natgillin/translations-raw huggingface dataset:
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 zdravila IDflu intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0, 5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
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) za protitelesa anti- HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
Geometric mean of titre
Geometrično povprečje titra (1/ razr) Stopnja serozaščite (%) *
298.0
81, 7 (78, 0; 85, 6) 77, 0
39.9
298, 0 (282; 315) 93, 3
(1/ dil)
39, 9 (38, 3; 41, 6) 55, 7
(78.0; 85.6)
(75, 3; 78, 6)
(282; 315)
(92, 3; 94, 3)
Seroprotection rate (%) *
Serokonverzija ali značilna stopnja
Seroconversion or significant increase rate (%) ** Geometric mean of titre ratio (GMTR)
Razmerje geometričnega povprečja titra
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 age and over.
Zdravilo 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.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/ dil) and 181.0 (1/ dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
Za vse tri seve gripe, v primerjavi z intramuskularnim cepivom, so bila GMT razmerja med 34, 8 (1/ razred.) in 181, 0 (1/ razred.), stopnje serozaščite med 48, 9% in 87, 9%, serokonverzija ali
13 5.2 Pharmacokinetic properties
13 značilne stopnje povečanja med 30, 0% in 46, 9% in GMTR med 3, 04 in 5, 35 krat nad izhodiščem titrov HI.
14 The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro- needle (1.5 mm) and a needle shielding system.
14 Sistem za mikro- injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro- iglo (1, 5 mm) in s sistemom za zaščito igle.
15 INSTRUCTIONS FOR USE
15 NAVODILA ZA UPORABO
Activated needle shield
Injekcija je uspešna ne glede na prisotnost izpuščaja.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Aktivirajte zaščito igle
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F- 69007 Lyon, Francija.
Sanofi Pasteur Parc Industriel d’ Incarville 27100 Val-de-Reuil France
Sanofi Pasteur Parc Industriel d’ Incarville 27100 Val- de- Reuil Francija
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca( ev), odgovornega (ih) za sproščanje serije
Sanofi Pasteur Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l’ Etoile France
Sanofi Pasteur Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l’ Etoile Francija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kakor je opisano v verziji 8. 0 in navedeno v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje pred in po začetku trženja zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu, kot je potrjeno v različici 1. 0 Načrta upravljanja tveganja (NUT), predstavljeno v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet in vseh posodobitvah NUT s katerimi se je strinjal Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Predložiti je treba dopolnjen Načrt upravljanja tveganja v skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP) istočasno, kot naslednje Periodično poročilo o varnosti zdravila (PSUR).
19 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
19 V dodatno je potrebno vložiti nadgrajen NUT • če prejme nove informacije, ki bi lahko vplivale na Specifikacijo varnosti, farmakovigilančni načrt ali Načrt zmanjševanja tveganja • v 60 dneh od pojava pomembnega zaključka (za znižanje farmakovigilančnega tveganja) • na zahtevo EMEA
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 PODATKI NA ZUNANJI OVOJNINI Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro- injiciranje
Strains 2006/ 2007
Zdravilo IDflu 9 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran) Sevi 2006/ 2007
A/ New Caledonia/ 20/ 99 (H1N1) like strain (IVR-116) 9 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (IVR- 116) 9 mikrogramov HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (NYMC X-161) 9 micrograms HA**
A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (NYMC X- 161) 9 mikrogramov HA **
B/ Malaysia/ 2506/ 2004 like strain 9 micrograms HA**
B / Malaysia/ 2506/ 2004 podoben sevu 9 mikrogramov HA **
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections
natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat in voda za injekcije
Suspension for injection Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 1 Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 10 Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 20
Suspenzija za injiciranje Napolnjena brizga z mikro- injekcijskim sistemom (0, 1 ml) - pakiranje z 1 enoto Napolnjena brizga z mikro- injekcijskim sistemom (0, 1 ml) - pakiranje po 10 Napolnjena brizga z mikro- injekcijskim sistemom (0, 1 ml) – pakiranje po 20
Intradermal use.
Intradermalna uporaba.
IDflu does not contain more than 0.05 microgram ovalbumin per dose.
Zdravilo IDflu ne vsebuje več kot 0, 05 mikrogramov ovalbumina na odmerek.
Sanofi Pasteur SA, 2, avenue Pont Pasteur F-69007 Lyon France
Sanofi Pasteur SA, 2, avenue Pont Pasteur F- 69007 Lyon Francija
EU/ 0/ 00/ 000/ 000 - pack of 1 pre-filled syringe with a Micro-Injection System EU/ 0/ 00/ 000/ 000 - pack of 10 pre-filled syringes with a Micro-Injection System EU/ 0/ 00/ 000/ 000 - pack of 20 pre-filled syringes with a Micro-Injection System
EU/ 0/ 00/ 000/ 000 - pakiranje z 1 napolnjeno brizgo s sistemom za mikro- injiciranje EU/ 0/ 00/ 000/ 000 - pakiranje z 10 napolnjenimi brizgami s sistemom za mikro- injiciranje EU/ 0/ 00/ 000/ 000 - pakiranje z 20 napolnjenimi brizgami s sistemom za mikro- injiciranje
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 PODATKI NA ZUNANJI OVOJNINI Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro- injiciranje
Strains 2006/ 2007
Zdravilo IDflu 15 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran) Sevi 2006/ 2007
A/ New Caledonia/ 20/ 99 (H1N1) like strain (IVR-116) 15 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (IVR- 116) 15 mikrogramov HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (NYMC X-161) 15 micrograms HA**
A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (NYMC X- 161) 15 mikrogramov HA **
B/ Malaysia/ 2506/ 2004 like strain 15 micrograms HA**
B / Malaysia/ 2506/ 2004 podoben sevu 15 mikrogramov HA **
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat in voda za injekcije
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
IDflu 9 µg/ strain suspension for injection Influenza vaccine Strains 2006/ 2007 Intradermal use
Zdravilo IDflu 9 µg/ sev suspenzija za injiciranje Cepivo proti gripi Sevi 2006/ 2007 Intradermalna uporaba
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Strains 2006/ 2007 Intradermal use
Zdravilo IDflu 15 µg/ sev suspenzija za injiciranje Cepivo proti gripi Sevi 2006/ 2007 Intradermalna uporaba
29 PACKAGE LEAFLET:
29 NAVODILO ZA UPORABO:
Read all of this leaflet carefully before you receive this vaccine.
Pred cepljenjem natančno in v celoti preberite to navodilo.
What IDflu is and what it is used for 2.
Kaj je zdravilo IDflu in za kaj ga uporabljamo 2.
Before you use IDflu 3.
Kaj morate vedeti, preden boste vzeli zdravilo IDflu 3.
How to use IDflu 4.
Kako uporabljati zdravilo IDflu 4.
How to store IDflu 6.
Shranjevanje zdravila IDflu 6.
WHAT IDflu IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO IDflu IN ZA KAJ GA UPORABLJAMO
The vaccine may be administered to adults up to 59 years of age, especially in those who run an increased risk of associated complications.
Cepivo se lahko daje odraslim, starim do 59 let, še zlasti tistim, pri katerih obstaja povečano tveganje za z gripo povezane zaplete.
When an injection of IDflu is given, the immune system (body's natural defences) will develop protection against flu infection.
Po injiciranju zdravila IDflu razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi z gripo.
IDflu will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Zdravilo IDflu pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
BEFORE YOU USE IDflu
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO IDflu
Do not use IDflu
Ne uporabljajte zdravila IDflu
- If you are allergic (hypersensitive) to:
- če ste alergični na (preobčutljivi na):
The active substances, or any of the other ingredients of IDflu listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
zdravilno učinkovino ali katerokoli sestavino zdravila IDflu, navedeno v poglavju 6 tega navodila pod poglavjem ''DODATNE INFORMACIJE'',
To eggs, chicken proteins, neomycin, formaldehyde and octoxinol 9.
jajca, piščančje beljakovine, neomicin, formaldehid in oktoksinol 9.
- If you have an illness with fever or acute infection, the vaccination shall be postponed until after
- če imate bolezen s povišano telesno temperaturo ali akutno okužbo, morate cepljenje prestaviti
you have recovered.
na kasnejše obdobje, ko si opomorete.
Take special care with IDflu
Bodite posebno pozorni pri jemanju zdravila IDflu
- You should tell your doctor before vaccination if you have a poor immune response
Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi
(immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
- IDflu should under no circumstances be administered into a vein (intravascularly).
- Cepiva IDflu se pod nobenim pogojem ne sme dajati v žilo (intravaskularno).
- If, for any reason, you have a blood test within a few days following an influenza vaccination,
- Če morate v dneh po cepljenju proti gripi opraviti krvni test o tem obvestite svojega zdravnika.
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.
- Children and adolescents:
- Otroci in mladostniki:
IDflu is not recommended for use in children and adolescents below 18 years.
Uporaba zdravil IDflu ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
It
- Druga cepiva: zdravilo IDflu se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
should be noted that the side effects may be intensified.
Zavedati se je treba, da se neželeni učinki lahko stopnjujejo.
- Tell your doctor if you have been treated with medicines that may reduce your immune
- Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv,
response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Povejte zdravniku ali farmacevtu, če ste noseči, če mislite, da ste noseči ali če dojite.
Your doctor or pharmacist will be able to decide if you should receive IDflu.
Zdravnik ali farmacevt se bo odločil, ali boste prejeli cepivo IDflu.
The vaccine is unlikely to affect your ability to drive or use machines.
Ni verjetno, da bi cepivo vplivalo na sposobnost vožnje ali upravljanja strojev.
HOW TO USE IDflu
KAKO UPORABLJATI ZDRAVILO IDflu
IDflu is administered to you by your doctor or nurse.
Z zdravilom IDflu vas cepi zdravnik ali medicinska sestra.
Adults from 18 to 59 of age receive one 0.1 ml dose.
Odrasli, stari od 18 do 59 let, prejmejo odmerek 0, 1 ml.
IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
Zdravilo IDflu se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
Like all medicines, IDflu can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo IDflu neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
During clinical trials, the following side effects were reported with the use of IDflu.
V kliničnih preskušanjih so pri uporabi zdravila IDflu opazili naslednje neželene učinke.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Zelo pogosti (se pojavijo pri več kot 1 cepljenemu od 10) Pogosti (se pojavijo pri 1 do 10 cepljenih od 100) Občasni (se pojavijo pri 1 do 10 cepljenih od 1. 000) Redki (se pojavijo pri 1 do 10 cepljenih od 10. 000) Zelo redki (se pojavijo pri manj kot 1 cepljenemu od 10. 000) Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
- At the injection site: redness, swelling, hardness, itching and pain.
- Na mestu injiciranja: pordelost, otekanje, otrdelost, srbenje in bolečina.
- Feeling generally unwell, headache and muscular pain.
- Splošno počutje nelagodja, glavobol in bolečine v mišicah.
- Bruising at the injection site
- modrica na mestu injiciranja
- Shivering and fever (38.0°C or higher).
- tresenje, povišana telesna temperatura (38, 0°C ali več).
- Tiredness, swelling of the glands in the neck, armpit or groin, tingling or numbness, joint pain,
- utrujenost, oteklost žlez vratu, pazduhe ali dimelj, ščemenje ali odrevenelost, bolečine v sklepih,
itching and rash.
srbenje in izpuščaj.
Rare • Increased sweating.
- Povečano znojenje.
The following side effects have been reported with other influenza vaccines: • temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding • allergic reactions which can lead in rare cases:
V povezavi z drugimi cepivi proti gripi so poročali o naslednjih neželenih učinkih: • začasno zmanjšanje števila krvnih delcev, imenovanih trombocitov, ki lahko povzročijo modrice ali krvavenje • alergijske reakcije, ki lahko v redkih primerih povzročijo:
- to a failure of the circulatory system (shock) leading to medical emergency
- odpoved obtočilnega sistema (šok), ki privede do nujne medicinske pomoči
- to swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe
- oteklost obraza, jezika ali žrela, težave pri požiranju, izpuščaje in oteženo dihanje (angioedem)
(angioedema) • pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré syndrome which causes extreme weakness and paralysis • vessel inflammation which may result in very rare cases in temporary kidney problems • skin reactions that may spread throughout the body including hives.
• bolečine na živčnih poteh, konvulzije, povezane s povišano telesno temperaturo, bolezni živčevja, vključno z vnetjem možganov ali hrbtenjače, vnetjem živcev ali Guillain- Barréjev sindrom, ki povzroča izjemno utrujenost in paralizo. • vnetje žil, ki lahko v zelo redkih primerih povzroči začasne težave z ledvicami • kožne reakcije, ki se lahko širijo po telesu, vključno z izpuščaji.
You should see your doctor immediately if you experience symptoms of angioedema, such as:
Nemudoma poiščite zdravniško pomoč, če občutite simptome angioedema kot npr.: • otekel obraz, jezik ali žrelo • težave pri požiranju • izpuščaji in oteženo dihanje.
HOW TO STORE IDflu
SHRANJEVANJE ZDRAVILA IDflu
Do not use IDflu after the expiry date which is stated on the carton after EXP.
Zdravila IDflu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2ºC – 8ºC).
What IDflu contains
Kaj vsebuje cepivo IDflu
The active substances are split Influenza virus*, inactivated, containing antigens equivalent to the following strains:
Zdravilna učinkovina so razgrajeni virusi gripe *, inaktivirani z antigeni, ki ustrezajo naslednjim sevom:
A/New Caledonia/20/99 (H1N1) like strain (A/New Caledonia/20/99 (IVR-116)) 9 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (A/ New Caledonia/ 20/ 99 (IVR- 116)) 9 mikrogramov HA **
32 A/Wisconsin/67/2005 (H3N2) like strain (A/Wisconsin/67/2005 (NYMC X-161)) 9 micrograms HA**
32 A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 9 mikrogramov HA **
B/ Malaysia/2506/2004 like strain (B/Malaysia/2506/2004) 9 micrograms HA**
B / Malaysia/ 2506/ 2004, podoben sevu (B/ Malaysia/ 2506/ 2004) 9 mikrogramov HA **
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2006/2007 season.
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in Odločbi EU za sezono 2006/ 2007.
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate potassium dihydrogen phosphate and water for injections.
Pomožne snovi so: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat in voda za injekcije.
What IDflu looks like and contents of the pack
Izgled zdravila IDflu in vsebina pakiranja
IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in packs of 1, 10 or 20.
Zdravilo IDflu je suspenzija za injiciranje v napolnjenih injekcijskih brizgah z 0, 1 ml s sistemom za mikro- injiciranje, pakirana po 1, 10 ali 20 enot.
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
Magyarország sanofi-aventis zrt Tel.: +36 1 505 2723
Magyarország Sanofi- aventis zrt Tel.: +36 1 505 2723
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ ---------------------------------------------------------------------------------------------------------------------------
< Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------------
34 The following information is intended for medical or healthcare professionals only:
• Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju • Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine. • The vaccine should be allowed to reach room temperature before use. • The vaccine should not be used if foreign particles are present in the suspension. • It is not necessary to shake the vaccine before use. • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro- needle (1.5 mm) and a needle shielding system.
34 • Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti. • Cepiva pred uporabo ni potrebno pretresati. • Sistem za mikro- injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro- iglo (1, 5 mm) in s sistemom za zaščito igle.
Plunger
Blazinice za prste
Needle shield
Zaščita za iglo
35 INSTRUCTIONS FOR USE
35 NAVODILA ZA UPORABO
Please read the instruction before use
Pred uporabo preberite navodila 2 / SISTEM ZA MIKROINJICIRANJE DRŽITE 1 / ODSTRANITE POKROV IGLE MED PALCEM IN SREDINCEM
cap from the Micro-Injection System.
Ne spuščajte
36 PACKAGE LEAFLET:
36 NAVODILO ZA UPORABO:
IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo IDflu 15 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
The active substances or any of the other ingredients of IDflu listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
zdravilno učinkovino ali katerokoli sestavino zdravila IDflu, navedeno v poglavju 6 tega navodila pod poglavjem ''DODATNE INFORMACIJE'',
have an illness with fever or acute infection, the vaccination shall be postponed until after
- če imate bolezen s povišano telesno temperaturo ali akutno okužbo, morate cepljenje prestaviti
37 Using other medicines
37 Uporaba drugih zdravil
Individuals 60 years of age and over receive one 0.1 ml dose.
Odrasli starejši od 60 let, prejmejo odmerek 0, 1 ml.
- At the injection site: redness, hardness, swelling, itching and pain.
- Na mestu injiciranja: pordelost, otrdelost, otekanje, srbenje in bolečina.
- Feeling generally unwell, fever (38.0°C or higher) and shivering.
- utrujenost, bolečine v sklepih in povečano znojenje.
38 Uncommon
38 Redki