FrancophonIA/ELRC3.0 huggingface dataset:
English: Clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam
Slovenian: Klorazepat, diazepam, estazolam, flurazepam, peroralni midazolam in triazolam
English: Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir.
Slovenian: Med sočasno uporabo teh zdravil in protiretrovirusnih odmerkov ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov.
English: glecaprevir/pibrentasvir and simeprevir); - anxiety medicine, buspirone; - asthma medicine, theophylline, salmeterol; - atovaquone, a medicine used to treat a certain type of pneumonia and malaria;
Slovenian: - astemizol ali terfenadin (pogosto se uporabljata za zdravljenje simptomov alergije - ti zdravili utegneta biti na voljo brez recepta), - amiodaron, bepiridil, dronedaron, enkainid, flekainid, propafenon, kinidin (uporabljajo se za odpravljanje nerednega bitja srca), - dihidroergotamin, ergotamin (uporabljata se za zdravljenje migrenskega glavobola),
English: Saquinavir4 ↑ 15-fold ↑ 5-fold Ritonavir
Slovenian: Sakvinavir4 ↑ 15-krat
English: Common Increased amylase, decreased free and total thyroxine
Slovenian: Preiskave pogosto zvišanje amilaze, znižanje prostega in celotnega tiroksina občasno zvišanje glukoze, zvišanje magnezija, zvišanje alkalne fosfataze
English: • flushing, feeling hot
Slovenian: - občutek siljenja na bruhanje (navzea) - rdečica, občutek vročine
English: The mean average change from baseline over 16 weeks for HIV RNA levels was -0.79 log10 (maximum mean decrease: 1.29 log10) in the ritonavir group versus -0.01 log10 in the control group.
Slovenian: Srednja povprečna sprememba v primerjavi z izhodiščno koncentracijo HIV RNA v 16 tednih je bila -0,79 log10
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands
Slovenian: AbbVie Logistics B.V., Zuiderzeelaan 53,
English: Nevirapine 200 q12h
Slovenian: Nevirapin ↔ ↔ Ritonavir ↔ ↔
English: Calcium hydrogen phosphate, anhydrous Silica, colloidal anhydrous Sodium stearyl fumarate
Slovenian: koloidni brezvodni silicijev dioksid, natrijev stearilfumarat.
English: The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses.
Slovenian: Za uporabo z ritonavirjem kot farmakokinetičnim stopnjevalcem so odobreni naslednji zaviralci proteaz
English: Feed serving to patient.
Slovenian: Postrezite pripravljeno mešanico bolniku.
English: Ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer
Slovenian: Ritonavir, odmerjan kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec Bolniki s kronično drisko ali malabsorpcijo
English: HMG-CoA reductase inhibitors which are highly dependent on CYP3A metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Slovenian: CYP3A (npr. lovastatin in simvastatin), je treba med sočasno uporabo z ritonavirjem, odmerjanem kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, pričakovati izrazito zvišanje njihove koncentracije v plazmi.
English: Common Insomnia, anxiety, confusion, disturbance in attention, syncope, seizure
Slovenian: Bolezni živčevja zelo pogosti dizgevzija, parestezija okrog ust in periferna parestezija, glavobol, omotica, periferna nevropatija pogosti nespečnost, anksioznost, zmedenost, motnje pozornosti, sinkopa, konvulzije
English: − Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone) as Norvir may raise the blood levels of these medicines which may lead to Cushing's syndrome (development of a rounded face) and reduce production of the hormone cortisol.
Slovenian: − Rifampicin in sakvinavir (prvi je zdravilo proti tuberkulozi, drugi zdravilo proti HIV), ker lahko sočasna uporaba z zdravilom Norvir povzroči resno okvaro jeter − Bosentan, riociguat (za pljučno arterijsko hipertenzijo), ker lahko zdravilo Norvir poveča koncentracijo tega zdravila v krvi.
English: Eating peanut butter, hazelnut chocolate spread, or black currant syrup immediately after taking the medication may help clear the aftertaste from your mouth.
Slovenian: Da odpravite ta priokus, lahko takoj po zaužitju praška zaužijete arašidovo maslo, čokoladni lešnikov namaz ali sirup črnega ribeza.
English: • Periodic Safety Update Reports
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM • Redno posodobljena periodična poročila o varnosti zdravila (PSUR)
English: 50 µg, single dose 500 q12h
Slovenian: 50 µg, posamičen odmerek
English: Anti-gout treatments
Slovenian: Protimikrobna zdravila
English: 100 q12h
Slovenian: 100 na 12 ur
English: • increase in cholesterol
Slovenian: zvišanje kreatinina)
English: ↑ 17-fold ND
Slovenian: Darunavir ↑ 14-krat
English: • weight loss
Slovenian: Uporaba brizge
English: 200 q12h
Slovenian: 200 na 12 ur
English: • loss of appetite
Slovenian: - vetrovi (napenjanje) - izguba apetita - razjede v ustih
English: Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with ritonavir.
Slovenian: Med sočasno uporabo loratidina in ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov.
English: 50, oral single dose
Slovenian: 100, posamičen peroralni odmerek
English: Because ritonavir is highly protein bound it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis.
Slovenian: Ker je ritonavir v veliki meri vezan na beljakovine, ni verjetno,
English: This interaction may be due to modification of P-glycoprotein mediated digoxin efflux by ritonavir dosed as an antriretroviral agent or as a pharmacokinetic enhancer.
Slovenian: Interakcija je morda posledica tega, da ritonavir, odmerjan kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, spremeni s
English: Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with ritonavir.
Slovenian: Med sočasno uporabo teh zdravil in protiretrovirusnih odmerkov ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov .
English: 0.5 single IV dose 300 q12h, 3 days
Slovenian: 3 mg/kg na 8 ur 500 na 12 ur ↓ 43 %
English: Very common Fatigue including asthenia, flushing, feeling hot
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost vključno z astenijo, rdečica, občutek vročine pogosti zvišana telesna temperatura, hujšanje
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Slovenian: ali C je treba upoštevati tudi ustrezne informacije o teh zdravilih.
English: 3 mg/kg q8h 500 q12h ↓ 43% An increased dose of theophylline may be required when co-administered with ritonavir, due to induction of CYP1A2.
Slovenian: Zaradi indukcije CYP1A2 utegne biti med sočasno uporabo z ritonavirjem potreben večji odmerek teofilina.
English: Co-administration of encorafenib and ritonavir should be avoided.
Slovenian: Sočasni uporabi enkorafeniba in ritonavirja se je potrebno izogniti.
English: Anaphylaxis
Slovenian: - nespečnost
English: 500 q12h ↑ 3.4-fold
Slovenian: 500 na 12 ur ↑ 3,4-krat
English: Clinical trials confirmed the safety and efficacy of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.
Slovenian: Klinična preskušanja so potrdila varnost in učinkovitost 700 mg fosamprenavirja dvakrat na dan s 100 mg ritonavirja dvakrat na dan. Ritonavir s fosamprenavirjem ni raziskan v odmerkih, večjih od 100 mg dvakrat na dan. Za dodatne informacije glejte povzetek glavnih značilnosti za fosamprenavir.
English: • kidney failure
Slovenian: Okvara ledvic
English: Clarithromycin doses greater than 1 g per day should not be coadministered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Slovenian: odmerjanim kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, ne smete uporabljati odmerkov klaritromicina, večjih od 1 g na dan.
English: Clarithromycin doses greater than 1 g per day should not be co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Slovenian: Sildenafil za zdravljenje erektilne disfunkcije je treba previdno uporabljati z ritonavirjem, odmerjanim kot protiretrovirusnim zdravilom ali farmakokinetičnim stopnjevalcem.
English: 30 sachets per carton.
Slovenian: Ena škatla vsebuje 30 vrečic.
English: 1000 q12h
Slovenian: 1000 na 12 ur
English: Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition.
Slovenian: Darunavir ↑ 14-krat Ritonavir zavira CYP3A in tako zviša koncentracijo darunavirja v serumu.
English: ↑ 16-fold
Slovenian: Ritonavir ↔ ↔
English: The concomitant use of ritonavir is not recommended due to potential increase in vorapaxar exposure (see section 4.5).
Slovenian: Sočasna uporaba ritonavirja ni priporočljiva zaradi možnosti povečane izpostavljenosti vorapaksarju
English: (See section 4 Possible side effects)
Slovenian: (glejte poglavje 4.3).
English: − dihydroergotamine, ergotamine (used to treat migraine headache);
Slovenian: - avanafil ali vardenafil (uporabljata se za zdravljenje erektilne disfunkcije),
English: 200 q8h ↑ 77%
Slovenian: Maravirok ↑ 161 % ↑ 28 %
English: Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition.
Slovenian: Ritonavir zavira CYP3A4 in tako zviša koncentracijo atazanavirja v serumu.
English: Hyperplasia of the retinal pigment epithelium (RPE) and retinal degeneration have been seen in all of the rodent studies conducted with ritonavir, but have not been seen in dogs.
Slovenian: V vseh študijah ritonavirja pri glodalcih so ugotavljali hiperplazijo mrežničnega pigmentnega epitelija in mrežnično degeneracijo;
English: Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine or sertraline.
Slovenian: CYP2D6, zato je treba pričakovati, da zviša koncentracijo haloperidola, risperidona in tioridazina.
English: − Multipacks comprising 3 bottles each containing 30 film-coated tablets (90 tablets)
Slovenian: Norvir filmsko obložene tablete so na voljo v treh pakiranjih: - 1 plastenka s 30 filmsko obloženimi tabletami, - 1 plastenka s 60 filmsko obloženimi tabletami, - multipakiranje združuje 3 plastenke, vsaka od njih vsebuje 30 filmsko obloženih tablet (90 tablet).
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors ATC code: J05AE03
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci proteaz.
English: 6.25 mg Powder for solution for injection Intravenous use
Slovenian: 6.25 mg Prašek za raztopino za injiciranje
English: 6 vials l t o r
Slovenian: 6 vial o č
English: Invented name Strength Pharmaceutical Form
Slovenian: Zaščiteno ime Jakost
English: Further information on Semglee can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Semglee so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Semglee is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Semglee is used once a day at the same time each day.
Slovenian: Zdravilo Semglee se daje enkrat dnevno, vsak dan ob istem času.
English: What measures are being taken to ensure the safe and effective use of Semglee?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Semglee?
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Slovenian: Sladkorna bolezen je bolezen, pri kateri je raven glukoze v krvi visoka, bodisi zato, ker telo ne more proizvajati insulina (sladkorna bolezen tipa 1), bodisi zato, ker telo ne proizvede dovolj insulina oziroma ga ne more učinkovito izrabiti (sladkorna bolezen tipa 2).
English: Patients can inject themselves with Semglee if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo injicirajo sami, če so bili za to ustrezno usposobljeni.
English: As for all medicines, data on the use of Semglee is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Semglee stalno spremljajo.
English: Semglee (insulin glargine) EMA/57790/2018
Slovenian: Semglee (insulin glargin) EMA/57790/2018
English: An overview of Semglee and why it is authorised in the EU
Slovenian: Pregled zdravila Semglee in zakaj je odobreno v EU
English: However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects.
Slovenian: Vendar pa je podporna študija pri 558 bolnikih s sladkorno boleznijo tipa 1 pokazala, da imata zdravili Semglee in Lantus podobne učinke.
English: Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Slovenian: Ker je zdravilo Semglee podobno biološko zdravilo, študije o učinkovitosti in varnosti niso bile potrebne, ker sta za insulin glargin dobro raziskani.
English: What benefits of Semglee have been shown in studies?
Slovenian: Kakšne koristi zdravila Semglee so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Semglee have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Semglee upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Semglee (insulin glargine)
Slovenian: Semglee (insulin glargin)
English: Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Semglee, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Semglee authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Semglee odobreno v EU?
English: The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Slovenian: Najpogostejši neželeni učinek zdravila Semglee (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je hipoglikemija (nizka raven glukoze v krvi).
English: Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus.
Slovenian: Pri bolnikih, vključenih v študijo, so pred tem izmerili raven glikoziliranega hemoglobina (HbA1c), snovi, ki kaže, kako dobro je glukoza v krvi nadzorovana in ki je bila urejena z zdravilom Lantus; ob nadaljnjem 24-tedenskem zdravljenju bodisi z zdravilom Semglee bodisi z zdravilom Lantus se je pokazalo, da je raven HbA1c primerljivo dobro nadzorovana pri obeh zdravilih, pri čemer se je raven pri bolnikih, ki so prejemali zdravilo Semglee, spremenila povprečno za 0,14 %, pri tistih, ki so prejemali zdravilo Lantus, pa za 0,11 %.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Semglee po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Lantus.
English: Other information about Semglee
Slovenian: Druge informacije o zdravilu Semglee
English: The reference medicine for Semglee is Lantus.
Slovenian: Referenčno zdravilo za zdravilo Semglee je zdravilo Lantus.
English: For more information about using Semglee, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Semglee glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Semglee?
Slovenian: Kakšna tveganja so povezana z zdravilom Semglee?
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Slovenian: Injicira se v podkožje, in sicer v trebuh, stegno ali nadlaket.
English: Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Slovenian: Insulin glargin, zdravilna učinkovina v zdravilu Semglee, po injiciranju vstopa v krvni obtok počasneje kot humani insulin, zato deluje dlje.
English: The dose of Semglee is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Slovenian: Odmerek zdravila Semglee se prilagodi posameznemu bolniku ter je odvisen od bolnikove ravni glukoze (sladkorja) v krvi in zdravljenja z drugimi zdravili, ki vsebujejo insulin.
English: What is Semglee and what is it used for?
Slovenian: Kaj je zdravilo Semglee in za kaj se uporablja?
English: Semglee is a ‘biosimilar medicine'.
Slovenian: Zdravilo Semglee je „podobno biološko zdravilo“.
English: Semglee is a medicine used to treat diabetes in patients from 2 years of age.
Slovenian: Semglee je zdravilo za zdravljenje sladkorne bolezni pri bolnikih, starejših od dveh let.
English: For the full list of side effects and restrictions with Semglee, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Semglee glejte navodilo za uporabo.
English: Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose.
Slovenian: Dodatne študije so pokazale, da se zdravilo Semglee absorbira v kri enako kot referenčno zdravilo Lantus, zato je mogoče predpostaviti, da podobno deluje na glukozo v krvi.
English: Therefore, the Agency's view was that, as for Lantus, the benefit of Semglee outweighs the identified risk and it can be authorised in the EU.
Slovenian: Agencija je menila, da koristi zdravila Semglee, enako kot pri zdravilu Lantus, odtehtajo znana tveganja in se zdravilo lahko odobri za uporabo v EU.
English: Semglee is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Slovenian: Nadomestni insulin v zdravilu Semglee deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
English: How is Semglee used?
Slovenian: Kako se zdravilo Semglee uporablja?
English: Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine in Semglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Semglee primerjali z zdravilom Lantus, so pokazale, da je insulin glargin v zdravilu Semglee po zgradbi, čistosti in biološkem delovanju zelo podoben insulinu glarginu v zdravilu Lantus.
English: Semglee is available in pre-filled disposable pens and can only be obtained with a prescription.
Slovenian: Zdravilo Semglee je na voljo v obliki napolnjenih peresnikov za enkratno uporabo, predpisovanje in izdaja zdravila pa je le na recept.
English: Semglee can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.
Slovenian: Pri bolnikih, ki imajo sladkorno bolezen tipa 2, se lahko zdravilo Semglee uporablja sočasno s peroralnimi zdravili proti sladkorni bolezni.
English: How does Semglee work?
Slovenian: Kako zdravilo Semglee deluje?
English: Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013
Slovenian: Datum prve odobritve: 20. maj 2008 Datum zadnjega podaljšanja: 20. maj 2013
English: This effect continued over the observation period of up to 33 months.
Slovenian: Ta vpliv se je nadaljeval med obdobjem opazovanja do 33 mesecev.
English: • Getting off to a good start!
Slovenian: • Priprava za dober začetek
English: - If you have ever had an allergic reaction to latex.
Slovenian: - če ste imeli kdaj alergijsko reakcijo na lateks.
English: Experience with exposure during the second and third trimesters is very limited.
Slovenian: Izkušnje z izpostavljenostjo zdravilu v drugem in tretjem trimesečju so zelo omejene.
English: Component of a 3-month multipack.
Slovenian: Del 3-mesečnega skupnega pakiranja.
English: The instructions include the following main steps:
Slovenian: Navodila obsegajo naslednje korake:
English: - Always use a sterile (aseptic) technique as described in here.
Slovenian: - Vedno uporabite sterilno (aseptično) tehniko, kot je opisano tukaj.
English: You will find that within a few weeks your treatment will become a natural part of your routine.
Slovenian: V nekaj tednih bo zdravljenje postalo del vaše rutine.
English: Put the vial on the table.
Slovenian: Vialo postavite na mizo.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Slovenian: Na osnovi podatkov iz študij na živalih (glejte poglavje 5.3) obstaja možnost povečanega tveganja za spontani splav.
English: The optimal dose has not been fully clarified.
Slovenian: Optimalni odmerek še ni povsem ugotovljen.
English: Your doctor or nurse can tell you more about this.
Slovenian: Vaš zdravnik ali medicinska sestra vam lahko pove več o tem.
English: Subgroup analyses according to baseline factors demonstrated evidence of efficacy in all subgroups evaluated.
Slovenian: Analiza podskupin glede na izhodiščne dejavnike je pokazala dokaze o učinkovitosti v vseh ocenjenih podskupinah.
English: You will need the medicine:
Slovenian: Potrebujete zdravilo:
English: Start with your first injection (or your last injection if you are not a new Extavia user).
Slovenian: - Začnite s prvo injekcijo (ali zadnjo injekcijo, če niste novi uporabnik zdravila Extavia).
English: These may be symptoms of a serious allergic reaction, which may become life threatening.
Slovenian: To so lahko simptomi resne alergične reakcije, ki lahko postane življenjsko nevarna.
English: ► Tell your doctor, if any of the above applies to you.
Slovenian: ► Obvestite svojega zdravnika, če karkoli od zgoraj navedenega velja za vas.
English: Follow-up of patients is continuing in order to provide additional data.
Slovenian: Bolnike še naprej spremljajo, da bi pridobili nadaljnje podatke.
English: 10 - Hold the vial between your thumb and fingers.
Slovenian: 10 -Vialo držite med palcem in drugimi prsti.
English: - If you have monoclonal gammopathy.
Slovenian: - če imate monoklonsko gamopatijo.
English: This is called demyelination.
Slovenian: Postopek se imenuje demielinizacija.
English: 60% (53) of these patients returned to negative status based on the last available assessment within the 5-year period.
Slovenian: 60 % (53) od teh bolnikov se je v petletnem obdobju vrnilo na negativni status glede na zadnjo dostopno meritev.
English: Experience with other interferons suggest a potential for impairment of male and female fertility.
Slovenian: Izkušnje z drugimi interferoni nakazujejo možnost okvare moške in ženske plodnosti.
English: - Prepare each dose only when you are ready for an injection.
Slovenian: - Vsak odmerek pripravite šele, ko ste pripravljeni na injiciranje.