FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of breast-feeding neo-natal animals showed no indication of adverse reactions when exposed to amifampridine through breast-milk.
Slovenian: Ocena dojenih novorojenih mladičev ni pokazala nobenih neželenih učinkov pri izpostavljenosti amifampridinu preko materinega mleka.
English: Dizziness1, hypoaesthesia1, paraesthesia1
Slovenian: Bolezni živčevja omotica1, hipestezija1, parestezija1
English: • Sedatives (e.g. barbiturates)
Slovenian: • uspavala (npr. barbiturati).
English: Tmax (hr) t 1/2 (hr)
Slovenian: Tmax (h) t 1/2 (h)
English: However, in a similar study in pregnant rabbits, there was no effect on embryo-foetal viability when evaluated just prior to birth at doses up to 57 mg/kg/day.
Slovenian: V podobni študiji pri brejih podganjih samicah ni bilo opaženega vpliva na preživetje zarodka/ploda pred skotitvijo pri odmerkih do 57 mg/kg/dan.
English: • Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as:  Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),  Antiarrhythmic medicine (e.g., disopyramide)  Medicines to treat digestive problems (e.g., cisapride, domperidone)
Slovenian: • sočasno z zdravili, ki lahko spremenijo električno aktivnost srca (podaljšanje intervala QT, kar je razvidno na elektrokardiogramu), npr:  sultoprid (zdravilo, ki se predpiše za zdravljenje določenih vedenjskih bolezni pri odraslih),  antiaritmiki (npr. dizopiramid)  zdravila za zdravljenje prebavnih težav (npr. cisaprid, domperidon)
English: The concomitant use of amifampridine and medicinal products with cholinergic effects (e.g. direct or indirect cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into consideration.
Slovenian: Sočasna uporaba amifampridina in zdravil s holinergičnimi učinki (npr. neposredni ali posredni zaviralci holinesteraze) lahko poveča učinek obeh zdravil, kar je treba upoštevati.
English: How to take FIRDAPSE
Slovenian: Kako jemati zdravilo FIRDAPSE
English: The European Medicines Agency (EMA) will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
English: Hyperhidrosis1, cold sweat1
Slovenian: Bolezni kože in podkožja hiperhidroza1, hladen znoj1
English: Store in the original blister in order to protect from light and moisture.
Slovenian: Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred svetlobo in vlago.
English:  Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole)
Slovenian:  zdravila za zdravljenje okužb - antibiotiki (npr. rifampicin) in antimikotiki (npr. ketokonazol)
English: The decision to administer proconvulsant or epileptic-threshold lowering substances concomitantly should be carefully considered in the light of the severity of the associated risks.
Slovenian: O sočasni uporabi prokonvulzantnih učinkovin ali snovi, ki znižujejo prag za nastanek epileptičnega napada, je treba presoditi ob upoštevanju resnosti povezanih tveganj.
English: Cardiac disorders Cardiac rhythm disorders, palpitations
Slovenian: Srčne bolezni motnje srčnega ritma, palpitacije neznana
English: The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
Slovenian: Zdravilo FIRDAPSE je treba jemati v razdeljenih odmerkih, trikrat ali štirikrat na dan. Priporočeni začetni odmerek je 15 mg amifampridina na dan, ki pa se lahko povečuje po 5 mg vsakih 4 do 5 dni do največ 60 mg na dan.
English: • Tramadol (a painkiller)
Slovenian: • tramadol (zdravilo proti bolečinam),
English: QMG Scoresa
Slovenian: Ocene QMGa
English: Table 3: Mean PK Parameters of Amifampridine in Healthy Subjects after Single Oral Doses (5-30mg) in Slow and Fast Acetylator Phenotypes
Slovenian: Preglednica 3: Povprečni FK parametri za amifampridin pri zdravih prostovoljcih po enkratnem peroralnem odmerku (5-30mg) pri fenotipih počasnih in hitrih acetilatorjev
English: There was no effect of amifampridine phosphate on heart rate, atrioventricular conduction or cardiac depolarization as measured by the heart rate, PR and QRS interval durations.
Slovenian: Amifampridinfosfat glede na meritve srčnega utripa ter trajanja intervalov PR in QRS ni imel nobenega učinka na srčni utrip, atrioventrikularno prevajanje ali depolarizacijo srca.
English: Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
Slovenian: Na voljo so predklinični podatki o vplivu amifampridina na sposobnost razmnoževanja.
English: AUC0-∞ (ng·hr/ml)
Slovenian: AUC0-∞ (ng·h/ml)
English: • Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine)
Slovenian: • zdravila za zdravljenje duševnih motenj (npr. haloperidol, karbamazapin, klorpromazin, klozapin),
English: Marketing Authorisation Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Slovenian: Imetnik dovoljenja za promet z zdravilom BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
English: Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
Slovenian: Psihiatrične motnje motnje spanja, tesnoba neznana konvulzije, horea, mioklonija, zaspanost, šibkost, utrujenost, glavobol neznana
English: • Fits (convulsions)
Slovenian: • napadov (konvulzij),
English: Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes
Slovenian: Preglednica 4: Povprečni FK parametri amifampridina pri osebah z normalnim in okvarjenim delovanjem ledvic po dajanju enkratnega peroralnega odmerka (10 mg) pri počasnih in hitrih fenotipih acetilatorja
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets amifampridine
Slovenian: IME ZDRAVILA FIRDAPSE 10 mg tablete amifampridin
English: • Anxiety, sleep disorders, drowsiness
Slovenian: • tesnoba, motnje spanja, zaspanost
English: 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Slovenian: 1 Neželeni učinki, o katerih so poročali v klinični študiji za ocenitev učinkov amifampridina na repolarizacijo srca pri enkratnem odmerku 30 mg ali 60 mg pri zdravih prostovoljcih.
English: Do not stop treatment without consulting your doctor.
Slovenian: Zdravila FIRDAPSE ne smete prenehati uporabljati, ne da bi se prej posvetovali z zdravnikom.
English: Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate
Slovenian: Preglednica 2: Farmakokinetični parametri za amifampridin na tešče in s hrano po dajanju enega preoralnega odmerka amifampridin fospfata
English: Medicinal products with cholinergic effects
Slovenian: Zdravila s holinergičnimi učinki
English: Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Slovenian: Učinkovine, ki so močni zaviralci encimov, ki presnavljajo zdravila (glejte poglavje 5.2) Ni verjetno, da bi močni zaviralci encima citokrom P450 (CYP450), npr. cimetidin, ketokonazol, zavrli presnovo amifampridina s humanimi encimi N-acetil-transferaze (NAT) in povzročili povečano izpostavljenost amifampridinu.
English: The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4).
Slovenian: A je v prvi vrsti odgovorna presnova z N-acetilacijo; fenotip acetilatorja pa ima večji učinek na presnovo posameznika in izločanje amifampridina kot izločanje z delovanjem ledvic (glejte preglednico 4).
English: The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function.
Slovenian: Pri bolnikih z ledvično ali jetrno okvaro je treba odmerek amifampridina titrirati počasneje kot pri tistih z normalnim delovanjem ledvic ali jeter.
English: For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended.
Slovenian: Pri bolnikih z blago okvarjenim delovanjem ledvic ali jeter je priporočeni začetni odmerek 10 mg amifampridina (5 mg dvakrat na dan) na dan.
English: What FIRDAPSE contains
Slovenian: Kaj vsebuje navodilo
English: There was significantly higher exposure to amifampridine in slow acetylators compared to fast acetylators.
Slovenian: Pri počasnih acetilatorjih so v primerjavi s hitrimi acetilatorji opazili bistveno višjo izpostavljenost amifampridinu.
English: Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).
Slovenian: Kliničnih podatkov o uporabi amifampridina pri nosečnicah ni. Amifampridin ni imel učinka na preživetje in razvoj zarodka/ploda pri kuncih, pri podganjih samicah pa je bila opažena višja stopnja mrtvorojenih mladičev (glejte poglavje 5.3).
English: Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Slovenian: Ena tableta vsebuje količino amifampridinijevega fosfata, ki ustreza 10 mg amifampridina.
English: Due to adverse reactions such as drowsiness, dizziness, seizures and blurred vision, amifampridine may have minor or moderate influence on the ability to drive or use machines (see section 4.8).
Slovenian: Amifampridin ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji zaradi neželenih učinkov kot so zaspanost, omotica, napadi in zamegljen vid (glejte poglavje 4.8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 10 mg amifampridina v obliki amifampridinijevega fosfata.
English: Elevated liver enzyme levels (transaminases)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišane ravni jetrnih encimo (transminaz)
English: Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
Slovenian: Zdravila, ki delujejo kot depolarizirajoči mišični relaksanti Sočasna uporaba amifampridina in zdravil z depolarizirajočimi relaksacijskimi učinki na mišice (npr. suksametonij) lahko zmanjša učinek obeh zdravil, kar je treba upoštevati.
English: No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
Slovenian: V predkliničnih študijah amifampridina ni bilo opaženega vpliva na plodnost (glejte poglavje 5.3).
English: MedDRA System organ class
Slovenian: MedDRA podatkovna baza glede na organske sisteme
English: For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended.
Slovenian: Pri bolnikih z blagimi težavami jeter ali ledvic je priporočeni začetni odmerek 10 mg (5 mg dvakrat na dan) zdravila FIRDAPSE.
English: Fed* (N=46)
Slovenian: Na tešče (n=45)
English: Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic,
Slovenian: Zdravila z atropinskimi učinki so triciklični antidepresivi, večina atropinskih antihistaminikov H1, antiholinergiki, zdravila za zdravljenje Parkinsonove bolezni, atropinski antispazmodiki, dizopiramid, fenotiazinski nevroleptiki in klozapin.
English: (ng·hr/ml )
Slovenian: (ng·h/ml)
English: Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Slovenian: Neželeni učinki, o katerih so poročali v klinični študiji za ocenitev učinkov amifampridina na repolarizacijo srca pri enkratnem odmerku 30 mg ali 60 mg pri zdravih prostovoljcih.
English: Non depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects (e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into consideration.
Slovenian: Zdravila, ki delujejo kot nedepolarizirajoči mišični relaksanti Sočasna uporaba amifampridina in zdravil z nedepolarizirajočimi relaksacijskimi učinki na mišice (npr. mivakurij in piperkurij) lahko zmanjša učinek obeh zdravil, kar morate upoštevati.
English: • Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone,
Slovenian: • zdravila, ki lahko spremenijo električno aktivnost srca (podaljšanje intervala QT - ki ga zazna elektrokardiogram), npr. sultoprid, dizopiramid, cisaprid, domperidon, rifampicin in ketokonazol (glejte „Ne jemljite zdravila FIRDAPSE”)
English: Upward dose titration should be discontinued if any adverse reaction occurs (see section 4.2).
Slovenian: Če se pojavijo neželeni učinki, je treba titracijo s povečevanjem odmerka prekiniti (glejte poglavje 4.2).
English: For these patients the dose of FIRDAPSE should be increased more slowly than in those without liver or kidney problems with doses increased in 5 mg increments every 7 days.
Slovenian: Pri teh bolnikih je treba odmerek zdravila FIRDAPSE povečevati počasneje kot pri tistih brez težav z jetri ali ledvicami.
English: Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study.
Slovenian: rituksimab, intravenski imunoglobulin G in plazmaferezo, so bile iz študije izvzeti.
English: Cold extremities1
Slovenian: Žilne bolezni hladne okončine1
English: • Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
Slovenian: • zdravila za relaksacijo mišic (npr. mivakurij, piperkurij, suksametonij),
English: No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Slovenian: Po uporabi amifampridinfosfata niso pri nobenem preskušancu nastopile nove klinično pomembne morfološke spremembe EKG-ja. Amifampridinfosfat ni imel opaznega učinka na repolarizacijo srca, ocenjeno z uporabo intervala QTc.
English: Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Slovenian: Ne glede na to je treba bolnike ob uvedbi zdravljenja z močnim zaviralcem encimov ali zaviralcem ledvičnih transporterjev natančno spremljati glede pojava neželenih učinkov.
English: Do not drive or operate machines if you experience these side effects.
Slovenian: Če se ti neželeni učinki pojavijo pri vas, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
English: Do not take FIRDAPSE
Slovenian: Ne jemljite zdravila FIRDAPSE:
English: Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.
Slovenian: Za več informacij o biološki uporabnosti amifampridina na tešče in s hrano glejte poglavje 5.2.
English: • A history of fits (convulsions)
Slovenian: • zdravstveno zgodovino epileptičnih napadov (konvulzij),
English: • Liver problems
Slovenian: • težave z ledvicami,
English: There are no data on the pharmacokinetics of amifampridine in paediatric patients (see sections 4.2).
Slovenian: Podatkov o farmakokinetiki amifampridina pri otrocih ni (glejte poglavje 4.2).
English: If you have any doubts, ask your doctor or pharmacist for advice.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Perforated unit dose thermoformed blisters
Slovenian: Perforirani enoodmerni termoformirani pretisni omoti
English: Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhialna hipersekrecija, napad astme pri astmatičnih bolnikih ali bolnikih z anamnezo astme, kašelj neznana oralna hipestezija1, oralna parestezija1, periferna in peribukalna parestezija, navzea1
English: FIRDAPSE should be used with caution in patients with liver or kidney problems.
Slovenian: Bolniki s težavami z jetri ali ledvicami: Bolniki s težavami z jetri ali ledvicami morajo zdravilo FIRDAPSE jemati previdno.
English: FIRDAPSE should be used with caution in patients with renal or hepatic impairment.
Slovenian: Pri bolnikih z ledvično ali jetrno okvaro je potrebna previdnost pri jemanju zdravila FIRDAPSE.
English: SGI Scoresb
Slovenian: Ocene SGIb
English: Microcrystalline cellulose
Slovenian: Mediana LSd
English: Mean Amifampridine PK Parameters
Slovenian: Povprečni FM parametri amifampridina
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje količino amifampridinijevega fosfata, ki ustreza 10 mg amifampridina.
English: • Nausea
Slovenian: • driska
English: • Medicines to treat Parkinson's disease - anticholinergics (e.g. trihexylphenidyl, mesylate),
Slovenian: • zdravila za zdravljenje Parkinsonove bolezni - antiholinergiki (npr. triheksilfenidil, mesilat), zaviralci MAO-B (npr. selegilin, deprenil), zaviralci COMT (npr. entakapon),
English: How to store FIRDAPSE
Slovenian: Shranjevanje zdravila FIRDAPSE
English: Mean 3-N-acetyl Amifampridine PK Parameters
Slovenian: Povprečni FK parametri za 3-N-acetil amifampridin
English: Warnings and precautions Talk to your doctor or pharmacist before taking FIRDAPSE.
Slovenian: Pred začetkom jemanja zdravila FIRDAPSE se posvetujte z zdravnikom ali farmacevtom.
English: (hr) mean (S.D.), range
Slovenian: (hr) povprečni razpon (SD)
English: Anhydrous colloidal silica
Slovenian: Ocene CGI-Ic
English: (ng/ml) mean (S.D.), range
Slovenian: (ng/ml) povprečni razpon (SD)
English: Carcinogenicity risk
Slovenian: Kancerogenost
English: Diarrhoea, epigastralgia
Slovenian: Bolezni prebavil diareja, bolečina v epigastričnem predelu neznana
English: A starting dose of 5 mg (half tablet) FIRDAPSE daily is recommended in patients with moderate or severe liver or kidney problems.
Slovenian: Pri bolnikih z zmernimi ali hudimi težavami jeter ali ledvic je priporočeni dnevni začetni odmerek 5 mg (polovica tablete) zdravila FIRDAPSE.
English: Upward dose titration should be discontinued if any adverse reaction or ECG abnormality is observed.
Slovenian: Če se pojavijo neželeni učinki ali nenormalnosti EKG, je treba titracijo s povečevanjem odmerka prekiniti.
English: If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Slovenian: V primeru prekinitve zdravljenja se lahko pri bolnikih pojavijo simptomi Lambert-Eatonovega miastenijskega sindroma (LEMS).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: AUC0-∞ (ng·hr/ml) Mean (S.D.), range
Slovenian: AUC0-∞ (ng·hr/ml) povprečni razpon (SD)
English: A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function.
Slovenian: Pri bolnikih z zmerno ali hudo okvarjenim delovanjem ledvic ali jeter je priporočeni začetni odmerek 5 mg amifampridina (polovica tablete) enkrat na dan.
English: LS Meand
Slovenian: Blaga okvara
English: (see section 5.3).
Slovenian: (glejte poglavje 5.2).
English: It is important that you follow this advice.
Slovenian: Pomembno je, da ta nasvet upoštevate.
English: Proposed review period: Materials will be reviewed annually.
Slovenian: Predlagano obdobje za pregled: Gradiva bodo pregledana letno.
English: See sections 4.4 and 4.8.
Slovenian: Glejte poglavji 4.4 in 4.8.
English: What are the symptoms?
Slovenian: Kakšni so simptomi?
English: It is very important that you read and understand the information about this serious reaction.
Slovenian: Zelo pomembno je, da preberete in razumete informacije o tej hudi reakciji.
English: • if they drink alcohol
Slovenian: • če uživajo alkohol;
English: You need to keep taking it every day to stop your illness getting worse.
Slovenian: Jemati ga morate redno vsak dan, da se vaša bolezen ne bo slabšala.
English: Date of latest renewal: 17 November 2014
Slovenian: Datum zadnjega podaljšanja: 17. november 2014
English: Conclusions supported non-inferiority regardless of analysis method.
Slovenian: Sklepi so potrjevali neinferiornost ne glede na metodo analize.
English: SIDE 2
Slovenian: STRAN 2
English: When do these reactions happen?
Slovenian: Kdaj se pojavijo te reakcije?
English: • if you are seriously overweight (especially if you are a woman)
Slovenian: • če imate prekomerno telesno maso (še posebej, če ste ženska);
English: Children Under 25 kg:
Slovenian: Otroci z manj kot 25 kg:
English: ATC code: J05AR02.
Slovenian: Oznaka ATC: J05AR02.
English: WARNING!
Slovenian: OPOZORILO!
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Week 4 (n = 166)
Slovenian: 4. teden (n = 166)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 17 December 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 17. december 2004
English: It also increases the CD4 cell count in your blood.
Slovenian: Poveča tudi število celic CD4 v vaši krvi.
English: Stay in regular contact with your doctor
Slovenian: Bodite v rednih stikih z zdravnikom.
English: Therefore the following should be adhered to:
Slovenian: Zato je treba upoštevati naslednje:
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Slovenian: Če ga vzamete, se vam lahko krvni tlak v nekaj urah nevarno zniža, kar lahko povzroči smrt.
English: • methadone, used as a heroin substitute.
Slovenian: • metadon, ki se uporablja kot nadomestilo za heroin.
English: Who gets these reactions?
Slovenian: Komu se pojavijo te reakcije?
English: You may still develop other infections and illnesses linked to HIV infection.
Slovenian: Še vedno pa se vam lahko pojavijo druge okužbe in bolezni, povezane z okužbo s HIV.
English: Component of a multipack, not to be sold separately
Slovenian: Sestavni del pakiranja po več enot, ki se ne prodaja ločeno.
English: (see reverse of card)
Slovenian: (glejte hrbtno stran kartice)
English: Talk to your doctor before you start again.
Slovenian: Posvetujte se z zdravnikom, preden ga začnete jemati znova.
English: The educational material includes 3 model case studies to demonstrate different clinical scenarios and their management.
Slovenian: Študije primerov preobčutljivosti Izobraževalno gradivo vključuje 3 modelne študije primerov za prikaz različnih kliničnih scenarijev in njihovega obvladovanja.
English: The primary efficacy analysis was performed at week 48 with study continuation to week 96 and demonstrated non-inferiority.
Slovenian: Primarna analiza učinkovitosti je bila opravljena po 48 tednih, študija pa se je nadaljevala do 96. tedna in je dokazala neinferiornost.