natgillin/translations-raw huggingface dataset:
In order to further investigate the safety and reactogenicity of Pandemic influenza vaccine H5N1 AstraZeneca, the MAH should conduct an open-label single arm interventional study to evaluate the safety and immunogenicity of P/LAIV in children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Za dodatno proučitev varnosti in reaktogenosti Cepiva proti pandemski gripi H5N1 AstraZeneca mora imetnik dovoljenja za promet z zdravilom med naslednjo razglašeno pandemijo opraviti odprto intervencijsko študijo z eno skupino (enim krakom) za oceno varnosti in imunogenosti P/LAIV pri otrocih in mladostnikih, starih od 12 mesecev do manj kot 18 let.
Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine containing four strains), except Pandemic influenza vaccine H5N1 AstraZeneca provides protection against a single influenza strain in an officially declared pandemic.
Cepivo proti pandemski gripi H5N1 AstraZeneca je podobno cepivu Fluenz Tetra (nosnemu cepivu proti gripi, ki vsebuje štiri seve), le da Cepivo proti pandemski gripi H5N1 AstraZeneca ščiti samo pred enim sevom gripe med uradno razglašeno pandemijo.
Vaccine recipients under treatment with influenza antiviral agents should not receive Pandemic influenza vaccine H5N1 AstraZeneca until 48 hours after the cessation of influenza antiviral therapy.
Prejemniki cepiva, ki trenutno prejemajo zdravljenje s protivirusnimi zdravili proti gripi, smejo Cepivo proti pandemski gripi H5N1 AstraZeneca dobiti šele 48 ur po prenehanju protivirusnega zdravljenja proti gripi.
• Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise.
• Otrokom še 4 tedne po cepljenju s Cepivom proti pandemski gripi H5N1 AstraZeneca ne dajajte acetilsalicilne kisline (to je zdravilna učinkovina, ki jo vsebujejo številna zdravila proti bolečinam in zdravila za zniževanje visoke telesne temperature), razen če vam zdravnik, medicinska sestra ali farmacevt naroči drugače.
(See also How Pandemic influenza vaccine H5N1 AstraZeneca is given, in section 3).
(Glej tudi "Kako se daje Cepivo proti pandemski gripi H5N1 AstraZeneca" v 3. poglavju).
Non-clinical data with the Pandemic influenza vaccine H5N1 AstraZeneca, and the seasonal vaccines T/LAIV and Fluenz Tetra reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance, and neurovirulence.
Predklinični podatki za Cepivo proti pandemski gripi H5N1 AstraZeneca ter sezonski cepivi T/LAIV in Fluenz Tetra na osnovi običajnih predkliničnih študij toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja, lokalnega prenašanja in nevrovirulence ne kažejo posebnega tveganja za človeka.
Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible influence on the ability to drive and use machines.
Cepivo proti pandemski gripi H5N1 AstraZeneca nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The virus must infect and replicate in cells lining the nasopharynx of the vaccine recipient in order to induce protective immunity.
Za nastanek zaščitne imunosti mora virus pri prejemniku cepiva okužiti celice sluznice nazofarinksa in se v njih razmnoževati.
Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Pandemic influenza vaccine H5N1
Namestitev nosnika Ko je oseba v pokončnem položaju, namestite konico nekoliko v nosnico, da zagotovite vnos Cepiva proti pandemski gripi H5N1 AstraZeneca v nos.
• nose bleed
• krvavitev iz nosu
• Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible influence on the ability to drive and use machines.
• Cepivo proti pandemski gripi H5N1 AstraZeneca nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Nasal spray, suspension 10 single-use nasal applicators (0.2 ml each)
pršilo za nos, suspenzija 10 nosnikov za enkratno uporabo (vsak 0,2 ml)
If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
Če imate dodatna vprašanja o tem cepivu, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
The antibody response in A/Vietnam/1203/2004 P/LAIV-primed subjects also exceeded that observed after 2 doses of inactivated vaccine in P/LAIV-naïve subjects (see Table 3).
Pri preiskovancih, ki so primarno prejeli P/LAIV A/Vietnam/1203/2004, je odziv protiteles presegel tudi odziv, opažen po 2 odmerkih inaktiviranega cepiva pri preiskovancih, ki prej niso dobili P/LAIV (glejte preglednico 3).
In clinical study CIR 239, the safety, infectivity, and immunogenicity of a live attenuated vaccine derived from A/Hong Kong/213/2003 (H5N1) influenza isolate were evaluated in 17 subjects who received one dose of 10
V klinični študiji CIR 239 so varnost, infektivnost in imunogenost živega oslabljenega cepiva, pridobljenega iz izolata gripe A/Hong Kong/213/2003 (H5N1), ocenili pri 17 preiskovancih, ki so prejeli en odmerek 10
In order to further corroborate the efficacy of Pandemic influenza vaccine H5N1 AstraZeneca, the MAH should conduct an observational effectiveness study in community dwelling children and adolescents from 12 months to less than 18 years of age against laboratory confirmed influenza during the next declared pandemic.
Za dodatno potrditev učinkovitosti Cepiva proti pandemski gripi H5N1 AstraZeneca mora imetnik dovoljenja za promet z zdravilom med naslednjo razglašeno pandemijo opraviti opazovalno študijo učinkovitosti proti laboratorijsko potrjeni gripi med otroki in mladostniki, starimi od 12 mesecev do manj kot 18 let, ki bivajo v domačem okolju.
Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance.
Cepivo proti pandemski gripi H5N1 AstraZeneca je treba uporabljati v skladu z uradnimi smernicami.
In clinical study CIR 217, the safety, infectivity and immunogenicity of a live attenuated vaccine derived from A/Vietnam/1203/2004 (H5N1) influenza isolate were evaluated in 21 subjects who received one 10
V klinični študiji CIR 217 so varnost, infektivnost in imunogenost živega oslabljenega cepiva, pridobljenega iz izolata gripe A/Vietnam/1203/2004 (H5N1), ocenili pri enaindvajsetih preiskovancih, ki so prejeli en 10
Corresponding rates for infants and toddlers 12-23 months of age were 5.4% and 3.6% for T/LAIV and injectable influenza vaccine, respectively.
Ustrezna deleža pri dojenčkih in malčkih v starosti od 12 do 23 mesecev sta bila 5,4 % s T/LAIV in 3,6 % s cepivom proti gripi za injiciranje.
He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.
Presodil bo, ali je Cepivo proti pandemski gripi H5N1 AstraZeneca primerno za vas.
Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent influenza (flu) in an officially declared pandemic.
Cepivo proti pandemski gripi H5N1 AstraZeneca je cepivo za preprečevanje gripe v primeru uradno razglašene pandemije.
Shedding of the H5N1 vaccine virus in adults was extremely limited.
Izločanje virusa H5N1, ki je v cepivu, je bilo pri odraslih zelo majhno.
After 1 or 2 doses of 10 TCID50 vaccine, HAI and IgA seroresponses were each detected in 10% and 52% of subjects and nasal IgA responses were detected in 19% of subjects.
TCID50 cepiva so serološka odziva HAI in IgA ugotovili pri 10 % in 52 % preiskovancev, IgA odziv v nosnem izpirku pa pri 19 % preiskovancev.
There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving the seasonal T/LAIV vaccine in a US-based health insurance claims database.
Evidentirani podatki o 138 nosečnicah, ki so (po podatkovni bazi zdravstvenih zavarovalniških zahtevkov v ZDA) prejele sezonsko cepivo T/LAIV, niso pokazali znakov pomembnih neželenih izidov pri materah.
No data exist regarding the safety of intranasal administration of Pandemic influenza vaccine H5N1 AstraZeneca in children with unrepaired craniofacial malformations.
Podatkov o varnosti intranazalne uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca pri otrocih z nepopravljenimi kraniofacialnimi malformacijami ni.
• Pandemic influenza vaccine H5N1 AstraZeneca is not recommended for breast-feeding women.
• Cepivo proti pandemski gripi H5N1 AstraZeneca ni priporočljivo za ženske, ki dojijo.
A total of 20 subjects (12 T/LAIV, 0.3%; 8 injectable influenza vaccine, 0.2%) were hospitalised in association with medically significant wheezing.
V celoti je bilo zaradi zdravstveno pomembnega piskajočega dihanja v bolnišnico sprejetih 20 preiskovancev (12 (0,3 %) v skupini s T/LAIV in 8 (0,2 %) v skupini s cepivom proti gripi za injiciranje).
In an active-controlled clinical study (MI-CP111) conducted with T/LAIV in comparison to the injectable influenza trivalent vaccine, an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants 6-11 months of age (6.1% T/LAIV versus 2.6% injectable influenza vaccine).
V tej klinični študiji so pri dojenčkih v starosti od 6 do 11 mesecev v obdobju 180 dni po zadnjem odmerku cepiva opažali večji delež sprejemov v bolnišnico (zaradi katerega koli vzroka) (T/LAIV 6,1 %, cepivo proti gripi za injiciranje 2,6 %).
P/LAIV H5N1-primed subjects developed vigorous antibody responses to wild-type H5N1 virus upon subsequent exposure to the inactivated H5N1 vaccine, although such antibody responses were not detectable after the primary 2 doses in the majority of the subjects.
Pri preiskovancih, ki so primarno prejeli P/LAIV H5N1, se je po nadaljnji izpostavljenosti inaktiviranemu cepivu H5N1 razvil intenziven odziv protiteles proti divjemu tipu virusa H5N1, čeprav takšen odziv po primarnih 2 odmerkih pri večini preiskovancev ni bil zaznaven.
In order to define the shelf life of Pandemic influenza vaccine H5N1 AstraZeneca on a strain-specific basis, the MAH should generate strain-specific stability data for the actual pandemic strain.
Za določitev roka uporabnosti za Cepivo proti pandemski gripi H5N1 AstraZeneca specifično glede na seve mora imetnik dovoljenja za promet z zdravilom pripraviti za sev specifične podatke o stabilnosti za dejanski sev pandemije.
In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% T/LAIV versus 3.8% injectable influenza vaccine).
Piskajoče dihanje pri otrocih, mlajših od 24 mesecev V isti študiji so v obdobju 42 dni opažali večji delež piskajočega dihanja pri dojenčkih in malčkih v starosti od 6 do 23 mesecev (T/LAIV 5,9 % in cepivo proti gripi za injiciranje 3,8 %).
Healthcare providers need to assess the benefits and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to these individuals.
Zdravniki morajo oceniti koristi in možna tveganja uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca pri takšnih bolnikih.
After 1 or 2 doses of TCID50 vaccine, haemagglutination inhibition (HAI) and IgA seroresponses were each detected in 10% subjects, and nasal wash IgA responses were detected in 24% subjects.
TCID50 cepiva so vsakega od seroloških odzivov (inhibicijo hemaglutinacije [HAI] in IgA odziv) ugotovili pri 10 % preiskovancev, IgA odziv v nosnem izpirku pa pri 24 % preiskovancev.
It is not known whether Pandemic influenza vaccine H5N1 AstraZeneca is excreted in human milk.
Ni znano, ali se Cepivo proti pandemski gripi H5N1 AstraZeneca pri človeku izloča v materino mleko.
Vaccine recipients should be informed that Pandemic influenza vaccine H5N1 AstraZeneca is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Prejemnikom Cepiva proti pandemski gripi H5N1 AstraZeneca je treba povedati, da je to cepivo z oslabljenim živim virusom, ki se lahko prenese na imunsko oslabele osebe, s katerimi ima prejemnik stik.
The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Druge sestavine so saharoza, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, želatina (svinjska, tip A), argininijev klorid, natrijev glutamat monohidrat in voda za injekcije.
If any of these apply, tell your doctor, nurse or pharmacist before vaccination.
Če karkoli od tega velja za vas, morate pred cepljenjem obvestiti zdravnika, medicinsko sestro ali farmacevta.
Healthcare providers need to assess the benefit and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to pregnant women.
Zdravniki morajo oceniti koristi in možna tveganja uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca pri nosečnicah.
Pandemic influenza vaccine H5N1 AstraZeneca vaccine virus is grown in chicken eggs.
Virus v Cepivu proti pandemski gripi H5N1 AstraZeneca je pridobljen v kokošjih jajcih.
Improved efficacy (95% CI) matched strains
Izboljšana učinkovitost (95 % IZ) ujemajoči se sevi
- If any of the side effects gets serious, talk to your doctor, nurse or pharmacist.
- Če kateri koli neželen učinek postane resen, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
This medicine has been given “conditional approval”.
Cepivo je pridobilo t. i. "pogojno dovoljenje za promet".
Excipients: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Pomožne snovi: saharoza, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, želatina (svinjska, tip A), argininijev klorid, natrijev glutamat monohidrat, voda za injekcije.
The MAH should conduct an observational prospective cohort safety study in a large sample of children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Imetnik dovoljenja za promet z zdravilom mora med naslednjo razglašeno pandemijo opraviti opazovalno prospektivno kohortno študijo z velikim vzorcem otrok in mladostnikov, starih od 12 mesecev do manj kot 18 let.
Check expiry date Product must be used before date on applicator label.
Preverite rok uporabnosti Cepivo uporabite pred datumom navedenim na nalepki nosnika.
Rare (≥ 1/10,000 to < 1/1,000)
Redki (≥ 1/10.000 do < 1/1.000)
What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca
Kaj morate vedeti, preden boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca
• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils as described below.
• Cepivo proti pandemski gripi H5N1 AstraZeneca se daje kot razdeljen odmerek v obe nosnici, kot je opisano spodaj.
Antibody response developed rapidly in P/LAIV H5N1-primed subjects.
Odziv protiteles se je pri preiskovancih, ki so primarno dobili P/LAIV H5N1, razvil hitro.
Similarly from the VAERS, in 113 reports of pregnant women who had received AstraZeneca's (H1N1) 2009 Monovalent Vaccine Live, Intranasal, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Prav tako na podlagi VAERS niso ugotovili neobičajnih vzorcev zapletov med nosečnostjo ali izidov pri plodu v 113 poročilih o nosečnicah, ki so prejele AstraZenecino (H1N1) 2009 monovalentno živo cepivo intranazalno.
HAI responses were not detected in any of the subjects after either the first or second dose of the vaccine.
Ne po prvem ne po drugem odmerku cepiva niso pri nobenem preiskovancu ugotovili odziva HAI.
Reassortant influenza virus (live attenuated) of the following strain:
Reasortirani virus gripe (živ, oslabljen) seva:
Improved efficacy (95% CI) all strains regardless of match
Izboljšana učinkovitost (95 % IZ) vsi sevi, ne glede na ujemanje
T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
V 3 študijah, kontroliranih z aktivno učinkovino, se je T/LAIV izkazalo za superiorno glede na cepivo proti gripi za injiciranje.
Pandemic influenza vaccine H5N1 AstraZeneca Pandemic influenza vaccine
Cepivo proti pandemski gripi H5N1 AstraZeneca cepivo proti pandemski gripi
No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 AstraZeneca on male and female fertility.
O možnih vplivih Cepiva proti pandemski gripi H5N1 AstraZeneca na plodnost moških in žensk ni podatkov.
If any of these apply, tell your doctor, nurse or pharmacist.
Če karkoli od tega velja za vas, morate obvestiti zdravnika, medicinsko sestro ali farmacevta.
median tissue culture infectious dose (TCID50) , with 18 of those subjects receiving a second dose 4-8 weeks later.
median infektivni odmerek tkivne kulture(TCID50); 18 od teh preiskovancev je od
There are no data available on the use of Pandemic influenza vaccine H5N1 AstraZeneca in pregnant women.
Nosečnost Podatkov o uporabi Cepiva proti pandemski gripi H5N1 AstraZeneca pri nosečnicah ni.
What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for
Kaj je Cepivo proti pandemski gripi H5N1 AstraZeneca in za kaj ga uporabljamo
Pandemic influenza vaccine H5N1 AstraZeneca must not be injected.
Cepiva proti pandemski gripi H5N1 AstraZeneca se ne sme injicirati.
How to store Pandemic influenza vaccine H5N1 AstraZeneca Contents of the pack and other information
Shranjevanje Cepiva proti pandemski gripi H5N1 AstraZeneca Vsebina pakiranja in dodatne informacije
Very rare (may affect up to 1 in 1,000,000 people):
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Efficacy (95% CI) matched strains
Učinkovitost (95 % IZ) ujemajoči se sevi
Peak incidence of vaccine virus recovery occurred 1-2 days post-vaccination in clinical studies with Pandemic influenza vaccine H5N1 AstraZeneca.
Največjo pojavnost virusa iz cepiva so v kliničnih študijah s Cepivom proti pandemski gripi H5N1 AstraZeneca ugotovili 1 do 2 dneva po cepljenju.
Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.
Zdravnik, medicinska sestra ali farmacevt bo presodil, ali se cepivo lahko uporabi sočasno z drugimi cepivi.
Efficacy (95% CI) all strains regardless of match
Učinkovitost (95 % IZ) vsi sevi, ne glede na ujemanje
Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca:
Drugi možni neželeni učinki Cepiva proti pandemski gripi H5N1 AstraZeneca so:
Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
6.1 Seznam pomožnih snovi saharoza natrijev dihidrogenfosfat natrijev hidrogenfosfat želatina (svinjska, vrsta A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
Tell your doctor straightaway or seek urgent medical care if you experience any of the effects above.
Če se vam pojavi kateri od zgoraj omenjenih učinkov, morate nemudoma obvestiti zdravnika ali poiskati nujno zdravniško pomoč.
Pandemic influenza vaccine H5N1 AstraZeneca will be given as a spray in each nostril.
Cepivo proti pandemski gripi H5N1 AstraZeneca boste dobili kot pršilo v vsako nosnico.
M = months.
l = let.
Data regarding co-administration of the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) with live attenuated vaccines (measles, mumps, and rubella vaccine (MMR), varicella vaccine, and orally-administered poliovirus) are available and suggest that concomitant admininstration of Pandemic influenza vaccine H5N1 AstraZeneca with these live vaccines may be acceptable.
Na voljo so podatki o sočasni uporabi sezonskega trivalentnega živega cepiva proti gripi intranazalno (T/LAIV) z živimi oslabljenimi cepivi (proti ošpicam, mumpsu in rdečkam (MMR), cepivom proti noricam in peroralnim s poliovirusom).
General disorders and administration site conditions Very common: Malaise
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: splošno slabo počutje Pogosti: zvišana telesna temperatura
Antibody responses in P/LAIV H5N1-primed subjects were also broader.
Širši je bil tudi odziv protiteles pri preiskovancih, ki so primarno dobili P/LAIV H5N1.
• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils.
• Cepivo proti pandemski gripi H5N1 AstraZeneca se aplicira kot razdeljen odmerek v obe nosnici.
• runny or stuffy nose
• izcedek iz nosu ali zamašen nos
D153-P514 Europe 6 to 71 M 2,085 2002-2003
6 do 71 m 2.085 2002-2003
Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils.
Cepivo proti pandemski gripi H5N1 AstraZeneca se daje kot razdeljen odmerek v obe nosnici.
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Cepivo proti pandemski gripi H5N1 AstraZeneca, pršilo za nos, suspenzija cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno)
Pandemic influenza vaccine H5N1 AstraZeneca must only be used as a nasal spray.
Cepivo proti pandemski gripi H5N1 AstraZeneca se sme uporabljati le kot pršilo za nos.
Pandemic influenza vaccine H5N1 AstraZeneca is for nasal use only.
Cepivo proti pandemski gripi H5N1 AstraZeneca je le za nazalno uporabo.
Pandemic influenza vaccine H5N1 AstraZeneca IS FOR NASAL USE ONLY.
Cepivo proti pandemski gripi H5N1 AstraZeneca JE SAMO ZA NAZALNO UPORABO.
Twenty-one additional subjects received one dose of the vaccine virus at TCID50, with 19 of those subjects receiving a second dose 4-8 weeks later.
TCID50; 19 od teh preiskovancev je od 4 do 8 tednov pozneje prejelo drugi odmerek.
You should not be given Pandemic influenza vaccine H5N1 AstraZeneca:
Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete dobiti:
What Pandemic influenza vaccine H5N1 AstraZeneca looks like and contents of the pack
Izgled Cepiva proti pandemski gripi H5N1 AstraZeneca in vsebina pakiranja
Figure 1 Pandemic influenza vaccine H5N1 AstraZeneca Administration
Slika 1 Uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (live attenuated, nasal)
Cepivo proti pandemski gripi H5N1 AstraZeneca pršilo za nos, suspenzija cepivo proti pandemski gripi (živo, oslabljeno, nazalno)
Do not inject Pandemic influenza vaccine H5N1 AstraZeneca.
Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete injicirati.
Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Oznaka ATC: J07BB03
• Refer to the Pandemic influenza vaccine H5N1 AstraZeneca administration diagram (Figure 1) for step-by-step administration instructions.
• Za navodila za uporabo po korakih glejte diagram uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca (slika 1).
How to store Pandemic influenza vaccine H5N1 AstraZeneca
Kako deluje Cepivo proti pandemski gripi H5N1 AstraZeneca
What Pandemic influenza vaccine H5N1 AstraZeneca contains
Kaj vsebuje Cepivo proti pandemski gripi H5N1 AstraZeneca
How Pandemic influenza vaccine H5N1 AstraZeneca is given
Kako se daje Cepivo proti pandemski gripi H5N1 AstraZeneca
You can breathe normally while you are given Pandemic influenza vaccine H5N1 AstraZeneca.
Medtem, ko boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca, lahko normalno dihate.
The referral procedure started on 29 April 2005.
Napotitveni postopek se je pričel 29. aprila 2005.
On 23 march 2005, Fujisawa
23. marca 2005 je podjetje Fujisawa
A Decision was issued by the European Commission on 10/04/06.
Evropska komisija je odločbo izdala dne 10/04/2006.
Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors.
Takrolimus je makrolidni imunosupresiv, ki spada v farmakološki razred zaviralcev kalcinevrina.
The CHMP gave a positive opinion on 26 January 2006 recommending the harmonisation of the SPC for Prograf and associated names.
CHMP je podal pozitivno mnenje 26. januarja 2006 in s tem priporočil uskladitev SPC za Prograf in z njim povezana imena.
GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion)
GmbH v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I Mnenja)