natgillin/translations-raw huggingface dataset:
WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS AND WHAT IT IS USED FOR
KAJ JE PREPANDEMIČNO CEPIVO PROTI GRIPI (H5N1) (Z DELCI VIRIONOV, INAKTIVIRANO, Z ADJUVANSOM) GLAXOSMITHKLINE BIOLOGICALS 3, 75 µg IN ZA KAJ GA UPORABLJAMO
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 to 60 years old.
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg uporabljamo pri odraslih, starih od 18 do 60 let.
When a person is given the vaccine, the immune system (the body’ s natural defence system) will produce its own protection (antibodies) against the disease.
Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) pred boleznijo.
As with all vaccines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg may not fully protect all persons who are vaccinated.
Kot druga cepiva tudi Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
BEFORE YOU RECEIVE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg
KAJ MORATE VEDETI, PREDEN BOSTE CEPLJENI S PREPANDEMIČNIM CEPIVOM PROTI GRIPI (H5N1) (Z DELCI VIRIONOV, INAKTIVIRANO, Z ADJUVANSOM) GLAXOSMITHKLINE BIOLOGICALS 3, 75 µg
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should not be given:
S Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg ne smete biti cepljeni:
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde,
• če se je pri vas kdaj pojavila nenadna, smrtno nevarna alergijska reakcija na katerokoli sestavino Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg (navedena so na koncu tega navodila) ali na katerokoli od naslednjih snovi, ki so lahko prisotne v manjših količinah: jajčne ali piščančje proteine,
26 gentamicin sulphate (antibiotic) or sodium deoxycholate.
26 ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Blažja okužba, npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg o tem vseeno posvetujte s svojim zdravnikom.
Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Bodite posebno pozorni pri cepljenju s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg:
(see section 6.
• če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, smrtno nevarne alergijske reakcije) na katerokoli sestavino cepiva, tiomersal, jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat (glejte poglavje 6, Dodatne informacije). • če imate težave z imunskim sistemom.
Further information). • if you have problems with your immune system, since your response to the vaccine may then be poor. • if you are having a blood test to look for evidence of infection with certain viruses.
V tem primeru je odziv na cepljenje lahko slabši. • če morate opraviti krvne preiskave zaradi testiranja na okužbe z nekaterimi virusi.
In the first few weeks after vaccination with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg the results of these tests may not be correct.
V prvih nekaj tednih po cepljenju s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg so lahko rezultati teh preiskav napačni.
Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Zdravnika obvestite tudi, če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom.
Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
O sočasnem cepljenju s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg in drugimi cepivi ni podatkov, zato Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg ni namenjeno za uporabo skupaj z drugimi cepivi.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Če jemljete katerokoli zdravilo, ki zmanjšuje imunost proti okužbam, ali se zdravite s katerokoli drugo obliko zdravljenja, ki vpliva na imunski sistem (npr. obsevanje), ste s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg lahko cepljeni, vendar pa je odziv na cepivo lahko slabši.
Pregnancy and breast-feeding There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Nosečnost in dojenje O uporabi Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg med nosečnostjo in dojenjem ni podatkov.
Please tell your doctor if you are/ may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Njegova navodila natančno upoštevajte.
Driving and using machines Some effects mentioned under section 4. “ Possible side effects” may affect the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri učinki, navedeni v poglavju 4, "Možni neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Important information about some of the ingredients of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Pomembne informacije o nekaterih sestavinah Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg Cepivo vsebuje tiomersal (konzervans), ki lahko povzroči alergijsko reakcijo.
27 This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i. e. essentially sodium- and potassium-free.
27 To cepivo vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek, kar v bistvu pomeni “ brez natrija ” in “ brez kalija ”.
HOW PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS GIVEN
KAKO UPORABLJATI PREPANDEMIČNO CEPIVO PROTI GRIPI (H5N1) (Z DELCI VIRIONOV, INAKTIVIRANO, Z ADJUVANSOM) GLAXOSMITHKLINE BIOLOGICALS 3, 75 µg
You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Prejeli boste dva odmerka Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg.
The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg vam bo zdravnik ali medicinska sestra dal/ dala v obliki injekcije v mišico nadlakti.
Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
♦ Very common (these may occur with 1 in 10 doses or more of the vaccine): • Tiredness • Headache • Pain, redness, swelling or a hard lump at the injection site • Fever • Aching muscles, joint pain
♦ Zelo pogosti (pojavijo se lahko pri 1 od 10 odmerkov cepiva ali pogosteje): • utrujenost. • glavobol. • bolečina, rdečina, oteklina ali zatrdlina na mestu injiciranja. • zvišana telesna temperatura. • bolečine v mišicah, bolečine v sklepih.
♦ Common (these may occur with up to 1 in 10 doses of the vaccine): • Warmth, itching or bruising at the injection site • Increased sweating, shivering, flu-like symptoms • Swollen glands in the neck, armpit or groin
♦ Pogosti (pojavi se lahko pri do 1 od 10 odmerkov cepiva): • občutek toplote, srbenje ali modrica na mestu injiciranja. • močnejše znojenje, drgetanje, gripi podobni simptomi. • oteklina vratnih, podpazdušnih ali dimeljskih bezgavk.
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Tingling or numbness of the hands or feet • Dizziness • Sleepiness • Sleeplessness • Diarrhoea, vomiting, stomach pain, feeling sick • Itching, rash • Generally feeling unwell
♦ Občasni (pojavi se lahko pri do 1 od 100 odmerkov cepiva): • mravljinčenje ali odrevenelost v rokah ali nogah. • omotica. • zaspanost. • nespečnost • driska, bruhanje, bolečine v želodcu, siljenje na bruhanje. • srbenje, izpuščaj. • splošno slabo počutje.
Other side effects which have occurred in the days or weeks after vaccination with ordinary flu vaccines include:
Drugi neželeni učinki, ki so se pojavili v dnevih ali tednih po cepljenju z običajnimi cepivi proti gripi, so:
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
♦ Občasni (pojavijo se lahko pri do 1 od 100 odmerkov cepiva): • generalizirane kožne reakcije, vključno z urtikarijo (koprivnic).
♦ Rare (these may occur with up to 1 in 1,000 doses of the vaccine): • Severe stabbing or throbbing pain along one or more nerves
28 ♦ Redki (pojavijo se lahko pri do 1 od 1. 000 odmerkov cepiva): • hujša zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev. • krči • znižanje števila trombocitov s posledičnim pojavom krvavitev ali modric. • alergijske reakcije z nevarnim znižanjem krvnega tlaka, ki lahko brez zdravljenja povzročijo kolaps, komo in smrt.
♦ Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Narrowing or blockage of blood vessels with kidney problems • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may spread across the body.
♦ Zelo redki (pojavi se lahko pri do 1 od 10. 000 odmerkov cepiva): • zoženje ali zapora krvnih žil z ledvičnimi težavami. • prehodno vnetje možganov in živcev, kar lahko povzroči bolečino, šibkost in ohromelost, ki lahko zajame celo telo.
HOW TO STORE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg
SHRANJEVANJE PREPANDEMIČNEGA CEPIVA PROTI GRIPI (H5N1) (Z DELCI VIRIONOV, INAKTIVIRANO, Z ADJUVANSOM) GLAXOSMITHKLINE BIOLOGICALS 3, 75 µg
After mixing, use the vaccine within 24 hours and do not store above 25°C.
Shranjujte pri temperaturi do 25 °C.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
Kaj vsebuje Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg
- Active substance:
- Zdravilna učinkovina:
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Po premešanju en odmerek (0, 5 ml) vsebuje 3, 75 mikrogramov hemaglutinina naslednjega seva virusa gripe:
This compound contains squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams).
Viala z emulzijo vsebuje "adjuvans" (AS03), ki je sestavljen iz skvalena (10, 68 miligramov), DL- α- tokoferola (11, 86 miligramov) in polisorbata 80 (4, 85 miligramov).
Adjuvants are used to improve the body’ s response to the vaccine.
Adjuvans se uporablja zato, da okrepi telesni imunski odziv na cepivo.
- Other ingredients:
- Pomožne snovi:
29 What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Izgled Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg in vsebina pakiranja
One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Eno pakiranje Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg vsebuje:
- one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
- eno pakiranje s 50 vialami po 2, 5 ml suspenzije (zdravilna učinkovina) za 10 odmerkov
- two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
- dve pakiranji s 25 vialami po 2, 5 ml emulzije (adjuvans) za 10 odmerkov
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
30 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
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 / ---------------------------------------------------------------------------------------------------------------------
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
What is HBVAXPRO?
Kaj je zdravilo HBVAXPRO?
HBVAXPRO is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
Zdravilo HBVAXPRO je cepivo, ki je na voljo v obliki suspenzije za injiciranje v vialah in napolnjenih injekcijskih brizgah.
HBVAXPRO is available in two strengths (10 and 40 micrograms/ ml).
Zdravilo HBVAXPRO je na voljo v dveh jakostih (10 in 40 mikrogramov/ ml).
What is HBVAXPRO used for?
Za kaj se zdravilo HBVAXPRO uporablja?
HBVAXPRO is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
Zdravilo HBVAXPRO se uporablja kot cepivo proti virusu hepatitisa B pri ljudeh, ki jih ogroža okužba s tem virusom, pri čemer morajo biti ogrožene skupine določene na podlagi uradnih priporočil.
How is HBVAXPRO used?
Kako se zdravilo HBVAXPRO uporablja?
A course of vaccination should include at least three injections of HBVAXPRO.
Ciklus cepljenja mora obsegati vsaj tri injekcije zdravila HBVAXPRO.
The recommended dose for children up to the age of 15 years is 0.5 ml of the lower strength (10 micrograms/ ml) at each injection.
Priporočeni odmerek za otroke, stare do 15 let, je 0, 5 ml zdravila nižje jakosti (10 mikrogramov/ ml) z vsako injekcijo.
The higher strength (40 micrograms/ ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
Zdravilo z večjo jakostjo (40 mikrogramov/ ml) se uporablja pri bolnikih, ki so na dializi (tehnika čiščenja krvi) ali nanjo čakajo.
HBVAXPRO is usually given as an injection into the muscle of the thigh in babies and infants, and of the shoulder in children, adolescents and adults.
Zdravilo HBVAXPRO se navadno daje kot injekcija v mišičje stegna pri novorojenčkih in dojenčkih ter v ramo pri otrocih, mladostnikih in odraslih.
The timing of injections depends on the patient ’ s age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Čas dajanja injekcij je odvisen od starosti bolnika, moči njegovega imunskega sistema, odziva na cepljenje in verjetnosti okužbe z virusom hepatitisa B.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Vse podrobnosti so na voljo v Povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
How does HBVAXPRO work?
Kako zdravilo HBVAXPRO deluje?
HBVAXPRO is a vaccine.
Zdravilo HBVAXPRO je cepivo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „ naučijo “, kako naj se brani pred boleznimi.
HBVAXPRO contains small amounts of ‘ surface antigens ’ (proteins from the surface) of the hepatitis B virus.
Zdravilo HBVAXPRO vsebuje majhne količine „ površinskih antigenov “ (beljakovin s površine) virusa hepatitisa B.
When a person is given the vaccine, the immune system recognises the surface antigens as ‘ foreign’ and makes antibodies against them.
Ko oseba prejme cepivo, imunski sistem prepozna površinske beljakovine kot „ tujke “ in začne proti njim tvoriti protitelesa.
The surface antigens in HBVAXPRO are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce
Površinske antigene v zdravilu HBVAXPRO proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNA “, pri kateri kvasovka prejeme gen (DNA), s katerim lahko tvori te beljakovine.
The surface antigens are also ‘ adsorbed’.
Površinski antigeni so tudi „ adsorbirani “.
HBVAXPRO was specifically developed from a vaccine that was already in use in the European Union (EU), in order to remove the preservative thiomersal, which contains mercury.
Zdravilo HBVAXPRO je bilo posebej razvito iz cepiva, ki je že bilo v uporabi v Evropski uniji (EU), pri čemer so iz njega odstranili konzervans tiomersal, ki vsebuje živo srebro.
Repeated exposure to mercury from sources such as medicines and foods could lead to it building up in the organs.
Ponavljajoča se izpostavitev živemu srebru iz virov, kakršna so zdravila in živila, lahko povzroči njegovo kopičenje v organih.
This build-up could be dangerous and is a cause of concern.
To kopičenje je lahko nevarno in predstavlja razlog za zaskrbljenost.
How has HBVAXPRO been studied?
Kako je bilo zdravilo HBVAXPRO raziskano?
Because the active substance used in HBVAXPRO was already authorised for use in the EU, there have been no formal studies of HBVAXPRO.
Ker je bila zdravilna učinkovina v zdravilu HBVAXPRO že odobrena za uporabo v EU, formalne študije zdravila HBVAXPRO niso bile izvedene.
The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVAXPRO.
Družba je priskrbela informacije o primerjavi drugih cepiv s tiomersalom ali brez njega, vključno s študijami cepiva, ki vsebuje isto zdravilno učinkovino kot HBVAXPRO.
What benefit has HBVAXPRO shown during the studies?
Kakšne koristi je zdravilo HBVAXPRO izkazalo med raziskavami?
The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Rezultati predstavljenih študij so pokazali, da so cepiva, ki niso vsebovala tiomersala, izzvala nastanek zaščitne ravni protiteles proti virusu hepatitisa B, ki so bile na koncu ciklusa cepljenja podobne kot ravni pri cepivih, ki so vsebovala tiomersal.
This included the vaccines that contain the same active substance as HBVAXPRO.
To vključuje tudi cepiva, ki vsebujejo isto zdravilno učinkovino kot zdravilo HBVAXPRO.
What is the risk associated with HBVAXPRO?
Kakšna tveganja so povezana z zdravilom HBVAXPRO?
The most common side effects with HBVAXPRO (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
Najpogostejši neželeni učinki zdravila HBVAXPRO (opaženi pri 1 do 10 bolnikih izmed 100) so reakcije na mestu injiciranja, ki vključujejo prehodno občutljivost, eritem (pordelost) in induracijo (otrdlina).
For the full list of side effects reported with HBVAXPRO, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila HBVAXPRO, glejte Navodilo za uporabo.
HBVAXPRO should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Zdravila HBVAXPRO ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino ali katerokoli drugo sestavino zdravila.
It should not be used in people with a severe fever.
Zdravila ne smejo uporabljati bolniki z močno povišano telesno temperaturo.
As for all vaccines, if HBVAXPRO is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Kot pri vseh cepivih obstaja tudi pri uporabi zdravila HBVAXPRO pri veliko prezgodaj rojenih nedonošenčkih tveganje, da dobijo apnejo (kratki zastoji dihanja).
Why has HBVAXPRO been approved?
Zakaj je bilo zdravilo HBVAXPRO odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da odstranitev tiomersala iz cepiva ni zmanjšala učinkovitosti zaščite proti virusu hepatitisa B, temveč je zmanjšala nevarnost cepiv.
Therefore, the Committee decided that HBVAXPRO’ s benefits are greater than its risks for active immunisation against hepatitis B virus infection caused by all known subtypes in people considered at risk of exposure to hepatitis B virus.
Zaradi tega je odbor zaključil, da so koristi cepiva HBVAXPRO za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri osebah, ki jih ogroža okužba s tem virusom, večje od z njim povezanih tveganj.
The Committee recommended that HBVAXPRO be given marketing authorisation.
Odbor je priporočil, da se za zdravilo HBVAXPRO odobri dovoljenje za promet.