FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET: Meloxidyl 0.5 mg/ml oral suspension for cats 15 & 5 ml
Slovenian: NAVODILO ZA UPORABO Meloxidyl 0.5 mg/ml peroralna suspenzija za mačke 15 ml & 5 ml
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni )
English: Cardboard box containing 15 ml high density polyethylene bottle with one measuring syringe.
Slovenian: Kartonska škatla s 15 ml polietilensko plastenko visoke gostote z eno odmerno brizgo.
English: For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Slovenian: Za pomožno terapijo pri zdravljenju akutnega mastitisa ob ustreznem antibiotičnem zdravljenju.
English: - Do not use in cats less than 6 weeks of age.
Slovenian: Ne uporabite pri mačkah, mlajših od 6 tednov.
English: For the relief of pain associated with equine colic.
Slovenian: Za lajšanje bolečin povezanih s kolikami.
English: Meat and offal: 5 days
Slovenian: Meso in organi: 5 dni
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Slovenian: Pri konjih se pojavi prehodna oteklina, ki spontano izgine.
English: One ml of Meloxidyl 20 mg/ml solution for injection contains:
Slovenian: Vsak ml raztopine za injiciranje Meloxidyl 20 mg/ml vsebuje:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months Shelf life after first opening the immediate packaging: 6 months
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 30 mesecev Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni
English: • Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Slovenian: • Druga nesteroidna protivnetna zdravila, diuretiki, antikoagulansi, aminoglikozidni antibiotiki in snovi z visoko vezavo na beljakovine se lahko kompetitivno vežejo, kar lahko privede do toksičnih učinkov.
English: Push down and unscrew bottle top.
Slovenian: Zaporko pritisnite navzdol in jo odvijte.
English: Excipients
Slovenian: Ksilitol
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdose symptomatic treatment should be initiated.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Pri prevelikem odmerjanju uvedemo simptomatsko zdravljenje.
English: Interaction with other medicinal products and other forms of interactions: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
English: Meloxidyl 1.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Slovenian: Meloxidyl 1,5 mg/ ml peroralna raztopina se lahko uporabi za nadaljnjo terapijo z dozo 0,1 mg meloksikama/ kg telesne mase 24 ur po dajanju podkožne injekcije.
English: Shelf life after first opening the immediate packaging: 6 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine : 6 mesecev.
English: Meloxidyl 1.5 mg/ml oral suspension for dogs.
Slovenian: NAVODILO ZA UPORABO Meloxidyl 1.5 mg/ml peroralna suspenzija za pse.
English: Meloxidyl 1.5 mg/ml oral suspension for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Slovenian: Meloxidyl 1,5 mg/ ml peroralna raztopina za pse se lahko uporabi za nadaljnjo terapijo z odmerkom 0,1 mg meloksikama/ kg telesne mase 24 ur po dajanju podkožne injekcije.
English: Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
Slovenian: Lajšanje bolečine in umirjanje vnetja pri kroničnih mišično - skeletnih obolenjih pri mačkah.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE( IH ) SESTAVIN Vsak ml vsebuje:
English: Meat and offal: 15 days Milk: 5 days
Slovenian: Meso in organi: 15 dni Mleko: 5 dni Prašiči:
English: The syringe fits onto the bottle and has a kg-body weight scale (from 1 kg to 10 kg) which corresponds to the maintenance dose (i.e. 0.05 mg meloxicam/kg body weight).
Slovenian: Brizga se prilega na stekleničko in ima merilno skalo z oznakami telesne mase v kilogramih (od 1 kg do 10 kg), ki ustrezajo vzdrževalnemu odmerku (0.05 mg meloksikama na kilogram telesne mase).
English: 10 ml bottle in a cardboard box
Slovenian: 10 ml plastenka v kartonski škatli
English: 100 ml bottle in a cardboard box
Slovenian: 100 ml plastenka v kartonski škatli
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), navedenega na zunanji ovojnini in steklenički.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the cardboard box and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na kartonski škatli in viali.
English: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Slovenian: Za umirjanje kliničnih znakov pri akutnih okužbah dihal pri goveduh ob ustreznem antibiotičnem zdravljenju.
English: - Do not use in pregnant or lactating animals.
Slovenian: - Ne uporabite pri brejih živalih in živalih v obdobju laktacije.
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Slovenian: Zdravljenje nadaljujemo z enim peroralnim, vzdrževalnim odmerkom (v 24 urnih intervalih) 0.1 mg meloksikama na kilogram telesne mase.
English: Silica colloidal anhydrous Sorbitol liquid non-crystallising Glycerol, xylitol Sodium benzoate Citric acid anhydrous Purified water.
Slovenian: Silicijev dioksid, koloidni, brezvodni Sorbitol tekoči, nekristalizirajoči Glicerol
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight.
Slovenian: Zdravljenje nadaljujemo z enim peroralnim, vzdrževalnim odmerkom (v 24 urnih presledkih) po 0.05 mg meloksikama na kilogram telesne mase.
English: Ethanol, anhydrous Poloxamer 188
Slovenian: Poloksamer 188
English: Z.I.
Slovenian: C.
English: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Slovenian: Enkratna podkožna injekcija 0,3 mg meloksikama/ kg telesne mase ( npr. 0,06 ml/ kg telesne mase ) pred operacijo, npr. istočasno z indukcijo anestezije.
English: Equidae 20 μg/kg 65 μg/kg
Slovenian: Kopitarji 20 μg/kg 65 μg/kg
English: Special precautions for use in animals:
Slovenian: Odmerki za posamezno živalsko vrsto:
English: Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Slovenian: Začetni odmerek prvi dan zdravljenja je 0.2 mg meloksikama na kilogram telesne mase.
English: Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Slovenian: Enkratna intravenska ali podkožna injekcija 0,2 mg meloksikama/ kg telesne mase (npr. 0,4 ml/10 kg telesne mase ) pred operacijo, npr. istočasno z indukcijo anestezije.
English: Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Slovenian: Zmanjšanje pooperativne bolečine in vnetja po ortopedskih posegih in posegih na mehkih tkivih.
English: EXP
Slovenian: Rp-Vet
English: Do not use in pregnant or lactating mares.
Slovenian: Ne uporabljajte pri brejih kobilah ali kobilah v laktaciji.
English: Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale -10 avenue de la Ballastière - 33500 Libourne - France
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:Ceva Santé Animale -10 avenue de la Ballastière - 33500 Libourne - FRANCIJA
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Slovenian: Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
English: The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight).
Slovenian: Brizga se prilega na stekleničko in ima merilno skalo z oznakami telesne mase v kilogramih, ki ustrezajo vzdrževalnemu odmerku ( 0.1 mg meloksikama na kilogram telesne mase).
English: Manufacturers responsible for batch release: Ceva Santé Animale
Slovenian: Proizvajalec odgovoren za sproščanje serij:Ceva Santé Animale Z.I.
English: PACKAGE LEAFLET: Meloxidyl 5 mg/ml solution for injection for dogs, cats 10 ml
Slovenian: NAVODILO ZA UPORABO Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke 10 ml
English: Ceva Santé Animale - 10 avenue de la Ballastière - 33500 Libourne - France
Slovenian: Ceva Santé Animale - 10 avenue de la Ballastière - 33500 Libourne - FRANCIJA
English: 1 ml contains 20 mg of meloxicam.
Slovenian: KOLIČINA UČINKOVIN(E) 1 ml vsebuje 20 mg meloksikama.
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdose, symptomatic treatment should be initiated.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri nenamernem vnosu prevelikega odmerka uvedemo simptomatsko zdravljenje.
English: Label of 100 ml vial
Slovenian: Nalepka na 10 ml viali
English: Muscle
Slovenian: Meloksikam
English: Solution for injection
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje
English: Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day.
Slovenian: Začetni odmerek prvi dan zdravljenja je 0.1 mg meloksikama na kilogram telesne mase peroralno.
English: EXP {month/year} Once broached, use within 28 days.
Slovenian: Načeto/odprto zdravilo uporabite v 28 dneh.
English: Dogs and cats
Slovenian: CILJNE ŽIVALSKE VRSTE Psi in mačke
English: Meloxidyl must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Meloxidyl-a ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
English: Label of 5 ml vial
Slovenian: Nalepka na 50 ml viali
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Slovenian: Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
English: One ml of Meloxidyl 0.5 mg/ml oral suspension for cats contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml Meloxidyl 0.5 mg/ml peroralne suspenzije za mačke vsebuje: Učinkovina (e)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 15 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla s 15 ml plastenko Kartonska škatla s 5 ml plastenko
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Slovenian: Enkratna podkožna injekcija 0,2 mg meloksikama/kg telesne mase ( npr. 0,4 ml/10 kg telesne mase ).
English: Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: Ne uporabite pri živalih z obolenji prebavil, kot so razdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
English: • In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: • V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: Typical adverse reactions of Non Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Slovenian: Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
English: Meloxidyl 20 mg/ml solution for injection for cattle, pigs, horses Meloxicam
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 20 mg/ml, raztopina za injiciranje za govedo, prašiče, konje Meloxicam
English: Solution for injection Clear, colourless to yellowish solution.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje Prozorna brezbarvna do rumenkasta raztopina.
English: Meloxidyl 20 mg/ml solution for injection for cattle, pigs and horses
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
English: 1 ml contains 1.5 mg of meloxicam
Slovenian: 1.5 mg meloksikama
English: Meloxicam 5 mg/ml Excipients: Ethanol 150 mg/ml
Slovenian: Pomožna snov: Etanol, brezvodni 150 mg
English: • Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if there is a potential risk of increased renal toxicity.
Slovenian: • Zaradi možne povečane toksičnosti za ledvice se dajanju zdravila ogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
English: DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15.01.2007
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 50 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla s 50 ml vialo Kartonska škatla s 100 ml vialo Kartonska škatla z 250 ml vialo
English: Meloxidyl 5 mg/ml solution for injection for dogs, cats Meloxicam
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke Meloxicam
English: The product must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Zdravila ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
English: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France
Slovenian: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne Francija
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko zdravila.
English: • People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Slovenian: • Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
English: - Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: - Ne uporabite pri živalih z obolenji prebavil, kot so zdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Slovenian: Enkratna podkožna ali intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml/100 kg telesne mase).
English: 1 ml contains 5 mg of meloxicam.
Slovenian: KOLIČINA UČINKOVIN(E) 1 ml vsebuje 5 mg meloksikama.
English: 1 ml contains 0.5 mg of meloxicam.
Slovenian: NAVEDBA UČINKOVIN(E) 1 ml vsebuje 0,5 mg meloksikama.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Slovenian: Imetnik dovoljenja za promet z zdravilom: Ceva Santé Animale
English: Meloxidyl 5 mg/ml solution for injection for dogs and cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke
English: Liver Kidney
Slovenian: Etanol brezvodni
English: Meloxidyl in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Meloxidyl ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi..
English: ROUTE(S) OF ADMINISTRATION
Slovenian: Pot(i) in način uporabe
English: High density polyethylene bottle with high density polyethylene tamper evidence screw cap.
Slovenian: Visokogostotna polietilenska plastenka z visokogostotno polietilensko varnostno zaporko.
English: - Xanthan gum - Silica colloidal anhydrous - Sorbitol liquid non-crystallising - Glycerol - Xylitol - Sodium benzoate (E 211) - Citric acid anhydrous - Purified water
Slovenian: Natrijev benzoat (E 211) Citronska kislina, brezvodna Prečiščena voda
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 10 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla z 10 ml plastenko Kartonska škatla z 32 ml plastenko Kartonska škatla s 100 ml plastenko
English: Active substance (s)
Slovenian: Učinkovina (e)
English: Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Slovenian: Psi: enkratno dajanje 0,2 mg meloksikama /kg telesne mase ( 0,4 ml/10 kg) Mačke: enkratno dajanje 0,3 mg meloksikama /kg telesne mase ( 0,06 ml/kg )
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label of 100 ml vial
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na 100 ml viali
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Slovenian: Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev) in apatija.
English: Meloxicam 20 mg
Slovenian: Učinkovina(e): Meloksikam 20 mg
English: People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila ( NSAID) naj se izogibajo stiku z zdravilom.
English: Pale yellow suspension.
Slovenian: FARMACEVTSKA OBLIKA Bledorumena suspenzija.
English: EXP Once opened, use within 6 months.
Slovenian: Načeto zdravilo uporabite v 6 mesecih.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Slovenian: Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično - skeletnih obolenjih.
English: People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
English: EU/2/06/070/008 EU/2/06/070/010
Slovenian: EU/2/06/070/010
English: Pack sizes:
Slovenian: DRUGE INFORMACIJE Velikost pakiranja:
English: Meloxidyl 0.5 mg/ml oral suspension for cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 0.5 mg/ml, peroralna suspenzija za mačke.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerna samoinjiciranje lahko povzroči bolečino.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.
Slovenian: Za lajšanje znakov vnetij in zmanjšanje bolečine pri akutnih in kroničnih lokomotornih motnjah.
English: Package size
Slovenian: Vsebina Velikost pakiranje
English: 0.75 mg/ml Solution for infusion
Slovenian: 0.75 mg/ml Raztopina za infundiranje Intravenska uporaba Viala (steklena) 100 ml
English: EU numbers Invented name Strengths Pharmaceutical Forms
Slovenian: Številka EU Zaščiteno ime Jakost
English: Route of administration Packaging
Slovenian: Farmacevtska oblika Pot uporabe
English: EMA/CHMP/774318/2018 EMEA/H/C/004682
Slovenian: EMA/522792/2018 EMEA/H/C/004682
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Slovenian: Pljučna funkcija je bila izmerjena po štirih in osmih tednih zdravljenja.
English: It is also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Slovenian: Uporablja se tudi pri bolnikih, ki so mutacijo F508del podedovali od enega starša in imajo tudi eno od naslednjih mutacij CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G ali 3849+10kbC→T.
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Slovenian: FEV1 je največja količina zraka, ki jo lahko oseba izdihne v eni sekundi, in je merilo, kako dobro pljuča delujejo.
English: Therefore, the European Medicines Agency decided that Symkevi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Symkevi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The main measure of effectiveness was based on improvement in patients' FEV1.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje bolnikovega FEV1.
English: In the latter group, there is a lack of authorised therapies.
Slovenian: V drugi skupini ni odobrenih zdravljenj.
English: What measures are being taken to ensure the safe and effective use of Symkevi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Symkevi?
English: Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Symkevi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Symkevi
Slovenian: Druge informacije o zdravilu Symkevi
English: The recommended daily dose is one tablet of Symkevi in the morning and one ivacaftor tablet (150 mg) in the evening, about 12 hours later.
Slovenian: Priporočeni dnevni odmerek je ena tableta zdravila Symkevi zjutraj in ena tableta ivakaftorja (150 mg) zvečer, približno 12 ur pozneje.
English: As for all medicines, data on the use of Symkevi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Symkevi stalno spremljajo.
English: Symkevi (tezacaftor / ivacaftor)
Slovenian: Symkevi (tezakaftor/ivakaftor)
English: What benefits of Symkevi have been shown in studies?
Slovenian: Kakšne koristi zdravila Symkevi so se pokazale v študijah?
English: The most common side effects with Symkevi (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Slovenian: Najpogostejša neželena učinka zdravila Symkevi (ki se lahko pojavita pri več kot 1 bolniku od 10) sta glavobol in nazofaringitis (vnetje nosu in žrela).