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA do eā av nim ilo rav Zd
ed 2.
t me 2.
ris After reconstitution, 1 dose (0.5 ml) contains:
pro Po rekonstituciji cepiva 1 odmerek (0, 5 ml) vsebuje:
tho Diphtheria toxoid1 Tetanus toxoid1 Inactivated Bordetella pertussis 2 Hepatitis B surface antigen (rDNA) 2, 3
Davični toksoid1 Tetanusni toksoid1 Inaktivirana bakterija Bordetella pertussis2
not less than 30 International Units not less than 60 International Units not less than 4 International Units 10 micrograms
ne manj kot 30 mednarodnih enot ne manj kot 60 mednarodnih enot ne manj kot 4 mednarodne enote
au Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
(poliribozilribitol- fosfat) 2
2.5 micrograms
2, 5 mikrograma
conjugated to tetanus toxoid as a carrier
konjugiran na tetanusni toksoid kot nosilec
5-10 micrograms
– 10 mikrogramov
r 1 Total:
nja 1 Skupno:
0.40 milligrams Al3+
0, 26 miligrama Al 3+ adsorbiran na aluminijev hidroksid 2 Skupno:
produced in Saccharomyces cerevisae cells by recombinant DNA technology lon For excipients, see section 6.1.
0, 40 miligrama Al 3+ adsorbiran na aluminijev fosfat 3 pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae lje Za pomožne snovi glejte poglavje 6. 1. vo
PHARMACEUTICAL FORM no
FARMACEVTSKA OBLIKA do