FrancophonIA/ELRC3.0 huggingface dataset:
English: • P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
Slovenian: • P1 Program 1: 5 mikrogramov učinkovine v ustniku, 25 inhalacijskih ciklov.
English: Ventavis 20 microgram/ml; 1 ml
Slovenian: Ventavis 20 mikrogramov/ml; 1 ml
English: Multipack: 168 (4 x 42) ampoules with 1 ml.
Slovenian: Večkratno pakiranje: 168 (4 x 42) ampul z 1 ml
English: Ventavis 10 microgram/ml; 2 ml
Slovenian: Ventavis 10 mikrogramov/ml; 2 ml
English: The ampoules containing 1 ml are marked with two coloured rings (white - yellow).
Slovenian: Ampule, ki vsebujejo 1 ml raztopine, so označene z dvema barvnima obročema (bel-rumen).
English: 2.5 mcg
Slovenian: 2,5 mikrogramov
English: 100 ampoules with 2 ml.
Slovenian: 100 ampul z 2 ml
English: At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser.
Slovenian: Ob uvedbi zdravljenja z zdravilom Ventavis naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja.
English: Posology
Slovenian: Pripomoček
English: The nebulising device delivers 5 microgram iloprost at the mouthpiece.
Slovenian: Nebulator skozi ustnik dovede 5 mikrogramov iloprosta.
English: 300 ampoules with 2 ml.
Slovenian: 300 ampul z 2 ml
English: 42 AMPOULES WITH 1 ML
Slovenian: 42 AMPUL Z 1 ML
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ventavis Vsebina pakiranja in dodatne informacije
English: Ventavis 20 microgram/ml is available in the following packs: - Pack containing 30 ampoules or 42 ampoules for use with the Breelib and I-Neb nebuliser.
Slovenian: Zdravilo Ventavis 20 mikrogramov/ml je na voljo v naslednjih pakiranjih: - pakiranje s 30 ampulami ali z 42 ampulami za uporabo z nebulatorjem Breelib ali I-Neb - večkratno pakiranje s 168 (4 x 42) ampulami za uporabo z nebulatorjem Breelib ali I-Neb - večkratno pakiranje, ki vsebuje 168 (4 x 42) ampul in set za uporabo nebulatorja Breelib
English: Each ampoule with 1 ml contains 10 microgram iloprost.
Slovenian: Ena ampula z 1 ml raztopine vsebuje 10 mikrogramov iloprosta.
English: For the 5 microgram dose of Ventavis 20 microgram/ml the medication chamber with the gold coloured latch is used together with the gold control disc.
Slovenian: Za odmerek 5 mikrogramov zdravila Ventavis 20 mikrogramov/ml se uporablja prostor za zdravilo z zlatim zapahom in zlatim nadzornim diskom.
English: Part of a multipack containing 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Slovenian: Del škatle večkratnega pakiranja, ki vsebuje 168 (4 x 42) ampul z 1 ml in set za uporabo nebulatorja Breelib (1 ustnik in 1 prostor za zdravilo).
English: The dose of Ventavis and the duration of treatment that is right for you depend on your individual condition.
Slovenian: Od vašega splošnega stanja je odvisno, kolikšen odmerek zdravila Ventavis je primeren za vas in koliko časa naj traja zdravljenje.
English: Trometamol
Slovenian: trombocitopenija
English: Iloprost
Slovenian: Odmerek
English: Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Slovenian: Pri bolnikih s sočasno kronično obstruktivno pljučno boleznijo (KOPB) in hudo astmo koristnost zdravila Ventavis ni bila dokazana.
English: Rash
Slovenian: trismus
English: • For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc.
Slovenian: • Za odmerek 5 mikrogramov se uporablja prostor za zdravilo z vijoličastim zapahom in vijoličastim nadzornim diskom.
English: P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
Slovenian: • P2 Program 2: 2,5 mikrograma učinkovine v ustniku, 10 inhalacijskih ciklov.
English: 168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
Slovenian: 168 (4 x 42) AMPUL Z 1 ML IN SET ZA UPORABO NEBULATORJA BREELIB
English: Ventavis 20 microgram/ml
Slovenian: Ventavis 20 mikrogramov/ml
English: • I-Neb nebuliser
Slovenian: • Nebulator I-Neb
English: Chest discomfort / chest pain Cough
Slovenian: - neprijeten občutek v prsnem košu/bolečine v prsnem košu
English: At initiation of Ventavis treatment with Venta-Neb the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 2 ml ampoule of Ventavis 10 microgram/ml.
Slovenian: Ob uvedbi zdravljenja z zdravilom Ventavis z nebulatorjem Venta-Neb naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja z uporabo 2 ml ampule zdravila Ventavis
English: Ventavis 10 microgram/ml; 1 ml
Slovenian: Ventavis 10 mikrogramov/ml; 1 ml
English: Each ampoule with 2 ml contains 20 microgram iloprost.
Slovenian: Ena ampula z 2 ml raztopine vsebuje 20 mikrogramov iloprosta.
English: • 3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white - pink).
Slovenian: • Brezbarvne 3-mililitrske ampule iz stekla tipa I, ki vsebujejo 2 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (bel-rožnat).
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow - red).
Slovenian: • Brezbarvne 1-mililitrske ampule iz stekla tipa I, ki vsebujejo 1 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (rumen-rdeč).
English: As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
Slovenian: zaviranje delovanja trombocitov, dihalno stisko) in splošne znake zastrupitve, kot so apatija, motnje ravnotežja in motnje zaradi spremembe položaja telesa.
English: Ethanol 96%
Slovenian: (placebo 9 %).
English: Ventavis 10 microgram/ml
Slovenian: Ventavis 10 mikrogramov/ml
English: Only patients who are maintained at the 5 microgram dose and who have repeatedly experienced extended inhalation times with Ventavis 10 microgram/ml, which could result in incomplete inhalation, may be considered suitable for switching to Ventavis 20 microgram/ml.
Slovenian: 5 mikrogramov vijoličast vijoličast 6,5 min Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator Prehod na zdravilo 20 mikrogramov/ml je primeren le za bolnike, pri katerih se uporablja vzdrževalni odmerek 5 mikrogramov in pri katerih je bil čas inhaliranja zdravila Ventavis 10 mikrogramov/ml zaradi nepopolnih inhalacij večkrat podaljšan.
English: Ventavis 20 microgram/ml nebuliser solution Clear, colourless to slightly yellowish solution.
Slovenian: Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator bistra, brezbarvna do rahlo rumenkasta raztopina
English: Each ampoule with 1 ml contains 20 microgram iloprost.
Slovenian: Ena ampula z 1 ml raztopine vsebuje 20 mikrogramov iloprosta.
English: Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Slovenian: Večkratno pakiranje: 168 (4 x 42) ampul z 1 ml in set za uporabo nebulatorja Breelib (1 ustnik in 1 prostor za zdravilo).
English: • In general, you will need to take special care to try and avoid effects of low blood pressure,
Slovenian: da znižujejo krvni tlak, je treba paziti, da ne bi prišlo do dodatnega znižanja krvnega tlaka.
English: 1 ml ampoule white - yellow ring
Slovenian: 1 ml ampula bel-rumen obroč
English: A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost at the concentration of 10 microgram/ml: N=101; placebo n=102) with stable pulmonary hypertension.
Slovenian: 10 mikrogramov/ml: n = 101, placebo: n = 102) s stabilno pljučno hipertenzijo.
English: Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Slovenian: Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator
English: Room ventilation
Slovenian: Zračenje prostora
English: • 2 ml ampoules for the use with Venta-Neb: Pack containing 30, 90, 100 or 300 ampoules.
Slovenian: • 2 ml ampule za uporabo z nebulatorjem Venta-Neb: pakiranje, ki vsebuje 30, 90, 100 ali 300 ampul večkratno pakiranje, ki vsebuje 90 (3 x 30) ali 300 (10 x 30) ampul Ampule, ki vsebujejo 2 ml raztopine, so označene z dvema barvnima obročema (bel-rožnat).
English: The dose delivered by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc. Each medication chamber is colour coded and has a corresponding colour coded control disc.
Slovenian: Vsak prostor za zdravilo je označen z barvno oznako in ima nadzorni disk, označen z ustrezno barvo.
English: Symptoms can include chest pain, a heart attack within the last six months, a weak heart (decompensated cardiac failure) which is not under close medical observation, severe unstable heartbeat, a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension),
Slovenian: srčno popuščanje (dekompenzirana srčna bolezen), ki ni pod skrbnim zdravniškim nadzorom, hudo neenakomerno bitje srca,
English: Bayer Vital GmbH Tel: +49 (0)214-30 513 48
Slovenian: Tel: +49 (0)214-30 513 48
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use.
Slovenian: Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis 20 mikrogramov/ml, označena z dvema barvnima obročema (rumen-rdeč), neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
English: Ampoules with 1 ml nebuliser solution (for the use of Breelib or I-Neb AAD): Packages containing:
Slovenian: Ampule z 1 ml inhalacijske raztopine za nebulator (za uporabo z nebulatorjem Breelib ali I-Neb AAD) Pakiranje vsebuje: - 30 ampul - 42 ampul.
English: Just before you start to inhale, take the yellow-red colour coded ampoule of Ventavis 20 microgram/ml, break the glass ampoule and pour the complete contents of 1 ml into the nebuliser medication golden chamber.
Slovenian: 20 mikrogramov/ml, prelomite stekleno ampulo in celotno vsebino 1 mililitra zlijte v zlat prostor za zdravilo v nebulatorju.
English: Different nebuliser devices can be used to administer Ventavis 20µg/ml.
Slovenian: Za dovajanje zdravila Ventavis 20 mikrogramov/ml se lahko uporabljajo različni nebulatorji.
English: For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Slovenian: Za vsako inhalacijo se vsebina ene 2-mililitrske ampule Ventavis 10 mikrogramov/ml inhalacijske raztopine za nebulator, označena z dvema barvnima obročema (bel-rožnat) neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
English: Ventavis 10 microgram/ml, Nebuliser solution Iloprost
Slovenian: Ventavis 10 mikrogramov/ml, inhalacijska raztopina za nebulator iloprost
English: In general, when starting Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece.
Slovenian: Na začetku zdravljenja z zdravilom Ventavis naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik.
English: Ventavis 10 mcg/ml (1 ml ampoule with white and yellow rings)
Slovenian: Ventavis 10 mikrogramov/ml (z belim in rumenim obročem).
English: Drug product
Slovenian: Z ZDRAVILOM
English: The need to adapt and/or change the therapy should be considered (see section 4.8).
Slovenian: Pogostejše pojavljanje sinkope je lahko znak nezadostnega zdravljenja, premalo učinkovitega zdravljenja in/ali poslabšanja bolezni, zato je treba razmisliti o prilagoditvi in/ali spremembi obstoječega zdravljenja (glejte poglavje 4.8).
English: Multipack containing 90 (3x30) or 300 (10x30) ampoules.
Slovenian: - 90 (3 x 30) ampul - 300 (10 x 30) ampul.
English: Ventavis 20 mcg/ml 1 ml ampoule yellow-red ring
Slovenian: 20 mikrogramov/ml (1 ml ampula rumen-rdeč obroč)
English: Always take Ventavis exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila Ventavis natančno upoštevajte navodila zdravnika.
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow).
Slovenian: • Brezbarvne 1-mililitrske ampule iz stekla tipa I, ki vsebujejo 1 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (bel-rumen).
English: Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Slovenian: Ventavis 10 mikrogramov/ml (1 ml ampula bel-rumen obroč)
English: General disorders and administration site condition
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem§
English: Dyspnoea Pharyngolaryngeal pain
Slovenian: Druge posebne skupine bolnikov Okvara ledvic
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use.
Slovenian: Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis, označena z dvema barvnima obročema (bel-rumen), neposredno pred uporabo prenese v prostor za zdravilo.
English: Marketing Authorisation Holder:
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi:
English: For the 5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the purple coloured latch is used together with the purple control disc.
Slovenian: Za odmerek 5 mikrogramov zdravila Ventavis 10 mikrogramov/ml se uporablja prostor za zdravilo z vijoličastim zapahom in vijoličastim nadzornim diskom.
English: Ampoule coloured rings
Slovenian: Barvni obroč na ampuli
English: Ventavis 20 microgram/ml nebuliser solution Iloprost
Slovenian: Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
English: Comparable systemic exposures (AUC (0-tlast)) and approximately 30% higher maximum serum concentrations (Cmax) were found following inhalation of Ventavis 20 microgram/ml compared to Ventavis 10 microgram/ml which was in line with the observed shorter inhalation time using Ventavis 20 microgram/ml.
Slovenian: Ventavis 20 mikrogramov/ml v primerjavi z zdravilom Ventavis 10 mikrogramov/ml, kar je v skladu z opaženim krajšim časom inhaliranja po uporabi zdravila Ventavis 20 mikrogramov/ml.
English: Vascular disorders
Slovenian: nitro vazodilatatorji,
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 10 microgram/ml, with two coloured rings (white - yellow), is transferred into the medication chamber immediately before use.
Slovenian: Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis 10 mikrogramov/ml, označena z dvema barvnima obročema (bel-rumen), neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
English: If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 2 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
Slovenian: 5 mikrogramov iloprosta z uporabo 2 ml ampule zdravila Ventavis 10 mikrogramov/ml in ga vzdrževati.
English: • rash
Slovenian: • kašelj
English: Talk to your doctor, pharmacist or nurse before using Ventavis:
Slovenian: Pred začetkom uporabe zdravila Ventavis se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Symptoms can include chest pain, - a heart attack within the last six months, - a weak heart (decompensated cardiac failure) which is not under close medical observation, - severe unstable heartbeat, - a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension),
Slovenian: - srčni infarkt v zadnjih šestih mesecih - dekompenzirano srčno popuščanje, ki ni pod zdravniškim nadzorom
English: medication chamber).
Slovenian: Zapah prostora za zdravilo
English: Ventavis 20 microgram/ml nebuliser solution
Slovenian: Ventavis 20 mikrogramov/ml Breelib
English: If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 1 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
Slovenian: 5 mikrogramov iloprosta z uporabo 1 ml ampule zdravila Ventavis 10 mikrogramov/ml in ga vzdrževati.
English: Dysgeusia
Slovenian: • omotica
English: I-Neb AAD Estimated inhalation time
Slovenian: I-Neb AAD Zapah prostora za zdravilo
English: Bayer S.p.A. Tel: +39 02 397 81
Slovenian: Tel: +39 02 397 81
English: Other special populations
Slovenian: DRUGI PODATKI
English: Dosage
Slovenian: Ventavis
English: Pain in jaw/trismus
Slovenian: - omotica - bruhanje - driska
English: Check with your doctor or pharmacist if you are unsure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: − Myocardial infarction within the last six months.
Slovenian: Simptomi lahko vključujejo bolečine v prsnem košu, srčni napad v zadnjih šestih mesecih,
English: At initiation of Ventavis treatment with I-Neb system the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 1 ml ampoule of Ventavis 10 microgram/ml.
Slovenian: Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator (1 ml ampula) Ob uvedbi zdravljenja z zdravilom Ventavis z nebulatorjem I-Neb naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja z uporabo 1 ml ampule zdravila Ventavis
English: • 90 (3x30) ampoules
Slovenian: 90 (3 x 30) AMPUL Z 2 ML
English: 2.5 mcg 5 mcg
Slovenian: 2,5 mikrogramov 5 mikrogramov
English: Dose per inhalation session
Slovenian: Odmerek na posamezno inhalacijo
English: Medication chamber latch
Slovenian: Bayer HealthCare
English: ACE inhibitors.
Slovenian: zaviralci angiotenzinske konvertaze (zaviralci ACE).
English: Genotoxic potential, tumourigenicity
Slovenian: Genotoksičnost, kancerogeni potencial
English: Ventavis 10 mcg/ml
Slovenian: Ventavis 10 mikrogramov/ ml
English: Ventavis 10 microgram/ml nebuliser solution Iloprost
Slovenian: Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
English: 30 ampoules with 1 ml 42 ampoules with 1 ml Multipack: 168 (4 x 42) ampoules with 1 ml
Slovenian: 30 AMPUL Z 1 ML 42 AMPUL Z 1 ML
English: Common: may affect up to 1 in 10 people
Slovenian: - oteklost udov (periferni edem) Pogosti: pojavijo se lahko pri 1 od 10 bolnikov
English: Package leaflet: Information for the user Ventavis 20 microgram/ml nebuliser solution
Slovenian: Navodilo za uporabo Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
English: ILD may be fatal.
Slovenian: ILD je lahko smrtna.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018
Slovenian: Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 28. maj 2018
English: Take your next dose at the scheduled time.
Slovenian: Naslednji odmerek vzemite ob načrtovanem času.
English: The mean age of the study population was 37.9 years.
Slovenian: Povprečna starost populacije študije je bila 37,9 let.
English: Potential to prolong the QT interval
Slovenian: Potencial za podaljšanje intervala QT
English: Characteristics in specific groups of patients
Slovenian: Značilnosti v specifičnih skupinah bolnikov
English: The study results are shown in Table 1.
Slovenian: Rezultati študije so prikazani v preglednici 1.
English: • balance problems.
Slovenian: • težave z ravnotežjem.
English: Efficacy in patients with high disease activity:
Slovenian: Učinkovitost pri bolnikih z zelo aktivno boleznijo:
English: These symptoms vary from patient to patient but usually involve:
Slovenian: Ti simptomi se razlikujejo od bolnika do bolnika, vendar običajno obsegajo:
English: This can cause physical disabilities that may interfere with your daily activities.
Slovenian: To lahko povzroči telesne nezmožnosti, ki motijo vaše dnevne dejavnosti.
English: Use of alternative contraceptive methods is recommended.
Slovenian: Priporočljiva je uporaba drugih metod kontracepcije.
English: However, this is most likely an underestimation since extensive organ distribution was observed in rats.
Slovenian: Vendar je to najverjetneje podcenjeno, ker so pri podganah opazili obsežno porazdelitev v organe.
English: - you have respiratory symptoms.
Slovenian: - če imate respiratorne simptome.
English: MS is a long-term illness that affects the central nervous system (CNS).
Slovenian: MS je dolgotrajna bolezen, ki prizadene centralni živčni sistem (CŽS).
English: If they become pregnant:
Slovenian: Če zanosijo:
English: The recovery time varied between months and years.
Slovenian: Trajanje okrevanja je bilo od nekaj mesecev do let.
English: Serious opportunistic infections occurred in 0.2% of each group.
Slovenian: Resne oportunistične okužbe so se v obeh skupinah pojavile pri 0,2 % bolnikov.
English: Information to educate the patient:
Slovenian: Informacije za izobraževanje bolnika:
English: Accelerated elimination procedure
Slovenian: Postopek pospešenega izločanja
English: The choice between the 3 elimination procedures should depend on the patient's tolerability.
Slovenian: Odločitev med 3 postopki izločanja naj temelji na bolnikovem prenašanju.
English: This stops nerves from working properly.
Slovenian: Zaradi tega živci ne delujejo več pravilno.
English: Please read section 4.
Slovenian: Preberite poglavje 4.
English: - you have an infection.
Slovenian: - če imate okužbo.
English: Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Slovenian: Ženske v rodni dobi ne smejo jemati tega zdravila brez uporabe zanesljive kontracepcije.
English: This may lead to an additive effect on the immune system and caution is, therefore, indicated.
Slovenian: To lahko privede do aditivnega učinka na imunski sistem, zato je potrebna previdnost.
English: TOWER-study
Slovenian: študija TOWER
English: These elevations occurred mostly within the first 6 months of treatment.
Slovenian: Do teh zvišanj je večinoma prišlo v prvih 6 mesecih zdravljenja.
English: What multiple sclerosis is
Slovenian: Kaj je multipla skleroza
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Slovenian: V primeru zvišanja ALT (SGPT) med 2in 3-kratno zgornjo mejo normalnih vrednosti, je treba spremljanje izvajati vsak teden.
English: - you are going to have a vaccination.
Slovenian: - če načrtujete cepljenje.
English: The mean number of relapses within the year before study inclusion was 1.4.
Slovenian: Povprečno število zagonov v letu pred vključitvijo v raziskavo je bilo 1,4.
English: Each wallet is placed in a protective sleeve.
Slovenian: Vsaka pretisna zgibanka je v zaščitnem ovoju.
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Slovenian: Bolnike je treba natančno spremljati glede znakov in simptomov čezmerne izpostavljenosti zdravilom in preučiti možnost zmanjšanja odmerka teh zdravil.
English: Although human data are lacking, no effect on male and female fertility is anticipated.
Slovenian: Čeprav podatkov pri ljudeh ni, se učinki na plodnost pri moških in ženskah ne pričakujejo.
English: In such cases, patients should refrain from driving and using machines.
Slovenian: V takšnih primerih bolniki ne smejo voziti ali upravljati strojev.
English: The long term safety of these combinations in the treatment of multiple sclerosis has not been established.
Slovenian: Dolgoročna varnost teh kombinacij pri zdravljenju multiple skleroze ni bila raziskana.