natgillin/translations-raw huggingface dataset:
‘How to use Betaferon' in the first part of this leaflet.
Kako uporabljati zdravilo Betaferon v prvem delu tega navodila za uporabo.
► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
Zdravilo Betaferon je namenjeno za uporabo pri bolnikih ► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
B) Getting ready to inject C) Reconstituting the solution, step by step D) Drawing up the injection E) Making the injection F) Quick review of the process
C) Rekonstitucija raztopine po korakih D) Izvlek količine za injiciranje
Discard the vial with the remaining solution.
Viale z ostankom raztopine zavrzite.
4th dosage step (1.0 ml) for treatment days 19, 21, 23
4. korak odmerjanja (1,0 ml) za 19., 21. in 23. dan zdravljenja
Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Laboratorijske preiskave Pri bolnikih z motnjami v delovanju ščitnice v anamnezi se priporoča redno opravljanje preiskav delovanja ščitnice oziroma kot je klinično indicirano.
The Betaferon powder is provided in a 3-millilitre vial, containing 300 microgram (9.6 million IU) interferon beta-1b per vial.
Prašek zdravila Betaferon je na voljo v 3-mililitrski viali, ki vsebuje 300 mikrogramov (9,6 milijonov i.e.) interferona beta-1b na vialo.
For skin disinfection use an appropriate disinfectant.
Za razkuževanje kože uporabite ustrezno razkužilo.
Betaferon microgram (Placebo) n=124 (n=123)
n = 124 (n = 123)
- the number of platelets (which help the blood to clot) may fall (thrombocytopenia) - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 ‘Warnings and precautions' - suicide attempt - mood swings - convulsion
- povečajo se lahko vrednosti določenih vrst maščob v krvi (trigliceridi) (to pokažejo krvne preiskave), glejte poglavje 2, Opozorila in previdnostni ukrepi - poskus samomora
► If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
► Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Betaferon microgram (Placebo) n=360 (n=358)
n = 360 (n = 358)
0.5 ml for the injections at day 7, 9 and 11 of therapy.
0,5 ml za injiciranje na 7., 9. in 11. dan zdravljenja
Blood and lymphatic system disorders Lymphocyte count decreased (<1,500/mm³) ×
Bolezni krvi in limfatičnega sistema zmanjšano število limfocitov (< 1.500/mm³) × Λ °
It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Pokazali so, da zdravilo Betaferon zmanjša pogostnost in resnost zagonov, zmanjša število dni v bolnišnici zaradi bolezni in podaljša čas brez relapsov.
When starting treatment with Betaferon, it is tolerated best by gradually increasing the dose, i.e. starting with just 0.25 ml of the medication and then increasing, after every 3rd injection, first to 0.5 ml, then to 0.75 ml and then finally to the full dose (1 ml) of Betaferon.
Bolniki bolje prenašajo, če se na začetku zdravljenja z zdravilom Betaferon odmerek postopoma povečuje, tj. začne se samo z 0,25 ml zdravila in nato povečuje po vsaki tretji injekciji najprej do
3 Vial adapters with needles + 6 alcohol wipes
III. 3 adapterji za viale z iglami + 6 alkoholnih blazinic
Your doctor has prescribed Betaferon to treat your MS. You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of the package leaflet, section 3.
Na začetku zdravljenja boste zdravilo Betaferon bolje prenašali, če boste zdravljenje začeli z manjšimi odmerki in jih postopoma povečevali do celotnega odmerka (glejte prvi del navodila, poglavje 3.
This will give each injection site a chance to fully recover before receiving another injection.
Tako si bo mesto injiciranja povsem opomoglo, preden ga boste ponovno uporabili za injiciranje.
Slowly pull the plunger back to withdraw all the solution out of the vial and into the syringe.
Bat počasi povlecite nazaj in vso raztopino iz viale izvlecite v brizgo.
This second triple pack should be used for treatment days 7, 9 and 11.
To drugo tridelno pakiranje je namenjeno za uporabo 7., 9. in 11. dan zdravljenja.
Betaferon 250 mcg n=292
Betaferon mikrogramov n = 292
Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Nefrotski sindrom Med zdravljenjem z zdravili, ki vsebujejo interferon beta, so poročali o primerih nefrotskega sindroma pri različnih predhodnih nefropatijah, vključno s fokalno segmentno glomerulosklerozo (kolapsno spremenjeni glomeruli), glomerulonefritisom z minimalnimi spremembami, membranoproliferativnim glomerulonefritisom in membransko glomerulopatijo.
6 - Inject the medicine using a slow, steady push on the plunger.
6 - S počasnim, enakomernim potiskanjem na bat injicirajte zdravilo.
This may suggest an inflammation of the pancreas (pancreatitis), which has been reported with Betaferon use.
Morda to kaže na vnetje trebušne slinavke (pankreatitis), o katerem poročajo pri bolnikih, ki jemljejo zdravilo Betaferon.
Use red triple pack No. 2 for treatment days 7, 9 and 11
Uporabite rdeče tridelno pakiranje 2 za 7., 9. in 11. dan zdravljenja.
Advice on which areas to choose is given in the first part of this Annex.
Nasvet o predelih, primernih za injiciranje, je v prvem delu dodatka.
0.75 ml for the injections at day 13, 15 and 17 of therapy.
0,75 ml za injiciranje na 13., 15. in 17. dan zdravljenja
AREA 2
PRILOGA II
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Način uporabe subkutano injiciranje Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
Finally, after finishing with the green pack, start using the blue triple pack which is clearly marked with a "4" on the top right hand side of the box.
Na koncu, po končani uporabi zelenega tridelnega pakiranja, začnite z uporabo modrega tridelnega pakiranja, ki je jasno označeno s številko »4« na zgornji strani škatle.
Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Betaferon.
Za spremljanje nastanka protiteles proti zdravilu Betaferon so bolnikom v nadzorovanih kliničnih preskušanjih vsake 3 mesece odvzeli vzorce seruma.
Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
O dogodkih so poročali v različnih obdobjih zdravljenja in se lahko pojavijo nekaj tednov do nekaj let po začetku zdravljenja z interferonom beta.
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).
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.
Ear and labyrinth disorders Ear pain
Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesu
− You will have a check of the function of your thyroid gland, regularly or whenever thought necessary by your doctor for other reasons.
- Delovanje ščitnice je treba preverjati redno ali tudi dodatno zaradi drugih razlogov, če tako presodi zdravnik.
In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to CDMS in a statistically significant and clinically meaningful manner.
V s placebom nadzorovanem obdobju je zdravilo Betaferon statistično značilno in klinično pomembno (preglednica 3) podaljšalo čas od prvega kliničnega dogodka do CDMS.
− You will need blood tests to measure the number of your blood cells, blood chemistry and your liver enzymes.
- Opraviti morate krvne preiskave za pregled celotne krvne slike, biokemične krvne preiskave in preiskave delovanja jeter.
Vial (with powder for solution for injection): Human albumin
Viala (s praškom za raztopino za injiciranje) humani albumin manitol
− in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
− v vehiklu (raztopina natrijevega klorida 5,4 mg/ml (0,54 % m/v)): natrijev klorid, voda za injekcije.
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).
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).
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.
mrzlica, artralgija, splošno slabo počutje, znojenje, glavobol ali mialgija), ki je predvsem posledica farmakoloških učinkov zdravila in reakcije na mestu injiciranja.
Start by using the yellow triple pack which is clearly marked with a “1” on the top right hand side of the box.
Začnite z uporabo rumenega tridelnega pakiranja, ki je jasno označeno s številko »1« na zgornji strani škatle.
3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 Vial adapters with needles + 6 alcohol wipes
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
This third triple pack should be used for treatment days 13, 15 and 17.
To tretje tridelno pakiranje je namenjeno za uporabo 13., 15. in 17. dan zdravljenja.
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.
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.
What Betaferon looks like and contents of the pack
Izgled zdravila Betaferon in vsebina pakiranja
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)
ŠKATLA POSAMEZNEGA PAKIRANJA KOT VMESNEGA PAKIRANJA V ŠKATLI Z VEČ PAKIRANJI ALI VEČMESEČNIMI PAKIRANJI (BREZ PODATKOV ZA 'BLUE
Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.
Za raztopitev praška Betaferon v viali uporabite ves vehikel iz brizge.
Symptoms include redness, swelling, change in the skin colour, inflammation, pain and hypersensitivity.
Simptomi vključujejo rdečico, otekanje, spremembo barve kože, vnetje, bolečino in preobčutljivost.
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
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Keep the syringe horizontal.
Brizgo držite v vodoravnem položaju.
Psychiatric disorders Depression
Psihiatrične motnje depresija tesnoba
This first triple pack should be used for treatment days 1, 3 and 5.
To prvo tridelno pakiranje je namenjeno za uporabo 1., 3. in 5. dan zdravljenja.
Use yellow triple pack No. 1 for treatment days 1, 3 and 5
Uporabite rumeno tridelno pakiranje 1 za 1., 3. in 5. dan zdravljenja.
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
3 ml prozorna viala (steklo tipa I) z zamaškom iz butilne gume (tip I) in prekrivno zaporko iz aluminija
Betaferon microgram (Placebo) n=292 (n=176)
n = 292 (n = 176)
Use then the red triple pack 2 containing 3 syringes with a 0.5-ml marking, for treatment days 7, 9 and 11.
Potem uporabite rdeče tridelno pakiranje 2, ki vsebuje 3 brizge z oznako 0,5 ml za 7., 9. in 11. dan zdravljenja.
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.
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.
Triple pack 1 is designed to help you prepare the first 3 injections (days 1, 3 and 5).
Tridelno pakiranje 1 je namenjeno vam v pomoč pri pripravi prvih treh injekcij (1., 3. in 5. dan).
Talk to your doctor, pharmacist or nurse for further information.
Za več informacij se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro.
Infections and infestations Infection
Infekcijske in parazitske bolezni infekcije absces
HR = 0.60 [0.39, 0.92]
RT = 0,60 [0,39; 0,92]
− use an aseptic injection technique
- izvedejo injiciranje v aseptičnih pogojih,
2 - Use an alcohol wipe to clean the skin at the injection site.
2 - Z alkoholno blazinico očistite mesto injiciranja.
− if you experience symptoms like irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
- če imate simptome, kot so nepravilen srčni utrip, otekanje gležnjev ali nog ali kratka sapa.
AREA 3
PRILOGA III
Triple pack 4 is designed to help you prepare the next 3 injections (days 19, 21 and 23).
Tridelno pakiranje 4 je namenjeno vam v pomoč pri pripravi naslednjih treh injekcij (19., 21. in 23.
Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
15.000 do 21.000 daltonov.
- 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
- poveča se lahko vrednost specifičnega jetrnega encima (gama GT), ki nastaja v jetrih (to pokažejo krvne preiskave)
What Betaferon is and what it is used for
Kaj je zdravilo Betaferon in za kaj ga uporabljamo Kaj je zdravilo Betaferon
► Uncommon (may affect up to 1 in 100 users):
► občasni (pojavijo se lahko pri največ 1 do 100 bolnikov)
1 vial adapter with needle + 2 alcohol wipes
1 adapter za vialo z iglo + 2 alkoholni blazinici
Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11).
Tridelno pakiranje 2 je namenjeno vam v pomoč pri pripravi naslednjih treh injekcij (7., 9. in 11. dan).
This equals 250 microgram (8.0 million IU) interferon beta-1b.
To ustreza 250 mikrogramom (8,0 milijonov i.e.) interferona beta-1b.
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)
ŠKATLA TRIDELNEGA PAKIRANJA (3 VIALE / 3 NAPOLNJENE INJEKCIJSKE BRIZGE) KOT ENOTA V SETU ZA TITRIRANJE (BREZ PODATKOV ZA 'BLUE BOX')
You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
DEL II: MENJAVANJE MEST INJICIRANJA Za vsako injiciranje je treba izbrati drugo mesto injiciranja, da si predeli opomorejo in da preprečite okužbo.
Betaferon can also be administered with an auto-injector.
Pomembno: Zdravilo Betaferon lahko dajate tudi z avtoinjektorjem.
E) Making the injection
E) Priprava injekcije
Now you are ready to attach the pre-filled solvent syringe to the vial adapter.
Zdaj lahko pritrdite napolnjeno injekcijsko brizgo z vehiklom na adapter za vialo.
− 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.
- Izberite stalno, primerno, otrokom nedosegljivo mesto, kjer boste imeli zdravilo Betaferon in druge pripomočke vedno pri roki.
- 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,
- 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
After reconstitution, immediate use is recommended.
Zdravilo je priporočljivo uporabiti takoj po rekonstituciji.
HR = 0.63 [0.48, 0.83]
RT = 0,63 [0,48; 0,83]
► Injection site reactions.
► reakcije na mestu injiciranja.
Kaplan-Meier estimates
Ocena po Kaplan
Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Pakiranje s 15 posameznimi pakiranji, del 3-mesečnega pakiranja, ki vsebuje 45 (3 x 15) posameznih pakiranj.
Time to CDMS
Spremenljivke primarne učinkovitosti Čas do CDMS
Nervous system disorders
Bolezni živčevja konvulzije
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).
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.
HR = 0.53 [0.39, 0.73]
RT = 0,53 [0,39; 0,73]
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
Bolniki, ki so prejemali zdravilo Betaferon, so dobro prenašali zdravljenje recidivov s kortikosteroidi oz. ACTH, ki je trajalo do 28 dni.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Bolezni dihal, prsnega koša in mediastinalnega prostora okužbe zgornjih dihal sinuzitis močnejši kašelj dispneja *
Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Nadaljujte z zelenim tridelnim pakiranjem 3, ki vsebuje 3 brizge z oznako 0,75 ml za 13., 15. in 17. dan zdravljenja.
There is no evidence of Betaferon having an effect on the duration of relapses.
Ni dokazov, da bi zdravilo Betaferon vplivalo na trajanje recidivov ali na simptome med recidivi.
Throw the wipe away.
- Vialo odstranite z brizge.
3rd dosage step (0.75 ml) for treatment days 13, 15, 17
3. korak odmerjanja (0,75 ml) za 13., 15. in 17. dan zdravljenja
Start with the yellow triple pack 1 containing 3 syringes with a 0.25-ml marking, for treatment days 1, 3 and 5.
Začnite z rumenim tridelnim pakiranjem 1, ki vsebuje 3 brizge z oznako 0,25 ml za 1., 3. in 5. dan zdravljenja.
1st dosage step (0.25 ml) for treatment days 1, 3, 5
1. korak odmerjanja (0,25 ml) za 1., 3. in 5. dan zdravljenja
• 3 Betaferon vials (with powder for solution for injection)
Viala (s praškom za raztopino za injiciranje)
No studies of the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost razmnoževanja niso izvedli.
Nephrotic syndrome, glomerulosclerosis (see section 4.4)2, 3
Bolezni sečil nefrotski sindrom, glomeruloskleroza (glejte poglavje
‘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.
Kako uporabljati zdravilo Betaferon v prvem delu navodila za uporabo in dodatek - Postopek za samoinjiciranje v drugem delu navodila za uporabo.
Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or lightheadedness.
Simptomi lahko vključujejo povečano nastajanje modric, krvavitve, povišano telesno temperaturo, izjemno šibkost,
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).
EDSS v vsaj eni točki glede na izhodišče) je bilo manjše v skupini, ki je bila takoj zdravljena
Slowly push the plunger of the syringe in all the way to transfer all of the solvent into the vial.
Bat brizge počasi potisnite do konca in ves vehikel prenesite v vialo.
It contains specially marked syringes with 0.75 ml marking.
Vsebuje brizge z oznako 0,75 ml.
White blood cell count decreased (<3,000/mm³) × Λ * °
zmanjšano število levkocitov (< 3.000/mm³) × Λ * °
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").
("skupina s takojšnjim zdravljenjem"), in bolnikov, ki so bili na začetku randomizirani v skupino, ki je prejemala placebo ("skupina z odloženim zdravljenjem").
Cardiomyopathy2
Srčne bolezni tahikardija kardiomiopatija2
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Na splošno se na začetku zdravljenja priporoča titriranje odmerka, da bi povečali toleranco za zdravilo
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.
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
- if you have severe liver disease (see ‘Warnings and precautions', ‘Other medicines and Betaferon' and section 4 ‘Possible side effects').
Možni neželeni učinki), - če imate hudo bolezen jeter (glejte Opozorila in previdnostni ukrepi in Druga zdravila in zdravilo Betaferon in poglavje 4.
HR = 0.59 [0.42, 0.83]
RT = 0,59 [0,42; 0,83]
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
Po končani uporabi rdečega tridelnega pakiranja, začnite z uporabo zelenega tridelnega pakiranja, ki je jasno označeno s številko »3« na zgornji strani škatle.
Delayed Betaferon 250 mcg n=176
odloženo zdravljenje z zdravilom Betaferon mikrogramov n = 176
Suicide attempt (see also section 4.4), Emotional lability
Psihiatrične motnje zmedenost poskus samomora (glejte tudi poglavje 4.4),
Part of a multipack containing 12 single packs.
Del škatle z več pakiranji, ki vsebuje 12 posameznih pakiranj.
1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
1 viala s praškom za raztopino za injiciranje vsebuje 300 mikrogramov (9,6 milijonov i.e.).
Betaferon 250 microgram (Placebo) n=317 (n=308)
n = 317 (n = 308)
3 Vials with powder: 300 microgram (9.6 m IU) per vial.
3 viale s praškom: 300 mikrogramov (9,6 milijonov i.e.) na vialo.
Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Simptomi so lahko rdečica, otekanje, sprememba barve kože, vnetje, bolečina, preobčutljivost, poškodbe tkiva (nekroza).
Part of a multipack containing 5 single packs.
Del škatle z več pakiranji, ki vsebuje 5 posameznih pakiranj.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients treated with Betaferon.
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.
Pack comprising 14 single packs, part of a 2-month pack containing 28 (2 x 14) single packs.
Pakiranje s 14 posameznimi pakiranji, del 2-mesečnega pakiranja, ki vsebuje 28 (2 x 14) posameznih pakiranj.