FrancophonIA/ELRC3.0 huggingface dataset:
English: What SOMAC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Slovenian: Izgled zdravila SOMAC Control in vsebina pakiranja Gastrorezistentne tablete so rumene, ovalne, obojestransko izbočene filmsko obložene tablete z oznako “P20” na eni strani.
English: SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Slovenian: Zdravilo SOMAC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka uporabnost je odvisna od pH želodčnega soka (npr. ketokonazol).
English: See ‘Other medicines and SOMAC Control'.
Slovenian: Glejte “Druga zdravila in zdravilo SOMAC Control” v nadaljevanju.
English: SOMAC Control should not be used during breast-feeding.
Slovenian: Zdravila Somac Control se med dojenjem ne sme uporabljati
English: Do not take SOMAC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Slovenian: Ne jemljite zdravila SOMAC Control z drugimi zdravili, ki zavirajo izločanje želodčne kisline, kot so drugi zaviralci protonske črpalke (omeprazol, lansoprazol ali rabeprazol) ali antagonisti histaminskih receptorjev H2 (npr. ranitidin, famotidin).
English: What SOMAC Control contains - The active substance is pantoprazole.
Slovenian: Kaj vsebuje zdravilo SOMAC Control - Zdravilna učinkovina je pantoprazol.
English: SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila SOMAC Control pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: If you take more SOMAC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Slovenian: Če ste vzeli večji odmerek zdravila SOMAC Control, kot bi smeli Če ste vzeli večji odmerek zdravila SOMAC Control, kot bi smeli, o tem obvestite svojega zdravnika ali farmacevta.
English: Do not take a double dose to make up for the forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo SOMAC Control Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: - You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor.
Slovenian: - SOMAC Control tablet ne smete jemati dlje kot 4 tedne brez posveta z zdravnikom.
English: How to take SOMAC Control
Slovenian: Kako jemati zdravilo SOMAC Control
English: SOMAC Control 20 mg gastro-resistant tablets Pantoprazole
Slovenian: SOMAC Control 20 mg gastrorezistentne tablete pantoprazol
English: SOMAC Control 20 mg gastro-resistant tablets
Slovenian: SOMAC Control 20 mg gastrorezistentne tablete
English: SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Slovenian: SOMAC Control 20 mg gastrorezistentnih tablet se ne sme žvečiti ali drobiti.
English: Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor.
Slovenian: Ne jemljite tablet SOMAC Control več kot 4 tedne brez posveta pri zdravniku.
English: SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Slovenian: Zdravilo SOMAC Control uporabljamo za kratkotrajno zdravljenje simptomov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
English: SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Slovenian: Zdravilo SOMAC Control je indicirano za kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
English: SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Slovenian: Zdravila SOMAC Control ne smejo jemati otroci in mladostniki, mlajši od 18 let.
English: Agranulocytosis Thrombocytopenia; Leukopenia,
Slovenian: Bolezni krvi in limfatičnega sistema agranulocito za trombocitop enija, levkopenija, pancitopenij
English: Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Slovenian: Zdravilo SOMAC Control lahko vpliva na delovanje nekaterih drugih zdravil, še posebej zdravil, ki vsebujejo naslednje zdravilne učinkovine: - če jemljete zaviralce proteaze HIV, kot sta atazanavir; nelfinavir (za zdravljenje okužbe z virusom HIV).
English: Do not take SOMAC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Slovenian: Ne jemljite zdravila SOMAC Control - če ste alergični na pantoprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: How to store SOMAC Control
Slovenian: Shranjevanje zdravila SOMAC Control
English: Liver enzymes increased (transaminases , γ-GT)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišana vrednost jetrnih encimov (aminotransfera ze, γ-GT)
English: However adverse reactions such as dizziness and visual disturbances may occur (see section 4.8).
Slovenian: Zdravilo SOMAC Control nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar pa se lahko pojavijo neželeni učinki, kot so omotica in motnje vida (glejte poglavje 4.8).
English: Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Slovenian: Presnovne in prehranske motnje hiperilipide mije in zvišana vrednost lipidov (trigliceridi, holesterol), spremembe telesne mase hiponatriemija, hipomagneziemija, hipokalciemija
English: anaphylactic reactions and anaphylactic shock)
Slovenian: Bolezni imunskega sistema preobčutljiv ost (vključno z anafilaktični mi reakcijami in anafilaktični m šokom)
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk ginekomastij
English: Takeda Italia S.p.A. Tel: +3906502601
Slovenian: Tel: +3906502601
English: - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Slovenian: Če jemljete metotreksat, lahko zdravnik začasno prekine zdravljenje z zdravilom SOMAC Control,
English: Stop taking SOMAC Control when you are completely symptom-free.
Slovenian: Ko simptomi bolezni popolnoma minejo, zdravilo SOMAC Control nehajte jemati.
English: SOMAC Control may stop certain other medicines from working properly.
Slovenian: saj boste morda morali prekiniti zdravljenje z zdravilom SOMAC Control.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable shall ensure that the following conditions are fulfilled by the MAH(s):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kadar je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
English: ATCvet code: QP51AX08.
Slovenian: Oznaka ATCvet: QP51AX08.
English: The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Slovenian: Zdravilo ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
English: Fatro Polska Sp. z o.o.
Slovenian: Polska Fatro Polska Sp. z o.o.
English: Do not use in case of diarrhoea established for more than 24 hours and in weak animals.
Slovenian: Ne uporabite pri driskah, ki trajajo dlje kot 24 ur, in pri oslabelih živalih.
English: 0.03 mg For the full list of excipients, see section 6.1.
Slovenian: 0,03 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: 3) If the metering pump is used for the first time (or hasn't been used for a few days), carefully pump till a drop of solution is formed on top of the nozzle.
Slovenian: 3) Če merilno črpalko uporabljate prvič (ali je niste uporabljali nekaj dni), previdno črpajte, dokler se na vrhu šobe ne pojavi kaplja raztopine.
English: Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost)
English: Not for use in animals from which milk is produced for human consumption
Slovenian: Ne uporablja se za živali, katerih mleko je namenjeno za prehrano ljudi
English: Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Slovenian: Po dajanju zdravila prvemu teletu ga moramo sistematično dajati vsem naslednjim novorojenim teletom, vse dokler traja nevarnost driske, ki jo povzroča C. parvum.
English: The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5
Slovenian: Koncentraciji, potrebni za 50- in 90-odstotno zaviranje parazitov v preskusu in vitro, sta: IC50 < 0,1 µg/ml in IC90 4,5 µg/ml.
English: 1) Screw the metering pump on the bottle.
Slovenian: 1) Merilno črpalko navijte na steklenico.
English: The bioavailability of the drug in the calf following single oral administration is about 80%.
Slovenian: Biološka razpoložljivost zdravila je pri teletih po enkratnem peroralnem odmerku približno 80 %.
English: Tartrazine (E102)
Slovenian: Tartrazin (E102)
English: 30 μg/kg
Slovenian: 30 µg/kg
English: Date of first authorisation: 13/12/2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 13/12/2016
English: In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
Slovenian: Zelo redko se lahko pri zdravljenih živalih poveča pojavnost driske.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Slovenian: Halofuginon laktat je sol, katere učinek proti protozojem in Cryptosporidium parvum so dokazali in vitro ter pri umetnih in naravnih okužbah.
English: Benzoic acid (E210)
Slovenian: Benzojska kislina (E210)
English: Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Slovenian: Če se pojavijo znaki, ki jih povzroča prevelik odmerek, moramo zdravljenje nemudoma prekiniti in žival hraniti z mlekom ali mlečnim nadomestkom brez dodanega zdravila.
English: In case of skin and eye contact wash the exposed area thoroughly with clean water.
Slovenian: V primeru nenamernega razlitja po koži ali stika z očmi kožo ali oči temeljito sperite s čisto vodo.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Slovenian: Pretežno je učinkovita proti prostim oblikam parazita (sporozoitom,
English: Each bottle is sealed with a polypropylene cap. Each package also contains a 4 ml metering pump that consists of several components made out of high, low and linear low density polyethylene, polypropylene, stainless steel and silicone.
Slovenian: Vsako pakiranje vsebuje tudi merilno črpalko za odmerjanje 4 ml z več sestavnimi deli iz polietilena visoke in nizke gostote ter linearnega polietilena nizke gostote, polipropilena, nerjavnega jekla in silikona.
English: For smaller or higher weights, a precise calculation should be performed (4 ml/20 kg).
Slovenian: Za teleta z manjšo ali večjo telesno maso je treba odmerek natančno izračunati (4 ml/20 kg).
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti za zdravilno učinkovino ali za katero koli pomožno snov.
English: Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Slovenian: Farmakoterapevtska skupina: drugi antiprotozoiki, halofuginon.
English: 71 08503 Gurb-Vic, Barcelona Spain
Slovenian: 71 08503 Gurb-Vic, Barcelona Španija
English: 5) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Slovenian: 5) Sprožilec merilne črpalke potegnite do konca, da odmerite odmerek, ki ustreza 4 ml raztopine.
English: Wear protective gloves while handling the product.
Slovenian: Uporabljajte zaščitne rokavice.
English: Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0
Slovenian: Österreich Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu, niso vključene v Uredbo (ES) št. 470/2009.
English: Active substance:
Slovenian: Pomožni snovi:
English: 0.50 mg Equivalent to 0.6086 mg of halofuginone lactate
Slovenian: 0,50 mg Enakovredno 0,6086 mg halofuginonovega laktata.
English: Shelf-life after first opening the container: 6 months.
Slovenian: EXP {mesec/leto} Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.
English: 4) Restrain the calf and insert the nozzle of the metering pump into the calves mouth.
Slovenian: 4) Poskrbite, da bo tele mirovalo, in mu šobo merilne črpalke vstavite v usta.
English: Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
English: To ensure a correct dosage, an appropriate metering pump for administration of ‘HALAGON' is included.
Slovenian: Zaradi natančnega odmerjanja je priložena ustrezna merilna črpalka za dajanje zdravila HALAGON.
English: • Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection.
Slovenian: • Ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
English: Halofuginone (as lactate salt)
Slovenian: Halofuginon (v obliki laktata)
English: However, in order to make the HALAGON treatment easier, a simplified dosage scheme is proposed:
Slovenian: Za enostavnejše zdravljenje z zdravilom HALAGON lahko uporabimo naslednjo shemo odmerjanja:
English: • Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis.
Slovenian: • Preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je že v preteklosti pojavila kriptosporidioza.
English: Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 - 45 kg and 12 ml for calves of 45 - 60 kg, respectively).
Slovenian: Da bi tele dobilo želeno količino, sprožilec potegnite dvakrat (tj. 8 ml za teleta, ki tehtajo 35 do 45 kg) oziroma trikrat (tj. 12 ml za teleta, ki tehtajo 45 do 60 kg).
English: For treatment of anorexic calves, the product should be administered in half a liter of an electrolyte solution.
Slovenian: Anoreksičnim teletom dajemo zdravilo v polovici litra elektrolitske raztopine.
English: Hankóczy Jenõ utca 21/A HU-1022 Budapest Tel.: +36 30 650 0 650
Slovenian: Magyarország Panon VetPharma Kft. Hankóczy Jenõ utca 21/A HU-1022 Budapest Tel.: +36 30 650 0 650
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Ecuphar nv
English: WDT eG
Slovenian: Deutschland WDT eG
English: • 45 kg < calves < 60 kg: 12 ml of HALAGON once a day during 7 consecutive days
Slovenian: • 45 kg < teleta < 60 kg: 12 ml zdravila HALAGON, 1-krat na dan, 7 zaporednih dni
English: Once broached, use by …
Slovenian: Načeto zdravilo porabite do ...
English: Administer after colostrum feeding, or after milk or milk replacer feeding only.
Slovenian: Zdravilo dajemo le po hranjenju s kolostrumom, mlekom ali mlečnim nadomestkom.
English: Clear yellow oral solution.
Slovenian: Bistra rumena peroralna raztopina.
English: An appropriate device for oral administration is included.
Slovenian: Priložena je ustrezna naprava za peroralno dajanje.
English: • 35 kg < calves ≤ 45 kg: 8 ml of HALAGON once a day during 7 consecutive days
Slovenian: • 35 kg < teleta ≤ 45 kg: 8 ml zdravila HALAGON, 1-krat na dan, 7 zaporednih dni
English: EMDOKA bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgium
Slovenian: EMDOKA bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja kartonska ovojnina
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Slovenian: Končna razpolovna doba izločanja je 11,7 ure po intravenskem dajanju in
English: Bovine 10 μg/kg 25 μg/kg
Slovenian: Halofuginon Halofuginon Govedo 10 µg/kg 25 µg/kg
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Slovenian: Osebe z znano preobčutljivostjo za zdravilno učinkovino ali za katero koli pomožno snov naj bodo previdne pri dajanju veterinarskega zdravila.
English: The dosage is: 100 μg of halofuginone / kg bw / once a day for 7 consecutive days, i.e. 4 ml of HALAGON / 20 kg bw / once a day for 7 consecutive days.
Slovenian: Odmerjanje: 100 µg halofuginona/kg telesne mase, 1-krat na dan, 7 zaporednih dni, to je 4 ml zdravila HALAGON/20 kg telesne mase, 1-krat na dan, 7 zaporednih dni.
English: Cardboard box containing one bottle (high-density polyethylene) of 290 ml, 490 ml or 980 ml of the oral solution.
Slovenian: Kartonska škatla, ki vsebuje eno plastenko (iz polietilena visoke gostote) z 290 ml, 490 ml ali 980 ml peroralne raztopine.
English: Cardboard box with high density polyethylene bottles of 290 ml, 490 and 980 ml.
Slovenian: Kartonska škatla s plastenkami iz polietilena visoke gostote z 290 ml, 490 ml in 980 ml raztopine.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: 6) Put the protector cap back on the nozzle.
Slovenian: 6) Zaščitni pokrovček nataknite nazaj na šobo.
English: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Slovenian: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: Luxembourg/Luxemburg
Slovenian: Luxembourg/Luxemburg Ecuphar nv
English: The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije
English: In new-born calves:
Slovenian: Novorojena teleta:
English: ES-08503 Gurb-Vic, Barcelona Tel: +34 93 886 01 00
Slovenian: Sant Hipòlit, km 71 ES-08503 Gurb-Vic, Barcelona Tel: +34 93 886 01 00
English: PHARMACEUTICAL PARTICULARS 6.1.
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf-life after first opening the immediate packaging: 6 months.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 6 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
English: Antiparasitic agents/Agents acting against protozoa
Slovenian: Antiparazitiki/Ant iprotozoiki
English: EU/2/16/201/001 (290 ml) EU/2/16/201/002 (490 ml) EU/2/16/201/003(980 ml)
Slovenian: EU/2/16/201/002 (490 ml)
English: HALAGON 0.5 mg/ml oral solution halofuginone
Slovenian: HALAGON 0,5 mg/ml, peroralna raztopina Halofuginon
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: Izdelovalec, odgovoren za sproščanje serij:
English: HALAGON 0.5 mg/ml oral solution for calves halofuginone (as lactate salt)
Slovenian: HALAGON 0,5 mg/ml, peroralna raztopina za teleta halofuginon (v obliki laktata)
English: Contraindications
Slovenian: INDIKACIJE
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE AMTERIALS, IF ANY
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: IMETNIK DOVOLJENJ(A) ZA PROMET
English: Panon VetPharma Kft.
Slovenian: Peroralna raztopina.
English: HALAGON 0.5mg/ml oral solution for calves.
Slovenian: HALAGON 0,5 mg/ml, peroralna raztopina za teleta.
English: Polska
Slovenian: Belgija
English: Target species
Slovenian: Živalska vrsta
English: Special warnings
Slovenian: 12 POSEBNA OPOZORILA
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM REVIZIJE BESEDILA DD. mesec LLLL
English: 2) Remove the protector cap from the nozzle.
Slovenian: 2) S šobe odstranite zaščitni pokrovček.
English: Target tissues
Slovenian: Peroralna raztopina
English: Oral solution.
Slovenian: Za peroralno uporabo.
English: Oral Solution
Slovenian: NAVEDBA UČINKOVINE
English: SPECIAL WARNING(S)
Slovenian: 4.4 Posebna opozorila
English: Manufacturer responsible for batch release: Divasa-Farmavic, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom: EMDOKA bvba
English: It is taken morning and evening.
Slovenian: Jemlje se zjutraj in zvečer.
English: Further information on Stayveer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Stayveer so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Stayveer?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Stayveer?
English: This medicine is the same as Tracleer, which is already authorised in the EU.
Slovenian: To zdravilo je enako zdravilu Tracleer, ki je že odobreno v Evropski uniji (EU).
English: What benefits of Stayveer have been shown in studies?
Slovenian: Kakšne koristi zdravila Stayveer so se pokazale v študijah?
English: In adults, the starting dose is 62.5 mg twice a day for four weeks, which is increased to the usual dose of 125 mg twice a day.
Slovenian: Pri odraslih je začetni odmerek 62,5 mg dvakrat na dan štiri tedne, kar se poveča na običajni odmerek 125 mg dvakrat na dan.
English: What is Stayveer and what is it used for?
Slovenian: Kaj je zdravilo Stayveer in za kaj se uporablja?
English: Stayveer is available as film-coated tablets (62.5 mg and 125 mg).
Slovenian: Na voljo je v obliki filmsko obloženih tablet (62,5 mg in 125 mg).
English: ‘Class II' involves slight limitation of physical activity.
Slovenian: funkcijski razred pomeni rahlo omejitev telesne dejavnosti.
English: Stayveer received a marketing authorisation valid throughout the EU on 24 June 2013.
Slovenian: Za zdravilo Stayveer je bilo 24. junija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Stayveer's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Stayveer večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Stayveer are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Stayveer stalno spremljajo.
English: An overview of Stayveer and why it is authorised in the EU
Slovenian: Pregled zdravila Stayveer in zakaj je odobreno v EU