FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients at low to moderate immunological risk were studied in the phase 3 ciclosporin elimination-Rapamune maintenance study, which included patients receiving a renal allograft from a cadaveric or living donor.
Slovenian: Bolnike z majhnim do zmernim imunološkim tveganjem, vključno z bolniki z alogenim ledvičnim presadkom umrlega ali živega darovalca, so vključili v študijo III. faze ukinitve ciklosporina vzdrževalnega zdravljenja z zdravilom Rapamune.
English: Reporting of side effects
Slovenian: Poročanje oneželenih učinkih
English: The incidence of any adverse reaction(s) may increase as the trough sirolimus level increases.
Slovenian: Incidenca kateregakoli neželenega učinka se lahko zveča z zvečanjem najnižje koncentracije sirolimusa.
English: Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Slovenian: Sočasna uporaba sirolimusa in ketokonazola ni priporočljiva (glejte poglavje 4.4).
English: Lung and liver transplant populations
Slovenian: Populacija s presadki pljuč in jeter
English: Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids, and ascorbyl palmitate).
Slovenian: Druge sestavine zdravila so: polisorbat 80 (E433) in phosal 50 PG (fosfatidilholin, propilenglikol [E1520], mono- in digliceridi, etanol, maščobne kisline iz soje in askorbilpalmitat).
English: The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Slovenian: Vrednosti Cmax, tmax in AUC eritromicina v plazmi so se povečale za 1,6-krat, 1,3-krat in 1,7-krat.
English: In some cases, ovarian cysts and these menstrual disorders have resolved upon discontinuation of Rapamune.
Slovenian: V nekaterih primerih so po prenehanju jemanja zdravila Rapamune ovarijske ciste in motnje menstrualnega cikla izzvenele.
English: Rapamune 1 mg coated tablets 3 years.
Slovenian: Rapamune 1 mg obložene tablete 3 leta
English: Reductions in testicular weights and/or histological lesions (e.g. tubular atrophy and tubular giant cells) were observed in rats and in a monkey study.
Slovenian: Pri podganah in v študiji na opicah so opazili zmanjšanje mase testisov in/ali histološke spremembe (npr. tubularna atrofija in pojav tubularnih celic velikank).
English: Rapamune should be taken consistently, either with or without food.
Slovenian: Zdravilo Rapamune vedno jemljite enako, bodisi s hrano bodisi brez nje.
English: Then place the capped dosing syringe in the carrying case provided.
Slovenian: Zaščiteno napolnjeno brizgo nato položite v priloženo škatlo za hranjenje odmerne brizge.
English: Rapamune 0.5 mg coated tablets, Rapamune 1 mg coated tablets, Rapamune 2 mg coated tablets:
Slovenian: Rapamune 0,5 mg obložene tablete, Rapamune 1 mg obložene tablete, Rapamune 2 mg obložene tablete:
English: Rifampicin (CYP3A4 inducer)
Slovenian: Rifampicin (induktor CYP3A4)
English: Very common: may affect more than 1 in 10 people
Slovenian: Pogosti:pojavijo se lahko pri največ 1 od 10 bolnikov okužbe (vključno z življenjsko ogrožajočimiokužbami),
English: Cases of BK virus-associated nephropathy, as well as cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Slovenian: Pri bolnikih, zdravljenih z imunosupresivi, vključno z zdravilom Rapamune, so poročali o primerih nefropatije, povezane z virusom BK, in o primerih progresivne multifokalne levkoencefalopatije (PML), povezane z virusom JC.
English: After dilution (see section 6.6), the preparation should be used immediately.
Slovenian: Po redčenju je treba zdravilo uporabiti takoj (glejte poglavje 6.6).
English: (1) in patients with hepatic impairment (2) when inducers or inhibitors of CYP3A4 are concurrently administered and after their discontinuation (see section 4.5) and/or (3) if ciclosporin dosing is markedly reduced or discontinued, as these populations are most likely to have special dosing requirements.
Slovenian: in/ali (3) če odmerjanje ciklosporina znatno zmanjšamo ali prekinemo, ker so pri teh bolnikih posebne zahteve glede odmerjanja najverjetnejše.
English: Seven major metabolites, including hydroxyl, demethyl, and hydroxydemethyl, are identifiable in whole blood.
Slovenian: V krvi so opredelili sedem pomembnejših presnovkov, med njimi hidroksilno, demetilno in hidroksidemetilno obliko.
English: Each coated tablet contains 2 mg sirolimus.
Slovenian: Ena obložena tableta vsebuje 2 mg sirolimusa.
English: Rapamune 2 mg coated tablets 3 years.
Slovenian: Rapamune 2 mg obložene tablete 3 leta
English: INFORMATION IN BRAILLE Rapamune 0.5 mg
Slovenian: Rapamune 0,5 mg
English: Grapefruit juice affects CYP3A4-mediated metabolism and must, therefore, be avoided.
Slovenian: Sok grenivke vpliva na presnovo, povezano z izoencimom CYP3A4, zato se je treba njegovi uporabi med zdravljenjem izogibati.
English: Pericardial effusion
Slovenian: peroralna raztopina
English: Each coated tablet contains 1 mg sirolimus.
Slovenian: Ena obložena tableta vsebuje 1 mg sirolimusa.
English: Rapamune 1 mg/mL oral solution sirolimus
Slovenian: Rapamune 1 mg/ml peroralna raztopina sirolimus
English: It helps to control your body's immune system after you have received a kidney transplant.
Slovenian: Po presaditvi ledvice pomaga nadzorovati vaš imunski sistem.
English: Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus.
Slovenian: Rapamune 0,5 mg: ena obložena tableta vsebuje 0,5 mg sirolimusa.
English: The concomitant use of Rapamune with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced haemolytic uraemic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy (HUS/TTP/TMA).
Slovenian: Sočasna uporaba zdravila Rapamune z zaviralcem kalcinevrina lahko poveča tveganje za hemolitičnouremični sindrom/trombotično trombocitopenično purpuro/trombotično mikroangiopatijo (HUS/TTP/TMA), izzvanimi z zaviralcem kalcinevrina.
English: INFORMATION IN BRAILLE Rapamune 2 mg
Slovenian: Rapamune 2 mg
English: Impairments of sperm parameters have been observed among some patients treated with Rapamune.
Slovenian: Pri nekaterih bolnikih, zdravljenih z zdravilom Rapamune, so ugotovili poslabšanje parametrov semenčic.
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively.
Slovenian: Vrednosti Cmax, tmax in AUC sirolimusa v polni krvi so se povečale za 4,4-krat, 1,4-krat oziroma 4,2-krat.
English: Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus.
Slovenian: Rapamune 2 mg: ena obložena tableta vsebuje 2 mg sirolimusa.
English: Verapamil (CYP3A4 inhibitor)
Slovenian: Verapamil (zaviralec CYP3A4)
English: Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets sirolimus
Slovenian: Rapamune 0,5 mg obložene tablete Rapamune 1 mg obložene tablete Rapamune 2 mg obložene tablete sirolimus
English: Increased rates of biopsy confirmed acute rejection (BCAR) in renal transplant patients have been observed with concomitant use of sirolimus with ACE inhibitors (see section 5.1).
Slovenian: Pri sočasni uporabi sirolimusa in zaviralcev ACE so pri bolnikih s presadki ledvic opazili večji delež z biopsijo potrjene akutne zavrnitve (BCAR - Biopsy Confirmed Acute Rejection) (glejte poglavje 5.1).
English: Hepatic impairment
Slovenian: Maligne bolezni
English: Leucopenia
Slovenian: limfedem
English: Blood creatinine increased *See section below.
Slovenian: Preiskave zvišanje laktatdehidrogenaze v krvi, zvišanje kreatinina v krvi *Glejte nadaljevanje.
English: Rapamune 1 mg/mL oral solution:
Slovenian: Rapamune 1 mg/ml peroralna raztopina:
English: The Rapamune group failed to demonstrate superiority to the control group in terms of the first occurrence of biopsy confirmed acute rejection, graft loss, or death.
Slovenian: Glede prvega pojava z biopsijo potrjene akutne zavrnitve presadka, izgube presadka ali smrti za skupino z zdravilom Rapamune niso uspeli dokazati superiornosti v primerjavi s kontrolno skupino.
English: Ciclosporin (CYP3A4 substrate)
Slovenian: Ciklosporin (substrat za CYP3A4)
English: Rapamune 0.5 mg coated tablets sirolimus
Slovenian: Rapamune 0,5 mg obložene tablete sirolimus
English: Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Slovenian: Vrednosti Cmax, tmax in AUC sirolimusa so se povečale za 1,4-krat, 1,3-krat oziroma 1,6-krat.
English: Each mL of Rapamune contains 1 mg sirolimus.
Slovenian: 1 ml zdravila Rapamune vsebuje 1 mg sirolimusa.
English: Oral solution 60 mL bottle
Slovenian: peroralna raztopina 60 ml steklenica
English: Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus.
Slovenian: Rapamune 1 mg: ena obložena tableta vsebuje 1 mg sirolimusa.
English: This study compared Rapamune (dose adjusted to 5-15 ng/mL) with placebo for a 12-month treatment period, followed by a 12-month observation period in patients with TSC-LAM or S-LAM. Eighty-nine (89) patients were enrolled at 13 study sites in the United States, Canada, and Japan of which 81 patients had S-LAM; of these patients with S-LAM, 39 were randomised to receive placebo and 42 to receive Rapamune.
Slovenian: V 13 raziskovalnih centrih v Združenih državah, Kanadi in na Japonskem so v študijo vključili 89 bolnikov, od katerih jih je S-LAM imelo 81, ki so jih randomizirali tako, da je 39 bolnikov s SLAM prejemalo placebo in 42 bolnikov zdravilo Rapamune.
English: Diltiazem (CYP3A4 inhibitor)
Slovenian: Diltiazem (zaviralec CYP3A4)
English: Patients administered Rapamune should be monitored for hyperlipidaemia using laboratory tests and if hyperlipidaemia is detected, subsequent interventions such as diet, exercise, and lipid-lowering agents should be initiated.
Slovenian: Bolnike, ki prejemajo zdravilo Rapamune, je treba z laboratorijskimi testi spremljati glede pojava hiperlipidemije.
English: Rare reports of fatal hepatic necrosis have been reported with elevated trough sirolimus levels.
Slovenian: Ob zvečani najmanjši koncentraciji sirolimusa so poročali o redkih primerih nekroze jeter s smrtnim izidom.
English: Infectious diarrhoea with Clostridium difficile
Slovenian: Srčne bolezni tahikardija perikardialni izliv
English: MARKETING AUTHORISATION NUMBER(S) Rapamune 0.5 mg coated tablets EU/1/01/171/013-14
Slovenian: Rapamune 0,5 mg obložene tablete EU/1/01/171/013-014
English: Renal function should be monitored during concomitant administration of Rapamune and ciclosporin.
Slovenian: Med sočasno uporabo zdravila Rapamune in ciklosporina je treba spremljati delovanje ledvic.
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively.
Slovenian: Vrednosti Cmax, tmax in AUC sirolimusa v polni krvi so se povečale za 2,3-krat, 1,1-krat oziroma 2,2-krat.
English: Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Slovenian: Sočasna uporaba sirolimusa in vorikonazola ni priporočljiva (glejte poglavje 4.4).
English: INFORMATION IN BRAILLE Rapamune 1 mg
Slovenian: Rapamune 1 mg
English: Patients with a body mass index (BMI) greater than 30 kg/m2 may be at increased risk of abnormal wound healing based on data from the medical literature.
Slovenian: Podatki iz medicinske literature kažejo, da je lahko tveganje za nenormalno celjenje ran večje pri bolnikih, ki imajo indeks telesne mase (ITM) večji od 30 kg/m
English: Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets Bleeding from the lung
Slovenian: nemelanomski kožni rak* limfom*, maligni melanom*, potransplantacijska limfoproliferativ na motnja nevroendokrini karcinom kože*
English: Voriconazole (CYP3A4 inhibitor)
Slovenian: Vorikonazol (zaviralec CYP3A4)
English: Rapamune 0.5 mg is supplied to you as tan-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 0.5 mg” on one side.
Slovenian: Zdravilo Rapamune 0,5 mg so rumenorjave trikotne obložene tablete, ki so na eni strani označene z "RAPAMUNE 0,5 mg".
English: Venous thrombosis (including deep vein thrombosis)
Slovenian: Žilne bolezni hipertenzija, limfokela venska tromboza (vključno z globoko vensko trombozo)
English: Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.
Slovenian: Pri bolnikih z de novo presajenimi pljuči, ki so uporabljali sirolimus kot del imunosupresivnega zdravljenja so poročali o primerih dehiscence bronhialnih anastomoz, ki so bili večinoma smrtni.
English: Neutropaenia
Slovenian: Odmerjanje
English: Rapamune 2 mg coated tablets
Slovenian: Rapamune 2 mg obložene tablete sirolimus
English: Rapamune 2 mg is supplied to you as yellow to beige-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 2 mg” on one side.
Slovenian: Zdravilo Rapamune 2 mg so rumene do bež trikotne obložene tablete, ki so na eni strani označene z "RAPAMUNE 2 mg".
English: Protein in the urine, occasionally severe and associated with side effects, such as swelling Scarring in the kidney that may reduce kidney function Too much fluid collecting in the tissues due to irregular lymph function Low blood platelets, with or without rash (thrombocytopaenic purpura) Serious allergic reactions that can cause peeling of the skin Tuberculosis
Slovenian: Občasni:pojavijo se lahko pri največ 1 od 100 bolnikov rak limfnega tkiva (limfom/popresaditveni limfoproliferativni sindrom), kombinirano zmanjšanještevilardečih inbelih krvničk terkrvnihploščic, krvavitev iz pljuč, beljakovine v urinu,ki jih je včasih veliko, kar je povezanoz neželenimi učinki, na primer otekanjem, brazgotinjenjeledvic, ki lahko zmanjšadelovanje ledvic, prekomerno zastajanje tekočine v tkivih zaradi motenega odtoka limfe, nizka raven krvnih ploščicz izpuščajem ali brez njega(trombocitopenična purpura), resne alergijske reakcije, ki lahko povzročijo luščenje kože, tuberkuloza, okužba z virusom Epstein-Barr, infekcijska driska zaradi bakterije Clostridium difficile, resna okvara jeter.
English: Rapamune 0.5 mg coated tablets
Slovenian: Rapamune 0,5 mg tablete sirolimus
English: Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose.
Slovenian: Rapamune 2 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 214,4 mg saharoze.
English: Erythromycin (CYP3A4 inhibitor)
Slovenian: Eritromicin (zaviralec CYP3A4)
English: Rapamune 1 mg is supplied to you as white-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 1 mg” on one side.
Slovenian: Rapamune 1 mg obložene tablete bela trikotna obložena tableta, na eni strani označena z “RAPAMUNE 1 mg”
English: Rapamune 1 mg coated tablets
Slovenian: Rapamune 1 mg obložene tablete sirolimus
English: Also, when switching between different tablet strengths, verification of trough concentrations is recommended.
Slovenian: Preverjanje najmanjše koncentracije sirolimusa v krvi je priporočljivo tudi ob prehodu na drugo jakost tablet.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj, akne eksfoliativni dermatitis preobčutljivostni vaskulitis
English: NAME OF THE MEDICINAL PRODUCT Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets
Slovenian: Rapamune 0,5 mg obložene tablete Rapamune 1 mg obložene tablete Rapamune 2 mg obložene tablete
English: How to store Rapamune
Slovenian: Shranjevanje zdravila Rapamune
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose.
Slovenian: Rapamune 0,5 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 215,7 mg saharoze.
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose.
Slovenian: Rapamune 1 mg obložene tablete Ena tableta vsebuje 86,4 mg laktoze monohidrata in 215,8 mg saharoze.
English: Your doctor will need to perform blood tests to measure Rapamune concentrations.
Slovenian: Za določitev koncentracije zdravila Rapamune vas bo zdravnik napotil na krvne preiskave.
English: With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
Slovenian: Vzemite odmerno brizgo in jo namestite v odprtino nastavka.
English: 4.1 ng/mL (14 to 24 ng/mL) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
Slovenian: Vzdrževalno zdravljenje: Od 3. do 12. meseca po ukinitvi ciklosporina so bile pri bolnikih srednje vrednosti (10., 90. percentil) najmanjših koncentracij sirolimusa (izražene kot vrednosti kromatogafskega preskusa) 19 ± 4,1 ng/ml (od 14 do 24 ng/ml), dnevnih odmerkov pa 8,2 ± 4,2 mg (od 3,6 do 13,6 mg) (glejte poglavje 4.2).
English: The concomitant use of sirolimus with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced HUS/TTP/TMA.
Slovenian: Sočasna uporaba sirolimusa z zaviralcem kalcinevrina lahko poveča tveganje za hemolitično-uremični sindrom/trombotično trombocitopenično purpuro/trombotično mikroangiopatijo (HUS/TTP/TMA), izzvanimi z zaviralcem kalcinevrina.
English: Instructions on how to dilute Rapamune
Slovenian: Navodila za redčenje zdravila Rapamune
English: Contents of the pack and other information What Rapamune contains
Slovenian: Shranjevanje zdravila Rapamune Vsebina pakiranja in dodatne informacije
English: Sirolimus has been administered concurrently with the following agents in clinical studies: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, corticosteroids and cytotoxic antibodies.
Slovenian: Zdravila za zaviranje imunske odzivnosti (samo bolniki s presadki ledvic) V kliničnih študijah so sirolimus uporabljali sočasno z naslednjimi učinkovinami: takrolimus, ciklosporin, azatioprin, mikofenolat mofetil, kortikosteroidi in citotoksična protitelesa.
English: Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side.
Slovenian: Rapamune 2 mg obložene tablete rumena do bež trikotna obložena tableta, na eni strani označena z “RAPAMUNE 2 mg”
English: Hepatic failure*
Slovenian: odpoved jeter*
English: Each mL of Rapamune oral solution contains 1 mg of sirolimus.
Slovenian: 1 ml peroralne raztopine zdravila Rapamune vsebuje 1 mg sirolimusa.
English: Oral solution
Slovenian: peroralna uporaba
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu.
English: Tan-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 0.5 mg” on one side.
Slovenian: Rapamune 0,5 mg obložene tablete rumenorjava trikotna obložena tableta, na eni strani označena z “RAPAMUNE 0,5 mg”
English: (glass) in prefilled pen
Slovenian: injekcijski vložek (steklo) v napolnjenem injekcijskem peresniku
English: The mutual recognition procedure (UK/V/0355/001/MR) started on 26 November 2009.
Slovenian: Postopek medsebojnega priznavanja (UK/V/0355/001/MR) se je začel 26. novembra 2009.
English: The final opinion was converted into a Decision by the European Commission on 5 August 2011.
Slovenian: Končno mnenje je bilo dne 5. avgusta 2011 spremenjeno v odločbo Evropske komisije.
English: Oral explanations were given on 12 January 2011.
Slovenian: Ustna pojasnila so bila podana 12. januarja 2011.
English: Nine CVMP members expressed divergent positions, which are appended to the opinion.
Slovenian: Devet članov odbora CVMP je izrazilo različna stališča, ki so priložena mnenju odbora.
English: The Committee appointed Mr Johan Schefferlie as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Slovenian: Odbor je imenoval Johana Schefferliea kot poročevalca in Ruth Kearsley kot soporočevalko.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, the Netherlands, that the safety and efficacy of the product had not been sufficiently demonstrated.
Slovenian: Združeno kraljestvo je kot referenčna država članica 2. julija 2010 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Evropsko agencijo za zdravila zaradi zadržkov, ki jih je izpostavila zadevna država članica Nizozemska, in sicer da varnost in učinkovitost zdravila nista bili zadostno dokazani.
English: Written explanations were provided by the marketing authorisation holder on 13 September 2011 and 10 March 2011.
Slovenian: Pisna pojasnila je imetnik dovoljenja za promet z zdravilom predložil 13. septembra 2011 in 10. marca 2011.
English: The grounds for the lifting of the suspension of the marketing authorisation are provided in Annex III.
Slovenian: Razlogi za preklic začasnega umika dovoljenja za promet z zdravilom so navedeni v Prilogi III.
English: There was disagreement between the Reference Member State and Concerned Member State on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.
Slovenian: Referenčna država članica in zadevna država članica se nista strinjali glede dokazov biološke enakovrednosti in ustreznosti predlagane karence.
English: International non-proprietary name (inn): amoxicillin, clavulanic acid and prednisolone
Slovenian: Mednarodno nelastniško ime (INN): amoksicilin, klavulanska kislina in prednizolon
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Nisamox via a mutual recognition procedure in the Netherlands on the basis of the marketing authorisation granted by the United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom družba Norbrook Laboratories Ltd je predložila vlogo za zdravilo Nisamox prek postopka medsebojnega priznavanja na Nizozemskem na podlagi dovoljenja za promet z zdravilom, ki je bilo odobreno v Združenem kraljestvu.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Slovenian: Ker je Ruth Kearsley odstopila kot članica odbora CVMP, je bila na njeno mesto imenovana Helen Jukes, ki je prevzela soporočevalstvo.
English: The list of product names concerned is given in Annex I. The scientific conclusions and the grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation are provided in Annex II.
Slovenian: Seznam zadevnih imen zdravil je na voljo v Prilogi I. Znanstveni zaključki in podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom ter začasen umik obstoječega dovoljenja za promet z zdravilom sta na voljo v Prilogi II.
English: Nisamox Lactating Cow Intramammary Suspension (Nisamox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Slovenian: Zdravilo Nisamox Lactating Cow Intramammary Suspension (Nisamox) je intramamarna suspenzija, ki vsebuje amoksicilin, klavulansko kislino in prednizolon.
English: Nisamox is intended for the treatment of mastitis in lactating cows.
Slovenian: Zdravilo Nisamox je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije.
English: The application was submitted as a generic of the reference product, Synulox Lactating Cow Intramammary Suspension marketed by Pfizer Ltd.
Slovenian: Vloga je bila predložena kot vloga za generično zdravilo referenčnega zdravila Synulox Lactating Cow Intramammary Suspension, ki ga trži družba Pfizer Ltd.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Nisamox Lactating Cow Intramammary Suspension is
Slovenian: CVMP je zato po presoji ocene trenutno razpoložljivih podatkov, ki jo je opravil poročevalec, menil, da je razmerje med koristmi in tveganji za zdravilo Nisamox Lactating Cow Intramammary Suspension negativno, in 6. aprila 2011 sprejel mnenje, v katerem priporoča zavrnitev odobritve dovoljenja za promet z zdravilom in začasen umik obstoječega dovoljenja za promet.