FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Table 10: Efficacy and adherence in study CO-US-104-0380 (Partners PrEP)
Maltese: Effikaċja u aderenza fl-istudju CO-US-104-0380 (Partners PrEP)
English: Emtricitabine/Tenofovir disoproxil Mylan.
Maltese: X'fih Emtricitabine/Tenofovir disoproxil Mylan
English: Taking Emtricitabine/Tenofovir disoproxil Mylan with other medicines containing didanosine (for treatment of HIV infection): Taking emtricitabine/tenofovir disoproxil with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Maltese: Li tieħu emtricitabine/tenofovir disoproxil ma' mediċini antivirali oħra li fihom didanosine jista' jgħolli l-livelli ta' didanosine fid-demm tiegħek u jista' jnaqqas l-għadd taċ-ċelluli CD4 tiegħek.
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see sections 4.2 and 4.4).
Maltese: emtricitabine/tenofovir disoproxil mhuwiex rakkomandat f'individwi li għadhom m'għalqux it-18il sena b'indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.4).
English: Discontinuation of emtricitabine/tenofovir disoproxil therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Maltese: It-twaqqif tat-terapija b'emtricitabine/tenofovir disoproxil f'pazjenti infettati bl-HBV jista' jkun assoċjat ma' aggravamenti akuti severi tal-epatite.
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Maltese: Il-mutazzjoni K65R tista' ukoll tintgħażel minn abacavir jew didanosine u tikkawża tnaqqis fis-sensittività għal dawn il-mediċini flimkien ma' lamivudine, emtricitabine u tenofovir.
English: However, in some HIV-1 infected patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Maltese: Madankollu, f'xi pazjenti infettati bl-HIV-1, tnaqqis fit-tneħħija tal-kreatinina m'għaddietx kompletament minkejja t-twaqqif ta' tenofovir disoproxil.
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Maltese: Emtricitabine, ukoll, ma impedixxix lill-enzima uridine-5' diphosphoglucuronyl transferase, li hija responsabbli għall-glukoronidazzjoni.
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV:
Maltese: Id-doża rakkomandata ta' Emtricitabine/Tenofovir disoproxil Mylan biex tittratta l-HIV jew biex tnaqqas ir-riskju li tieħu l-HIV hija:
English: Renal impairment: As emtricitabine/tenofovir disoproxil may cause renal damage, monitoring of renal function is recommended (see section 4.4).
Maltese: Indeboliment renali: Billi emtricitabine/tenofovir disoproxil jista' jikkawża ħsara renali, il-monitoraġġ tal-funzjoni renali hu rakkomandat (ara sezzjoni 4.4).
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Maltese: Dożaġġ imnaqqas ta' 250 mg ta' didanosine mogħti flimkien ma' terapija b'tenofovir disoproxil kien assoċjat ma' rapporti ta' rati għoljin ta' ħsara viroloġika f'diversi kumbinazzjonijiet li kienu ttestjati għat-trattament ta' infezzjoni bl-HIV-1.
English: • Talk to your doctor if you are over 65.
Maltese: • Kellem lit-tabib tiegħek jekk għandek iktar minn 65 sena.
English: • That Emtricitabine/Tenofovir disoproxil Mylan may cause a reduction in BMD and the effects of Emtricitabine/Tenofovir disoproxil Mylan associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients
Maltese: • Jekk qed tieħu Emtricitabine/Tenofovir disoproxil Mylan biex tnaqqas ir-riskju li tieħu lHIV, tiqafx tieħu din il-mediċina u tinsiex tieħu xi doża.
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Maltese: Sa 30% tad-doża ta' emtricitabine u madwar 10% tad-doża ta' tenofovir tista titneħħa permezz ta' dijaliżi tad-demm.
English: Precautions to prevent transmission of HIV by infected individuals should be taken in accordance with national guidelines.
Maltese: Prekawzjonijiet għallprevenzjoni tat-trasmissjoni tal-HIV minn individwi infettati għandhom jittieħdu skont il-linji gwida nazzjonali.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Bottle packs
Maltese: Pakketti tal-folji
English: Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Maltese: Id-doża rakkomandata ta' Emtricitabine/Tenofovir disoproxil Mylan sabiex jitnaqqas ir-riskju li wieħed jieħu HIV hija:
English: Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Maltese: Madankollu, ma kien hemm l-ebda riskju miżjud ta' ksur jew evidenza ta' anormalitajiet fl-għadam klinikament sinifikanti wara 144 ġimgħa.
English: Lamivudine/Tenofovir disoproxil
Maltese: Lamivudine/Tenofovir disoproxil Lamivudine:
English: Only Case or Cohort samples from subjects randomised to either tenofovir disoproxil 245 mg or emtricitabine/tenofovir disoproxil were evaluated for detectable plasma tenofovir levels.
Maltese: Huma biss il-kampjuni ta' Każ jew Gruppi mill-individwi magħżula b'mod każwali għal tenofovir disoproxil 245 mg jew emtricitabine/tenofovir disoproxil li kienu evalwati għal livelli ta' tenofovir skoperti fil-plażma.
English: BMD Z scores declined by 0.012 for lumbar spine and by 0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Maltese: 338 għall-ġisem kollu fl-64 individwu li ġew ittrattati b'tenofovir disoproxil għal 96 ġimgħa.
English: • joint or muscle aches
Maltese: • nifs qawwi u mgħaġġel
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Maltese: Is-sigurtà u effikaċja ta' emtricitabine/tenofovir disoproxil fit-tfal taħt l-età ta' 12-il sena ma ġewx determinati s'issa.
English: Female
Maltese: FOLJA
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Maltese: Sejbiet fl-istudji fuq il-firien u xxadini indikaw li kien hemm tnaqqis konness mas-sustanza fl-assorbiment intestinali ta' phosphate b'potenzjali ta' tnaqqis sekondarju fil-BMD.
English: Renal management in HIV-1 infected patients
Maltese: Trattament tal-infezzjoni bl-HIV-1 fil-popolazzjoni pedjatrika
English: 3 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Maltese: 3 Din ir-reazzjoni avversa kienet identifikata minn sorveljanza ta' wara t-tqegħid fis-suq iżda mhux osservata fi studji kliniċi kkontrollati randomised fuq pazjenti adulti jew fi studji kliniċi fuq persuni pedjatriċi bl-HIV għal emtricitabine jew fi studji kliniċi kkontrollati randomised jew il-programm ta' aċċess imkabbar ta' tenofovir disoproxil għal tenofovir disoproxil.
English: Emtricitabine/tenofovir disoproxil should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during emtricitabine/tenofovir disoproxil therapy.
Maltese: Emtricitabine/tenofovir disoproxil m'għandux jinbeda f'pazjenti pedjatriċi b'indeboliment tal-kliewi u għandu jitwaqqaf f'pazjenti pedjatriċi li jiżviluppaw indeboliment tal-kliewi waqt l-użu ta' emtricitabine/tenofovir disoproxil.
English: • liver and pancreas problems
Maltese: • problemi fil-fwied u fil-frixa
English: The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Maltese: Il-farmakokinetiċi ta' emtricitabine ma ġewx studjati f'individwi li m'humiex infettati bl-HBV, bi gradi diversi ta' insuffiċjenza epatika.
English: Emtricitabine/Tenofovir disoproxil Mylan with food and drink
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Mylan biex tittratta
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: neutropenia
Maltese: Osteonekrożi
English: Co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Maltese: L-għoti ta' emtricitabine/tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4).
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/tenofovir disoproxil use.
Maltese: Jekk anormalitajiet renali huma suspettati jew osservati, allura konsultazzjoni ma' nefroloġista għandha tiġi kkunsidrata għall-waqfien tal-użu ta' Emtricitabine/tenofovir disoproxil.
English: HIV-1 infected patients receiving emtricitabine/tenofovir disoproxil or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Maltese: Pazjenti infettati bl-HIV-1 li jirċievu emtricitabine/tenofovir disoproxil jew kwalunkwe terapija antiretrovirali oħra jistgħu jkomplu jiżviluppaw infezzjonijiet opportunistiċi u kumplikazzjonijiet oħra tal-infezzjoni tal-HIV, u għalhekk għandhom jibqgħu taħt osservazzjoni klinika mill-qrib minn tobba esperjenzati fit-trattament ta' pazjenti b'mard assoċjat mal-HIV.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Lamivudine:
Maltese: Rilpivirine:
English: Do not take Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Maltese: HIV jew biex tnaqqas ir-riskju li tieħu HIV jekk inti allerġiku għal emtricitabine, tenofovir, tenofovir disoproxil, jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Maltese: It-tobba għandhom jirreferu għal-linji gwida kurrenti tat-trattament tal-HIV għall-immaniġġjar tal-infezzjoni tal-HIV f'pazjenti koinfettati bil-virus tal-epatite B (HBV) jew bil-virus tal-epatite Ċ (HCV).
English: There are uncertainties associated with the long -term renal and bone effects of tenofovir disoproxil during the treatment of HIV-1 infection in the paediatric population.
Maltese: Hemm inċertezzi marbuta mal-effetti fit-tul fuq il-kliewi u l-għadam ta' tenofovir disoproxil matul ittrattament tal-infezzjoni bl-HIV-1 fil-popolazzjoni pedjatrika.
English: • If you notice 12 hours or more after the time you usually take Emtricitabine/Tenofovir disoproxil Mylan, forget about the missed dose.
Maltese: • Jekk tinduna 12-il siegħa jew iżjed wara l-ħin li normalment tieħu Emtricitabine/Tenofovir disoproxil Mylan, insa d-doża li tkun insejt.
English: Recommendation concerning co-administration with emtricitabine/tenofovir disoproxil (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' emtricitabine/tenofovir disoproxil (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic
Maltese: • It-tfal komunement kellhom għadd baxx taċ-ċelluli ħomor tad-demm (anemija).
English: Emtricitabine/tenofovir disoproxil can cause dizziness.
Maltese: Emtricitabine/tenofovir disoproxil tista' tikkawża sturdament.
English: APPROPRIATE
Maltese: astenja
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Maltese: Pazjenti f'riskju ta' indeboliment renali (bħal pazjenti b'fatturi ta' riskju renali fil-linja bażi, mard ta' l-HIV li jkun fi stadju avvanzat, jew pazjenti li jkunu qed jirċievu prodotti mediċinali nefrotossiċi fl-istess ħin) ghandhom riskju akbar li jkollhom irkupru mhux komplet talfunzjoni renali minkejja t- twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z score, and 0.184 and 0.027 in total body BMD Z score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Maltese: 032 u 0.087 fil-punteġġ Z tal-ispina lumbari, u -0.184 u -0.
English: Emtricitabine/tenofovir disoproxil should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections).
Maltese: Emtricitabine/tenofovir disoproxil għandu jintuża biss għal profilassi ta' qabel l-esponiment bħala parti minn strateġija globali għall-prevenzjoni tal-infezzjoni tal-HIV-1 li tinkludi l-użu ta' miżuri ta' prevenzjoni oħrajn tal-HIV-1 (eż. l-użu konsistenti u korrett ta' kondoms, l-għarfien tal-istat tal-HIV-1, l-ittestjar regolari għal infezzjonijiet oħra trasmessi sesswalment).
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Maltese: It-tossiċità fl-għadam f'firien u klieb adulti żgħażagħ seħħet f'esponimenti li kienu ≥ 5-darbiet iżjed mill-esponiment f'pazjenti pedjatriċi jew adulti; it-tossiċità fl-għadam seħħet f'xadini ġuvenili infettati f'esponimenti għoljin ħafna wara dożaġġ taħt il-ġilda (≥ 40-darba iżjed mill-esponiment fil-pazjenti).
English: Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to
Maltese: AUC: ↑ 142% (↑ 123 sa ↑ 164) Cmax: ↑ 55% (↑ 41 sa ↑ 71) Cmin: ↑ 301% (↑ 257 sa ↑ 350)
English: Co-administration and risk of renal toxicity
Maltese: L-għoti flimkien u riskju ta' tossiċità tal-kliewi
English: Blister packs
Maltese: TAGĦRIF
English: PHARMACOLOGICAL PROPERTIES
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
English: • Any signs of inflammation or infection.
Maltese: • Kwalunkwe sinjali ta' infjammazzjoni jew infezzjoni.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u lopinavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to
Maltese: Cmax: ↑ 77% (↑ 53 sa ↑ 104) Cmin: ↑ 121% (↑ 100 sa ↑ 143)
English: • fatty liver
Maltese: • ebusija fil-ġogi
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' ledipasvir/sofosbuvir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Maltese: L-analiżi ta' l-effikaċja sekondarja fuq perjodu ta' 144 ġimgħa kienet tinkludi l-proporzjon ta' pazjenti b'konċentrazzjonijiet tal-RNA tal-HIV-1 ta' < 400 jew < 50 kopja/mL, u l-bidla mil-linja bażi fl-għadd taċ-ċelluli tas-CD4.
English: NARCOTIC ANALGESICS Methadone/Tenofovir disoproxil
Maltese: Methadone/Tenofovir disoproxil
English: Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of
Maltese: Preparazzjonijiet separati ta' emtricitabine u tenofovir disoproxil huma disponibbli għat-trattament talinfezzjoni tal-HIV-1 jekk ikun meħtieġ li titwaqqaf jew tiġi modifikata d-doża ta' wieħed mill komponenti ta' Emtricitabine/Tenofovir disoproxil Mylan.
English: Adefovir dipivoxil and emtricitabine/tenofovir disoproxil should not be administered concomitantly (see section 4.4).
Maltese: Adefovir dipivoxil u Emtricitabine/tenofovir disoproxil ma għandhomx jingħataw fl-istess ħin (ara sezzjoni 4.4).
English: Individuals with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving emtricitabine/tenofovir disoproxil (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, monitoraġġ mill-qrib tal-funzjoni renali hu rakkomandat fi kwalunkwe individwu b'indeboliment renali li huwa trattat b'emtricitabine/tenofovir disoproxil (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
Maltese: • infjammazzjoni tal-kliewi, tgħaddi ħafna awrina u tħossok bil-għatx, falliment tal-kliewi, ħsara liċ-ċelluli tubuli tal-kliewi
English: The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Maltese: Iż-żieda flesponiment ta' tenofovir tista' ssaħħaħ effetti avversi marbuta ma' tenofovir, li jinkludu disturbi renali.
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Maltese: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg pilloli miksija b'rita
English: If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxil, whether or not you also have HIV.
Maltese: Jekk għandek HBV, hemm riskju serju ta' problemi tal-fwied meta tieqaf tieħu emtricitabine/tenofovir disoproxil, kemm jekk għandek l-HIV jew le.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjoni ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, ledipasvir/sofosbivir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Pack size pre-filled syringe (glass) 1 ml (30 mg/ml)
Maltese: Daqs tal-pakkett siringa mimlija għal-lest (ħġieġ)
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA Isem (ivvintat)
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Maltese: Swensweg 5, 2031 GA Haarlem L-Olanda
English: Propylene glycol
Maltese: Talc Propylene glycol
English: Hydroxypropylcellulose (E463) Titanium dioxide (E171) Red iron oxide (E172) Talc
Maltese: Hydroxypropylcellulose (E463) Titanium dioxide (E171) Red iron oxide (E172)
English: 3542 DR Utrecht The Netherlands
Maltese: 3542 DR Utrecht
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, l-Olanda
English: Cytochrome P450 2C19 (CYP2C19)
Maltese: Cytochrome P450 (CYP2C19)
English: Hallucinations, confusion
Maltese: Alluċinazzjonijiet, konfużjoni
English: Danmark Teva Denmark A.S. Tlf: +45 44 98 55 11
Maltese: Teva Denmark A.S. Tlf: +45 44 98 55 11
English: System Organ Class
Maltese: Sistema talklassifika tal-organi
English: TEVA PHARMA, S.L.U.
Maltese: TEVA PHARMA, S.
English: Acute coronary syndrome
Maltese: Sindromu koronarju akut
English: Thrombotic Thrombocytopenic Purpura (TTP)
Maltese: Purpura Tromboċitopenika Trombotika (TTP)
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: Tromboċitopenja, lewkopenja, eosinofilja
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Maltese: Dermatite bulloża (nekroliżi tossika ta' l-epidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedima, raxx eritematika, urtikarja, ekżema, lichen planus
English: Several polymorphic CYP450 enzymes activate clopidogrel.
Maltese: Ħafna enzimi CYP450 polimorfiċi jattivaw clopidogrel.
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Twaqqfu avvenimenti kardjovaskulari ġodda (punt primarju ta' tmien), bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) u 14% (CI: -31.6, 44.2), waqt l-intervalli ta' studju ta' 0-1, 1-3, 3-6, 6-9 u 9-12 xhur, rispettivament.
English: Extensive metabolism: CYP2C19*1/*1
Maltese: Metaboliżmu estensiv: CYP2C19*1/*1