natgillin/translations-raw huggingface dataset:
Cosentyx 150 mg solution for injection in pre-filled pen secukinumab
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab s.c.
Histidine
Cosentyx;
Cosentyx 150 mg solution for injection in pre-filled pen
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
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.
To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, ki jo imenujemo interlevkin-17A (IL-17A).
4.8 Undesirable effects a. Summary of the safety profile
4.8 Neželeni učinki a. povzetek varnostnega profila
Data were as follows (values in brackets show the 95% confidence intervals):
Pridobili so naslednje podatke (vrednosti v oklepajih kažejo 95 % intervale zaupanja):
Date of latest renewal: 24 February 2014
Datum zadnjega podaljšanja: 24. februar 2014
- Headache and muscular pain.
- Glavobol in bolečine v mišicah.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 February 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24. februar 2009
Pack size of 1 or 10 or 20.
Velikost pakiranja je 1 ali 10 ali 20.
The use of IDflu should be based on official recommendations.
Uporaba cepiva IDflu mora temeljiti na uradnih priporočilih.
• Any of the other ingredients of this vaccine (listed in section 6),
• katerokoli sestavino tega cepiva (navedeno v poglavju 6)
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in Odločbi EU za
The vein test is unnecessary.
Venski test ni potreben.
Micro-Injection System
Sistem za mikroinjiciranje
Genotoxicity and carcinogenic potential were not assessed because these studies are not appropriate for a vaccine.
Potenciala genotoksičnosti in karcinogenosti niso ocenili, saj te študije za cepivo niso primerne.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Pred cepljenjem natančno in v celoti preberite to navodilo, ker vsebuje za vas pomembne podatke.
• Risk Management Plan (RMP)
ZDRAVILA • Načrt zaobvladovanje tveganja (RMP)
You should see your doctor immediately if you experience symptoms of angioedema, such as:
Nemudoma poiščite zdravniško pomoč, če občutite simptome angioedema kot npr.:
Non-clinical data revealed no special hazard for humans based on animal studies.
Neklinični podatki niso pokazali posebnih nevarnosti za ljudi na podlagi študij na živalih.
* propagated in fertilised hens' eggs from healthy chicken flocks
* razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat
Hold the system by placing the thumb and middle finger only on the finger pads; the index finger remains free.
Sistem držite tako, da ga nastavite med palec in sredinec samo na blazinice za prste; kazalec ostane prost.
• 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.
• 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).
Please read the instructions before use
Pred uporabo preberite navodila
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
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
B A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 N = 2,586
B A/New Caledonia/20/99 A/Wisconsin/67/2005 B/Malaysia/2506/2004
The transient false positive reactions could be due to the IgM response by the vaccine.
Prehodno lažne pozitivne reakcije so lahko posledica proizvajanja IgM kot odziv na cepivo.
Nevertheless, single and repeated administrations led to transient local erythema and oedema.
Vendar pa je enkratno in večkratno dajanje povzročilo prehodni lokali eritem in edem.
- Feeling generally unwell, fever (38.0°C or higher) and shivering.
- Splošno počutje nelagodja, povišana telesna temperatura (38,0°C ali več) in tresenje.
Full effect of the vaccine is generally achieved 2-3 weeks after the
Popolni učinek cepiva je običajno dosežen v 2 do 3 tednih po cepljenju.
The vaccine is a colourless and opalescent suspension.
Cepivo je brezbarvna in motna suspenzija.
The vaccine was immunogenic in mice and rabbits.
Cepivo je bilo imunogeno pri miših in kuncih.
Most of side effects listed above disappeared without treatment within 1 to 3 days after onset.
Večina zgoraj naštetih neželenih učinkov izzveni brez zdravljenja v 1 do 3 dni.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2ºC - 8ºC).
Most reactions resolved spontaneously within 1 to 3 days after onset.
Večina reakcij je spontano izzvenela v 1 do 3 dneh po nastanku.
Children and adolescents IDflu is not recommended for use in children and adolescents below 18 years.
Cepivo IDflu ni priporočeno za uporabo pri otrocih in mladostnikih pod 18 let.
- If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor.
- Če morate v dneh po cepljenju proti gripi opraviti krvni test o tem obvestite svojega zdravnika.
Immediately dispose of the system in the nearest sharps collector.
Nemudoma odstranite sistem v najbližji koš za ostre predmete.
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).
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).
Finger pads
Prstne blazinice
Do not place fingers on the windows.
Pazite, da okenc ne zakrijete s prsti.
What you need to know before you use IDflu
Kaj morate vedeti, preden boste uporabili cepivo IDflu
In the absence of compatibility studies, this medicinal product must not be mixed with other
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
Paresthesia, neuritis
Parestezija, neuritis Pruritus,
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Po ponovnem vsakoletnem cepljenju je bil profil varnosti cepiva IDflu podoben prejšnjim injekcijam.
Immunisation should be carried out on separate limbs.
Imunizacijo je potrebno opraviti na ločenih okončinah.
- This vaccine should under no circumstances be administered into a vein (intravascularly).
- To cepivo se pod nobenim pogojem ne sme dajati v žilo (intravaskularno).
Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, the following events may be reported:
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:
4.7 Effects on ability to drive and use machines IDflu has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
Overdose is unlikely to have any untoward effect.
Ni verjetno, da bi preveliko odmerjanje povzročilo kakršne koli neželene učinke.
In repeated-dose toxicity studies in rabbits there was no significant evidence of systemic toxicity.
Študije toksičnosti pri ponavljajočih se odmerkih niso pokazale značilnih dokazov sistemske toksičnosti.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE
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.
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.
Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02 Immunogenicity
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
The most common reactions occurring after vaccine administration were local reactions at injection
Najpogostejše reakcije po cepljenju so bile lokalne reakcije na mestu vboda.
What IDflu is and what it is used for
Kaj je cepivo IDflu in za kaj ga uporabljamo
The Western Blot technique disproves the false-positive ELISA test results.
Tehnika Western Blot je lažne pozitivne rezultate, pridobljene z metodo ELISA, ovrgla.
Keep the syringe in the outer carton in order to protect from light.
Shranjujte brizgo v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Cepivo lahko vpliva na rezultate krvnih testov za HIV-1, virus hepatitisa C in HTLV-1.
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
2/ SISTEM ZA MIKROINJICIRANJE DRŽITE MED PALCEM IN SREDINCEM
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Francija
• Vessel inflammation which may result in very rare cases in temporary kidney problems.
• vnetje žil, ki lahko v zelo redkih primerih povzroči začasne težave z ledvicami
The safety of IDflu has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of IDflu.
Varnost cepiva IDflu je bila ocenjena v 3 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 3.372 oseb cepljenih z zdravilom IDflu.
The needle shielding system is designed to cover the micro-needle after use.
Sistem za zaščito igle je zasnovan tako, da po uporabi mikro-iglo pokrije.
Seroprotection is generally obtained within 2 to 3 weeks.
Serozaščita običajno nastopi v 2 do 3 tednih.
Very limited data in immunocompromised patients are available for IDflu.
Na voljo je zelo malo podatkov o uporabi cepiva IDflu pri imunokompromitiranih bolnikih.
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.
Opozorila glede rokovanja s cepivom in dajanja cepiva Za navodila za uporabo zdravila pred dajanjem glejte poglavje 6.6.
HOW TO USE IDflu
KAKO UPORABLJATI CEPIVO IDflu
Fertility and toxicity studies to reproduction in females have not identified any specific potential hazard for humans.
Študije plodnosti in toksičnosti za razmnoževanje niso pokazale posebne nevarnosti za ljudi.
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.
Ko mikroiglo vstavite, vzdržujte rahel pritisk na površini kože in injicirajte cepivo s kazalcem, s katerim pritiskate na bat.
Apparent local reactions after intradermal administration were more frequent than after intramuscular administration of an adjuvanted or non-adjuvanted comparator vaccine.
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.
Systemic safety profile of IDflu is similar to the comparator vaccine, adjuvanted or non-adjuvanted,
Sistemski profil varnosti cepiva IDflu je podoben primerjanemu cepivu z adjuvansom ali brez, ki se
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).
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).
* In some cases, local redness lasted up to 7 days.
* V nekaterih primerih je lokalna pordelost trajala do 7 dni c. možni neželeni dogodki
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).
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
Immunisation should be carried out by intradermal route.
Način uporabe Imunizacija se izvaja intradermalno.
It is not necessary to shake the vaccine before use.
Cepiva pred uporabo ni potrebno pretresati.
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - Francija Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Francija
1/ REMOVE NEEDLE CAP
1/ ODSTRANITE POKROV IGLE
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
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
Remove the needle cap from the
Pokrov igle odstranite s
• It is not necessary to shake the vaccine before use.
• Cepiva pred uporabo ni potrebno pretresati.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/507/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/507/004
• 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.
• začasno zmanjšanje števila krvnih delcev, imenovanih trombocitov, ki lahko povzročijo modrice ali krvavenje, prehodno oteklost žlez vratu, pazduhe ali dimelj
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of IDflu.
V kliničnih preizkusih in v obdobju po prihodu cepiva IDflu na trg so poročali o sledečih neželenih učinkih
IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
Cepivo IDflu se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
What IDflu looks like and contents of the pack
Izgled cepiva IDflu in vsebina pakiranja
The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually
Po cepljenju se trajanje imunosti na homologne seve ali na seve, ki so tesno povezani s sevi cepiva, razlikuje, običajno pa traja od 6 do 12 mesecev.
Other vaccines or medicines and IDflu Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
- If you have an illness with fever or acute infection, the vaccination shall be postponed until
- če imate bolezen s povišano telesno temperaturo ali akutno okužbo, morate cepljenje prestaviti na kasnejše obdobje, ko si opomorete.
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Preobčutljivost na zdravilno učinkovino, na katero koli pomožno snov navedeno v poglavju 6.1 ali na katere izmed naslednjih sledov: jajc (ovalbumin, piščančje beljakovine), neomicina, formaldehida in
Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain.
Zelo pogosti (lahko prizadanejo več kot 1 med 10 cepljenimi) - Na mestu injiciranja: pordelost, otrdelost, otekanje, srbenje in bolečina.
(immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
- Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4-povečanje titra HI po cepljenju
IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Cepivo ID flu je tako imunogeno kot primerjalno trivalentno cepivo z adjuvansom (ki vsebuje MF-59) v smislu GMT za vsakega od 3 sevov gripe po metodi SRH in za 2 seva po metodi HI.
Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Cepiva IDflu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- Other vaccines: IDflu can be given at the same time as other vaccines by using separate limbs.
- Druga cepiva: cepivo IDflu se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
IDflu should under no circumstances be administered intravascularly.
Cepivo IDflu se pod nobenim pogojem ne sme dajati intravaskularno.
This vaccine is intended for individuals 60 years of age and over.
To cepivo uporabljajo starejši od 60 let.
The active substances are Influenza virus (inactivated split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09 ............................................................................................................................. 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) ............................................................................................................................. 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............ 15 mikrogramov HA**
Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Neznani Alergijska reakcija, ki vključuje generalizirano kožno reakcijo kot je urtikaria, anafilaktično reakcijo, angioedem, šok
4/ INJECT USING THE INDEX FINGER
4/ INJICIRAJTE S KAZALCEM
IDflu is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
Pediatrična populacija Uporaba zdravila IDflu zaradi pomanjkljivih podatkov o varnosti in učinkovitosti ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
Posology Individuals 60 years of age and over: 0.1 ml.
Odmerjanje Odrasli starejši od 60 let: 0,1 ml.
With the same hand, push very firmly with the thumb on the plunger to activate the You hear a click and a shield comes out to cover the needle.
Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
Intradermal 15µg A/H3N2
Intradermalno 15 µg
1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System
1 napolnjena brizga (0,1 ml) z mikro-injekcijskim sistemom 10 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom 20 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom
The recommended site of administration is the region of the deltoid.
Priporočeno mesto cepljenja je predel deltoidne mišice.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not
V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno cepljenje ni potrebno.
IDflu is a vaccine.This vaccine is recommended to help to protect you against flu.
Cepivo se priporoča za zaščito proti gripi.
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite*, serokonverzijo ali značilne stopnje povečanja** in razmerje geometričnega povprečja titrov (GMTR)
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
V randomiziranih primerjalnih preskušanjih faze III je 2606 oseb, starih nad 60 let, prejelo 0,1 ml cepiva IDflu intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0,5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of
Cepivo IDflu je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih nad 60 let.
Interference with serological testing: See section 4.5.
Interferenca s serološkimi testi: glejte poglavje 4.5. 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Justification for not including Braille is accepted.
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications.
Cepivo se lahko daje odraslim starejšim od 60 let, še zlasti tistim, pri katerih obstaja povečano
Immunisation shall be postponed in subjects with febrile illness or acute infection.
Imunizacijo pri osebah s povišano telesno temperaturo ali akutno okužbo je treba preložiti.