FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that animals are treated in the early stages of respiratory disease and that their response is evaluated within 48 hours.
Maltese: Huwa rrakkomandat li l-annimali jiġu kkurati fil-fażijiet bikrin tal-mard respiratorju u li r-rispons tagħhom jiġi evalwat fi żmien 48 siegħa.
English: In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Maltese: Fil-frat, jiġi injettat taħt il-ġilda, u d-doża tiġi diviża fi frat li jiżnu aktar minn 300 kg sabiex mhux aktar minn 7.5 ml jiġu injettati f'sit wieħed.
English: In all studies, Draxxin was at least as effective as the comparator medicines.
Maltese: Fl-istudji kollha, Draxxin kien tal-inqas effettiv daqs il-mediċini komparaturi.
English: In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
Maltese: Fil-majjali, jiġi injettat f'muskolu, u d-doża tiġi diviża f'majjali li jiżnu aktar minn 80 kg sabiex mhux aktar minn 2 ml jiġu injettati f'sit wieħed.
English: The 25 mg/ml solution for injection is for pigs only whilst the 100 mg/ml solution for injection is for cattle, pigs and sheep.
Maltese: Is-soluzzjoni ta' 25 mg/ml għallinjezzjoni hija għall-majjali filwaqt li s-soluzzjoni ta' 100 mg/ml għall-injezzjoni hija għall-frat, għall-majjali, u n-nagħaġ.
English: Draxxin can also be used for metaphylaxis of BRD and SRD.
Maltese: Draxxin jista' jintuża wkoll għall-metafilassi tal-BRD u l-SRD.
English: Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
Maltese: Draxxin tqabbel ma' tilmikosin jew florfenikol (antibijotiċi oħrajn), u, fl-istudji ta' prevenzjoni ma' plaċebo wkoll (kura finta).
English: For effectiveness in treating foot rot in sheep, Draxxin was compared to tilmicosin in a study involving 477 sheep with typical signs of foot rot (foul smell, damaged tissue between the claws of at least one foot and lameness).
Maltese: Għall-effikaċja fil-kura tan-nekrobaċillożi fin-nagħaġ, Draxxin tqabbel ma' tilmikosin fi studju li involva 477 nagħġa b'sinjali tipiċi tan-nekrobaċillożi (riħa tinten, ħsara tessutali bejn il-qawqbiet ta' mill-inqas sieq waħda u zappip).
English: • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
Maltese: • keratokonġunktivite bovina infettuża (IBK) fi frat, marda tal-għajnejn ikkawżata mill
English: Temporary pain and swelling at the injection site in cattle can last up to 30 days after subcutaneous injection.
Maltese: Uġigħ temporanju u nefħa fis-sit tal-injezzjoni fil-frat tista' ddum sa 30 jum wara injezzjoni taħt ilġilda.
English: Draxxin was as effective as tilmicosin in treating the early stages of severe foot rot.
Maltese: Draxxin kien effettiv daqs tilmikosin fil-kura ta' fażijiet bikrin tan-nekrobaċillożi severa.
English: The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with the antibiotics tiamulin or florfenicol.
Maltese: L-effikaċja ta' Draxxin fil-kura ta' SRD ġiet studjata f'majjali f'żewġ studji ewlenin, fejn ġiet imqabbla mal-antibijotiċi tiamulin jew florfenikol.
English: In sheep, Draxxin is injected into the neck muscle.
Maltese: Fin-nagħaġ, Draxxin jiġi injettat fil-muskolu tal-għonq.
English: The most common side effects with Draxxin in sheep (which may affect more than 1 in 10 sheep) are short lived signs of discomfort (head shaking, rubbing the injection site and backing away) lasting only a few minutes.
Maltese: L-effetti sekondarji l-aktar komuni bi Draxxin fin-nagħaġ (li jistgħu jaffettwaw aktar minn nagħġa1 f'għaxra) huma sinjali żgħar ta' skumdità (xengil tar-ras, ħakk fis-sit tal-injezzjoni u rtirar) li jdumu biss ftit minuti.
English: The main measure of effectiveness was clinical cure rate (no SRD or mild SRD) on day 14.
Maltese: Il-kejl ewlieni tal-effikaċja kien ir-rata ta' kura klinika (l-ebda SRD jew SRD ħafifa) fl-14-il jum.
English: Draxxin should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics.
Maltese: Draxxin ma għandux jintuża f'annimali li huma ipersensittivi (allerġiċi) għal antibijotiċi makrolidi.
English: For more information about treatment with Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Maltese: Madankollu, it-tielet studju ma sab l-ebda differenza bejn l-effikaċja ta' Draxxin, loksitetraċiklina u l-plaċebo.
English: Treatment with Draxxin was compared to another antibiotic, tildipirosin.
Maltese: Draxxin tqabblet ma' antibijotiku ieħor, it-tildipirosin.
English: Draxxin can cause eye irritation.
Maltese: Draxxin jista' jirrita l-għajnejn.
English: How does Draxxin work?
Maltese: X'inhu Draxxin u għal xiex jintuża?
English: • Early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires systemic treatment (treatment with a medicine given by mouth or by injection).
Maltese: • Fażijiet bikrin ta' nekrobaċillożi fin-nagħaġ ikkawżata minn Dichelobacter nodosus, li teħtieġ kura sistemika (kura b'mediċina li tingħata mill-ħalq jew b'injezzjoni).
English: For the metaphylaxis of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo.
Maltese: Għall-prevenzjoni ta' SRD, l-effikaċja ta' Draxxin ġiet studjata f'sitt studji ewlenin, li fihom tqabblet ma' plaċebo.
English: 15 March 2013
Maltese: 15 ta' Marzu 2013
English: 1 For information on the outcome of this review, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
Maltese: 1 Għal informazzjoni dwar ir-riżultat ta' din ir-reviżjoni, ara: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
English: Due to the close similarity of Evicel and Quixil, the CHMP concluded its review of Evicel and Quixil in November 20121.
Maltese: Minħabba ssimilarità kbira bejn Evicel u Quixil, is-CHMP ikkonkluda r-reviżjoni tiegħu ta' Evicel u Quixil f'Novembru 20121.
English: For Evicel, Quixil, Tisseel, Tissucol and Artiss, the solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Maltese: Għal Evicel, Quixil, Tisseel, Tissucol u Artiss, attwalment is-soluzzjoni tiġi sprejjata permezz tal-arja jew tad-dijossidu tal-karbonju (CO2) taħt pressjoni.
English: What are fibrin sealants?
Maltese: X'inhuma siġillanti tal-fibrina?
English: What are the recommendations for surgeons?
Maltese: X'inhuma r-rakkomandazzjonijiet għall-kirurgi?
English: Several fibrin sealants have been authorised in European Union (EU) Member States through national procedures.
Maltese: Bosta siġillanti tal-fibrina ġew awtorizzati fl-Istati Membri tal-Unjoni Ewropea (UE) permezz ta' proċeduri nazzjonali.
English: These include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Maltese: Dawn jinkludu Quixil, Tisseel, Tissucol, Artiss u Beriplast P (u ismijiet assoċjati).
English: On 13 December 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), following concerns over the risk of gas embolism when these medicines are given by spray application.
Maltese: Fit-13 ta' Diċembru 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja tas-siġillanti tal-fibrina Tisseel, Tissucol, Artiss u Beriplast P (u ismijiet assoċjati), wara tħassib dwar irriskju ta' emboliżmu tal-gass meta dawn il-mediċini jingħataw b'applikazzjoni sprej.
English: • Surgeons should note the potential risk of gas embolism with incorrect spray application of Tisseel, Tissucol and Artiss and take the necessary precautions detailed in the updated prescribing advice for these medicines.
Maltese: • Il-kirurgi għandhom jinnutaw ir-riskju potenzjali ta' emboliżmu tal-gass b'applikazzjoni ħażina ta' Tisseel, Tissucol u Artiss u jieħdu l-prekawzjonijiet neċessarji dettaljati fil-parir aġġornat dwar ilpreskrizzjoni għal dawn il-mediċini.
English: The CHMP reviewed the available safety data on fibrin sealants from clinical studies, post-marketing use and the published literature, focusing on reported cases of confirmed or suspected gas embolism.
Maltese: Is-CHMP irreveda d-dejta disponibbli dwar is-sigurtà ta' siġillanti tal-fibrina minn studji kliniċi, l-użu wara t-tqegħid fis-suq u mil-letteratura ppubblikata, u ffoka fuq każijiet irrapportati ta' każijiet ikkonfermati jew suspettati ta' emboliżmu tal-gass.
English: • the wording of the product information should be strengthened and educational materials updated to provide clear and consistent information to surgeons on the recommended pressure and distance during spray application;
Maltese: • it-test tal-informazzjoni dwar il-prodott għandu jissaħħaħ u l-materjal edukattiv għandu jiġi aġġornat biex tiġi pprovduta informazzjoni ċara u konsistenti lill-kirurgi dwar il-pressjoni u d distanza rakkomandata b'applikazzjoni sprej;
English: • the company for Tisseel, Tissucol and Artiss should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and which have labels stating the recommended pressure and distance;
Maltese: • il-kumpanija għal Tisseel, Tissucol u Artiss għandha tiżgura li dawn il-prodotti jintużaw b'regolaturi tal-pressjoni li ma jaqbżux il-pressjoni massima meħtieġa biex twassal is-siġillant tal-fibrina, u li jkun fihom tikketti li jiddikjaraw il-pressjoni u d-distanza rakkomandata;
English: Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni tas-siġillanti talfibrina Tisseel, Tissucol, Artiss u Beriplast P (u ismijiet assoċjati) li jingħataw b'applikazzjoni sprej
English: They are composed of two solutions, one containing fibrinogen and another containing thrombin, both of which are proteins involved in the blood clotting process.
Maltese: Huma magħmula minn żewġ soluzzjonijiet, waħda li fiha fibrinogen u l-oħra li fiha thrombin, it-tnejn huma proteini involuti fil-proċess tal-għaqid tad-demm.
English: A group of experts in blood products, haemostasis (the stopping of bleeding) and surgery was also consulted.
Maltese: Ġie kkonsultat ukoll grupp ta' esperti fil-prodotti tad-demm, fl-emostasi (it-twaqqif tal-fsada) u fil-kirurġija.
English: Why were fibrin sealants reviewed?
Maltese: Għaliex ġew riveduti s-siġillanti tal-fibrina?
English: • the product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of possible gas embolism.
Maltese: • l-informazzjoni dwar il-prodott għandha tinkludi twissija li r-riskju ta' emboliżmu tal-gass jidher li huwa ogħla meta siġillanti tal-fibrina jiġu sprejjati bl-użu tal-arja, meta mqabbla mas-CO2, u l pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali possibbli ta' emboliżmu tal-gass.
English: The CHMP noted that all of the cases of gas embolism seen with Evicel and Quixil were related to the use of the spray device at higher-than-recommended pressures or in closer proximity to the tissue surface than recommended.
Maltese: Is-CHMP innota li l-każijiet kollha ta' emboliżmu tal-gass li dehru b'Evicel u Quixil kienu relatati malużu tal-apparat tal-isprej fi pressjonijiet ogħla minn dawk irrakkomandati jew f'prossimità eqreb lejn ilwiċċ tat-tessut milli rrakkomandat.
English: As Beriplast P (and associated names) does not require a gas-assisted spray device, the CHMP concluded that there is no risk of gas embolism with this product when used in accordance with the prescribing advice and with the recommended device.
Maltese: Peress li Beriplast P (u ismijiet assoċjati) ma jeħtieġx apparat tal-isprej megħjun mill-gass, is-CHMP ikkonkluda li ma hemmx riskju ta' emboliżmu tal-gass b'dan il-prodott meta jintuża skont il-parir għallpreskrizzjoni u bl-apparat irrakkomandat.
English: Beriplast P does not require a gas-assisted spray device.
Maltese: Beriplast P ma jeħtieġx apparat tal-isprej megħjun mill-gass.
English: When the two solutions are mixed together, thrombin breaks fibrinogen up into smaller units called fibrin.
Maltese: Meta ż-żewġ soluzzjonijiet jitħalltu flimkien, thrombin ikisser lil fibrinogen f'unitajiet iżgħar imsejħa fibrina.
English: In particular, when spraying these products: the recommended pressures should not be exceeded, and the sealant should not be sprayed at a closer distance than recommended; patients should be closely monitored for signs of possible gas embolism (by measuring blood pressure, pulse rate, and oxygen and CO2 levels in the blood).
Maltese: B'mod partikolari, meta dawn il-prodotti jiġu sprejjati: il-pressjonijiet rakkomandati ma għandhomx jinqabżu, u s-siġillant ma għandux jiġi sprejjat f'distanza eqreb minn dik rakkomandata; il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali possibbli ta' emboliżmu tal-gass (billi titkejjel il-pressjoni tad-demm, ir-rata tal-polz, u l-livelli tal-ossiġenu u s-CO2 fid-demm).
English: Fibrin sealants are medicines that are used as a sealant (glue) during surgery to help reduce local bleeding.
Maltese: Siġillanti tal-fibrina huma mediċini li jintużaw bħala siġillant (kolla) matul kirurġija biex jgħinu jnaqqsu fsada lokali.
English: • There is no risk of gas embolism with Beriplast P when used in accordance with the prescribing advice and with the recommended device.
Maltese: • Ma hemm l-ebda riskju ta' emboliżmu tal-gass bi Beriplast P meta jintuża skont il-parir dwar ilpreskrizzjoni u bl-apparat rakkomandat.
English: Following cases of gas embolism (presence of a gas bubble in the blood that affects the blood flow) reported in association with the use of Evicel and Quixil, in May 2012 the European Commission asked the CHMP to issue an opinion on whether the marketing authorisation for Evicel should be maintained,
Maltese: Wara każijiet ta' emboliżmu tal-gass (preżenza ta' bużżieqa tal-gass fid-demm li taffettwa l-fluss taddemm) irrapportati b'rabta mal-użu ta' Evicel u Quixil, f'Mejju 2012 il-Kummissjoni Ewropea talbet lisCHMP biex joħroġ opinjoni dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq għal Evicel għandhiex tinżamm, tiġi varjata, sospiża jew irtirata madwar l-UE.
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, stopping the bleeding.
Maltese: Il-fibrina imbagħad tingħaqad (teħel flimkien) u tifforma embolu tal-fibrina li tgħin lill-ferita tfieq, u twaqqaf il-fsada.
English: Regarding Tisseel, Tissucol and Artiss (and associated names), the CHMP concluded that, although the risk of gas embolism was considered very low, risk minimisation measures should be implemented when these medicines are given by spray application to help ensure they are used safely.
Maltese: Fir-rigward ta' Tisseel, Tissucol u Artiss (u ismijiet assoċjati), is-CHMP ikkonkluda li, għalkemm ir-riskju ta' emboliżmu tal-gass kien ikkunsidrat bħala baxx ħafna, meta dawn il-mediċini jingħataw b'applikazzjoni sprej għandhom jiġu implimentati miżuri ta' minimizzazzjoni tar-riskji biex jgħinu jiżguraw li jintużaw b'mod sigur.
English: The Committee also agreed that the company marketing Tisseel, Tissucol and Artiss should provide a letter to relevant healthcare professionals in the EU including important information on the safe use of these medicines.
Maltese: Il-Kumitat qabel ukoll li l-kumpanija li tqiegħed Tisseel, Tissucol u Artiss fis-suq għandha tipprovdi ittra lill-professjonisti tal-kura tas-saħħa fl-UE rilevanti li fiha tinkludi informazzjoni importanti dwar l-użu sigur ta' dawn il-mediċini.
English: 30 x 1 tablets (unit dose)
Maltese: Daqs tal-pakkett folja (PVC/PVDC/alu) 30 pillola folja (PVC/PVDC/alu) 30 × 1 pillola (doża waħda)
English: (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa
English: Control regimen (n=635)
Maltese: Skeda ta' kontroll (n=635)
English: St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Dose (mg)
Maltese: Doża (mg)
English: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL United Kingdom
Maltese: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL Ir-Renju Unit
English: b C.I., confidence interval.
Maltese: b C.I., intervall ta' kunfidenza.
English: Total active HMG Co-A reductase inhibitors:
Maltese: Inibituri attivi totali HMG Co-A reductase:
English: Verapamil, Felodipine, Nifedipine and Nicardipine
Maltese: Verapamil, Felodipine, Nifedipine u Nicardipine
English: SN: <NN:>
Maltese: <NN:>
English: Metabolic parameters
Maltese: Parametri metaboliċi
English: rare photoallergic dermatitis
Maltese: rari dermatite fotoallerġika‡
English: Hard capsule
Maltese: Kapsula iebsa
English: Antiviral activity
Maltese: Attività antivirali
English: Date of latest renewal: 23 April 2014
Maltese: Data tal-aħħar tiġdid: 23 ta' April 2014
English: (see section 4.3).
Maltese: (ara sezzjoni 4.3).
English: Efavirenz regimen (n=1,008)
Maltese: Skeda b'Efavirenz (n=1,008)
English: ZDV + 3TC EFV + IDV 206 IDV +
Maltese: ZDV + 3TC EFV + IDV 206
English: 25 to < 32.5
Maltese: 25 sa < 32.5
English: 42 x 1 hard capsules: blister
Maltese: 42 x 1 kapsula iebsa: folja
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (eg, cyclosporine, tacrolimus, sirolimus)/Efavirenz
Maltese: Immunosuppressanti metabolizzati minn CYP3A4 (eż., cyclosporine, tacrolimus, sirolimus)/Efavirenz
English: 15 to < 20
Maltese: 15 sa < 20
English: b 95% confidence intervals.
Maltese: b intervalli ta' kunfidenza ta' 95%.
English: For a summary of clinical and pharmacodynamic information, see section 5.1.
Maltese: Għal taqsira tal-informazzjoni klinika u farmakodinamika, ara sezzjoni 5.1.
English: ZDV + 3TC
Maltese: IDV + ZDV + 3TC
English: Cardiac Electrophysiology
Maltese: Elettrofiżjoloġija Kardijaka
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Maltese: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine;
English: (See section 4.4.)
Maltese: (Ara sezzjoni 4.4.).
English: These metabolites are essentially inactive against HIV-1.
Maltese: Dawn il-metaboliti essenzjalment mhumiex attivi kontra HIV-1.
English: Frequency is defined using the following convention: 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); or very rare (< 1/10,000).
Maltese: Il-frekwenza hija definita permezz tal-konvenzjoni li ġejja: 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); jew rari ħafna (< 1/10,000).
English: a NC = F, noncompleter = failure.
Maltese: a NC = F, mhux komplut = falliment.
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Maltese: FARMAĊEWTIKA U KONTENUT 30 kapsula iebsa
English: Mean Cmin µg/mL
Maltese: Medja tas-Cmin µg/mL
English: 32.5 to < 40
Maltese: 32.5 sa < 40
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Maltese: Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma substrati ta' isoenzimi CYP450
English: Efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
Maltese: Efavirenz jintrabat ħafna (bejn wieħed u ieħor 99.5 - 99.75 %) mal-proteini tal-plażma umana, speċjalment albumina.
English: Atazanavir (pm): AUC: ↔*/** (↓10 to ↑26)
Maltese: Atazanavir (pm): AUC: ↔*/** (↓ 10 sa
English: 20 to < 25
Maltese: 20 sa < 25
English: Depomedroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM single dose DMPA)
Maltese: Depomedroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM doża waħda DMPA)
English: Antifungals
Maltese: Antifungali
English: Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital.
Maltese: Mediċini użati biex jikkuraw konvulżjonijiet/attakki (antikonvulżjonijiet): carbamazepine, phenytoin, phenobarbital.
English: Medicines used to treat fungal infections (antifungals): voriconazole.
Maltese: Mediċini użati biex jikkuraw infezzjonijiet fungali (antifungali): voriconazole.
English: Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1.
Maltese: Efavirenz huwa induttur in vivo ta' CYP3A4, CYP2B6 u UGT1A1.
English: Ketoconazole and other imidazole antifungals
Maltese: Ketoconazole u antifungali imidazole oħra
English: Hydroxybupropion: AUC: ↔
Maltese: Hydroxybupropion:
English: For the drug-drug interaction with etonogestrel implant, the PRAC noted the available data from 16 case reports and the published literature articles by Vieira et al., 2014 and Chappel et al., 2017.
Maltese: Għall-interazzjoni bejn il-mediċini b'impjant ta' etonogestrel, il-PRAC innota d-data disponibbli minn 16-il rapport ta' każijiet u l-artikli tal-letteratura ppubblikati minn Vieira et al., 2014 u Chappel et al., 2017.
English: 5 to < 7.5
Maltese: 5 sa < 7.5
English: Outer carton PC:
Maltese: Kartuna ta' barra PC:
English: MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
Maltese: Danmark MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
English: EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a NC = F, noncompleter = failure.
Maltese: EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a NC = F, mhux komplut = falliment.
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
Maltese: Mediċini użati biex jikkuraw infezzjoni bil-virus tal-epatite Ċ: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
English: c S.E.M., standard error of the mean.
Maltese: c S.E.M., żball standardizzat tal-medja.
English: Tel.: +420 233 010 111 dpoc_czechslovak @merck.com
Maltese: Tel.: +420 233 010 111 dpoc_czechslovak @merck.
English: Skin and subcutaneous tissue disorders very common rash (11.6%)*
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda komuni ħafna raxx (11.6 %)*
English: HORMONAL CONTRACEPTIVES Oral:
Maltese: KONTRAĊETTIVI ORMONALI
English: UNIQUE IDENTIFIED - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Kartuna ta' barra: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: (CYP2B6 induction)
Maltese: (Induzzjoni ta' CYP2B6)
English: The potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild type viral strains.
Maltese: Il-qawwa ta' efavirenz fil-kulturi taċ-ċelluli kontra varjanti virali bis-sostituzzjonijiet ta' amino acid fil-pożizzjonijiet 48, 108, 179, 181 or 236 fl-RT jew varjanti bis-sostituzzjonijiet ta' amino acid fi protease kienet simili għal dik osservata kontra razez virali wild type.
English: common pruritus uncommon erythema multiforme, Stevens-Johnson syndrome*
Maltese: komuni ħakk mhux komuni eritema multiforme, sindromu ta' StevensJohnson*
English: Nervous system disorders common cerebellar coordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)*
Maltese: Disturbi fis-sistema nervuża komuni disturbi fil-koordinazzjoni taċ-ċervellett u filbilanċ‡, disturbi fl-attenzjoni (3.6 %), sturdament (8.5 %), uġigħ ta' ras (5.7 %), ngħas (2.0 %)*
English: cells/mm (S.E.M.
Maltese: ċelluli /mm3 (S.E.M.