FrancophonIA/ELRC3.0 huggingface dataset:
English: Alkaline phosphatase, AST, and ALT ≤ 5 times upper limit of normal is acceptable if liver has tumour involvement.
Slovenian: Če so jetra tumorsko prizadeta, so sprejemljive vrednosti alkalne fosfataze, AST in ALT  5-kratnik zgornje meje normalnih vrednosti.
English: • Response rate (%) (95% CI)
Slovenian: Odziv (n: ustrezen za odziv) Stopnja odzivnosti (%) (95 % IZ) Stabilna bolezen (%)
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Clear, colorless 10 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 100 mg of pemetrexed.
Slovenian: Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje Prozorna, brezbarvna 10 ml viala iz stekla tipa I z gumijasto zaporko iz klorobutila in aluminijasto zaporko, ki vsebuje 100 mg pemetrekseda.
English: Pemetrexed Sandoz 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 1000 mg: Vsaka viala vsebuje 1000 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 500 mg: Vsaka viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Clear, colorless 100 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 1000 mg of pemetrexed.
Slovenian: Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje Prozorna, brezbarvna 100 ml viala iz stekla tipa I z gumijasto zaporko iz klorobutila in aluminijasto zaporko, ki vsebuje 1000 mg pemetrekseda.
English: • Irritation of the skin and itching
Slovenian: • Draženje kože in srbenje
English: Pemetrexed Sandoz 100 mg
Slovenian: Pemetreksed Sandoz 100 mg
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 100 mg: Vsaka viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Pemetrexed Sandoz 100 mg:
Slovenian: Pemetreksed Sandoz 100 mg:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/15/1037/003
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Slovenian: Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Manufacturer Ebewe Pharma Ges.m.b.H Nfg.KG
Slovenian: Ebewe Pharma Ges.m.b.H Nfg.KG Mondseestrasse 11, A-4866 Unterach
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje (brez konzervansa), tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: SGPT (ALT) elevation 7.9
Slovenian: SGPT (ALT)
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje (brez konzervansa), tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Special precautions for disposal and other handling
Slovenian: Navodila za uporabo, ravnanje z zdravilom in odlaganje
English: The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Slovenian: infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21-dnevnega ciklusa.
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Other medicines and Pemetrexed Sandoz
Slovenian: Shranjevanje zdravila Pemetreksed Sandoz
English: Warnings and precautions Talk to your doctor or pharmacist before receiving Pemetrexed Sandoz.
Slovenian: Pred začetkom uporabe zdravila Pemetreksed Sandoz se posvetujte s svojim zdravnikom ali z bolnišničnim farmacevtom.
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 1000 mg viale pripravite z 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje (brez konzervansa), tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Serious cardiovascular events, including myocardial infarction and cerebrovascular events, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Slovenian: Občasno so v kliničnih študijah pemetrekseda, običajno ob sočasnem dajanju z drugo citotoksično učinkovino, poročali o resnih srčnožilnih dogodkih, vključno z miokardnim infarktom in možganskožilnimi dogodki.
English: Frequency Event**
Slovenian: Organski sistem Pogostnost Dogodek**
English: Leucocytes decreased Haemoglobin decreased 26.2
Slovenian: Znižani nevtrofilci/ granulociti Znižani levkociti Znižan hemoglobin
English: • Pain in the abdomen
Slovenian: •Bolečina v prsnem košu
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Slovenian: - če dojite, morate med zdravljenjem z zdravilom Pemetreksed Sandoz dojenje prekiniti.
English: Oesophagitis/ radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Slovenian: V kliničnih preskušanjih s pemetreksedom so občasno poročali o ezofagitisu/radiacijskem ezofagitisu.
English: Nervous system disorders
Slovenian: Znižani trombociti NevropatijaSenzorična
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Common Taste disturbance Eye disorders Common Conjunctivitis Diarrhoea
Slovenian: Diareja Bruhanje Stomatitis/ Faringitis Slabost Anoreksija
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Cytotoxic EXPIRY DATE
Slovenian: Pemetrexed Placebo
English: • Muscle weakness
Slovenian: •Mišična oslabelost
English: • HR
Slovenian: RT
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Median time to tumour progression (months)
Slovenian: Log Rank p-vrednost* Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
English: Leucocytes decreased
Slovenian: Bolezni sečil
English: Contents of the pack and other information What Pemetrexed Sandoz contains The active substance is pemetrexed.
Slovenian: Shranjevanje zdravila Pemetreksed Sandoz Vsebina pakiranja in dodatne informacije
English: Posology
Slovenian: Srbenje
English: Fatigue Pain
Slovenian: Prednost pvrednost
English: Common Neuropathysensory
Slovenian: Zelo pogosto Nevropatijasenzorična
English: Novem meloxicam
Slovenian: Novem meloksikam
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Novem, veljavno po vsej Evropski uniji, izdala 2. marca 2004.
English: Other information about Novem:
Slovenian: Druge informacije o zdravilu Novem:
English: The full EPAR for Novem can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Novem je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: What are the risks associated with Novem?
Slovenian: Kakšna tveganja so povezana z zdravilom Novem?
English: What is Novem and what is it used for?
Slovenian: Kaj je zdravilo Novem in za kaj se uporablja?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Novem večje od njegovih tveganj in priporočil njegovo odobritev za uporabo v EU.
English: Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses.
Slovenian: Izvedene so bile ustrezne študije pri različnih ciljnih živalih, katerih namen je bil dokazati učinkovitost in varnost zdravila Novem pri njegovih odobrenih uporabah.
English: What benefits of Novem have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Novem izkazalo v študijah?
English: Why is Novem approved?
Slovenian: Zakaj je bilo zdravilo Novem odobreno?
English: The withdrawal period for meat is five days.
Slovenian: Karenca za meso je pet dni.
English: If the product is accidentally self-injected, the advice of a doctor should be sought immediately.
Slovenian: Če človek zdravilo nenamerno zaužije, se je treba nemudoma posvetovati z zdravnikom.
English: The withdrawal period is 15 days for meat and five days for milk.
Slovenian: Karenca je 15 dni za meso in pet dni za mleko.
English: Injections are given under the skin for cattle and into the muscles for pigs.
Slovenian: Pri govedu se injicira pod kožo, pri prašičih pa v mišico.
English: The dose to use depends on the animal and its bodyweight.
Slovenian: Uporabljeni odmerek je odvisen od živali in njene telesne mase.
English: • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
Slovenian: • šepavosti in vnetja pri neinfektivnih lokomotornih obolenjih (bolezni, ki prizadenejo gibalne sposobnosti živali);
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Slovenian: Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Novem.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Slovenian: Prostaglandini so snovi, ki sprožajo vnetje, bolečino in izcejanje tekočine (izcejanje tekočine iz krvnih žil med vnetnim procesom) in povišano telesno temperaturo, meloksikam pa te bolezenske znake zmanjšuje.
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Slovenian: Novem je protivnetno zdravilo, ki se uporablja pri govedu in prašičih.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Slovenian: Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilo Novem vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Slovenian: • akutne okužbe dihal (okužbe pljuč in dihalnih poti) skupaj z antibiotiki;
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Slovenian: Študije pri govedu so pokazale, da je v primerjavi z uporabo zgolj antibiotikov dodajanje zdravila Novem antibiotičnemu zdravljenju bistveno izboljšalo klinične parametre in znižalo povišano telesno temperaturo.
English: • pain following minor soft tissue surgery such as castration
Slovenian: • bolečine po manjših kirurških posegih na mehkih tkivih, kot je npr. kastracija;
English: For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Novem naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re hydration therapy (medicines given by mouth to restore water levels in the body)
Slovenian: • driske pri teletih, starejših od enega tedna, ter pri mladem govedu zunaj obdobja laktacije, skupaj z zdravljenjem s peroralno rehidracijo (zdravila, ki se dajejo peroralno za uravnavanje količine vode v telesu);
English: Novem is available as a solution for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Novem je na voljo v obliki raztopine za injiciranje, njegovo predpisovanje in izdaja zdravila pa je le na recept.
English: In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Slovenian: V zelo redkih primerih se pojavijo anafilaktične (alergijske) reakcije, ki utegnejo biti zelo resne (celo smrtne) in jih je treba zdraviti simptomatsko.Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z živaljo?
English: In pigs, Novem is used to treat:
Slovenian: Pri prašičih se zdravilo Novem uporablja za zdravljenje:
English: Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Slovenian: Podobno se je izkazalo, da je zdravljenje, pri katerem sta uporabljena rehidracijska raztopina in zdravilo Novem, učinkovitejše od rehidracijske raztopine kot samostojnega zdravila.
English: How is Novem used?
Slovenian: Kako se zdravilo Novem uporablja?
English: This document is a summary of the European Public Assessment Report.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Novem.
English: How does Novem work?
Slovenian: Kako zdravilo Novem deluje?
English: • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
Slovenian: • akutnega mastitisa (vnetja vimena) skupaj z glavnim zdravljenjem z antibiotiki.
English: • pain following dehorning in calves
Slovenian: • bolečine po kirurški odstranitvi rogov pri teletih;
English: In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Slovenian: Pri manj kot 10 % goveda, zdravljenega v kliničnih študijah, so opazili le blago, prehodno oteklino na mestu injiciranja zdravila v podkožje.
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Slovenian: • okužb po oprasitvi (kotitvi mladičev), kot sta puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalaktija), skupaj z glavnim zdravljenjem z antibiotiki.
English: The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora v sodelovanju z referenčno državo članico dogovoriti o ustreznem postopku, ki bo uporabljen za izpolnjevanje tega pogoja.
English: The MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora reformulirati zdravilo tako, da bo vsebovalo raven magnezija, ki temelji na najsodobnejšem znanju na strokovnem področju.
English: For the suspension of the marketing authorisations of Numeta G13%E to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Slovenian: Za preklic začasnega umika dovoljenj za promet z zdravilom Numeta G13%E morajo nacionalni pristojni organi držav članic preveriti, ali imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
English: Annex III Condition for lifting the suspension of the marketing authorisations
Slovenian: Pogoj za preklic začasnega umika dovoljenj za promet z zdravili
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Slovenian: Numeta G13%E in povezanimi imeni
English: --1 Hydrocortisone aceponate: 1.11 mg/ml; Miconazole (as nitrate form): 15.1 mg/ml; Gentamicin (as sulphate form): 1,505 IU/ml.
Slovenian: --1 Hydrokortizon aceponat 1,11 mg/ml, Miconazolev obliki nitrata 15,1 mg/ml, Gentamicin v obliki sulfata 1505 IU/ml.
English: Strength
Slovenian: Ovojnina
English: Pharmaceutical form
Slovenian: Jakost Farmacevtska oblika
English: Auricular use Multi-dose container (PP)
Slovenian: Avricularno Večodmerni vsebnik s črpalko
English: Content Package size Withdrawal period
Slovenian: Vsebina Velikost pakiranja Karenca
English: 1 container
Slovenian: 1 vsebnik Navedba ni smiselna
English: EMA/CHMP/761027/2012 EMEA/H/C/002506
Slovenian: 13. december 2012 EMA/130145/2013 EMEA/H/C/002506
English: For more information on biosimilar medicines, see the questions-and-answers document here.
Slovenian: Za več informacij o biološko podobnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
English: It was to be available as a solution for injection.
Slovenian: Na voljo naj bi bilo v obliki suspenzije za injiciranje.
English: The initial concerns related mainly to the manufacture of the medicine and whether Solumarv was sufficiently similar to its reference medicine.
Slovenian: Prvotni pomisleki so bili v glavnem povezani s proizvodnjo zdravila in z vprašanjem, ali je zdravilo Solumarv dovolj podobno referenčnemu zdravilu.
English: The reference medicine for Solumarv in this application was Humulin S.
Slovenian: Referenčno zdravilo za zdravilo Solumarv v tej vlogi je bilo zdravilo Humulin S.
English: The insulin in Solumarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Slovenian: Insulin v zdravilu Solumarv se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdela ga bakterija, ki je prejela gen (DNK), s pomočjo katerega lahko tvori insulin.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Solumarv in clinical trials.
Slovenian: Družba je CHMP obvestila, da v času umika vloge ni bilo bolnikov, ki bi v kliničnih študijah prejemali zdravilo Solumarv.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solumarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Slovenian: Družba Marvel LifeSciences Ltd je dne 15. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Solumarv, namenjenim zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze v krvi.
English: Solumarv is a medicine that contains the active substance human insulin.
Slovenian: Solumarv je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
English: Withdrawal of the marketing authorisation application for Solumarv (human insulin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Solumarv (humani insulin)
English: Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Slovenian: Zdravilo Solumarv naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze (sladkorja) v krvi.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Solumarv could not have been approved.
Slovenian: Po oceni začetne dokumentacije je CHMP izrazil velike zadržke in je začasno menil, da zdravila Solumarv ni mogoče odobriti.
English: The application was a joint application from Marvel LifeSciences for Solumarv and two other medicines (Isomarv medium and Combimarv, also developed as biosimilar medicines).
Slovenian: Vloga, ki jo je predložila družba Marvel LifeSciences, je bila skupna vloga za zdravilo Solumarv in dve drugi zdravili (Solumarv in Combimarv, ki sta bili prav tako razviti kot podobni biološki zdravili).
English: What is Solumarv?
Slovenian: Kaj je zdravilo Solumarv?
English: Solumarv was developed as a biosimilar medicine.
Slovenian: Zdravilo Solumarv je bilo razvito kot biološko podobno zdravilo.
English: Solumarv was intended as a replacement insulin that is similar to the insulin made by the body.
Slovenian: Zdravilo Solumarv naj bi bilo nadomestni insulin, ki je podoben insulinu, ki nastaja v telesu.