FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-bilanċ globali bejn il-benefiċċju u rriskju għall-prodotti kkonċernati huwa pożittiv u rrakkomanda emendi għall-perjodi tal-irtirar għall-frat, għan-nagħaġ u għall-mogħoż biex tiġi pprovduta assigurazzjoni għas-sikurezza tal-konsumatur.
English: ANNEX
Maltese: MILL
English: • That Thelin is teratogenic
Maltese: • Li Thelin hu teratoġinku
English: • Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium oNeed for regular monitoring of INR oBe aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
Maltese: • L-effett ta' Thelin fuq il-ħruġ tad-demm o Interazzjoni ma' warfarin u antagonisti ta' vitamina K li jwasslu għal żieda fl-INR o Il-ħtieġa li tnaqqas id-doża stabbilita ta' l-antagonisti ta' vitamina K meta tibda t terapija b'sitaxentan o Ibda l-kura bl-antagonisti ta' vitamina K b'doża mnaqqsa jekk diġà qed jingħata sitaxentan sodium o Il-ħtieġa ta' monitoraġġ regolari ta' l-INR o Kun af dwar il-potenzjal ta' emorraġija u investiga kif suppost o Żieda fir-riskju li tinfaraġ u ħruġ ta' demm ġinġivali
English: > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Maltese: • >8 x ULN:
English: The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Maltese: o Dettalji anonimi tal-pazjent - età, sess u etoloġija tal-PAH o Mediċini li jittieħdu fl-istess ħin o Raġuni dwar għaliex Thelin m'għadux jingħata o ADRs ○ L-ADRs serji kollha ○ Żieda fl-enzimi tal-fwied sa > 3 x ULN ○ Żieda fil-bilirubina tat-tip dirett ta' > 2x ULN ○ Anemija ○ Emorraġija ○ Tqala u r-riżultat ○ Edema pulmonari (assoċjata ma' mard okklużiv tal-vini)
English: • Physician information about Thelin
Maltese: • Tagħrif għat-tobba dwar Thelin
English: The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin.
Maltese: L-MAH għandu jwaqqaf programm ta' sorveljanza biex jiġbor tagħrif dwar: id-demografija talpazjenti li jingħataw Thelin, kwalunkwe reazzjonijiet avversi u raġunijiet li minħabba fihom Thelin ma jibqax jingħata.
English: • That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
Maltese: • Li d-database tas-sigurtà ta' Thelin hi limitata u li t-tobba huma mħeġġa biex jirreġistraw ilpazjenti fil-programm ta' sorveljanza biex jiżdied l-għarfien dwar l-inċidenza ta' reazzjonijiet avversi importanti tal-mediċina (ADRs - adverse drug reactions).
English: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
Maltese: • Li Thelin hu teratoġeniku o L-użu ta' kontraċezzjoni effettiva għan-nisa li qegħdin fl-età li jista' jkollhom it-tfal o Interazzjoni possibbli ma' kontraċettivi orali u żieda fir-riskju ta' tromboemboliżmu o Il-ħtieġa li pazjenti nisa jkunu avżati dwar it-teratoġeniċità, il-kontraċezzjoni, u jekk meħtieġ, il-bżonn li jsir test tat-tqala u x'għandhom jagħmlu jekk joħorġu tqal o Riferiment ta' pazjenti li jinqabdu tqal lil tabib li jkun speċjalizzat jew li għandu esperjenza fit-teratoloġija u d-dijanjosi tagħha, għal evalwazzjoni u pariri
English: > 5 and ≤ 8 × ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Maltese: Ikkonferma billi tagħmel test ieħor tal-fwied; jekk dan ikun ikkonfermat, waqqaf il-kura u segwi l-livelli ta' aminotransferases ta' l-inqas kull ġimagħtejn sakemm il-livelli jiġu għan-normal.
English: Blister (OPA/Alu/PVC) 60 tablets
Maltese: Folja (OPA/Alu/PVC)
English: Name
Maltese: Numru ta' l-EU Isem
English: Tablet container (HDPE) 60 tablets
Maltese: Flixkun (HDPE)
English: NC= Failure
Maltese: NC= Falliment
English: St. John's wort
Maltese: John's wort
English: QD BID Difference [95% CI]
Maltese: QD BID Differenza [95% CI]
English: DM-6705 (delamanid active metabolite):
Maltese: DM-6705 (delamanid metabolit attiv):
English: 15 to 25
Maltese: 15 sa 25
English: Gender, Race and Age
Maltese: Sess, Razza u Età
English: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland
Maltese: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Irlanda
English: Important information
Maltese: Informazzjoni Importanti
English: 15 to 20 kg > 20 to 25 kg > 25 to 30 kg > 30 to 35 kg > 35 to 40 kg
Maltese: 15 to 20 kg > 20 to 25 kg > 25 to 30 kg > 30 to 35 kg
English: Kaletra contains polyoxyl 40 hydrogenated castor oil.
Maltese: Kaletra fih polyoxyl 40 hydrogenated castor oil.
English: > 25 to 35
Maltese: > 25 sa 35
English: Adults and adolescents
Maltese: Adulti u adoloxxenti
English: Corticosteroids Dexamethasone
Maltese: Kortikosterojdi Dexamethasone
English: Postpartum n = 17**
Maltese: Wara t-tqala n = 17**
English: Kaletra is an antiretroviral medicine.
Maltese: Kaletra huwa mediċina antiretrovirali.
English: * n = 18 for Cmax ** n = 16 for Cpredose
Maltese: * n = 18 għal Cmax ** n = 16 għal Cpredose
English: Lamotrigine and Valproate Lamotrigine:
Maltese: Lamotrigine u Valproate Lamotrigine:
English: 60 ml oral solution
Maltese: 60 ml soluzzjoni orali
English: 2.25 ml 2.75 ml 3.50 ml 4.00 ml 4.75 ml
Maltese: 2.25 ml 2.75 ml 3.50 ml 4.00 ml
English: 67061 Ludwigshafen Germany
Maltese: 67061 Ludwigshafen Il-Ġermanja
English: Abacavir, Zidovudine:
Maltese: Abacavir, Zidovudine Abacavir, Zidovudine:
English: Body Surface Area* (m2) Twice daily oral solution dose (dose in mg)
Maltese: > 6 xhur sa 18-il sena Body Surface Area* (m2) Twice daily oral solution dose (dose in mg)
English: (equivalent to 245 mg tenofovir disoproxil)
Maltese: 245 mg tenofovir disoproxil)
English: Not known Stevens-Johnson syndrome, erythema multiforme
Maltese: Sindromu ta' Stevens-Johnson, erythema multiforme
English: Rifabutin, 150 mg QD Rifabutin (parent drug and active 25-O-desacetyl metabolite):
Maltese: Rifabutin, 150 mg QD Rifabutin (mediċina prinċipali u metabolit attiv 25-O-desacetyl):
English: AUC and Cmax ↓ ~50%
Maltese: AUC u Cmax ↓ ~50%
English: 4 tablets (400/100 mg) 5 tablets (500/125 mg)
Maltese: 4 pilloli (400/100 mg) 5 pilloli (500/125 mg)
English: At steady state, lopinavir is approximately 98 − 99% bound to serum proteins.
Maltese: Fi steady-state lopinavir huwa approssimattivament 98-99% marbut mal-proteini tas-serum.
English: HIV CCR5 - antagonist Maraviroc
Maltese: Antagonisti ta' HIV CCR5 Maraviroc
English: Parenteral Midazolam:
Maltese: Midazolam Parenterali:
English: Fluvastatin is partially metabolised by CYP2C9.
Maltese: Fluvastatin jiġi parzjalment metabolizzat minn CYP2C9.
English: For larger volumes an alternative pack is available.
Maltese: Għal volumi iżgħar hemm disponibbli pakkett alternattiv.
English: Erectile dysfunction medicines (avanafil, vardenafil, sildenafil, tadalafil)
Maltese: Mediċini għad-disfunzjoni erettili(avanafil, vardenafil, sildenafil, tadalafil)
English: • damage to nerves of the peripheral nervous system;
Maltese: − ħsara fin-nervituri tas sistema nervuża periferali;
English: b. Tabulated list of adverse reactions
Maltese: b. Tabella ta'reazzjonijiet avversi
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz, 600 mg QD Lopinavir:
Maltese: Inibituri non-nucleoside reverse transcriptase (NNRTIs): Efavirenz, 600 mg QD Lopinavir:
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Maltese: BSA (m2) = √ (Tul (ċentimetri) X Piż (kilogrammi) / 3600)
English: • HIV-1 integrase inhibitor (e.g. raltegravir);
Maltese: - inibitur tal-HIV-1 integrase (eż. raltegravir);
English: Nucleoside/Nucleotide reverse transcriptase inhibitors (NRTIs) Stavudine, Lamivudine Lopinavir: ↔
Maltese: Inibituri nukleoside/nukleotidereverse transcriptase(NRTIs) Stavudine, Lamivudine Lopinavir: ↔
English: Phosphodiesterase(PDE5) inhibitors Avanafil (ritonavir 600 mg BID)
Maltese: Inibituri ta' Phosphodiesterase(PDE5) Avanafil (ritonavir 600 mg BID)
English: • non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
Maltese: - inibituri non-nucleoside reverse transcriptase (NNRTIs) (eż.efavirenz, nevirapine);
English: 3 tablets (300/75 mg)
Maltese: 3 pilloli (300/75 mg)
English: HCV direct acting antivirals Elbasvir/grazoprevir (50/200 mg QD)
Maltese: Antivirali li jaġixxu direttament kontra l-HCV Elbasvir/grazoprevir (50/200 mg QD)
English: Kaletra contains 42% v/v alcohol.
Maltese: Kaletra fih 42% v/v alcoħol.
English: • steroids (e.g. budesonide, dexamethasone, fluticasone propionate, ethinyl oestradiol,
Maltese: - sterojdi (eż. budesonide, dexamethasone, fluticasone propionate, ethinyl oestradiol, triamcinolone);
English: For volumes up to 2 ml.
Maltese: Għal volumi sa 2 ml.
English: AUC: ↑ 49-fold
Maltese: AUC: ↑ 49-darba
English: Kaletra oral solution:
Maltese: Kaletra soluzzjoni orali:
English: Immunosuppressants Cyclosporin, Sirolimus (rapamycin), and Tacrolimus
Maltese: Immuno-suppressanti Cyclosporin, Sirolimus (rapamycin), u Tacrolimus
English: The median follow-up was 48 weeks in Cohort I and 72 weeks in Cohort II.
Maltese: Is-segwitu medjan kien ta' 48 ġimgħat f'Cohort I u 72 ġimgħat f'Cohort II.
English: Integrase inhibitor Raltegravir
Maltese: Inibitur tal- Integrase Raltegravir
English: Sedatives/hypnotics
Maltese: Mediċini Sedattivi/Ipnotiċi
English: Cmax: ↑
Maltese: AUC: ↑ Cmax: ↑
English: • antidepressants (e.g. trazodone, bupropion);
Maltese: - anti-dipressanti (eż. trazodone, bupropion);
English: Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases.
Maltese: Lopinavir huwa impeditur tal-protejaż ta' HIV-1 u HIV-2 .
English: Beta2-adrenoceptor agonist (long acting) Salmeterol
Maltese: Beta2-adrenoceptor agonist (iħalli effett fit-tul)
English: Antiretroviral Agents
Maltese: Aġenti Antiretrovirali
English: Buproprion and its active metabolite, hydroxybupropion:
Maltese: Buproprion u l-metabolit attiv tiegħu, hydroxybupropion:
English: Date of first authorisation: 20 March 2001 Date of latest renewal: 20 March 2011
Maltese: Data ta' l-aħħar tiġdid: 20 ta' Marzu 2011
English: 2 tablets (200/50 mg)
Maltese: 2 pilloli (200/50 mg)
English: AUC0-12 μg•hr/mL
Maltese: AUC0-12 μg•siegħa/mL
English: Based on BSA (mg/m2)*
Maltese: Ibbażat fuq BSA (mg/m2)* Frekwenza
English: Cortisol levels ↓ 86%
Maltese: Konċentrazzjoni fil-plażma ↑ Livelli ta'cortisol ↓ 86%
English: Carbamazepine and Phenobarbital
Maltese: Carbamazepine u Phenobarbital
English: Thyroid hormone replacement therapy Levothyroxine
Maltese: Terapija ta' sostituzzjoni ta' ormon tat-tirojde Levothyroxine
English: Antihistamines Astemizole Terfenadine
Maltese: Astemizole Terfenadine
English: Interactions with medicinal products
Maltese: Interazzjonijiet ma' prodotti mediċinali
English: Phosphodiesterase (PDE5) inhibitors
Maltese: Inibituri ta' Phosphodiesterase(PDE5)
English: Table 8
Maltese: Tabella 8
English: • an abnormality in your electrocardiogram (ECG) called atrioventricular block;
Maltese: - abnormalita' fl-elettrokardjogramma (ECG) li msejħa imblukkar atrioventrikulari;
English: Antiviral activity in vitro
Maltese: Attività antiviraliin vitro
English: Bepridil, Systemic Lidocaine, and Quinidine
Maltese: Bepridil, Systemic Lidocaine, u Quinidine
English: Black ‘O' ring
Maltese: Ċirku ‘O' iswed
English: Talc
Maltese: Talkum
English: Age ≥ 6 weeks to < 6 months cohort (N = 18):
Maltese: Age ≥ 6 ġimgħat sa < 6 xhur cohort (N = 18):
English: ≥ 15 to 40 kg
Maltese: ≥ 15 sa 40 kg
English: vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
Maltese: vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (fih ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, levomenthol.
English: AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
Maltese: KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
English: ‘ml' mark
Maltese: Planġer marka ‘ml'
English: (inhibition of CYP3A enzymes)
Maltese: (inibizzjoni tal-enzimiCYP3A)
English: Table 5
Maltese: Tabella 5
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltrali u talconnective tissue
English: Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Maltese: Kaletra (80 mg + 20 mg) / ml soluzzjoni orali (lopinavir + ritonavir)
English: In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
Maltese: Fl-assenza u presenza ta' 50% serum uman, il-medja IC50 ta' lopinavir kontra HIV-1IIIB f'ċelluli MT4 kien 17 nM u 102 nM, rispettivament.
English: Pravastatin is not metabolised by CYP450.
Maltese: Pravastatin ma jiġix metabolizzat minn CYP450.
English: Each 1 ml contains 356.3 mg of alcohol (42.4% v/v), 168.6 mg of high fructose corn syrup, 152.7 mg of propylene glycol (15.3% w/v) (see section 4.3), 10.2 mg of polyoxyl 40 hydrogenated castor oil and 4.1 mg of acesulfame potassium (see section 4.4).
Maltese: Kull 1 ml fih 356.3 mg alcoħol (42.4% v/v), 168.6 mg corn syrup bil-fructose għoli, 152.7 mg propylene glycol (15.3% w/v) (ara sezzjoni 4.3), 10.2 mg polyoxyl 40 hydrogenated castor oil u 4.1 mg acesulfame potassium (ara sezzjoni 4.4).
English: AUC: ↑ 5.9-fold
Maltese: AUC: ↑ 5.9-darbiet
English: Microsomal triglyceride transfer protein (MTTP) inhibitor
Maltese: Impeditur tal-proteina li tittrasferixxi ltrigliċerida microsomali (MTTPmicrosomal triglyceride transfer protein)
English: • 120 ml (2 bottles x 60 ml).
Maltese: − 120 ml (2 fliexken x 60 ml).
English: • Store in a refrigerator (2°C - 8°C).
Maltese: - Aħżen fi friġġ (2°C - 8°C).
English: Fluticasone propionate, 50 µg intranasal 4 times daily:
Maltese: Fluticasone propionate: 50µg applikat fl-imnieħer erba' darbiet kuljum:
English: • elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
Maltese: - elbasvir/grazoprevir (użati biex jittrattaw il-virus kroniku tal-epatite Ċ [HCV]);
English: EU/1/01/172/004 EU/1/01/172/005 EU/1/01/172/007 EU/1/01/172/008
Maltese: EU/1/01/172/005 EU/1/01/172/007 EU/1/01/172/008
English: Age ≥ 6 months to < 12 years cohort (N = 53):
Maltese: Age ≥ 6 xhur sa < 12-il sena cohort (N = 53):
English: High doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended.
Maltese: Dożi għolja ta' ketoconazole u itraconazole (> 200 mg/kuljum) m'humiex rakkomandati.
English: Lopinavir is essentially completely metabolised by CYP3A.
Maltese: Essenzjalment il-lopinavir huwa kompletament metaboliżżat minn CYP3A.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Maltese: F'dan il-kwadru , il-mutazzjonijiet f'HIV protease kienu assoċjati bi tnaqqis ta' suxxettibilità in vitro għal lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T,
English: Ranitidine (150 mg single dose)
Maltese: Ranitidine (150 mg doża waħda)
English: Inhaled, injectable or intranasal fluticasone propionate, budesonide, triamcinolone
Maltese: Miġbud mill-imnifsejn, injettabbli jew applikat fl-imnieħer fluticasone propionate, budesonide, triamcinolone
English: AUC: ↑ 2.17-fold Cmax: ↑ 2.04-fold Ctrough: ↑ 2.36-fold (inhibition of CYP3A/efflux transporters)
Maltese: AUC: ↑ 2.17- darbiet Cmax: ↑ 2.04- darbiet Ctrough: ↑ 2.36- darbiet (Inibizzjoni tattrasportaturi/effluss ta' CYP3A) Dasabuvir: ↔
English: HCV protease inhibitors Simeprevir 200 mg daily (ritonavir 100 mg BID)
Maltese: Inibituri ta'HCV protease Simeprevir 200 mg daily (ritonavir 100 mg BID [darbtejn kuljum])
English: Monitor for ADRs related to ceritinib.
Maltese: Issorvelja għall-ADRs relatati ma' ceritinib.
English: Outcomes at Week 48: Study M98-957
Maltese: Riżultati ta' ġimgħa 48: Studju M98-957
English: • 300 ml (5 bottles x 60 ml).
Maltese: − 300 ml (5 fliexken x 60 ml).
English: • HIV CCR5-antagonist (e.g. maraviroc);
Maltese: quinidine); - antagonist tal-HIV CCR5 (eż. maraviroc);
English: Herbal products St John's wort (Hypericum perforatum)
Maltese: Fexfiex tar-Raba' (St John's wort)(Hypericum perforatum)
English: This may be unsuitable in hereditary fructose intolerance.
Maltese: Din tista ma taqbilx ma min għandu intoleranza ta' fructose ereditarja.
English: • anti-epilepsy medicines (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine and valproate);
Maltese: - mediċini għal kontra l-epilessija (eż. carbamazepine, phenytoin, phenobarbital, lamotrigine u valproate);
English: 0.7 ml (57.5/14.4 mg) 1.2 ml (96/24 mg) 1.4 ml (115/28.8 mg) 2.2 ml (172.5/43.1 mg) 2.3 ml (184/46 mg) 2.9 ml (230/57.5 mg) 3.6 ml (287.5/71.9 mg) 3.7 ml (299/74.8 mg) 4.0 ml (322/80.5 mg) 4.3 ml (345/86.3 mg) 5 ml (402.5/100.6 mg) *Body surface area can be calculated with the following equation BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Maltese: 0.7 ml (57.5/14.4 mg) 1.2 ml (96/24 mg) 1.4 ml (115/28.8 mg) 2.2 ml (172.5/43.1 mg) 2.3 ml (184/46 mg) 2.9 ml (230/57.5
English: Kaletra does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
Maltese: F'konċentrazzjoni klinika rilevanti, Kaletra ma jimpedixxix CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 jew CYP1A2 (ara sezzjoni 4.3).
English: Mutations V82A, I54V and M46I emerged most frequently.
Maltese: Mutazzjonijiet V82A, I54V u M461 kienu l-iktar li ħarġu.
English: Overall failure rate combining the treatment differences across age strata, weighted by the precision of the estimate within each age stratum p=0.015 (Cohort I); p< 0.001 (Cohort II)
Maltese: Rata ta' falliment globali li tiġbor id-differenza ta' trattament madwar l-istrata ta'età, ippeżat bil-preċiżjoni tal-estimi fi ħdan kull stratum ta' età p = 0.015 (Cohort I); p <0.
English: Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women
Maltese: Medja (%CV) fi Stat fiss tal-Parametri Farmokinetiċi ta' Lopinavir f'Nisa Tqal Infettati bl
English: KONCERT/PENTA 18 is a prospective multicentre, randomised, open-label study that evaluated the pharmacokinetic profile, efficacy and safety of twice-daily versus once-daily dosing of lopinavir/ritonavir 100 mg/25 mg tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173).
Maltese: KONCERT/PENTA 18 huwa studju multicentre prospettiv, randomised uopen -label li evalwa l-profil farmakokinetiku, l-effikaċja u s-sigurtà ta'dożaġġ ta' darbtejn kuljum versus darba kuljum ta'pilloli ta'lopinavir/ritonavir 100 mg/25 mgdożati skont il-piż bħala partimit-terapija antiretrovirali kombinata(cART) fit-tfal infettati b'HIV-1 li huma soppressi viroloġikament (n = 173).
English: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, United Kingdom AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Maltese: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Renju Unit AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, l-Olanda
English: Renal Insufficiency
Maltese: Indeboliment renali
English: Refer to colchicine prescribing information.
Maltese: Irreferi għall-informazzjoni talpreskrizzjoni ta' colchicine.
English: Lopinavir AUC over a 24 hour dosing interval averaged 206.5 ± 89.7 µg•h/ml.
Maltese: Lopinavir AUC wara dużaġġ ta' 24 siegħa kienet ta medja ta' 206.5 ± 89.7 µg·h/ml.
English: Resistance to nelfinavir, defined as the presence of the D30N or L90M mutation in protease, was observed in 41/96 (43%) patients.
Maltese: mutazzjoni D30N jew L90M tal-proteaż, ġiet osservata f' 41/96 (43%) tal-pazjenti.
English: The EC50 of lopinavir against the 56 baseline viral isolates ranged from 0.6 to 96-fold higher than the EC50 against wild type HIV.
Maltese: L-EC50 ta' lopinavir kontra is-56 iżolat virali fil-linja bażi varja bejn 0.6 u 96 darba aktar mill-EC50 kontra l-HIV ta' tip mhux ikkultivat.
English: Hazard ratio for death or failure of therapy* * Failure defined as clinical, immunological disease progression, virological failure or regimen limiting ART toxicity p=0.0005 (40 week arm); p< 0.0008 (96 week arm)
Maltese: *Falliment iddefinit bħala kliniku, progressjoni immunoloġika tal-marda, falliment viroloġiku jew dożaġġ bi tossiċità limitata ta' ART p=0.0005 (fergħa ta' 40 ġimgħa); p< 0.0008 (fergħa ta' 96 ġimgħat)
English: triamcinolone);
Maltese: tacrolimus);
English: • protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
Maltese: - inibituri tal-‘protease' (eż., fosamprenavir, indinavir, ritonanvir, saquinavir, tipranavir);
English: Outcomes at Week 48: Study M98-940* Antiretroviral Naïve (N=44)
Maltese: Riżultati ta' ġimgħa 48: Studju M98-940* Dawk li ma ħadux mediċina antiretrovirali qabel (N=44)
English: Oral contraceptives Ethinyl Oestradiol
Maltese: Ethinyl Oestradiol
English: Uncommon Tinnitus, vertigo
Maltese: Tisfir tal-widnejn, vertigo
English: • sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery).
Maltese: - sildenafil użat għat-trattament ta' ipertensjoni arterjali pulmonari (pressjoni għolja fl-arterja talpulmun).
English: Patients were administered emtricitabine 200 mg once daily and tenofovir DF 300 mg once daily (equivalent to 245 mg tenofovir disoproxil).
Maltese: Pazjenti ġew mogħtija emtricitabine 200 mg darba kuljum u tenofovir DF 300 mg darba kuljum (ekwivalenti għal 245 mg tenofovir disoproxil).
English: Mean age of patients enrolled was 39 years (range: 19 to 71); 75% were Caucasian, and 78% were male.
Maltese: L-eta' medja tal-pazjenti kienet ta' 39 sena (tkopri min 19 sa 71); 75% kienu Caucasian, u 78% kienu maskili.
English: AUC: ↑ 2.71-fold Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold
Maltese: AUC: ↑ 2.71- darbiet Cmax: ↑ 1.87- darbiet C24: ↑ 3.58- darbiet
English: Around 85% of patients had a viral load of < 100,000 copies/ml.
Maltese: Madwar 85% talpazjenti kellhom ammont virali ta' <100,000 kopji/ml.
English: - 300 ml (5 bottles x 60 ml) with 5 x 5 ml syringes with 0.1 ml graduations
Maltese: − 300 ml (5 fliexken x 60 ml) bi 5 x 5 ml siringi bi gradazzjonijiet ta' 0.1 ml.
English: Outcomes at Week 24: Study M97-765
Maltese: Studju M97-765