natgillin/translations-raw huggingface dataset:
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery. 
Zmanjšanje pooperativne bolečine in vnetja po ortopedskih posegih in posegih na mehkih tkivih.
EXP 
Rp-Vet
Do not use in pregnant or lactating mares. 
Ne uporabljajte pri brejih kobilah ali kobilah v laktaciji.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale -10 avenue de la Ballastière - 33500 Libourne - France 
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:Ceva Santé Animale -10 avenue de la Ballastière - 33500 Libourne - FRANCIJA
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents. 
Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
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). 
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).
Manufacturers responsible for batch release: Ceva Santé Animale 
Proizvajalec odgovoren za sproščanje serij:Ceva Santé Animale Z.I.
PACKAGE LEAFLET: Meloxidyl 5 mg/ml solution for injection for dogs, cats 10 ml 
NAVODILO ZA UPORABO Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke 10 ml
Ceva Santé Animale - 10 avenue de la Ballastière - 33500 Libourne - France 
Ceva Santé Animale - 10 avenue de la Ballastière - 33500 Libourne - FRANCIJA
1 ml contains 20 mg of meloxicam. 
KOLIČINA UČINKOVIN(E) 1 ml vsebuje 20 mg meloksikama.
Overdose (symptoms, emergency procedures, antidotes): In the case of overdose, symptomatic treatment should be initiated. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri nenamernem vnosu prevelikega odmerka uvedemo simptomatsko zdravljenje.
Label of 100 ml vial 
Nalepka na 10 ml viali
Muscle 
Meloksikam
Solution for injection 
FARMACEVTSKA OBLIKA Raztopina za injiciranje
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. 
Začetni odmerek prvi dan zdravljenja je 0.1 mg meloksikama na kilogram telesne mase peroralno.
EXP {month/year} Once broached, use within 28 days. 
Načeto/odprto zdravilo uporabite v 28 dneh.
Dogs and cats 
CILJNE ŽIVALSKE VRSTE Psi in mačke
Meloxidyl must not be administered in conjunction with other NSAIDs or glucocorticosteroids. 
Meloxidyl-a ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
Label of 5 ml vial 
Nalepka na 50 ml viali
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3). 
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
One ml of Meloxidyl 0.5 mg/ml oral suspension for cats contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml Meloxidyl 0.5 mg/ml peroralne suspenzije za mačke vsebuje: Učinkovina (e)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 15 ml vial 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla s 15 ml plastenko Kartonska škatla s 5 ml plastenko
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight). 
Enkratna podkožna injekcija 0,2 mg meloksikama/kg telesne mase ( npr. 0,4 ml/10 kg telesne mase ).
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. 
Ne uporabite pri živalih z obolenji prebavil, kot so razdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
• In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 
• V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
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. 
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.
Meloxidyl 20 mg/ml solution for injection for cattle, pigs, horses Meloxicam 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 20 mg/ml, raztopina za injiciranje za govedo, prašiče, konje Meloxicam
Solution for injection Clear, colourless to yellowish solution. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje Prozorna brezbarvna do rumenkasta raztopina.
Meloxidyl 20 mg/ml solution for injection for cattle, pigs and horses 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 20 mg/ml, raztopina za injiciranje za govedo, prašiče in konje
1 ml contains 1.5 mg of meloxicam 
1.5 mg meloksikama
Meloxicam 5 mg/ml Excipients: Ethanol 150 mg/ml 
Pomožna snov: Etanol, brezvodni 150 mg
• Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if there is a potential risk of increased renal toxicity. 
• Zaradi možne povečane toksičnosti za ledvice se dajanju zdravila ogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15.01.2007
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 50 ml vial 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla s 50 ml vialo Kartonska škatla s 100 ml vialo Kartonska škatla z 250 ml vialo
Meloxidyl 5 mg/ml solution for injection for dogs, cats Meloxicam 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke Meloxicam
The product must not be administered in conjunction with other NSAIDs or glucocorticosteroids. 
Zdravila ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France 
Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne Francija
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko zdravila.
• People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product. 
• Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
- Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. 
- Ne uporabite pri živalih z obolenji prebavil, kot so zdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight). 
Enkratna podkožna ali intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml/100 kg telesne mase).
1 ml contains 5 mg of meloxicam. 
KOLIČINA UČINKOVIN(E) 1 ml vsebuje 5 mg meloksikama.
1 ml contains 0.5 mg of meloxicam. 
NAVEDBA UČINKOVIN(E) 1 ml vsebuje 0,5 mg meloksikama.
NAME OF THE VETERINARY MEDICINAL PRODUCT 
Imetnik dovoljenja za promet z zdravilom: Ceva Santé Animale
Meloxidyl 5 mg/ml solution for injection for dogs and cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 5 mg/ml raztopina za injiciranje za pse in mačke
Liver Kidney 
Etanol brezvodni
Meloxidyl in conjunction with other NSAIDs or glucocorticosteroids. 
Meloxidyl ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi..
ROUTE(S) OF ADMINISTRATION 
Pot(i) in način uporabe
High density polyethylene bottle with high density polyethylene tamper evidence screw cap. 
Visokogostotna polietilenska plastenka z visokogostotno polietilensko varnostno zaporko.
- Xanthan gum - Silica colloidal anhydrous - Sorbitol liquid non-crystallising - Glycerol - Xylitol - Sodium benzoate (E 211) - Citric acid anhydrous - Purified water 
Natrijev benzoat (E 211) Citronska kislina, brezvodna Prečiščena voda
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 10 ml vial 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla z 10 ml plastenko Kartonska škatla z 32 ml plastenko Kartonska škatla s 100 ml plastenko
Active substance (s) 
Učinkovina (e)
Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg). 
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 )
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label of 100 ml vial 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na 100 ml viali
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. 
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev) in apatija.
Meloxicam 20 mg 
Učinkovina(e): Meloksikam 20 mg
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila ( NSAID) naj se izogibajo stiku z zdravilom.
Pale yellow suspension. 
FARMACEVTSKA OBLIKA Bledorumena suspenzija.
EXP Once opened, use within 6 months. 
Načeto zdravilo uporabite v 6 mesecih.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično - skeletnih obolenjih.
People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
Pack sizes: 
DRUGE INFORMACIJE Velikost pakiranja:
Meloxidyl 0.5 mg/ml oral suspension for cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Meloxidyl 0.5 mg/ml, peroralna suspenzija za mačke.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerna samoinjiciranje lahko povzroči bolečino.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders. 
Za lajšanje znakov vnetij in zmanjšanje bolečine pri akutnih in kroničnih lokomotornih motnjah.
Package size 
Vsebina Velikost pakiranje
0.75 mg/ml Solution for infusion 
0.75 mg/ml Raztopina za infundiranje Intravenska uporaba Viala (steklena) 100 ml
EU numbers Invented name Strengths Pharmaceutical Forms 
Številka EU Zaščiteno ime Jakost
Route of administration Packaging 
Farmacevtska oblika Pot uporabe
Lung function was measured after 4 weeks and 8 weeks of treatment. 
Pljučna funkcija je bila izmerjena po štirih in osmih tednih zdravljenja.
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. 
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.
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. 
FEV1 je največja količina zraka, ki jo lahko oseba izdihne v eni sekundi, in je merilo, kako dobro pljuča delujejo.
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. 
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.
The main measure of effectiveness was based on improvement in patients' FEV1. 
Glavno merilo učinkovitosti je bilo izboljšanje bolnikovega FEV1.
In the latter group, there is a lack of authorised therapies. 
V drugi skupini ni odobrenih zdravljenj.
What measures are being taken to ensure the safe and effective use of Symkevi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Symkevi?
Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Symkevi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Symkevi 
Druge informacije o zdravilu Symkevi
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. 
Priporočeni dnevni odmerek je ena tableta zdravila Symkevi zjutraj in ena tableta ivakaftorja (150 mg) zvečer, približno 12 ur pozneje.
As for all medicines, data on the use of Symkevi are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Symkevi stalno spremljajo.
What benefits of Symkevi have been shown in studies? 
Kakšne koristi zdravila Symkevi so se pokazale v študijah?
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). 
Najpogostejša neželena učinka zdravila Symkevi (ki se lahko pojavita pri več kot 1 bolniku od 10) sta glavobol in nazofaringitis (vnetje nosu in žrela).
Why is Symkevi authorised in the EU? 
Zakaj je bilo zdravilo Symkevi odobreno v EU?
Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Symkevi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Symkevi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Symkevi and why it is authorised in the EU 
Pregled zdravila Symkevi in zakaj je odobreno v EU
Symkevi is available as tablets. 
Zdravilo Symkevi je na voljo v obliki tablet.
For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Symkevi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor. 
Ena tableta vsebuje 100 mg tezakaftorja in 150 mg ivakaftorja.
What is Symkevi and what is it used for? 
Kaj je zdravilo Symkevi in za kaj se uporablja?
What are the risks associated with Symkevi? 
Kakšna tveganja so povezana z zdravilom Symkevi?
Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection. 
Kopičenje gostih in lepljivih izločkov v pljučih povzroča vnetje in dolgotrajno okužbo.
Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo. 
Pri bolnikih, ki so jemali zdravilo Symkevi in ivakaftor, se je FEV1 povprečno povečal za 6,5 odstotne točke, v primerjavi s povečanjem za 4,4 odstotne točke pri bolnikih, ki so jemali samo ivakaftor, in zmanjšanjem za 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs. 
Cistična fibroza je dedna bolezen, ki ima resne učinke na pljuča, prebavila in druge organe.
These actions make mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease. 
S temi učinkovanji se razredčijo sluz in prebavni sokovi, s čimer se ublažijo simptomi bolezni.
Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone. 
Zdravilo Symkevi je treba jemati skupaj s še enim zdravilom, ki vsebuje samo 150 mg ivakaftorja.
The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works. 
Te mutacije zmanjšujejo število beljakovin CFTR na celični površini ali pa vplivajo na način delovanja beljakovine.
Cystic fibrosis is caused by mutations in the CFTR gene. 
Cistično fibrozo povzročajo mutacije v genu CFTR.
Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017. 
Cistična fibroza je redka bolezen, zato je bilo zdravilo Symkevi 27. februarja 2017 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Symkevi should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above. 
Zdravilo Symkevi lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze, in sicer samo bolnikom, ki imajo potrjene zgoraj opisane mutacije.
As a result, these secretions become thick and cause blockage. 
Posledično se tovrstni izločki zgostijo in povzročajo zaporo.
Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above. 
Symkevi je zdravilo za zdravljenje cistične fibroze pri bolnikih, starejših od 12 let.
After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo. 
Po 24 tednih zdravljenja se je FEV1 pri bolnikih, ki so jemali zdravilo Symkevi v kombinaciji z ivakaftorjem, povprečno povečal za 3,4 odstotne točke, pri bolnikih, ki so jemali placebo, pa se je zmanjšal za 0,6 odstotne točke.
In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking. 
V prvi skupini je zdravilo Symkevi lahko možnost zdravljenja zlasti pri tistih, ki zaradi neželenih učinkov ali medsebojnega vplivanja drugih zdravil, ki jih prejemajo, ne morejo prejemati kombinacije ivakaftorja in lumakaftorja (še enega zdravila za zdravljenje cistične fibroze).
One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein. 
Ena od učinkovin v zdravilu Symkevi, tezakaftor, poveča število beljakovin CFTR na celični površini, druga učinkovina, ivakaftor, pa poveča delovanje okvarjene beljakovine CFTR.
Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR). 
Zdravilo Symkevi se uporablja pri bolnikih z mutacijo (spremembo), imenovano F508del, v genu za beljakovino, imenovano „regulator transmembranske prevodnosti pri cistični fibrozi“ (CFTR).
In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth. 
V črevesju zapora vodov iz trebušne slinavke upočasni prebavo hrane in povzroča slabšo rast.
For the full list of side effects and restrictions with Symkevi, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Symkevi glejte navodilo za uporabo.
This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices. 
Ta gen proizvaja beljakovino CFTR, ki deluje na površini celic in uravnava nastajanje sluzi in prebavnih sokov.
How does Symkevi work? 
Kako zdravilo Symkevi deluje?
The doses may also need to be adjusted in patients with reduced liver function. 
Pri bolnikih z zmanjšanim delovanjem jeter je treba odmerke včasih zmanjšati.
The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents. 
V prvo študijo je bilo vključenih 510 bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od obeh staršev.
How is Symkevi used? 
Kako se zdravilo Symkevi uporablja?
Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene. 
Zdravilo Symkevi se uporablja pri bolnikih, ki so podedovali mutacijo F508del od obeh staršev, zato je ta prisotna v obeh kopijah gena CFTR.
The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections. 
„zmerni ali močni zaviralec CYP3A“, kakršni so nekateri antibiotiki ali zdravila proti glivičnim okužbam.
Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment). 
Zdravilo Symkevi v kombinaciji z ivakaftorjem so primerjali s placebom (zdravilom brez učinkovine).
Symkevi contains the active substances tezacaftor and ivacaftor. 
Zdravilo Symkevi vsebuje učinkovini tezakaftor in ivakaftor.
Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations. 
Zdravilo Symkevi je učinkovito zdravljenje bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od obeh staršev, ali bolnikov, ki so mutacijo F508del podedovali od enega starša in imajo nekatere druge mutacije.
The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation. 
V drugi študiji, v katero je bilo vključenih 248 bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od enega starša in so imeli še eno mutacijo CFTR.
Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo. 
Zdravilo Symkevi v kombinaciji z ivakaftorjem so primerjali z ivakaftorjem samim in placebom.
Cystic fibrosis affects the cells that produce mucus and digestive juices. 
Prizadene celice, ki proizvajajo sluz in prebavne sokove.
Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above. 
V dveh glavnih študijah pri bolnikih s cistično fibrozo, starejših od 12 let, se je pokazalo, da zdravilo Symkevi v kombinaciji z ivakaftorjem učinkovito izboljšuje pljučno funkcijo.
Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Več informacij o trenutnih uporabah zdravila Sutent je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Sutent has been authorised since July 2006 and contains the active substance sunitinib. 
Zdravilo Sutent je odobreno od julija 2006 in vsebuje učinkovino sunitinib.
The evaluation had finished and the CHMP had given a negative opinion. 
Postopek ocenjevanja je bil zaključen in odbor CHMP je izrazil negativno mnenje.
The active substance in Sutent, sunitinib, is a protein kinase inhibitor. 
Učinkovina v zdravilu Sutent, sunitinib, je zaviralec protein kinaze.