FrancophonIA/ELRC3.0 huggingface dataset:
English: A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been administered in a time window of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older aged 60 years and above.
Slovenian: so opravili poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 v časovnem oknu od 12 do 24 mesecev po primarnem cepljenju z dvema odmerkoma cepiva s sevom A/Vietnam/1203/2004.
English: The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Slovenian: A/Vietnam/1203/2004) je bila ocenjena v treh kliničnih študijah pri odraslih, starih od 18 do 59 let (n=961) in pri starejših osebah, starih 60 let in več (n=391), in sicer po shemi cepljenja 0. in 21.
English: • Immunoglobulin is not to be given with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Slovenian: • Ni podatkov o subkutanem injiciranju cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Slovenian: Odstotek oseb, ki imajo titer nevtralizirajočih protiteles enak ali večji od 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji:
English: Dublin 2
Slovenian: PRILOGA II
English: Vomiting Diarrhoea
Slovenian: BOLEZNI MIŠIČNO
English: Influenza-like illness
Slovenian: ŽILNE BOLEZNI
English: Very common Common Common Common Common
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage
Slovenian: utrujenost pireksija mrzlica slabo počutje gripi podobna bolezen nelagoden občutek v prsnem košu reakcije na mestu injiciranja
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB01 Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je pridobilo dovoljenje za promet v ”izjemnih okoliščinah”.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months and older.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je cepivo, ki se uporablja za osebe od 6. meseca starosti naprej, za preprečevanje influence (gripe) v uradno razglašenih pandemskih razmerah.
English: In the event of either being observed, discard the vaccine.
Slovenian: Če je to nujno za zagotavljanje takojšnje zaščite, pa je dovoljeno cepivo
English: • hardness, redness or swelling at the injection site
Slovenian: • otrdlina, rdečina ali oteklina na mestu injiciranja,
English: Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
Slovenian: H5N1 BAXTER (A/Vietnam/1203/2004) Imunogenost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (sev
English: • stuffy or runny nose
Slovenian: • izcedek iz nosu, • driska,
English: Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Slovenian: * površina SRH ≥ 25 mm² Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
English: EAR AND LABYRINTH DISORDERS
Slovenian: UŠESNE BOLEZNI, VKLJUČNO Z MOTNJAMI LABIRINTA
English: • Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Slovenian: • Po uporabi podobnega cepiva proti gripi s celimi virioni, razmnoženimi v celicah Vero,
English: • vertigo (motion sickness)
Slovenian: • omotica, • zaspanost,
English: Oropharyngeal pain Rhinorrhoea
Slovenian: nazofaringitis pogosti
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Slovenian: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
English: MARKETING AUTHORIZATION HOLDER
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: Oropharyngeal pain Cough
Slovenian: limfadenopatija občasni
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may affect your ability to drive or use machines.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER lahko povzroči omotico ali slabost,
English: • increased sweating
Slovenian: • povečano potenje,
English: • fatigue (feeling tired)
Slovenian: • utrujenost, • mrzlica,
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Keep this medicine out of the sight and reach of children.
Slovenian: Shranjevanje cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Zdravilo shranjujte nedosegljivo otrokom!
English: • Injection site pruritus
Slovenian: • draženje na mestu injiciranja • srbečica na mestu injiciranja
English: Decreased appetite
Slovenian: zmanjšan apetit pogosti občasni občasni
English: narrow SMQ “Convulsions”
Slovenian: ozko standardizirano iskanje po MedDRA (Standardised MedDRA Query - SMQ) ”konvulzije”
English: Other medicines and PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: NERVOUS SYSTEM DISORDERS
Slovenian: LIMFATIČNEGA SISTEMA
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose syringe (0.5ml)
Slovenian: Enoodmerna injekcijska brizga (0,5 ml)
English: Posology
Slovenian: PROSTORA
English: Uncommon Very Common
Slovenian: sinkopa zelo pogosti občasni občasni pogosti občasni
English: • hardness, redness, swelling or bruising at the injection site
Slovenian: • bolečine v sklepih ali mišicah, • otrdlina, rdečina, oteklina ali podplutba na mestu injiciranja,
English: EYE DISORDERs
Slovenian: • draženje oči,
English: SRH assay
Slovenian: Test SRH Test MN
English: Dose
Slovenian: dan.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Slovenian: - Revizijo pogostnosti izvedeta imetnik dovoljenja za promet z zdravilom (MAH) in
English: Conjunctivitis Eye irritation
Slovenian: BOLEZNI ŽIVČEVJA
English: Revaccination: every year.
Slovenian: Ponovno cepljenje: enkrat letno.
English: ATC Vet code: QI06AJ02
Slovenian: Oznaka ATC vet :QI06AJ02
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http://www.emea.europa.eu/.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/04/049/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/04/049/001-002
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/02/2005
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23/02/2005
English: Date of last renewal: 15/01/2010
Slovenian: Datum podaljšanja dovoljenja za promet: 15/01/2010
English: The reaction was transient If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: Use only in healthy animals.
Slovenian: Cepite le zdrave živali.
English: Shelf life of the veterinary medicinal product as packaged for sale:18 months.
Slovenian: 6.3 Rok uporabnosti Rok uporabnosti zdravila v pakiranju za prodajo : 18 mesecev.
English: Where high levels of maternal antibodies against R, C or Ch components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Slovenian: Kjer je pričakovati visoke titre maternalnih protiteles proti R, C ali Ch komponentam (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
English: EU/2/04/049/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/049/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Slovenian: EU/2/04/049/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/049/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
English: Per dose of 1ml:
Slovenian: V odmerku po 1 ml:
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov izdelovalcev biološke zdravilne učinkovine (zdravilnih učinkovin).
English: 1 ml 1: cell culture infective dose 50%
Slovenian: 1: 50% infektivni odmerek za celično kulturo
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite v obdobju brejosti.
English: No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Slovenian: Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs and excretion, - against Chlamydophila felis infection to reduce clinical signs.
Slovenian: Aktivna imunizacija 8 tednov starih mačk in starejših: - Proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj - Proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj in zmanjšanje izločanja virusov,
English: Shelf life after reconstitution: use immediately after reconstitution
Slovenian: Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili : uporabite takoj po rekonstituciji
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C) Protect from light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku).
English: Water for injection ....................................................................................................................... q.s.
Slovenian: Vehikel: Voda za injiciranje......................................................................................................................... q.s.
English: In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Slovenian: V zelo redkih primerih sta se en teden do tri tedne po ponovnem cepljenju pri odraslih mačkah pojavili prehodna hipertermija in letargičnost, včasih tudi v povezavi s šepanjem.
English: The duration of immunity is 1 year after the last (re-)vaccination.
Slovenian: Živali so odporne eno leto po zadnjem cepljenju.
English: If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Slovenian: V primeru samo-injiciranja se takoj posvetujte z zdravnikom in mu povejte, da je prišlo do samo-injiciranja z živim cepivom, ki vsebuje klamidijo.
English: Store and transport refrigerated (2 °C - 8 °C) Protect from light.
Slovenian: Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku).
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Slovenian: Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto zaporko.
English: This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products.
Slovenian: Oseba, ki daje zdravilo živalim, ne sme imeti oslabljenega imunskega sistema ali uživati zdravila, ki slabijo imunski sistem.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z Merialovim neadjuviranim cepivom proti levkemiji mačk.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Liofilizat in vehikel za suspenzijo za injiciranje.
English: ROUTE(S) OF ADMINISTRATION Subcutaneous use
Slovenian: POT(I) UPORABE ZDRAVILA Subkutana uporaba
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Slovenian: Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa, kalicivirusu in Chlamydophila felis.
English: EXPIRY DATE EXP (mm/yyyy)
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (mesec/leto)
English: 2: egg infective dose 50%
Slovenian: 2: 50% infektivni odmerek za embrionirana kokošja jajca
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim cepivom proti steklini.
English: Lyophilisate and solvent for suspension for injection.
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje
English: Manufacturer for the batch release: MERIAL
Slovenian: Izdelovalec, odgovoren za sprostitev serije MERIAL
English: Inject by subcutaneous route one dose (1ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Slovenian: Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte odmerek (1-ml) cepiva v podkožje, po naslednjem razporedu:
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Slovenian: Po rekonstituciji liofilizirane sestavine z vehiklom injicirajte 1 ml odmerek (1 ml) cepiva v podkožje, po naslednjem razporedu:
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Slovenian: POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Slovenian: Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Odpadne snovi odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
English: CONTRAINDICATIONS Do not use in pregnant animals.
Slovenian: KONTRAINDIKACIJE Ne uporabite v obdobju brejosti.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamydiosis.
Slovenian: Cepivo proti virusnemu rinotraheitisu, kalicivirusu in klamidiozi.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent
Slovenian: Vsebnik z10 stekleničkami z 1 odmerkom liofilizata in 10 stekleničkami po 1 ml vehikla Vsebnik s 50 stekleničkami z 1 odmerkom liofilizata in 50 stekleničkami po 1 ml vehikla
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate and solvent for suspension for injection
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh liofilizat in vehikel za suspenzijo za injiciranje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh
English: Marketing authorisation holder: MERIAL
Slovenian: Imetnik dovoljenja za promet z zdravilom MERIAL
English: D. STATEMENT OF THE MRLs Not applicable
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent
Slovenian: Vsebnik z10 stekleničkami liofilizata in 10 stekleničkami vehikla Vsebnik s 50 stekleničkami liofilizata in 50 stekleničkami vehikla
English: 29, avenue Tony Garnier 69007 LYON FRANCE
Slovenian: 29 avenue Tony Garnier 69007 LYON FRANCIJA
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate for injection
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Purevax RCCh liofilizat za injiciranje.
English: 29, avenue Tony Garnier F-69007 LYON FRANCE
Slovenian: 29 avenue Tony Garnier F-69007 LYON FRANCIJA
English: Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... ≥ 104.9 CCID50 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains) .............................. ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) .................................................................... ≥ 103.0 EID50 Excipient:
Slovenian: Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in G1) ......................... ≥ 2,0 enot v testu ELISA
English: Per dose of 1ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Slovenian: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................ ≥ 104,9 CCID50
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
Slovenian: F-69800 Saint Priest
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Slovenian: Imunost proti kužnemu rinotraheitisu, kalicivirusu mačk in Chlamydophila felis nastopi 1 teden po osnovnem cepljenju.
English: Special precautions for storage
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
English: Gentamicin, at most.......................................................................................................................... 28 µg Solvent:
Slovenian: Pomožna snov: Gentamicin, največ ........................................................................................................................... 28 µg
English: Keep out of the reach and sight of children.
Slovenian: Zaščitite pred svetlobo.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavna različica povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so končne različice, ki so bile sestavljene med postopkom koordinacijske skupine.
English: Your doctor will want to monitor you closely for at least 16 weeks.
Slovenian: Zdravnik vas bo želel natančneje spremljati vsaj 16 tednov.
English: 40 to less than 60 60 to less than 100 above 100
Slovenian: 40 do manj kot 60 60 do manj kot 100 več kot 100
English: Do not give this medicine to children under 18 years of age as no data are available on its safety and effectiveness in this group.
Slovenian: Ne dajajte tega zdravila otrokom, mlajšim od 18 let, ker podatki o njegovi varnosti in učinkovitosti v tej skupini niso na voljo.
English: Elderly population (> 65 years old)
Slovenian: Starejši (> 65 let)
English: In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Slovenian: V skladu z nacionalnimi priporočili utegne vaš zdravnik presoditi, da potrebujete dodatne ukrepe za preprečevanje okužbe.
English: The infusion will take approximately 2 hours.
Slovenian: Infuzija traja približno 2 uri.
English: Minimum infusion duration minutes (hours)
Slovenian: Najkrajše trajanje infuzije minute (ure)
English: Vaccination may further activate complement.
Slovenian: Cepljenje lahko še bolj aktivira komplement.
English: ≥ 40 to < 60 ≥ 60 to < 100
Slovenian: ≥ 40 do < 60 ≥ 60 do < 100
English: Your first dose is called the loading dose.
Slovenian: Vaš prvi odmerek se imenuje polnilni odmerek.
English: Other systemic infections
Slovenian: Druge sistemske okužbe
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2019
Slovenian: Datum prve odobritve: 02. julij 2019
English: Aseptic technique must be used.
Slovenian: Uporabljena naj bo aseptična tehnika.
English: Pack size of one vial.
Slovenian: Pakiranje z eno vialo.
English: The effects of the medicine on an unborn child are not known.
Slovenian: Učinki zdravila na nerojenega otroka niso znani.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: A risk to infants cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1371/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1371/001
English: The patient should be monitored for one hour following infusion.
Slovenian: Bolnikovo stanje je treba spremljati eno uro po infuziji.
English: Ravulizumab should be given to a pregnant woman only if clearly needed.
Slovenian: Ravulizumab je dovoljeno dati nosečnici samo, če je to nedvomno potrebno.
English: Male Female
Slovenian: moški ženski
English: You should also be aware that vaccination may not always prevent this type of infection.
Slovenian: Zavedati se morate tudi, da cepljenje ne prepreči tovrstnih okužb.
English: The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established.
Slovenian: Varnost in učinkovitost ravulizumaba pri otrocih s PNH, starih od 0 do < 18 let, nista bili dokazani.