natgillin/translations-raw huggingface dataset:
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ ml and 50.1 mIU/ ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
V 3. mesecu so bili v skupini bolnikov, ki so bili cepljeni s cepivom Fendrix geometrični srednji titri 223, 0 i. e. / l, titre protiteles proti- HBs ≥100 i. e. / l pa je imelo 41% bolnikov.
After completion of a four dose primary course (i. e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.
Po zaključenem osnovnem cepljenju s štirimi odmerki cepiva (npr. v 7. mesecu) je bilo 90, 9% oseb, ki so bile cepljene s cepivom Fendrix serozaščitenih (≥10 i. e/ l) pred okužbo z virusom hepatitisa B v primerjavi s 84, 4% oseb v kontrolni skupini, ki so bile cepljene s komercialno dostopnim cepivom proti hepatitisu B.
At month 7, GMTs were 3559.2 mIU/ ml and 933.0 mIU/ ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
V 7. mesecu so bili v kontrolni skupini geometrični srednji titri 933, 0 i. e. / l, titre protiteles proti- HBs ≥100 i. e. / l pa je imelo 67, 5% bolnikov.
Antibody persistence
6 Persistenca protiteles
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients.
Dokazano je bilo, da pri predhemodializnih in hemodializnih bolnikih protitelesa proti- HBs persistirajo vsaj 36 mesecev po osnovnem cepljenju (0, 1, 2, 6 mesec) s cepivom Fendrix.
At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.
V 36. mesecu je 80, 4% omenjenih bolnikov še imelo zaščitni titer protiteles (titer proti- HBs ≥10 i. e. / l) v primerjavi z 51, 3% bolnikov, ki so bili cepljeni s komercialno dostopnim cepivom proti hepatitisu B.
6 At month 36, GMTs were 154.1 mIU/ ml and 111.9 mIU/ ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥ 100 mIU/ ml respectively.
V 36. mesecu so bili v skupini bolnikov, ki so bili cepljeni s cepivom Fendrix geometrični srednji titri 154, 1 i. e. / l, titre protiteles proti- HBs ≥100 i. e. / l pa je imelo 58, 7% bolnikov.
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6).
Predklinični podatki na osnovi običajnih študij na živalih (akutna toksičnost in toksičnost pri ponavljajočih se odmerkih, farmakološke varnosti za kardiovaskularni in respiratorni sistem in škodljivi vplivi na sposobnost razmnoževanja vključno z brejostjo in peri - ter postnatalnim razvojem psičkov do odstavitve) ne kažejo posebnega tveganja za človeka (glejte poglavje 4. 6).
For adjuvants, see section 2.
6. 2 Inkompatibilnosti
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
0, 5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) s priloženo injekcijsko iglo ali brez v pakiranju po 1, ali brez priloženih injekcijskih igel v pakiranju po 10.
7 The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/ or change in physical appearance.
Pred in po tem, ko se cepivo pretrese, ga je potrebno vizualno pregledati glede morebitne prisotnosti tujih delcev in/ ali spremenjenega fizikalnega videza.
02 February 2005
02. februar 2005
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: / www. emea. europa. eu
9 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
89, rue de l’ Institut – 1330 Rixensart Belgium
89, rue de l’ Institut – 1330 Rixensart Belgija
The Marketing Authorisation Holder will continue to submit 6-monthly PSUR’ s.
Imetnik dovoljenja za promet bo nadaljeval s 6 mesečno predajo PSURov.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH SEPARATE NEEDLE:
12 PODATKI NA ZUNANJI OVOJNINI NAPOLNJENA INJEKCIJSKA BRIZGA S PRILOŽENO INJEKCIJSKO IGLO:
PACK OF 1 PRE-FILLED SYRINGE WITHOUT NEEDLE:
PAKIRANJE PO 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE:
PACK OF 1 PRE-FILLED SYRINGE WITHOUT NEEDLES:
PAKIRANJE PO 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE:
PACK OF 10
PAKIRANJE PO 10
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Fendrix suspenzija za injiciranje Adsorbirano rekombinantno cepivo proti hepatitisu B (rDNA) z adjuvansom
Hepatitis B surface antigen1, 2, 3 1 adjuvanted by AS04C containing:
1 odmerek (0, 5 ml): površinski antigen virusa hepatitisa B1, 2, 3 1 adjuvans AS04C, ki vsebuje:
Pre-filled syringe Separate needle 1 dose (0.5 ml)
Napolnjena injekcijska brizga Priložena injekcijska igla 1 odmerek (0, 5 ml)
Pre-filled syringe 1 dose (0.5 ml)
Napolnjena injekcijska brizga brez injekcijske igle 1 odmerek (0, 5 ml)
Pre-filled syringe 10 x 1 dose 1 dose (0.5 ml)
Napolnjena injekcijska brizga brez injekcijske igle 10 x 1 odmerek 1 odmerek (0, 5 ml)
Intramuscular use Shake before use
Intramuskularna uporaba Pred uporabo pretresite
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
EU/ 1/ 04/ 0299/ 001 – pack of 1 with separate needle EU/ 1/ 04/ 0299/ 002 – pack of 1 without needle EU/ 1/ 04/ 0299/ 003 – pack of 10 without needles
EU/ 1/ 04/ 0299/ 001 – pakiranje po 1 s priloženo injekcijsko iglo EU/ 1/ 04/ 0299/ 002 – pakiranje po 1 EU/ 1/ 04/ 0299/ 003 – pakiranje po 10
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PACK SIZE OF 1 SYRINGE WITH A SEPARATE NEEDLE PACK SIZE OF 1 SYRINGE WITHOUT NEEDLE PACK SIZE OF 10 SYRINGES WITHOUT NEEDLES
PAKIRANJE PO 10
Fendrix suspension for injection IM
Fendrix suspenzija za injiciranje i. m.
17 PACKAGE LEAFLET:
17 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you start receiving this vaccine.
Preden pričnete dobivati to cepivo, natančno preberite navodilo!
What Fendrix is and what it is used for 2.
Kaj je cepivo Fendrix in za kaj ga uporabljamo 2.
Before you receive Fendrix 3.
Kaj morate vedeti, preden boste prejeli cepivo Fendrix 3.
How Fendrix is given 4.
Kako se cepivo Fendrix uporablja 4.
How to store Fendrix 6.
Shranjevanje cepiva Fendrix 6.
WHAT FENDRIX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO FENDRIX IN ZA KAJ GA UPORABLJAMO
Fendrix is a vaccine which prevents hepatitis B disease in patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients) from the age of 15 years onwards.
Fendrix je cepivo, ki se pri bolnikih, ki so starejši od 15 let in imajo ledvično insuficinco (vključno s predhemodializnimi in hemodializnimi bolniki) uporablja za preprečevanje hepatitisa B.
The vaccine works by causing the body to produce its own protection (antibodies) against the disease.
Cepivo deluje tako, da v telesu spodbudi ustvarjanje lastne zaščite (protiteles) proti tej nalezljivi bolezni.
MPL is included in this vaccine as an adjuvant and aluminium phosphate as an adsorbent.
V cepivo je vključen MPL kot adjuvans, aluminijev fosfat pa kot adsorbent.
These substances are included in Fendrix to accelerate, improve and prolong the protective effect of the vaccine.
Ti dve sestavini sta vključeni v cepivo Fendrix, da bi se pospešil, izboljšal in podaljšal zaščitni učinek cepiva.
Hepatitis B disease is caused by the hepatitis B virus.
Hepatitis B je bolezen, ki jo povzroča virus hepatitisa B.
It causes the liver to become swollen (inflamed).
Okužba z virusom hepatitisa B povzroči oteklino jeter (vnetje).
Symptoms may not be seen for 6 weeks to 6 months after infection.
Bolezenski znaki se lahko pojavijo šele 6 tednov do 6 mesecev po okužbi.
Others have mild flu-like symptoms, but some people can become very ill.
Nekateri imajo lahko le znake blage gripe, nekateri pa lahko hudo zbolijo.
They may be extremely tired, and have dark urine, pale faces, yellowish skin and/ or eyes (jaundice), and other symptoms possibly requiring hospitalisation.
Ti ljudje so lahko zelo utrujeni, imajo temen urin, svetlo blato, rumenkasto kožo in/ ali oči (zlatenica) in druge bolezenske znake zaradi katerih je lahko potreben sprejem v bolnišnico.
But some people, who may not even have had symptoms can remain infected.
Vendar pa posamezniki, ki ne kažejo bolezenskih znakov, ostanejo okuženi.
Hepatitis B virus carriers can infect others throughout their lives.
Imenujejo se klicenosci virusa hepatitisa B in lahko ves čas življenja prenašajo virus hepatitisa B na druge.
Hepatitis B virus carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Pri klicenoscih virusa hepatitisa B obstaja tveganje za resne bolezni jeter kot sta ciroza (brazgotinjenje jeter) in rak jeter.
As with all vaccines, Fendrix cannot completely prevent infections with hepatitis B virus, even after you have received the complete primary course of four doses.
Podobno kot velja pri drugih cepivih, se tudi s cepivom Fendrix okužba z virusom hepatitisa B ne more popolnoma preprečiti in to kljub popolnemu osnovnemu cepljenju s štirimi odmerki cepiva.
Also, if you have already been infected with hepatitis B virus prior to receiving Fendrix, but you are not yet feeling unwell, Fendrix may not be able to prevent you from becoming ill.
Če ste bili pred cepljenjem s cepivom Fendrix že okuženi z virusom hepatitisa B, vendar pa še niste imeli bolezenskih znakov, s cepivom Fendrix morda ne bo možno preprečiti bolezni.
Fendrix can only help to protect you against infection with hepatitis B virus.
Cepivo Fendrix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa B.
It cannot protect you against other infections that can affect the liver and that can cause symptoms similar to those of hepatitis B virus infection.
Ne more vas zaščititi pred drugimi okužbami, ki lahko prizadenejo jetra in ki lahko povzročijo podobne bolezenske znake kot okužba z virusom hepatitisa B.
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B virus infection.
Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po cepljenju s cepivom Fendrix pričakuje tudi preventiva hepatitisa D.
Vaccination is the best way to protect against this disease.
18 Cepljenje je najboljši način za zaščito pred to boleznijo.
None of the components in the vaccine are infectious.
Nobena od komponent cepiva ne more povzročiti okužbe.
BEFORE YOU RECEIVE FENDRIX
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI CEPIVO FENDRIX
Fendrix should not be given:
Cepiva Fendrix ne smete prejeti:
• if you have previously had any allergic reaction to Fendrix, or any ingredient contained in this vaccine.
• če ste predhodno imeli kakršno koli alergijsko reakcijo na cepivo Fendrix ali na katero koli sestavino tega cepiva.
The active substances and other ingredients in Fendrix are listed at the end of the leaflet.
Aktivne sestavine in pomožne snovi cepiva Fendrix so navedene na koncu navodila.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue; • if you have previously had an allergic reaction to any vaccine against hepatitis B disease; • if you have a severe infection with a high temperature.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika. • če ste predhodno imeli alergijsko reakcijo na katero koli cepivo proti hepatitisu B. • če imate hudo okužbo z visoko telesno temperaturo.
In these cases, the vaccination will be postponed until you have recovered.
V tem primeru se bo cepljenje odložilo, dokler ne boste ozdraveli.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Blažja okužba, npr. prehlad ne bi smela biti težava, vendar se vseeno najprej pogovorite z zdravnikom.
Take special care with Fendrix Tell your doctor if you have any known allergies.
Bodite posebno pozorni pri cepljenju s cepivom Fendrix Če imate kakršno koli alergijo, to povejte svojemu zdravniku.
Tell your doctor if you have experienced any health problems after previous administration of a vaccine.
Če ste po predhodnem cepljenju imeli kakršne koli zdravstvene težave, to povejte svojemu zdravniku.
Taking other medicines Tell your doctor if you have recently had or expect to shortly have any other vaccinations.
Jemanje drugih zdravil Svojemu zdravniku povejte, če ste bili ali pričakuje, da boste v kratkem cepljeni s katerim koli drugim cepivom.
An interval of at least 2 to 3 weeks between Fendrix and any other vaccine is recommended.
Med cepljenjem s cepivom Fendrix in katerim koli drugim cepivom priporočamo presledek vsaj 2 do 3 tedne.
If Fendrix is to be given at the same time as specific hepatitis B immunoglobulins, these should be given at different injection sites.
Če boste sočasno s cepivom Fendrix prejeli tudi specifične imunoglobuline proti hepatitisu B, jih morate dobiti na ločenih mestih.
Your doctor will be able to advise you .”
Posvetujte se z zdravnikom.
Pregnancy and breast-feeding Tell your doctor if you are or think you may be pregnant.
Nosečnost in dojenje Če menite, da ste noseči, to povejte svojemu zdravniku.
Tell your doctor if you are breast-feeding.
Če dojite, to povejte svojemu zdravniku.
Driving and using machines Take special care while driving and using machines as Fendrix may give you headache or make you feel tired.
Vpliv na sposobnost upravljanja vozil in strojev Med vožnjo vozil in upravljanjem strojev bodite še posebej previdni, saj lahko cepivo Fendrix povzroči glavobol ali utrujenost.
HOW FENDRIX IS GIVEN
KAKO SE CEPIVO FENDRIX UPORABLJA
If you are a patient with renal insufficiency, you will receive a total of four injections.
Če ste bolnik z ledvično insuficienco boste skupno prejeli štiri odmerke cepiva.
These will be given within a time period of 6 months.
Odmerke boste prejeli v 6 mesecih.
Each injection is given on a separate visit.
Vsak odmerek boste dobili ob drugem obisku.
The first dose will be given on an agreed date with your doctor and the remaining three doses will be given one month, two months, and six months after the first dose.
Zdravnik se bo odločil, kdaj boste dobili prvi odmerek, preostale tri odmerke pa boste dobili en mesec, dva meseca in šest mesecev po prejemu prvega odmerka.
First dose:
Prvi odmerek:
Second dose:
Drugi odmerek:
Third dose:
Tretji odmerek:
Fourth dose:
Četrti odmerek:
at an elected date 1 month later 2 months after the first dose 6 months after the first dose
ob izbranem času po enem mesecu 2 meseca po prvem odmerku 6 mesecev po prvem odmerku
Once you have received the first injection of Fendrix, the subsequent injections need to be of the same vaccine.
Ko ste enkrat prejeli prvi odmerek cepiva Fendrix, se morajo tudi preostala cepljenja opraviti z istim cepivom.
The doctor or nurse will inform you when you should come back for the subsequent injections.
Zdravnik ali medicinska sestra vam bosta naročila, kdaj se morate vrniti zaradi naslednjega odmerka.
Your doctor will advise you on the possible need for extra doses, and future booster doses.
Zdravnik vam po povedal ali boste v prihodnosti morda potrebovali še dodatne odmerke in obnovitvene odmerke.
Fendrix can be used as a booster dose after a primary vaccination course with either a commercial recombinant hepatitis B vaccine or Fendrix.
Cepivo Fendrix se lahko uporabi za obnovitveni odmerek po končanem
19 If you miss a scheduled injection, talk to your doctor and arrange another visit.
19 osnovnem cepljenju s komercialno dostopnimi rekombinantnimi cepivi proti hepatitisu B ali končanem osnovnem cepljenju s cepivom Fendrix.
Make sure you finish the complete vaccination course of four injections.
Preverite ali ste prejeli vse štiri načrtovane odmerke cepiva.
The doctor or nurse will give Fendrix as an injection into the muscle, usually in your upper arm.
Cepivo Fendrix vam bo dal zdravnik ali medicinska sestra in sicer v obliki injekcije v mišico, običajno v zgornji predel roke.
They will take care that Fendrix is not given into a blood vessel and into the skin.
Pri cepljenju bosta pazila, da cepiva Fendrix ne bosta dala v krvno žilo ali kožo.
Like all medicines, Fendrix can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Fendrix neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects that occurred during a clinical trial with Fendrix in pre-haemodialysis and haemodialysis patients were as follows:
Neželeni učinki, ki so se pojavili med kliničnim preskušanjem s cepivom Fendrix pri bolnikih, ki se naj bi zdravili in bolnikih, ki so se zdravili s hemodializo so naslednji:
♦ Very common (more than 1 per 10 doses of vaccine): • Pain or discomfort at the injection site • Fatigue • Headache
♦ zelo pogosti (več kot 1 na 10 odmerkov cepiva):
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): • Redness, swelling at the injection site • Fever • Stomach and digestive complaints
♦ pogosti (manj kot 1 na 10, vendar več kot 1 na 100 odmerkov cepiva):
♦ Uncommon (less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • Chills • Other injection site reaction • Red raised skin rash
♦ občasni (manj kot 1 na 100, vendar več kot 1 na 1. 000 odmerkov cepiva): • mrazenje • druge reakcije na mestu injiciranja • nad nivo kože privzdignjen kožni izpuščaj
Healthy subjects were also included in clinical studies.
V klinične študije so bile vključene tudi zdrave osebe.
In addition, the following effects were rarely observed:
Neželeni učinki zaradi cepiva Fendrix so bili v glavnem primerljivi s tistimi pri predhemodializnih in hemodializnih bolnikih Razen teh so bili opaženi še naslednji neželeni učinki:
♦ Rare (less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine): • Allergy, unusual tiredness, hot flushes, • Dizziness • Thirst • Back pain, swelling of the tendons • Nervousness • Viral infection
♦ redki (manj kot 1 na 1. 000, vendar več kot 1 na 10. 000 odmerkov cepiva): • alergija, neobičajna utrujenost, vročinski valovi • omotica • žeja • bolečine v hrbtu, otekanje kit • živčnost • virusne okužbe
Allergic reactions, including anaphylactoid reactions, may occur very rarely (less than 1 per 10,000 doses of vaccine).
Zelo redko se lahko pojavijo alergijske reakcije vključno z anafilaktoidnimi reakcijami (manj kot 1 na 10. 000 odmerkov cepiva).
These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Te se lahko pojavijo v obliki omejenih ali razširjenih kožnih izpuščajev, ki so lahko srbeči ali mehurčasti, otekanje oči ali obraza, oteženo dihanje in požiranje, nenadno zmanjšanje krvnega tlaka in izguba zavesti.
Such reactions may occur before leaving the doctor’s surgery.
Te reakcije se lahko pojavijo še pred odhodom iz ordinacije.
However, you should seek immediate treatment in any event.
V katerem koli primeru morate nujno poiskati zdravniško pomoč.
Additional side effects that have been reported very rarely (less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with hepatitis B vaccines, include fits, faints, disease of the nerves of the eye, multiple sclerosis, loss of sensation in, or of the ability to move some parts of the body, severe headache with stiff neck, disruption of the normal brain functions.
20 Drugi neželeni učinki, o katerih so poročali zelo redko (manj kot 1 na 10. 000 odmerkov cepiva), več dni ali tednov po cepljenju s cepivi proti hepatitisu B so: krči, omedlevica, bolezen očesnih živcev, multipla skleroza, izguba občutka ali sposobnosti za premikanje posameznih delov telesa, hud glavobol z otrdelim vratom, zbadanje, moteno normalno delovanje možganov.
20 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE FENDRIX
SHRANJEVANJE CEPIVA FENDRIX
Do not use Fendrix after the expiry date which is stated on the carton.
Cepiva Fendrix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Fendrix contains
Kaj vsebuje cepivo Fendrix
The active substance contained in 1 dose (0.5 ml) of Fendrix is:
Aktivna sestavina v 1 odmerku (0, 5 ml) cepiva Fendrix je:
Hepatitis B surface antigen 1, 2, 3 1 adjuvanted by AS04C containing:
površinski antigen virusa hepatitisa B 1, 2, 3 1 adjuvans AS04C, ki vsebuje:
- 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
- 3- O- desacil- 4 '- monofosforil lipid A (MPL) 2 2 adsorbiran na aluminijev fosfat (skupno 0, 5 miligramov Al3+) 3
The other ingredients in the vaccine are: sodium chloride, water for injections.
pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae).
What Fendrix looks like and contents of the pack
Pomožne snovi cepiva Fendrix so: natrijev klorid in voda za injekcije.
Suspension for injection in prefilled syringe.
Izgled cepiva Fendrix in vsebina pakiranja
Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Cepivo Fendrix je bela, mlečna suspenzija v stekleni napolnjeni injekcijski brizgi (0, 5 ml).
Fendrix is available in packs of 1 with or without separate needle and in pack size of 10 without needles.
Cepivo Fendrix je na voljo v pakiranjih z 1 napolnjeno injekcijsko brizgo z ločeno iglo ali brez nje in v pakiranjih z 10 napolnjenimi injekcijskimi brizgami brez igel.
This leaflet was last approved in 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 /
The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance.
Pred ali po tem, ko se cepivo pretrese, ga je potrebno vizualno pregledati glede morebitne prisotnosti tujih delcev in/ ali spremenjenega fizikalnega videza.
Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.
S cepivom Fendrix se ne sme cepiti oseb, ki so preobčutljive za aktivne sestavine ali katero koli pomožno snov cepiva Fendrix.
Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.
23 Ker lahko intramuskularno dajanje cepiva v glutealno mišičnino vodi v suboptimalni odziv na cepivo, se je temu načinu dajanja potrebno izogibati.