FrancophonIA/ELRC3.0 huggingface dataset:
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Maltese: Peress li l-pożizzjoni tas-CMDh ġiet adottata b'vot ta' maġġoranza, intbagħtet lill-Kummissjoni Ewropea, li approvatha u fit-23 ta' Ġunju 2014 adottat deċiżjoni legalment vinkolanti madwar l-UE kollha.
English: The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes have been made to the product information to minimise the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use.
Maltese: Is-CMDh qabel li l-bilanċ tal-benefiċċju-riskju ta' dawn il-mediċini jibqa' pożittiv, madankollu, saru xi bidliet fl-informazzjoni tal-prodott sabiex jiġi minimizzat ir-riskju magħruf ta' tnaqqis filviġilanza mentali u tnaqqis fil-ħila ta' sewqan u tħaddim ta' magni l-għada filgħodu wara li jintuża.
English: Zolpidem is a medicine used for the short-term treatment of insomnia.
Maltese: Zolpidem huwa mediċina li tintuża għall-kura fuq żmien qasir ta' insomnja.
English: • Since the risk of reduced mental alertness and driving ability seems to increase if zolpidem is taken together with other medicines that cause drowsiness or lack of alertness, or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Maltese: • Peress li r-riskju ta' tnaqqis fil-viġilanza mentali u l-ħila ta' sewqan jidher li jiżdied jekk zolpidem jittieħed flimkien ma' mediċini oħra li jikkawżaw ħedla jew nuqqas ta' viġilanza mentali, jew malalkoħol jew drogi illeċiti, dawn is-sustanzi m'għandhomx jintużaw meta jkun qed jittieħed zolpidem.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Reviżjoni ta' din id-dejta kienet l-ewwel saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji ta' Farmakoviġilanza (PRAC).
English: Date of last renewal: 23 July 2008
Maltese: Data tal-aħħar tiġdid: 23 Lulju 2008
English: INFORMATION IN BRAILLE novonorm 1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE novonorm 1 mg
English: - The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets.
Maltese: - Is-sustanzi l-oħra huma:microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide isfar (E172) fil-pilloli ta' 1 mg biss u iron oxide aħmar (E172) fil-pilloli ta' 2 mg biss.
English: Do not take NovoNorm
Maltese: Tiħux NovoNorm
English: Polacrilin potassium Povidone (polyvidone) Glycerol 85%
Maltese: Glycerol 85%
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 August 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Awwissu 1998
English: NAME OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Maltese: SUQ Novo Nordisk A/S
English: The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Maltese: clopidogrel, sustanzi oħra kontra d-dijabete, inibituri ta' monoamine oxidase (MAOIs), sustanzi beta blokkanti mhux selettivi, inibituri ta' angiotensin converting enzyme (ACE), saliċilati, NSAIDs, octreotide, alkoħol, u sterojdi anaboliċi.
English: INFORMATION IN BRAILLE novonorm 0.5 mg
Maltese: novonorm 0.5 mg
English: Package leaflet: Information for the user NovoNorm 0.5 mg tablets NovoNorm 1 mg tablets NovoNorm 2 mg tablets
Maltese: Informazzjoni għall-utent NovoNorm ta' 0.5 mg NovoNorm 1 mg NovoNorm 2 mg
English: NovoNorm with alcohol
Maltese: NovoNorm ma' alkoħol
English: Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.
Maltese: Ġew magħmula studji ta' terapija kombinata ma' insulina Neutral Protamine Hagedorn (NPH) jew ma' thiazolidinediones.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 0.5 mg tablets Repaglinide
Maltese: NovoNorm 0.5 mg pilloli Repaglinide
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 0.5 mg tablets
Maltese: NovoNorm 0.5 mg pilloli
English: EU/1/98/076/004 30 tablets EU/1/98/076/005 90 tablets EU/1/98/076/006 120 tablets EU/1/98/076/023 270 tablets
Maltese: EU/1/98/076/004 30 pillola EU/1/98/076/005 90 pillola EU/1/98/076/006 120 pillola EU/1/98/076/023 270 pillola
English: INFORMATION IN BRAILLE novonorm 2 mg
Maltese: novonorm 2 mg
English: EU/1/98/076/011 30 tablets EU/1/98/076/012 90 tablets EU/1/98/076/013 120 tablets EU/1/98/076/024 270 tablets
Maltese: EU/1/98/076/011 30 pillola EU/1/98/076/012 90 pillola EU/1/98/076/013 120 pillola EU/1/98/076/024 270 pillola
English: EU/1/98/076/018 30 tablets EU/1/98/076/019 90 tablets EU/1/98/076/020 120 tablets EU/1/98/076/022 270 tablets
Maltese: EU/1/98/076/018 30 pillola EU/1/98/076/019 90 pillola EU/1/98/076/020 120 pillola EU/1/98/076/022 270 pillola
English: • Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal repaglinide jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 2 mg tablets
Maltese: NovoNorm 2 mg pilloli
English: Repaglinide is eliminated rapidly within 4 - 6 hours from the blood.
Maltese: Eliminazzjoni Repaglinide jiġi eliminat malajr mid-demm fi żmien 4-6 sigħat.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 1 mg tablets
Maltese: NovoNorm 1 mg pilloli
English: • If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
Maltese: • Jekk tieħu gemfibrozil (mediċina biex tnaqqas il-livelli għoljin ta' xaħam fid-demm).
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 1 mg tablets Repaglinide
Maltese: NovoNorm 1 mg pilloli Repaglinide
English: What you need to know before you take NovoNorm).
Maltese: (ara Tieħux NovoNorm).
English: NovoNorm tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Maltese: Il-pilloli NovoNorm huma tondi u konvessi u mnaqqxa bil-logo ta' Novo Nordisk (Apis bull).
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/011-013, EU/1/98/076/024
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/076/011-013, EU/1/98/076/024
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 2 mg tablets Repaglinide
Maltese: NovoNorm 2 mg pilloli Repaglinide
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/018-020, EU/1/98/076/022
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/076/018-020, EU/1/98/076/022
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/004-006, EU/1/98/076/023
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/076/004-006, EU/1/98/076/023
English: Abdominal pain, diarrhoea
Maltese: Uġigħ addominali, dijarea Komuni
English: • If you are under 18 or over 75 years of age.
Maltese: • Jekk għandek inqas minn 18-il sena jew iżjed minn 75 sena, NovoNorm m'huwiex rakkomandat..
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Maltese: i.e, l-ipogliċemija.
English: Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Maltese: Pillola Il-pilloli ta' repaglinide huma sofor, tondi u konvessi u inċiżi bil-logo Novo Nordisk (Apis bull).
English: • Thiazides (diuretics or ‘water pills')
Maltese: • Thiazides (dijuretiċi jew ‘pilloli biex tneħħi l-ilma żejjed'
English: However, the benefit risk profile remains to be established when comparing to other combination therapies.
Maltese: Madankollu l-profil tal-benefiċċju riskju għad irid jiġi stabbilit meta mqabbel ma' terapiji kombinati oħra.
English: * see section Description of selected adverse reactions below Description of selected adverse reactions Allergic reactions
Maltese: Sensittività eċċessiva* Mhux magħruf * ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi partikulari aktar 'l isfel Deskrizzjoni ta' reazzjonijiet avversi partikulari Reazzjonijiet allerġiċi
English: PHARMACEUTICAL PARTICULARS
Maltese: IL-PRODOTTI MEDIĊINALI,
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide
Maltese: Kull pillola fiha: 0.5 mg ta' repaglinide
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide
Maltese: Kull pillola fiha 2 mg ta' repaglinide
English: Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla Farmaċewtika
English: ATC vet code: QI06AL01.
Maltese: Kodiċi tal-vet ATC: QI06AL01.
English: Eagles Earles Medium with Hepes
Maltese: Eagles Earles Medium ma' Hepes
English: Adjuvant: mineral oil.
Maltese: Adjuvant: żejt minerali.
English: Relative potency (R.P.)
Maltese: Potenza Relattiva (P.R.)
English: Inactivated FPV / FCV / FVR / Chlam / FeLV.
Maltese: FPV / FCV / FVR / Chlam / FeLV inattivati.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) FPV / FCV / FVR / Chlam / FeLV
Maltese: TAS-SUSTANZA(I) ATTIVA(I) FPV / FCV / FVR / Chlam / FeLV
English: Packaging:
Maltese: Ippakkjar:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Date of last renewal: 27 February 2007.
Maltese: Data tal-ewwel awtorizzazzjoni: 5 ta' Frar 1997 Data tal-aħħar tiġdid: 27 ta' Frar 2007
English: CONTRAINDICATIONS
Maltese: KONTRAINDIKAZJONIJIET
English: See section 4.4 for further details.
Maltese: Ara Sezzjoni 4.4 għal aktar dettalji.
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' SKADENZA EXP {xahar / sena}
English: 10 x 1 ml single dose syringes 20 x 1 ml single dose syringes 25 x 1 ml single dose syringes
Maltese: 10 siringi ta' doża waħda x 1 ml 20 siringa ta' doża waħda x 1 ml 25 siringa ta' doża waħda x 1 ml.
English: Fevaxyn Pentofel stimulates the development of active immunity against feline panleucopenia virus, feline rhinotracheitis virus, feline calicivirus, Chlamydophila felis and feline leukaemia virus.
Maltese: Fevaxyn Pentofel jistimula l-iżvilupp tal-immunità attiva kontra l-panleucopenia virus fil felini, rhinotracheitis virus fil-felini, kaliċivirus fil-felini, Chlamydophila felis u l-leukaemia virus fil-felini.
English: Inactivated feline panleucopenia virus, strain CU4 Inactivated feline calicivirus, strain 255
Maltese: Virus inattivat tal-panleucopenia fil-felini, strejn CU4 Kaliċivirus inattivat tal-felini, strejn 255
English: In very rare cases an anaphylactoid reaction with oedema, pruritis, respiratory and cardiac distress, severe gastrointestinal signs or shock has been seen during the first hours after vaccination.
Maltese: F'każijiet rari ħafna, reazzjoni anafilattojde b'edema, ħakk, tbatija respiratorja u kardijaka, sinjali gastrointestinali qalila jew xokk ġew osservati waqt l-ewwel sigħat wara t-tilqima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Fevaxyn Pentofel for cats
Maltese: VETERINARJU Fevaxyn Pentofel għal qatates
English: Adjuvants
Maltese: IEĦOR
English: STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA'L-MRLs
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml (single dose syringe):
Maltese: U KWANTITATTIVA Doża waħda ta' 1 ml fiha (siringa ta' doża waħda):
English: One cardboard box containing 10, 20 or 25 single dose (1 ml) pre-filled syringes and 10, 20 or 25 sterile needles respectively.
Maltese: Kaxxa waħda tal-kartun li fiha 10, 20 jew 25 siringi ta' doża waħda (1 ml), li diġa mimlija u 10, 20 jew 25 labar sterilizzati rispettivament.
English: TARGET SPECIES
Maltese: PREKAWZJONIJIET SPECJALI
English: Disposal: read package leaflet.
Maltese: Rivaċċinazzjoni: tilqima waħda kull sena.
English: 25 x 1 ml presentation: Box containing 25 single dose prefilled syringes and 25 sterile needles.
Maltese: Preżentazzjoni ta' 25 x 1 ml: Kaxxa li fiha 25 siringi mimlijin bil-lest ta' doża waħda u 25 labar sterili.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 10 x 1 ML SINGLE DOSE SYRINGES, 20 x 1 ML SINGLE DOSE SYRINGES , 25 x 1 ML SINGLE DOSE SYRINGES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TA' SIRINGI TA' DOŻA WAĦDA TA' 1 ML X 10, SIRINGI TA' DOŻA WAĦDA TA' 1 ML X 20, SIRINGI TA' DOŻA WAĦDA TA' 1 ML X 25
English: 20 x 1 ml presentation: Box containing 20 single dose prefilled syringes and 20 sterile needles.
Maltese: Preżentazzjoni ta' 20 x 1 ml: Kaxxa li fiha 20 siringi mimlijin bil-lest ta' doża waħda u 20 labar sterili.
English: For the active immunisation of healthy cats 9 weeks or older against feline panleucopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and Chlamydophila felis.
Maltese: INDIKAZZJONI(JIET) Għall-immunizzazzjoni attiva ta' qtates tal-eta' ta' 9 ġimgħat jew ikbar li jkunu b'saħħithom, kontra l-virusis tal-panlewkopenija fil-felini u l-lewkimja fil-felini u kontra mard respiratorju ikkawżat mill-virus tar-rinotrakeite fil-felini, kaliċivirus fil-felini u Chlamydophila felis.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Fevaxyn Pentofel, suspension for injection for cats
Maltese: VETERINARJU Fevaxyn Pentofel sospensjoni għall-injezzjoni, għal qtates
English: No undesirable effects other than those observed and mentioned in section 4.6 “Adverse reactions” have been observed.
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati ħlief dawk li ġew osservati u msemmija fissezzjoni 4.6 “Effetti mhux mixtieqa”.
English: Pharmacotherapeutic group: immunologicals for felidae, inactivated viral and inactivated bacterial vaccines for cats.
Maltese: Prodotti immunoloġiċi għall-felidae, vaċċin għal qtates virali inattivat u batteriku inattivat.
English: 10 x 1 ml presentation: Box containing 10 single dose prefilled syringes and 10 sterile needles.
Maltese: Preżentazzjoni ta' 10 x 1 ml: Kaxxa li fiha 10 siringi mimlijin bil-lest ta' doża waħda u 10 labar sterili.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/96/002/001-003
Maltese: EU/2/96/002/001-003
English: Active components
Maltese: Sustanzi Attivi
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml (single dose syringe):
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OHRA Doża waħda ta' 1 ml fiha (siringa ta' doża waħda):
English: Inactivated feline rhinotracheitis virus, strain 605 Inactivated Chlamydophila felis, strain Cello Inactivated feline leukaemia virus, strain 61E
Maltese: Virus inattivat tar-Rhinotracheitis fil-felini, strejn 605
English: Basic vaccination of cats 9 weeks and older: two doses at an interval of 3 to 4 weeks.
Maltese: Tilqima bażika ta' qtates tal-eta' ta' 9 ġimgħat jew ikbar: żewġ dożi f'intervall ta' bejn 3 sa 4 ġimgħat.
English: See section 4.5 for guidance about treatment.
Maltese: Ara Sezzjoni 4.5 għal-gwida dwar it-trattament.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIOLOĠIĊI ATTIVI
English: Vaccination does not affect the course of feline leukaemia virus (FeLV) infection in cats already infected with FeLV at the time of vaccination, implying that such cats will excrete FeLV irrespective of vaccination; consequently, these animals will constitute a hazard to susceptible cats in their environment.
Maltese: It-tilqim ma jeffettwax il-kors tal-infezzjoni tal-feline leukaemia virus (FeLV) fi qtates li diġa huma nfettati bil-FeLV fil-ħin tat-tilqim, għaliex dawn il-qtates joħorġu l-FeLV irrispettivament mit-tilqim; konsegwentement, dawn l-annimali jistgħu ikunu ta' periklu għal qtates suxxettibbli fl-ambjent tagħhom.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/96/002/001 10 x 1 ml
Maltese: EU/2/96/002/001 10 x 1 ml
English: None.
Maltese: Ċ.
English: An additional dose is recommended for kittens living in high-risk feline leukaemia virus (FeLV) environments whose first dose was administered before 12 weeks of age.
Maltese: Doża addizzjonali hija rakkommandata għal friegħ ta' qtates li jgħixu f'ambjent li għandu riskju għoli ta' feline leukaemia virus (FeLV) fejn l-ewwel doża ġiet amministrata qabel l-eta' ta' 12-il ġimgħa.
English: STATEMENT OF THE MRLs Not applicable.
Maltese: DIKJARAZZJONI TAL-MRLs Mhux applikabbli.
English: PACKAGE LEAFLET: Fevaxyn Pentofel, suspension for injection for cats
Maltese: Fevaxyn Pentofel, sospensjoni għall-injezzjoni, għal qatates
English: In case of an anaphylactoid reaction, adrenaline should be administered intramuscularly.
Maltese: F'każ ta' reazzjoni anafilattojde, l-adrenalina għandha tingħata ġol-muskolu.
English: 48 tablets
Maltese: 48 pilloli
English: 50 mg Film-coated tabletOral use blister (alu/alu)
Maltese: 50 mg Pillola miksija b'rita Użu orali folja (alu/alu)
English: b Snapshot analysis.
Maltese: b Analiżi snapshot.
English: Gilead Sciences Ελλάς Μ.ΕΠΕ.
Maltese: Κύπρος Gilead Sciences Ελλάς Μ.ΕΠΕ.
English: ATC code: J05AR08.
Maltese: J05AR08.
English: EU/1/11/737/001 EU/1/11/737/002
Maltese: EU/1/11/737/002
English: Macrolide antibiotics Clarithromycin Erythromycin
Maltese: Antibijotiċi macrolide Clarithromycin Erythromycin
English: hypokalaemia3, 5
Maltese: ipofosfatimja3, 5
English: Eviplera contains lactose monohydrate.
Maltese: Eviplera fih lactose monohydrate.
English: Resistance to emtricitabine/lamivudine (M184I/V)
Maltese: Reżistenza għal emtricitabine/lamivudine (M184I/V)
English: County Cork
Maltese: County Cork L-Irlanda
English: 1 Adverse reaction identified for emtricitabine.
Maltese: 1 Reazzjoni avversa identifikata għal emtricitabine.
English: Study GS-US-264-0111
Maltese: Studju GS-US-264-0111
English: • St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
Maltese: INIBITURI PHOSPHODIESTERASE TA' TIP 5 (PDE-5) Sildenafil/Emtricitabine
English: 3 Phenotypic resistance (Antivirogram).
Maltese: 2 Reżistenza fenotipika (Antivirogram).
English: Resistance to tenofovir (K65R)
Maltese: Reżistenza għal tenofovir (K65R) 2/66
English: increased bilirubin1, 2
Maltese: żieda fil-bilirubina1, 2
English: The absolute bioavailability of emtricitabine from 200 mg hard capsules was estimated to be 93%.
Maltese: Il-bijodisponibilità assoluta ta' emtricitabine minn 200 mg ġiet stmata li hi 93%.
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (IC50 is 9.2 µM).
Maltese: Rilpivirine jinibixxi P-glikoproteina (P-gp) in vitro (IC50 hi 9.2 µM).
English: HIV-1 RNA < 50 copies/mL
Maltese: HIV-1 RNA <50 kopja/mL
English: 2 Adverse reaction identified for rilpivirine hydrochloride.
Maltese: 2 Reazzjoni avversa identifikata għal rilpivirine hydrochloride.
English: Study GS-US-264-0106
Maltese: Studju GS-US-264-0106
English: • foscarnet, ganciclovir, cidofovir (for viral infections)
Maltese: • foscarnet, ganciclovir, cidofovir (għal infezzjonijiet virali)
English: • amphotericin B, pentamidine (for fungal infections)
Maltese: • amphotericin B, pentamidine (għal infezzjonijiet fungali)
English: Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate.
Maltese: Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, u magnesium stearate.
English: In patients with phenotypic data (n = 66)
Maltese: F'pazjenti b'dejta fenotipika (n = 66)
English: • proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
Maltese: • inibituri tal-pompa tal-proton, bħal omeprazole, esomeprazole, lansoprazole, pantoprazole,
English: Resistance to rilpivirine2 Cross-resistance3 to etravirine efavirenz nevirapine
Maltese: Cross-resistance2 għal etravirine efavirenz nevirapine
English: Gilead Sciences Tél: + 33 (0) 1 46 09 41 00
Maltese: Tél : + 33 (0) 1 46 09 41 00
English: Nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs/N[t]RTIs) Didanosine/Emtricitabine
Maltese: Inibituri ta' nucleoside jew ta' nucleotide reverse transcriptase (NRTIs/N[t]RTIs) Didanosine/Emtricitabine
English: Demographic Characteristics Median age (range), years
Maltese: Karatteristiċi Demografiċi Medjan ta' età (medda), snin
English: • antacids (aluminium/magnesium hydroxide or calcium carbonate)
Maltese: • antaċidi (aluminium/magnesium hydroxide jew calcium carbonate)
English: Alternatively, switching to another antiretroviral regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Maltese: B'mod alternattiv, jista' jitqies ilqlib għal kors antiretrovirali ieħor (ara sezzjonijiet 4.4, 4.6, 5.1 u 5.2).
English: Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, and triacetin.
Maltese: Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, u triacetin.
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Maltese: Rilpivirine hu diarylpyrimidine NNRTI ta' HIV-1.
English: In study C209 (n = 690), the BR was emtricitabine/tenofovir disoproxil.
Maltese: Fi studju C209 (n = 690), il-kors fl-isfond kien emtricitabine/tenofovir disoproxil.
English: EU/1/11/737/002 90 (3 bottles of 30) film-coated tablets.
Maltese: EU/1/11/737/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Antacids (e.g. aluminium or magnesium hydroxide, calcium carbonate)
Maltese: Antaċidi (eż. aluminium jew magnesium hydroxide, calcium carbonate)
English: Eviplera [outer packaging only]
Maltese: Eviplera [pakkett ta' barra biss]
English: Eviplera contains lactose and sunset yellow aluminium lake (E110)
Maltese: Eviplera fih lactose u sunset yellow aluminium lake (E110)
English: • the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Maltese: • il-mediċini kontra l-konvulżjoni carbamazepine, oxcarbazepine, phenobarbital, phenytoin
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin/Emtricitabine
Maltese: INIBITURI TA' HMG-COA REDUCTASE Atorvastatin/Emtricitabine
English: anaemia1, 4
Maltese: Mhux komuni: anemija1, 4
English: Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110).
Maltese: Kull pillola miksija b'rita fiha 277 mg ta' lactose monohydrate u 4 mikrogrammi ta' sunset yellow aluminium lake (E110).
English: See section 4.8, Description of selected adverse reactions.
Maltese: Ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: Antifungals Ketoconazole/Emtricitabine
Maltese: Antifungali Ketoconazole/Emtricitabine
English: EU/1/11/737/001 30 film-coated tablets.
Maltese: EU/1/11/737/001 30 pillola miksija b'rita
English: hepatitis3, hepatic steatosis3
Maltese: epatite3, steatożi tal-fwied3
English: 3 Adverse reaction identified for tenofovir disoproxil.
Maltese: 3 Reazzjoni avversa identifikata għal tenofovir disoproxil.