FrancophonIA/ELRC3.0 huggingface dataset:
English: Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body.
Slovenian: Svetlomodre kapsule, velikost 1, približno 19 mm, z oznako »OPC 25« na pokrovčku in »Bial« na telesu.
English: Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder.,
Slovenian: slušne halucinacije, nočne more, motnje spanja
English: Abnormal dreams, Hallucination, Hallucination visual, Insomnia
Slovenian: halucinacije, vizualne halucinacije, nespečnost anksioznost, depresija,
English: Responders, n (%) 55 (45.5)
Slovenian: Odzivne osebe, n (%) 55 (45,5) Razlika glede na placebo vrednost p
English: Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.
Slovenian: Zdravilo Ongentys lahko poveča njihov učinek; - zdravila, ki vsebujejo kinidin, ki se uporablja za zdravljenje nenormalnega srčnega utripa ali malarije.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OPA/Al/PVC//Al
Slovenian: PRETISNI OMOT OPA/Al/PVC//Al
English: It is not known if Ongentys passes into breast milk in humans.
Slovenian: Ni znano, ali se zdravilo Ongentys izloča v materino mleko.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
English: Dry eye
Slovenian: Očesne bolezni suho oko
English: Hypertension, Hypotension
Slovenian: Žilne bolezni ortostatska hipotenzija hipertenzija, hipotenzija
English: Entacapone (N=122)
Slovenian: Entakapon (N=122)
English: Opicapone showed a marked (>90%) and long-lasting (>24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone.
Slovenian: Opikapon je pri zdravih prostovoljcih po dajanju 50 mg opikapona pokazal izrazito (> 90 %) in dolgotrajno (> 24 ur) zaviranje COMT.
English: CI = confidence interval; LS mean = least square mean; N = number of non-missing values; OPC = opicapone.
Slovenian: IZ = interval zaupanja; Povprečje LS = povprečje po metodi najmanjših kvadratov [LS, least squares]; N = število nemanjkajočih vrednosti; OPC = opikapon a. Čas vklopa brez obremenjujočih diskinezij = čas vklopa z neobremenjujočimi diskinezijami + čas vklopa brez diskinezij
English: Ongentys may increase their effect; - medicines used to treat heart failure such as dobutamine, dopamine or dopexamine.
Slovenian: Zdravilo Ongentys lahko poveča njihov učinek; - zdravilo, ki se uporablja za zdravljenje srčne odpovedi, kot so dobutamin, dopamin ali dopeksamin.
English: Ongentys 50 mg hard capsules are dark blue, approximately 19 mm length, with “OPC 50” and “Bial” printed on the capsules.
Slovenian: Zdravilo Ongentys 50 mg trde kapsule so temnomodre kapsule, dolge približno 19 mm, na njih sta natisnjeni oznaki »OPC 50« in »Bial«.
English: Decreased appetite, Hypertriglyceridaemia
Slovenian: Presnovne in prehranske motnje zmanjšan apetit, hipertrigliceridemija
English: Common: may affect up to 1 in 10 people - constipation - dry mouth - vomiting (being sick) - increased levels of the enzyme (creatine kinase) in your blood
Slovenian: - suha usta - bruhanje - povečane ravni encima (kreatin kinaze) v krvi
English: A study conducted in healthy subjects showed that there were no changes in repaglinide's exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg.
Slovenian: Študija z zdravimi prostovoljci je pokazala, da se izpostavljenost repaglinidu pri dajanju repaglinida po večkratnih odmerkih 50 mg opikapona enkrat na dan ni spremenila.
English: Ongentys is to be administered as an adjunct to levodopa treatment.
Slovenian: Zdravilo Ongentys se daje kot dodatno zdravljenje k levodopi.
English: Uncommon: may affect up to 1 in 100 people - palpitations or irregular heartbeat - blocked ear - dry eye - pain or swelling of the abdomen - indigestion - weight loss - loss of appetite - increased levels of triglycerides (fats) in your blood - muscle twitching, stiffness or pain - pain in arms or legs - altered sense of taste - excessive body movements - fainting - anxiety - depression - hearing things which do not exist - nightmares - sleep disorder - abnormal colour of urine - need to wake and pass urine at night - shortness of breath - high or low blood pressure
Slovenian: - povečane ravni trigliceridov (maščob) v krvi - trzanje, togost ali bolečine v mišicah - bolečine v rokah ali nogah - spremenjen občutek za okus - pretirani telesni gibi - omedlevica - anksioznost - depresija - slišanje neobstoječih stvari - nočne more - motnja spanja
English: Bottles: 10, 30 or 90 capsules.
Slovenian: Plastenke: 10, 30 ali 90 kapsul.
English: Ongentys may increase their effect; - medicines used to treat allergic reactions such as adrenaline.
Slovenian: - zdravila, ki se uporabljajo za zdravljenje alergijskih reakcij, kot je adrenalin.
English: Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični spazmi trzanje mišice, mišično-skeletna togost, mialgija,
English: 10 hard capsules 30 hard capsules
Slovenian: 30 trdih kapsul
English: Lactose monohydrate Sodium starch glycolate, Type A Maize starch, pregelatinized Magnesium stearate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule laktoza monohidrat natrijev karboksimetilškrob, vrsta A koruzni škrob, predgeliran magnezijev stearat
English: OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules Not all pack sizes may be marketed.
Slovenian: Pretisni omoti iz OPA/Al/PVC//Al vsebujejo 10, 30 ali 90 kapsul.
English: SN:
Slovenian: n.s.
English: Tell your doctor if you are taking: - medicines for depression or anxiety such as venlafaxine, maprotiline and desipramine.
Slovenian: - zdravila proti depresiji ali tesnobi, kot so venlafaksin, maprotilin in dezipramin.
English: Contents of the pack and other information What Ongentys contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ongentys - Učinkovina je opikapon.
English: Bottles: Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Plastenke: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: Ongentys is for oral use.
Slovenian: Zdravilo Ongentys se jemlje peroralno.
English: Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia
Slovenian: Bolezni prebavil zaprtost, suha usta, bruhanje abdominalna distenzija, bolečina v trebuhu, bolečina v zgornjem delu trebuha,
English: Contact your doctor straight away if you experience any side effects at the start of treatment.
Slovenian: Če se na začetku zdravljenja pojavijo kateri neželeni učinki, se takoj posvetujte z zdravnikom.
English: Indigo carmine aluminium lake (E132) Erythrosine (E127)
Slovenian: Ovoj kapsule želatina indigotin (E132) eritrozin (E127) titanov dioksid (E171)
English: How to store Ongentys
Slovenian: Shranjevanje zdravila Ongentys
English: Common: may affect up to 1 in 10 people - constipation - dry mouth - vomiting (being sick) - increased levels of the enzyme (creatine kinase) in your blood - muscle spasm
Slovenian: - suha usta - bruhanje - povečane ravni encima (kreatin kinaze) v krvi - mišični krči - omotičnost
English: Blisters: 10 or 30 capsules.
Slovenian: Plastenke: 10 ali 30 kapsul.
English: The bioavailability of opicapone was significantly higher in patients with moderate chronic hepatic impairment and no safety concerns were observed.
Slovenian: Farmakokinetiko opikapona so ovrednotili pri zdravih osebah in pri bolnikih z zmerno kronično okvaro jeter po dajanju enega odmerka 50 mg. Biološka uporabnost opikapona je bila občutno višja pri bolnikih z zmerno kronično okvaro jeter, pomislekov glede varnosti pa niso opazili.
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta kongestija ušesa
English: Each hard capsule contains 50 mg of opicapone.
Slovenian: Ena trda kapsula vsebuje 50 mg opikapona.
English: Chromaturia, Nocturia
Slovenian: Bolezni sečil kromaturija, nikturija
English: Each hard capsule contains 25 mg of opicapone.
Slovenian: Ena trda kapsula vsebuje 25 mg opikapona.
English: Each capsule contains 25 mg of opicapone.
Slovenian: Ena kapsula vsebuje 25 mg opikapona.
English: Ongentys 25 mg capsules opicapone
Slovenian: Ongentys 25 mg kapsule opikapon
English: Ongentys 50 mg capsules opicapone
Slovenian: Ongentys 50 mg kapsule opikapon
English: Dizziness, Headache, Somnolence
Slovenian: - glavobol - zaspanost
English: Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate.
Slovenian: Zdravilo Ongentys lahko poveča njihov učinek; - zdravila, ki se uporabljajo za visok holesterol, kot so rosuvastatin, simvastatin, atorvastatin ali pravastatin.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 10 trdih kapsul
English: Bial - Portela & Cª., S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Bial - Portela & Cª, S.A.
English: OPC 25 mg OPC 50 mg OPC 5 mg - Placebo OPC 25 mg - Placebo OPC 50 mg - Placebo
Slovenian: OPC 5 mg - placebo OPC 25 mg - placebo
English: DATE OF REVISION OF THE TEXT
Slovenian: Sprememba v času izklopa
English: Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with “OPC 25” and “Bial” printed on the capsules.
Slovenian: Izgled zdravila Ongentys in vsebina pakiranja Zdravilo Ongentys 25 mg trde kapsule so svetlomodre kapsule, dolge približno 19 mm, na njih sta natisnjeni oznaki »OPC 25« in »Bial«.
English: Opicapone exposure increased in a dose proportional manner following once-daily multiple dose administration up to 50 mg opicapone.
Slovenian: Po večkratnem odmerjanju do 50 mg opikapona enkrat na dan se je izpostavljenost opikaponu povečala sorazmerno z odmerkom.
English: Weight decreased
Slovenian: Skrajšanje časa izklopa
English: Bottles: 10 or 30 capsules.
Slovenian: Pretisni omoti: 10 ali 30 kapsul.
English: Hepatic impairment
Slovenian: bolečine v okončinah
English: Blisters: Store in the original blister in order to protect from moisture.
Slovenian: Pretisni omoti: Shranjujte v originalni pretisnem omotu za zagotovitev zaščite pred vlago.
English: 95% CI
Slovenian: N Povprečje LS 95-odstotni IZ Vrednost p
English: EU/1/15/1066/001 10 hard capsules EU/1/15/1066/008 30 hard capsules
Slovenian: EU/1/15/1066/008 30 trdih kapsul
English: Tel:+351 22 986 61 00
Slovenian: 4745-457 S. Mamede do Coronado Portugalska tel: +351 22 986 61 00 faks: +351 22 986 61 90
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A).
Slovenian: Pri bolnikih z blago okvaro jeter (stopnje A po Child-Pughu) odmerka ni treba prilagajati.
English: Constipation, Dry mouth, Vomiting
Slovenian: - zamašeno uho - suho oko - boleč ali otekel trebuh
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Bial - Portela & Cª, S.A.
English: Keep the bottle tightly closed in order to protect from moisture
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: EU/1/15/1066/009 10 hard capsules EU/1/15/1066/010 30 hard capsules
Slovenian: EU/1/15/1066/010 30 trdih kapsul
English: OPC 25 mg
Slovenian: Placebo OPC 25 mg
English: Ongentys 25 mg hard capsules
Slovenian: IME ZDRAVILA Ongentys 25 mg trde kapsule
English: OPC 25 mg OPC 50 mg OPC 25 mg - placebo OPC 50 mg - placebo
Slovenian: Placebo OPC 5 mg OPC 25 mg
English: Posology
Slovenian: TRAKU
English: Ongentys 50 mg hard capsules
Slovenian: IME ZDRAVILA Ongentys 50 mg trde kapsule
English: EU/1/15/1066/005 10 hard capsules EU/1/15/1066/006 30 hard capsules EU/1/15/1066/007 90 hard capsules
Slovenian: EU/1/15/1066/007 90 trdih kapsul
English: Capsule shell
Slovenian: 90 trdih kapsul
English: EU/1/15/1066/002 10 hard capsules EU/1/15/1066/003 30 hard capsules EU/1/15/1066/004 90 hard capsules
Slovenian: EU/1/15/1066/004 90 trdih kapsul
English: • Risk Management Plan (RMP)
Slovenian: • Načrt zaobvladovanje tveganja (RMP)
English: Date of first authorisation: 24 February 2009 Date of latest renewal: 24 February 2014
Slovenian: Datum prve odobritve: 24. februar 2009 Datum zadnjega podaljšanja: 24. februar 2014
English: Paresthesia, neuritis
Slovenian: Parestezija, neuritis
English: Interference with serological testing: See section 4.5.
Slovenian: Interferenca s serološkimi testi: glejte poglavje 4.5.
English: Store in refrigerator.
Slovenian: Shranjujte v hladilniku.
English: The use of INTANZA should be based on official recommendations.
Slovenian: Uporaba cepiva INTANZA mora temeljiti na uradnih priporočilih.
English: INTANZA is a vaccine.
Slovenian: INTANZA je cepivo.
English: This vaccine is recommended to help to protect you against flu.
Slovenian: Cepivo se priporoča za zaščito proti gripi.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
English: Children and adolescents INTANZA is not recommended for use in children and adolescents below 18 years.
Slovenian: Otroci in mladostniki Cepivo INTANZA ni priporočeno za uporabo pri otrocih in mladostnikih pod 18 let.
English: - Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
Slovenian: - Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv, kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
English: The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
Slovenian: Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih po cepljenju in zajeli po svetu po prihodu cepiva na trg, po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥1/1000 do < 1/100); redki (≥ 1/10000 do < 1/1000); zelo redki (< 1/10000); neznani (se jih ne da oceniti na podlagi razpoložljivih podatkov).
English: Please read the instruction before use
Slovenian: Pred uporabo preberite navodila
English: - You should tell your doctor before vaccination if you have a poor immune response (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
Slovenian: - Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
English: B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA**
Slovenian: B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............ 15 mikrogramov HA**
English: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France For any information about this medicine, please contact the local representative of the Marketing
Slovenian: Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - Francija Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Francija Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
English: The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA.
Slovenian: Varnost cepiva INTANZA je bila ocenjena v 3 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 3.372 oseb cepljenih z zdravilom INTANZA.
English: Justification for not including Braille is accepted.
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: What INTANZA is and what it is used for What you need to know before you use INTANZA
Slovenian: Kaj je cepivo INTANZA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili cepivo INTANZA
English: With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Slovenian: Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
English: Immunisation should be carried out by intradermal route.
Slovenian: Imunizacija se izvaja intradermalno.
English: INTANZA may be given at the same time as other vaccines.
Slovenian: Zdravilo INTANZA se lahko daje sočasno z drugimi cepivi.
English: In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Slovenian: V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite*, serokonverzijo ali značilne stopnje povečanja** in razmerje geometričnega povprečja titrov (GMTR) za protitelesa anti-HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
English: INTANZA may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3).
Slovenian: Cepivo INTANZA lahko vsebuje sledove jajc kot je ovalbumin ter sledove neomicina, formaldehida in oktoksinola 9, ki se uporabljajo v procesu izdelave zdravila (glejte poglavje 4.3).
English: EU/1/08/505/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/505/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/505/006 - pack of 20 pre-filled syringes with a Micro-Injection System
Slovenian: EU/1/08/505/004 - pakiranje z 1 napolnjeno brizgo s sistemom za mikro-injiciranje EU/1/08/505/005 - pakiranje z 10 napolnjenimi brizgami s sistemom za mikro-injiciranje EU/1/08/505/006 - pakiranje z 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
English: ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
Slovenian: ** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4-povečanje titra HI po cepljenju GMTR (geometric mean titer ratio): razmerje geometričnega povprečja titra posameznika (titri pred
English: Very limited data in immunocompromised patients are available for INTANZA.
Slovenian: Na voljo je zelo malo podatkov o uporabi cepiva INTANZA pri imunokompromitiranih bolnikih.
English: What you need to know before you use INTANZA
Slovenian: Kaj morate vedeti, preden boste uporabili cepivo INTANZA
English: *In some cases, local redness lasted up to 7 days.
Slovenian: * V nekaterih primerih je lokalna pordelost trajala do 7 dni c. možni neželeni dogodki
English: What INTANZA is and what it is used for
Slovenian: Kaj je cepivo INTANZA in za kaj ga uporabljamo
English: INTANZA 15 µg/strain 2017/2018 Influenza vaccine
Slovenian: INTANZA 15 µg/sev 2017/2018
English: HOW TO USE INTANZA
Slovenian: KAKO UPORABLJATI CEPIVO INTANZA
English: Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Slovenian: Alergijska reakcija, ki vključuje generalizirano kožno reakcijo kot je urtikaria, anafilaktično reakcijo, angioedem, šok
English: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France.
Slovenian: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Francija.
English: INTANZA has no or negligible influence on the ability to drive and use machines.
Slovenian: Cepivo INTANZA nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
English: What INTANZA looks like and contents of the pack
Slovenian: Izgled cepiva INTANZA in vsebina pakiranja
English: In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Slovenian: V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno cepljenje ni potrebno.
English: INTANZA should under no circumstances be administered intravascularly.
Slovenian: Cepivo INTANZA se pod nobenim pogojem ne sme dajati intravaskularno.
English: During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of INTANZA.
Slovenian: V kliničnih preizkusih in v obdobju po prihodu cepiva INTANZA na trg so poročali o sledečih neželenih učinkih
English: - Other vaccines: INTANZA can be given at the same time as other vaccines by using separate limbs.
Slovenian: - Druga cepiva: cepivo INTANZA se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Slovenian: Cepiva INTANZA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
Slovenian: Uporaba zdravila INTANZA zaradi pomanjkljivih podatkov o varnosti in učinkovitosti ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: Pre-filled syringe label text
Slovenian: Besedilo na nalepki za napolnjeno brizgo
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Other vaccines or medicines and INTANZA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Marketing Authorisation Holder: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon,
Slovenian: Imetnik dovoljenja za promet: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Francija.
English: 0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
Slovenian: 0,1 ml suspenzije v napolnjeni brizgi (steklo) s sistemom za mikro-injiciranje, s pritrjeno mikro-iglo, opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
English: INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper
Slovenian: Cepivo INTANZA se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).