FrancophonIA/ELRC3.0 huggingface dataset:
English: Film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 49 x 1 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 84 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
Slovenian: filmsko obložene tablete 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 42 filmsko obloženih tablet 49 x 1 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obloženih tablet 70 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet 98 x 1 filmsko obloženih tablet 100 filmsko obloženih tablet 100 x 1 filmsko obloženih tablet 112 filmsko obloženih tablet
English: FREQUENCY ADVERSE REACTION
Slovenian: Neznane pogostnosti psihotične reakcije
English: Think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, s posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, in magnezijev stearat, vse v jedru tablete; ter hipermeloza, makrogol 400, titanov dioksid (E 171) rumeni in rdeči železov oksid (E 172), vse v oblogi tablete.
English: Memantine hydrochloride Week 2, Day 8 9 10 11 12 13 14 7 Film-coated tablets Ebixa 10 mg
Slovenian: Ebixa 10 mg memantinijev klorid Teden 2, Dan 8 9 10 11 12 13 14 7 filmsko obloženih tablet Ebixa 10 mg
English: One pump actuation contains 5 mg memantine hydrochloride.
Slovenian: En pritisk navzdol vsebuje 5 mg memantinijevega klorida.
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Slovenian: 1. teden (1.-7. dan): Vzemite po eno 5 mg tableto enkrat dnevno (bela do belkasta, ovalno podolgovata), jemljite 7 dni.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: Week 2 (day 8-14) The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Slovenian: 2. teden (8.-14. dan) Bolnik mora sedem dni jemati eno 10 mg filmsko obloženo tableto (10 mg) na dan.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina 5 - 29 ml/min) naj bo dnevni odmerek 10 mg na dan.
English: What Ebixa contains
Slovenian: Kaj vsebuje zdravilo Ebixa
English: Ebixa 10 mg tablets
Slovenian: Ebixa 10 mg tablete
English: Week 2 (day 8-14) The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days.
Slovenian: 2. teden (8.-14. dan) Bolnik mora sedem dni jemati 1 ml raztopine (10 mg) na dan, kar ustreza dvema pritiskoma navzdol.
English: Week 1 (day 1-7) The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Slovenian: 1. teden (1.-7. dan) Bolnik mora sedem dni jemati polovico 10 mg filmsko obložene tablete (5 mg) na dan.
English: The recommended dose of Ebixa for adults and older people is 20 mg once a day.
Slovenian: Za odrasle in starejše bolnike je priporočeni odmerek zdravila Ebixa 20 mg enkrat dnevno.
English: OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Slovenian: ZUNANJA NALEPKA NA VEČKRATNEM PAKIRANJU V FOLIJI (VKLJUČUJOČ t.i.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171) and iron oxide yellow (E172), all in the tablet coating.
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid in magnezijev stearat, vse v jedru tablete; ter hipermeloza, makrogol 400, titanov dioksid (E 171) in rumeni železov oksid (E 172), vse v oblogi tablete.
English: Ebixa 10 mg film-coated tablets Ebixa 20 mg film-coated tablets
Slovenian: Ebixa 10 mg filmsko obložene tablete Ebixa 20 mg filmsko obložene tablete
English: Week 3 (day 15-21) The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Slovenian: 3. teden (15.-21. dan) Bolnik mora sedem dni jemati 1.5 ml raztopine (15 mg) na dan, kar ustreza trem pritiskom navzdol.
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
Slovenian: 3. teden (15.-21. dan) Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
English: Week 4 (day 22-28) The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong) for 7 days.
Slovenian: 4. teden (22.-28. dan) Bolnik naj 7 dni jemlje eno 20 mg filmsko obloženo tableto na dan (sivo rdeča, ovalno podolgovata).
English: The solution is clear and colourless to light yellowish.
Slovenian: peroralna raztopina Raztopina je prozorna in brezbarvna do rahlo rumenkasta.
English: three pump actuations week 4 and beyond
Slovenian: 4. teden in naprej štirje pritiski navzdol
English: In patients with severe renal impairment (creatinine clearance 529 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina 5 - 29 ml/min) naj bo dnevni odmerek 10 mg (1 ml raztopine, kar ustreza dvema pritiskoma navzdol).
English: Week 1 (day 1-7) The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.
Slovenian: 1. teden (1.-7. dan) Bolnik mora sedem dni jemati 0.5 ml raztopine (5 mg) na dan, kar ustreza enemu pritisku navzdol.
English: Ebixa 10 mg film-coated tablets
Slovenian: Ebixa 10 mg filmsko obložene tablete
English: 7 film-coated tablets of Ebixa 20 mg
Slovenian: 7 filmsko obloženih tablet Ebixa 20 mg
English: Ebixa 20 mg film-coated tablets Memantine hydrochloride
Slovenian: Ebixa 20 mg filmsko obložene tablete memantinijev klorid
English: In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day.
Slovenian: Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 - 49 ml/min) naj bo dnevni odmerek 10 mg.
English: Additional for 10 mg film-coated tablets: Iron oxide yellow
Slovenian: Dodatno za 10 mg filmsko obložene tablete: železov oksid, rumen
English: Tablet cores for 5/10/15/20 mg film-coated tablets: Microcrystalline cellulose Croscarmellose sodium
Slovenian: Jedro tablete pri 5/10/15/20 mg filmsko obloženih tabletah: mikrokristalna celuloza natrijev karmelozat, premreženi brezvoden koloidni silicijev dioksid magnezijev stearat
English: BLISTER FOR TABLETS
Slovenian: PRETISNI OMOT ZA TABLETE
English: Ebixa 10 mg film-coated tablets Memantine hydrochloride
Slovenian: Ebixa 10 mg filmsko obložene tablete memantinijev klorid
English: Week 4 (day 22-28): Take one 20 mg tablet per day (grey-red, oval-oblong) for 7 days.
Slovenian: 4. teden (22.-28. dan): Vzemite po eno 20 mg tableto enkrat dnevno (sivo rdeča, ovalno podolgovata), jemljite 7 dni.
English: Treatment initiation pack
Slovenian: Pakiranje za uvajalno zdravljenje.
English: Gait abnormal
Slovenian: Občasni neobičajna hoja
English: Potassium sorbate Sorbitol E420
Slovenian: 6.1 Seznam pomožnih snovi kalijev sorbat sorbitol E420 prečiščena voda
English: 7 film-coated tablets of Ebixa 15 mg
Slovenian: 7 filmsko obloženih tablet Ebixa 15 mg
English: Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Slovenian: Vsaka aktivacija črpalke (en pritisk navzdol) dovede 0.5 ml raztopine, ki vsebuje 5 mg memantinijevega klorida, kar ustreza 4.16 mg memantina.
English: Ebixa 5 mg/pump actuation oral solution Memantine hydrochloride
Slovenian: Ebixa 5 mg/pritisk peroralna raztopina memantinijev klorid
English: 7 film-coated tablets of Ebixa 10 mg
Slovenian: 7 filmsko obloženih tablet Ebixa 10 mg
English: Ebixa 20 mg film-coated tablets
Slovenian: Ebixa 20 mg filmsko obložene tablete
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
Slovenian: • glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost za zdravilo
English: Ebixa 5 mg/pump actuation oral solution
Slovenian: Ebixa 5 mg/pritisk peroralna raztopina
English: Hallucinations
Slovenian: Občasni halucinacije
English: If you get any side effects, talk to your doctor or pharmacis.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: EXP {MM.YYYY} See embossed stamp.
Slovenian: Uporabno do: {MM.LLLL} Glejte reljefni odtis.
English: two pump actuations week 3
Slovenian: 2. teden dva pritiska navzdol
English: The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Slovenian: 15 mg filmsko obložene tablete so oranžne do sivo oranžne, ovalno podolgovate, z vtisnjeno številko "15" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Slovenian: PODATKI NA PRETISNIH OMOTIH ALI TRAKOVIH
English: Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Slovenian: Ebixa 15 mg filmsko obložene tablete so oranžne do sivo oranžne, ovalno podolgovate, z vtisnjeno številko "15" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: How to store Ebixa
Slovenian: Shranjevanje zdravila Ebixa
English: Before you take Ebixa
Slovenian: Ne jemljite zdravila Ebixa
English: Week 1 (day 1-7) The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
Slovenian: Bolnik naj 7 dni jemlje eno 5 mg filmsko obloženo tableto na dan (bela do belkasta, ovalno podolgovata).
English: Ebixa 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Slovenian: Ebixa 5 mg filmsko obložene tablete so bele do belkaste, ovalno podolgovate, z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: Ebixa 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings ‘1 0' on one side and ‘M M' on the other side.
Slovenian: Ebixa 10 mg filmsko obložene tablete so bledo rumene do rumene, ovalne, z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in vtisnjeno besedo "M M" na drugi strani.
English: Tablet coat for 5/10/15/20 mg film-coated tablets: Hypromellose
Slovenian: Obloga tablete pri 5/10/15/20 mg filmsko obloženih tabletah: hipermeloza makrogol 400 titanov dioksid
English: The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Slovenian: 20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: Ebixa 5 mg
Slovenian: Ebixa 5 mg/pritisk raztopina
English: Ebixa 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Slovenian: Ebixa 20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: Ebixa film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings “1 0” on one side and “M M” on the other side.
Slovenian: Ebixa filmsko obložene tablete so bledo rumene do rumene, ovalne, filmsko obložene tablete z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in besedo "M M" na drugi strani.
English: Dose titration
Slovenian: Občasni bruhanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA PRIMARNO OVOJNINO/DEL VEČKRATNEGA PAKIRANJA (BREZ t.i. MODREGA OKENCA)
English: Lot {number} See embossed stamp.
Slovenian: Številka serije {številka} Glejte reljefni odtis.
English: Ebixa film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Slovenian: Ebixa filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, filmsko obložene tablete z vtisnjeno številko "20" na eni strani in besedo "MEM" na drugi strani.
English: The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Slovenian: 5 mg filmsko obložene tablete so bele do belkaste, ovalno podolgovate, z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and “MEM” on the other side
Slovenian: Bledo rdeče do sivo rdeče, ovalno podolgovate filmsko obložene tablete, z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
English: one pump actuation week 2
Slovenian: 1. teden en pritisk navzdol
English: The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and imprint ‘1 0' on one side and ‘M M' on the other side.
Slovenian: 10 mg filmsko obložene tablete so bledo rumene do rumene, ovalne, z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in vtisnjeno besedo "M M" na drugi strani.
English: Pale yellow to yellow, oval shaped film-coated tablets with breaking line and imprint “1 0” on one side and “M M” on the other side.
Slovenian: Bledo rumene do rumene, ovalne filmsko obložene tablete, z razdelilno zarezo in vtisnjeno številko "1 0" na eni strani in vtisnjeno besedo "M M" na drugi strani.
English: half a 10 mg tablet week 2
Slovenian: 3. teden ena in pol 10 mg tableta
English: Elevated liver function test
Slovenian: Bolezni jeter, žolčnika in žolčevodov Pogosti zvišane vrednosti testov jetrne funkcije
English: Week 3 (day 15-21) The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Slovenian: Bolnik naj 7 dni jemlje eno 15 mg filmsko obloženo tableto na dan (sivo oranžna, ovalno podolgovata).
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Slovenian: V klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet, pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici KPSS ("Kratkem preskusu spoznavnih sposobnosti" oz. MMSE ali "Mini-mental State Examination") ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice CIBIC-plus - ("Clinician's Interview-Based Impression of Change Plus Caregiver Input" oz. "Vtis sprememb na osnovi kliničnega intervjuja"): p=0,025; ADCS-ADLsev ("Alzheimer's Disease Consortium Studies Activities of Daily Livingmodified for severe dementia" oz. "Vprašalnik vsakodnevnih aktivnosti): p=0,003; SIB ("Severe Impairment Battery" oz. "Baterije za hudo prizadetost"): p=0,002).
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Slovenian: V klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet, pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici KPSS ("Kratkem preskusu spoznavnih sposobnosti" oz. MMSE ali "Mini-mental State Examination") ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice CIBIC-plus - ("Clinician's Interview-Based Impression of Change Plus Caregiver Input" oz. "Vtis sprememb na osnovi kliničnega intervjuja"): p=0,025; ADCS-ADLsev ("Alzheimer's Disease Consortium Studies Activities of Daily Livingmodified for severe dementia" oz. "Vprašalnik vsakodnevnih aktivnosti"): p=0,003; SIB ("Severe Impairment Battery" oz. "Baterije za hudo prizadetost"): p=0,002).
English: Tablet coat for 10/20 mg film-coated tablets: Hypromellose
Slovenian: Obloga tablete pri 10/20 mg filmsko obloženih tabletah: hipromeloza makrogol 400 titanov dioksid
English: In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Slovenian: Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 - 49 ml/min) naj bo dnevni odmerek 10 mg (1 ml raztopine, kar ustreza dvema pritiskoma navzdol).Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša do 20 mg dnevno, po standardni titracijski shemi.
English: Memantine hydrochloride Week 1, Day 1 2 3 4 5 6 7 7 Film-coated tablets Ebixa 5 mg
Slovenian: Ebixa 5 mg memantinijev klorid Teden 1, Dan 1 2 3 4 5 6 7
English: Four pump actuations
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Small white particles may be present.
Slovenian: Morda so prisotni majhni beli delci.
English: 2013/2014 season
Slovenian: Sezona 2013/2014
English: 107.0±0.5 FFU***
Slovenian: 107,0±0,5 FFE***
English: The vaccine targets three strains of influenza virus each year, following the annual recommendations by the World Health Organisation.
Slovenian: Cepivo vsako leto cilja na tri seve virusa gripe v skladu z vsakoletnimi priporočili Svetovne zdravstvene organizacije.
English: The use of FLUENZ should be based on official recommendations.
Slovenian: Uporaba cepiva FLUENZ mora temeljiti na uradnih priporočilih.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 January 2011
Slovenian: Datum prve odobritve: 27. januarja 2011
English: (See also, How Fluenz is given, in section 3).
Slovenian: (Glejte tudi Kako se aplicira cepivo Fluenz, poglavje 3).
English: Adverse reaction frequencies are reported as: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Very rare (< 1/10,000)
Slovenian: Pogostnosti neželenih učinkov so poročane kot: zelo pogosti (≥1/10) pogosti (≥1/100 do <1/10) občasni (≥1/1.000 do <1/100) zelo redki (<1/10.000)
English: .......................................................................................................per 0.2 ml dose
Slovenian: .......................................................................................................na 0,2 ml odmerek
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation)
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: The vaccine is unlikely to have an effect on the ability to drive and use machines.
Slovenian: Cepivo najverjetneje ne vpliva na sposobnost vožnje ali uporabe strojev.
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
Slovenian: • če vam je vaš zdravnik povedal, da imate oslabljen imunski sistem kot posledico bolezni, zdravila, ki ga jemljete ali drugega načina zdravljenja.
English: All strains regardless of match
Slovenian: Vsi sevi neodvisno od ujemanja
English: Name and address of the manufacturers of the biological active substance(s)
Slovenian: Ime in naslov izdelovalcev biološke zdravilne učinkovine (učinkovin)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Slovenian: Prejemniki cepiva morajo, kjer je to mogoče, preprečiti tesen stik s hudo imunsko oslabljenimi osebami (npr. prejemniki kostnega mozga, ki po presaditvi potrebujejo izolacijo) še 1-2 tedna po cepljenju.
English: • if you are under 18 years of age and already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Slovenian: • če ste stari manj kot 18 let in že jemljete acetilsalicilno kislino (snov, prisotna v številnih zdravilih za lajšanje bolečin in nižanje povišane telesne temperature).
English: FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Slovenian: Cepiva FLUENZ se ne sme uporabiti pri otrocih in mladostnikih s hudo astmo ali aktivnim sopenjem, saj te osebe niso bile ustrezno preučene v kliničnih študijah.
English: • if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”).
Slovenian: • če ste alergični na jajca, jajčne beljakovine, gentamicin, na želatino ali katero koli sestavino cepiva Fluenz (navedeno v poglavju 6 ”Vsebina pakiranja in dodatne informacije”).
English: What you need to know before you are given Fluenz
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Fluenz
English: It is used in children and adolescents 24 months to less than 18 years of age.
Slovenian: Uporablja se za otroke in mladostnike stare od 24 mesecev in manj kot 18 let.
English: FLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple years, in various regions and using different vaccine strains.
Slovenian: Cepivo FLUENZ je prejelo več kot 30.000 oseb v kontroliranih kliničnih študijah v obdobju več let, v različnih regijah in z uporabo različnih sevov cepiva.
English: What Fluenz is and what it is used for
Slovenian: Kaj je cepivo Fluenz in za kaj ga uporabljamo
English: Follow your doctor, nurse or pharmacist's instructions about when your child should return for the second dose.
Slovenian: Upoštevajte navodila zdravnika, medicinske sestre ali farmacevta glede tega, kdaj naj se otrok vrne po drugi odmerek.