FrancophonIA/ELRC3.0 huggingface dataset:
English: Corticosteroids Prednisone/ Dolutegravir1
Maltese: Kortikosterojdi Prednisone/ Dolutegravir1
English: Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Rilpivirine
Maltese: aluminium magnesium hydroxide, u/jew calcium cardonate)/Rilpivirine
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Maltese: Hemm informazzjoni disponibbli limitata dwar il-potenzjal għal interazzjoni farmakodinamika bejn rilpivirine u prodotti mediċinali li jtawlu l-intervall tal-QTc tal-ECG.
English: The single INI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3fold to 3.6-fold from reference).
Maltese: Is-sostituzzjonijiet reżistenti għall-INI waħdiena T66K, I151L, u S153Y taw tnaqqis ta' aktar minn 2 darbiet fis-suxxettibbiltà ta' dolutegravir (medda: 2.3 darbiet għal 3.6 darbiet mir-referenza).
English: H2-recepter antagonists Famotidine
Maltese: Antagonisti tar-riċettur H2 Famotidine
English: AUC ↓ 76% Cmin NA Cmax ↓ 85%
Maltese: AUC ↓ 76% Cmin MA Cmax ↓ 85%
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000),
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Maltese: Id-data farmakokinetika turi li l-esponiment totali (AUC) għal rilpivirine bħala parti minn reġimenen antiretrovirali kien madwar 30 % aktar baxx waqt it-tqala meta mqabbel ma' wara t-tqala (6-12-il ġimgħa).
English: Where possible, alternatives such as azithromycin should be considered.
Maltese: Fejn ikun possibbli, għandhom jiġu kkunsidrati alternattivi bħal azithromycin.
English: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent fits) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
Maltese: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (mediċini biex jikkuraw l-epilessija u biex jipprevjenu l-aċċessjonijiet) - rifampicin, rifapentine (mediċini li jintużaw biex jikkuraw xi infezzjonijiet batteriċi bħat-tuberkulożi)
English: AUC ↑ 13% Cmin NA Cmax ↑ 21%
Maltese: AUC ↑ 13% Cmin MA Cmax ↑ 21%
English: Rilpivirine AUC(0-∞) was increased by 57% and 72% and Cmax by 89% and 117%, with moderate and high fat meals respectively, compared to fasted conditions.
Maltese: rilpivirine żdiedet b'57 % u 72 % u s-Cmax b'89 % u 117 %, b'ikel b'xaħam moderat u għoli rispettivament,
English: The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Maltese: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C u M230I.
English: African-America/African Heritage/Other Age (years)
Maltese: Afrikan-Amerikan/Nisel Afrikan/Oħra
English: PI
Maltese: L
English: In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Maltese: Fl-analiżi ta' ġimgħa 48, 31 minn 62 ta' insuffiċjenzi viroloġiċi ta' rilpivirine kellhom RAMs ta' NNRTI u NRTI konkomitanti; 17 minn dawk iil-31 kellhom ilkombinazzjoni ta' E138K u M184I.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta'
English: Proton pump inhibitors Omeprazole Lansoprazole
Maltese: Inibituri tal-pompa tal-proton Omeprazole
English: In the pooled analysis, 54%, 26%, and 20% of subjects were receiving an NNRTI, PI, or INI (respectively) as their baseline third treatment agent class prior to randomisation.
Maltese: Fl-analiżi miġbura, 54 %, 26 %, u 20 % tal-individwi rċivew NNRTI, PI, jew INI (rispettivament) bħala t-tielet klassi ta' aġent ta' kura tagħhom fil-linja bażi qabel ir-randomizzazzjoni.
English: The efficacy and safety of switching from an antiretroviral regimen (containing 2 NRTIs plus either an INI, an NNRTI, or a PI) to a dual regimen of dolutegravir 50 mg and rilpivirine 25 mg was evaluated in 2 identical 48-week, randomised, open-label, multicentre, parallel-group, non-inferiority studies SWORD-1 (201636) and SWORD-2 (201637).
Maltese: jew PI) għal reġimenen doppju ta' dolutegravir 50 mg u rilpivirine 25 mg ġew evalwati f'2 studji identiċi, ta' 48 ġimgħa, randomisedi, open-label, multiċentriċi, ta' grupp parallel, ta' non-inferjorità SWORD-1 (201636) u SWORD-2 (201637).
English: Anticoagulants Dabigatran etexilate/ Dolutegravir
Maltese: Dabigatran etexilate/ Dolutegravir
English: Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected.
Maltese: Huwa mistenni tnaqqis minħabba l-induzzjoni ta' enzimi ta' UGT1A1 u CYP3A, huwa mistenni tnaqqis simili flesponiment kif osservat b'carbamazepine.
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age and weighing ≥40 kg) showed that dolutegravir 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg orally once daily.
Maltese: Il-farmakokinetika ta' dolutegravir f'10 adolexxenti infettati bl-HIV-1 li esperjenzaw kura antiretrovirali (età ta' 12 sa <18-il sena u li jiżnu ≥40 kg) uriet li dolutegravir 50 mg dożaġġ orali ta' darba kuljum irriżulta f'esponiment għal dolutegravir komparabbli ma' dak osservat fl-adulti li rċivew dolutegravir 50 mg oralment darba kuljum.
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Maltese: L-attività ta' rilpivirine hi medjata minn inibizzjoni mhux kompetittiva ta' reverse transcriptase tal-HIV-1 (RT).
English: Sofosbuvir ↔ AUC ↔ Cmax ↑ 21% Sofosbuvir metabolite GS
Maltese: Sofosbuvir ↔ AUC ↔ Cmax ↑ 21% Metabolit GS-331007 ta' sofosbuvir ↔ AUC ↔
English: Herbal products St. John's wort/ Dolutegravir
Maltese: John's wort/Dolutegravir
English: AUC ↓ 14% Cmin NA Cmax ↓ 14%
Maltese: AUC ↓ 14% Cmin MA Cmax ↓ 14%
English: Site-directed INI mutant virus
Maltese: Cross-resistance Virus mutanti INI dirett mis-sit
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Maltese: Meta dożi supraterapewtiċi ta' 75 mg darba kuljum u 300 mg darba kuljum ta' rilpivirine ġew studjati f'adulti b'saħħithom, il-medja tad-differenzi massimi time‑m atched (95% upper confidence bound) flintervall tal-QTcF mill-plaċebo wara l-korrezzjoni tal-linja bażi kienu ta' 10.7 (15.3) u 23.3 (28.4) ms, rispettivament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/002
Maltese: EU/1/18/1282/001 EU/1/18/1282/002
English: Anticonvulsants Carbamazepine/ Dolutegravir1
Maltese: Prodotti antitkonvulsivi Carbamazepine/ Dolutegravir1
English: In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Maltese: F'nisa li kienu qed jirċievu 25 mg darba kuljum waqt it-2 trimestru tat-tqala, il-valuri intraindividwali medji għall-valuri totali ta' Cmax, AUC24h u Cmin ta' rilpivirine kienu, rispettivament, 21 %, 29 % u 35 % aktar baxxi meta mqabbla ma' wara t-tqala; waqt it-3 trimestru tat-tqala, il-valuri ta' Cmax, AUC24h u Cmin kienu, rispettivament, 20 %, 31 % u 42 % aktar baxxi meta mqabbla ma' wara t-tqala (ara sezzjonijiet 4.2, 4.4. u
English: The pharmacokinetics of rilpivirine in 36 antiretroviral treatment-naïve HIV-1 infected adolescent subjects (12 to <18 years of age) receiving rilpivirine 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Maltese: Il-farmakokinetika ta' rilpivirine f'36 individwu adolexxent infettati bl-HIV-1 li esperjenzaw kura antiretrovirali (età ta' 12 sa 18-il sena) li kienu qegħdin jirċievu rilpivirine 25 mg darba kuljum kienet komparabbli għal dik fl-adulti infettati bl-HIV-1 li qatt ma ħadu kura qabel li kienu qegħdin jirċievu 25 mg darba kuljum.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, cytochrome P450 (CYP)3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP); therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Maltese: Dolutegravir huwa wkoll substrat ta' UGT1A3, UGT1A9, ċitokromu P450 (CYP)3A4, P-glycoprotein (P-gp,), u proteina ta' reżistenza għall-kanċer tas-sider (BCRP) għalhekk prodotti mediċinali li jinduċu dawn l-enzimi jistgħu jnaqqsu l-konċentrazzjoni fil-plażma ta' dolutegravir u jnaqqsu leffett terapewtiku ta' dolutegravir (ara Tabella 1).
English: Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine
Maltese: Juluca 50 mg/25 mg pilloli miksijin b'rita dolutegravir/rilpivirine
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Maltese: G118R ibaxxi s-suxxettibbiltà dolutegravir f'mutanti diretti lejn is-sit (FC 10), iżda ma ġiex identifikat f'pazjenti li jirċievu dolutegravir fil-programm tal-Fażi III.
English: Not known Frequency cannot be estimated from the available data:
Maltese: Il-frekwenza ma tistax tiġi stmata mid-data disponibbli:
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Maltese: Din il-kombinazzjoni tista' żżid ir riskju għal aċidożi lattika f'pazjenti b'indeboliment tal-kliewi moderat (tneħħija tal-kreatinina ta' stadju 3a [CrCl] 45- 59 mL/min) u huwa rakkomandat approċċ b'kawtela.
English: Resistance to rilpivirine was considered present when FC in EC50 value was above the biological cut-off (BCO) of the assay.
Maltese: Ir-reżistenza għal rilpivirine ġiet ikkunsidrata preżenti meta FC fil-valur EC50 kien aktar mill-cut-off bijoloġiku (BCO, biological cut-off) tal-analiżi.
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and rilpivirine belongs to a group of anti-retroviral medicines called nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: Dolutegravir jappartjeni għal grupp ta' mediċini antiretrovirali msejħa inibituri ta' integrase (INIs), u rilpivirine jappartjeni għal grupp ta' mediċini antiretrovirali msejħa inibituri ta' non nucleoside reverse transcriptase (NNRTIs).
English: Macrolide antibiotics Clarithromycin Erythromycin /Dolutegravir
Maltese: Clarithromycin Erythromycin /Dolutegravir
English: Clinical safety data with Juluca is limited.
Maltese: Sommarju tal-profil tas-sigurtà Data dwar is-sigurtà klinika b'Juluca hija limitata.
English: There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in study C213 (33 to 93 kg), similar to what was observed in adults.
Maltese: Ma kien hemm l-ebda impatt tal-piż tal-ġisem fuq il-farmakokinetika ta' rilpivirine f'individwi pedjatriċi fi studju C213 (33 sa 93 kg), simili għal dak li ġie osservat fl-adulti.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one amino acid substitution at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity (FC≤BCO) against 64 (96%) of these strains.
Maltese: Virus mutanti NNRTI dirett mis-sit F'sensiela ta' 67 razza tal-HIV-1 rikombinanti fil-laboratorju b'sostituzzjoni waħda tal-amino aċidu f'pożizzjonijiet RT assoċjati ma' reżistenza għal NNRTI, li kienu jinkludu l-iktar K103N u Y181C li jinsabu b'mod komuni, rilpivirine wera attività antivirali (FC≤BCO) kontra 64 (96%) ta' dawn ir-razez.
English: The unbound fraction of dolutegravir in plasma is increased at low levels of serum albumin (<35 g/L) as seen in subjects with moderate hepatic impairment.
Maltese: Il-frazzjoni mhux marbuta ta' dolutegravir fil-plażma tiżdied f'livelli baxxi ta' albumin fis-serum (<35 g/L) kif jidher f'individwi b'indeboliment epatiku moderat.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.56 times the 50 mg human clinical exposure based on AUC).
Maltese: Fil-fniek, ġie osservat effett tossiku matern (tnaqqis fil-konsum tal-ikel, insuffiċjenti/ebda ppurgar/awrina, żieda fil-piż tal-ġisem imrażżna) b'1000 mg/kg (0.56 darba l-50 mg esponiment kliniku talbniedem abbażi tal-AUC).
English: In a DEXA substudy mean bone mineral density (BMD) increased from Baseline to Week 48 in subjects who switched to dolutegravir plus rilpivirine (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing antiretroviral regimen (0.05% total hip and 0.15% lumbar spine.
Maltese: Ġimgħa 48 f'individwi li qelbu għal dolutegravir flimkien ma' rilpivirine (1.34% total tal-ġenb u 1.46% sinsla tad-dahar lumbari) meta mqabbel ma' dawk li baqgħu fuq il-kura b'reġimenen antiretrovirali li fih TDF (0.05% total tal-ġenb u 0.15% sinsla tad-dahar lumbari.
English: In a Week 96 pooled analyses of virologic failures with baseline viral load ≤100,000 copies/mL and resistance to rilpivirine (n = 5), subjects had cross-resistance to efavirenz (n = 3), etravirine (n = 4), and nevirapine (n = 1).
Maltese: Pazjenti adulti infettati bl-HIV-1 li ma ġewx ikkurati preċedentement Fl-analiżijiet miġbura ta' Ġimgħa 96 ta' insuffiċjenzi viroloġiċi b'tagħbija virali fil-linja bażi ≤100,000 kopja/mL u b'reżistenza għal rilpivirine (n = 5), l-individwi kellhom reżistenza inkroċjata għal efavirenz (n = 3), etravirine (n = 4), u nevirapine (n = 1).
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Maltese: CYP1A2, CYP2B6 jew CYP3A4.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Maltese: Ma ġiex iddeterminat valur cut-off fenotipiku klinikament rilevanti (FC kontra virus tat-tip selvaġġ);
English: common increased bilirubin uncommon hepatitis rare acute hepatic failure**
Maltese: komuni bilirubina miżjuda mhux komuni epatite rari insuffiċjenza akuta tal-fwied**
English: gp).
Maltese: gastriku).
English: AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
Maltese: L-AUC fissemen kienet ta' 7 % u 17 % fit-tessut rettali ta' dawk fil-plażma korrispondenti fi stat fiss.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni "Reazzjonijiet Allerġiċi” f'sezzjoni 4 ta' dan il-fuljett.
English: Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (clades A, B, C, D, F, G, H) primary isolates with IC50 values ranging from 0.07 to 1.01 nM and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM.
Maltese: (clades A, B, C, D, F, G, H) b'valuri IC50 li jvarjaw minn 0.07 sa 1.01 nM u iżolati primarji ta' grupp O b'valuri EC50 li jvarjaw minn 2.88 sa 8.45 nM.
English: Pharmacokinetic data in subjects >65 years old are very limited.
Maltese: Data farmakokinetika f'individwi li kellhom >65 sena hija limitata ħafna.
English: • allergic (hypersensitivity) reaction (see ‘allergic reactions' earlier in this section)
Maltese: • reazzjoni allerġika (sensittività eċċessiva) (ara “reazzjonijiet allerġiċi” aktar 'il fuq f'din is-sezzjoni)
English: • decrease in haemoglobin
Maltese: • nuqqas fl-emoglobina
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji rilevanti huma retinite kkawżata minn ċitomegalovirus, infezzjonijiet b'mikobatteriċi ġeneralizzati u/jew fokali u Pneumocystis jirovecii pneumonia.
English: In a rilpivirine study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Maltese: Fi studju li qabbel 8 pazjenti b'indeboliment tal-fwied ħafif (Child‑Pugh Klassi A) ma' 8 kontrolli mqabblin u 8 pazjenti b'indeboliment tal-fwied moderat (Child‑Pugh K lassi A) ma' 8 kontrolli mqabblin,
English: • difficulty in sleeping (insomnia).
Maltese: • diffikultà biex torqod (insomnja).
English: Steadystate administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine (see section 4.4).
Maltese: L-għoti fl-istat fiss ta' rilpivirine 75 mg darba kuljum u 300 mg darba kuljum irriżulta f'medja tas-Cmax ta' madwar 2.6 drabi iżjed u 6.7 drabi iżjed, rispettivament, ogħla mill-medja tas-Cmax fl istat fiss osservata bid-doża rakkomandata ta' 25 mg ta' rilpivirine darba kuljum (ara sezzjoni 4.4).
English: (induction of CYP3A enzymes).
Maltese: (induzzjoni ta' enzimi ta' CYP3A).
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni komuni ħafna kolesterol totali miżjud (fi stat sajjem) kolesterol LDL miżjud (fi stat sajjem)
English: Drug Interactions Medicinal products by therapeutic areas
Maltese: Interazzjonijiet Mediċinali Prodotti mediċinali skont iż-żoni terapewtiċi
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Maltese: Kull pillola fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir u rilpivirine hydrochloride ekwivalenti għal 25 mg rilpivirine.
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Maltese: L-AUC fil-fluwidu ċervikovaġinali, it tessut ċervikali u tessut vaġinali kienet 6-10 % ta' dawk fil-plażma korrispondenti fi stat fiss.
English: Co-administration of Juluca with St. John's wort is contraindicated (see section 4.3).
Maltese: John's wort huwa kontrindikat (ara sezzjoni 4.3).
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Maltese: Wara għoti orali, il-konċentrazzjoni massima fil-plażma ta' rilpivirine ġeneralment tinkiseb fi żmien 4-5 sigħat.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions).
Maltese: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Irbit kumpless ma' joni polivalenti).
English: Other medicines and Juluca
Maltese: Mediċini oħra u Juluca
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Maltese: prodotti mediċinali li huma substrati ta' kwalunkwe enzima jew trasportatur maġġuri bħal CYP3A4, CYP2C9 u P-gp (għal aktar informazzjoni ara sezzjoni 5.2)
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions).
Maltese: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Irbit kumpless ma' joni polivalenti).
English: In limited data from small numbers of women in study IMPAACT P1026 who received dolutegravir 50 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total dolutegravir Cmax, AUC24h and C24h values were, respectively, 26%, 37% and 51% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 25%, 29% and 34% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Maltese: F'data limitata minn numri żgħar ta' nisa fl-istudju IMPAACT P1026 li rċievew dolutegravir 50 mg darba kuljum matul it-tieni trimestru tat-tqala, il-valuri medji intra-individwali għal valuri Cmax, AUC24h u C24h ta' dolutegravir totali kienu, rispettivament, 26%, 37% u 51% aktar baxxi meta mqabbla ma' wara t-twelid; matul it-tielet trimestru tat-tqala, il-valuri Cmax, AUC24h u Cmin kienu, rispettivament, 25%, 29% u 34% aktar baxxi meta mqabbla ma' wara t-twelid (ara s-sezzjonijiet 4.2, 4.4. and 4.6).
English: Antacid medicines
Maltese: Mediċini antaċidi
English: Co-administration with the following medicinal products: - dofetilide; - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; - rifampicin, rifapentine; - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment; - St John's wort (Hypericum perforatum).
Maltese: - dofetilide; - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; - rifampicin, rifapentine; - inibituri tal-pompa tal-proton, bħal omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole;
English: Considering all of the available in vitro and in vivo data, the following amino acid substitutions, when present at baseline, are likely to affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I or M230L.
Maltese: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I jew M230L.
English: The IC50 for dolutegravir against various laboratory strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Maltese: L-IC50 għal dolutegravir f'diversi razez tal-laboratorju permezz ta' PBMC kien 0.5 nM, u meta ntużaw ċelluli MT-4, varja minn 0.7-2 nM.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Maltese: Antivirali għal użu sistemiku, antivirali għall-kura ta' infezzjonijiet tal-HIV,
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
Maltese: Pakkett multiplu: 90 (3 pakketti ta' 30) pillola MOD TA' KIF U MNEJN JINGĦATA
English: In phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure.
Maltese: fażi 3, esponiment aktar baxx ta' rilpivirine, simili għal dak li deher waqt it-tqala, ġie assoċjat ma' riskju miżjud ta' insuffiċjenza viroloġika.
English: Reporting of suspected adverse reactions
Maltese: Antaċidi u supplimenti Antaċidi (eż.,
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: - Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull unita ta' dożaġġ, jiġifieri hija essenzjalment “mingħajr sodium”.
English: Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes).
Maltese: Huwa mistenni esponiment miżjud ta' rilpivirine (inibizzjoni ta' enzimi ta' CYP3A).
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir and rilpivirine
Maltese: Effett ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' dolutegravir u rilpivirine