FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Fi studju retrospettiv, 122 tifel u tifla riċevituri ta' trapjant tal-fwied (età ta' 16-il jum - 18-il sena, età medjana ta' 2.5 snin) irċevew minimu ta' 14-il jum ta' ganciclovir fil-vini 5 mg/kg darbtejn kuljum segwit minn monitoraġġ preventiv ta' CMV permezz ta' PCR. Tlieta u erbgħin pazjent kienu meqjusa li kellhom riskju għoli ta' CMV u 79 kellhom normali.
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.
Maltese: Hija disponibbli dejta limitata biss fi trabi tat-twelid jew trabi bl-HIV/AIDS jew b'infezzjoni konġenitali sintomatika ta' CMV kkurati b'valganciclovir jew ganciclovir, madankollu l-profil ta' sigurtà jidher li huwa konsistenti mal-profil ta' sigurtà magħruf ta' valganciclovir/ganciclovir.
English: Probenecid given with oral ganciclovir resulted in statistically decreased renal clearance of ganciclovir, and led to clinically significant increased exposure.
Maltese: Probenecid mogħti ma' ganciclovir orali wassal għal tneħħija statistikament imnaqqsa ta' ganciclovir mill-kliewi, u wassal għal żieda klinikament sinifikanti fl-espożizzjoni.
English: The risk of neutropenia is not predictable on the basis of the number of neutrophils before treatment.
Maltese: Newtropenija Ir-riskju ta' newtropenija mhuwiex prevedibbli fuq il-bażi tan-numru ta' newtrofili qabel it-trattament.
English: Ganciclovir is not metabolised to a significant extent.
Maltese: Ganciclovir ma jiġix metabolizzat b'mod sinifikanti.
English: What Cymevene is
Maltese: X'inhu 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.
Maltese: 3.48 ± 0.68 mL/min/kg (N = 20), li tikkorrispondi għal 90%−101% ta' ganciclovir mogħti.
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).
Maltese: Ibbażat fuq lokkorrenza ta' aspermatoġenesi f'esponimenti ta' ganciclovir taħt il-livelli terapewtiċi fi studji fuq lannimali, huwa meqjus probabbli li ganciclovir jista' jikkawża inibizzjoni temporanja jew permanenti tal-ispermatoġenesi fil-bniedem (ara sezzjoni 4.4).
English: Men must be advised to practice barrier contraception during treatment, and for at least 90 days thereafter, unless it is certain that the female partner is not at risk of pregnancy (see sections 4.6, 4.8 and 5.3).
Maltese: L-irġiel għandhom jingħataw parir biex jużaw kontraċezzjoni forma ta' barriera waqt it-trattament, u għal mill-inqas 90 jum wara, sakemm ma jkunx ċert li s-sieħba ma tkunx f'riskju ta' tqala (ara sezzjonijiet 4.6, 4.8 u 5.3).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
Maltese: Kull kunjett fih 500 mg ta' ganciclovir (bħala ganciclovir sodium).
English: • you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine
Maltese: • inti allerġiku għal ganciclovir, valganciclovir jew għal xi sustanza oħra ta' din il-mediċina
English: Of these, 25 received ganciclovir and 17 received no treatment.
Maltese: Minn dawn, 25 irċevew ganciclovir u 17 ma rċevew l-ebda trattament.
English: * The frequencies of these adverse reactions are derived from post-marketing experience, all other frequency categories are based on the frequency recorded in clinical trials.
Maltese: * Il-frekwenzi ta' dawn ir-reazzjonijiet avversi huma derivati minn esperjenza ta' wara t-tqegħid fis-suq, il kategoriji ta' frekwenza l-oħra kollha huma bbażati fuq il-frekwenza rreġistrata fi provi kliniċi.
English: • hallucinations - hearing or seeing things that are not real.
Maltese: • raxx • alluċinazzjonijiet - tisma' jew tara affarijiet li mhumiex reali.
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).
Maltese: III, randomised u kkontrollat, 100 tarbija tat-twelid (età ta' 3-33 jum, età medjana ta' 12-il jum) b'CMV konġenitali sintomatika severa b'involviment tas-CNS, irċevew ganciclovir fil-vini
English: Ganciclovir IV
Maltese: • il-piż tiegħek
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.
Maltese: Terapija ta' manteniment: 5 mg/kg mogħtija bħala infużjoni fil-vini fuq medda ta' siegħa, darba kuljum 7 ijiem fil-ġimgħa jew 6 mg/kg darba kuljum 5 ijiem fil-ġimgħa.
English: In patients with normal renal function, more than 90% of the intravenously administered ganciclovir dose is recovered unchanged in the urine within 24 hours.
Maltese: F'pazjenti b'funzjoni renali normali, aktar minn 90% tad-doża mogħtija fil-vini ta' ganciclovir tiġi rkuprata mhux mibdula flawrina fi żmien 24 siegħa.
English: Immune system disorders: Uncommon (≥ 1/1000, < 1/100):
Maltese: Disturbi fis-sistema immuni: Mhux komuni (≥ 1/1000, < 1/100):
English: Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia.
Maltese: Pazjenti b'għadd baxx ta' plejtlits fil-linja bażi (< 100,000/ml) għandhom riskju akbar li jiżviluppaw tromboċitopenija.
English: Mean Ganciclovir Plasma half-life (hours)
Maltese: Half-life Medja ta' Ganciclovir fil-Plasma
English: Formal safety studies with ganciclovir have not been conducted in children under 12 years of age but based on experience with valganciclovir, a pro-drug of ganciclovir, the overall safety profile of the active drug is similar in paediatric and adult patients.
Maltese: Ma twettqux studji formali dwar is-sigurtà b'ganciclovir fi tfal ta' età inqas minn 12-il sena iżda abbażi ta' esperjenza b'valganciclovir, pro-droga ta' ganciclovir, il-profil globali tas-sigurtà tal mediċina attiva huwa simili f'pazjenti pedjatriċi u adulti.
English: - Pre-emptive therapy:
Maltese: Disturbi gastro-intestinali:
English: Uncommon (≥ 1/1000, <1/100):
Maltese: Mhux komuni (≥ 1/1000, < 1/100):
English: Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with AIDS (see section 4.4).
Maltese: Pazjenti b'immunosoppressjoni jatroġenika minħabba trattament b'mediċini immunosoppressivi għandhom riskju akbar ta' tromboċitopenija minn pazjenti bl-AIDS (ara sezzjoni 4.4).
English: Ganciclovir was associated with a decrease in the detection of CMV by culture or polymerase chain reaction.
Maltese: permezz ta' koltura jew polymerase chain reaction.
English: • stomach pain, constipation, wind, indigestion
Maltese: • uġigħ fl-istonku, stitikezza, gass, indiġestjoni
English: • fits
Maltese: • truxija
English: In animal studies ganciclovir impaired fertility in male and female mice.
Maltese: Fi studji fuq l-annimali ganciclovir impedixxa l-fertilità fi ġrieden maskili u femminili.
English: Dizziness
Maltese: Ġestjoni
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.
Maltese: newtropenija, granuloċitopenija - Tossiċità fil-fwied: epatite, disturb fil-funzjoni tal-fwied - Tossiċità fil-kliewi: aggravar ta' ematurja f'pazjent b'indeboliment tal-kliewi eżistenti minn qabel,
English: • hydroxyurea - used for a problem called polycythemia, sickle cell disease and cancer,
Maltese: • hydroxyurea - użat għal problema imsejjħa poliċitemija, għall-marda taċ-ċellula forma ta' minġel u għall-kanċer,
English: Breastfeeding
Maltese: Panċitopenija
English: • uneven heartbeat
Maltese: • diffikultà biex torqod
English: Nausea
Maltese: Konvulżjoni
English: Cymevene and associated names (see Annex I) 500 mg powder for concentrate for solution for infusion.
Maltese: Cymevene u ismijiet assoċjati (ara Anness I) 500 mg trab għal konċentrat għal soluzzjoni għallinfużjoni.
English: Dysgeusia (taste disturbance) Hypoaesthesia
Maltese: TWISSIJA(IET) SPEĊJALI
English: Neuropathy peripheral Convulsion
Maltese: Newropatija periferali
English: Excipients
Maltese: Ipoestesija
English: • eye infection (conjunctivitis)
Maltese: • infezzjoni fl-għajn (konġuntivite)
English: Macular oedema Retinal detachment Vitreous floaters Eye pain
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW PARTI
English: LIST OF EXCIPIENTS This medicinal product contains sodium.
Maltese: TA' EĊĊIPJENTI Dan il-prodott mediċinali fih sodium.
English: How to store Cymevene
Maltese: X'fih Cymevene
English: Cymevene should be administered as recommended in section 4.2 to reduce the risk of local tissue irritation.
Maltese: Cymevene għandu jingħata kif rakkomandat fis-sezzjoni 4.2 biex jitnaqqas ir-riskju ta' irritazzjoni lokali fittessut.
English: The pharmacokinetics of intravenous ganciclovir in infants and children were consistent with those observed in neonates and adults.
Maltese: Il-farmakokinetika ta' ganciclovir fil-vini fi trabi u tfal kienet konsistenti ma' dik osservata fi trabi tat-twelid u adulti.
English: Viruses containing mutations in the UL97 gene are resistant to ganciclovir alone, whereas viruses with mutations in the UL54 gene are resistant to ganciclovir but may show cross-resistance to other antivirals that also target viral polymerase.
Maltese: Virusis li għandhom mutazzjonijiet fil-ġene UL97 huma reżistenti għal ganciclovir biss, filwaqt li virusis b'mutazzjonijiet fil-ġene UL54 huma reżistenti għal ganciclovir iżda jistgħu juru reżistenza inkroċjata għal antivirali oħra li wkoll jimmiraw polymerase virali.
English: None of the ganciclovir recipients had worsening hearing from baseline to 6 months, compared with 7 control patients (p < 0.01).
Maltese: L-ebda wieħed minn dawk li rċevew ganciclovir ma kellu aggravar tas-smigħ mil-linja bażi sa 6 xhur wara, meta mqabbel ma' 7 pazjenti tal-kontroll (p < 0.01).
English: Reproductive system and breast disorders: Uncommon (≥ 1/1000, < 1/100):
Maltese: Disturbi fis-sistema riproduttiva u fis-sider: Mhux komuni (≥ 1/1000, < 1/100):
English: Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow depression have been observed in patients treated with ganciclovir.
Maltese: Lewkopenija, newtropenija, anemija, tromboċitopenija u panċitopenija severi
English: Thrombocytopenia Leucopenia Pancytopenia
Maltese: palpitazzjonijiet jew ġilda pallida
English: Cardiac arrhythmias
Maltese: Anemija aplastika*
English: Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible.
Maltese: Minħabba x-xebh tal-istruttura kimika ta' ganciclovir u dik ta' aciclovir u penciclovir, hija possibbli reazzjoni ta' sensittività eċċessiva inkroċjata bejn dawn il-mediċini.
English: The range of exposures was comparable to those observed in adults.
Maltese: Il-firxa talesponimenti kienet komparabbli ma' dik osservata fl-adulti.
English: Add a volume of 100ml of diluent to the reconstituted solution.
Maltese: Żid volum ta' 100ml ta' dilwent mas-soluzzjoni rikostitwita.
English: Alopecia Urticaria Dry skin
Maltese: Jekk tieqaf tuża Cymevene
English: Toxicity may be enhanced when ganciclovir is co-administered with other drugs known to be myelosuppressive or associated with renal impairment (such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, doxorubicin, amphotericin B, mycophenolate mofetil, trimethoprim/sulphamethoxazole, and hydroxyurea) as well as nucleoside analogues (including zidovudine).
Maltese: Newtropenija kienet l-unika reazzjoni avversa tal mediċina severa osservata waqt l-istudju u għalkemm l-ebda wieħed/waħda mit-tfal ma kellhom bżonn waqfien tat-trattament, 4 kellhom bżonn trattament b'fattur li jistimula l-kolonji ta' granuloċiti (G-CSF - granulocyte colony-stimulating factor) biex jinżamm l-għadd assolut ta' newtrofili > 400 ċellula/mm3.
English: Available in packs of 1 vial or 5 vials.
Maltese: Disponibbli f'pakketti ta' kunjett wieħed jew 5 kunjetti.
English: For storage conditions of the reconstituted concentrate, see sections 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-konċentrat rikostitwit, ara sezzjoni 6.3.
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.
Maltese: Tagħtix permezz ta' injezzjoni ġol-muskoli jew taħt il-ġilda għax dan jista' jwassal għal irritazzjoni severa fit-tessut minħabba l-pH għolja (~11) tas-soluzzjoni ta' ganciclovir.
English: Also do this for at least 30 days after Cymevene has been stopped.
Maltese: Agħmel dan ukoll għal mill-inqas 30 jum wara li jitwaqqaf Cymevene.
English: For storage conditions after reconstitution and after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Caution should be exercised in the handling of Cymevene.
Maltese: Mediċini oħra u Cymevene
English: Dysphagia
Maltese: Kontraċezzjoni
English: Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections.
Maltese: Stabbiltà kimika u fiżika waqt l-użu ntweriet għall-prodott rikostitwit għal 12-il siegħa f'temperatura ta' 25°C wara dissoluzzjoni ma' ilma għall-injezzjonijiet.
English: Single-dose glass vials of 10 mL with fluoro-resin laminated rubber stopper and aluminum closure with flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjetti tal-ħġieġ ta' doża waħda ta' 10 mL b'tapp tal-lastku laminat bi fluoro-resin u għeluq tal aluminju b'għatu flip-off.
English: It is used in adults and adolescents 12 years and older.
Maltese: Jintuża f'adulti u adolexxenti minn 12-il sena 'l fuq.
English: Since renal function decreases with age, ganciclovir should be administered to the elderly with special consideration for their renal status (see section 4.2).
Maltese: Peress li l-funzjoni tal-kliewi tonqos bl-età, ganciclovir għandu jingħata lill-anzjani b'konsiderazzjoni speċjali tal-istat talkliewi tagħhom (ara sezzjoni 4.2).
English: If the blood cell counts are significantly reduced during therapy with ganciclovir, treatment with haematopoietic growth factors and/or discontinuation of treatment should be considered (see sections 4.4 and 4.8).
Maltese: għandu jiġi kkunsidrat trattament b'fatturi ematopoetiċi tat-tkabbir u/jew twaqqif tat-trattament (ara sezzjonijiet 4.4 u 4.8).
English: Vials of Cymevene are supplied in packs of 1 or 5.
Maltese: Kunjetti ta' Cymevene huma disponibbli f'pakketti ta' wieħed jew 5.
English: This belongs to a group called anti-viral medicines.
Maltese: Dan jagħmel parti minn grupp ta' mediċini li jissejħu anti-virali.
English: Patients with Renal Impairment Undergoing Haemodialysis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: • muscle pain or spasms
Maltese: • uġigħ jew spażmi fil-muskoli
English: Hepato-biliary disorders: Common (≥ 1/100, < 1/10):
Maltese: Disturbi fil-qalb: Mhux komuni (≥ 1/1000, < 1/100):
English: Abdominal distention Mouth ulceration Pancreatitis
Maltese: Nefħa addominali Ulċeri fil-ħalq
English: As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
Maltese: Peress li fil-biċċa l-kbira lfosforilazzjoni hija dipendenti fuq il-kinase virali, fosforilazzjoni ta' ganciclovir isseħħ preferibilment f'ċelluli infettati mill-virus.
English: Dyspnoea
Maltese: Disfaġja
English: Renal impairment: It is expected that an overdose of ganciclovir could result in increased renal toxicity in patients with renal impairment (see section 4.4).
Maltese: Huwa mistenni li doża eċċessiva ta' ganciclovir tista' twassal għal żieda fit tossiċità tal-kliewi f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 4.4).
English: • liver and kidney problems shown in tests
Maltese: • problemi serji fil-kliewi osservati fit-testijiet
English: Therapy should not be initiated if the absolute neutrophil count is less than 500 cells/µL or the platelet count is less than 25,000 cells/µL or the haemoglobin is less than 8 g/dL (see sections 4.2 and 4.8).
Maltese: 25,000 ċellula/μL jew l-emoglobina tkun anqas minn 8 g/dL (ara sezzjonijiet 4.2 u 4.8).
English: Bone marrow failure
Maltese: GĦAMLA KWALITATTIVA
English: Based upon animal studies where aspermatogenesis was induced at ganciclovir systemic exposures below therapeutic levels, it is considered likely that ganciclovir causes inhibition of human spermatogenesis.
Maltese: Abbażi ta' studji fuq lannimali fejn aspermatoġenesi kienet indotta b'esponimenti sistemiċi għal ganciclovir taħt il-livelli terapewtiċi, huwa meqjus probabbli li ganciclovir jikkawża inibizzjoni ta' spermatoġenesi fil-bniedem.
English: Induction therapy: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 7 - 14 days.
Maltese: Terapija ta' induzzjoni: 5 mg/kg mogħtija bħala infużjoni fil-vini fuq medda ta' siegħa, kull 12-il siegħa għal 7 - 14-il jum.
English: Deafness
Maltese: Dermatite
English: Male patients must be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir unless it is certain that the female partner is not at risk of pregnancy (see sections 4.4 and 5.3).
Maltese: Pazjenti rġiel għandhom jingħataw parir biex jużaw kontraċezzjoni forma ta' barriera waqt u għal mill-inqas 90 jum wara trattament b'ganciclovir sakemm ma jkunx ċert li s-sieħba ma tkunx f'riskju ta' tqala (ara sezzjonijiet 4.4 u 5.3).
English: Patients with renal impairment have an increased elimination half-life and, depending on renal function, it ranges from about 6 to 17 hours (see section 4.2 for dose modifications required in patients with renal impairment).
Maltese: Pazjenti b'indeboliment tal-kliewi għandhom half-life tal-eliminazzjoni miżjuda u skont il-funzjoni tal-kliewi, din tvarja minn madwar 6 sa 17-il siegħa (ara sezzjoni 4.2 għal modifikazzjonijiet fid-doża meħtieġa f'pazjenti b'indeboliment tal-kliewi).
English: In patients treated with ganciclovir the most serious and common adverse drug reactions are haematological reactions and include neutropenia, anaemia and thrombocytopenia.
Maltese: F'pazjenti ttrattati b'ganciclovir l-aktar reazzjonijiet avversi serji u komuni tal-mediċina huma reazzjonijiet ematoloġiċi u jinkludu newtropenija, anemija u tromboċitopenija.
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.
Maltese: Matul l-ewwel 14-il jum ta' għoti huwa rakkomandat li jitwettaq l-għadd ta' ċelluli bojod tad-demm (preferibbilment bħala test differenzjali) kull jumejn; f'pazjenti b'livelli baxxi ta' newtrofili fil-linja bażi (< 1000 newtrofili/μl), dawk li żviluppaw lewkopenija waqt terapija preċedenti flimkien ma' sustanzi mijelotossiċi oħra, u dawk b'indeboliment tal-kliewi, dan il-monitoraġġ għandu jsir kuljum.
English: Oral ganciclovir is no longer available but adverse reactions reported with its use can also be expected to occur in patients receiving intravenous ganciclovir.
Maltese: Ganciclovir orali m'għadux disponibbli iżda reazzjonijiet avversi rrappurtati bl-użu tiegħu jistgħu jiġu mistennija li jseħħu wkoll f'pazjenti li jkunu qed jirċievu ganciclovir filvini.
English: Ganciclovir is predominantly eliminated by renal excretion via glomerular filtration and active tubular secretion of unchanged ganciclovir.
Maltese: Ganciclovir fil-biċċa l-kbira huwa eliminat permezz ta' tneħħija mill-kliewi permezz ta' filtrazzjoni mill-glomeruli u sekrezzjoni tubulari attiva ta' ganciclovir mhux mibdul.
English: This should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta ta' sodium ikkontrollat.
English: The cell count usually normalises within 2 to 5
Maltese: Din tissejjaħ infużjoni fil-vini u normalment tieħu siegħa.
English: Therapeutic guidelines should be consulted.
Maltese: Għandhom jiġu kkonsultati linji gwida terapewtiċi.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: EMA/421017/2015 Rev 1 EMEA/H/A-30/1372
Maltese: Rev 1 EMEA/H/A-30/1372
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.
Maltese: Id-dożi jvarjaw bejn 250 mg u 2 g darbtejn jew tliet darbiet kuljum għal adulti u tfal li jiżnu iktar minn 40 kilogramma, u bejn 20 sa 200 mg għal kull kilogramma kuljum għal tfal li jiżnu inqas minn 40 kilogramma.
English: What is Amoxil?
Maltese: X'inhu Amoxil?
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.
Maltese: Amoxil jitqiegħed fis-suq fl-Istati Membri tal-UE li ġejjin: il-Belġju, Ċipru, Franza, il-Greċja, l-Irlanda, ilLatvja, il-Litwanja, il-Lussemburgu, Malta, il-Portugall, Spanja u r-Renju Unit.
English: • Acute pyelonephritis;
Maltese: • Pjelonefrite akuta;
English: Additionally, Amoxil should no longer be used in several other indications (treatment of bronchitis, acute lung disease, urethritis (inflammation of the urethra, the tube that carries urine from the bladder out of the body), gonococcal infections, male genital infections, gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), enteritis (inflammation of the small intestine) with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, and serious infections caused by Haemophilus influenzae).
Maltese: Barra minn hekk, Amoxil m'għandux jibqa' jintuża f'diversi indikazzjonijiet oħrajn (kura ta' bronkite, mard talpulmun akut, uretrite (infjammazzjoni tal-uretra, it-tubu li jġorr l-awrina mill-borża tal-awrina għal barra l-ġisem), infezzjonijiet gonokokkali, infezzjonijiet ġenitali fl-irġiel, gonorrea (infezzjoni trażmessa sesswalment ikkawżata minn batterja msejħa Neisseria gonorrhoeae), enterite (infjammazzjoni talmusrana ż-żgħira) b'batterimija u infezzjonijiet intraaddominali bħal peritonite, koleċistite u kolanġite akuta, u infezzjonijiet serji kkawżati minn Haemophilus influenzae).
English: It contains the active substance amoxicillin which belongs to the ‘beta-lactam' family (the family that includes penicillins).
Maltese: Fih is-sustanza attiva amoxicillin li tagħmel parti mill-familja "beta-lactam" (il-familja li tinkludi l-peniċillini).
English: A decision on this opinion was issued by the European Commission on 20/08/2015.
Maltese: Il-Kummissjoni Ewropea ħarġet opinjoni dwar din id-deċiżjoni fi 20/08/2015.
English: • Helicobacter pylori eradication;
Maltese: • Qerda ta' Helicobacter pylori;