FrancophonIA/ELRC3.0 huggingface dataset:
English: Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Maltese: Masican kien mistenni li jintuża biex jikkura tumur gastrointestinali stromali (GIST), kanċer tal-istonku u tal-musrana, fl-adulti li jkollhom kanċer li ma jistax jitneħħa kirurġikament jew li jkun infirex u qed isir agħar minkejja l-kura b'imatinib, mediċina oħra użata biex tikkura dan il-kanċer.
English: The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
Maltese: II", studju esploratorju ddisinjat biex jara jekk mediċina għandhiex tigi investigata iktar.
English: What did the company present to support its application?
Maltese: X'kienu t-tħassib ewlieni tas-CHMP li wasslu għar-rifjut?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fl-20 ta' Marzu 2014.
English: surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Maltese: ċelluli tal-kanċer, li jinkludi r-riċetturi li huma involuti fl-istimulazzjoni taċ-ċelloli biex jinqasmu bla kontroll.
English: Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Maltese: Għalkemm il-grupp ta' pazjenti kkurati b'Masican dehru li għexu ħajja itwal minn dawk ikkurati b'sunitinib, il-possibbiltà li din kienet sejba b'kumbinazzjoni ma setgħetx tiġi eskluża minħabba n-natura sperimentali tal-istudju u għax evidenza oħra ta' appoġġ kienet nieqsa.
English: The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
Maltese: Is-CHMP kien imħasseb ukoll li l-informazzjoni ta' sigurtà kienet disponibbli biss għall-ftit pazjenti kkurati b'Masican bid-doża proposta u din ma tippermettix evalwazzjoni sħiħa tal-effetti sekondarji talmediċina.
English: Refusal of the marketing authorisation for Masican (masitinib)
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Masican (masitinib)
English: Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Maltese: Barra minn hekk, kien għad hemm problemi pendenti relatati mal-kontroll ta' kwalità matul il-manifattura tiegħu.
English: The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Halagon is a ‘generic medicine'.
Maltese: Halagon huwa "mediċina ġenerika".
English: Halagon EMA/664633/2016
Maltese: EMA/848937/2016 Halagon
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom wkoll il-firxa tal-marda billi tipprevjeni l-formazzjoni ta' ooċisti, li huma stadju fiċ-ċiklu tal-ħajja tal-parassita li jiġu mgħoddija fir-rawt.
English: The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum.
Maltese: Is-sustanza attiva f'Halagon, alofuġinon, tipprevjeni t-tkabbir ta' Cryptosporidium parvum.
English: This is a summary of the European public assessment report (EPAR) for Halagon.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Halagon.
English: The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Halagon fil-13/12/2016.
English: The company provided data on the quality and manufacture of Halagon.
Maltese: Il-kumpanija pprovdiet data dwar il-kwalità u l-manifattura ta' Halagon.
English: The medicine contains the active substance halofuginone.
Maltese: Il-mediċina fiha s-sustanza attiva alofuġinon.
English: Why is Halagon approved?
Maltese: Għaliex ġie approvat Halagon?
English: Halagon halofuginone
Maltese: Informazzjoni oħra dwar Halagon
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea.
Maltese: Dan huwa parassita li jappartjeni għall-familja ‘protożoa' li jinvadi s-sistema diġestiva, u jikkawża d-dijarea.
English: This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
Maltese: Dan ifisser li Halagon huwa simili għall-"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Halocur.
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Maltese: Biex tiġi evitata d-dijarea, il-kura għandha tibda fi żmien 24 sa 48 siegħa mit-twelid; biex titnaqqas id-dijarea, il-kura għandha tibda fiż-żmien 24 siegħa mill-bidu tad-dijarea.
English: Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Maltese: Halagon huwa mediċina użata biex tikkura għoġġiela tat-twelid biex tiġi evitata jew titnaqqas id-dijarea kkawżata minn organiżmu msejjaħ Cryptosporidium parvum.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Halagon, inkluż il-prekawzjonijiet xierqa li għandhom jiġu segwiti mill-professjonisti tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom meta jużaw Halagon.
English: No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Maltese: Ma kien jeħtieġ l-ebda studju addizzjonali peress li Halagon huwa soluzzjoni orali bbażata fuq l-ilma li fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, fl-istess konċentrazzjonijiet.
English: Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Maltese: Halagon jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli bħala soluzzjoni orali (likwidu li għandu jittieħed mill-ħalq).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, Halagon wera li għandu kwalità komparabbli għal Halocur.
English: Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Maltese: Minħabba li Halagon huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-prekawzjonijiet huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Halagon huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: How has Halagon been studied?
Maltese: Kif ġie studjat Halagon?
English: Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CVMP kienet li, bħal fil-każ ta' Halocur, il-benefiċċji huma akbar mir-riskji identifikati.
English: What are the benefits and risks of Halagon?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Halagon?
English: • That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis.
Maltese: • Li Vibativ għandu riskju ta' nefrotossiċità inkluż riskju ogħla ta' mortalità f'pazjenti b'falliment akut tal-kliewi li kien jeżisti minn qabel u li għalhekk huwa kontraindikat għal pazjenti b'falliment akut tal-kliewi li kien jeżisti minn qabel u pazjenti bi tneħħija ta' kreatinina < 30ml/min, inklużi l-pazjenti li qegħdin fuq emodijalisi.
English: • That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
Maltese: • Li hemm riskju potenzjali ta' teratoġeniċità u Vibativ huwa kontraindikat waqt it-tqala.
English: • There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking drugs known to prolong the QT interval.
Maltese: • Hemm riskju ta' prolongazzjoni QTc, u Vibativ għandu jintuża b'kawtela fuq pazjenti li qed jieħdu prodotti mediċinali li huma magħrufin li jtawlu l-intervall ta' QT.
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Maltese: • Li hemm riskju ta' reazzjonijiet marbuta mal-infużjoni, inklużi reazzjonijiet bħal tassindromu tar-Raġel Ħamrani.
English: • That the benefit risk balance for the Complicated Skin and Soft Tissue Infections indication was assessed as negative by the Committee for Medicinal Products for Human Use (CHMP), therefore Vibativ should not be used in this or other indications not approved.
Maltese: • Li l-bilanċ bejn il-benefiċċji u r-riskji f'każ ta' Infezzjonijiet Ikkumplikati tal-Ġilda u tat-Tessuti Rotob (Complicated Skin and Soft Tissue Infections) ġie meqjus bħala wieħed negattiv mill-Kumitat għall-Prodotti Mediċinali għall-Bnedmin (CHMPCommittee for Medicinal Products for Human Use), u għalhekk Vibativ m'għandux jintuża meta jkun hemm din l-indikazzjoni jew indikazzjonijiet oħra mingħajr
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Maltese: Kundizzjonijiet jew restrizzjonijiet b'rabta mal-użu sigur u effettiv tal-prodott mediċinali li għandhom jiġu implimentati mill-Istati Membri.
English: • The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
Maltese: • Ir-rwol u l-użu tal-Istiker b'Lista ta' Kontrolli Għal Min Jippreskrivi, inkluża fil-pakkett tal-prodott, li tiddokumenta l-istat tat-tqala stabbilit qabel ma tingħata d-doża.
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Maltese: • Il-professjonisti tas-saħħa għandhom ikunu jafu li l-għoti ta' Vibativ jista' jinterferixxi f'xi testijiet tal-laboratorju relatati mal-koagulazzjoni u f'testijiet kwalitattivi u
English: 31-546 Krakow
Maltese: 31-546 Krakow Il-Polonja
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren
English: Sorbitol solution (3.2g , 10.2 g, 13.4 g)/ Lamivudine
Maltese: Soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
English: See Section 4 for more information.
Maltese: Ara Sezzjoni 4 għal aktar informazzjoni.
English: Tablet film-coat Hypromellose 3cP Hypromellose 6cP Polysorbate 80
Maltese: Hypromellose 3cP Hypromellose 6cP Polysorbate 80
English: Cellulose, microcrystalline Sodium starch glycolate (Type A) Sodium stearyl fumarate
Maltese: Cellulose, microcrystalline Sodium starch glycolate (Tip A) Sodium stearyl fumerate
English: Date of first authorisation: 02 March 2011 Date of latest renewal: 19 November 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2015
English: Tablet film-coat: Hypromellose 3cP, hypromellose 6cP, polysorbate 80, macrogol 400, titanium dioxide E171.
Maltese: Il-kiska tal-pillola bir-rita fiha: Hypromellose, 3cP, hypromellose 6cP, polysorbate 80, macrogol 400, titanium dioxide E171.
English: Look out for important symptoms
Maltese: Oqgħod attent għal sintomi importanti
English: Phenytoin AUC ↑↓
Maltese: L-AUC ta' Phenytoin ↑↓
English: Single dose lamivudine oral solution 300 mg Lamivudine:
Maltese: Doża waħda lamivudine soluzzjoni orali 300 mg Lamivudine:
English: • methadone, used as a heroin substitute
Maltese: • methadone, jintuża bħala sostitut tal-eroina
English: ANTIFUNGALS
Maltese: ANTIFUNGALI
English: ANTIMYCOBACTERIALS
Maltese: ANTIMICOBATTERIĊI
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine.
Maltese: Kura, speċjalment terapija akuta, flimkien ma' prodotti mediċinali li jistgħu jkunu nefrotossiċi jew mijelosoppressivi (eż. pentamidine sistemiku, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine u doxorubicin) tista' wkoll iżżid ir-riskju ta' reazzjonijiet avversi għal zidovudine.
English: Children who weigh between 14 and 21 kg
Maltese: Tfal li jiżnu bejn 14 u 21 kg
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Maltese: Il-half-life osservata ta' lamivudine hi ta' bejn 5 sa 7 sigħat.
English: Teva Pharma, S.L.U Tél: +34 91 387 32 80
Maltese: L.U Tél: +34 91 387 32 80
English: The median (range) lamivudine and zidovudine tmax values were 0.75 (0.50-2.00) hours and 0.50 (0.25-2.00) hours respectively.
Maltese: Il-valuri tmax ta' (firxa) medja għal lamivudine u zidovudine kienu 0.75 (0.50-2.00) sigħat u 0.50 (0.25-2.00) sigħat rispettivament.
English: Interaction not studied.
Maltese: Interaction ma ġietx studjata.
English: Two patterns of multi-drug resistance mutations, the first characterised by mutations in the HIV reverse transcriptase at codons 62, 75, 77, 116 and 151 and the second involving a T69S mutation plus a 6-base pair insert at the same position, result in phenotypic resistance to AZT as well as to the other approved NRTIs.
Maltese: Żewġ skemi ta' mutazzjonijiet għal reżistenza minn diversi mediċini, l-ewwel ikkaraterizzat minn mutazzjonijiet fl-HIV reverse transcriptase f'kodons 62, 75, 77, 116 u 151 u t-tieni jinvolvi mutazzjoni f'T69S flimkien ma' entrata ta' 6 bażijiet pari fl-istess pożizzjoni, jirriżultaw f'reżistenza fenotipika għal AZT kif ukoll għall-NRTIs approvati l-oħra.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare
Maltese: Il-frekwenzi huma mfissra hekk: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000) u rari ħafna (< 1/10,000).
English: Children who weigh between 21 and 30 kg
Maltese: Tfal li jiżnu bejn 21 u 30 kg
English: 80 Mogilska St.
Maltese: Teva Operations Sp. z.o.o. 80 Mogilska St.
English: Rare: Insomnia, paraesthesiae, somnolence, loss of mental acuity, convulsions
Maltese: Insomnija, paraestesje, ngħas, titlef l-akutezza mentali, konvulżjonijiet.
English: Cssmax levels were 4.45 μM (1.19 μg/ml) following a dose of 120 mg zidovudine (in solution)/m2 body surface area and 7.7 μM (2.06 μg/ml) at 180 mg/m2 body surface area.
Maltese: Livelli ta' Cssmax kienu ta' 4.45 μM (1.19 μg/ml) segwiti b'doża ta' 120 mg zidovudine (f'soluzzjoni)/m2 erja superfiċjali tal-ġisem u 7.7 μM (2.06 μg/ml) f'180 mg/m2 tal-erja superfiċjali tal-ġisem.
English: Following single dose lamivudine/zidovudine administration in healthy volunteers, mean (CV) lamivudine and zidovudine Cmax values were 1.6 µg/ml (32 %) and 2.0 µg/ml (40 %), respectively and the corresponding values for AUC were 6.1 µg h/ml (20 %) and 2.4 µg h/ml (29 %) respectively.
Maltese: lamivudine u zidovudine Cmax kien ta' 1.6 µg/ml (32 %) u 2.0 µg/ml (40 %) rispettivament u l-valuri korrispondenti għal AUC kienu 6.1 µg h/ml (20 %) u 2.4 µg h/ml (29 %) rispettivament.
English: The bioavailability of oral lamivudine in adults is normally between 80-85 % and for zidovudine 60-70 %.
Maltese: Il-bijodisponibilità ta' lamivudine li jittieħed mill-ħalq minn adulti hi normalment bejn 80 % u 85 % u għal zidovudine din hi ta' 60-70%.
English: Zidovudine AUC ↓48% (UGT induction)
Maltese: Zidovudine AUC ↓48% (induzzjoni ta' UGT
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: • inflammation of the pancreas (pancreatitis)
Maltese: • -frixa (pankrejatite)
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg darba kuljum għal 5 ijiem/300 mg doża waħda)
English: Zidovudine AUC ↑43% Methadone AUC ↔
Maltese: L-AUC ta' Zidovudine ↑43% L-AUC ta' Methadone AUC ↔
English: Teva Operations Poland Sp. z.o.o.
Maltese: Teva Operations Poland Sp. z.o.o. 80 Mogilska St.
English: Additionally, lamivudine has activity against hepatitis B virus (HBV).
Maltese: Barra minn hekk, lamivudine għandu attività kontra l-virus tal-epatite B (HBV).
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Maltese: • mediċini (normalment likwidi) li fihom sorbitol u alkoħol ieħor taz-zokkor (bħal xylitol, mannitol, lactitol jew maltitol), jekk jittieħdu regolarment.
English: OPA/Alu/PVC Aluminium blisters
Maltese: Folji tal-aluminju OPA/Alu/PVC
English: • vincristine, vinblastine or doxorubicin, to treat cancer.
Maltese: • vincristine, vinblastine jew doxorubicin, biex jikkuraw il-kanċer.
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.
Maltese: Għalhekk, ftit li xejn hemm possibbiltà għal interazzjonijiet ma' mediċini antiretrovirali impedituri ta' protease, mhux nuklejosidi u prodotti mediċinali oħra mmetabolizzati mill-enzimi P450 prinċipali.
English: 3'-amino-3'deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing.
Maltese: 3'-amino-3'-deoxythymidine (AMT) ġie identifikat bħala metabolit ta' zidovudine wara li ttieħed bħala doża ġol-vina.
English: Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2).
Maltese: Lamivudine/Zidovudine Teva hu indikat bħala parti mit-terapija ta' kombinazzjoni antiretrovirali għat-trattament minn infezzjoni bil-Vajrus ta' Immunodefiċjenza fil-Bniedem (HIV) (ara sezzjoni 4.2).
English: 9/l (see section 4.2).
Maltese: Prodott, sezzjoni 4.2).
English: Zidovudine is contraindicated in patients with abnormally low neutrophil counts (<0.75 x 109/l), or abnormally low haemoglobin levels (<7.5 g/dl or 4.65 mmol/l).
Maltese: (<0.75 x 109/l), jew hemm livelli ta' emaglobina abnormalment baxxi (<7.5 g/dl or 4.65 mmol/l).
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Maltese: Mutanti tal-M184V juru suxxettibiltà mnaqqsa ħafna għal lamivudine u juru tnaqqis tal-ħila replikattiva virali in vitro.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: L-aktar reazzjonijiet avversi rrappurtati huma disturbi ematoloġiċi (anemija, newtropenja) u disturbi metaboliċi (iperlaktejtimja, iperlipasemja).
English: • high doses of co-trimoxazole, an antibiotic.
Maltese: • dożi għoljin ta' co-trimoxazole (antibijotiku)
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine and nevirapine).
Maltese: Ma deher ebda effett antiagonistiku in vitro b'lamivudine u b'antiretrovirali oħrajn (aġenti ttestjati: abacavir, didanosine u nevirapine).
English: Clinical Experience
Maltese: Esperjenza klinika
English: Lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Maltese: Lamivudine u zidovudine mhumiex immetabolizzati b'mod sinifikanti permezz tal-enzimi taċ-ċitokroma P450 (bħal ma huma CYP 3A4, CYP 2C9 jew CYP 2D6) u lanqas ma jimpedixxu jew jinduċu din is-sistema ta' enzimi.
English: Monitor phenytoin concentrations.
Maltese: Issorvelja konċentrazzjonijiet għal phenytoin.
English: Patients at increased risk should be followed closely.
Maltese: Pazjenti f'riskju qawwi għandhom ikunu taħt osservazzjoni stretta.
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS)
Maltese: TAR-RIĊETTUR H1 TAL-ISTAMINA)
English: The combination of lamivudine with cladribine is not recommended (see section 4.5).
Maltese: It-taħlita ta' lamivudine ma' cladribine mhux rakkomandata (ara sezzjoni 4.5).
English: ANTIRETROVIRAL MEDICINAL PRODUCTS
Maltese: ANTIRETROVIRALI
English: The frequency of this is unknown (see section 4.4).
Maltese: Il-frekwenza ta' din għadu mhux magħruf (ara sezzjoni 4.4)
English: Monitor for signs of zidovudine toxicity (see section 4.8).
Maltese: tossiċità ta' zidovudine (ara sezzjoni 4.8).
English: However, absolute bioavailability (approximately 55-65 %) was reduced in paediatric patients below 12 years of age.
Maltese: Madankollu l-bijodisponibilità assoluta (madwar 55-65 %) kienet mnaqqsa f'pazjenti li m'għalqux
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Valproic acid/Zidovudine (250 mg or 500 mg thrice daily/100 mg thrice daily)
Maltese: Valproic acid/Zidovudine (250 mg jew 500 mg tlieta kuljum/100 mg tlieta kuljum)
English: Lamivudine-TP and zidovudine-TP have selective inhibitory activity against HIV-1 and HIV-2 replication in vitro; lamivudine is also active against zidovudine-resistant clinical isolates of HIV.
Maltese: Il-metodi prinċipali ta' azzjoni tagħhom huwa li jwaqqaf il-katina tar-reverse transcription tal-virus. Lamivudine-TP u zidovudine -TP għandhom attività inibitorja selettiva kontra r-replikazzjoni in vitro ta' l-HIV-1 u l-HIV-2; lamivudine hu attiv ukoll kontra iżolati kliniċi tal-HIV li huma reżistenti għal zidovudine.
English: ANTICONVULSANTS
Maltese: ANTIKONVULSIVI