natgillin/translations-raw huggingface dataset:
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or in clinical trials.
Varnosti cepiva Optaflu v nosečnosti in pri dojenju niso ocenili v predkliničnih študijah ali kliničnih preskušanjih.
In general data from influenza vaccinations in pregnant women do not indicate adverse fetal and maternal outcomes attributable to the vaccine.
Podatki iz cepljenj proti gripi pri nosečnicah na splošno ne kažejo na neželene učinke na plod ali mater, ki bi jih lahko pripisali cepivu.
Optaflu may be used during lactation.
Cepivo Optaflu se lahko uporablja med dojenjem.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Ni verjetno, da bi cepivo vplivalo na sposobnost vožnje in upravljanja s stroji.
Adverse reactions from clinical trials:
Neželeni učinki iz kliničnih preskušanj:
The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program.
Varnost cepiva Optaflu so ocenili v šestih randomiziranih, aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.
Overall 3439 single doses of Optaflu were administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older).
Skupaj 3439 enkratnih odmerkov cepiva Optaflu so dali 2366 odraslim, starim od 18 do 60 let, in 1073 starejšim osebam, starim 61 let ali več.
Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.
Pri vseh osebah v prvih treh tednih po cepljenju ter pri približno 3100 cepljenih osebah med šestmesečnim obdobjem sledenja so ocenili varnost in reaktogenost ter zbrali podatke o resnih neželenih učinkih.
So far there are no data from post-marketing experiences with Optaflu.
Postmarketinških izkušenj s cepivom Optaflu za zdaj ni.
In adults, the following undesirable effects have been observed during clinical trials with Optaflu:
Pri odraslih so med kliničnimi preskušanji s cepivom Optaflu opazili naslednje neželene učinke.
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1000 to < 1/ 100); rare (≥ 1/ 10000 to < 1/ 1000); very rare (< 1/ 10000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
3 Frequency in adults (18-60 years of age)
3 Pogostnost pri odraslih (18– 60 let)
Organ class Blood and lymphatic system disorders
Organski sistem Bolezni krvi in limfatičnega sistema
Very common ≥ 1/ 10
Zelo pogosti ≥ 1/ 10
Common ≥ 1/ 100 to < 1/ 10
Pogosti ≥ 1/ 100 do < / 10
Uncommon ≥ 1/ 1000 to < 1/ 100
Občasni ≥ 1/ 1. 000 do < 1/ 100
Rare ≥ 1/ 10,000 to < 1/ 1000
Redki ≥ 1/ 10. 000 do < 1/ 1. 000
Very rare < 1/ 10,000 Transient thrombocytopenia
Zelo redki < 1/ 10. 000 Prehodna trombocitopenija
Headache*
Glavobol *
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Nevrološke motnje, kot so encefalomielitis, nevritis in Guillain - Barréjev sindrom
Sweating*
Potenje *
Generalised skin reactions including pruritus, urticaria or non-specific rash
Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali neznačilnim izpuščajem
Myalgia*, arthralgia*
Mialgija *, artralgija *
Vasculitis, possibly associated with transient renal involvement
Vaskulitis, ki je lahko povezan s prehodno prizadetostjo ledvic
Erythema*, pain* Malaise*,
Eritem *, bolečina * Slabotnost *,
Swelling*, ecchymosis*, induration* Fever*,
Otekanje *, ekhimoza *, induracija *
Local lymphadeno- pathy
Lokalna limfadenopa - tija
fatigue*
utrujenost * Zvišana telesna temperatura *, tresenje *
shivering* Gastrointestinal disorders such as abdominal pain, diarrhoea or dyspepsia*
Telesna temperatura nad 39, 0 °C
Fever greater than 39.0°C
Bolezni prebavil: bolečina v trebuhu, diareja ali dispepsija *
Allergic reactions, in very rare cases leading to shock
Alergijske reakcije, ki v redkih primerih povzročijo šok
In the elderly frequencies were similar, exept for headache and pain which were classified as ‘ common’.
Pri starejših je bila pogostnost podobna, z izjemo glavobola in bolečine, ki sta bila razvrščena kot ‘ pogosta ’.
The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).
Stopnja pogostnosti zmerne in hude bolečine po cepljenju s cepivom Optaflu je podobna stopnji pri cepivih, pridobljenih iz jajc; vendar so pri cepivu Optaflu opazili rahlo povečano tveganje za pojav blage kratkotrajne bolečine na mestu injiciranja v podskupini starejših oseb, ki so jih cepili (8% v primerjavi s 6% pri cepivu, pridobljenem iz jajc).
With egg-derived influenza vaccines neuralgia, paraesthesia and febrile convulsions have been observed rarely.
4 Pri cepivih proti gripi, pridobljenih iz jajc, so nevralgijo, parestezijo in febrilne konvulzije opazili redko.
Overdosage is unlikely to have any untoward effect.
Ni verjetno, da bi preveliko odmerjanje imelo kakršenkoli neugoden učinek.
Influenza vaccine, ATC-Code:
Cepiva proti gripi, Oznaka ATC:
In this comparative trial against an egg-derived influenza vaccine the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju s cepivom, pridobljenim iz jajc, so bili stopnja serološke zaščite *, stopnja serološke konverzije ali pomembnega povečanja ** in razmerje geometrične srednje vrednosti (GMR – Geometric Mean Ratio) za protitelesa proti HA (izmerjeno z inhibicijo hemaglutinina) ocenjeni glede na predhodno določene kriterije.
Data for adults were as follows (values in brackets show the 95% confidence intervals):
Podatki pri odraslih so bili naslednji (vrednosti v oklepajih so 95- odstotni intervali zaupanja):
Strain specific anti-HA
Protitelo proti HA, specifično za
antibody
sev
N=650 N=650
N = 650 N = 650
N=650
N = 650
Seroconversion/ Significant increase rate GMR
konverzije/ pomembnega povečanja
* Seroprotection = HI titers ≥ 40
* Serološka zaščita = titri HI ≥ 40
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥ 40; Significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer
** Serološka konverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40; pomembno povečanje = pozitiven titer HI pred cepljenjem in vsaj 4- kratno povečanje titra HI po cepljenju.
Data for elderly were as follows (values in brackets show the 95% confidence intervals):
Podatki pri odraslih so bili naslednji (vrednosti v oklepajih so 95- odstotni intervali zaupanja):
N=672
N = 672
672
N = 672
(72, 79)
(72; 79) 48%
(96, 98)
(96; 98) 65%
48% (44, 52) 4.62
(44; 52)
65% (61, 68) 5.91
(61; 68)
76% (72, 79) 9.63
(72; 79)
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥ 40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.
** Serološka konverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40; pomembno povečanje = pozitiven titer HI pred cepljenjem in vsaj 4- kratno povečanje titra HI po cepljenju.
Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers.
Pri vseh treh sevih gripe je bila stopnja serološke zaščite pri cepivih, pridobljenih iz jajc, med 85 in 98%, stopnja
Non-clinical data reveal no special hazard for humans based on animal studies that are appropriate for the safety assessment of vaccines.
Predklinični podatki na osnovi študij na živalih, ki so ustrezne za oceno varnosti cepiv, ne kažejo posebnega tveganja za človeka.
In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
V študijah toksičnosti pri ponavljajočih se odmerkih pri kuncih ni bilo dokazov o sistemski toksičnosti in cepivo so lokalno dobro prenašali.
Genotoxicity, carcinogenic potential, and toxicity to reproduction were not assessed because these studies are not appropriate for a vaccine.
Genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja niso ocenili, ker te študije niso ustrezne za cepiva.
Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Disodium phosphate dihydrate, Potassium dihydrogen phosphate, Water for injections.
Natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat, vodo za injekcije.
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
0, 5 ml suspenzije v napolnjenih injekcijskih brizgah (steklo vrste I) z batnim zamaškom iz bromobutilne gume.
Pack sizes of 1, 10 or 20 (2 × 10), each with or without needle are available.
Velikosti pakiranja po 1, 10 ali 20 (2 × 10); vsa so na voljo z iglo ali brez nje.
Unused vaccine and other waste material should be disposed of in compliance with local rules for the disposal of products of this nature.
6 Neuporabljeno cepivo in drug odpadni material zavrzite v skladu z lokalnimi predpisi za odstranjevanje tovrstnih izdelkov.
KG Emil-von-Behring-Strasse 76 D-35041 Marburg GERMANY
KG Emil- von- Behring- Strasse 76 D- 35041 Marburg NEMČIJA
01 June 2007
01. junij 2007
KG Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
KG Emil- von- Behring- Strasse 76 D- 35041 Marburg Nemčija
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance vzpostavljen in deluje, preden da zdravilo v promet.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu.
An updated Risk management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use.
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).
Box: syringe with needle
Škatla: brizga z iglo
Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2007/ 2008 season)
Optaflu suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti gripi (površinski antigen, inaktiviran, pripravljen na celičnih kulturah) (sezona 2007/ 2008)
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
Sev, podoben B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004)
15 micrograms HA** per 0.5 ml dose
15 mikrogramov HA ** na 0, 5- mililitrski odmerek
Suspension for injection 1 x pre-filled syringe (0.5 ml) with needle 10 x pre-filled syringes (0.5 ml) with needle 2 x 10 pre-filled syringes (0.5 ml) with needle
Suspenzija za injiciranje 1 napolnjena injekcijska brizga (0, 5 ml) z iglo 10 napolnjenih injekcijskih brizg (0, 5 ml) z iglo 2 x 10 napolnjenih injekcijskih brizg (0, 5 ml) z iglo
For intramuscular injection
Za intramuskularno injiciranje
12 Keep out of the reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom!
Do not inject intravascularly!
Ne injicirajte intravaskularno!
Exp.:
Uporabno do
Box: syringe without needle
Škatla: brizga brez igle
1 x pre-filled syringe (0.5 ml) without needle 10 x pre-filled syringes (0.5 ml) without needle 2 x 10 pre-filled syringes (0.5 ml) without needle
1 napolnjena injekcijska brizga (0, 5 ml) brez igle 10 napolnjenih injekcijskih brizg (0, 5 ml) brez igle 2 x 10 napolnjenih injekcijskih brizg (0, 5 ml) brez igle
15 Justification for not using Braille accepted.
NAVODILA ZA UPORABO
Optaflu (2007/ 2008 season)
Optaflu (sezona 2007/ 2008)
i. m. injection
i. m. injekcija
Optaflu suspension for injection in a pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Optaflu, suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti gripi (inaktiviran plaščni antigen, pripravljen na celičnih kulturah)
What Optaflu is and what it is used for 2.
Kaj je cepivoOptaflu in za kaj ga uporabljamo 2.
Before you use Optaflu 3.
Kaj morate vedeti, preden boste uporabili cepivo Optaflu 3.
How to use Optaflu 4.
Kako uporabljati cepivo Optaflu 4.
How to store Optaflu 6.
Shranjevanje cepiva Optaflu 6.
WHAT OPTAFLU IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO OPTAFLU IN ZA KAJ GA UPORABLJAMO
Due to the kind of manufacturing Optaflu is free of chicken/ egg protein.
Zaradi načina izdelave cepivo Optaflu ne vsebuje piščančjih/ jajčnih beljakovin.
For manufacturing the vaccine the influenza virus was killed and prepared in a special way that the vaccine only contains influenza virus surface proteins (influenza virus surface antigens).
Za izdelavo cepiva je bil virus gripe ubit in pripravljen na poseben način, tako da cepivo vsebuje samo površinske beljakovine virusa gripe (površinski antigeni virusa gripe).
These proteins stimulate your immune system so that it can develop a protection against flu.
Te beljakovine spodbujajo vaš imunski sistem, tako da lahko razvije zaščito proti gripi.
BEFORE YOU USE OPTAFLU
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI CEPIVO OPTAFLU
You must NOT use Optaflu • if you are allergic (hypersensitive) to influenza vaccine or any of the other ingredients of Optaflu • if you have an acute illness associated with fever • if you have an acute infection.
Cepiva Optaflu NE smete uporabljati: • če ste alergični na (preobčutljivi za) cepivo proti gripi ali katerokoli sestavino cepiva Optaflu; • če imate akutno bolezen, ki jo spremlja zvišana telesna temperatura; • če imate akutno okužbo.
Take special care with Optaflu BEFORE receiving the vaccine • you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e. g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “ Taking other medicines”). • your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Bodite posebno pozorni pri uporabi cepiva Optaflu PREDEN prejmete cepivo: • morate vi povedati zdravniku, če je vaš imunski sistem okvarjen in ali prejemate zdravljenje, ki vpliva na imunski sistem, npr. zdravila proti raku (kemoterapija) ali kortikosteroidna zdravila (glejte poglavje 2, "Jemanje drugih zdravil"); • bosta zdravnik ali medicinska sestra zagotovila, da bosta na voljo ustrezno zdravljenje in zdravstveni nadzor v primeru redke anafilaktične reakcije (zelo hude alergijske reakcije s simptomi, kot so težave pri dihanju, vrtoglavica, šibek in hiter srčni utrip ter kožni izpuščaj) po uporabi.
This reaction may occur with Optaflu as with all vaccines that are injected.
Do te reakcije lahko pride pri uporabi cepiva Optaflu tako kot pri vseh cepivih, ki se injicirajo.
WHILE receiving the vaccine • your doctor or nurse will take care not to inject Optaflu into a blood vessel.
MED prejemanjem cepiva: • bosta zdravnik ali medicinska sestra poskrbela, da ne bosta injicirala cepiva Optaflu v krvno žilo.
19 • Optaflu is not recommended for use in children below 18 years of age since there is no information available.
19 Otroci in mladostniki • Podatkov o uporabi cepiva Optaflu pri otrocih, mlajših od 18 let, ni, zato uporaba pri njih ni priporočljiva.
Taking other medicines Special care should be taken if you are receiving Optaflu and any of the following medicines at the same time: • medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system.
Jemanje drugih zdravil Treba je biti zelo previden, če sočasno prejemate cepiva Optaflu in katerokoli od naslednjih zdravil: • zdravila proti raku (kemoterapija), kortikosteroidna zdravila (kot je kortizon) ali druga zdravila, ki vplivajo na imunski sistem.
Tell your doctor if you are being treated with such medicines.
Zdravniku povejte, če se zdravite s takšnimi zdravili.
The immune response of your body may be weakened.
Imunski odziv telesa je lahko oslabljen.
Therefore the vaccine may work less effectively. • other vaccines.
Zato je cepivo lahko manj učinkovito; • druga cepiva.
The safety of Optaflu in pregnant and breast-feeding women has not been determined.
Varnosti cepiva Optaflu pri nosečnicah in ženskah, ki dojijo, niso določili.
Therefore your doctor will decide whether you should receive Optaflu if you are pregnant or breast- feeding.
Zato se bo zdravnik odločil, ali smete prejeti cepivo Optaflu, če ste noseči ali če dojite.
Important information about some of the ingredients of Optaflu This medicine contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
Pomembne informacije o nekaterih sestavinah cepiva Optaflu To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘ brez natrija ’.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i. e. essentially ‘ potassium- free’.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni ‘ brez kalija ’.
HOW TO USE OPTAFLU
KAKO UPORABLJATI CEPIVO OPTAFLU
Optaflu is applied to you by your doctor or nurse.
Cepivo Optaflu vam da zdravnik ali medicinska sestra.
Usual dose for persons of 18 years and older:
Običajni odmerek za osebe, stare 18 let ali več:
0.5 ml of Optaflu suspension.
0, 5 ml suspenzije cepiva Optaflu.
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle).
Cepivo Optaflu se injicira v mišico na vrhu nadlahti (deltoidno mišico).
Optaflu should under no circumstances be injected into a blood vessel.
Cepivo Optaflu se v nobenem primeru ne sme injicirati v krvno žilo.
Like all medicines, Optaflu can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Optaflu neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following undesirable effects have been observed during clinical trials:
Naslednje neželene učinke so opazili med kliničnimi preskušanji:
Very common Common Uncommon Rare Very rare
Zelo pogosti Pogosti
in more than 1 in 10 vaccinees in more than 1 in 100 vaccinees, but less than 1 in 10 vaccinees in more than 1 in 1,000 vaccinees, but less than 1 in 100 vaccinees in more than 1 in 10,000 vaccinees, but less than 1 in 1,000 vaccinees in less than 1 in 10,000 vaccinees, including isolated reports
pri več kot 1 od 10 cepljenih oseb pri več kot 1 od 100 cepljenih oseb, vendar pri manj kot 1 od 10 cepljenih oseb
20 Very serious side effects Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:
20 Zelo redki: • težave pri dihanju, vrtoglavica, šibek in hiter srčni utrip ter kožni izpuščaj, ki so simptomi anafilaktičnega reakcije (zelo hude alergijske reakcije).
Very rare: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) Rare: • numbness and tingling sensation • painful disorders of the nerves, e. g. attacks of extreme pain in the face, throat or ear fits (convulsions) (only observed with egg-derived influenza vaccines)
Redki: • otrplost in občutek mravljinčenja; • boleče motnje živcev, npr. napadi hude bolečine v obrazu, grlu ali ušesu; epileptični napadi (konvulzije) (opazili so jih samo pri cepivih proti gripi, pridobljenih iz jajc).
Very rare: • skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the blood vessels • fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are symptoms of an inflammation of the brain and spinal cord • weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves
Zelo redki: • kožni izpuščaji, zvišana telesna temperatura, bolečina v sklepih ali težave z ledvicami, ki so simptomi vnetja krvnih žil • zvišana telesna temperatura, glavobol, bruhanje in dremavost, ki se stopnjuje v komo ali epileptične napade (konvulzije), ki so simptomi vnetja možganov in hrbtenjače • šibkost, ki se začenja v nogah in napreduje v roke, z otrplostjo in mravljinčenjem, ki so simptomi vnetja živcev
Serious side effects Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:
Resni neželeni učinki Takoj povejte zdravniku, če opazite kateregakoli od naslednjih neželenih učinkov; morda boste potrebovali medicinsko pomoč:
Very Rare: • bleeding or bruising which are symptoms of a low platelet count in the blood
Zelo redki: • krvavitve ali modrice, ki so simptomi majhnega števila trombocitov v krvi.
Mild side effects Very common: • flu-like symptoms such as headache, feeling of discomfort, tiredness. • Pain, reddening.
Blagi neželeni učinki Zelo pogosti: • simptomi, podobni gripi, kot so glavobol, občutek nelagodja, in utrujenost; • bolečina, rdečica.
Pain and headache were common in the elderly.
Pri starejših sta bila bolečina in glavobol pogosta.
Common: • sweating, joint and muscle pain, chills, hardening or swelling at the site of the injection, bruising, fever, shivering • gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract These reactions are usually mild and only last a few days.
Te reakcije so navadno blage in trajajo le nekaj dni.
Uncommon: • generalised skin reactions such as itching, bumps on the skin or non-specific rash
Občasni: • splošne kožne reakcije, kot so srbenje, bule na koži ali neznačilni izpuščaj.
Rare: • swelling and pain of local lymphnodes • Fever greater than 39.0 °C
Redki: • otekanje in bolečina v lokalnih bezgavkah; • telesna temperatura nad 39, 0 °C.
HOW TO STORE OPTAFLU
SHRANJEVANJE CEPIVA OPTAFLU
The expiry date refers to the last day of that month.
Cepiva Optaflu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
Storage conditions of the unopened product: • Store in a refrigerator (2 °C to 8 °C). • Do not freeze. • Keep the pre-filled syringe in the carton in order to protect from light.
21 Pogoji shranjevanja neodprtega zdravila: • Shranjujte v hladilniku (2 °C - 8 °C). • Ne zamrzujte. • Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Preparation of the product before use:
Priprava zdravila pred uporabo:
Your doctor or nurse will take care that Optaflu should be allowed to reach room temperature before use and is shaken before use.
Zdravnik ali medicinska sestra bosta poskrbela, da cepivo Optaflu pred uporabo doseže sobno temperaturo in ga pretresla.
What Optaflu contains The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Kaj vsebuje cepivo Optaflu Zdravilne učinkovine so površinski antigeni virusa gripe (hemaglutinin in nevraminidaza) *, inaktivirani, naslednjih sevov:
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) ……………………………………
Sev, podoben B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004) ……………………………………