FrancophonIA/ELRC3.0 huggingface dataset:
English: 9 - Connect the syringe to the opening on the side of the vial adapter by inserting the end of the syringe and tightening carefully with a clockwise “push and twist” motion (see arrow).
Slovenian: 9 - Povežite brizgo z odprtino na stranici adapterja za vialo, tako da vstavite konico brizge, jo potisnete in zasučete v smeri urnega kazalca (glejte puščico) ter tako sestavite sklop brizge.
English: Ear and labyrinth disorders Ear pain
Slovenian: Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesu
English: − You will have a check of the function of your thyroid gland, regularly or whenever thought necessary by your doctor for other reasons.
Slovenian: - Delovanje ščitnice je treba preverjati redno ali tudi dodatno zaradi drugih razlogov, če tako presodi zdravnik.
English: In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to CDMS in a statistically significant and clinically meaningful manner.
Slovenian: V s placebom nadzorovanem obdobju je zdravilo Betaferon statistično značilno in klinično pomembno (preglednica 3) podaljšalo čas od prvega kliničnega dogodka do CDMS.
English: − You will need blood tests to measure the number of your blood cells, blood chemistry and your liver enzymes.
Slovenian: - Opraviti morate krvne preiskave za pregled celotne krvne slike, biokemične krvne preiskave in preiskave delovanja jeter.
English: Vial (with powder for solution for injection): Human albumin
Slovenian: Viala (s praškom za raztopino za injiciranje) humani albumin manitol
English: − in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
Slovenian: − v vehiklu (raztopina natrijevega klorida 5,4 mg/ml (0,54 % m/v)): natrijev klorid, voda za injekcije.
English: The solvent for Betaferon is provided in a 2.25-millilitre pre-filled syringe and contains 1.2 ml sodium chloride solution 5.4 mg/ml (0.54% w/v).
Slovenian: Vehikel za zdravilo Betaferon je na voljo v 2,25-mililitrski napolnjeni brizgi in vsebuje 1,2 ml raztopine natrijevega klorida 5,4 mg/ml (0,54 % m/v).
English: The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Slovenian: mrzlica, artralgija, splošno slabo počutje, znojenje, glavobol ali mialgija), ki je predvsem posledica farmakoloških učinkov zdravila in reakcije na mestu injiciranja.
English: Start by using the yellow triple pack which is clearly marked with a “1” on the top right hand side of the box.
Slovenian: Začnite z uporabo rumenega tridelnega pakiranja, ki je jasno označeno s številko »1« na zgornji strani škatle.
English: 3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 Vial adapters with needles + 6 alcohol wipes
Slovenian: 3 napolnjene injekcijske brizge z 1,2 ml vehikla: raztopina natrijevega klorida 5,4 mg/ml 3 adapterji za viale z iglami + 6 alkoholnih blazinic
English: This third triple pack should be used for treatment days 13, 15 and 17.
Slovenian: To tretje tridelno pakiranje je namenjeno za uporabo 13., 15. in 17. dan zdravljenja.
English: Use the blue triple pack 4 containing 3 syringes with a 0.25; 0.5; 0.75 and 1.0-ml marking, for treatment days 19, 21 and 23.
Slovenian: Uporabite modro tridelno pakiranje 4, ki vsebuje 3 brizge z oznakami 0,25, 0,5, 0,75 in 1 ml za 19., 21. in 23. dan zdravljenja.
English: What Betaferon looks like and contents of the pack
Slovenian: Izgled zdravila Betaferon in vsebina pakiranja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF THE SINGLE PACK AS AN INTERMEDIATE PACK OF MULTIPACKS OR MULTI-MONTH PACKS (WITHOUT BLUE BOX)
Slovenian: ŠKATLA POSAMEZNEGA PAKIRANJA KOT VMESNEGA PAKIRANJA V ŠKATLI Z VEČ PAKIRANJI ALI VEČMESEČNIMI PAKIRANJI (BREZ PODATKOV ZA 'BLUE
English: Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.
Slovenian: Za raztopitev praška Betaferon v viali uporabite ves vehikel iz brizge.
English: Symptoms include redness, swelling, change in the skin colour, inflammation, pain and hypersensitivity.
Slovenian: Simptomi vključujejo rdečico, otekanje, spremembo barve kože, vnetje, bolečino in preobčutljivost.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Keep the syringe horizontal.
Slovenian: Brizgo držite v vodoravnem položaju.
English: Psychiatric disorders Depression
Slovenian: Psihiatrične motnje depresija tesnoba
English: This first triple pack should be used for treatment days 1, 3 and 5.
Slovenian: To prvo tridelno pakiranje je namenjeno za uporabo 1., 3. in 5. dan zdravljenja.
English: Use yellow triple pack No. 1 for treatment days 1, 3 and 5
Slovenian: Uporabite rumeno tridelno pakiranje 1 za 1., 3. in 5. dan zdravljenja.
English: Vial (with powder for solution for injection): 3 ml clear vial (type I glass) with a butyl rubber stopper (type I) and aluminium overseal and
Slovenian: 3 ml prozorna viala (steklo tipa I) z zamaškom iz butilne gume (tip I) in prekrivno zaporko iz aluminija
English: UAB Bayer Tel. +370 5 23 36 868
Slovenian: Tel. +370 5 23 36 868
English: Betaferon microgram (Placebo) n=292 (n=176)
Slovenian: n = 292 (n = 176)
English: Use then the red triple pack 2 containing 3 syringes with a 0.5-ml marking, for treatment days 7, 9 and 11.
Slovenian: Potem uporabite rdeče tridelno pakiranje 2, ki vsebuje 3 brizge z oznako 0,5 ml za 7., 9. in 11. dan zdravljenja.
English: Patients with single lesions may continue on Betaferon provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Betaferon.
Slovenian: Če nekroza ni preveč obsežna, se lahko pri bolnikih s posameznimi lezijami nadaljuje zdravljenje z zdravilom Betaferon, ker se je pri nekaterih bolnikih med zdravljenjem z zdravilom Betaferon nekroza na mestu injiciranja zacelila.
English: Triple pack 1 is designed to help you prepare the first 3 injections (days 1, 3 and 5).
Slovenian: Tridelno pakiranje 1 je namenjeno vam v pomoč pri pripravi prvih treh injekcij (1., 3. in 5. dan).
English: Talk to your doctor, pharmacist or nurse for further information.
Slovenian: Za več informacij se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro.
English: Infections and infestations Infection
Slovenian: Infekcijske in parazitske bolezni infekcije absces
English: HR = 0.60 [0.39, 0.92]
Slovenian: RT = 0,60 [0,39; 0,92]
English: − use an aseptic injection technique
Slovenian: - izvedejo injiciranje v aseptičnih pogojih,
English: 2 - Use an alcohol wipe to clean the skin at the injection site.
Slovenian: 2 - Z alkoholno blazinico očistite mesto injiciranja.
English: − if you experience symptoms like irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
Slovenian: - če imate simptome, kot so nepravilen srčni utrip, otekanje gležnjev ali nog ali kratka sapa.
English: AREA 3
Slovenian: PRILOGA III
English: Triple pack 4 is designed to help you prepare the next 3 injections (days 19, 21 and 23).
Slovenian: Tridelno pakiranje 4 je namenjeno vam v pomoč pri pripravi naslednjih treh injekcij (19., 21. in 23.
English: Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Slovenian: 15.000 do 21.000 daltonov.
English: - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests) - inflammation of the liver (hepatitis) - skin discolouration
Slovenian: - poveča se lahko vrednost specifičnega jetrnega encima (gama GT), ki nastaja v jetrih (to pokažejo krvne preiskave)
English: What Betaferon is and what it is used for
Slovenian: Kaj je zdravilo Betaferon in za kaj ga uporabljamo Kaj je zdravilo Betaferon
English: ► Uncommon (may affect up to 1 in 100 users):
Slovenian: ► občasni (pojavijo se lahko pri največ 1 do 100 bolnikov)
English: 1 vial adapter with needle + 2 alcohol wipes
Slovenian: 1 adapter za vialo z iglo + 2 alkoholni blazinici
English: Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11).
Slovenian: Tridelno pakiranje 2 je namenjeno vam v pomoč pri pripravi naslednjih treh injekcij (7., 9. in 11. dan).
English: This equals 250 microgram (8.0 million IU) interferon beta-1b.
Slovenian: To ustreza 250 mikrogramom (8,0 milijonov i.e.) interferona beta-1b.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF THE TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF THE TITRATION PACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA TRIDELNEGA PAKIRANJA (3 VIALE / 3 NAPOLNJENE INJEKCIJSKE BRIZGE) KOT ENOTA V SETU ZA TITRIRANJE (BREZ PODATKOV ZA 'BLUE BOX')
English: You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
Slovenian: DEL II: MENJAVANJE MEST INJICIRANJA Za vsako injiciranje je treba izbrati drugo mesto injiciranja, da si predeli opomorejo in da preprečite okužbo.
English: Betaferon can also be administered with an auto-injector.
Slovenian: Pomembno: Zdravilo Betaferon lahko dajate tudi z avtoinjektorjem.
English: E) Making the injection
Slovenian: E) Priprava injekcije
English: Now you are ready to attach the pre-filled solvent syringe to the vial adapter.
Slovenian: Zdaj lahko pritrdite napolnjeno injekcijsko brizgo z vehiklom na adapter za vialo.
English: − Set up a permanent storage area in a convenient location out of the sight and reach of children so your Betaferon and other supplies are always easy to find.
Slovenian: - Izberite stalno, primerno, otrokom nedosegljivo mesto, kjer boste imeli zdravilo Betaferon in druge pripomočke vedno pri roki.
English: - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels (vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract,
Slovenian: - zmanjšanje števila belih krvnih celic, otekanje bezgavk (limfadenopatija) - znižanje vrednosti sladkorja v krvi (hipoglikemija) - depresija, tesnoba - glavobol, omotica, nespečnost, migrena, otrplost ali občutek ščemenja (parestezija) - vnetje očesa (konjunktivitis), motnje vida - bolečine v ušesu
English: After reconstitution, immediate use is recommended.
Slovenian: Zdravilo je priporočljivo uporabiti takoj po rekonstituciji.
English: Tél/Tel: +32-(0)2-535 63 11
Slovenian: Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
English: HR = 0.63 [0.48, 0.83]
Slovenian: RT = 0,63 [0,48; 0,83]
English: ► Injection site reactions.
Slovenian: ► reakcije na mestu injiciranja.
English: Kaplan-Meier estimates
Slovenian: Ocena po Kaplan
English: Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Slovenian: Pakiranje s 15 posameznimi pakiranji, del 3-mesečnega pakiranja, ki vsebuje 45 (3 x 15) posameznih pakiranj.
English: Time to CDMS
Slovenian: Spremenljivke primarne učinkovitosti Čas do CDMS
English: Nervous system disorders
Slovenian: Bolezni živčevja konvulzije
English: Tel: +46-(0)8-580 223 00
Slovenian: Bayer AB Tel: +46-(0)8-580 223 00
English: One controlled clinical trial with Betaferon was performed in patients with a single clinical event and MRI features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Slovenian: Enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo Pri bolnikih z enim samim kliničnim dogodkom in izvidi magnetnoresonančnega slikanja, ki kažejo na multiplo sklerozo (vsaj dve klinično tihi leziji na T2-poudarjenem magnetnoresonančnem slikanju) so izvedli nadzorovano klinično preskušanje.
English: HR = 0.53 [0.39, 0.73]
Slovenian: RT = 0,53 [0,39; 0,73]
English: Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
Slovenian: Bolniki, ki so prejemali zdravilo Betaferon, so dobro prenašali zdravljenje recidivov s kortikosteroidi oz. ACTH, ki je trajalo do 28 dni.
English: Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora okužbe zgornjih dihal sinuzitis močnejši kašelj dispneja *
English: Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Slovenian: Nadaljujte z zelenim tridelnim pakiranjem 3, ki vsebuje 3 brizge z oznako 0,75 ml za 13., 15. in 17. dan zdravljenja.
English: There is no evidence of Betaferon having an effect on the duration of relapses.
Slovenian: Ni dokazov, da bi zdravilo Betaferon vplivalo na trajanje recidivov ali na simptome med recidivi.
English: Throw the wipe away.
Slovenian: - Vialo odstranite z brizge.
English: 3rd dosage step (0.75 ml) for treatment days 13, 15, 17
Slovenian: 3. korak odmerjanja (0,75 ml) za 13., 15. in 17. dan zdravljenja
English: Start with the yellow triple pack 1 containing 3 syringes with a 0.25-ml marking, for treatment days 1, 3 and 5.
Slovenian: Začnite z rumenim tridelnim pakiranjem 1, ki vsebuje 3 brizge z oznako 0,25 ml za 1., 3. in 5. dan zdravljenja.
English: 1st dosage step (0.25 ml) for treatment days 1, 3, 5
Slovenian: 1. korak odmerjanja (0,25 ml) za 1., 3. in 5. dan zdravljenja
English: • 3 Betaferon vials (with powder for solution for injection)
Slovenian: Viala (s praškom za raztopino za injiciranje)
English: No studies of the effects on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu na sposobnost razmnoževanja niso izvedli.
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)2, 3
Slovenian: Bolezni sečil nefrotski sindrom, glomeruloskleroza (glejte poglavje
English: ‘How to use Betaferon' in the first part of the package leaflet and to the Annex 'Self-injection procedure' in the second part of the package leaflet.
Slovenian: Kako uporabljati zdravilo Betaferon v prvem delu navodila za uporabo in dodatek - Postopek za samoinjiciranje v drugem delu navodila za uporabo.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or lightheadedness.
Slovenian: Simptomi lahko vključujejo povečano nastajanje modric, krvavitve, povišano telesno temperaturo, izjemno šibkost,
English: EDSS progression (confirmed increase in EDSS of at least one point compared to baseline) was lower in the immediate treatment group (Table 3, significant effect after 3 years, no significant effect after 5 years).
Slovenian: EDSS v vsaj eni točki glede na izhodišče) je bilo manjše v skupini, ki je bila takoj zdravljena
English: Slowly push the plunger of the syringe in all the way to transfer all of the solvent into the vial.
Slovenian: Bat brizge počasi potisnite do konca in ves vehikel prenesite v vialo.
English: It contains specially marked syringes with 0.75 ml marking.
Slovenian: Vsebuje brizge z oznako 0,75 ml.
English: White blood cell count decreased (<3,000/mm³) × Λ * °
Slovenian: zmanjšano število levkocitov (< 3.000/mm³) × Λ * °
English: After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Betaferon to evaluate the effects of immediate versus delayed start of Betaferon treatment, comparing patients initially randomized to Betaferon ("immediate treatment group") or to placebo ("delayed treatment group").
Slovenian: ("skupina s takojšnjim zdravljenjem"), in bolnikov, ki so bili na začetku randomizirani v skupino, ki je prejemala placebo ("skupina z odloženim zdravljenjem").
English: Cardiomyopathy2
Slovenian: Srčne bolezni tahikardija kardiomiopatija2
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Slovenian: Na splošno se na začetku zdravljenja priporoča titriranje odmerka, da bi povečali toleranco za zdravilo
English: Solvent (with sodium chloride solution 5.4 mg/ml (0.54% w/v)): 2.25 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Slovenian: Vehikel (z raztopino natrijevega klorida 5,4 mg/ml (0,54 % m/v)) 2,25 ml napolnjena injekcijska brizga (steklo tipa I) z 1,2 ml vehikla
English: - if you have severe liver disease (see ‘Warnings and precautions', ‘Other medicines and Betaferon' and section 4 ‘Possible side effects').
Slovenian: Možni neželeni učinki), - če imate hudo bolezen jeter (glejte Opozorila in previdnostni ukrepi in Druga zdravila in zdravilo Betaferon in poglavje 4.
English: HR = 0.59 [0.42, 0.83]
Slovenian: RT = 0,59 [0,42; 0,83]
English: After finishing with the red pack, start using the green triple pack which is clearly marked with a "3" on the top right hand side of the box
Slovenian: Po končani uporabi rdečega tridelnega pakiranja, začnite z uporabo zelenega tridelnega pakiranja, ki je jasno označeno s številko »3« na zgornji strani škatle.
English: Delayed Betaferon 250 mcg n=176
Slovenian: odloženo zdravljenje z zdravilom Betaferon mikrogramov n = 176
English: Suicide attempt (see also section 4.4), Emotional lability
Slovenian: Psihiatrične motnje zmedenost poskus samomora (glejte tudi poglavje 4.4),
English: Part of a multipack containing 12 single packs.
Slovenian: Del škatle z več pakiranji, ki vsebuje 12 posameznih pakiranj.
English: 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
Slovenian: 1 viala s praškom za raztopino za injiciranje vsebuje 300 mikrogramov (9,6 milijonov i.e.).
English: Betaferon 250 microgram (Placebo) n=317 (n=308)
Slovenian: n = 317 (n = 308)
English: 3 Vials with powder: 300 microgram (9.6 m IU) per vial.
Slovenian: 3 viale s praškom: 300 mikrogramov (9,6 milijonov i.e.) na vialo.
English: Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Slovenian: Simptomi so lahko rdečica, otekanje, sprememba barve kože, vnetje, bolečina, preobčutljivost, poškodbe tkiva (nekroza).
English: Part of a multipack containing 5 single packs.
Slovenian: Del škatle z več pakiranji, ki vsebuje 5 posameznih pakiranj.
English: As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients treated with Betaferon.
Slovenian: Tako kot pri drugih interferonih beta so bili tudi pri bolnikih, zdravljenih z zdravilom Betaferon, opisani redki primeri hude jetrne okvare, vključno s primeri odpovedi jeter.
English: Pack comprising 14 single packs, part of a 2-month pack containing 28 (2 x 14) single packs.
Slovenian: Pakiranje s 14 posameznimi pakiranji, del 2-mesečnega pakiranja, ki vsebuje 28 (2 x 14) posameznih pakiranj.
English: - After your injection, fill in the used injection site and date on the table in your injection record
Slovenian: - Po injiciranju v tabelo na kartici vpišite datum in mesto injiciranja, ki ste ga uporabili (glejte primer Zapisovanje mest injiciranja in datumov).
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Slovenian: O dogodkih so poročali ob različnih časovnih točkah, običajno nekaj mesecev po začetku zdravljenja z interferonom beta.
English: 3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ml.
Slovenian: 3 napolnjene injekcijske brizge z vehiklom za rekonstitucijo; vsaka vsebuje 1,2 ml natrijevega klorida 5,4 mg/ml.
English: Triple pack 3 is designed to help you prepare the next 3 injections (days 13, 15 and 17).
Slovenian: Tridelno pakiranje 3 je namenjeno vam v pomoč pri pripravi naslednjih treh injekcij (13., 15. in 17.
English: It contains specially marked syringes with 0.25 ml marking.
Slovenian: Vsebuje brizge z oznako 0,25 ml.
English: Rotation Cycle 5: Lower left section of each area
Slovenian: Rotacijski cikel 1: zgornji levi del vsakega predela Rotacijski cikel 2: spodnji desni del vsakega predela Rotacijski cikel 3: srednji levi del vsakega predela Rotacijski cikel 4: zgornji desni del vsakega predela Rotacijski cikel 5: spodnji levi del vsakega predela Rotacijski cikel 6: srednji desni del vsakega predela
English: A-1121 Vienna
Slovenian: Dr.-Boehringer-Gasse 5-11 A-1121, Dunaj Avstrija
English: Injection site reactions occurred frequently after administration of Betaferon.
Slovenian: Po uporabi zdravila Betaferon se pogosto pojavijo reakcije na mestu injiciranja.
English: • 6 alcohol wipes for skin and vial cleaning
Slovenian: - 6 alkoholnih blazinic za čiščenje kože in vial.
English: 'Warnings and precautions' and follow the instructions in Part II ‘Rotating injection sites' and Part III (Betaferon Medication Record) of the Annex 'Self-injection procedure'.
Slovenian: Mesto injiciranja morate redno menjavati (glejte poglavje 2, Opozorila in previdnostni ukrepi in upoštevajte navodila v delu II, Menjavanje mest injiciranja in delu III (Kartica o uporabi zdravila Betaferon) v dodatku - Postopek samoinjiciranja.
English: 3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU).
Slovenian: 3 viale s praškom za raztopino za injiciranje, vsaka vsebuje 300 mikrogramov (9,6 milijonov i.e.) na vialo.
English: Number of patients completed the trial phase
Slovenian: ki so zaključili preskušanje
English: If you have a Betaferon titration pack you will find 4 differently coloured and numbered triple packs, each containing:
Slovenian: ► Preverjanje vsebine pakiranja V setu za titriranje so štiri različno obarvana in oštevilčena tridelna pakiranja, ki vsebujejo:
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Slovenian: Najpogostejši neželeni učinki so ► gripi podobni simptomi, kot so zvišana telesna temperatura, mrzlica, bolečine v sklepih, splošno slabo počutje, znojenje, glavobol ali bolečine v mišicah.
English: Do not remove the vial adapter from the blister pack at this stage.
Slovenian: Adapterja za vialo ne vzemite iz pretisnega omota.
English: For each titration step use the complete amount of solvent for reconstitution of the Betaferon powder, then draw up the required dose into the syringe.
Slovenian: Za vsako titriranje uporabite celotno količino vehikla za rekonstitucijo praška
English: 37% versus delayed Betaferon
Slovenian: 37 % v primerjavi z odloženim zdravljenjem z zdravilom Betaferon
English: Pack sizes
Slovenian: Sprostite bat.
English: Betaferon may cause side effects in the central nervous system (see section 4.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Betaferon lahko povzroči neželene učinke osrednjega živčevja (glejte poglavje 4, Možni neželeni učinki).
English: Bayer Limited Tel: +353 1 299 93 13
Slovenian: Tel: +353 1 299 93 13
English: 3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only.
Slovenian: 3 - Z alkoholno blazinico očistite vrh viale.
English: NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection
Slovenian: Betaferon 250 mikrogramov/ml prašek in vehikel za raztopino za injiciranje
English: Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs.
Slovenian: Del pakiranja, ki vsebuje 15 posameznih pakiranj v 3-mesečnem pakiranju s 3 x 15 posameznimi pakiranji.
English: Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaferon during clinical trials.
Slovenian: Med kliničnimi preskušanji so se pri bolnikih, ki so prejemali zdravilo Betaferon, zelo pogosto (v večini primerov blago in prehodno) asimptomatsko povečale vrednosti serumskih transaminaz.