natgillin/translations-raw huggingface dataset:
Then prime the pen by setting the dose arrow at 37.5 scale-mark highlighted with a small dot.
puščica za odmerek držalo vložka batni obroček predirna konica pokrovček napolnjenega
Pull out the injection button as far as it will go, remove the outer needle cap and the inner needle cap and hold the pre-filled pen with the needle pointing upwards.
notranji pokrovček igle zunanji pokrovček igle zanka za zapiranje
Tap the reservoir holder gently with the finger so that any air bubbles rise up towards the needle.
Izvlecite gumb za injiciranje vse dokler gre, odstranite zunanji pokrovček igle in notranji pokrovček igle ter držite peresnik tako, da je igla usmerjena navzgor.
With the needle still pointing upwards, depress the injection button fully.
Z iglo še vedno usmerjeno navzgor, popolnoma pritisnite gumb za injiciranje.
A drop of liquid must appear at the tip of the needle; this indicates that your pre-filled pen is primed for injection.
Na konici igle se mora prikazati kaplja tekočine; To je znak, da je vaš napolnjen peresnik pripravljen za injiciranje.
The amount of liquid seen at the needle tip is just the overfill from the pre-filled pen (generally less than 37.5 IU).
Količina tekočine, ki jo vidite na konici igle je samo prenapolnjen del napolnjenega injekcijskega peresnika (na splošno manj kot 37, 5 i. e.).
If no liquid appears the first time, repeat a second time until a drop of liquid appears at the needle tip.
Če se prvič ne pojavi tekočina, ponovite postopek drugič, do pojava kaplje tekočine na konici injekcijske igle.
Then set the dose as describe in section 4.
Nato nastavite odmerek, kot je opisano v točki 4.
273 direction until the dose arrow is pointing to the dose you require (The black dosage dial lets you set the dose in steps of 37.5 IU.
(Črna številčnica za odmerjanje, omogoča nastavitev odmerka v korakih po 37, 5 i. e.
The minimum dose and the maximum dose that you can set are respectively equal to 37.5 IU and 450 IU).
Najmanjši odmerek, ki ga lahko nastavite je enak 37, 5 i. e. in največji odmerek je enak 450 i. e.
If after having pulled out the injection button you realize that you have set and loaded a wrong dose, do not inject.
Če potem, ko ste povlekli injekcijski gumb, ugotovite, da ste nastavili in napolnili napačen odmerek, ga ne injicirajte.
274 2.
272 2.
The red dosage control scale on the injection button enables you to check whether the last dose will be complete or not.
Rdeča številčnica za kontrolo odmerka na gumbu za injiciranje vam omogoča preverjanje, ali bo zadnji odmerek popoln ali ne.
If the loaded dose is no sufficient to complete your injection, you have two possibilities: a.
Če napolnjeni odmerek ne zadošča za injiciranje celotnega nastavljenega odmerka, imate dve možnosti: a.
Inject the partial dose (remained in this pre-filled pen) and then complete immediately the injection of the rest of the dose using a new pre-filled pen (do not forget to record the partial dose). b.
Injicirajte delni odmerek (kolikor je ostalo v tem napolnjenem peresniku) in nato takoj injicirajte preostali del odmerka z uporabo novega napolnjenega peresnika (ne pozabite si zabeležiti delnega odmerka). b.
These problems may effect more than 10 patients out of 100 treated.
Te težave prizadenejo več kot 10 od 100 bolnikov, ki se zdravijo.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see also section 2) can occur (between 1 and 10 patients out of 100 treated patients).
Po zdravljenju z GONALOM - f, ki mu sledi dajanje človeškega horionskega gonadotropina, se lahko pojavi stanje (pri 1 do 10 bolnicah od 100 bolnic, ki se zdravijo), ki se imenuje sindrom hiperstimulacije jajčnikov (glejte tudi poglavje 2).
275 Side effects in men Men may experience some breast development, acne or weight gain due to treatment with hCG (between 1 and 10% of the patients).
273 Neželeni učinki pri moških Pri moških se lahko zaradi zdravljenja s hCG- jem pojavijo razvoj prsi, akne ali pridobivanje telesne mase (pri 1 in 10% bolnikov).
Each cartridge delivers 900 IU (equivalent 66 micrograms) in 1.5 ml.
(enakovredno 66 mikrogramov) v 1, 5 ml.
What GONAL-f looks like and contents of the pack
274 Izgled zdravila GONAL- f in vsebina pakiranja
It is supplied in packs of 1 pre-filled pen and 14 needles for administration.
Dobavlja se v škatlicah z 1 napolnjenim injekcijskim peresnikom in 14 injekcijskimi iglami za dajanje zdravila.
276 Marketing Authorisation Holder
Imetnik dovoljenja za promet z zdravilom
Merck Serono S. p. A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy.
Merck Serono S. p. A., Via delle Magnolie 15, I - 70026 Modugno (Bari), Italija
277 Ελλάδα Merck A. E.
275 Ελλάδα Merck A. E.
PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS
PREPANDEMIČNO CEPIVO PROTI GRIPI (H5N1) Z DELCI VIRIONOV, INAKTIVIRANO (Z ADJUVANSOM) GLAXOSMITHKLINE BIOLOGICALS
What is ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals’? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a vaccine that is given by injection.
Kaj je „ prepandemično cepivo proti gripi (h5n1) z delci virionov, inaktivirano (z adjuvansom) Glaxosmithkline Biologicals “?
It contains parts of influenza (flu) viruses that have been inactivated (killed).
„ Prepandemično cepivo proti gripi (h5n1) z delci virionov, inaktivirano (z adjuvansom) Glaxosmithkline Biologicals “ je cepivo, ki se daje z injiciranjem.
The vaccine contains a flu strain called ‘ A/ VietNam/ 1194/ 2004 NIBRG-14’ (H5N1).
Cepivo vsebuje sev gripe, imenovan „ A/ VietNam/ 1194/ 2004 NIBRG- 14 “ (H5N1).
This vaccine is the same as Prepandrix, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Prepandrix, ki je že odobreno v Evropski uniji (EU).
The company that makes Prepandrix has agreed that its scientific data can be used for this vaccine.
Družba, ki izdeluje zdravilo Prepandrix, je privolila v to, da se znanstveni podatki tega zdravila uporabljajo tudi za to cepivo.
What is the vaccine used for? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a vaccine for use in adults aged between 18 and 60 years to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
„ Prepandemično cepivo proti gripi (h5n1) z delci virionov, inaktivirano (z adjuvansom) Glaxosmithkline Biologicals “ je cepivo, namenjeno za uporabo pri odraslih v starosti od 18 do 60 let za zaščito proti gripi, ki jo povzroča sev (tip) H5N1 virusa gripe A.
The vaccine is given by injection into the upper arm muscle in two doses, at least three weeks apart.
Cepivo se daje z injiciranjem v mišico nadlakti v dveh odmerkih v razmaku najmanj treh tednov.
How does the vaccine work? ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ is a ‘ prepandemic’ vaccine.
„ Prepandemično cepivo proti gripi (h5n1) z delci virionov, inaktivirano (z adjuvansom) Glaxosmithkline Biologicals “ je „ prepandemično “ cepivo.
This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
To je posebna vrsta cepiva, namenjena za zaščito proti sevu gripe, ki lahko povzročiti pandemijo v prihodnosti.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Zdravstvene strokovnjake skrbi, da bi utegnil naslednjo pandemično gripo povzročiti sev virusa H5N1.
The vaccine has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Cepivo je bilo razvito, da bi nudilo zaščito proti temu sevu, tako da ga je mogoče uporabiti pred ali med pandemijo gripe.
This vaccine contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „ učijo “, kako naj se brani pred boleznijo.
The virus has first been inactivated (killed) so that it does not cause any disease.
To cepivo vsebuje majhno količino hemaglutininov (beljakovin s površine)
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. virusa H5N1.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Virus je bil najprej inaktiviran (uničen), tako da ne povzroča bolezni.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Ko oseba prejme cepivo, imunski sistem prepozna virus kot tujek in proti njemu razvije protitelesa.
This may help to protect against the disease caused by the virus.
V tem primeru lahko imunski sistem, če je ponovno izpostavljen virusu, hitreje tvori protitelesa.
The resulting ‘ emulsion’ is then injected.
Tako dobljena „ emulzija “ se nato injicira.
The emulsion contains an ‘ adjuvant ’ (a compound containing oil) to stimulate a better response.
Emulzija vsebuje tudi „ adjuvans “ (spojino, ki vsebuje olje) za stimulacijo boljšega odziva.
The effects of the vaccine were first tested in experimental models before being studied in humans.
Učinki zdravila so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of the vaccine included 400 healthy adults and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘ immunogenicity’).
V glavno študijo cepiva je bilo vključenih 400 zdravih odraslih.
The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
V njej so primerjali učinkovitost različnih odmerkov cepiva, z adjuvansom ali brez njega, pri sprožanju tvorbe protiteles (imunogenost).
The injections were given 21 days apart.
Injekciji sta bili aplicirani v razmiku 21 dni.
The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Glavno merilo učinkovitosti je bila koncentracija protiteles proti virusu gripe v krvi v treh različnih obdobjih: pred cepljenjem, na dan drugega cepljenja (21. dan) in 21 dni kasneje (42. dan).
Additional studies were used to support the main study and to demonstrate the vaccine’ s safety.
V podporo glavni študiji in za dokazovanje varnosti cepiva so bile izvedene dodatne študije.
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
V skladu z merili, ki jih je določil Odbor za zdravila za uporabo v humani medicini (CHMP), mora prepandemično cepivo, da lahko velja kot primerno, zagotoviti zaščitno koncentracijo protiteles pri vsaj 70% ljudi.
The main study showed that the vaccine containing 3.75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria.
Glavna študija je pokazala, da cepivo, ki vsebuje 3, 75 mikrograma hemaglutinina in adjuvans, povzroči protitelesni odziv, ki zadovolji to merilo.
At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
21 dni po drugem injiciranju je imelo 84% ljudi, ki so prejeli cepivo, koncentracijo protiteles, ki bi jih zaščitila proti H5N1.
The most common side effects with ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals’ (occurred with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Najpogostejši neželeni učinki „ prepandemičnega cepiva proti gripi (h5n1) z delci virionov, inaktiviranega (z adjuvansom) Glaxosmithkline Biologicals “ (ki so se pojavili pri 1 od 10 odmerkov cepiva) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (zatrdlina, oteklina, bolečina, rdečina), zvišana telesna temperatura in utrujenost.
The vaccine should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Cepivo se ne sme dajati osebam, ki so imele analifaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki se v sledeh (v zelo nizkih količinah) nahajajo v cepivu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
Vaccination should be delayed in people who have a sudden fever.
Pri osebah, ki imajo nenadno zvišano telesno temperaturo, je treba cepljenje odložiti.
The CHMP decided that the benefits of ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi „ prepandemičnega cepiva proti gripi (h5n1) z delci virionov, inaktiviranega (z adjuvansom) Glaxosmithkline Biologicals “ pri aktivni imunizaciji proti podtipu H5N1 virusa gripe A večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the EU for ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ to GlaxoSmithKline Biologicals S. A. on 26 September 2008.
Evropska komisija je dovoljenje za promet s „ prepandemičnim cepivom proti gripi (h5n1) z delci virionov, inaktiviranim (z adjuvansom) Glaxosmithkline Biologicals “, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 26. septembra 2008.
Strength
Jakos t
Prepandemic influenza
Prepandemično cepivo proti gripi (H5N1) (z delci
3.75 µg HA
3, 75 µ g HA
Suspension and Emulsion for
Suspenzija in emulzija za emulzijo za
suspension (H5N1): vial (glass)
suspenzija (H5N1): viala (steklo) emulzija (adjuvans):
2.5 ml (suspension)
2, 5 ml (suspenzija) 2, 5 ml (emulzija)
50 vials (suspension)
50 vial (suspenzija) 2 x 25 vial (emulzija)
vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline Biologicals
virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals
2.5 ml (emulsion)
injiciranje
2 x 25 vials (emulsion)
viala (steklo)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg suspenzija in emulzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
After mixing, 1 dose (0.5 ml) contains:
Po premešanju 1 odmerek (0, 5 ml) vsebuje:
Split influenza virus inactivated, containing antigen* equivalent to:
Inaktivirane delce virusa gripe z vsebnostjo antigena *, ki ustreza:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * propagated in eggs ** haemagglutinin
3, 75 mikrogramov ** A/ VietNam/ 1194/ 2004 (H5N1) podobnemu sevu (NIBRG- 14) * namnožen v jajcih ** hemaglutinin
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
Adjuvans AS03, ki je sestavljen iz skvalena (10, 68 miligramov), DL- α- tokoferola (11, 86 miligramov) in polisorbata 80 (4, 85 miligramov).
It contains 5 micrograms thiomersal
Vsebuje 5 mikrogramov tiomersala.
This indication is based on immunogenicity data from healthy subjects aged 18-60 years following administration of two doses of vaccine prepared from A/ VietNam/ 1194/ 2004 NIBRG-14 (H5N1) (see section 5.1).
Indikacija temelji na podatkih o imunogenosti pri zdravih prostovoljcih, starih od 18 do 60 let, po cepljenju z dvema odmerkoma cepiva, pripravljenega iz A/ VietNam/ 1194/ 2004 NIBRG- 14 (H5N1) (glejte poglavje 5. 1).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg je treba uporabljati v skladu z uradnimi smernicami.
Adults from the age of 18 to 60 years:
Odrasli, stari od 18 do 60 let:
1 dose of 0.5 ml at an elected date.
1 odmerek 0, 5 ml na izbrani dan.
A second dose of vaccine should be given after an interval of at least three weeks.
Drugi odmerek cepiva morajo prejeti najmanj 3 tedne po prvem odmerku.
There is no experience in children and adults above 60 years of age.
Pri otrocih in odraslih, starejših od 60 let, ni izkušenj.
2 For further information, see section 5.1.
2 Za dodatne informacije glejte poglavje 5. 1.
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Anafilaksijska reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali zaostanke v sledeh (jajčni in piščančji proteini, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
See sections 4.4, 4.8 and 6.1.
Glejte poglavja 4. 4, 4. 8 in 6. 1.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaksijske reakcije) za zdravilno učinkovino, katerokoli pomožno snov, tiomersal ali zaostanke (jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg se v nobenem primeru ne sme injicirati v žilo ali v kožo.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov na osnovi ELISA metode za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV- 1), virusu hepatitisa C in še posebej proti HTLV- 1.
No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
O uporabi Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg ali kateregakoli drugega cepiva z adjuvansom AS03 pri nosečnicah ni podatkov.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ foetal development, parturition or post-natal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost, nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
3 There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
3 O uporabi Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg med dojenjem ni podatkov.
The potential benefits to the mother and risks to the infant should be considered before administering Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Pred cepljenjem doječe matere s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg je treba presoditi o možnih koristih za mater in tveganjih za dojenega otroka.
Some of the effects mentioned under section 4.8 “ Undesirable Effects” may affect the ability to drive or operate machinery.
Nekateri učinki, navedeni v poglavju 4. 8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
The incidence of adverse reactions has been evaluated in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/ AS03.
Pojavnost neželenih učinkov je bila ovrednotena pri približno 5. 000 osebah, starih 18 let in starejših, ki so prejele cepiva z vsaj 3, 75 mikrograma HA/ AS03.
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000)
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)
Nervous system disorders Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Bolezni živčevja Zelo pogosti: glavobol Občasni: parestezije, somnolenca, omotica
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
Bolezni kože in podkožja Pogosti: ekhimoza na mestu injiciranja, močnejše znojenje Občasni: srbenje, izpuščaj
Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo pogosti: artralgija, mialgija
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: induracija, oteklina, bolečina in rdečina na mestu injiciranja, zvišana telesna temperatura, utrujenost Pogosti: drgetanje, gripi podobna bolezen, reakcije na mestu injiciranja (kot so občutek toplote, srbenje) Občasni: splošno slabo počutje
• Post-marketing surveillance
4 • Spremljanje cepiva po pridobitvi dovoljenja za promet
4 No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
Podatki o spremljanju Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg po pridobitvi dovoljenja za promet niso na voljo.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Cepivo kot konzervans vsebuje tiomersal (organska živosrebrova spojina), ki lahko povzroči preobčutljivostne reakcije (glejte poglavje 4. 4).
Immune response against vaccine strain contained in Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Imunski odziv proti cepilnemu sevu, ki ga vsebuje Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg: