FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean values for the steady state volume of distribution (0.7 L/kg) and systemic clearance (3.15 ± 0.47 mL/min/kg at 4 mg/kg and 3.55 ± 0.35 mL/min/kg at 6 mg/kg) were comparable to those observed in adults with normal renal function.
Croatian: (3,15 ± 0,47 ml/min/kg pri dozi od 4 mg/kg i 3,55 ± 0,35 ml/min/kg pri dozi od 6 mg/kg) bila je usporediva s onom primijećenom u odraslih s normalnom bubrežnom funkcijom.
English: Sodium chloride, dextrose 5%, Ringer's or lactated Ringer's solutions are determined chemically or physically compatible with Cymevene.
Croatian: Utvrđeno je da su otopina natrijeva klorida od 0,9%, otopina glukoze od 5%, Ringerova otopina i Ringerova otopina s laktatom kemijski ili fizikalno kompatibilne s lijekom Cymevene.
English: Neuropathy peripheral Convulsion
Croatian: hipoestezija parestezija periferna neuropatija konvulzije omaglica
English: See Serious side effects at the top of section 4 for more information.
Croatian: Za više informacija, pogledajte odlomak „Ozbiljne nuspojave“ na početku dijela 4.
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.
Croatian: Ne smije se primijeniti intramuskularnom niti supkutanom injekcijom jer to može dovesti do teške iritacije tkiva zbog visoke pH vrijednosti (~11) otopine ganciklovira.
English: For patients with severe leucopenia, neutropenia, anaemia and/or thrombocytopenia it is recommended to consider the use of treatment with haematopoietic growth factors and/or the interruption of ganciclovir therapy (see sections 4.2 and 4.8).
Croatian: U bolesnika u kojih se javi teška leukopenija, neutropenija, anemija i/ili trombocitopenija preporučuje se razmotriti liječenje hematopoetskim faktorima rasta i/ili prekid liječenja ganciklovirom (vidjeti dijelove
English: Patients with Renal Impairment Undergoing Haemodialysis
Croatian: Bolesnici s oštećenjem funkcije bubrega na hemodijalizi
English: Vials of Cymevene are supplied in packs of 1 or 5.
Croatian: Pakiranje sadrži 1 ili 5 bočica lijeka Cymevene.
English: Hypersensitivity to the active substance or valganciclovir or to any of the excipients listed in section
Croatian: Preosjetljivost na djelatnu tvar, valganciklovir ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • shaking or fits
Croatian: • tresavica ili napadaji
English: How to use Cymevene
Croatian: Kako primjenjivati Cymevene
English: Therefore, adverse drug reactions reported with intravenous or oral ganciclovir or with valganciclovir are included in the table of adverse reactions.
Croatian: Stoga su u tablicu nuspojava uključene nuspojave lijeka prijavljene kod primjene intravenskog ili peroralnog oblika ganciklovira kao i kod primjene valganciklovira.
English: - Prophylaxis:
Croatian: Profilaksa:
English: Reconstituted solutions of Cymevene range in colour from colourless to light yellow.
Croatian: Boja rekonstituirane otopine lijeka Cymevene može varirati od bezbojne do svijetložute.
English: - Induction treatment: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 1421 days.
Croatian: Uvodno liječenje: 5 mg/kg, primijenjeno intravenskom infuzijom u trajanju od jednog sata, svakih 12 sati tijekom 14 - 21 dana.
English: Precaution to be taken before handling or administering the medicinal product: Since ganciclovir is considered a potential teratogen and carcinogen in humans, caution should be taken in its handling (see section 6.6).
Croatian: Budući da se ganciklovir smatra potencijalno teratogenim i kancerogenim za ljude, pri rukovanju lijekom potreban je oprez (vidjeti dio 6.6).
English: • you are breast-feeding (see Breast-feeding subsection).
Croatian: • ako dojite (pogledajte odlomak „Dojenje“)
English: ganciclovir, some with fatal outcomes, have been received from clinical trials and during post-marketing experience.
Croatian: Prijave o predoziranju intravenski primijenjenim ganciklovirom prikupljene su tijekom kliničkih ispitivanja i iskustava nakon stavljanja lijeka u promet.
English: Ganciclovir should not be used concomitantly with imipenem-cilastatin unless the potential benefits outweigh the potential risks (see section 4.5).
Croatian: Ganciklovir se ne smije primjenjivati istodobno s imipenemom/cilastatinom, osim ako moguća korist nadilazi moguće rizike
English: The vial should be gently swirled in order to ensure complete wetting of the product.
Croatian: Bočicu treba lagano vrtjeti kako bi se sav sadržaj natopio.
English: Induction therapy: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 7 - 14 days.
Croatian: Uvodno liječenje: 5 mg/kg primijenjeno intravenskom infuzijom u trajanju od jednog sata, svakih 12 sati tijekom 7 - 14 dana.
English: Back pain Myalgia Arthralgia Muscle spasms
Croatian: bol u leđima mialgija artralgija spazmi mišića
English: The possibility of viral resistance should be considered in patients who repeatedly achieve a poor clinical response or experience continuous viral excretion during treatment.
Croatian: U bolesnika koji opetovano ostvaruju slab klinički odgovor ili stalno izlučuju virus tijekom liječenja treba razmotriti mogućnost virusne rezistencije.
English: Visual impairment Conjunctivitis
Croatian: poremećaj vida konjunktivitis
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.
Croatian: Odgovarajuća srednja vrijednost sistemskog klirensa iznosila je 4,66 ± 1,72 ml/min/kg, srednja vrijednost bubrežnog klirensa 3,49 ± 2,40 ml/min/kg, a srednji poluvijek eliminacije 2,49 ± 0,57 sati.
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.
Croatian: Pri intravenskoj primjeni u dozama od 5 i 10 mg/kg na dan primijećen je porast AUC-a
English: Abdominal pain Abdominal pain upper Constipation Flatulence
Croatian: mučnina povraćanje bol u abdomenu bol u gornjem dijelu abdomena konstipacija flatulencija disfagija dispepsija
English: Each glass vial contains 500 mg ganciclovir as ganciclovir sodium.
Croatian: Jedna staklena bočica sadrži 500 mg ganciklovira u obliku ganciklovirnatrija.
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.
Croatian: Terapija održavanja: 5 mg/kg primijenjeno intravenskom infuzijom u trajanju od jednog sata, jedanput dnevno tijekom 7 dana u tjednu ili 6 mg/kg jedanput dnevno tijekom 5 dana u tjednu.
English: You should not become pregnant while using this medicine.
Croatian: Ne smijete zatrudnjeti dok se liječite ovim lijekom jer bi on mogao naštetiti nerođenom djetetu.
English: • feeling tired, dizzy, weak or generally unwell
Croatian: • umor, omaglica, slabost, opće loše osjećanje
English: Please refer to the Summary of Product Characteristics for full prescribing information.
Croatian: Za cjelovite informacije o lijeku pročitajte Sažetak opisa svojstava lijeka.
English: • bacterial skin infection - signs include red, painful or swollen skin
Croatian: • gljivična infekcija kandidom i gljivična infekcija usta kandidom • bakterijska infekcija kože - znakovi uključuju crvenu, bolnu ili otečenu kožu
English: <To be completed nationally]
Croatian: <[Ispunjava država članica]>
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Cymevene.
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Cymevene.
English: days after discontinuation of the drug or dose reduction (see section 4.4).
Croatian: Broj stanica obično se normalizira unutar 2 do 5 dana nakon prekida primjene lijeka ili smanjenja doze (vidjeti dio 4.4).
English: You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Cymevene.
Croatian: Dok se liječite lijekom Cymevene, može se pojaviti pospanost, omaglica, smetenost ili drhtanje kao i gubitak ravnoteže ili napadaji.
English: 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.
Croatian: Daje se 5 mg/kg intravenskom infuzijom u trajanju od jednog sata, jedanput dnevno tijekom 7 dana u tjednu ili 6 mg/kg jedanput dnevno tijekom 5 dana u tjednu.
English: Do not use Cymevene if you are breast-feeding.
Croatian: Ne smijete primjenjivati Cymevene ako dojite.
English: Side effects in children and adolescents The following side effects are more likely in children:
Croatian: Sljedeće su nuspojave vjerojatnije u djece: • vrućica
English: The majority of the reports were either not associated with any adverse reactions, or included one or more of the adverse reactions listed below: - Haematological toxicity: myelosuppression including pancytopenia, medullary aplasia, leucopenia, neutropenia, granulocytopenia - Hepatotoxicity: hepatitis, liver function disorder - Renal toxicity: worsening of haematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine.
Croatian: neutropeniju, granulocitopeniju hepatotoksičnost: hepatitis, poremećaj jetrene funkcije bubrežna toksičnost: pogoršanje hematurije u bolesnika s postojećim oštećenjem bubrega, akutno zatajenje bubrega, povišena razina kreatinina gastrointestinalna toksičnost: bol u abdomenu, proljev, povraćanje neurotoksičnost: generalizirani tremor, konvulzije
English: >70 mL/min 5.0 mg/kg q12h
Croatian: >70 ml/min 5,0 mg/kg svakih 12 sati
English: Tabulated list of adverse reactions Infections and infestations:
Croatian: Opći poremećaji i reakcije na mjestu primjene:
English: Aseptic technique should be used throughout to reconstitute lyophilised Cymevene.
Croatian: Tijekom cijelog postupka rekonstitucije liofiliziranog lijeka Cymevene potrebno je primjenjivati aseptičnu tehniku.
English: Decreased appetite Anorexia
Croatian: smanjen tek anoreksija smanjenje tjelesne težine
English: During intermittent haemodialysis, estimates for the clearance of ganciclovir ranged from 42−92 mL/min, resulting in intra-dialytic half-lives of 3.3−4.5 hours.
Croatian: 92 ml/min, što rezultira poluvijekom od 3,3 do 4,5 sati u razdobljima između dijaliza.
English: Convulsions have been reported in patients taking ganciclovir and imipenem−cilastatin concomitantly.
Croatian: U bolesnika koji su istodobno uzimali ganciklovir i imipenem/cilastatin prijavljene su konvulzije.
English: • problems swallowing
Croatian: • otežano gutanje
English: Common (≥ 1/100, <1/10):
Croatian: Često (≥ 1/100 i < 1/10):
English: 1.25 mg/kg/day
Croatian: 1,25 mg/kg/dan
English: As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
Croatian: Budući da fosforilacija uvelike ovisi o virusnoj kinazi,
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.
Croatian: Izbjegavajte izravan kontakt ili udisanje praška u bočici ili izravan kontakt otopine s kožom i sluznicama.
English: Respiratory, thoracic and mediastinal disorders: Very common (≥ 1/10):
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često (≥ 1/10):
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.
Croatian: Ne smije se koristiti bakteriostatska voda za injekcije koja sadrži parabene (parahidroksibenzoate) jer oni nisu kompatibilni s lijekom Cymevene i mogu uzrokovati precipitaciju.
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).
Croatian: medijan dobi 12 dana) s teškom simptomatskom kongenitalnom CMV bolešću koja je zahvaćala SŽS primalo je intravenski ganciklovir u dozi od 6 mg/kg dvaput na dan tijekom 6 tjedana (n = 48) ili nije primalo nikakvo antivirusno liječenje (n = 52).
English: Dysphagia
Croatian: dispneja
English: • uneven heartbeat
Croatian: • neravnomjerni otkucaji srca
English: • stomach pain, constipation, wind, indigestion
Croatian: • bolovi u trbuhu, proljev ili povraćanje
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Cymevene.
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego primijenite Cymevene.
English: Convulsions have been reported in patients taking imipenem-cilastatin and ganciclovir.
Croatian: Primjena s drugim lijekovima U bolesnika koji su uzimali imipenem/cilastatin i ganciklovir prijavljene su konvulzije.
English: While you are using Cymevene your doctor will do regular blood tests.
Croatian: Dok se liječite lijekom Cymevene, liječnik će redovito obavljati krvne pretrage kako bi provjerio je li doza koju primate odgovarajuća doza za Vas.
English: <10 mL/min 1.25 mg/kg 3x/wk after haemodialysis
Croatian: 0,625 mg/kg/dan <10 ml/min 1,25 mg/kg 3 x tjedno nakon hemodijalize 0,625 mg/kg 3 x tjedno nakon hemodijalize
English: Reproductive system and breast disorders: Uncommon (≥ 1/1000, < 1/100):
Croatian: Poremećaji reproduktivnog sustava i dojki Manje često (≥ 1/1000 i < 1/100):
English: 2.5 mg/kg/day
Croatian: 2,5 mg/kg/dan
English: 50-69 mL/min 2.5 mg/kg q12h
Croatian: 50-69 ml/min 2,5 mg/kg svakih 12 sati
English: Depression Anxiety
Croatian: depresija koštane srži
English: Musculo-skeletal and connective tissue disorders: Common (≥ 1/100, < 1/10):
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često (≥ 1/100 i < 1/10):
English: • low white blood cell counts.
Croatian: • bolovi u trbuhu • nizak broj bijelih krvnih stanica
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Croatian: 14. NAČIN IZDAVANJA LIJEKA [Ispunjava država članica]
English: 5.0 mg/kg/day
Croatian: 5,0 mg/kg/dan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
Croatian: 1 bočica sadrži 500 mg ganciklovira (u obliku ganciklovirnatrija).
English: Using this medicine
Croatian: Primjena lijeka
English: How often you will have Cymevene and how long you keep using it will also vary.
Croatian: Učestalost primjene lijeka Cymevene i trajanje liječenja također se razlikuju.
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).
Croatian: 92 pedijatrijska primatelja presatka bubrega i/ili jetre (u dobi od 7 mjeseci do 18 godina, medijan dobi 9 godina).
English: 5 vials
Croatian: 1 bočica 5 bočica
English: Cymevene contains the active substance ganciclovir.
Croatian: Što je Cymevene Cymevene sadrži djelatnu tvar ganciklovir, koji se ubraja u skupinu antivirusnih lijekova.
English: Agranulocytosis* Aplastic anaemia* Granulocytopenia*
Croatian: agranulocitoza*
English: Neutropenia Anaemia.
Croatian: neutropenija anemija
English: Estimated creatinine clearance can be calculated from serum creatinine using the following formulae: For males: (140 - age [years]) x (body weight [kg])
Croatian: Procijenjeni klirens kreatinina može se izračunati na temelju vrijednosti serumskog kreatinina prema sljedećoj formuli:
English: Viral resistance
Croatian: Rezistencija virusa
English: Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow depression have been observed in patients treated with ganciclovir.
Croatian: U bolesnika liječenih ganciklovirom primijećene su teška leukopenija, neutropenija, anemija, trombocitopenija, pancitopenija i depresija koštane srži.
English: Cellulitis
Croatian: Trombocitopenija
English: Nausea
Croatian: kašalj
English: Retinal detachment
Croatian: Prijavljivanje nuspojava
English: Common: may affect up to 1 in 10 people
Croatian: Česte: mogu se javiti u do 1 na 10 osoba • glavobolja
English: Psychiatric disorders: Common (≥ 1/100, < 1/10):
Croatian: Infekcije i infestacije: Često (≥ 1/100 i < 1/10):
English: Gastrointestinal disorders: Very common (≥ 1/10):
Croatian: Poremećaji probavnog sustava Vrlo često (≥ 1/10):
English: disease with CNS involvement received 6 weeks of intravenous ganciclovir 6 mg/kg every 12 hours or no treatment.
Croatian: U randomiziranom kontroliranom ispitivanju, 100 novorođenčadi (u dobi od ≤ 1 mjeseca) sa simptomatskom kongenitalnom CMV bolešću koja je zahvaćala SŽS primalo je 6-tjedno liječenje intravenskim ganciklovirom u dozi od 6 mg/kg svakih 12 sati ili nije primalo nikakvo liječenje.
English: - Gastrointestinal toxicity: abdominal pain, diarrhoea, vomiting - Neurotoxicity: generalised tremor, convulsion
Croatian: - hematološka toksičnost: mijelosupresija, uključujući pancitopeniju, medularnu aplaziju, leukopeniju,
English: Male infertility
Croatian: srčane aritmije
English: • back, chest or joint pain
Croatian: • bolovi u leđima, prsnom košu ili zglobovima
English: Uncommon (≥ 1/1000, <1/100):
Croatian: Manje često (≥ 1/1000 i < 1/100):
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
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite neku od sljedećih nuspojava:
English: • you have low white blood cell, red blood cell or platelet counts - your doctor will do blood tests before you start and during your treatment
Croatian: - Vaš će liječnik provesti krvne pretrage prije početka liječenja i tijekom liječenja
English: Fatigue Pyrexia Chills Pain Chest pain Malaise Asthenia Injection site reaction Note: Valganciclovir is a pro-drug of ganciclovir, and adverse reactions associated with valganciclovir can be expected to occur with ganciclovir.
Croatian: Napomena: Valganciklovir je predlijek ganciklovira pa se nuspojave povezane s primjenom valganciklovira mogu očekivati i kod primjene ganciklovira.
English: • urine infection - signs include fever, passing urine more often, pain when passing urine
Croatian: • bolovi u trbuhu, zatvor, vjetrovi i probavne tegobe infekcija mokraćnih putova - znakovi uključuju vrućicu, učestalo mokrenje, bol pri mokrenju
English: Probenecid
Croatian: • proljev
English: • feeling or being sick
Croatian: • mučnina ili povraćanje
English: In a randomised, controlled study, 100 neonates (≤1 month of age) with symptomatic congenital CMV
Croatian: U randomiziranom kontroliranom ispitivanju faze III, 100 novorođenčadi (u dobi od 3 do 33 dana,
English: The duration of prophylaxis is based on the risk of CMV disease, local treatment guidelines should be consulted.
Croatian: CMV bolesti; potrebno je slijediti lokalne smjernice za liječenje.
English: Dyspepsia
Croatian: proljev
English: Creatinine clearance renal decreased Renal impairment
Croatian: smanjen bubrežni klirens kreatinina poremećaj funkcije bubrega povišene razine kreatinina u krvi
English: • hair loss
Croatian: • nedostatak zraka
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Potreban je oprez pri rukovanju lijekom Cymevene
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: The areas harmonised include:
Croatian: Područja koja se moraju uskladiti uključuju:
English: EMA/421017/2015 Rev 1 EMEA/H/A-30/1372
Croatian: EMA/421017/2015 Rev 1 EMEA/H/C/-30/1372
English: A decision on this opinion was issued by the European Commission on 20/08/2015.
Croatian: Europska Komisija donijela je odluku o ovom mišljenju 20/08/2015.
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.
Croatian: Raspon doze je između 250 mg i 2 g dva do tri puta na dan za odrasle osobe i djecu koja teže više od 40 kilograma, te od 20 do 200 mg po kilogramu po danu za djecu koja teže manje od 40 kilograma.
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.
Croatian: Amoxil je stavljen u promet u sljedećim državama članicama EU-a: Belgiji, Cipru, Francuskoj, Grčkoj, Irskoj, Latviji, Litvi, Luksemburgu, Malti, Portugalu, Španjolskoj i Ujedinjenoj Kraljevini.
English: What is Amoxil?
Croatian: Što je Amoxil?
English: Amoxil has been authorised in the EU via national procedures.
Croatian: Amoxil je odobren u EU-u nacionalnim postupcima.
English: Why was Amoxil reviewed?
Croatian: Zašto je Amoxil pregledan?
English: It works by attaching to proteins on the surface of bacteria.
Croatian: Djeluje vezujući se na proteine na površini bakterija.
English: In some countries it is available under the trade names Amoxicilline Biogaran and Clamoxyl.
Croatian: U pojedinim je državama dostupan pod trgovačkim nazivima Amoxicilline Biogaran i Clamoxyl.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Croatian: Time sprječava bakterije u izgradnji staničnih stjenki, te ih naposljetku ubija.
English: The company that markets these medicines is GlaxoSmithKline.
Croatian: Tvrtka koja stavlja ove lijekove u promet je GlaxoSmithKline.
English: These formulations can be used to treat adults and children with the following bacterial infections:
Croatian: Te formulacije mogu se koristiti za liječenje odraslih osoba i djece sa sljedećim bakterijskim infekcijama:
English: Amoxil is an antibiotic used to treat a wide range of bacterial infections.
Croatian: Amoxil je antibiotik koji se koristi za liječenje širokog spektra bakterijskih infekcija.
English: • Bacteraemia (bacteria detected in the blood) that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Croatian: • bakteremija (bakterije otkrivena u krvi) koja nastupa zajedno s, ili se sumnja da je povezana s, bilo kojom prethodno navedenom infekcijom.
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).
Croatian: Odbor je također uskladio druge odjeljke sažetka opisa svojstava lijekova, uključujući odjeljke 4.4. (Posebna upozorenja i mjere opreza pri uporabi), 4.6. (Plodnost, trudnoća i dojenje) i 4.8. (Nuspojave).
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.
Croatian: CHMP je također suglasan da se Amoxil ne smije više primjenjivati u liječenju ženskih genitalnih infekcija jer nije dostupno dovoljno kliničkih podataka koji bi podržali tu indikaciju.
English: Questions and answers on Amoxil and associated names (amoxicillin)
Croatian: Pitanja i odgovori o lijeku Amoxil i povezanim nazivima (moksicilin)
English: This is either because antibiotics are no longer used to treat these conditions, or because other antibiotics have been shown to be more effective than amoxicillin.
Croatian: Razlog je tomu ili činjenica da se antibiotici više ne koriste za liječenje navedenih stanja ili činjenica da su se drugi antibiotici pokazali djelotvornijima od amoksicilina.