natgillin/translations-raw huggingface dataset:
If, for some reason, you are not able to inject Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Če si zaradi kakršnegakoli razloga zdravila Betaferon ne morete vbrizgati takoj, lahko rekonstituirano raztopino v brizgi do 3 ure hranite v hladilniku.
E) Making the injection
E) Injiciranje
1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
1 - Izberite mesto injiciranja (glejte nasvet na začetku in diagrame na koncu tega Dodatka) in dogodek zabeležite v kartici uporabe zdravila.
91 3 - Remove the cap from the needle by pulling not twisting it.
Pokrov povlecite, ne upogibajte ga.
4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
91 4 - Kožo okoli dezinficiranega mesta nežno stisnite (da jo nekoliko dvignete).
Turn the syringe-vial-assembly over, then withdraw plunger to redraw the dissolved drug.
Sestavo brizge in viale obrnite navzgor, in izvlecite bat, da izvlečete raztopljeno zdravilo.
Remove needle cap just before injection - you are now ready to inject.
Sedaj ste pripravljeni na injiciranje.
The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours).
Raztopino si injicirajte nemudoma po pripravi (če to mi možno, raztopino shranite v hladilnik in si jo injicirajte v 3 urah).
92 PART II:
DEL II:
ROTATING INJECTION SITES
MENJAVANJE MEST INJICIRANJA
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.
On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites all together), left, right, upper, middle and lower part of each area.
V našem razporedu je vsak predel razdeljen na 6 mest injiciranja (kar skupno tvori 48 mest injiciranja): na zgornji, srednji in spodnji del na levi in desni strani.
Rotation Schedule:
92 Načrt izmeničnega injiciranja:
To help you rotate the injection sites appropriately we recommend that you keep a record of the date and location of your injection.
Da bi ustrezno rotirali mesta injiciranja, priporočamo, da si datum in mesto injiciranja zapišete.
Rotation Cycle 1:
Rotacijski cikel 1:
Upper left section of each area
Zgornji levi del vsakega predela
Rotation Cycle 2:
Rotacijski cikel 2:
Lower right section of each area
Spodnji desni del vsakega predela
Rotation Cycle 3:
Rotacijski cikel 3:
Middle left section of each area
Srednji levi del vsakega predela
Rotation Cycle 4
Rotacijski cikel 4:
Upper right section of each area
Zgornji desni del vsakega predela
Rotation Cycle 5:
Rotacijski cikel 5:
Lower left section of each area
Spodnji levi del vsakega predela
Rotation Cycle 6:
Rotacijski cikel 6:
Middle right section of each area
Srednji desni del vsakega predela
PART III:
DEL III:
BETAFERON Medication record
Kartica o uporabi zdravila BETAFERON
Instructions for keeping track of your injection sites and dates Start with your first injection.
Navodila za zapisovanje mest injiciranja in datumov Začnite s prvo injekcijo (ali zadnjo injekcijo, če niste novi uporabnik zdravila Betaferon).
If you have already been using Betaferon start with the area that has not been used during the last rotation cycle, i.e. the past 16 days).
Če ste že uporabljali zdravilo Betaferon, začnite s predelom, ki ga v zadnjem rotacijskem ciklusu, tj. zadnjih 16 dni niste uporabili.
93 ROTATION SCHEDULE
93 NAČRT MENJAVANJA MEST INJICIRANJA:
AREA 1
PREDEL
AREA 2
PREDEL
AREA 3
PREDEL
AREA 4
PREDEL
10 – 15 cm from groin
10– 15 cm
AREA 5
PREDEL
AREA 6
PREDEL
AREA 78
PREDEL
AREA 87
PREDEL
94 EXAMPLE OF A MEDICATION RECORD:
94 PRIMER KARTICE O UPORABI ZDRAVILA:
95 PACKAGE LEAFLET:
95 NAVODILO ZA UPORABO
Betaferon 250 microgram/ml, Powder and solvent for solution for injection Interferon beta -1b
Betaferon 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje Interferon beta- 1b
How to use Betaferon 4.
Kaj morate vedeti, preden boste uporabili zdravilo Betaferon 3.
Further information Annex – self injection procedure
Kako uporabljati zdravilo Betaferon Možni neželeni učinki Shranjevanje zdravila Betaferon Dodatne informacije Dodatek – postopek samoinjiciranja
What Betaferon is:
Kaj je zdravilo Betaferon
Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Zdravilo Betaferon je vrsta zdravila, znanega kot interferon za zdravljenje multiple skleroze.
How Betaferon works:
Kako deluje zdravilo Betaferon
Betaferon has been shown to delay progression to definite 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.
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Recidivno- remitentna multipla skleroza: bolniki z recidivno- remitentno MS imajo občasne zagone ali relapse, med katerimi se simptomi znatno poslabšajo.
96 Secondary progressive multiple sclerosis:
96 Sekundarno progresivna multipla skleroza:
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.
V nekaterih primerih pri bolnikih z recidivno - remitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarno progresivna MS.
What Betaferon is used for:
Za kaj se uporablja zdravilo Betaferon
Betaferon is for use in patients
Zdravilo Betaferon je namenjeno za uporabo pri bolnikih
► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
Zdravnik bo pred zdravljenjem izključil možnost kakršnegakoli drugega vzroka za te simptome.
► who suffer from relapsing -remitting multiple sclerosis, with at least two relapses within the last two years.
► z recidivno- remitentno multiplo sklerozo z vsaj dvema relapsoma v zadnjih dveh letih.
Before you use Betaferon
Kaj morate vedeti, preden boste uporabili zdravilo Betaferon
Do not use Betaferon:
Ne uporabljajte zdravila Betaferon
You should not start treatment with Betaferon (see ‘Pregnancy’).
Ne začnite zdravljenja z zdravilom Betaferon (glejte poglavje Nosečnost),
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
- če ste alergični na (preobčutljivi za) naravni ali rekombinantni interferon beta, humani albumin
any of the other ingredients of Betaferon.
ali katerokoli sestavino zdravila Betaferon,
- if you currently suffer from severe depression and/or suicidal thoughts (see ‘Take special
- če imate trenutno hudo depresijo, samomorilne misli ali oboje (glejte poglavji Bodite
care’ and 4.
posebno pozorni pri uporabi zdravila Betaferon in 4.
Possible side effects).
Možni neželeni učinki),
- if you have severe liver disease (see ‘Take special care’, ‘Using other medicines’, and 4.
- če imate hudo bolezen jeter (glejte poglavja Bodite posebno pozorni pri uporabi zdravila
‘Possible side effects’).
Možni neželeni učinki).
► Tell your doctor if any of the above applies to you.
► Obvestite svojega zdravnika, če karkoli od zgoraj navedenega velja za vas.
Take special care with Betaferon:
Bodite posebno pozorni pri uporabi zdravila Betaferon
Your doctor also needs to know the following before you are given Betaferon:
Predno vam zdravnik predpiše zdravilo Betaferon, ga obvestite
− If you have monoclonal gammopathy.
- če imate monoklonsko gamopatijo.
This is a disorder of the immune system where an abnormal protein is found in the blood.
To je motnja imunskega sistema, pri kateri so v krvi
Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Pri uporabi zdravil kot je Betaferon se lahko pojavijo težave z majhnimi žilami (kapilarami) (sindrom sistemske kapilarne krvavitve).
− If you have had depression or are depressed or previously had thoughts of suicide.
Med
Your doctor will closely monitor you during treatment.
zdravljenjem vas bo zdravnik pozorno nadzoroval.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon’).
Če so vaša depresija in/ ali samomorilne misli resne, vam ne bodo predpisali zdravila Betaferon (glejte tudi poglavje Ne uporabljajte zdravila Betaferon).
− 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.
- če ste imeli epileptične napade ali jemljete zdravila za zdravljenje epilepsije (antiepileptike)
− If you have severe kidney problems your doctor may monitor your kidney function during treatment.
Med zdravljenjem bo vaš zdravnik spremljal delovanje ledvic.
► Tell your doctor if any of these applies to you.
► Obvestite svojega zdravnika, če karkoli od naštetega velja za vas.
97 Your doctor also needs to know the following whilst you are using Betaferon:
97 Med uporabljanjem zdravila Betaferon morate vašega zdravnika obvestiti tudi
− 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 se pojavijo simptomi, kot je srbenje po vsem telesu, oteklost obraza in/ ali jezika ali
− If you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
- če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z
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.
Če postanete med uporabo zdravila Betaferon depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadzoroval ali pretehtal možnost prekinitve zdravljenja.
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Betaferon (see also ‘Do not use Betaferon’).
Če imate hudo depresijo in/ ali samomorilne misli, vam ne bodo predpisali zdravila Betaferon (glejte tudi poglavje Ne uporabljajte zdravila Betaferon).
− If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
- če opazite kakršnekoli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam
− 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.
če opazite srbenje po vsem telesu, rumeno obarvanje kože in očesnih beločnic ter nagnjenost k podplutbam.
− 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
98 − 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).
Symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity.
Simptomi vključujejo rdečico, otekanje, spremembo barve kože, vnetje, bolečino in preobčutljivost.
To reduce the risk of getting injection site reactions you must: − use a sterile (aseptic) injection technique, − rotate the injection sites with each injection (see Annex ‘Self-injection procedure’, Part II, in the second part of this leaflet).
uporabljajte sterilno (aseptično) tehniko injiciranja, pri vsakem odmerku menjavajte mesto injiciranja (glejte Dodatek Postopek samoinjiciranja).
► Stop injections with Betaferon and talk to your doctor
► prenehajte z injiciranjem zdravila Betaferon in se posvetujte z zdravnikom,
- medicines which need a certain liver enzyme system (known as cytochrome P450 system) for
- zdravili, ki potrebujejo določen jetrni encimski sistem (t. i. sistem citokrom P450) za
their removal from the body, for example medicines used to treat epilepsy (like phenytoin).
odstranitev iz telesa, na primer z zdravili, ki se uporabljajo za zdravljenje epilepsije (kot je fenitoin),
99 Using Betaferon with food and drink:
99
Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
- zdravili, ki vplivajo na nastajanje krvnih celic.
Children and adolescents:
Uporaba zdravila Betaferon skupaj s hrano in pijačo
There have been no formal clinical trials undertaken in children or adolescents.
Otroci in mladostniki
However, there is some data available in children and adolescents from 12 to 16 years.
Kliničnih preskušanj pri otrocih ali mladostnikih niso izvedli.
► 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.
Betaferon treatment should not be started if you are pregnant (see also ‘Do not use Betaferon’).
Če ste noseči, ne smete začeti zdravljenja z zdravilom Betaferon (glejte tudi poglavje Ne uporabljajte zdravila Betaferon).
► 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.
100 Dose:
100 Pri uporabi zdravila Betaferon natančno upoštevajte zdravnikova navodila.
The usual dose is: every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex ‘Self-injection procedure’ in the second part of this leaflet) injected under the skin (subcutaneously).
Običajni odmerek je: vsak drugi dan (enkrat na dva dni) 1 ml pripravljene raztopine zdravila Betaferon (glejte Dodatek Postopek samoinjiciranja) injicirane pod kožo (subkutano).
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 to 0.5 ml, 0.75 ml and then finally to the full (1 ml) dose of Betaferon.
Bolniki bolje prenašajo, če se na začetku zdravljenja z zdravilom Betaferon odmerek postopoma povečuje, t. j. začne se samo z 0, 25 ml zdravila in nato povečuje po vsaki tretji injekciji do 0, 5 ml, 0, 75 ml in nato končno do celotnega (1 ml) odmerka zdravila Betaferon.
Preparing the injection:
Priprava injekcije
Before injection, the Betaferon solution has to be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Pred injiciranjem je treba raztopino zdravila Betaferon pripraviti iz viale s praškom zdravila Betaferon in 1, 2 ml vehikla iz napolnjene injekcijske brizge.
This will either be done by your doctor or his/her assistant or by yourself after you have been carefully trained.
To bodo naredili bodisi zdravnik ali njegovo osebje bodisi vi sami, potem ko se boste za to zadostno usposobili.
For details how the Betaferon solution for injection is prepared see Annex ‘Self-injection procedure’, Part I.
Glede podrobnejših navodil o uporabi raztopine za injiciranje Betaferon glejte dodatek Postopek samoinjiciranja, del I.
Detailed instructions for self-injection of Betaferon under the skin are provided in Part IE of the Annex ’Self-injection procedure’.
Podrobnejša navodila za samoinjiciranje zdravila Betaferon pod kožo so navedena v delu IE v dodatku Postopek samoinjiciranja.
See ‘Take special care with Betaferon’ and follow the instructions in Part II ‘Rotating injection sites’ and Part III (Betaferon Medication Record) of the Annex ’Self-injection procedure’.
Mesto injiciranja morate redno menjavati (glejte poglavje Bodite posebno pozorni pri uporabi zdravila Betaferon in upoštevajte navodila v delu II, Menjavanje mest injiciranja in delu III (Kartica o uporabi zdravila Betaferon) v dodatku Postopek samoinjiciranja.
If you use more Betaferon than you should:
Če ste uporabili večji odmerek zdravila Betaferon, kot bi smeli
Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Uporaba odmerka zdravila Betaferon, ki je večkrat presegel odmerek priporočen za zdravljenje multiple skleroze, ni vodila do življenjsko ogrožujočih stanj.
If you forget to use Betaferon:
Če ste pozabili vzeti zdravilo Betaferon
Do not inject a double dose to make up for a forgotten single dose.
Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you stop using Betaferon:
Če ste prenehali uporabljati zdravilo Betaferon
Talk to your doctor if you stop or wish to stop treatment.
Pogovorite se s svojim zdravnikom, če ste prenehali ali želite prenehati z zdravljenjem.
► If you have any further questions on the use of this product, ask your doctor or pharmacist.
101 ► Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, Betaferon can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Betaferon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
101 At the beginning of treatment side effects are common but in general they become less with further treatment.
Na začetku zdravljenja so neželeni učinki pogosti, a z nadaljevanjem zdravljenja praviloma izzvenijo.
Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Najpogostejši neželeni učinki so: ► gripi podobni simptomi, kot so zvišana telesna temperatura, mrzlica, bolečine v sklepih, splošno slabo počutje, potenje, glavobol ali bolečine v mišicah.
Injection site reactions.
reakcije na mestu injiciranja.
Symptoms can be redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis.
Simptomi so lahko rdečica, otekanje, sprememba barve kože, vnetje, bolečina, preobčutljivost, nekroza.
See ‘Take special care’ in section 2 for more information and what to do, if you experience an injection site reaction.
Če opazite reakcije na mestu injiciranja, glejte poglavje Bodite posebno pozorni pri uporabi zdravila Betaferon v poglavju 2 za več informacij in ravnanje v tem primeru.
Please talk to your doctor for further information.
Za več informacij se pogovorite s svojim zdravnikom.
To reduce side effects at the start of treatment, your doctor should start you on a low dose of Betaferon and increase it gradually (see section 3. ‘How to use Betaferon’).
Kako uporabljati zdravilo Betaferon).
Betaferon may also cause serious side effects.
Zdravilo Betaferon lahko povzroči tudi resne neželene učinke.
► Tell your doctor immediately and stop using Betaferon:
► Zdravnika nemudoma obvestite in prenehajte uporabljati zdravilo Betaferon:
− 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 se pojavijo simptomi, kot je srbenje po vsem telesu, otekanje obraza in/ ali
− if you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z zdravilom Betaferon, ali če se vam pojavijo samomorilne misli,
− if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
če opazite kakršnekoli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam zdi, da pogosto zbolevate za okužbami,
− 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.
če izgubite apetit, ste utrujeni, vam je slabo (navzeja), se pojavi ponavljajoče se bruhanje, predvsem, če opazite srbenje po vsem telesu, rumeno obarvanje kože in očesnih beločnic ter nagnjenost k podplutbam,
− 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,
− 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 temperaturo.
Table 1:
102 Preglednica 1:
Side effects which have occurred in clinical trials with Betaferon very commonly (at least 10 per 100 of the cases) and at a higher percentage than those observed with placebo.
(neželeni učinki, ki so se v kliničnih preskušanjih zdravila Betaferon pojavili zelo pogosto (vsaj 10 od 100 primerov) in v večjem odstotku kot pri placebu.
The table also includes side effects which occur in less than 10 per 100 but which were significantly associated with the treatment):
V preglednici so tudi neželeni učinki, ki se pojavljajo pri manj kot 10% primerov, a so pomembno povezani z zdravljenjem).
- reduced number of white blood cells, swollen lymph glands
- zmanjšanje števila belih krvnih celic, otekanje bezgavk
- decrease of sugar in the blood
- znižanje vrednosti sladkorja v krvi
- depression, anxiety
- depresija, tesnoba
- headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paresthesia)
- glavobol, omotica, nespečnost, migrena, otrplost ali občutek ščemenja (parestezija)
- conjunctivitis, abnormal vision
- vnetje očesne veznice, motnje vida
- ear pain
- bolečine v ušesu
- irregular, rapid beating or pulsation of the heart (palpitation)
- nepravilno, hitro bitje ali utripanje srca (palpitacije)
- redness and/or facial flushing due to widening of blood vessels, increased blood pressure
- rdečica in/ ali vročinski oblivi obraza zaradi širjenja žil, zvišan krvni tlak
- runny nose, cough, hoarseness due to infection of the upper respiratory tract
- izcedek iz nosu, kašelj, hripavost zaradi okužbe zgornjih dihal, vnetje sinusov, močnejši kašelj,
sinusitis, cough increased, shortness of breath
kratka sapa
- diarrhoea, constipation, nausea, vomiting, abdominal pain
- driska, zaprtost, slabost, bruhanje, bolečine v trebuhu
- rises in the blood levels of liver enzymes (will show up in blood tests)
povečane vrednosti jetrnih encimov v krvi (pokažejo krvne preiskave)
- skin disorder, rash
- bolezni kože, osip
- muscle stiffness (hypertonia),painful muscles (myalgia), muscular weakness (myasthenia),
- otrdelost mišic (hipertonija), bolečina v mišicah (mialgija), mišična šibkost (miastenija),
back pain, pain in extremities such as fingers and toes
bolečina v hrbtu, bolečine v okončinah, npr. v prstih na nogah in rokah
- holding urine (urine retention),protein in the urine (will show up in urine tests), urinary
- zastoj seča (retencija urina), beljakovine v seču (pokažejo urinske preiskave), pogosto
frequency, urinary incontinence, urinary urgency
mokrenje, nezmožnost zadrževanja urina, nuja na mokrenje
- painful periods (menstruation), menstrual disorder, heavy uterine bleeding especially between
- boleče mesečne krvavitve (menstruacija), menstruacijske motnje, močne krvavitve iz
menstrual periods, impotence
maternice, zlasti med mesečnimi krvavitvami, impotenca
- injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic
- reakcije na mestu injiciranja (vključno z rdečico, otekanjem, spremembo barve kože, vnetjem,