natgillin/translations-raw huggingface dataset:
1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ ml, 1 vial adapter with needle + 2 alcohol wipes
1 adapter za vialo z iglo + 2 alkoholni blazinici
Read the package leaflet before use.
Po rekonstituciji z vehiklom zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
After reconst. immediate use recommended.
Zdravilo je priporočljivo uporabiti takoj po pripravi.
Do not store above 25°C.
Shranjujte pri temperaturi do 25OC.
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 14 PACKS (WITHOUT BLUE BOX)
ŠKATLA Z 1 POSAMEZNIM PAKIRANJEM (1 VIALA/ 1 NAPOLNJENA INJEKCIJSKA BRIZGA), KOT ENOTA V ŠKATLI S 14 PAKIRANJI (BREZ BLUEBOXA)
300 mcg (9.6 mio IU) per vial.
300 mikrogramov (9, 6 milijonov i. e.) na vialo.
When reconstituted 250 mcg/ ml (8 mio IU/ ml) Interferon beta-1b.
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b.
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 PODATKI NA ZUNANJI OVOJNINI
CARTON OF 1 SINGLE PACK (1 VIAL/ 1 PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 5 PACKS (WITHOUT BLUE BOX)
ŠKATLA Z 1 POSAMEZNIM PAKIRANJEM (1 VIALA/ 1 NAPOLNJENA INJEKCIJSKA BRIZGA), KOT ENOTA V ŠKATLI S 5 PAKIRANJI (BREZ BLUEBOXA)
1 ml contains 250 microgram (8 million IU) Interferon beta-1b per ml when reconstituted.
1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b po rekonstituciji.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 PODATKI NA ZUNANJI OVOJNINI
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 1, 3, 5
DAN ZDRAVLJENJA
Triple pack 1 1st dosage step (0.25 ml) for treatment days 1, 3, 5
Tridelno pakiranje 1 1. korak odmerjanja (0, 25 ml) za 1., 3. in 5. dan zdravljenja
3 Vials with powder:
3 viale s praškom:
When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.
Po rekonstituciji 1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b.
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: natrijev klorid, 5, 4 mg/ ml, 3 adapterji za viale z iglami + 6 alkoholnih blazinic
For subcutaneous injection after reconstitution with solvent.
Po rekonstituciji z vehiklom zdravilo injicirajte subkutano. za enkratno uporabo Pred uporabo preberite priloženo navodilo.
Read the package leaflet before use.
Zdravilo shranjujte nedosegljivo otrokom.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Keep out of the reach and sight of children.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
OTHER SPECIAL WARNING(S), IF NECESSARY
Uporabno do {MM/ LLLL}
EXPIRY DATE
66 Zdravilo je priporočljivo uporabiti takoj po pripravi.
Bayer Schering Pharma AG D-13342 Berlin Germany 12.
Bayer Schering Pharma AG D- 13342 Berlin Nemčija
INSTRUCTIONS ON USE (text for inside the lid)
NAVODILA ZA UPORABO
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 za pripravo prvih treh injekcij (1., 3. in 5. dan).
Discard the vial with the remaining solution.
0, 25 ml za prve tri injekcije (1., 3. in 5. dan zdravljenja) Vialo z neporabljeno raztopino zavrzite.
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 PODATKI NA ZUNANJI OVOJNINI
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 7, 9, 11
DAN ZDRAVLJENJA
Triple pack 2 2nd dosage step (0.5 ml) for treatment days 7, 9, 11
Tridelno pakiranje 2 2. korak pri odmerjanju (0, 5 ml) za 7., 9. in 11. dan zdravljenja
EXPIRY DATE
68 Uporabno do {MM/ LLLL}
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 3 injekcij (7., 9. in 11. dan).
0.5 ml for the injections at day 7, 9 and 11 of therapy.
0, 5 ml za injekcije 7., 9. in 11. dan zdravljenja.
Betaferon 69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
69 PODATKI NA ZUNANJI OVOJNINI
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 13, 15, 17
DAN ZDRAVLJENJA
Triple pack 3 3rd dosage step (0.75 ml) for treatment days 13, 15, 17
Tridelno pakiranje 3 3. korak pri odmerjanju (0, 75 ml) za 13., 15. in 17.. dan zdravljenja
Keep out of the reach and sight of children
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXPIRY DATE
70 Zdravilo je priporočljivo uporabiti takoj po pripravi.
INSTRUCTIONS ON USE (text for inside the lid) Dear patient,
NAVODILA ZA UPORABO
0.75 ml for the injections at day 13, 15 and 17 of therapy.
0, 75 ml za injekcije 13., 15. in 17. dan zdravljenja.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 PODATKI NA ZUNANJI OVOJNINI
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 19, 21, 23
DAN ZDRAVLJENJA
Triple pack 4 4th dosage step (1.0 ml) for treatment days 19, 21, 23
Tridelno pakiranje 4 4. korak pri odmerjanju (1 ml) za 19., 21. in 23. dan zdravljenja
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 z 1, 2 ml vehikla: natrijev klorid, 5, 4 mg/ ml, 3 adapterji za viale z iglami + 6 alkoholnih blazinic
EXPIRY DATE
72 Uporabno do {MM/ LLLL}
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 3 injekcij (19., 21. in 23. dan).
Then draw up solution as far as the 1.0 ml mark on the syringe:
Potegnite raztopino kot je označeno na injekcijski brizgi:
1.0 ml for the injections at day 19, 21 and 23 of therapy.
1 ml za injekcije 19., 21. in 23. dan zdravljenja.
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (SOLVENT / BLISTER OF PRE-FILLED SYRINGE)
73 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU (VEHIKEL / PRETISNI OMOT NAPOLNJENE INJEKCIJSKE BRIZGE)
Solvent for reconstitution of Betaferon 1.2 ml sodium chloride solution 5.4 mg/ ml
Vehikel za rekonstitucijo Betaferona 1, 2 ml raztopine natrijevega klorida 5, 4 mg/ ml
74 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (SOLVENT / PREFILLED SYRINGE)
74 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
75 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIALs BETAFERON (VIALs / PFS))
75 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Betaferon 250 microgram/ ml, Powder for solution for injection Interferon beta-1b Subcutaneous use
Betaferon 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje Interferon beta- 1b Subkutana uporaba
250 mcg (8 MIO IU) per ml after reconstitution
250 mikrogramov (8 milijonov i. e.) / ml po rekonstituciji
77 PACKAGE LEAFLET:
77 NAVODILO ZA UPORABO
Do not pass it on to others.
- To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
please tell your doctor or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta
What Betaferon is and what it is used for 2.
Kaj je zdravilo Betaferon in za kaj ga uporabljamo 2.
Before you use Betaferon 3.
Kaj morate vedeti, preden boste uporabili zdravilo Betaferon 3.
How to use Betaferon 4.
Kako uporabljati zdravilo Betaferon 4.
How to store Betaferon 6.
Shranjevanje zdravila Betaferon 6.
Further information Annex – self injection procedure
Dodatne informacije Dodatek – postopek samoinjiciranja
What Betaferon is
Kaj je zdravilo Betaferon
In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Pri MS vnetje uniči zaščitno ovojnico (imenovano mielinska ovojnica), ki obdaja živce v osrednjem živčevju in prepreči njihovo pravilno delovanje.
Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Interferon beta- 1b lahko spremeni odziv imunskega sistema in tako pomaga pri zmanjševanju učinka bolezni.
How Betaferon helps fight your disease:
Kako zdravilo Betaferon pomaga v boju proti bolezni
Single clinical event indicating a high risk of developing multiple sclerosis:
Enkraten klinični dogodek, ki kaže na veliko tveganje za razvoj multiple skleroze: pokazali so, da zdravilo Betaferon upočasni napredovanje do dokončne multiple skleroze.
Betaferon has been shown to delay progression to definite multiple sclerosis.
Pokazali so, da zdravilo Betaferon zmanjša pogostnost in resnost zagonov, zmanjša število dni v bolnišnici zaradi bolezni in podaljša čas brez relapsov.
Relapsing-remitting multiple sclerosis:
78 Sekundarno progresivna multipla skleroza:
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
V nekaterih primerih pri bolnikih z recidivno - remitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarno progresivna MS.
Betaferon has been shown to cut down the number of attacks and make them less severe.
Bolniki s to obliko postajajo vedno bolj prizadeti, ne glede na to, ali imajo relapse ali ne.
It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Zdravilo Betaferon lahko zmanjša pogostnost in resnost zagonov ter upočasni napredovanje invalidnosti.
78 Secondary progressive multiple sclerosis:
► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS.
Zdravnik bo pred zdravljenjem izključil možnost kakršnegakoli drugega vzroka za te simptome.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
► z recidivno- remitentno multiplo sklerozo z vsaj dvema relapsoma v zadnjih dveh letih.
Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
► s sekundarno progresivno multiplo sklerozo, ki imajo aktivno bolezen, kar se kaže z relapsi.
What Betaferon is used for:
Kaj morate vedeti, preden boste uporabili zdravilo Betaferon
Betaferon is for use in patients
Ne uporabljajte zdravila Betaferon
► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
Ne začnite zdravljenja z zdravilom Betaferon (glejte poglavje Nosečnost),
Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
- če ste alergični na (preobčutljivi za) naravni ali rekombinantni interferon beta, humani albumin
► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years.
ali katerokoli sestavino zdravila Betaferon,
► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
- če imate trenutno hudo depresijo, samomorilne misli ali oboje (glejte poglavji Bodite
Before you use Betaferon
posebno pozorni pri uporabi zdravila Betaferon in 4.
Do not use Betaferon:
- če imate hudo bolezen jeter (glejte poglavja Bodite posebno pozorni pri uporabi zdravila
- if you are pregnant.
Betaferon, Uporaba drugih zdravil in 4.
You should not start treatment with Betaferon (see ‘ Pregnancy’).
Možni neželeni učinki).
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
Obvestite svojega zdravnika, če karkoli od zgoraj navedenega velja za vas.
any of the other ingredients of Betaferon.
Bodite posebno pozorni pri uporabi zdravila Betaferon
- if you currently suffer from severe depression and/ or suicidal thoughts (see ‘ Take special
Predno vam zdravnik predpiše zdravilo Betaferon, ga obvestite
care ’ and 4. ‘ Possible side effects’).
- če imate monoklonsko gamopatijo.
- if you have a severe liver diesease (see ‘ Take special care’, ‘ Using other medicines’ and
Pri uporabi zdravil kot je Betaferon se lahko pojavijo težave z majhnimi žilami (kapilarami) (sindrom sistemske kapilarne krvavitve).
4. ‘ Possible side effects’).
To lahko povzroči šok (kolaps) in celo smrt.
►
Med
Tell your doctor if any of the above applies to you.
zdravljenjem vas bo zdravnik pozorno nadzoroval.
Take special care with Betaferon:
- če ste imeli epileptične napade ali jemljete zdravila za zdravljenje epilepsije (antiepileptike)
Your doctor also needs to know the following before you are given Betaferon:
Možni neželeni učinki).
− If you have monoclonal gammopathy.
- če imate hude težave z ledvicami.
This can lead to shock (collapse) and even be fatal.
Med zdravljenjem bo vaš zdravnik spremljal delovanje ledvic.
− If you have had depression or are depressed or previously had thoughts of suicide.
► Obvestite svojega zdravnika, če karkoli od naštetega velja za vas.
− If you have ever had seizures or if you are taking medicines to treat epilepsy (anti- epileptics) (see also ‘Using other medicines’ and 4. ‘Possible side effects’) your doctor will monitor your treatment carefully.
79 Med uporabljanjem zdravila Betaferon morate vašega zdravnika obvestiti tudi
− If you have severe kidney problems your doctor may monitor your kidney function during treatment.
- če se pojavijo simptomi, kot je srbenje po vsem telesu, oteklost obraza in/ ali jezika ali
► Tell your doctor if any of these applies to you.
To so lahko simptomi resne alergične reakcije (preobčutljivosti), ki lahko postane življenjsko nevarna.
79 Your doctor also needs to know the following whilst you are using Betaferon:
- če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z
− If you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Če postanete med uporabo zdravila Betaferon depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadzoroval ali pretehtal možnost prekinitve zdravljenja.
These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Če imate hudo depresijo in/ ali samomorilne misli, vam ne bodo predpisali zdravila Betaferon (glejte tudi poglavje Ne uporabljajte zdravila Betaferon).
− If you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
- če opazite kakršnekoli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam
If you become depressed while you are on Betaferon, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
To so lahko simptomi zmanjšanja števila celic v krvi ali števila trombocitov v krvi (celice, ki pomagajo pri strjevanju krvi).
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Betaferon (see also ‘Do not use Betaferon’).
Morda vas bo moral zdravnik posebej nadzorovati.
− If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
- če izgubite apetit, ste utrujeni, vam je slabo, se pojavi ponavljajoče bruhanje, predvsem, če
− If you have loss of appetite, fatigue, feeling sick (nausea), repeated vomiting, especially if you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
opazite srbenje po vsem telesu, rumeno obarvanje kože in očesnih beločnic ter nagnjenost k podplutbam.
As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Betaferon.
Kot pri drugih interferonih beta so pri bolnikih, ki so uporabljali zdravilo Betaferon, opisali redke primere hude jetrne okvare, vključno s primeri jetrne odpovedi.
The most serious were reported in patients taking other drugs or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
O resnih neželenih učinkih so poročali pri bolnikih, ki so jemali še druga zdravila ali so imeli bolezni, ki vplivajo na jetra (npr. zloraba alkohola, resne okužbe).
− If you experience symptoms like irregular heart beat, 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.
This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Betaferon
Morda je to znak bolezni srčne mišice (kardiomiopatija), o kateri v redkih primerih poročajo pri bolnikih, ki jemljejo zdravilo Betaferon.
− If you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
- če imate bolečine v trebuhu, ki se širijo v hrbet, in/ ali vam je slabo ali imate zvišano telesno
This may suggest an inflammation of the pancreas (pancreatit is), which has been reported with Betaferon use.
Morda to kaže na vnetje trebušne slinavke (pankreatitis), o katerem poročajo pri bolnikih, ki jemljejo zdravilo Betaferon.
► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
► Takoj prenehajte uporabljati zdravilo Betaferon in obvestite svojega zdravnika, če se vam pojavi karkoli od naštetega.
Other things to consider when using Betaferon:
Drugi dejavniki, ki jih je treba upoštevati pri uporabi zdravila Betaferon
− 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, biokemijske krvne preiskave in
These blood tests will be in addition to the tests, which are normally done to monitor your MS.
Te krvne preiskave se opravijo poleg testov, ki so običajni za nadzor MS.
− If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you,.
- Če imate bolezen srca vas bodo morda gripi podobni simptomi, ki se pogosto pojavijo na
Betaferon must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly during the start of treatment.
Vaš zdravnik bo spremljal morebitno poslabšanje bolezni srca, še zlasti na začetku zdravljenja.
− 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
− Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
- Zdravilo Betaferon vsebuje humani albumin, zato obstaja morebitno tveganje za prenos
A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Tveganja za prenos Creutzfeld- Jakobove bolezni (CJD) ni mogoče izključiti.
80 − During treatment with Betaferon your body may produce substances which are called neutralising antibodies, which may react with Betaferon (neutralising activity).
nevtralizirajoča protitelesa, ki lahko reagirajo z zdravilom Betaferon (nevtraliziranje).
Injection site reactions:
Reakcije na mestu injiciranja
Symptoms include redness, swelling, change in the skin color, inflammation, pain, and hypersensitivity.
Simptomi vključujejo rdečico, otekanje, spremembo barve kože, vnetje, bolečino in preobčutljivost.
Dead skin and tissue around the injection site (necrosis) are reported less frequently.
Redkeje poročajo o primerih odmrtja kože in tkiva okoli mesta injiciranja (nekroza).
Injection site skin and tissue breakdown can result in scars forming.
Če so težave hude, bo morda moral zdravnik odstraniti tujke in mrtvo tkivo (debri).
If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
Manj pogosto je potrebna presaditev kože; celjenje lahko traja do 6 mesecev.
To reduce the risk of getting injection site reaction you must: − use a sterile (aseptic) injection technique, − rotate the injection sites with each injection (see Annex ‘Self- Injection procedure’).
uporabljajte sterilno (aseptično) tehniko injiciranja, pri vsakem odmerku menjavajte mesto injiciranja (glejte Dodatek Postopek samoinjiciranja).
Your doctor can tell you more about this.
O tem se posvetujte z vašim zdravnikom.
If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:
Če vam poči koža zaradi otekanja ali iztekanja tekočine z mesta injiciranja
► Stop injections with Betaferon and talk to your doctor.
► prenehajte z injiciranjem zdravila Betaferon in se posvetujte z zdravnikom,
► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Betaferon.
► lahko nadaljujete z uporabljanjem zdravila Betaferon, če je poškodovano le eno mesto injiciranja (lezija) in poškodbe tkiva (nekroza) niso obsežne,
► If you have more than one sore injection site (multiple lesions) you must stop using Betaferon until your skin has healed.
► in imate več poškodovanih mest injiciranja (multiple lezije), morate prenehati uporabljati zdravilo Betaferon, dokler se koža ne zaceli.
Betaferon should be used with caution with:
Zdravilo Betaferon je treba uporabljati previdno z:
81 Using Betaferon with food and drink:
81
Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
odstranitev iz telesa, na primer z zdravili, ki se uporabljajo za zdravljenje epilepsije (kot je fenitoin),
Children and adolescents:
- zdravili, ki vplivajo na nastajanje krvnih celic.
There have been no formal clinical trials undertaken in children or adolescents.
Uporaba zdravila Betaferon skupaj s hrano in pijačo
However, there is some data available in children and adolescents from 12 to 16 years.
Otroci in mladostniki
This data suggests that the safety profile from this age is the same as in adults for use of Betaferon 8 million IU under the skin (subcutaneously) every other day.
Vendar je pri otrocih in mladostnikih, starih od 12 do 16 let, na voljo nekaj podatkov, ki kažejo, da je varnostni profil pri osebah v tej starostni skupini, ki so jim vsak drugi dan pod kožo (subkutano) injicirali 8 milijonov i. e. zdravila Betaferon, enak kot pri odraslih.
Betaferon should not be used in children under 12 years of age as there is no information on this use.
Podatkov o uporabi zdravila Betaferon pri otrocih, mlajših od 12 let, ni, zato se ga pri tej starostni skupini ne sme uporabljati.
If you could get pregnant, use contraception while you are on Betaferon.
Če obstaja možnost da zanosite, morate med zdravljenjem z zdravilom Betaferon uporabljati kontracepcijo.
If you are pregnant or you think you may be, tell your doctor.
Če ste noseči ali mislite, da ste morda noseči, morate to povedati zdravniku.
If you wish to become pregnant, discuss this with your doctor first.
Če želite zanositi, se o tem prej posvetujte z zdravnikom.
If you become pregnant while using Betaferon, stop your treatment and contact your doctor immediately.
Če med zdravljenjem z zdravilom Betaferon zanosite, morate zdravljenje prekiniti in se takoj posvetovati s svojim zdravnikom.
It is not known whether Interferon beta-1b passes into human breast milk.
Ni znano, ali interferon beta- 1b prehaja v materino mleko.
However, it is theoretically possible that a breast-fed baby could experience serious side effects to Betaferon. ► Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Betaferon.
Vendar so pri dojenčkih teoretično možne resne neželene reakcije na zdravilo Betaferon. ► Posvetujte se s svojim zdravnikom, predno prenehate dojiti ali uporabljati zdravilo Betaferon.
Driving or using machines:
Vpliv na sposobnost upravljanja vozil in strojev
Betaferon may cause side effects in the central-nervous system (see section 4. ‘Possible side effects’).
Možni neželeni učinki).
Important information about some of the ingredients of Betaferon:
Pomembne informacije o nekaterih sestavinah zdravila Betaferon