natgillin/translations-raw huggingface dataset:
Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Potražite medicinski savjet u slučaju pojave hipertenzivne krize (vrlo visoki krvni tlak, kolaps), malignog neuroleptičkog sindroma (smetenost, znojenje, ukočenost mišića, povišena tjelesna temperatura, povišene razine enzima kreatin kinaze u krvi), serotoninskog sindroma (smetenost, povišeni krvni tlak, ukočenost mišića, halucinacije) i sniženog krvnog tlaka.
As this may be a class-effect, the concomitant administration of safinamide and pethidine is contraindicated (see section 4.3).
Kako to može biti učinak skupine, istodobna primjena safinamida i petidina je kontraindicirana (vidjeti dio 4.3).
Palpitations, tachycardia, sinus bradycardia, arrhythmia
Palpitacije, tahikardija, sinusna bradikardija, aritmija
Cough, dyspnoea, rhinorrhoea
Kašalj, dispneja, rinoreja
Male rat fertility is not affected (see section 5.3).
Nema utjecaja na plodnost mužjaka štakora (vidjeti dio 5.3).
Xadago is not recommended during pregnancy and in women of childbearing potential not using contraception.
Ne preporučuje se koristiti lijek Xadago tijekom trudnoće ni u žena u reproduktivne dobi koje ne koriste kontracepciju.
Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced.
Safinamid se ženama u reproduktivnoj dobi smije davati samo ako koriste odgovarajuću kontracepciju.
Hyperhidrosis, pruritus generalised, photosensitivity reaction, erythema
Hiperhidroza, opći svrbež, reakcija fotoosjetljivosti, eritem
Safinamide
Hipromeloza
Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis
Alopecija, mjehurići, kontaktni dermatitis, dermatoza, ekhimoza, lihenoidna keratoza, noćno znojenje, bolna koža, poremećaj pigmentacije, psorijaza, seboroični dermatitis
Some reports of ICDs have also been observed with other MAO-inhibitors.
Neki izvještaji o poremećajima kontrole impulsa primijećeni su i s drugim MAO inhibitorima.
There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products.
Postoje izvještaji o interakcijama lijekova prilikom istodobne primjene MAO inhibitora i simpatomimetičkih lijekova.
Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain
Benigna hiperplazija prostate, poremećaj dojke, bol u dojci
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors.
Ozbiljne nuspojave prijavljene su pri istodobnoj primjeni petidina i MAO inhibitora.
Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection
Bronhopneumonija, furunkul, nazofaringitis, pioderma, rinitis, infekcija zuba, virusna infekcija
Safinamide treatment has not been associated with any increase in the appearance of ICDs.
Liječenje safinamidom nije povezano s porastom pojave poremećaja kontrole impulsa.
C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Ispitivanje masene bilance pokazalo je da AUC0-24h nepromijenjenog 14C-safinamida u plazmi čini oko 30% AUC0-24h ukupne radioaktivnosti, ukazujući na opsežan metabolizam.
Hypertension, hypotension, varicose vein
Hipertenzija, hipotenzija, varikozne vene
Somnolence and dizziness may occur during safinamide treatment; you should be cautious about operating hazardous machines or driving, until you are reasonably certain that Xadago does not affect you in any way.
Trebate biti oprezni pri upravljanju opasnim strojevima ili vozilima sve dok niste razumno sigurni da Xadago ne utječe štetno na Vas ni na koji način.
Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555)
Titanijev dioksid (E171)
Dyskinesia somnolence dizziness, headache, Parkinson's disease
Diskinezija somnolencij a, omaglica, glavobolja, Parkinsonov a bolest
Paraesthesia, balance disorder, hypoaesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder
Parestezija, poremećaj ravnoteže, hipoestezija, distonija, nelagoda u glavi, dizartrija, sinkopa, kognitivni poremećaj
Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot
Umor, astenija, poremećaj hoda, periferni edem, bol, osjećaj vrućine
What Xadago contains - The active substance is safinamide.
Što Xadago sadrži Djelatna tvar je safinamid.
SE Standard Error, SD Standard deviation, LSM Least Square Mean, LS Diff.
Standard Error) standardna greška, SD (engl.
Warnings and precautions Talk to your doctor before taking Xadago - If you have liver problems - Patients and carers should be made aware that certain compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying have been reported with other medicines for Parkinson's disease.
- Ako imate probleme s jetrom - Bolesnici i njegovatelji moraju biti upoznati da su određena kompulzivna ponašanja, kao što su kompulzije, opsesivne misli, patološko kockanje, povećan libido, hiperseksualnost, impulzivno ponašanje i kompulzivno trošenje i kupovanje, prijavljena s drugim lijekovima za Parkinsonovu bolest.
A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with safinamide.
Prije uvođenja liječenja safinamidom potrebno je uzeti u obzir razdoblje ispiranja, koje odgovara trajanju 5 poluživota prethodno primijenjenog SSRI-ja.
Cachexia, hyperkalaemia
Kaheksija, hiperkalemija
Ask your doctor for advice before taking any of the following medicines together with Xadago: - Cold or cough remedies containing dextromethorphan, ephedrine or pseudoephedrine - Medicines called selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluoxetine or fluvoxamine) - Medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine - Medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin - Fluoroquinolone antibiotic such as ciprofloxacin - Medicines that affect the immune system such as methotrexate - Medicines to treat metastatic carcinoma such as topotecan - Medicine to treat pain and inflammation such as diclofenac - Medicines to treat type 2 diabetes such as glyburide, metformin - Medicines to treat virus infection such as aciclovir, ganciclovir
lijekovi za povišen kolesterol poput rosuvastatina, pitavastatina, pravastatina fluorokinolonski antibiotik, poput ciprofloksacina lijekovi koji utječu na imunološki sustav, poput metotreksata lijekovi za liječenje metastatskog karcinoma, poput topotekana lijek za liječenje boli i upale, poput diklofenaka lijekovi za liječenje dijabetesa tipa 2, poput gliburida i metformina lijekovi za liječenje virusnih infekcija, poput aciklovira i ganciklovira
Rare abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation
Kompulzije, delirij, dezorijentacija, iluzija, impulzivno ponašanje, gubitak libida, opsesivne misli, paranoja, preuranjena ejakulacija, napadi spavanja, društvene fobije, suicidalne ideje
Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma
Zamagljen vid, skotom, diplopija, fotofobija, poremećaj mrežnice, konjuktivitis, glaukom
Coordination abnormal, disturbance in attention, dysgeusia, hyporeflexia, radicular pain, Restless Legs Syndrome, sedation
Poremećena koordinacija, smetnja pažnje, disgeuzija, hiporefleksija, radikularna bol, sindrom nemirnih nogu, sedacija
If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4).
U slučaju da bolesnici uznapreduju od umjerenog do teškog oštećenja jetre, primjenu safinamida potrebno je prekinuti (vidjeti dio 4.4).
Renal impairment No change in dose is required for patients with renal impairment.
Nije potrebna promjena doze u bolesnika s oštećenjem bubrega.
OFF time (hrs) (c) Baseline (b)
OFF razdoblje (sati) (c)
ON time without troublesome dyskinesia (hrs) (c) Baseline (b)
ON razdoblje bez problematične diskinezije (sati) (c) Početna vrijednost (b) 9,3 (2,2
Via Lillo del Duca 10 20091 Bresso (MI) - Italy
20091 Bresso (MI) - Italija
Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.
Jedna filmom obložena tableta sadrži safinamidmetansulfonat u količini koja odgovara 50 mg safinamida.
Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.
Jedna filmom obložena tableta sadrži safinamidmetansulfonat u količini koja odgovara 100 mg safinamida.
Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma
Karcinom bazalnih stanica Akrohordon, melanocitni nevus, seboroična keratoza, papilom na koži
Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm
Bronhospazam, disfonija, orofaringealna bol, orofaringealni spazam
Uncommon (may affect up to 1 in 100 people): urine infection, skin cancer, low iron in your blood, low white cell count, red blood cell abnormality, decreased appetite, high fat in blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusional state, mood swings , increased interest in sex, abnormal thinking and perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction, head discomfort, difficulty in speaking, fainting, memory impairment, blurring of vision, blind spot, double vision, aversion to light, disorders of the light sensitive layer at the back of your eye, redness of the eyes, increased pressure in the eye, sensation of room spinning, feeling of heart beating, fast heartbeat, irregular heartbeat, slowed heartbeat , high blood pressure, low blood pressure, veins that have become large and twisted, cough, difficult breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, burning stomach, wind, feeling full, drooling, mouth ulcer, sweating, itching, sensitive to light, redness of the skin, back pain, joint pain, cramps, stiffness, pain in legs or arms, muscle weakness, sensation of heaviness, increased urination at night, pain upon urination, difficulty in having sex in males, fatigue, feeling weak, unsteady walking, swelling of your feet, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat in your blood, increased sugar in your blood, abnormal ECG, liver function test abnormal, abnormal urine tests, blood pressure decreased, blood pressure increased, abnormal eye test, fracture of your foot.
Manje često (mogu se javiti u do 1 od 100 osoba): infekcija mokraćnih puteva, rak kože, niska razina željeza u krvi, smanjen broj bijelih krvnih stanica, poremećaj broja crvenih krvnih stanica, smanjeni apetit, visoke razine masnoća u krvi, povećani apetit, visoka razina šećera u krvi, priviđanje stvari koje ne postoje, osjećaj tuge, poremećeni snovi, strah i zabrinutost, stanje smetenosti, promjene raspoloženja, povećana seksualna želja, poremećaj razmišljanja i percepcije, nemir, poremećaj spavanja, utrnulost, nesigurnost, gubitak osjeta, dugotrajne abnormalne kontrakcije mišića, nelagoda u glavi, poteškoće u govoru, nesvjestica, oštećenje pamćenja, zamućenje vida, slijepa pjega, dvoslike, nepodnošenje svjetlosti, poremećaj sloja osjetljivog na svjetlost u stražnjem dijelu oka, crvenilo očiju, povećan pritisak u oku, osjećaj da se soba vrti, osjećaj kucanja srca, ubrzani otkucaji srca, nepravilni otkucaji srca, usporeni otkucaji srca, povišeni krvni tlak, sniženi krvni tlak, vene koje su postale velike i prepletene, kašalj, otežano disanje, curenje iz nosa, zatvor, žgaravica, povraćanje, suha usta, proljev, bol u trbuhu, osjećaj žarenja u želucu, vjetrovi, osjećaj punine, slinjenje, vrijed u ustima, znojenje,
+) channels, and modulation of stimulated release of glutamate.
Safinamid je povezan s inhibicijom ovisnom o stanju natrijskih (Na+) kanala reguliranih naponom i modulaciji stimuliranog oslobađanja glutamata.
Weight decreased, weight increased, blood creatine phosphokinase increased, blood triglycerides increased, blood glucose increased, blood urea increased, blood alkaline phosphatase increased, blood bicarbonate increased, blood creatinine increased, electrocardiogram QT prolonged, liver function test
Smanjena tjelesna težina, povećana tjelesna težina, povišena kreatin fosfokinaza u krvi, povišeni trigliceridi u krvi, povišena glukoza u krvi, povišena urea u krvi,
Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus
Ambliopija, kromatopsija, dijabetička retinopatija, eritropsija, krvarenje u oku, bol u oku, edem kapka, hipermetropija, keratitis, pojačano suzenje, noćno sljepilo, edem papile, prezbiopija, strabizam
Peptic ulcer, retching, upper gastrointestinal haemorrhage
Peptički ulkus, dizanje želuca, krvarenje u gornjem dijelu gastrointestinalnog sustava
Nocturia, dysuria
Noćno mokrenje, dizurija
Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, gastritis, flatulence, abdominal distension,
Mučnina Zatvor, dispepsija, povraćanje, suha usta, proljev, bol u abdomenu, gastritis, flatulencija, distenzija abdomena, hipersekrecija sline, bolest gastroezofagealnog refluksa, aftozni stomatitis
The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g. serotonin syndrome), although rare, that have occurred when SSRIs and dextromethorphan have been used with MAO inhibitors.
Ova mjera opreza temelji se na pojavi ozbiljnih nuspojava (npr. serotoninskog sindroma), koji se, iako rijetko, javlja kada se SSRI-ijevi i dekstrometorfan primjenjuju zajedno s MAO inhibitorima.
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets
Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete
20091 Bresso (MI) - Italy Tel: +39 02 665241
20091 Bresso (MI) - Italija tel: +39 02 665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
Xadago 100 mg tablets safinamide
NAZIV LIJEKA Xadago 100 mg tablete safinamid
Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst
Ankilozantni spondilitis, bol u boku, oticanje zglobova, mišićno-koštana bol, mialgija, bol u vratu, osteoartritis, sinovijalna cista
Xadago 50 mg tablets safinamide
NAZIV LIJEKA Xadago 50 mg tablete safinamid
Xadago 50 mg film-coated tablets
Xadago 50 mg filmom obložene tablete
Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.
Xadago 100 mg su okrugle, bikonkavne, filmom obložene tablete promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
Xadago 100 mg film-coated tablets
Xadago 100 mg filmom obložene tablete
Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet.
Okrugla, bikonkavna, filmom obložena tableta promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet.
Okrugla, bikonkavna, filmom obložena tableta promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
Male rat fertility was not affected.
Nije bilo učinka na plodnost mužjaka štakora.
Blood calcium decreased, blood potassium decreased, blood cholesterol decreased, body temperature increased, cardiac murmur, cardiac stress test abnormal, haematocrit decreased, haemoglobin decreased, international normalised ratio decreased, lymphocyte count decreased,
Rijetko povišena alkalna fosfataza u krvi, povišen bikarbonat u krvi, povišen kreatinin u krvi, produljen QT elektrokardiograma, abnormalni nalaz pretrage funkcije jetre, abnormalni nalaz analize urina, povišeni krvni tlak, sniženi krvni tlak, abnormalni nalaz postupaka očne dijagnostike opterećenja srca, snižen hematokrit, snižen hemoglobin, snižen međunarodni normaliziran omjer, smanjen broj limfocita, smanjen broj trombocita, povišen lipoprotein vrlo niske gustoće
Cardiac disorders
Erektilna disfunkcija
95% CI p-value UPDRS II (c) Baseline (b)
UPDRS III (c) Početna vrijednost (b) 28,6 Promjena LSM (SE) -4,5
Xadago 100 mg film-coated tablets safinamide
Xadago 100 mg filmom obložene tablete safinamid
Xadago 50 mg film-coated tablets safinamide
Xadago 50 mg filmom obložene tablete safinamid
No dose adjustment is required in patients with mild hepatic impairment.
U bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doze.
Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
FARMACEUTSKI PODACI Popis pomoćnih tvari Jezgra tablete Celuloza, mikrokristalična
xadago 100 mg
16. PODACI NA BRAILLEOVOM PISMU xadago 100 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - filmom obložene tablete
ANNEX I
Krospovidon vrste A
Use in patients with severe hepatic impairment (see section 4.2).
Istodobno liječenje petidinom (vidjeti dijelove 4.4 i 4.5) Primjena u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide
Uputa o lijeku: Informacije za bolesnika Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete safinamid
Micturition urgency, polyuria, pyuria, urinary hesitation
Hitno mokrenje, poliurija, piurija, otežan početak mokrenja
What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.
Xadago 50 mg su okrugle, bikonkavne, filmom obložene tablete promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
Zambon Italia S.r.l.
Zambon Nederland B.V.
Tel: +39 02665241
Zambon Italia S.r.l. Tel: + 39 02665241
BLISTER
Nuspojave
General warning
Opća upozorenja
Hepatobiliary disorders
Metabolit
Tablet core
Magnezijev stearat
Fax: +39 02 66501492
Italija tel: +39 02665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
It may harm them,
poremećaji štitnjače
Symptoms may disappear completely or partly.
Simptomi mogu nestati potpuno ili djelomično.
The instructions include the following main steps:
Upute uključuju sljedeće glavne korake:
F) Quick review of the process
F) Brzi pregled procesa
Please read the instructions carefully and follow them step by step.
Molimo pažljivo pročitajte upute i pridržavajte ih se korak po korak.
Experience with exposure during the second and third trimester is very limited.
Iskustvo s izloženošću tijekom drugog i trećeg tromjesečja vrlo je ograničeno.
► Get a good start!
► Dobro se pripremite za početak!
Risk reduction
Redukcija rizika
Betaferon with food and drink
Betaferon s hranom i pićem
Betaferon itself does not affect the heart directly.
Betaferon sam po sebi ne utječe izravno na srce.
This is called a Rotation Cycle.
To se naziva rotacijski ciklus.
Dear patient,
Poštovani bolesniče,
This effect continued over the observation period of up to 33 months.
Taj se učinak nastavlja tijekom razdoblja promatranja do 33 mjeseca.
You can use the following rotation schedule.
Možete koristiti sljedeći raspored rotiranja.
If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Ako ste si zaboravili dati injekciju u odgovarajuće vrijeme učinite to čim se sjetite i potom nastavite sa sljedećom nakon 48 sati.
It is best to use your thumb rather than your nail as it could break.
Najbolje je upotrijebiti palac umjesto nokta jer se može slomiti.
This will help you to inject the required dose only.
To će vam pomoći injicirati samo potrebnu dozu.
Date of last renewal: 31 January 2006
Datum posljednje obnove odobrenja: 31. siječanj 2006.
− Try to give your injection at the same time of day.
Pokušajte si davati injekciju svaki put u isto vrijeme dana.
► Tell your doctor immediately:
► Odmah obavijestite svog liječnika:
However, there is some data available in children and adolescents from 12 to 16 years.
Međutim, dostupno je nešto podataka za djecu i adolescente u dobi od 12 do 16 godina.
As you get started, you may find the following helpful:
U početku će Vam možda pomoći sljedeće:
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Na temelju podataka o životinjama (vidjeti dio 5.3), moguć je povećan rizik od spontanog pobačaja.
The syringes have special markings for this dose.
Štrcaljke imaju posebnu oznaku za tu dozu.
It can cause disability temporarily, such as difficulty walking.
Može uzrokovati privremenu nesposobnost kao što su poteškoće u hodanju.
Single use.
Za jednokratnu uporabu.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Najprikladniji MedDRA termin koristi se za opisivanje određene reakcije i njezinih sinonima i srodnih stanja.
This can lead to shock (collapse) and even be fatal.
To stanje može uzrokovati šok (kolaps) te čak biti smrtonosno.
As with all therapeutic proteins, there is a potential for immunogenicity.
Kao i kod svih terapijskih proteina postoji mogućnost pojave imunogenosti.
Laboratory test
Laboratorijski testovi
Therefore Betaferon should not be used in this population.
Stoga se Betaferon ne smije upotrebljavati u toj populaciji.
Each single pack contains:
Svako pojedinačno pakiranje sadrži:
− Never re-use syringes or needles.
Nikada ne upotrebljavajte ponovno igle i štrcaljke.
Release the plunger, which may go back to its original position.
Oslobodite klip koji se može vratiti na svoj prvobitni položaj.
The injection site must be changed regularly.
Mjesto injiciranja mora se redovno mijenjati.
This package meets the patient's needs for the first 12 injections.
To pakiranje udovoljava bolesnikovim potrebama za prvih 12 injekcija.
− If you have monoclonal gammopathy.
Ako imate monoklonsku gamapatiju.
The optimal dose has not been fully clarified.
Optimalna doza još uvijek nije potpuno utvrđena.
If you come back to an area after one Rotation Cycle, choose the most distant injection site within this area.
Ako se vraćate na područje nakon jednog ciklusa rotacije odaberite najdalje mjesto injiciranja unutar tog područja.
Do not inject a double dose to make up for a forgotten single dose.
Nemojte injicirati dvostruku dozu da biste nadoknadili zaboravljenu pojedinačnu dozu.
How Betaferon helps fight your disease
Kako Vam Betaferon pomaže pobijediti bolest
It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Još uvijek nije jasno da li ta neutralizirajuća protutijela smanjuju djelotvornost liječenja.
Talk to your doctor if you stop or wish to stop treatment.
Razgovarajte sa svojim liječnikom ako prekinete ili želite prekinuti liječenje.
Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Ne zamrzavajte otopinu i nemojte čekati dulje od 3 sata na injiciranje.
Betaferon is available in pack sizes of:
Betaferon je dostupan u pakiranjima od: