FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back.
Slovenian: Če ste prenehali uporabljati zdravilo Cosentyx Če prenehate uporabljati zdravilo Cosentyx, to ne predstavlja nobene nevarnosti, vendar se v tem primeru lahko ponovno pojavijo simptomi psoriaze, psoriatičnega artritisa ali ankilozirajočega spondilitisa.
English: Cosentyx 150 mg powder for solution for injection secukinumab
Slovenian: Cosentyx 150 mg prašek za raztopino za injiciranje sekukinumab
English: Patients randomised to placebo who were non-responders at week 16 (early rescue) and all other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously), followed by the same dose every month.
Slovenian: Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), vsi drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
English: Patients randomised to receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month.
Slovenian: Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih je prišlo do odziva do tedna 16, so prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
English: ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
Slovenian: hsCRP (razmerje med kasnejšo in izhodiščno vrednostjo)
English: Patients randomised to placebo who were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose every month.
Slovenian: Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
English: During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg and 74.3% and 57.4% for 300 mg at week 52, respectively.
Slovenian: V obdobju slepega zdravljenja je do 52. tedna v skupini z odmerkom 150 mg odziv ASAS 20 doseglo 69,7 % in odziv ASAS 40 47,6 % bolnikov, v skupini z odmerkom 300 mg pa je odziv ASAS 20 doseglo 74,3 % in odziv ASAS 40 57,4 % bolnikov.
English: CARTON OF UNIT PACK - pre-filled syringe
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjena injekcijska brizga
English: Each pre-filled syringe contains 150 mg secukinumab.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 150 mg sekukinumaba.
English: • Talk to your doctor if you are breast-feeding or are planning to breast-feed.
Slovenian: • Če dojite ali nameravate začeti z dojenjem, se pogovorite s svojim zdravnikom.
English: One pre-filled pen contains 150 mg secukinumab in 1 ml of solution.
Slovenian: En napolnjen injekcijski peresnik vsebuje 150 mg sekukinumaba v 1 ml raztopine.
English: All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all endpoints at week 16.
Slovenian: * p<0,05, ** p<0,01, *** p<0,001; v primerjavi s placebom V PsA študiji 2 so za teden 24 vse vrednosti p prilagojene na večkratnost testiranja po vnaprej opredeljenem hierarhičnem redu, razen vrednosti p za odziv ACR 70, daktilitis in entezitis, ki so bile raziskovalni cilji študije, in vsi cilji študije za teden 16.
English: Finger grips
Slovenian: Gibljivost hrbtenice
English: Pack containing 2 pre-filled pens
Slovenian: Pakiranje vsebuje 2 napolnjena injekcijska peresnika.
English: ASAS partial remission, %
Slovenian: delna remisija po kriterijih ASAS, % 4,1
English: Each vial of powder contains 150 mg secukinumab.
Slovenian: Ena viala s praškom vsebuje 150 mg sekukinumaba.
English: Based on your response, your doctor may increase your dose to 300 mg.
Slovenian: Na osnovi vašega odziva vam bo zdravnik morda odmerek zvišal na 300 mg Ankilozirajoči spondilitis
English: Patients randomised to receive placebo who were non-responders at week 16 (early rescue) were then crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 16 followed by the same dose every month.
Slovenian: Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so po 16 tednih (zgodnje reševanje) prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano), nato pa so enak odmerek prejemali vsak mesec.
English: Your Cosentyx SensoReady pen:
Slovenian: Injekcijski peresnik SensoReady z zdravilom Cosentyx:
English: Cosentyx 150 mg solution for injection in pre-filled syringe secukinumab
Slovenian: Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab
English: Table 7 Clinical response in AS study 2 at week 16
Slovenian: Preglednica 7 Klinični odziv v AS študiji 2 po 16 tednih izid (vrednost p za primerjavo z uporabo placeba)
English: CARTON OF UNIT PACK - pre-filled pen
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjen injekcijski peresnik
English: Cosentyx 150 mg solution for injection in pre-filled syringe
Slovenian: Cosentyx 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Cosentyx is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Slovenian: Zdravilo Cosentyx je na voljo v posamičnem pakiranjih, ki vsebujejo 1 ali 2 napolnjeni injekcijski brizgi in v skupnem pakiranju, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
English: PASI 50 response n (%) 5 (8.2%) 48
Slovenian: odziv ACR 50 n (%) teden 16
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Slovenian: Napolnjeni injekcijski brizgi shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Store the syringes in the original package in order to protect from light.
Slovenian: Injekcijske brizge shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: PASI 90 response n (%) 3 (1.2%) 95
Slovenian: odziv PASI 90 n (%) teden 16
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled pen
Slovenian: ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU) - napolnjen injekcijski peresnik
English: Storage of the Cosentyx pre-filled syringe
Slovenian: Napolnjena injekcijska brizga z zdravilom Cosentyx
English: BLISTER OF PRE-FILLED SYRINGE
Slovenian: PRETISNI OMOT NAPOLNJENE INJEKCIJSKE BRIZGE
English: Cosentyx 150 mg solution for injection in pre-filled pen secukinumab
Slovenian: Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab s.c.
English: Histidine
Slovenian: Cosentyx;
English: Cosentyx 150 mg solution for injection in pre-filled pen
Slovenian: Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Slovenian: To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, ki jo imenujemo interlevkin-17A (IL-17A).
English: 4.8 Undesirable effects a. Summary of the safety profile
Slovenian: 4.8 Neželeni učinki a. povzetek varnostnega profila
English: Data were as follows (values in brackets show the 95% confidence intervals):
Slovenian: Pridobili so naslednje podatke (vrednosti v oklepajih kažejo 95 % intervale zaupanja):
English: Date of latest renewal: 24 February 2014
Slovenian: Datum zadnjega podaljšanja: 24. februar 2014
English: - Headache and muscular pain.
Slovenian: - Glavobol in bolečine v mišicah.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 February 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24. februar 2009
English: Pack size of 1 or 10 or 20.
Slovenian: Velikost pakiranja je 1 ali 10 ali 20.
English: The use of IDflu should be based on official recommendations.
Slovenian: Uporaba cepiva IDflu mora temeljiti na uradnih priporočilih.
English: • Any of the other ingredients of this vaccine (listed in section 6),
Slovenian: • katerokoli sestavino tega cepiva (navedeno v poglavju 6)
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for
Slovenian: Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in Odločbi EU za
English: The vein test is unnecessary.
Slovenian: Venski test ni potreben.
English: Micro-Injection System
Slovenian: Sistem za mikroinjiciranje
English: Genotoxicity and carcinogenic potential were not assessed because these studies are not appropriate for a vaccine.
Slovenian: Potenciala genotoksičnosti in karcinogenosti niso ocenili, saj te študije za cepivo niso primerne.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Pred cepljenjem natančno in v celoti preberite to navodilo, ker vsebuje za vas pomembne podatke.
English: • Risk Management Plan (RMP)
Slovenian: ZDRAVILA • Načrt zaobvladovanje tveganja (RMP)
English: You should see your doctor immediately if you experience symptoms of angioedema, such as:
Slovenian: Nemudoma poiščite zdravniško pomoč, če občutite simptome angioedema kot npr.:
English: Non-clinical data revealed no special hazard for humans based on animal studies.
Slovenian: Neklinični podatki niso pokazali posebnih nevarnosti za ljudi na podlagi študij na živalih.
English: * propagated in fertilised hens' eggs from healthy chicken flocks
Slovenian: * razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat
English: Hold the system by placing the thumb and middle finger only on the finger pads; the index finger remains free.
Slovenian: Sistem držite tako, da ga nastavite med palec in sredinec samo na blazinice za prste; kazalec ostane prost.
English: • Whenever the risk management system is modified, especially as the result of new information is received that may lead to a significant change to benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Please read the instructions before use
Slovenian: Pred uporabo preberite navodila
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega
English: B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 N = 2,586
Slovenian: B A/New Caledonia/20/99 A/Wisconsin/67/2005 B/Malaysia/2506/2004
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Slovenian: Prehodno lažne pozitivne reakcije so lahko posledica proizvajanja IgM kot odziv na cepivo.
English: Nevertheless, single and repeated administrations led to transient local erythema and oedema.
Slovenian: Vendar pa je enkratno in večkratno dajanje povzročilo prehodni lokali eritem in edem.
English: - Feeling generally unwell, fever (38.0°C or higher) and shivering.
Slovenian: - Splošno počutje nelagodja, povišana telesna temperatura (38,0°C ali več) in tresenje.
English: Full effect of the vaccine is generally achieved 2-3 weeks after the
Slovenian: Popolni učinek cepiva je običajno dosežen v 2 do 3 tednih po cepljenju.
English: The vaccine is a colourless and opalescent suspension.
Slovenian: Cepivo je brezbarvna in motna suspenzija.
English: The vaccine was immunogenic in mice and rabbits.
Slovenian: Cepivo je bilo imunogeno pri miših in kuncih.
English: Most of side effects listed above disappeared without treatment within 1 to 3 days after onset.
Slovenian: Večina zgoraj naštetih neželenih učinkov izzveni brez zdravljenja v 1 do 3 dni.
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2ºC - 8ºC).
English: Most reactions resolved spontaneously within 1 to 3 days after onset.
Slovenian: Večina reakcij je spontano izzvenela v 1 do 3 dneh po nastanku.
English: Children and adolescents IDflu is not recommended for use in children and adolescents below 18 years.
Slovenian: Cepivo IDflu ni priporočeno za uporabo pri otrocih in mladostnikih pod 18 let.
English: - If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor.
Slovenian: - Če morate v dneh po cepljenju proti gripi opraviti krvni test o tem obvestite svojega zdravnika.
English: Immediately dispose of the system in the nearest sharps collector.
Slovenian: Nemudoma odstranite sistem v najbližji koš za ostre predmete.
English: Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials).
Slovenian: Ocena varnosti se je izvajala za vse osebe v prvih 3 tednih po cepljenju, resne neželene reakcije pa so se beležili v šestmesečnem obdobju spremljanja pri 2974 osebah (udeleženih v dveh od treh kliničnih preskušanj).
English: Finger pads
Slovenian: Prstne blazinice
English: Do not place fingers on the windows.
Slovenian: Pazite, da okenc ne zakrijete s prsti.
English: What you need to know before you use IDflu
Slovenian: Kaj morate vedeti, preden boste uporabili cepivo IDflu
English: In the absence of compatibility studies, this medicinal product must not be mixed with other
Slovenian: Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
English: Paresthesia, neuritis
Slovenian: Parestezija, neuritis Pruritus,
English: After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Slovenian: Po ponovnem vsakoletnem cepljenju je bil profil varnosti cepiva IDflu podoben prejšnjim injekcijam.
English: Immunisation should be carried out on separate limbs.
Slovenian: Imunizacijo je potrebno opraviti na ločenih okončinah.
English: - This vaccine should under no circumstances be administered into a vein (intravascularly).
Slovenian: - To cepivo se pod nobenim pogojem ne sme dajati v žilo (intravaskularno).
English: Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported:
Slovenian: Na podlagi izkušenj s trivalentnimi inaktiviranimi cepivi proti gripi, ki se dajejo v obliki intramuskularne ali globoke subkutane injekcije, bi lahko poročali o sledečih neželenih dogodkih:
English: 4.7 Effects on ability to drive and use machines IDflu has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
English: Overdose is unlikely to have any untoward effect.
Slovenian: Ni verjetno, da bi preveliko odmerjanje povzročilo kakršne koli neželene učinke.
English: In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih niso pokazale značilnih dokazov sistemske toksičnosti.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE
English: Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Slovenian: Po cepljenju proti gripi so opazili lažne pozitivne rezultate seroloških testov, pridobljenih z metodo ELISA za odkrivanje protiteles proti HIV1, virusu hepatitisa C in še zlasti HTLV1.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02 Immunogenicity
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
English: The most common reactions occurring after vaccine administration were local reactions at injection
Slovenian: Najpogostejše reakcije po cepljenju so bile lokalne reakcije na mestu vboda.
English: What IDflu is and what it is used for
Slovenian: Kaj je cepivo IDflu in za kaj ga uporabljamo
English: The Western Blot technique disproves the false-positive ELISA test results.
Slovenian: Tehnika Western Blot je lažne pozitivne rezultate, pridobljene z metodo ELISA, ovrgla.
English: Keep the syringe in the outer carton in order to protect from light.
Slovenian: Shranjujte brizgo v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Slovenian: Cepivo lahko vpliva na rezultate krvnih testov za HIV-1, virus hepatitisa C in HTLV-1.
English: 2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Slovenian: 2/ SISTEM ZA MIKROINJICIRANJE DRŽITE MED PALCEM IN SREDINCEM
English: Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France
Slovenian: Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Francija
English: • Vessel inflammation which may result in very rare cases in temporary kidney problems.
Slovenian: • vnetje žil, ki lahko v zelo redkih primerih povzroči začasne težave z ledvicami
English: The safety of IDflu has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of IDflu.
Slovenian: Varnost cepiva IDflu je bila ocenjena v 3 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 3.372 oseb cepljenih z zdravilom IDflu.
English: The needle shielding system is designed to cover the micro-needle after use.
Slovenian: Sistem za zaščito igle je zasnovan tako, da po uporabi mikro-iglo pokrije.
English: Seroprotection is generally obtained within 2 to 3 weeks.
Slovenian: Serozaščita običajno nastopi v 2 do 3 tednih.
English: Very limited data in immunocompromised patients are available for IDflu.
Slovenian: Na voljo je zelo malo podatkov o uporabi cepiva IDflu pri imunokompromitiranih bolnikih.
English: Precautions to be taken before handling or administering the medicinal product For instructions on preparation of the medicinal product before administration, see section 6.6.
Slovenian: Opozorila glede rokovanja s cepivom in dajanja cepiva Za navodila za uporabo zdravila pred dajanjem glejte poglavje 6.6.
English: HOW TO USE IDflu
Slovenian: KAKO UPORABLJATI CEPIVO IDflu
English: Fertility and toxicity studies to reproduction in females have not identified any specific potential hazard for humans.
Slovenian: Študije plodnosti in toksičnosti za razmnoževanje niso pokazale posebne nevarnosti za ljudi.
English: Once the micro-needle has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger.
Slovenian: Ko mikroiglo vstavite, vzdržujte rahel pritisk na površini kože in injicirajte cepivo s kazalcem, s katerim pritiskate na bat.
English: Apparent local reactions after intradermal administration were more frequent than after intramuscular administration of an adjuvanted or non-adjuvanted comparator vaccine.
Slovenian: Očitne lokalne reakcije so bile po tem, ko je bilo cepivo odmerjeno intradermalno, bolj pogoste kot po intramuskularnem cepljenju s primerljivim cepivom ,ki je oziroma ni vsebovalo adjuvansa.
English: Systemic safety profile of IDflu is similar to the comparator vaccine, adjuvanted or non-adjuvanted,
Slovenian: Sistemski profil varnosti cepiva IDflu je podoben primerjanemu cepivu z adjuvansom ali brez, ki se
English: IDflu may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3).
Slovenian: Cepivo IDflu lahko vsebuje sledove jajc kot je ovalbumin ter sledove neomicina, formaldehida in oktoksinola 9, ki se uporabljajo v procesu izdelave zdravila (glejte poglavje 4.3).
English: * In some cases, local redness lasted up to 7 days.
Slovenian: * V nekaterih primerih je lokalna pordelost trajala do 7 dni c. možni neželeni dogodki
English: The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
Slovenian: b. povzetek tabelarno prikazanih neželenih učinkov Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih po cepljenju in zajeli po svetu po prihodu cepiva na trg, po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥1/1000 do < 1/100); redki (≥ 1/10000 do
English: Immunisation should be carried out by intradermal route.
Slovenian: Način uporabe Imunizacija se izvaja intradermalno.
English: It is not necessary to shake the vaccine before use.
Slovenian: Cepiva pred uporabo ni potrebno pretresati.
English: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Slovenian: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - Francija Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Francija
English: 1/ REMOVE NEEDLE CAP
Slovenian: 1/ ODSTRANITE POKROV IGLE
English: EU/1/08/507/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/507/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/507/006 - pack of 20 pre-filled syringes with a Micro-Injection System
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/507/004 - pakiranje z 1 napolnjeno brizgo s sistemom za mikro-injiciranje EU/1/08/507/005 - pakiranje z 10 napolnjenimi brizgami s sistemom za mikro-injiciranje EU/1/08/507/006 - pakiranje z 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
English: Remove the needle cap from the
Slovenian: Pokrov igle odstranite s
English: • It is not necessary to shake the vaccine before use.
Slovenian: • Cepiva pred uporabo ni potrebno pretresati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/507/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/507/004
English: • Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin.
Slovenian: • začasno zmanjšanje števila krvnih delcev, imenovanih trombocitov, ki lahko povzročijo modrice ali krvavenje, prehodno oteklost žlez vratu, pazduhe ali dimelj
English: During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of IDflu.
Slovenian: V kliničnih preizkusih in v obdobju po prihodu cepiva IDflu na trg so poročali o sledečih neželenih učinkih
English: IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
Slovenian: Cepivo IDflu se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
English: What IDflu looks like and contents of the pack
Slovenian: Izgled cepiva IDflu in vsebina pakiranja