FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised that dolutegravir, lamivudine or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Maltese: Il-pazjenti għandhom jiġu rrakkomandati li dolutegravir, lamivudine jew kwalunkwe terapija antiretrovirali oħra ma tikkurax infezzjoni tal-HIV u li xorta waħda jistgħu jiżviluppaw infezzjonijiet opportunistiċi u kumplikazzjonjiet oħra ta' infezzjoni tal-HIV.
English: DTG + 3TC N=716
Maltese: Data Kollettiva minn GEMINI-1 u GEMINI-2* DTG + 3TC N=716
English: There are limited data available on the use of Dovato in patients aged 65 years and over.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' Dovato f'pazjenti li għandhom 65 sena u aktar.
English: At baseline, in the pooled analysis, the median age of subjects was 33 years, 15% were female, 68% were white, 9% were CDC Stage 3 (AIDS), 20% had HIV-1 RNA >100,000 copies/mL, and 8% had CD4+ cell count less than 200 cells per mm3; these characteristics were similar between studies and treatment arms.
Maltese: Stadju 3 (AIDS), 20% kellhom HIV-1 RNA >100,000 kopja/mL, u 8% kellhom CD4+
English: • inflammation of the liver (hepatitis)
Maltese: • infjammazzjoni tal-fwied (epatite).
English: Polymorphisms in drug metabolising enzymes
Maltese: Parametri tal‑piż u metaboliċi
English: You need to know about important signs and symptoms to look out for while you're taking Dovato.
Maltese: Għandek tkun taf dwar sinjali u sintomi importanti li għandek toqgħod attent għalihom waqt li tkun qed tieħu Dovato.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir (see section 4.5).
Maltese: Id-doża rakkomandata ta' dolutegravir hija 50 mg darbtejn kuljum meta jingħata flimkien ma' rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St.
English: Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Maltese: Dolutegravir jista' jżid ilkonċentrazzjonijiet fil-plażma tal-prodotti mediċinali fejn l-eskrezzjoni hija dipendenti fuq OAT3.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control.
Maltese: Dovato ma' metformin, biex jinżamm kontroll gliċemiku.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Maltese: M'hemm ebda evidenza li l-polimorfiżmi komuni fl-enzimi li jimmetabolizzaw il-mediċina jibdlu lfarmakokinetika ta' dolutegravir sa punt klinikament sinifikanti.
English: Virologic Outcomes of Randomised Treatment at Week 48 (Snapshot algorithm) GEMINI-1 and GEMINI-2 Pooled Data*
Maltese: Tabella 3 Eżiti Viroloġiċi tat-Trattament Randomised fit-48 Ġimgħa (algoritmu Snapshot)
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Maltese: Id-data miksuba f'pazjenti b'indeboliment epatiku moderat sa sever turi li l-farmakokinetika ta' lamivudine mhijiex affettwata b'mod sinifikanti minn disfunzjoni epatika.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja gravi meta jkunu qed jieħdu taħlita ta' terapija antiretrovirali (CART), tista' tirriżulta reazzjoni ta' infjammazzjoni għal patoġeni bla sintomi jew dawk opportunistiċi residwali u din tista' tikkaġuna kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: No clinically significant drug interactions are expected between dolutegravir and lamivudine.
Maltese: Mhijiex mistennija interazzjoni mediċinali klinikament sinifikanti bejn dolutegravir u lamivudine.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Maltese: Daclatasvir ma bidilx il-konċentrazzjoni ta' dolutegravir fil-plażma sa punt klinikament rilevanti.
English: The median or mean IC50 values for lamivudine against lab-strains of HIV-1 ranged from 0.007 to 2.3 µM.
Maltese: Il-valuri medjani jew medji tal-IC50 għal lamivudine kontra razez tal-laboratorju ta' HIV-1 kienu jvarjaw minn 0.007 sa 2.3 µM.
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Maltese: L-istatus kliniku li jinklużi aminotransferases tal fwied u bilirubin għandu jiġi ssorveljat.
English: Tel: + 385 16051 999
Maltese: GlaxoSmithKline d.o.o. Tel: + 385 16051 999
English: When possible, avoid chronic coadministration of Dovato with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol).
Maltese: Fejn possibbli, evita l-għoti flimkien kroniku ta' Dovato ma' prodotti mediċinali li jkun fihom sorbitol jew poli-alkoħols oħra li jaħdmu b'mod osmotiku u alkoħols monosakkaridi (eż:
English: The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Maltese: L-aktar reazzjoni avversa severa rraportata b'dolutegravir kienet reazzjoni ta' sensittività eċċessiva li inkludiet raxx u effetti severi fuq il-fwied (ara sezzjoni 4.4).
English: When administered in fasted state, bioequivalence was achieved for lamivudine AUC, when comparing Dovato to lamivudine 300 mg co-administered with dolutegravir 50 mg. Lamivudine Cmax for Dovato was 32% higher than lamivudine 300 mg co-administered with dolutegravir 50 mg.
Maltese: Is-Cmax ta' lamivudine għal Dovato kienet 32% ogħla minn lamivudine 300 mg mogħti flimkien ma' dolutegravir 50 mg.
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity, with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Maltese: Fi prova randomizzata b'varjazzjoni fid-doża, l-individwi infettati b'HIV-1. ikkurati b'monoterapija b'dolutegravir (ING111521) urew attività antivirali rapida u dipendenti fuq id-doża u bi tnaqqis medju fl
English: Gender Male Female Race White African-American/African Heritage/Other Age (years)
Maltese: Afro-Amerikan/Nisel Afrikan/Oħra
English: Some late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Ġew irrapportati rarament xi disturbi newroloġiċi li jibdew tard (ipertonja, aċċessjoni, imġiba mhux normali).
English: The primary efficacy endpoint for each GEMINI trial was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITT-E population).
Maltese: Il-punt tat-tmiem primarju tal-effikaċja għal kull prova GEMINI kien il-proporzjon ta' individwi b'HIV-1 RNA tal-plażma <50 kopja/mL fit-48 Ġimgħa (algoritmu Snapshot għall-popolazzjoni ITT-E).
English: Lamivudine triphosphate shows significantly less affinity for host cell DNA polymerases.
Maltese: It-trifosfat ta' lamivudine juri ferm inqas affinità għallpolymerases tad-DNA taċ-ċelloli ospitanti.
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Maltese: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39%
English: Antiviral activity in cell culture
Maltese: Sustanzi attivi antivirali oħrajn
English: Calcium supplements/Dolutegravir (fasted intake)
Maltese: Supplimenti tal kalċju/Dolutegravir (teħid fuq stonku vojt)
English: Symptoms of infection and inflammation
Maltese: Sintomi ta' infezzjoni u infjammazzjoni
English: The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.
Maltese: Id-doża rakkomandata ta' Dovato fl-adulti u fl-adoloxxenti hija pillola waħda darba kuljum ta' 50 mg/300 mg.
English: • itching (pruritus)
Maltese: • raxx • ħakk (prurite)
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Maltese: L-IC50 għal dolutegravir f'diversi razez tal-laboratorju permezz ta' PBMC kienet 0.5 nM, u meta ntużaw ċelloli MT-4, varjat minn 0.7-2 nM. IC50s simili ntwerew għal iżolati kliniċi mingħajr ebda differenza ewlenija bejn is-sottotipi; f'pannell ta' 24 iżolati ta' HIV-1 ta' clades A, B, C, D, E, F u G u grupp O, il-valur medju tal-IC50 kien 0.2 nM (medda ta' 0.
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir or lamivudine was administered to adults in combination with other ARVs revealed no clinically relevant effect of gender on the exposure of dolutegravir or lamivudine.
Maltese: Analiżijiet PK tal-popolazzjoni permezz ta' data farmakokinetika kollettiva minn studji kliniċi fejn dolutegravir jew lamivudine ingħata lill-adulti flimkien ma' ARVs oħrajn ma wrew ebda effett klinikament rilevanti tal-ġeneru fuq l-esponiment għal dolutegravir jew lamivudine.
English: Elderly
Maltese: Ranitidine
English: No dose adjustment is necessary when Dovato is combined with tenofovir, didanosine, stavudine or zidovudine.
Maltese: tenofovir, didanosine, stavudine jew zidovudine.
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Disfunzjoni tal-mitokondrija wara esponiment in utero Analogi tan-nukleosidi u tan-nukleotidi jista' jkollhom impatt fuq il-funzjoni tal-mitokondrija sa grad varjabbli, li hu l-iktar notevoli bi stavudine, didanosine u zidovudine.
English: Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
Maltese: Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24%
English: Multivitamins (containing calcium, iron and magnesium) /Dolutegravir (fasted intake)
Maltese: Multivitamini (li fihom il kalċju, il-ħadid u l-manjeżju)
English: GSK Services Sp. z o.o.
Maltese: Informazzjoni għall-pazjent
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir was administered to adults in combination with other ARVs revealed no clinically relevant effect of race on the exposure of dolutegravir.
Maltese: Analiżijiet PK tal-popolazzjoni permezz ta' data farmakokinetika kollettiva minn studji kliniċi fejn dolutegravir ingħata lill-adulti flimkien ma' ARVs oħrajn ma wrew ebda effett klinikament rilevanti tarrazza fuq l-esponiment għal dolutegravir.
English: Allergic reactions
Maltese: Kontraċettivi orali
English: Teл.
Maltese: Sentejn.
English: If you could get pregnant while taking Dovato, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Maltese: Jekk tista' tinqabad tqila waqt li tkun qed tieħu Dovato, jeħtieġ li tuża metodu sigur ta' kontraċezzjoni (pereżempju, kondom) flimkien ma' metodi oħra ta' kontraċezzjoni li jinkludu kontraċettiv orali (il-pillola) jew kontraċettivi ormonali oħra (per eżempju, impjanti jew injezzjonijiet), sabiex tipprevjeni t-tqala.
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Maltese: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
English: Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Maltese: sejbiet kostituzzjonali, u xi drabi, disfunzjoni tal-organi, inkluż reazzjonijiet severi tal-fwied.
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Maltese: dolutegravir lill-fniek tqal f'dożi sa 1000 mg/kg kuljum mis-6 jum sat-18-il jum tal-ġestazzjoni ma wassalx għal tossiċita fl-iżvilupp jew teratoġeniċità (0.55 darba l-50 mg esponiment kliniku tal-bniedem, abbażi talAUC wara doża waħda fuq stonku vojt).
English: • rash
Maltese: • sturdament
English: Antidiabetics Metformin/Dolutegravir
Maltese: Metformin/Dolutegravir
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control (see section 4.5).
Maltese: Għandu jiġi kkunsidrat aġġustament tad-doża ta' metformin meta jinbeda jew jitwaqqaf l-għoti fl-istess waqt ta' Dovato ma' metformin, biex jinżamm kontroll gliċemiku (ara sezzjoni 4.5).
English: Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with Dovato.
Maltese: Metformin jitneħħa mill-kliewi u, għaldaqstant, huwa importanti li tiġi mmonitorjata l-funzjoni tal-kliewi meta jingħata fi trattament ma' Dovato.
English: Interaction not studied containing products, since both lamivudine (in Dovato) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Maltese: Dovato mhuwiex irrakkomandat għallużu flimkien ma' prodotti li fihom emtricitabine, peress li kemm lamivudine (f'Dovato) kif ukoll emtricitabine huma analogi taċ-ċitidina, (jiġifieri hemm riskju għal interazzjonijiet intraċellulari) (ara sezzjoni 4.4)
English: Dolutegravir increased metformin concentrations.
Maltese: Dolutegravir żied il-konċentrazzjonijiet ta' metformin.
English: Magnesium Stearate
Maltese: Metformin ↑ Dolutegravir ↔
English: Pregnancy
Maltese: Antikonvulsanti
English: • if you have a kidney problem.
Maltese: • Jekk inti għandek xi problemi tal-kliewi.
English: In 100% human serum, the mean fold shift for dolutegravir activity was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Maltese: F'100% seru tal-bniedem, il-bidla medja fil-valur għall-attività ta' dolutegravir kienet ta' 75 darba, u dan irriżulta f'IC90 aġġustata għall-proteina ta' 0.064 µg/mL. Lamivudine jesibixxi farmakokinetika lineari fuq il medda tad-doża terapewtika u juri twaħħil baxx mal-proteina tal-plażma (anqas minn 36%).
English: There are no clinical study data on the effects of Dovato in the paediatric population.
Maltese: M'hemm ebda data minn studji kliniċi fuq l-effetti ta' Dovato fil-popolazzjoni pedjatrika.
English: The higher lamivudine Cmax, is not considered clinically relevant.
Maltese: Din iż-żieda mhijiex meqjusa klinikament rilevanti.
English: Miscellaneous
Maltese: Anzjani
English: Tabulated summary of adverse reactions to Dovato based on clinical study and postmarketing experience with Dovato and its individual components Frequency
Maltese: Sommarju tabulat ta' reazzjonijiet avversi għal Dovato bbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq b'Dovato u l-komponenti individwali tiegħu
English: vomiting, flatulence, abdominal pain/ discomfort
Maltese: remettar, gass fl-istonku, uġigħ/skumdità addominali
English: When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir AUC0-t was 16% higher for Dovato than for dolutegravir 50 mg co-administered with lamivudine 300 mg.
Maltese: .2 Tagħrif farmakokinetiku Meta jingħata fuq stonku vojt, il-bijoekwivalenza rigward is-Cmax inkisbet għal dolutegravir, meta Dovato tqabbel ma' dolutegravir 50 mg mogħti flimkien ma' lamivudine 300 mg.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Maltese: Kull pillola miskija b'rita fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir u 300 mg ta'
English: Use in adolescents
Maltese: TA' EĊĊIPJENTI
English: • lack of energy (fatigue)
Maltese: • nuqqas ta' enerġija (għeja)
English: • sensation of weakness in the limbs.
Maltese: • sensazzjoni ta' dgħufija fir-riġlejn.
English: the St. John's wort co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Maltese: (formulazzjoni separata ta' dolutegravir hija disponibbli għal dan l-aġġustament tad-doża, ara sezzjoni 4.2).
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of race on PK parameters.
Maltese: M'hemm ebda evidenza li jkun meħtieġ aġġustament fid-doża ta' dolutegravir jew lamivudine abbażi tal-effetti tar razza fuq il-parametri PK.
English: Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
Maltese: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
English: Effect of dolutegravir and lamivudine on the pharmacokinetics of other medicinal products
Maltese: L-effett ta' dolutegravir u lamivudine fuq il-farmakokinetika ta' prodotti mediċinali oħrajn
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Maltese: Pakketti multipli li fihom 90 pillola miksija b'rita (3 pakketti ta' 30 pillola miksija b'rita) huma disponibbli wkoll.
English: Some clinical findings also support a possible interaction between lamivudine and cladribine.
Maltese: Xi sejbiet kliniċi jappoġġaw ukoll interazzjoni possibbli bejn lamivudine u cladribine.
English: In the Phase III studies for the dolutegravir single agent, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Maltese: u/jew C sakemm it-testijiet tal-kimika fil-fwied ta' linja bażi ma kinux jaqbżu b'5 darbiet il-limitu superjuri tan-normal (ULN).
English: Concomitant use of Dovato with cladribine is not recommended (see section 4.4).
Maltese: cladribine mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Maltese: (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tiġi stmata mid-data disponibbli).
English: Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine (see section 5.1).
Maltese: fl-adulti u fl-adolexxenti li għandhom aktar minn 12-il sena u li jiżnu minn tal-inqas 40 kg, mingħajr ebda reżistenza magħrufa jew issuspettata għall-klassi tal-inibitur tal-integrase, jew għal lamivudine (ara sezzjoni 5.1).
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Maltese: L-effett ta' trattament ta' kuljum fit-tul b'dożi għoljin ta' dolutegravir ġie evalwat fi studji tat-tossiċità b'doża orali ripetuta fil-firien (sa 26 ġimgħa) u fix-xadini (sa 38 ġimgħa).
English: Osteonecrosis
Maltese: Osteonekrożi
English: Trimethoprim (an inhibitor of these transporters) has been shown to increase lamivudine plasma concentrations, however the resulting increase was not clinically significant (see Table 1).
Maltese: Trimethoprim (inibitur ta' dawn it-trasportaturi) intwera li jżid ilkonċentrazzjonijiet ta' lamivudine fil-plażma, madankollu ż-żieda li rriżultat ma kinitx klinikament sinifikanti (ara Tabella 1).
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' disfunzjoni tal mitokondrija fi trabi li huma negattivi għal HIV li kienu esposti fl-utru u/jew wara t-twelid għall-analogi tan nukleosidi; dawn kienu jikkonċernaw b'mod predominanti t-trattament b'korsijiet li kien fihom zidovudine.
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the tipranavir/ritonavir co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Maltese: Dovato sakemm idum jingħata wkoll tipranavir/ritonavir (formulazzjoni separata ta' dolutegravir hija disponibbli għal dan l-aġġustament tad-doża, ara sezzjoni 4.2).
English: • abnormal dreams
Maltese: • ħolm anormali
English: Iron supplements/Dolutegravir (fasted intake)
Maltese: Supplimenti tal ħadid/Dolutegravir (teħid fuq stonku vojt)
English: Total blood and plasma drugrelated radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Maltese: Ilproporzjonijiet totali fil-konċentrazzjoni ta' radjuattività relatata mal-mediċina fil-plażma u d-demm kellhom medja ta' bejn 0.441 sa 0.535, u dan jindika assoċjazzjoni minima ta' radjuattività mal-komponenti ċellulari tad-demm.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Maltese: Lamivudine ma kienx teratoġeniku fi studji fl-annimali, iżda kien hemm indikazzjonijiet ta' żieda fl-imwiet bikrija tal-embrijuni fi fniek f'esponimenti sistemiċi relattivament baxxi, meta mqabbla ma' dawk miksuba fil-bnedmin.
English: In animal reproductive toxicology studies with dolutegravir, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Maltese: Fi studji tossikoloġiċi fuq ir-riproduzzjoni fl-annimali b'dolutegravir, ma ġewx identifikati eżiti negattivi fliżvilupp, inklużi difetti fit-tubu newrali (ara sezzjoni 5.3). Dolutegravir intwera li jgħaddi minn ġol-plaċenta fl-annimali.
English: Phase 1 Clinical PK/PD
Maltese: Fażi 1 PK/PD Klinika
English: 200 mg/vial (66,7 mg/ml)
Maltese: 200 mg/kunjett (66,7 mg/ml)
English: Re-examination procedure under Article 32(4) of Directive 2001/83/EC, as amended
Maltese: Proċedura ta' eżami mill-ġdid skont l-Artikolu 32(4) tad-Direttiva 2001/83/KE, kif emendat
English: 400 mg/vial (133,4 mg/ml)
Maltese: 400 mg/kunjett (133,4 mg/ml)
English: The originator product Targocid 400mg is registered in Germany since 10th March 1992.
Maltese: Il-prodott oriġinatur Targocid 400 mg ilu rreġistrat fil-Ġermanja sa mill10 ta' Marzu 1992.
English: Overall the total numbers of adverse events observed were similar for both treatments.
Maltese: Globalment in-numri totali ta' avvenimenti avversi osservati kienu simili għażżewġ trattamenti.
English: In 2005 Hospira UK submitted applications for Decentralised Procedure for Teicoplanin Hospira 200 mg & 400 mg powder and solvent for solution for injection in the framework of Article 28 of Directive 2001/83/EC, as amended.
Maltese: UK issottomettiet applikazzjonijiet għal Proċedura Deċentralizzata għal Teicoplanin Hospira 200 mg u 400 mg trab u solvent għal soluzzjoni għall-injezzjoni fil-qafas tal-Artikolu 28 tadDirettiva 2001/83/KE, kif emendata.
English: Taking into consideration the legal basis of the application, a clear negative trend was observed at the CHMP.
Maltese: Meta titqies il-bażi legali tal-applikazzjoni, ġiet osservata tendenza negattiva ċara fis-CHMP.
English: Therefore a bioequivalence study is not required, in line with the Note for Guidance on The Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98).
Maltese: Għaldaqstant mhuwiex meħtieġ studju ta' bijoekwivalenza, f'konformità man-Nota għal Gwida dwar LInvestigazzjoni tal-Bijodisponibbiltà u l-Bijoekwivalenza (CPMP/EWP/QWP/1401/98).