FrancophonIA/ELRC3.0 huggingface dataset:
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with ertapenem and may range in severity from mild to life-threatening.
Slovenian: Pri ertapenemu so poročali o z antibiotikom povezanim kolitisu in psevdomembranskem kolitisu, ki je lahko blag do življenjsko nevaren.
English: General properties
Slovenian: Splošne značilnosti
English: There are inadequate data on the safety and efficacy of ertapenem in patients with severe renal impairment to support a dose recommendation.
Slovenian: Podatkov o varnosti in učinkovitosti ertapenema pri bolnikih s hudo okvaro ledvic ni dovolj, da bi lahko izdelali priporočilo za odmerjanje.
English: For prevention of surgical site infections following surgery of the colon or rectum, the recommended dose of INVANZ is 1 g administered as a single intravenous dose 1 hour before surgery.
Slovenian: Priporočeni odmerek za preventivo pred okužbami na mestu kirurškega posega v debelem črevesju ali danki je 1 g, dan v obliki enkratnega intravenskega odmerka 1 uro pred kirurškim posegom.
English: There is no target-based cross-resistance between ertapenem and these substances.
Slovenian: Med ertapenemom in temi učinkovinami ni navzkrižne odpornosti, ki bi bila vezana na prijemališče.
English: There is no accumulation of ertapenem in adults following multiple intravenous doses ranging from 0.5 to 2 g daily.
Slovenian: Po večkratnih intravenskih odmerkih od 0,5 do 2 g dnevno pri odraslih ne pride do kopičenja ertapenema.
English: This medicine contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To zdravilo vsebuje približno 6,0 mEq (približno 137 mg) natrija na 1,0 g odmerek.
English: The recommended dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g/day).
Slovenian: Priporočeni odmerek zdravila INVANZ za odrasle in mladostnike, stare 13 let ali več, je 1 gram (g) enkrat na dan. Priporočeni odmerek za otroke, stare od 3 mesece do 12 let, je 15 mg/kg dvakrat na dan (odmerek ne sme biti večji od 1 g na dan).
English: Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL.
Slovenian: Vsebino 1 g viale zdravila INVANZ raztopite v 10 ml vode za injekcije ali raztopine natrijevega klorida 9 mg/ml (0,9 %), da dobite koncentrat s koncentracijo približno 100 mg/ml.
English: Common: Decreases in neutrophil count Uncommon: Increases in platelet count, activated partial thromboplastin time, prothrombin time, decreases in haemoglobin
Slovenian: Občasni: povečanje števila trombocitov, podaljšanje aktiviranega parcialnega tromboplastinskega časa, protrombinskega časa, znižanje hemoglobina
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Slovenian: Pri bolnikih, ki so se zdravili z betalaktamskimi antibiotiki, so poročali o hudih in občasno smrtnih preobčutljivostnih (anafilaktičnih) reakcijah.
English: • Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder
Slovenian: • vnetje žolčnika, oteženo požiranje, inkontinenca blata, zlatenica, okvara jeter,
English: There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation.
Slovenian: Podatkov o varnosti in učinkovitosti ertapenema pri bolnikih na hemodializi ni dovolj, da bi lahko izdelali priporočilo za odmerjanje.
English: Acute Pelvic Infections (API) 13 to 17 years
Slovenian: Akutne okužbe v medenici (Acute Pelvic Infections - API)
English: For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0 %), and elevations in ALT (2.9 %) and AST (2.8 %).
Slovenian: Pri bolnikih, ki so se zdravili samo z zdravilom INVANZ, so med zdravljenjem in v 14 dnevnem obdobju spremljanja po koncu zdravljenja najpogosteje poročali o naslednjih laboratorijskih nepravilnostih: padec števila nevtrofilcev (3,0 %) ter dvig ALT (2,9 %) in dvig AST (2,8 %).
English: (NB: Susceptibility of staphylococci to ertapenem is inferred from methicillin susceptibility and susceptibility of group A, B, C,& G streptococci is inferred from benzylpenicillin susceptibility)
Slovenian: • Referenčne vrednosti ne glede na vrsto: S ≤ 0,5 mg/l in R > 0,5 mg/l (Občutljivost stafilokokov na ertapenem se sklepa na osnovi občutljivosti na meticilin, občutljivost streptokokov skupin A, B, C in G se sklepa na osnovi občutljivosti na benzilpenicilin.)
English: • Intra-abdominal infections
Slovenian: Okužbe v trebuhu (Intraabdominal Infections - IAI)
English: • Dizziness, sleepiness, sleeplessness, confusion, seizure
Slovenian: • omotica, dremavost, nespečnost, zmedenost, epileptični napad,
English: Renal and urinary disorders Rare: Renal insufficiency, acute renal insufficiency
Slovenian: Redki: ledvična insuficienca, akutna ledvična insuficienca
English: Common: Diaper dermatitis Uncommon: Erythema, rash, petechiae
Slovenian: Pogosti: plenični dermatitis Občasni: eritem, izpuščaj, petehije
English: • Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site)
Slovenian: otekline na vbodnem mestu, ali uhajanjem tekočine v tkivo in kožo okrog vbodnega mesta),
English: - If you get any side effects, talk to your doctor, nurse or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Haematology
Slovenian: Hematološke
English: AUCs of total ertapenem and of unbound ertapenem are increased in patients with severe renal impairment (Clcr 5 to 30 mL/min/1.73 m2) approximately 2.6-fold and 3.4-fold, respectively, compared with healthy subjects.
Slovenian: Vrednost AUC celokupnega ertapenema je pri bolnikih s hudo okvaro ledvic (Clcr 5 do 30 ml/min/1,73 m2) v primerjavi z zdravimi posamezniki povečana za 2,6-krat, vrednost AUC nevezanega ertapenema pa za 3,4-krat.
English: For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: elevations in ALT (4.6 %), AST (4.6 %), alkaline phosphatase (3.8 %) and platelet count
Slovenian: Pri bolnikih, ki so prejemali samo zdravilo INVANZ, so med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja najpogosteje poročali o naslednjih laboratorijskih nepravilnostih: dvig ALT ( 4,6 %), AST (4,6 %), alkalne fosfataze (3,8 %) in števila trombocitov (3,0 %).
English: For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less; or
Slovenian: Za redčenje v infuzijski vrečki topila: v vrečko raztopine natrijevega klorida 9 mg/ml (0,9 %) prenesite količino, ki ustreza 15 mg/kg telesne teže (ne sme preseči 1 g/dan); končna koncentracija naj bo 20 mg/ml ali manj; ali
English: INVANZ 1 g powder for concentrate for solution for infusion
Slovenian: INVANZ 1 g prašek za koncentrat za raztopino za infundiranje
English: Warnings and precautions Talk to your doctor, nurse or pharmacist before taking INVANZ.
Slovenian: Pred začetkom uporabe zdravila INVANZ se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Rare: Genital bleeding
Slovenian: Redki: spremembe beločnice
English: AUCs of total ertapenem and of unbound ertapenem are increased in patients with moderate renal impairment (Clcr 31 to 59 mL/min/1.73 m2) approximately 1.5-fold and 1.8-fold, respectively, compared with healthy subjects.
Slovenian: Vrednost AUC celokupnega ertapenema je pri bolnikih z zmerno okvaro ledvic (Clcr 31 do 59 ml/min/1,73 m2) v primerjavi z zdravimi posamezniki povečana za 1,5-krat, vrednost AUC nevezanega ertapenema pa za 1,8-krat.
English: • Infection in the abdomen
Slovenian: • okužb v trebušni votlini,
English: For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less.
Slovenian: Za redčenje v viali topila: v vialo raztopine natrijevega klorida 9 mg/ml (0,9 %) prenesite količino, ki ustreza 15 mg/kg telesne teže (ne sme preseči 1 g/dan); končna koncentracija naj bo 20 mg/ml ali manj.
English: • Burning, itching, redness and warmth at infusion site, redness at injection site
Slovenian: • pekoč občutek, srbenje, rdečina in občutek toplote na mestu infuzije, rdečina na vbodnem mestu,
English: An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
Slovenian: Dodatno je v klinični študiji o preventivi pred okužbami po kirurškem posegu v kolorektalnem področju ertapenem v obliki enojnega 1-gramskega odmerka pred kirurškim posegom prejelo 476 bolnikov.
English: For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8 %), infused vein complication (4.5 %) and nausea (2.8 %).
Slovenian: Pri bolnikih, ki so se zdravili samo z zdravilom INVANZ, so bili najpogosteje poročani neželeni učinki med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja naslednji: driska (4,8 %), zapleti v zvezi z veno, v katero je bila nameščena infuzija (4,5 %) in navzea (2,8 %).
English: • Streptococcus pneumoniae: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Streptococcus pneumoniae: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: • Miscarriage, genital bleeding
Slovenian: • splav, krvavitev iz rodil,
English: Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents.
Slovenian: Pri sočasni uporabi valprojske kisline in karbapenemskih antibiotikov so poročali o znižanju koncentracij valprojske kisline, pri čemer lahko le te padejo pod terapevtsko območje.
English: Seizures
Slovenian: Redčenje
English: For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2 %) and infusion site pain
Slovenian: Pri bolnikih, ki so se zdravili samo z zdravilom INVANZ, so bili najpogosteje poročani neželeni učinki med zdravljenjem in v 14-dnevnem obdobju spremljanja po koncu zdravljenja naslednji: driska (5,2 %) in bolečina na vbodnem mestu infuzije (6,1 %).
English: Uncommon: Constipation, acid regurgitation, dry mouth, dyspepsia, abdominal pain Rare: Dysphagia, faecal incontinence, pelvic peritonitis Not known: teeth staining
Slovenian: Pogosti: driska, navzea, bruhanje Občasni: zaprtje, regurgitacija kisline, suha usta, dispepsija, bolečina v trebuhu Redki: disfagija, inkontinenca blata, peritonitis v medenici Neznana: obarvanje zob
English: What INVANZ contains
Slovenian: Kaj vsebuje zdravilo INVANZ
English: INVANZ 1 g powder for concentrate for solution for infusion Ertapenem
Slovenian: INVANZ 1 g prašek za koncentrat za raztopino za infundiranje ertapenem
English: Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution.
Slovenian: Pripravljeni koncentrat iz 1 g viale zdravila INVANZ prenesite v 50 ml vialo z raztopino natrijevega klorida 9 mg/ml (0,9 %).
English: Plasma concentrations of ertapenem are comparable in paediatric patients 13 to 17 years of age and adults following a 1 g once daily intravenous dose.
Slovenian: Plazemske koncentracije ertapenema po intravenskem odmerku 1 g enkrat dnevno pri otrocih, starih 13 do 17 let, in pri odraslih so primerljive.
English: For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution; or
Slovenian: Za redčenje v 50 ml vrečki topila: za pripravo 1 g odmerka koncentrat takoj prenesite v 50 ml vrečko raztopine natrijevega klorida 9 mg/ml (0,9 %); ali
English: Anaerobes:
Slovenian: Anaerobne bakterije:
English: • Haemophilus influenzae: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Haemophilus influenzae: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: Do not use INVANZ - if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections).
Slovenian: • če ste alergični na antibiotike, kot so penicilini, cefalosporini ali karbapenemi (uporabljajo se za zdravljenje različnih okužb).
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 20 mg/kg (up to a maximum dose of 1 g) dose in patients 13 to 17 years of age were 170.4 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 7.0 micrograms/mL at 12 hour postdose, and 1.1 microgram/mL at 24 hour postdose.
Slovenian: Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 20 mg/kg (do največjega odmerka 1 g) pri bolnikih, starih od 13 do 17 let, so znašale: 170,4 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 7,0 mikrogramov/ml 12 ur po odmerku in 1,1 mikrograma/ml 24 ur po odmerku.
English: • teeth staining
Slovenian: • obarvanje zob.
English: • M. catarrhalis: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • M. catarrhalis: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: • Enterobacterales: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Enterobacterales: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 9 micrograms/mL at 12 hour postdose, and 1 microgram/mL at 24 hour postdose.
Slovenian: Po eni 30-minutni intravenski infuziji 1-gramskega odmerka so bile povprečne plazemske koncentracije ertapenema pri zdravih mladih odraslih (starih 25 do 45 let) naslednje: 155 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 9 mikrogramov/ml 12 ur po odmerku in 1 mikrogram/ml 24 ur po odmerku.
English: • Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain, abnormal taste
Slovenian: • bolečina v trebuhu, utrujenost, glivna okužba, zvišana telesna temperatura, edem/otekanje,
English: Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection
Slovenian: Občasni: kandidoza v ustni votlini, kandidoza, glivična okužba, pseudomembranski enterokolitis, vaginitis Redki: pljučnica, dermatomikoze, postoperativne okužbe ran, okužba sečil
English: For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution and discard.
Slovenian: Za redčenje v 50 ml viali topila: za pripravo 1 g odmerka iz 50 ml viale z raztopino natrijevega klorida 9 mg/ml (0,9 %) odvzemite 10 ml raztopine in jo zavrzite.
English: How to store INVANZ
Slovenian: Shranjevanje zdravila INVANZ
English: • Gram positive anaerobes: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Gram pozitivni anaerobi: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/kg (up to a maximum dose of 1 g) dose in patients 3 to 23 months of age were 103.8 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), 13.5 micrograms/mL at 6 hour postdose, and 2.5 micrograms/mL at 12 hour postdose.
Slovenian: Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 15 mg/kg (do največjega odmerka 1 g) pri bolnikih, starih od 3 do 23 mesecev, so znašale: 103,8 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 13,5 mikrogramov/ml 6 ur po odmerku in 2,5 mikrograma/ml 12 ur po odmerku.
English: The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits.
Slovenian: Pripravljeno raztopino je treba, če ovojnina to dovoljuje, pred infundiranjem vizualno pregledati, da ne vsebuje vidnih delcev in da ni spremenila barve.
English: Common: Diarrhoea Uncommon: Faeces discoloured, melaena
Slovenian: Pogosti: driska Občasni: spremenjena barva blata, melena
English: • Gram negative anaerobes: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Gram negativni anaerobi: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: • Viridans group streptococci: S ≤ 0.5 mg/L and R > 0.5 mg/L
Slovenian: • Streptokoki skupine viridans: S ≤ 0,5 mg/l in R > 0,5 mg/l
English: Not known: Altered mental status (including aggression, delirium, disorientation, mental status changes)
Slovenian: Občasni: nespečnost, zmedenost Redki: vznemirjenost, anksioznost, depresija Neznana: spremenjeno duševno stanje (vključno z agresivnostjo, delirijem, dezorientiranostjo, spremembami duševnega stanja)
English: • Shortness of breath, sore throat
Slovenian: • kratka sapa, vneto žrelo,
English: Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in three patients 13 to 17 years of age were 155.9 micrograms/mL (Cmax) at 0.5 hour postdose (end of infusion), and 6.2 micrograms/mL at 12 hour postdose.
Slovenian: Povprečne plazemske koncentracije ertapenema po eni 30-minutni intravenski infuziji odmerka 1 g pri treh prostovoljcih, starih od 13 do 17 let, so znašale: 155,9 mikrogramov/ml (Cmax) 0,5 ure po odmerku (ob koncu infuzije), 12 ur po odmerku pa 6,2 mikrogramov/ml.
English: • Urinary tract infection, kidney impairment
Slovenian: • okužba sečil, okvara ledvic,
English: wheezing
Slovenian: Dojenje
English: • Skin redness, skin rash
Slovenian: • rdečica kože, izpuščaj po koži,
English: Disease Stratum
Slovenian: Žilne bolezni
English: Common: Infusion site pain Uncommon: Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth
Slovenian: Občasni: pekoč občutek, srbenje in eritem na mestu infuzije, eritem na mestu vboda, občutek toplote na mestu infuzije
English: • Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation,
Slovenian: • zaprtje, kandidoza v ustih, z antibiotiki povzročena driska, zgaga, suha usta, slaba prebava,
English: • muscle weakness
Slovenian: • šibkost mišic,
English: Not known: Anaphylaxis including anaphylactoid reactions
Slovenian: Bolezni imunskega sistema Redki: alergija Neznana: anafilaksija vključno z anafilaktoidnimi reakcijami
English: It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.
Slovenian: Pomembno je, da preden prejmete zdravilo INVANZ, zdravniku poveste, če dojite ali nameravate dojiti.
English: Common: Elevation in platelet count
Slovenian: Pogosti: povečanje števila trombocitov
English: The change in binding was < 12 % at peak plasma ertapenem concentration following a 1 g dose.
Slovenian: Pri maksimalni plazemski koncentraciji ertapenema po 1-gramskem odmerku je bila sprememba vezave manjša od 12 %.
English: Uncommon: Oral candidiasis, candidiasis, fungal infection, pseudomembranous enterocolitis, vaginitis
Slovenian: Redki: kongestija nosne sluznice, kašelj, krvavitev iz nosu, poki/hropci, piskanje
English: Ertapenem
Slovenian: Mešane
English: Adults 18 years of age and older Children and adolescents (3 months to 17 years of age)
Slovenian: Otroci in mladostniki (stari od 3 mesecev do 17 let)
English: EMEA/H/C/002419
Slovenian: EMA/828392/2011 EMEA/H/C/002419
English: The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.
Slovenian: Priporočeni odmerek za odrasle in mladostnike (stare 12 let in več) je ena tableta enkrat na dan.
English: The full EPAR for Desloratadine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Desloratadine Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Teva on 24 November 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Desloratadine Teva, veljavno po vsej Evropski uniji, odobrila dne 24. novembra 2011.
English: For more information about treatment with Desloratadine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Desloratadine Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: This means that Desloratadine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aerius.
English: What are the benefits and risks of Desloratadine Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Desloratadine Teva?
English: Desloratadine Teva is a ‘generic medicine'.
Slovenian: Desloratadine Teva je „generično zdravilo“.
English: Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Slovenian: Zdravilo Desloratadine Teva se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Desloratadine Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Desloratadine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Desloratadine Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Desloratadine Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Desloratadine Teva.
English: Other information about Desloratadine Teva
Slovenian: Druge informacije o zdravilu Desloratadine Teva
English: The Committee recommended that Desloratadine Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Desloratadine Teva odobri dovoljenje za promet.
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Desloratadine Teva primerljivo raven kakovosti kot zdravilo Aerius ter da mu je biološko enakovredno.