FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ni smiselno.
English: Advice on correct administration:
Slovenian: Nasvet o pravilni uporabi zdravila:
English: Before use the content of the sachet(s) containing the flavoured sucrose powder should be added to the bottle containing the solution for bee-hive dispersion as follows:
Slovenian: Pred uporabo vsebino vrečk(e), ki vsebuje(jo) aromatiziran saharozni prašek, na naslednji način dodajte v plastenko, ki vsebuje raztopino za disperzijo za čebeljo družino:
English: Final bee-hive dispersion (after mixing): Store in a refrigerator (2 °C - 8 °C).
Slovenian: Končna disperzija za čebeljo družino (po mešanju): Shranjujte v hladilniku (2 °C - 8 °C).
English: EU/2/17/216/002 (750 g solution)
Slovenian: EU/2/17/216/002 (raztopina s 750 g)
English: When possible, rotate the use of this product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Slovenian: Kadar je mogoče, to zdravilo uporabljajte izmenično z drugim odobrenim varocidom z drugačnim načinom delovanja, s čimer se zmanjša možnost, da bi pršice varoje razvile odpornost.
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Takoj se posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: When possible, rotate the use of this veterinary medicinal product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Slovenian: Kadar je mogoče, to zdravilo za uporabo v veterinarski medicini uporabljajte izmenično z drugim odobrenim varocidom z drugačnim načinom delovanja, s čimer se zmanjša možnost, da bi pršice varoje razvile odpornost.
English: Marker residue
Slovenian: Označeva lni ostanek
English: Excipients: For the full list of excipients, see section 6.1
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: This veterinary medicinal product is highly acidic and could have irritating and corrosive effects on the skin, eyes and mucous membranes.
Slovenian: To zdravilo za uporabo v veterinarski zdravili je zelo kislo in ima lahko dražilne in jedke učinke na kožo, oči in sluznice.
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: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED DD/MM/YYYY
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO DD/MM/LLLL
English: After overdosing, increased bee mortality was very commonly observed.
Slovenian: Po prevelikem odmerjanju so zelo pogosto opazili povečano umrljivost čebel.
English: Keep the bottle and the sachet in the outer carton in order to protect from light.
Slovenian: Plastenko in vrečko shranjujte v zunanji škatli, da se zaščitita pred svetlobo.
English: High-density polyethylene (HDPE) bottle with an HDPE/ polypropylene (PP) child-proof screw cap containing 375 g or 750 g solution.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z navojnim pokrovčkom iz HDPE/polipropilena (PP) z otroško zaščito, ki vsebuje 375 g ali 750 g raztopine.
English: Mix with Oxybee solution before use.
Slovenian: Pred uporabo zmešajte z Oxybee raztopino.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/216/001-002
English: After mixing the bee-hive dispersion: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Po mešanju disperzije za čebeljo družino: Shranjujte v hladilniku (2 °C-8 °C).
English: Open the sachet(s) of the sucrose powder with a pair of scissors.
Slovenian: škarjami odprite vrečko(e) s saharoznim praškom.
English: The final bee-hive dispersion is to be trickled onto the bees in the seams.
Slovenian: Končno disperzijo za čebelje družine nakapljajte na čebele v presledkih.
English: One sachet of 125 g of powder contains:
Slovenian: Ena vrečka s 125 g praška vsebuje:
English: Manufacturer responsible for batch release:
Slovenian: Nemčija Proizvajalec odgovoren za sproščanje serij:
English: Oxybee should not be used when honey supers are present.
Slovenian: Zdravilo Oxybee se ne sme uporabljati v prisotnosti mediščnih naklad.
English: Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Ne presezite priporočenega odmerka in tega zdravila za uporabo v veterinarski medicini ne uporabite več kot enkrat.
English: Four-layered foil (low-density polyethylene (LDPE)/ aluminium/ LDPE/ clay-coated paper) sealed sachets containing 125 g of flavoured sucrose.
Slovenian: Vrečka: Zaprte vrečke iz štiriplastne folije (iz polietilena nizke gostote (LDPE)/aluminija/LDPE/z glino premazanega papirja), ki vsebujejo 125 g aromatizirane saharoze.
English: Preparation of the final bee-hive dispersion:
Slovenian: Priprava končne disperzije za čebeljo družino:
English: 1 ml of mixed bee-hive dispersion contains:
Slovenian: 1 ml mešane disperzije za čebeljo družino vsebuje: Učinkovina:
English: Sucrose Anise oil Eucalyptus oil
Slovenian: Prašek: saharoza eterično olje janeža eterično olje evkalipta
English: A maximum dose of 5-6 ml of the final bee-hive dispersion should be administered once per seam occupied by bees.
Slovenian: V en presledek, ki ga zasedajo čebele, se sme enkrat nanesti največji odmerek 5-6 ml končne disperzije za čebeljo družino.
English: 17.5 g oxalic acid dihydrate (equivalent to 12.5 g of oxalic acid) (375 g solution) 35 g oxalic acid dihydrate (equivalent to 25.0 g of oxalic acid) (750 g solution)
Slovenian: 17,5 g oksalne kisline dihidrata (kar ustreza 12,5 g oksalne kisline) (raztopina s 375 g) 35 g oksalne kisline dihidrata (kar ustreza 25,0 g oksalne kisline) (raztopina s 750 g)
English: SPECIAL STORAGE CONDITIONS Keep the bottle in the outer carton in order to protect from light.
Slovenian: Plastenko shranjujte v zunanji škatli, da se zaščiti pred svetlobo.
English: This product has corrosive properties.
Slovenian: To zdravilo ima jedke lastnosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001 (375 g solution)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/216/001 (raztopina s 375 g)
English: Sucrose 125 g
Slovenian: Pomožne snovi: saharoza 125 g
English: The dispersion should be warm (30 - 35 °C) during application.
Slovenian: Disperzija mora biti med nanosom topla (30-35 °C).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (for powder and solution for bee-hive dispersion)
Slovenian: Kartonska škatla (za prašek in raztopino za disperzijo za čebeljo družino)
English: The active substance in Oxybee is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu Oxybee je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe
English: 6.5 Nature and composition of immediate packaging
Slovenian: 6.5 Vrsta ovojnine in vsebina Plastenka:
English: Oxybee has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Slovenian: Zdravilo Oxybee na delih čebelarske opreme, občutljivih za korozijo, deluje jedko.
English: WITHDRAWAL PERIOD(S) Withdrawal period (honey): Zero days Do not use during honey flow.
Slovenian: Karenca (med): nič dni Ne uporabljajte v času čebelje paše.
English: Sachet:
Slovenian: Odmerek:
English: One bottle of 375 g solution contains:
Slovenian: Ena plastenka s 375 g raztopine vsebuje:
English: 750 g oxalic acid dihydrate solution to achieve 888 ml bee-hive dispersion.
Slovenian: 750 g raztopine oksalne kisline dihidrata, iz katere se pripravi 888 ml disperzije za čebeljo družino.
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid) Colourless, clear to slightly turbid dispersion.
Slovenian: oksalna kislina dihidrat 39,4 mg (kar ustreza 28,1 mg oksalne kisline) brezbarvna, bistra do rahlo motna disperzija
English: One bottle of 750 g of solution contains:
Slovenian: Ena plastenka s 750 g raztopine vsebuje:
English: The full content of the sachet(s) should be poured into the bottle with the solution.
Slovenian: V plastenko z raztopino stresite celotno vsebino vrečk(e).
English: Citric acid monohydrate Glycerol (85%) Water, purified
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Raztopina: citronska kislina monohidrat glicerol (85 %)
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid)
Slovenian: oksalna kislina dihidrat 39,4 mg (kar ustreza 28,1 mg oksalne kisline) Pomožne snovi:
English: Preparation of the 444 ml final bee-hive dispersion: Pour the content of one sachet into the bottle containing 375 g of the oxalic acid dihydrate acid solution.
Slovenian: Priprava končne 444-ml disperzije za čebeljo družino: Vsebino ene vrečke stresite v plastenko, ki vsebuje 375 g raztopine oksalne kisline dihidrata.
English: insecticides
Slovenian: Plastenka
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ Zdravilo shranjujte nedosegljivo otrokom.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po prevelikem odmerjanju so zelo pogosto opazili povečano umrljivost čebel.
English: 375 g oxalic acid dihydrate solution to achieve 444 ml bee-hive dispersion.
Slovenian: 375 g raztopine oksalne kisline dihidrata, iz katere se pripravi 444 ml disperzije za čebeljo družino.
English: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid)
Slovenian: oksalna kislina dihidrat 35,0 g (kar ustreza 25,0 g oksalne kisline)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee solution for bee-hive dispersion oxalic acid dihydrate
Slovenian: Oxybee raztopina za disperzijo za čebeljo družino oksalna kislina dihidrat
English: Powder for bee-hive dispersion (sachet):
Slovenian: Prašek za disperzijo za čebeljo družino (vrečka):
English: STATEMENT OF ACTIVE SUBSTANCES One bottle contains:
Slovenian: Ena plastenka vsebuje:
English: Preparation of the 888 ml final dispersion: Pour the content of the two sachets into the bottle containing 750 g of the oxalic acid oxalic dihydrate acid solution.
Slovenian: Priprava končne 888-ml disperzije: Vsebino dveh vrečk stresite v plastenko, ki vsebuje 750 g raztopine oksalne kisline dihidrata.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product not subject to prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Powder and solution for bee-hive dispersion
Slovenian: Prašek in raztopina za disperzijo za čebeljo družino
English: The solution should be warm (30 - 35 °C) during application.
Slovenian: Raztopina mora biti med nanosom topla (30-35 °C).
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid) Clear and colourless solution.
Slovenian: oksalna kislina dihidrat 17,5 g (kar ustreza 12,5 g oksalne kisline) bistra in brezbarvna raztopina.
English: Mix with Oxybee powder as instructed, before use.
Slovenian: Pred uporabo po navodilih zmešajte z Oxybee praškom.
English: Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Slovenian: Oxybee prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino za medonosne čebele
English: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid) Clear and colourless solution.
Slovenian: oksalna kislina dihidrat 35,0 g (kar ustreza 25,0 g oksalne kisline) bistra in brezbarvna raztopina.
English: Solution for bee-hive dispersion (bottle containing the active substance): Clear and colourless solution.
Slovenian: Raztopina za disperzijo za čebeljo družino (plastenka, ki vsebuje učinkovino):
English: Preparation of the 888 ml final bee-hive dispersion: Pour the content of the two sachets into the bottle containing 750 g of the oxalic acid oxalic dihydrate acid solution.
Slovenian: Priprava končne 888-ml disperzije za čebeljo družino: Vsebino dveh vrečk stresite v plastenko, ki vsebuje 750 g raztopine oksalne kisline dihidrata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder for bee-hive dispersion sucrose
Slovenian: Oxybee prašek za disperzijo za čebeljo družino saharoza
English: In-hive use.
Slovenian: NAVODILO ZA UPORABO
English: Bees
Slovenian: KARENCA
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-hive use
Slovenian: NAČIN IN POT(I) UPORABE Dajanje v čebelji panj
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.1 Ciljne živalske vrste
English: One cardboard box containing one 500 ml bottle (containing 375 g oxalic acid dihydrate solution) and one sachet (containing 125 g sucrose powder), providing 444 ml of the final bee-hive dispersion after mixing.
Slovenian: Ena kartonska škatla, ki vsebuje eno 500-ml plastenko (vsebuje 375 g raztopine oksalne kisline dihidrata) in eno vrečko (vsebuje 125 g saharoze), iz česar po mešanju nastane 444 ml končne disperzije za čebeljo družino.
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-hive use.
Slovenian: NAČIN IN POT(I) UPORABE Dajanje v čebelji panj.
English: One cardboard box containing one HDPE bottle (750 g) and two sachets (each containing 125 g) providing 888 ml final bee-hive dispersion after mixing.
Slovenian: Ena kartonska škatla, ki vsebuje eno plastenko iz HDPE (750 g) in dve vrečki (vsaka po 125 g), iz česar po mešanju nastane 888 ml končne disperzije za čebeljo družino.
English: In clinical trials, increased bee mortality was very commonly observed.
Slovenian: V kliničnih preskušanjih so zelo pogosto opazili povečano umrljivost čebel, kar pa ni dolgoročno vplivalo na razvoj kolonij.
English: One cardboard box containing one HDPE bottle (375 g) and one sachet (125 g), providing 444 ml final bee-hive dispersion after mixing.
Slovenian: Ena kartonska škatla, ki vsebuje eno plastenko iz HDPE (375 g) in eno vrečko (125 g), iz česar po mešanju nastane 444 ml končne disperzije za čebeljo družino.
English: 1 bottle with 375 g oxalic acid dihydrate solution and one sachet (125 g) of sucrose powder, to achieve 444 ml bee-hive dispersion after mixing with sucrose.
Slovenian: Ena plastenka s 375 g raztopine oksalne kisline dihidrata in ena vrečka (125 g) saharoznega praška, iz česar po mešanju s saharozo nastane 444 ml disperzije za čebeljo družino.
English: One cardboard box containing one 1000 ml bottle (containing 750 g oxalic acid dihydrate solution) and two sachets (each containing 125 g sucrose powder), providing 888 ml of the final bee-hive dispersion after mixing.
Slovenian: Ena kartonska škatla, ki vsebuje eno 1 000-ml plastenko (vsebuje 750 g raztopine oksalne kisline dihidrata) in eno vrečko (vsebuje 125 g saharoze), iz česar po mešanju nastane 888 ml končne disperzije za čebeljo družino.
English: Powder and solution for bee-hive dispersion.
Slovenian: FARMACEVTSKA OBLIKA Prašek in raztopina za disperzijo za čebeljo družino.
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid)
Slovenian: oksalna kislina dihidrat 17,5 g (kar ustreza 12,5 g oksalne kisline) Pomožne snovi:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Slovenian: Oxybee prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino oksalna kislina dihidrat
English: No MRL required
Slovenian: Brez Rp-Vet.
English: 1 bottle with 750 g oxalic acid dihydrate solution and two sachets (each containing 125 g) of sucrose powder to achieve 888 ml bee-hive dispersion after mixing with sucrose.
Slovenian: Ena plastenka s 750 g raztopine oksalne kisline dihidrata in dve vrečki (vsaka po 125 g) saharoznega praška, iz česar po mešanju s saharozo nastane 888 ml disperzije za čebeljo družino.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Sachet
Slovenian: PODATKI NA STIČNI OVOJNINI Vrečka
English: INDICATION(S)
Slovenian: PRILOGA I
English: Pack size
Slovenian: 200 Raztopina za
English: Applicable to all products except those containing a polymethacrylate-triethylcitrate coating as modified-release mechanism.
Slovenian: Velja za vsa zdravila razen za tista, ki vsebujejo premaz iz polimetakrilat-trietilcitrata kot mehanizem za prirejeno sproščanje.
English: Any existing warnings on the interaction with alcohol should be deleted.
Slovenian: Vsa obstoječa opozorila v zvezi z medsebojnim delovanjem z alkoholom je treba izbrisati.
English: Summary of Product Characteristics 4.4 Special warnings and precautions for use
Slovenian: Povzetek glavnih značilnosti zdravila 4.4 Posebna opozorila in previdnostni ukrepi
English: Drinking alcohol whilst taking {product name} may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness.
Slovenian: Pitje alkohola med jemanjem zdravila {ime zdravila} lahko povzroči občutek zaspanosti ali poveča tveganje za pojav resnih neželenih učinkov, kot je plitko dihanje s tveganjem zaustavitve dihanja in izgube zavesti.
English: It is recommended not to drink alcohol while you're taking {product name}.
Slovenian: Priporočeno je, da med jemanjem zdravila {ime zdravila} ne pijete alkohola.
English: Package Leaflet Section 2 - Before you take {product name}
Slovenian: Navodilo za uporabo Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo {ime zdravila}
English: Alcohol may enhance the pharmacodynamic effects of {product name}; concomitant use should be avoided.
Slovenian: Alkohol lahko poveča farmakodinamične učinke zdravila {ime zdravila}; sočasni uporabi se je treba izogibati.
English: Amendments to be included in the relevant sections of the Summary of Products Characteristics, Package Leaflet and labelling
Slovenian: Spremembe, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja
English: Concomitant use of alcohol and {product name} may increase the undesirable effects of {product name}; concomitant use should be avoided.
Slovenian: Sočasna uporaba alkohola in zdravila {ime zdravila} lahko okrepi neželene učinke zdravila {ime zdravila}; sočasni uporabi se je treba izogibati.
English: For products having warnings regarding the interaction with alcohol, the existing wording in the SPC and package leaflet should be replaced by the wording below.
Slovenian: Pri zdravilih, za katera je bilo izdano opozorilo v zvezi z medsebojnim delovanjem z alkoholom, je treba obstoječe besedilo povzetka glavnih značilnosti zdravila in navodila za uporabo nadomestiti s spodaj navedenim besedilom.
English: For products not having warnings regarding the interaction with alcohol in the currently approved SPC and package leaflet, the below wording should be added.
Slovenian: Pri zdravilih, za katera v trenutno odobreni povzetek glavnih značilnosti zdravila in navodilo za uporabo ni bilo vključeno opozorilo v zvezi z medsebojnim delovanjem z alkoholom, je treba dodati spodaj navedeno besedilo.
English: Note: These amendments to the SPC, Package Leaflet and Labelling are valid at the time of the Commission Decision.
Slovenian: Ustrezna poglavja povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja Opomba : Ta dopolnila povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo so veljavna v času sprejetja odločbe Komisije.
English: (Invented) name
Slovenian: (Izmišljeno ) ime
English: This is the maximum dose.
Slovenian: To je največji odmerek.
English: If after 12 weeks the patient's condition is getting worse, then the doctor should review the treatment.
Slovenian: Če se po 12 tednih stanje bolnika poslabša, mora zdravnik preveriti potek zdravljenja.
English: It is taken as one tablet a day, preferably at the same time of the day.
Slovenian: Jemlje se kot ena tableta na dan, po možnosti ob isti uri.
English: Before treatment, the patients could walk around 366 metres in six minutes.
Slovenian: Pred zdravljenjem so bolniki lahko prehodili okrog 366 metrov v šestih minutah.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thelin on 10 August 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Thelin, veljavno po vsej Evropski uniji, odobrila dne 10. avgusta 2006.
English: The marketing authorisation holder is Pfizer Limited.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Pfizer Limited.
English: Caution is needed when Thelin is taken at the same time as some other medicines.
Slovenian: Previdnost je potrebna, če se zdravilo Thelin jemlje sočasno z nekaterimi drugimi zdravili.
English: What measures are being taken to ensure the safe use of Thelin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Thelin?
English: The study measured the improvement in exercise capacity by looking at the change in how far the patients could walk in six minutes after 12 to 18 weeks of treatment.
Slovenian: V študijah so merili izboljšanje vadbene zmogljivosti tako, da so proučevali spremembe v razdalji, ki so jo bolniki lahko prehodili v šestih minutah po 12 do 18 tednih zdravljenja.
English: However, the effectiveness was only considered sufficient in patients with class III disease.
Slovenian: Vendar pa je menil, da je učinkovitost zadostna le pri bolnikih z boleznijo razreda III.
English: In the patients with class III disease, this was around 46 metres.
Slovenian: Pri bolnikih z boleznijo razreda III je bila ta razlika okrog 46 metrov.
English: It is available as yellow-toorange, capsule-shaped tablets (100 mg).
Slovenian: Na voljo je v obliki rumeno do oranžnih tablet v obliki kapsule (100 mg).
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Slovenian: Ta tlak zmanjša količino kisika, ki lahko v pljučih pride v kri, zaradi česar je fizična dejavnost težja.
English: Other information about Thelin:
Slovenian: Druge informacije o zdravilu Thelin:
English: It must not be used in patients who have mild to severe problems with their liver or raised levels of some liver enzymes.
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo blage do hude težave z jetri ali povišano raven nekaterih jetrnih encimov.
English: For more information about treatment with Thelin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Thelin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se obrnite na zdravnika ali farmacevta.
English: Three doses of Thelin (50, 100 and 300 mg) have been compared with placebo (a dummy treatment) in three main studies involving a total of 523 patients with PAH, most of whom had class II or III disease.
Slovenian: Tri odmerke zdravila Thelin (50, 100 in 300 mg) so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, ki so vključevale skupno 523 bolnikov z arterijsko pljučno hipertenzijo, od katerih je imela večina bolezen razreda II ali III.
English: The most common side effect with Thelin (seen in more than 1 patient in 10) is headache.
Slovenian: Najpogostejši neželeni učinek zdravila (opažen pri več kot 1 bolniku izmed 10) je glavobol.
English: The company that makes Thelin will provide doctors and patients with educational material about the medicine.
Slovenian: Družba, ki proizvaja zdravilo Thelin, bo zdravnikom in bolnikom zagotovilo izobraževalno gradivo o zdravilu.
English: After 12 to 18 weeks, this distance had increased by 33 metres more in the patients taking 100 mg Thelin than in the patients taking placebo.
Slovenian: Po 12 do 18 tednih je bila ta razdalja pri bolnikih, ki so jemali 100 mg zdravila Thelin, za 33 metrov daljša kot pri bolnikih, ki so jemali placebo.