FrancophonIA/ELRC3.0 huggingface dataset:
English: The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Maltese: Ir-riżultati fl-adulti wkoll ipprovdew l-istess evidenza ta' appoġġ li turi li ImmunoGam tipproteġi kontra infezzjoni bil-virus talepatite B.
English: Finally, people at continuous risk of hepatitis B infection who did not show an immune response after vaccination may be given 500 IU (in adults) or 8 IU/kg (in children) every two months.
Maltese: IU (fl-adulti) u 8 IU/kg (fit-tfal) kull xahrejn.
English: ImmunoGam protects against the hepatitis B virus by keeping the blood levels of human hepatitis B immunoglobulins high enough so that they can attach to the virus and stimulate the immune system to destroy it.
Maltese: ImmunoGam tipproteġi kontra l-virus tal-epatite B billi żżomm illivelli tal-immunoglobini tal-epatite B tal-bniedem fid-demm għoljin biżżejjed sabiex ikunu jistgħu jeħlu mal-virus u jistimulaw lis-sistema immunitarja sabiex teqirdu.
English: How has ImmunoGam been studied?
Maltese: Kif ġiet studjata ImmunoGam?
English: ImmunoGam is given as an injection into a muscle.
Maltese: ImmunoGam tingħata bħala injezzjoni f'muskolu.
English: EMA/HMPC/441263/2013
Maltese: Merdqux EMA/HMPC/441263/2013
English: Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.
Maltese: Mediċini erbali huma normalment disponibbli bħala materjal erbali f'biċċiet żgħar li jintuża biex isiru tejiet erbali jew miżjuda mal-ilma biex jiġi prodott likwidu (infużjoni) biex jiġi applikat fuq il-ġilda.
English: It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Maltese: Ikkunsidra wkoll studji esperimentali ppubblikati li appoġġjaw l-użu talmerdqux fl-indikazzjonijiet approvati.
English: What are the risks associated with dittany of Crete herb medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini bil-merdqux?
English: Other information about dittany of Crete herb medicines
Maltese: Aktar informazzjoni dwar il-mediċini bil-merdqux
English: Further information on the HMPC assessment of dittany of Crete herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with dittany of Crete herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini bil-merdqux, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija:
English: How are dittany of Crete herb medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini bil-merdqux?
English: The HMPC concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems.
Maltese: ġimagħtejn; jekk is-sintomi jdumu aktar minn hekk, wieħed għandu jfittex parir mingħand prattikant tal-kura tas-saħħa kkwalifikat.
English: The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their ‘traditional use' in these conditions.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini bil-merdqux għal sogħla u problemi tal-istonku, imsaren jew ġilda huma bbażati fuq l-‘użu tradizzjonali' tagħhom f'dawn il-kundizzjonijiet.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dittany of Crete herb.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-merdqux.
English: Dittany of Crete herb
Maltese: Merdqux
English: % Difference [95% CI]
Maltese: % Differenza [95% CI]
English: 2333 BE Leiden Netherlands
Maltese: 2333 BE Leiden L-Olanda
English: ‡ Adjusted for neutropenic status; primary endpoint.
Maltese: ‡ Aġġustata għall-istat newtropeniku; punt finali primarju.
English: Renal effects
Maltese: Effetti Renali
English: Astellas Ireland Co. Ltd Killorglin
Maltese: Ireland Co. Ltd Killorglin
English: >R (Resistant)
Maltese: >R (Reżistenti)
English: Method of administration
Maltese: Metodu ta 'Amministrazzjoni
English: Liposomal Amphotericin B
Maltese: Amphotericin B Liposomali
English: System Organ Class
Maltese: Sistema tal-Klassifika ta' lOrgani
English: Currently available data are described in section 4.8, 5.1, 5.2.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8, 5.1, 5
English: Possible allergic-like symptoms
Maltese: Sintomi possibbli jixbћu allerġija
English: However, the difference was not significant and whether it translates into a relevant clinical difference is unknown.
Maltese: Madankollu, id-differenza ma kinitx sinifikanti u jekk jissarraf differenza klinika relevanti mhux magħruf.
English: ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
Maltese: guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua u C. dubliniensis.
English: ≥ 1/10,000 to
Maltese: ≥ 1/10,000 sa
English: Lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Maltese: Lactose monohydrate, citric acid anhydrous u sodium hydroxide.
English: Tabulated list of adverse reactions
Maltese: Lista tabulari ta 'reazzjonijiet avversi
English: Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Maltese: Killorglin, County Kerry L-Irlanda
English: The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Maltese: Il-volum tad-distribuzzjoni fiss (Vss) kien madwar 18-19-il litru.
English: In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Maltese: F'ċirkulazzjoni sistemika, micafungin jeħel ħafna mal-proteini tal-plażma (> 99%), l-aktar ma' l albumina.
English: Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Maltese: Infezzjonijiet oħra li żviluppaw kienu kkawżati minn Fusarium (pazjent 1 jew 2 rispettivament) u Zygomycetes (pazjent 1 u 0, rispettivament).
English: Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%).
Maltese: L-aktar reazzjonijiet frekwenti kienu żieda fl-AP (2.7%), AST (2.3%), ALT (2.0%), bilirubina fid-demm (1.6%) u riżultat tat-test tal-funzjoni tal-fwied anormali (1.5%).
English: Body weight > 40 kg Body weight ≤ 40 kg
Maltese: Piż tal-ġisem ≤ 40 kg
English: 1 MICs for C. tropicalis are 1-2 two-fold dilution steps higher than for C albicans and C. glabrata.
Maltese: 1. MICs għall C. tropicalis huma 1-2 passi ta 'dilwit doppji ogħla milli għal C. albicans u C. glabrata.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Din tippermetti monitoraġġ kontinwu tal-bilanċ ta 'benefiċċju / riskju tal-prodott mediċinali.
English: 4 -10 mg/kg/day*
Maltese: 4 -10 mg/kg/jum*
English: There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole.
Maltese: Kien hemm doża fissa kuljum ta' 50 mg(1.0 mg/kg) għal micafungin u 400 mg (8 mg/kg) għal fluconazole.
English: Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed.
Maltese: Saru studji ta' l-interazzjoni ma' mediċini oħra f'individwi b'saħħithom biex jiġi evalwat il-potenzjal ta' interazzjoni bejn micafungin u mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole u amphotericin B.
English: Treatment duration
Maltese: Tul tat-trattament
English: Mycamine contains no preservatives.
Maltese: Mycamine ma fihx preservattivi.
English: Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Maltese: Il-maġġoranza tal-pazjenti (97%, N=882) kellhom newtropenja fil-linja bażi (< 200 newtrofili/µL).
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, Tqala u Treddigħ
English: At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
Maltese: Fiż-żmien li daħlu fl-istudju, il-proporzjon ta' pazjenti pedjatriċi b'newtropenja kien diversi drabi ogħla minn ta' pazjenti adulti (40.2% u 7.3% ta' tfal u adulti, rispettivament), kif ukoll HSCT alloġenika (29.4% u 13.4%, rispettivament) u mallinità ematoloġika (29.1% u 8.7% rispettivament).
English: Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study.
Maltese: Is-suċċess tat-trattament kien definit bħala n-nuqqas ta' infezzjoni fungali sistemika ppruvata, probabbli, jew suspettata fit-tmiem tat-terapija u n-nuqqas ta' infezzjoni fungali sistemika ppruvata jew probabbli fit-tmiem ta' l-istudju.
English: In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
Maltese: Fit-tabella li ġejja, ir-reazzjonijiet avversi huma elenkati skond is-sistema tal-klassifika ta' l-organi u tterminu preferut MedDRA.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazjoni oħra
English: Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity.
Maltese: Dożi ta' kuljum ripetuti sa 8 mg/kg (doża totali massima 896 mg) f'pazjenti adulti ġew mogħtija fi provi kliniċi mingħajr ebda tossiċità rrappurtata li tillimita d-doża.
English: The median treatment duration was 14 days and the median average daily dose was 150 mg for micafungin (N=260) and 200 mg for fluconazole (N=258).
Maltese: kuljum kienet ta' 150 mg għal micafungin (N=260) u 200 mg għal fluconazole (N=258).
English: The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Maltese: Ir-rata ta' suċċess ta' trattament kienet statistikament ferm ogħla għal micafungin milli għal fluconazole (1.6% kontra 2.4% għal infezzjonijiet fil-punt ta' riferiment finali).
English: The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti kienu dardir (2.8%), żieda fl-alkaline phosphatase fid-demm (2.7%), flebite (2.5%, l-aktar f'pazjenti infettati bl-HIV b'linji periferali), rimettar (2.5%), u żieda fl-aspartate aminotransferase (2.3%).
English: Overall Treatment Success in the Per Protocol Set, Invasive Candidiasis Study Micafungin
Maltese: Suċċess Globali tat-Trattament fis-Sett Skond il-Protokoll, Studju dwar il-Kandidjasi Invażiva Micafungin
English: Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
Maltese: Ir-rabta ma' l-albumina huwa indipendenti mill-konċentrazzjoni ta' micafungin (10100 µg/ml).
English: Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Maltese: Ko-amministrazzjoni ta' micafungin u amphotericin B desoxycholate ġiet assoċjata ma' 30% żieda flespożizzjoni ta' amphotericin B desoxycholate.
English: Elderly: When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.
Maltese: Meta ngħata bħala infużjoni waħda ta' 50 mg fuq siegħa, il-farmakokinetiċi ta' micafungin fl-anzjani (età ta' bejn 66-78 sena) kienu simili għal dawk f'individwi żgħażagħ (20-24 sena).
English: Treatment of invasive candidiasis
Maltese: Trattament ta' kandidjasi invażiva
English: - The active substance is micafungin (as sodium).
Maltese: - Is-sustanza attiva hi micafungin (bħala sodium).
English: Candidaemia and Invasive Candidiasis: Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
Maltese: Micafungin (100 mg/kuljum jew 2 mg/kg/kuljum) kien effettiv daqs u tollerat aħjar minn amphotericin B liposomali (3 mg/kg) bħala l-ewwel trattament ta' preferenza ta' kandidemija u kandidjasi invażiva fi studju ta' nuqqas ta' inferjorità multinazzjonali, double-blind u randomised.
English: Endocrine disorders hyperhidrosis
Maltese: Disturbi fis-sistema endokrinarja iperidrosi
English: Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
Maltese: Suxxetibilità mnaqqsa għal echinocandins ġiet assoċjata ma' mutazzjonijiet fil-kodiċi tal-ġenI Fks1 U Fks2għal sottounità maġġuri ta' glucan synthase.
English: 100 mg
Maltese: 100 ml)
English: - The usual dose to treat an invasive Candida infection is 4-10 mg/kg per day.
Maltese: - Id-doża tas-soltu għall-kura ta' infezzjoni b'Candida invażiva hija ta' 4-10 mg/kg kuljum.
English: Prophylaxis of Candida infection
Maltese: Profilassi ta' infezzjoni Candida
English: The nature and incidence of adverse reactions were similar between treatment groups.
Maltese: In-natura u l-inċidenza ta' reazzjonijiet avversi kienu simili bejn il-gruppi ta' trattament.
English: Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Maltese: Wara doża waħda fil-vini ta' 14C-micafungin (25 mg) lil voluntiera b'saħħithom, 11.6% tar radjuattività kienet irkuprata fl-awrina u 71.0% fl-ippurgar fuq 28 jum.
English: 2 mg/kg/day*
Maltese: 2 mg/kg/kuljum*
English: Micafungin has been shown to be metabolised to several compounds; of these M-1 (catechol form), M-2 (methoxy form of M-1) and M-5 (hydroxylation at the side chain) of micafungin have been detected in systemic circulation.
Maltese: Micafungin intwera li jiġi metabolizzat għal diversi komposti; minn dawn M-1 (forma catechol), M-2
English: Renal and urinary disorders blood creatinine increased, blood urea increased, renal failure aggravated renal impairment (see section 4.4), acute renal failure
Maltese: insuffiċjenza renali aggravata indeboliment renali (ara sezzjoni 4.4). falliment renali akut
English: (frequency cannot be estimated from available data)
Maltese: (frekwenza ma tistax tiġi stmata mit tagħrif disponibbli)
English: Breakthrough Aspergillus infections were observed in 1 versus 7 patients, and proven or probable breakthrough Candida infections were observed in 4 versus 2 patients in the micafungin and fluconazole groups, respectively.
Maltese: Il-punt ta' riferiment finali għal infezzjonijiet ta' Aspergillus kienu osservati f'pazjent 1 kontra 7 u l-prova jew probabilità tal-punt ta' riferiment finali ta' infezzjonijiet ta' Candida kienu osservati f'4 kontra 2 pazjenti filgruppi ta' micafungin u fluconazole rispettivament.
English: Respiratory, thoracic and mediastinal disorders dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali dispnea
English: In rats, signs of haemolytic anaemia were observed after repeated bolus injection of micafungin.
Maltese: Fil-firien, ġew osservati sinjali ta' anemija emolitika wara injezzjonijiet ripetuti ta' bolus ta' micafungin.
English: Treatment of oesophageal candidiasis
Maltese: Trattament ta' kandidjasi esofagali
English: Cardiac disorders tachycardia, palpitations, bradycardia
Maltese: Disturbi fil-qalb takikardja, palpitazzjonijiet, bradikardja
English: Tel: + 385 1 670 01 02
Maltese: Astellas d.o.o. Tel: + 385 1 670 01 02
English: For reconstitution instructions see section 6.6.
Maltese: Għal struzzjonijiet dwar ir-rikostituzzjoni ara sezzjoni 6.6
English: Intravenous use.
Maltese: infezzjonijiet fungali.
English: Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Maltese: 001) u inċidenza aktar baxxa ta' reazzjonijiet relatati ma' l-infużjoni (p=0.001) mill-amphotericin B
English: Other medicines and Mycamine
Maltese: Mediċini oħra u Mycamine
English: Mycamine may cause the following other side effects:
Maltese: Mycamine jista' jikkawża ukoll l-effetti sekondarji li ġejjin:
English: • To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
Maltese: • Biex jiġu ttrattati adulti u adoloxxenti ≥ 16 sena t'eta li għandhom infezzjoni fungali fil-gerżuma (esofagu) meta jkun adattat trattament ġol-vina (intravenuż).
English: Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Maltese: Micafungin għandu potenzjal baxx ta' interazzjoni ma' mediċini metabolizzati permezz ta' proċessi medjati minn CYP3A.
English: 100 mg/day*
Maltese: 100 mg/kuljum*
English: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Maltese: Ibbażat fuq esperjenza mill-provi kliniċi, globalment 32.2% tal-pazjenti esperjenzaw reazzjonijiet avversi tal-mediċina.
English: Other Candida spp.
Maltese: Candida spp.oħra
English: Mycamine contains sodium
Maltese: Mycamine fih is-sodium
English: In repeat dose studies in dogs, haemolytic anaemia was not observed.
Maltese: Fi studji b'dożi ripetuti fil-klieb, ma ġietx osservata anemija emolitika.
English: Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients.
Maltese: It-trattament b'micafungin kien assoċjat b'indeboliment sinifikanti tal-funzjoni tal-fwied (żieda flALT, AST jew bilirubin totali > 3 darbiet ULN) kemm f'voluntieri b'saħħithom u pazjenti.
English: Metabolism and nutritional disorders hypokalaemia, hypomagnesaemia, hypocalcaemia hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
Maltese: ipokalċimja iponatremija, iperkalemija, ipofosfatemija, anoreksja
English: Investigations blood lactate dehydrogenase increased
Maltese: Investigazzjonijiet żieda ta' lactate dehydrogenase fiddemm
English: 3 mg/kg/day
Maltese: 3 mg/kg/kuljum
English: Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Maltese: Assorbiment Il-farmakokinetika hija linejari fuq il-medda tad-doża ta' kuljum ta' 12.5 mg sa 200 mg u 3 mg/kg sa
English: Diluted infusion solution
Maltese: koagulazzjoni intravaskulari mifruxa
English: 5 ml approx. 5 ml (20 mg/ml)
Maltese: 5 ml madwar 5 ml (20 mg/ml)
English: - The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, citric acid anhydrous u sodium hydroxide.
English: Even though micafungin is a substrate for CYP3A in vitro, hydroxylation by CYP3A is not a major pathway for micafungin metabolism in vivo.
Maltese: Anki jekk micafungin huwa substrat għal CYP3A in vitro, l-idroksilazzjoni b'CYP3A m'hix triq prinċipali għall-metaboliżmu ta' micafungin in vivo.
English: Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use, ATC code: J02AX05
Maltese: Antimikotiċi għal użu sistemiku, Antimikotiċi oħra għal użu sistemiku, Kodiċi ATC:
English: Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Maltese: Reazzjonijiet esfoljattivi tal-ġilda, bħas-sindromu Stevens-Johnson u nekroliżi epidermali tossika ġew irrapurtati.
English: Paediatric population
Maltese: Popolazjoni pedjattrika
English: Immune system disorders anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity anaphylactic and anaphylactoid shock (see section 4.4)
Maltese: Disturbi fis-sistema immuni reazzjoni anafilattika / anafilattojdi (ara sezzjoni 4.4),
English: The mean period of treatment was 19 days for micafungin and 18 days for fluconazole in the adult population (N=798) and 23 days for both treatment arms in the paediatric population (N=84).
Maltese: Il-perijodu medju ta' trattament kien ta' 19-il jum għal micafungin u 18-il jum għal fluconazole fil-popolazzjoni adulta (N=798) u 23 jum għaż-żewġ fergħat tat-trattament fil-popolazzjoni pedjatrika (N=84).
English: 150 mg/day
Maltese: 150 mg/kuljum
English: The drug is rapidly distributed into tissues.
Maltese: Il-mediċina hija distribwita malajr fit-tessuti.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Micafungin and liposomal amphotericin B were received for a median duration of 15 days (range, 4 to 42 days in adults; 12 to 42 days in children).
Maltese: 15-il jum (medda: 4 sa 42 jum f'adulti; 12 sa 42 jum fi tfal).
English: Testicular toxicity was observed in animal studies (see section 5.3).
Maltese: Tossiċità testikulari kienet osservata fi studju fuq l-annimali (ara sezzjoni 5.3).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Mekkaniżmu(/i) ta' reżistenza
English: Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
Maltese: 5 ml ta' soluzzjoni għall-infużjoni 9 mg/ml (0.9%) ta' sodium chloride jew soluzzjoni għallinfużjoni ta' glucose 50 mg/ml (5%) (meħudin minn flixkun/borża ta' 100 ml) għandhom jiġu injettati b'mod asettiku u bil-mod mal-ġenb il-wiċċ ta' ġewwa.
English: Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
Maltese: Citric acid anhydrous (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Micafungin may cause kidney problems, renal failure, and abnormal renal function test.
Maltese: Micafungin jista' jikkaġuna problemi fil-kliewi, insuffiċjenza renali u riżultati anormali fil-funzjoni renali.
English: In a study performed in patients with severe hepatic impairment (ChildPugh score 10-12) (n=8), lower plasma concentrations of micafungin and higher plasma concentrations of the hydroxide metabolite (M-5) were seen compared to healthy subjects (n=8).
Maltese: Fi studju li sar f'persuni b'indeboliment epatiku serju (punteġġ Child-Pugh 10-12) (n=8), dehru konċentrazzjonijiet baxxi ta' micafungin filplażma u konċentrazzjonijiet għoljin tal-metabolit hydroxide (M-5) fil-plażma meta mqabblin ma' pazjenti f'saħħithom (n=8).