FrancophonIA/ELRC3.0 huggingface dataset:
English: During the first 14 days of administration it is recommended that white blood cell count (preferably as a differential test) is conducted every second day; in patients with low baseline neutrophil levels (< 1000 neutrophils/µl), those who developed leucopenia during previous therapy with other myelotoxic substances, and those with renal impairment, this monitoring should be performed daily.
Slovenian: Bolnikom z majhnim izhodiščnim številom nevtrofilcev (< 1000 nevtrofilcev/µl), bolnikom, ki se jim je levkopenija pojavila med predhodnim zdravljenjem z drugimi mielotoksičnimi snovmi, in bolnikom z okvaro ledvic je treba krvno sliko kontrolirati vsak dan.
English: Ganciclovir may have a major influence on the ability to drive and use machines (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Ganciklovir ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji (glejte poglavje
English: None of the ganciclovir recipients had worsening hearing from baseline to 6 months, compared with 7 control patients (p < 0.01).
Slovenian: Sluh se od izhodišča do 6. meseca ni poslabšal pri nobenem prejemniku ganciklovirja, poslabšal pa se je pri 7 kontrolnih bolnikih
English: Reconstituted solutions of Cymevene range in colour from colourless to light yellow.
Slovenian: Barva rekonstituirane raztopine zdravila Cymevene je od brezbarvne do rumenkaste.
English: Back pain Myalgia Arthralgia Muscle spasms
Slovenian: bolečina v hrbtu mialgija artralgija spazmi mišic
English: days after discontinuation of the drug or dose reduction (see section 4.4).
Slovenian: Število celic se po navadi normalizira v 2 do 5 dneh po prenehanju uporabe zdravila ali zmanjšanju odmerka (glejte poglavje 4.4).
English: • low red blood cell counts - signs include feeling short of breath or tired, palpitations or pale skin.
Slovenian: • majhno število rdečih krvnih celic - med znaki so občutek kratke sape ali utrujenost, razbijanje srca (palpitacije) ali bledica kože,
English: Respiratory, thoracic and mediastinal disorders: Very common (≥ 1/10):
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: Zelo pogosti (≥ 1/10):
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Cymevene.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred začetkom uporabe zdravila Cymevene posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Maintenance therapy: 5 mg/kg given as an intravenous infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.
Slovenian: Vzdrževalno zdravljenje: 5 mg/kg v enourni intravenski infuziji enkrat na dan 7 dni na teden ali 6 mg/kg enkrat na dan 5 dni na teden.
English: Do not use Cymevene if you are breast-feeding.
Slovenian: Ne uporabljajte zdravila Cymevene, če dojite.
English: In a Phase III, randomised, controlled study, 100 neonates (3-33 days of age, median age 12 days) with severe symptomatic congenital CMV with CNS involvement, received either intravenous ganciclovir 6 mg/kg twice daily for 6 weeks (n = 48) or no antiviral treatment (n = 52).
Slovenian: V randomizirani, kontrolirani študiji III. faze je 100 novorojenčkov (starih od 3 do 33 dni, mediana starost 12 dni), ki so imeli hudo, simptomatsko kongenitalno citomegalovirusno bolezen z zajetostjo osrednjega živčevja, prejemalo bodisi intravenski ganciklovir 6 mg/kg dvakrat na dan 6 tednov
English: Dose modifications for patients with renal impairment:
Slovenian: Prilagoditev odmerka pri bolnikih z okvaro ledvic
English: - Gastrointestinal toxicity: abdominal pain, diarrhoea, vomiting - Neurotoxicity: generalised tremor, convulsion
Slovenian: - Gastrointestinalna toksičnost: bolečine v trebuhu, driska, bruhanje.
English: 0.625 mg/kg 3x/wk after haemodialysis
Slovenian: 0,625 mg/kg 3x/teden po hemodializi
English: INFORMATION IN BRAILLE Justification for not including Braille accepted [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: In a retrospective analysis, the safety and efficacy of ganciclovir was compared to valganciclovir in 92 paediatric kidney and/or liver transplant patients (7 months -18 years of age, median age 9 years).
Slovenian: 92 pediatričnih prejemnikih presajene ledvice in/ali jeter (starih od 7 mesecev do 18 let, mediana starost 9 let).
English: What Cymevene is used for
Slovenian: Za kaj uporabljamo zdravilo Cymevene
English: The mean systemic clearance ranged from 2.64 ± 0.38 mL/min/kg (N = 15) to 4.52 ± 2.79 mL/min/kg (N = 6) and renal clearance ranged from 2.57 ± 0.69 mL/min/kg (N = 15) to 3.48 ± 0.68 mL/min/kg (N = 20), corresponding to 90%−101% of administered ganciclovir.
Slovenian: 2,79 ml/min/kg (n = 6) in ledvični očistek je segal od 2,57 ± 0,69 ml/min/kg (n = 15) do 3,48 ±
English: Therefore, adverse drug reactions reported with intravenous or oral ganciclovir or with valganciclovir are included in the table of adverse reactions.
Slovenian: Zato so v preglednico neželenih učinkov vključeni neželeni učinki, zabeleženi z intravenskim in peroralnim ganciklovirjem ali z valganciklovirjem.
English: >70 mL/min 5.0 mg/kg q12h
Slovenian: > 70 ml/min 5,0 mg/kg na 12 ur
English: Driving and using machines
Slovenian: orodij ali strojev.
English: Each glass vial contains 500 mg ganciclovir as ganciclovir sodium.
Slovenian: Ena viala vsebuje 500 mg ganciklovirja v obliki natrijevega ganciklovirata.
English: • low white blood cell counts - with signs of infection such as sore throat, mouth ulcers or a fever
Slovenian: • majhno število belih krvnih celic - z znaki okužbe, npr. vnetjem žrela, razjedami v ustih ali zvišano telesno temperaturo
English: 0.625 mg/kg/day
Slovenian: 0,625 mg/kg/dan
English: Cymevene contains 43 mg of sodium in each 500mg dose.
Slovenian: En 500-mg odmerek zdravila Cymevene vsebuje 43 mg natrija.
English: Abdominal distention Mouth ulceration Pancreatitis
Slovenian: napihnjenost trebuha razjede v ustih pankreatitis
English: In patients with mild, moderate, and severe renal impairment, mean systemic clearances of 2.1, 1 and 0.3 mL/min/kg were observed.
Slovenian: Povprečni sistemski očistek je bil pri bolnikih z blago okvaro ledvic 2,1 ml/min/kg, z zmerno okvaro ledvic 1 ml/min/kg in s hudo okvaro ledvic 0,3 ml/min/kg.
English: The corresponding values of mean systemic clearance, mean renal clearance, and mean elimination half-life were 4.66 ± 1.72 mL/min/kg, 3.49 ± 2.40 mL/min/kg, and 2.49 ± 0.57 h, respectively.
Slovenian: Ustrezna vrednost povprečnega sistemskega očistka je bila 4,66 ± 1,72 ml/min/kg, povprečnega ledvičnega očistka 3,49 ± 2,40 ml/min/kg in povprečnega eliminacijskega razpolovnega časa 2,49 ± 0,57 ure.
English: Induction therapy: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 7 - 14 days.
Slovenian: Indukcijsko zdravljenje: 5 mg/kg v enourni intravenski infuziji vsakih 12 ur od 7 do 14 dni.
English: Add a volume of 100ml of diluent to the reconstituted solution.
Slovenian: Rekonstituirani raztopini dodajte 100 ml vehikla.
English: At intravenous doses of 5 and 10 mg/kg/day, an increase in the AUC of didanosine ranging from 38% to 67% has been observed.
Slovenian: AUC didanozina od 38 % do 67 %.
English: If you are not sure, talk to your doctor, pharmacist or nurse before using Cymevene.
Slovenian: Če ste negotovi, se pred začetkom uporabe zdravila Cymevene posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: If you are a woman who could get pregnant - use contraception while you are using Cymevene.
Slovenian: Če ste ženska v rodni dobi (tj. bi lahko zanosili), morate med zdravljenjem z zdravilom
English: Hypersensitivity to the active substance or valganciclovir or to any of the excipients listed in section
Slovenian: Preobčutljivost za zdravilno učinkovino, valganciklovir ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: What you need to know before you use Cymevene
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Cymevene Ne uporabljajte zdravila Cymevene:
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA {(Izmišljeno) ime in povezana imena (glejte Prilogo I) jakost farmacevtska oblika}
English: • your weight
Slovenian: • vaše starosti,
English: (listed in section 6)
Slovenian: (glejte poglavji 4.4 in 4.5).
English: prevention of CMV disease in patients with drug-induced immunosuppression (for example following organ transplantation or cancer chemotherapy).
Slovenian: (na primer po presaditvi organa ali kemoterapiji raka).
English: Estimated creatinine clearance can be calculated from serum creatinine using the following formulae: For males: (140 - age [years]) x (body weight [kg])
Slovenian: Za moške: (140 - starost [leta]) x (telesna masa [kg])
English: Blood creatinine increased
Slovenian: Očistek kreatinina
English: Induction dose
Slovenian: Indukcijski odmerek
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid direct contact with or inhalation of the powder contained in the vial or direct contact of the solution with skin or mucous membranes.
Slovenian: Izogibajte se neposrednemu stiku ali vdihavanju praška v viali in neposrednemu stiku raztopine s kožo ali sluznicami.
English: 1.25 mg/kg/day
Slovenian: 1,25 mg/kg/dan
English: How often you will have Cymevene and how long you keep using it will also vary.
Slovenian: Različna je tudi pogostnost uporabe zdravila Cymevene in trajanje zdravljenja z njim.
English: Dysphagia
Slovenian: dispneja
English: 50-69 mL/min 2.5 mg/kg q12h
Slovenian: 50-69 ml/min 2,5 mg/kg na 12 ur
English: Creatinine clearance renal decreased Renal impairment
Slovenian: zmanjšan očistek kreatinina okvara ledvic zvišanje kreatinina v krvi
English: • stomach pain, constipation, wind, indigestion
Slovenian: • izguba apetita, neješčnost ali hujšanje • bolečine v trebuhu, zaprtost, vetrovi, težave z želodcem
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri do 1 od 10 bolnikov
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
Slovenian: Ena viala vsebuje 500 mg ganciklovirja (v obliki natrijevega ganciklovirata).
English: How to store Cymevene
Slovenian: Shranjevanje zdravila Cymevene
English: Convulsions have been reported in patients taking imipenem-cilastatin and ganciclovir.
Slovenian: Pri bolnikih, ki so sočasno uporabljali imipenem-cilastatin in ganciklovir, so poročali o konvulzijah.
English: Cymevene should be used with caution in patients with pre-existing haematological cytopenia or a history of drug-related haematological cytopenia and in patients receiving radiotherapy.
Slovenian: bolnikih z anamnezo hematološke citopenije, povezane z zdravili, in bolnikih, ki prejemajo radioterapijo.
English: Common (≥ 1/100, <1/10):
Slovenian: Pogosti (≥ 1/100, < 1/10):
English: Musculo-skeletal and connective tissue disorders: Common (≥ 1/100, < 1/10):
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti (≥ 1/100, < 1/10):
English: Sodium chloride, dextrose 5%, Ringer's or lactated Ringer's solutions are determined chemically or physically compatible with Cymevene.
Slovenian: Ugotovljeno je, da so z zdravilom Cymevene kemijsko oz. fizikalno kompatibilne raztopina natrijevega klorida, 5-% raztopina dekstroze, Ringerjeva ali Ringer-laktatna raztopina.
English: Urinary tract infection
Slovenian: nevtropenija anemija
English: • back, chest or joint pain
Slovenian: • bolečine v hrbtu, prsih ali sklepih
English: • After that the doctor may prescribe the infusion once a day.
Slovenian: • Potem vam bo zdravnik morda predpisal infuzijo enkrat na dan. Osebe, ki imajo težave z ledvicami ali krvjo
English: In a prospective study, 36 severely immunocompromised paediatric patients (6 months - 16 years of age) with HIV and CMV infection received intravenous ganciclovir at a dose of 5 mg/kg per day for 2 days followed by oral ganciclovir for a median of 32 weeks.
Slovenian: let), okuženih s HIV in CMV, prejemalo intravenski ganciklovir v odmerku 5 mg/kg na dan 2 dni, nato pa peroralni ganciklovir mediano 32 tednov.
English: Cough
Slovenian: kašelj
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains ganciclovir sodium equivalent to 500 mg ganciclovir
Slovenian: Ena viala vsebuje natrijev ganciklovirat v količini, ki ustreza 500 mg ganciklovirja.
English: Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solution.
Slovenian: Ganciklovirja ne dajajte kot intramuskularno ali subkutano injekcijo, ker lahko to zaradi visokega pH
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.. Do not use bacteriostatic water for injections containing parabens (para-hydroxybenzoates) since these are incompatible with Cymevene and may cause precipitation.
Slovenian: Ne uporabljajte bakteriostatske vode za injekcije, ki vsebuje parabene (parahidroksibenzoate), ker ti niso inkompatibilni z zdravilom Cymevene in lahko povzročijo precipitacijo.
English: • what you are using the medicine for.
Slovenian: • vaše krvne slike, • tega, zakaj dobivate to zdravilo.
English: 2.5 mg/kg/day
Slovenian: 2,5 mg/kg/dan
English: Men If you are a man whose female partner could get pregnant - use a barrier method of contraception (such as condoms) while you are using Cymevene.
Slovenian: Če ste moški, čigar partnerka bi lahko zanosila, morate med zdravljenjem z zdravilom
English: Neutropenia Anaemia.
Slovenian: nevtropenijo, granulocitopenijo.
English: In a retrospective study, 122 paediatric liver transplantation recipients (16 days - 18 years of age, median age 2.5 years) received a minimum of 14 days of intravenous ganciclovir 5 mg/kg twice a day followed by pre-emptive CMV PCR monitoring.
Slovenian: mediana starost 2,5 leta) vsaj 14 dni prejemalo intravenski ganciklovir 5 mg/kg dvakrat na dan, nato pa preventivno deležnih spremljanja CMV z verižno reakcijo s polimerazo (PCR).
English: Immune system disorders: Uncommon (≥ 1/1000, < 1/100):
Slovenian: Bolezni imunskega sistema: Občasni (≥ 1/1.000, < 1/100):
English: • low red blood cell counts - signs include feeling short of breath or tired, palpitations or pale skin
Slovenian: • majhno število rdečih krvnih celic - med znaki so občutek kratke sape ali utrujenost,
English: Cellulitis
Slovenian: Trombocitopenija
English: Increased haematological monitoring may be warranted in patients with renal impairment.
Slovenian: Bolniki z okvaro ledvic lahko potrebujejo intenzivnejši hematološki nadzor.
English: • stomach pain
Slovenian: • oteklost trebuha
English: You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Cymevene.
Slovenian: izgubite lahko ravnotežje ali se vam pojavijo napadi krčev.
English: By one year after baseline, 5/24 ganciclovir recipients and 13/19 control patients had worsening hearing (p < 0.01).
Slovenian: Do enega leta po izhodišču je imelo poslabšanje sluha 5 od 24 prejemnikov ganciklovirja in
English: Retinal detachment
Slovenian: Odstop mrežnice
English: 5.0 mg/kg/day
Slovenian: 5,0 mg/kg/dan
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common: may affect more than 1 in 10 people
Slovenian: Zdravniku, farmacevtu ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov:
English: Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow depression have been observed in patients treated with ganciclovir.
Slovenian: Huda levkopenija, nevtropenija, anemija, trombocitopenija ali pancitopenija
English: Agranulocytosis* Aplastic anaemia* Granulocytopenia*
Slovenian: agranulocitoza*
English: Gastrointestinal disorders: Very common (≥ 1/10):
Slovenian: Bolezni prebavil: Zelo pogosti (≥ 1/10):
English: Dysgeusia (taste disturbance) Hypoaesthesia
Slovenian: glavobol nespečnost dizgevzija (motnja okušanja) hipestezija parestezije periferna nevropatija konvulzije omotica
English: Rare (≥ 1/10000, < 1/1000)
Slovenian: Redki (≥ 1/10.000, < 1/1.000):
English: Metabolic and nutrition disorders: Common (≥ 1/100, < 1/10):
Slovenian: Presnovne in prehranske motnje: Pogosti (≥ 1/100, < 1/10):
English: Twenty-one of 25 ganciclovir recipients had improved hearing or maintained normal hearing from baseline to 6 months compared with 10/17 control patients (84% and 59%, respectively p = 0.06).
Slovenian: (84 %) in pri 10 od 17 kontrolnih bolnikov (59 %) (p = 0,06).
English: Skin and subcutaneous tissues disorders: Common (≥ 1/100, < 1/10):
Slovenian: Bolezni kože in podkožja Pogosti (≥ 1/100, < 1/10):
English: Elimination
Slovenian: UPORABO
English: Uncommon (≥ 1/1000, < 1/100):
Slovenian: Občasni (≥ 1/1000, < 1/100):
English: Psychiatric disorders: Common (≥ 1/100, < 1/10):
Slovenian: Infekcijske in parazitske bolezni: Pogosti (≥ 1/100, < 1/10):
English: • flucytosine, amphotericin B - used for fungal infections,
Slovenian: • pentamidin - uporablja se za zdravljenje zajedalskih (parazitskih) ali pljučnih okužb, • flucitozin, amfotericin B - uporabljata se za zdravljenje glivičnih okužb,
English: If you use more Cymevene than you should
Slovenian: Če ste prenehali uporabljati zdravilo Cymevene
English: • changes to the way things taste
Slovenian: • spremenjeno zaznavanje okusov
English: Mycophenolate mofetil, stavudine, trimethoprim and zidovudine No significant pharmacokinetic interactions were observed when ganciclovir was administered in combination with either: mycophenolate mofetil, stavudine, trimethoprim or zidovudine.
Slovenian: Če je bil ganciklovir uporabljen v kombinaciji z mofetilmikofenolatom, stavudinom, trimetroprimom ali zidovudinom, niso ugotovili pomembnih farmakokinetičnih medsebojnih delovanj.
English: In a randomised, controlled study, 100 neonates (≤1 month of age) with symptomatic congenital CMV
Slovenian: V randomizirani, kontrolirani študiji je 100 novorojenčkov (starih ≤ 1 mesec) s simptomatsko kongenitalno citomegalovirusno boleznijo z zajetostjo osrednjega živčevja 6 tednov prejemalo intravenski ganciklovir 6 mg/kg na 12 ur ali nobenega zdravljenja.
English: Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions (see section 4.8).
Slovenian: (~11) raztopin ganciklovirja povzroči hudo draženje tkiva (glejte poglavje 4.8).
English: Tabulated list of adverse reactions Infections and infestations:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta:
English: Reproductive system and breast disorders: Uncommon (≥ 1/1000, < 1/100):
Slovenian: Motnje reprodukcije in dojk: Občasni (≥ 1/1.000, < 1/100):
English: Male infertility
Slovenian: moška neplodnost
English: • uneven heartbeat
Slovenian: • neenakomerno bitje srca
English: Only limited data are available in neonates or infants with HIV/AIDS or symptomatic congenital CMV infection treated with valganciclovir or ganciclovir, however the safety profile appears to be consistent with the known safety profile of valganciclovir/ganciclovir.
Slovenian: O novorojenčkih ali dojenčkih s HIV/AIDSom ali simptomatsko prirojeno citomegalovirusno okužbo,
English: Abdominal pain Abdominal pain upper Constipation Flatulence
Slovenian: utrujenost zvišana telesna temperatura mrzlica bolečina bolečine v prsih splošno slabo počutje astenija reakcija na mestu injiciranja
English: General disorders and administration site conditions: Common (≥ 1/100, < 1/10):
Slovenian: Splošne težave in spremembe na mestu aplikacije: Pogosti (≥ 1/100, < 1/10):
English: ganciclovir, some with fatal outcomes, have been received from clinical trials and during post-marketing experience.
Slovenian: V kliničnih preskušanjih in med obdobjem po prihodu zdravila na trg so poročali o primerih prevelikega odmerjanja intravenskega ganciklovirja; nekateri od teh primerov so bili smrtni.
English: Based on the occurrence of aspermatogenesis at ganciclovir exposures below therapeutic levels in animal studies, it is considered likely that ganciclovir may cause temporary or permanent inhibition of human spermatogenesis (see section 4.4).
Slovenian: Zato je verjetno, da lahko ganciklovir povzroči prehodno ali trajno zavrtje spermatogeneze pri človeku (glejte poglavje 4.4).
English: • stomach pain, diarrohea or being sick
Slovenian: • bolečine v trebuhu, driska ali slabost v želodcu • tresenje ali napadi krčev
English: Talk to your doctor, pharmacist or nurse before using Cymevene if:
Slovenian: Pred začetkom uporabe zdravila Cymevene se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Visual impairment Conjunctivitis
Slovenian: okvara vida konjunktivitis
English: 500 mg
Slovenian: 10 mg/ml.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: - Pre-emptive therapy:
Slovenian: - Preventivno zdravljenje:
English: Vascular disorders: Uncommon (≥ 1/1000, < 1/100):
Slovenian: Žilne bolezni: Občasni (≥ 1/1.000, < 1/100):
English: • problems swallowing
Slovenian: • težave s požiranjem
English: • fits
Slovenian: • gluhost
English: A decision on this opinion was issued by the European Commission on 20/08/2015.
Slovenian: Evropska komisija je izdala odločbo o tem mnenju dne 20/08/2015.
English: Amoxil is marketed in the following EU Member States: Belgium, Cyprus, France, Greece, Ireland, Latvia, Lithuania, Luxembourg, Malta, Portugal, Spain and the United Kingdom.
Slovenian: Zdravilo Amoxil se trži v naslednjih državah članicah EU: v Belgiji, na Cipru, v Franciji, Grčiji, na Irskem, v Latviji, Litvi, Luksemburgu, na Malti, Portugalskem, v Španiji in Združenem kraljestvu.
English: Doses range from 250 mg to 2 g two or three times a day for adults and children weighing more than 40 kilograms, and from 20 to 200 mg per kilogram per day for children weighing less than 40 kilograms.
Slovenian: Razpon odmerkov pri odraslih in otrocih s telesno maso, večjo od 40 kilogramov, je od 250 mg do 2 g dva ali trikrat na dan, pri otrocih s telesno maso, manjšo od 40 kilogramov, pa od 20 do 200 mg na kilogram.
English: Amoxil has been authorised in the EU via national procedures.
Slovenian: Zdravilo Amoxil je bilo v EU odobreno po nacionalnih postopkih.
English: Why was Amoxil reviewed?
Slovenian: Zakaj je bilo zdravilo Amoxil pregledano?
English: On 25 June 2015, the European Medicines Agency completed a review of Amoxil.
Slovenian: Evropska agencija za zdravila je 25. junija 2015 zaključila pregled zdravila Amoxil.
English: These formulations can be used to treat adults and children with the following bacterial infections:
Slovenian: Te formulacije se lahko uporabljajo pri odraslih in otrocih za zdravljenje naslednjih bakterijskih okužb:
English: Amoxil is an antibiotic used to treat a wide range of bacterial infections.
Slovenian: Zdravilo Amoxil je antibiotik, ki se uporablja za zdravljenje širokega razpona bakterijskih okužb.
English: The company that markets these medicines is GlaxoSmithKline.
Slovenian: Ta zdravila trži farmacevtska družba GlaxoSmithKline.
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), and 4.8 (side effects).
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (posebna opozorila in previdnostni ukrepi), 4.6 (plodnost, nosečnost in dojenje) ter 4.8 (neželeni učinki).
English: The CHMP also agreed that Amoxil should no longer be used to treat female genital infections, because not enough clinical data are available to support this indication.
Slovenian: Odbor CHMP je prav tako sklenil, da se zdravilo Amoxil ne sme več uporabljati za zdravljenje okužb ženskih spolovil, saj ni dovolj razpoložljivih kliničnih podatkov, ki bi podprli to indikacijo.