FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: The safety and efficacy of HALDOL Decanoate in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' HALDOL Decanoate fit-tfal u l-adolexxenti ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping HALDOL Decanoate if its excretion is faster than that of haloperidol in order to avoid the development or aggravation of extrapyramidal symptoms.
Maltese: Jekk ikun meħtieġ trattament konkomittanti bi prodott mediċinali kontra l-parkinson, huwa jista' jkollu jitkompla wara li HALDOL Decanoate jitwaqqaf jekk it-tneħħija tiegħu tkun aktar malajr minn dik ta' haloperidol sabiex jiġi evitat l-iżvilupp jew laggravar tas-sintomi ekstrapiramidali.
English: Haloperidol is extensively metabolised in the liver.
Maltese: Haloperidol huwa metabolizzat b'mod estensiv fil-fwied.
English: It is recommended that HALDOL Decanoate is not used alone in patients in whom depression is predominant.
Maltese: Huwa rrakkomandat li HALDOL Decanoate ma jintużax waħdu f'pazjenti li fihom id-depressjoni hija predominanti.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including HALDOL Decanoate, must be considered.
Maltese: Jekk jidhru s-sinjali u s-sintomi ta' diskjneżja tardiva, għandu jitqies it-twaqqif talantipsikotiċi kollha inkluż HALDOL Decanoate.
English: Heart problems are uncommon in people using Haldol Decanoate (may affect up to 1 in 100 people).
Maltese: Problemi fil-qalb mhumiex komuni f'persuni li jkunu qed jużaw Haldol Decanoate (jistgħu jaffettwaw sa persuna 1 minn kull 100).
English: • The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 20 mg/day.
Maltese: • Id-doża totali kombinata ta' haloperidol miż-żewġ formulazzjonijiet m'għandhiex taqbeż iddoża massima korrispondenti ta' haloperidol mill-ħalq ta' 20 mg/kuljum.
English: • You have a heart condition called ‘prolonged QT interval', or any other problem with your heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram)
Maltese: • Inti għandek kondizzjoni tal-qalb imsejħa ‘intervall QT imtawwal', jew kwalunkwe problema oħra bir-ritmu tal-qalb tiegħek li tidher bħala ntraċċar mhux normali fuq ECG
English: Inhibition or induction of CYP3A4, or inhibition of CYP2D6, may affect haloperidol metabolism.
Maltese: Inibizzjoni jew induzzjoni ta' CYP3A4, jew inibizzjoni ta' CYP2D6, jistgħu jaffettwaw il-metabliżmu ta' haloperidol.
English: • The most effective dose is expected to range between 25 and 75 mg.
Maltese: • L-aktar doża effettiva hija mistennija li tkun fuq firxa bejn 25 u 75 mg.
English: • It is recommended to adjust the haloperidol decanoate dose by up to 50 mg every 4 weeks
Maltese: • Huwa rrakkomandat li taġġusta d-doża ta' haloperidol decanoate b'sa 50 mg kull 4 ġimgħat
English: • Known QTc interval prolongation or congenital long QT syndrome.
Maltese: • Titwil magħruf tal-intervall QTc jew sindrom konġenitali ta' QT twil.
English: Other medicines and Haldol Decanoate
Maltese: Mediċini oħra u Haldol Decanoate
English: Reduced CYP2D6 enzyme activity may result in increased concentrations of haloperidol.
Maltese: Tnaqqis flattività tal-enzima CYP2D6 jista' jwassal għal żieda fil-konċentrazzjonijiet ta' haloperidol.
English: • The most effective dose is expected to range between 50 and 200 mg.
Maltese: • L-aktar doża effettiva hija mistennija li tkun fuq firxa bejn 50 u 200 mg.
English: Dystonic symptoms can include, but are not limited to, torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements, including oculogyric crisis.
Maltese: Sintomi distoniċi jistgħu jinkludu, iżda mhumiex limitati għal, tortikollis, tkerrieh tal-wiċċ, trismus, ilsien joħroġ 'il barra, u movimenti mhux normali tal-għajnejn, inkluż ħarsa fissa 'il fuq involontarja u fit-tul.
English: Sodium valproate is known to inhibit glucuronidation, but does not affect haloperidol plasma concentrations.
Maltese: Sodium valproate huwa magħruf li jinibixxi glukuronidazzjoni, iżda ma jaffetwax ilkonċentrazzjonijiet ta' haloperidol fil-plażma.
English: Extrapyramidal disorder
Maltese: Disturb ekstrapiramidal i
English: The frequency is unknown.
Maltese: Il-frekwenza mhix magħrufa.
English: Hepatic impairment
Maltese: Disturb psikotiku
English: Hyperthermia Hypothermia Gait disturbance Injection site abscess
Maltese: Amenorrea Galactorrea Dismenorrea Menorraġja Impotenza Ginekomastja Disturb filmenstrwazzjoni
English: In rodents, haloperidol administration showed a decrease in fertility, limited teratogenicity as well as embryo-toxic effects.
Maltese: Fl-annimali gerriema, l-għoti ta' haloperidol wera tnaqqis fil-fertilità, teratoġeniċità limitata kif ukoll effetti tossiċi għall-embriju.
English: Newborn infants exposed to antipsychotics (including haloperidol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Maltese: Trabi tat-twelid esposti għal antipsikotiċi (inkluż haloperidol) waqt it-tielet trimestru tat-tqala jkunu f'riskju ta' reazzjonijiet avversi inkluż sintomi ekstrapiramidali u/jew ta' twaqqif tal-mediċina li jistgħu jvarjaw fil-qawwa u t-tul tagħhom wara t-twelid.
English: Akinesia
Maltese: Anzjani
English: Medicinal products that may increase haloperidol plasma concentrations
Maltese: Prodotti mediċinali li jistgħu jnaqqsu l-konċentrazzjonijiet ta' haloperidol fil-plażma
English: The terminal elimination half-life of haloperidol after intramuscular injection with haloperidol decanoate is on average 3 weeks.
Maltese: Il-half-life terminali ta' eliminazzjoni ta' haloperidol wara injezzjoni ġol-muskolu b'haloperidol hija ta' madwar 3 ġimgħat.
English: Muscle spasms Muscle twitching Musculoskeletal stiffness
Maltese: Spażmi fil-muskoli Ġbid f'daqqa tal-muskoli
English: • Recent acute myocardial infarction.
Maltese: • Infart mijokardijaku riċenti akut.
English: Based on published data from multiple clinical studies, therapeutic response is obtained in most patients with acute or chronic schizophrenia at plasma concentrations of 1 to 10 ng/ml.
Maltese: Abbażi ta' dejta ppublikata minn ħafna studji kliniċi, rispons terapewtiku jinkiseb fil-biċċa l-kbira talpazjenti bi skiżofrenja akuta jew kronika b'konċentrazzjonijiet fil-plażma ta' 1 sa 10 ng/ml.
English: The pharmacokinetics of haloperidol following intramuscular injections of haloperidol decanoate are dose-related.
Maltese: Il-farmakokinetika ta' haloperidol wara injezzjonijiet ta' haloperidol decanoate ġol-muskolu hija marbuta mad-doża.
English: • Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free.
Maltese: • Żomm l-ampulla bejn is-saba' l-kbir u l-werrej, filwaqt li tħalli t-tarf tal-ampulla liberu.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletri ċi u tat-tessuti konnettivi
English: NAME OF THE MEDICINAL PRODUCT HALDOL Decanoate and associated names (see Annex I) 50 mg/ml solution for injection [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL Decanoate u ismijiet assoċjati (ara Anness I ) 50 mg/ml soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: • Headache
Maltese: Epatite
English: NAME OF THE MEDICINAL PRODUCT HALDOL Decanoate and associated names (see Annex I) 100 mg/ml solution for injection [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL Decanoate u ismijiet assoċjati (ara Anness I ) 100 mg/ml soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: Liver function test abnormal
Maltese: Riżultat mhux normali ta' test tal-funzjoni talfwied
English: • Problems with your heart beat (such as amiodarone, dofetilide, disopyramide, dronedarone,
Maltese: • Problemi bit-taħbit tal-qalb tiegħek (bħal amiodarone, dofetilide, disopyramide,
English: As the initial dose of haloperidol decanoate is based on a multiple of the daily oral haloperidol dose, specific guidance on switching from other antipsychotics cannot be provided (see section 5.1).
Maltese: Prodotti mediċinali li jistgħu jżidu l-konċentrazzjonijiet ta' haloperidol fil-plażma Haloperidol jiġi mmetabolizzat permezz ta' diversi rotot (ara sezzjoni 5.2).
English: Patients with depression
Maltese: Pazjenti b'depressjoni
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Maltese: Data tal-aħħar tiġdid: {JJ xahar SSSS}
English: Medicinal products that may decrease haloperidol plasma concentrations
Maltese: L-effett ta' haloperidol fuq prodotti mediċinali oħra
English: Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started.
Maltese: Disturbi fl-elettroliti bħal ipokalimja u ipomagnesimja jżidu r-riskju għal arritmiji tal-ventrikulu u għandhom jiġu kkoreġuti qabel ma jinbeda trattament b'haloperidol.
English: Haldol Decanoate and alcohol
Maltese: Haldol Decanoate u l-alkoħol
English: • Serious mental health problem, such as believing things that are not true (delusions) or seeing, feeling, hearing or smelling things that are not there (hallucinations)
Maltese: • Problema serja ta' saħħa mentali, bħal temmen affarijiet li mhumiex veri (delużjonijiet)
English: Cholestasis Jaundice
Maltese: Akajneżja Diskajneżja
English: • Feel very aggressive, hostile or violent.
Maltese: • Tħossok aggressiv/a, ostili jew vjolenti ħafna.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindrom ta' twaqqif ta' sustanza li tivvizzja fittrabi tat-twelid (ara sezzjoni 4.6)
English: • Stiff muscles and joints
Maltese: .8 Effetti mhux mixtieqa
English: This is longer than for the non-decanoate formulations, where the haloperidol terminal elimination half-life is on average 24 hours after oral administration and 21 hours after intramuscular administration.
Maltese: Din hija itwal minn dik tal-formulazzjonijiet li mhumiex decanoate, fejn ilhalf-life terminali ta' eliminazzjoni ta' haloperidol hija madwar 24 siegħa wara għoti mill-ħalq u
English: • History of ventricular arrhythmia or torsades de pointes.
Maltese: • Storja medika ta' arritmija tal-ventrikulu jew torsades de pointes.
English: • Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
Maltese: • Movimenti tal-ħalq, tal-ilsien, tax-xedaq u xi drabi tad-dirgħajn u r-riġlejn (diskajneżja tardiva)
English: Table 1: Haloperidol decanoate dose recommendations for adults aged 18 years and above
Maltese: Tabella 1: Rakkomandazzjonijiet għad-doża ta' Haloperidol decanoate għall-adulti li għandhom
English: Haloperidol causes efficient psychomotor sedation, which explains the favourable effect on mania and other agitation syndromes.
Maltese: Haloperidol jikkawża sedazzjoni psikomotorja effiċjenti, li jispjega l-effett favorevoli fuq il-manija u sindromi oħra ta' aġitazzjoni.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti [Biex timtela mill-pajjiż partikolari]
English: However, hepatic impairment may have significant effects on the pharmacokinetics of haloperidol because it is extensively metabolised in the liver.
Maltese: L-influwenza ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' haloperidol ma ġietx ivvalutata.
English: Haloperidol metabolites are not considered to make a significant contribution to its activity, although for the reduced metabolite of haloperidol, back-conversion to haloperidol cannot be fully ruled out.
Maltese: Il-metaboliti ta' haloperidol mhumiex meqjusa li jagħtu kontribut sinifikanti għall-attività tiegħu; għalkemm għall-metabolit imnaqqas ta' haloperidol konverżjoni lura għal haloperidol ma tistax tiġi eskluża kompletament.
English: Sudden death Face oedema Oedema
Maltese: Mewt zoptu Edima fil-wiċċ Edima
English: Look out for serious side effects
Maltese: Oqgħod attent/a għal effetti sekondarji serji
English: Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
Maltese: Problemi biex jiġu kkontrollati movimenti tal-ġisem jew tad-dirgħajn u r-riġlejn (disturb ekstrapiramidali), bħal:
English: • Parkinson's disease.
Maltese: Parkinsoniżmu
English: A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/ neonatal toxicity of haloperidol.
Maltese: Tqala Ammont moderat ta' dejta dwar l-użu waqt it-tqala (aktar minn 400 riżultat ta' tqala) juri li m'hemm l ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-użu ta' haloperidol.
English: Dyskinesia Dystonia Cogwheel rigidity Hypertonia Headache
Maltese: Kif għandek tuża Haldol Decanoate
English: Haloperidol suppresses delusions and hallucinations as a direct consequence of blocking dopaminergic signalling in the mesolimbic pathway.
Maltese: Haloperidol jissopressa delużjonijiet u alluċinazzjonijiet bħala kosegwenza diretta ta' imblokk talgħoti ta' sinjali dopaminerġiċi fis-sensiela ta' reazzjonijiet mesolimbiċi.
English: Angioedema Dermatitis exfoliative Leukocytoclastic vasculitis
Maltese: Fibrillazzjoni talventrikulu
English: • Fungal infections (such as pentamidine)
Maltese: • Infezzjonijiet bil-fungu (bħal pentamidine)
English: Haloperidol may antagonise the effect of levodopa and other dopamine agonists.
Maltese: Haloperidol huwa eliminat fil-ħalib tas-sider tal-bniedem.
English: Results from small clinical studies suggest a lower clearance and a longer elimination half-life of haloperidol in elderly patients.
Maltese: Riżultati minn studji kliniċi żgħar jissuġġerixxu tneħħija ta' haloperidol inqas u half-life ta' eliminazzjoni itwal f'pazjenti anzjani.
English: ½ line
Maltese: ½ linja
English: p-value = 0.0008).
Maltese: valur p = 0.0008).
English: 10 to < 12 12 to < 14 14 to < 17 17 to < 19 19 to < 22 22 to < 24 24 to < 27 27 to < 29 29 to < 32 32 to < 34 34 to < 35
Maltese: 10 sa < 12 12 sa < 14 14 sa < 17 17 sa < 19 19 sa < 22 22 sa < 24 24 sa < 27 27 sa < 29 29 sa < 32 32 sa < 34
English: Liver disease
Maltese: Stage Liver Disease)
English: Dose and formulation
Maltese: Doża u formulazzjoni
English: (log10 copies/ml)
Maltese: (log10 kopja/ml)
English: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany
Maltese: Lehnitzstrasse 70-98 D-16515 Oranienburg
English: ALT n (%)
Maltese: n (%)
English: 6.5 mg/kg granules 2 to < 12 years (n = 23)
Maltese: 6.5 mg/kg granijiet 2 sa < 12-il sena (n = 23)
English: - The active substance is tenofovir.
Maltese: - Is-sustanza attiva hi tenofovir.
English: Week 192 TDF-TDF PLB-TDF TDF-TDF PLB-TDF TDF-TDF PLB-TDF
Maltese: PLB-TDF TDF-TDF
English: One gram of granules contains 622 mg mannitol.
Maltese: Gramma waħda ta' granijiet fiha 622 mg ta' mannitol.
English: ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir (300 q.d./100 q.d.)
Maltese: Antiretrovirali Impedituri ta' protease Atazanavir/Ritonavir (300 q.d./100
English: Complete response (%)
Maltese: ALT (%)
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Maltese: HBeAg/serokonverżjoni n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
English: Silicon dioxide (E551)
Maltese: Silicon dioxide (E551) 6.2 Inkompatibbiltajiet
English: Total dose (mg) tenofovir disoproxil
Maltese: Doża totali (mg) ta' tenofovir disoproxil
English: Limited clinical data are available at the 6.5 mg/kg dose of the granules.
Maltese: Dejta klinika limitata hi disponiobbli fid-doża ta' 6.5 mg/kg tal-granijiet.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Maltese: Seba' pazjenti kellhom rata tal-filtrazzjoni glomerulari stmata (GFR) b'valuri bejn 70 u 90 mL/min/1.73 m2.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Maltese: Ilfrekwenza hija deskritta bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
English: HBsAg loss/seroconversion
Maltese: HBeAg/serokonverżjoni
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Maltese: Ma kien hemm l-ebda interazzjonijiet farmakokinetiċi klinikament sinifikanti meta tenofovir disoproxil ingħata flimkien ma' emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (imsaħħaħ b'ritonavir), methadone, ribavirin, rifampicin, tacrolimus, jew il- kontraċettiv ormonali norgestimate/ethinyl oestradiol.
English: • HIV paediatric educational brochure
Maltese: • Fuljett edukattiv dwar HIV pedjatrika
English: Please refer to the Summaries of Product Characteristics for Viread 33 mg/g granules and Viread 123 mg, 163 mg and 204 mg film-coated tablets.
Maltese: Prodott għal Viread 33 mg/g granijiet u Viread 123 mg, 163 mg u 204 mg pilloli miksija b'rita.
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07
Maltese: Antivirali għal użu sistemiku; impedituri ta' nukleoside u nukleotide reverse transcriptase, Kodiċi ATC:
English: Refer to section 2 “Viread contains lactose”.
Maltese: Irreferi għal sezzjoni 2 “Viread fih lactose”.
English: GS-331007 AUC: ↔
Maltese: GS-3310072 AUC: ↔ Cmax: ↔ Cmin: ↔
English: Table 11: Mean (± SD) tenofovir pharmacokinetic parameters by age groups for paediatric patients
Maltese: Tabella 11: Medja (± SD) tal-parametri farmakokinetiċi ta' tenofovir skont gruppi ta' età għal pazjenti pedjatriċi
English: • HBV paediatric educational brochure
Maltese: • Fuljett edukattiv dwar HBV pedjatrika
English: Viread contains the active substance tenofovir disoproxil.
Maltese: Viread fih s-sustanza attiva, tenofovir disoproxil.
English: Viread granules contain mannitol
Maltese: Viread granijiet fihom mannitol
English: Histological responsea,b (%)
Maltese: Rispons istoloġiku (%)b
English: 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg·h/ml, respectively.
Maltese: Il-medja (± SD) tas-Cmax u tal-AUCtau huma ta' 0.38 ± 0.13 μg/ml u 3.39 ± 1.22 μg·h/ml, rispettivament.
English: HIV-1 and Chronic hepatitis B
Maltese: HIV-1 u Epatite B kronika
English: Serology (%) HBeAg loss/ seroconversion HBsAg loss/ seroconversion
Maltese: Seroloġija (%) Tnaqqis/ serokonverżjoni ta' HbeAg
English: Administration of multiple doses of tenofovir disoproxil with a meal to HIV infected patients resulted in mean (%CV) tenofovir Cmax, AUC, and Cmin values of 326 (36.6%) ng/ml, 3,324 (41.2%) ng·h/ml and 64.4 (39.4%) ng/ml, respectively.
Maltese: L-għoti ta' dożi multipli ta' tenofovir disoproxil mal-ikel lill pazjenti infettati b'HIV irriżulta f'medja (%CV) ta' valuri ta' tenofovir Cmax, AUC, u Cmin ta' 326 (36.6%) ng/ml, 3,324 (41.2%) ng·h/ml u 64.4 (39.4%) ng/ml, rispettivament.
English: How to store Viread
Maltese: Tiħux Viread
English: Refer to section 2 “Viread granules contain mannitol”.
Maltese: Irreferi għal sezzjoni 2 “Viread granijiet fihom mannitol”.
English: + Raltegravir (400 mg b.i.d) +
Maltese: (400 mg b.i.d) +
English: Date of latest renewal: 14 December 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 5 ta' Frar 2002 Data tal-aħħar tiġdid: 14 ta' Diċembru 2011
English: Hydroxypropyl cellulose (E463)
Maltese: Microcrystalline cellulose (E460)
English: Tenofovir disoproxil was associated with significantly greater proportions of patients with undetectable HBV DNA (< 169 copies/ml [< 29 IU/ml]; the limit of quantification of the Roche Cobas Taqman HBV assay), when compared to adefovir dipivoxil (study GS-US-174-0102; 91%, 56% and study GS-US-174-0103; 69%, 9%), respectively.
Maltese: HBV li ma setgħetx tkun osservata (< 169 kopja/ml [< 29 IU/ml]; il-limitu tal-kwantifikazzjoni tal assaġġ Roche Cobas Taqman HBV), meta mqabbel ma' adefovir dipivoxil (studju GS-US-174-0102; 91%, 56% u studju GS-US-174-0103; 69%, 9%), rispettivament.
English: Doses of 132 mg, 65 mg and 33 mg tenofovir disoproxil granules once daily are recommended in adult patients with calculated creatinine clearance (CrCl) of 30 to 49 ml/min, 20 to 29 ml/min or 10 to 19 ml/min, respectively.
Maltese: Dożi ta' 132 mg, 65 mg u 33 mg ta' granijiet ta' tenofovir disoproxil darba kuljum huma rakkomandati f'pazjenti adulti bi tneħħija tal-krejatinina (CrCl) ta' 30 sa 49 ml/min, 20 sa 29 ml/min jew 10 sa 19 ml/min, rispettivament.
English: Experience beyond 48 weeks in studies GS-US-174-0102 and GS-US-174-0103
Maltese: GS-US-174-0102 u GS-US-174
English: Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg:
Maltese: Adulti u adolexxenti li għandhom minn 12 sa < 18-il sena u li jiżnu ≥ 35 kg:
English: Refer to Table 1.
Maltese: Tabella 1).
English: Cmax: ↓ 30% Cmin: N/A
Maltese: AUC: ↔ Cmax: ↓ 30% Cmin: N/A
English: Viread 245 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Viread 245 mg pilloli huma trattament għal infezzjoni bl-HIV (Virus ta' l-Immunodefiċjenza Umana).
English: Serology (%) HBeAg loss/seroconversion n/a n/a
Maltese: HBeAg/serokonverżjoni n/a n/a
English: AUC: ↑ 45% Cmax: ↑ 60%
Maltese: AUC: ↑ 45% Cmax: ↑ 60% Cmin: ↔
English: PC: {number} SN: {number} NN: {number} [Outer packaging only]
Maltese: {numru} NN: {numru}
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE) n (%)a
Maltese: Nuqqas ta' tollerabilità (twaqqif permanenti talmediċina tal-istudju minħabba li jiżviluppaw avvenimenti avversi (AE) mill-kura) n (%)a
English: Similar percentages of subjects in the TDF-TDF and PLB-TDF groups (37.5% and 41.7%, respectively) experienced seroconversion to anti-HBe through week 192.
Maltese: Perċentwali simili ta' individwi fil-gruppi ta' TDF-TDF u PLB-TDF (37.5% u 41.7%, rispettivament) esperjenzaw serokonverżjoni għal anti-HBe matul ġimgħa 192.
English: Viread 33 mg/g granules are a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Viread 33 mg/g granijiet huma trattament għal infezzjoni bl-HIV (Virus ta' l-Immunodefiċjenza Umana).
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin
Maltese: Effetti fuq il-livelli tal-mediċina Bidla perċentwali medja fl-AUC, Cmax,
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
Maltese: • mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil-muskoli).
English: Very common: dizziness Gastrointestinal disorders:
Maltese: sturdament Disturbi gastro-intestinali:
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/ml.
Maltese: Ir-rabta tal-proteini in vitro ta' tenofovir ma' proteini tal-plażma jew proteini fis-serum kienet anqas minn 0.7 and 7.2%, rispettivament, ogħla mill-medda tal-konċentrazzjoni ta' tenofovir 0.01 sa 25 µg/ml.
English: One level scoop delivers 1 g of granules which contains 33 mg of tenofovir disoproxil.
Maltese: Mgħarfa waħda mhux imburġata tforni 1 g ta' granijiet li fiha 33 mg ta' tenofovir disoproxil.
English: Clinical resistance
Maltese: Effikaċja klinika
English: After an initial decline of approximately -4.9 ml/min (using CockcroftGault equation) or -3.9 ml/min/1.73 m2 (using modification of diet in renal disease [MDRD] equation)
Maltese: madwar -4.9 ml/min (bl-użu tal-ekwazzjoni Cockcroft Gault) jew -3.9 ml/min/1.73 m² (bl-użu tal ekwazzjoni tal-modifikazzjoni tad-dieta f'mard renali [MDRD, modification of diet in renal disease])