FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with decompensated liver disease: The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study (GS-US-174-0108) in which adult patients received treatment with tenofovir disoproxil (n = 45) or emtricitabine plus tenofovir disoproxil (n = 45) or entecavir (n = 22) for 48 weeks.
Maltese: Il-profil tas-sigurtà ta' tenofovir disoproxil f'pazjenti b'mard mhux kumpensat tal-fwied kien evalwat fi studju (GS-US-174-0108) double blind, ikkontrollat b'mod attiv li fih il-pazjenti adulti rċivew trattament b'tenofovir disoproxil (n = 45) jew emtricitabine flimkien ma' tenofovir disoproxil (n = 45) jew entecavir (n = 22) għal 48 ġimgħa.
English: • Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:
Maltese: • Tfal li jkollhom minn 6 sa inqas minn 12-il sena li jiżnu minn 17 kg sa inqas minn 22 kg:
English: The safety of tenofovir disoproxil in the setting of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Maltese: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmakokinetiku għadha ma ġietx stabbilità.
English: • Children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg:
Maltese: • Tfal li jkollhom minn 6 sa inqas minn 12-il sena li jiżnu minn 28 kg sa inqas minn 35 kg:
English: In the HBeAg positive subjects randomised to emtricitabine plus tenofovir disoproxil, 13 of 68 subjects (19%) experienced HBeAg loss, and 7 of 68 subjects (10%) experienced anti-HBe seroconversion through week 240.
Maltese: HbeAg pożittivi li ġew randomised biex jirċievu emtricitabine flimkien ma' tenofovir disoproxil, 13 minn 68 individwu (19%) kellhom telf ta' HBeAg, u 7 minn 68 individwu (10%) kellhom serokonverżjoni anti-HBe sa ġimgħa 240.
English: If the granules mixture is chewed, it will taste very bitter.
Maltese: Viread granijiet fihom mannitol, li jista' jkollu effett lassattiv ħafif.
English: If Viread 204 mg film-coated tablets are discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Viread 204 mg pilloli miksija b'rita jitwaqqaf f'pazjenti infettati bil-virus tal-HIV kif ukoll bl epatite B (HBV), dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk lepatite tmur għall-agħar (ara sezzjoni 4.4).
English: Tests may also show:
Maltese: L-Irlanda Manifattur:
English: • flatulence
Maltese: • tħeddil
English: Baseline demographics were similar between the two treatment arms: At baseline, 52.5% of subjects were HBeAg negative, 47.5% were HBeAg positive, mean HBV DNA level was 6.5 log10 copies/ml, and mean ALT was 79 U/l, respectively.
Maltese: Fil-linja bażi, 52.5% tal-individwi kienu negattivi għal HBeAg, 47.
English: Viread 123 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with:
Maltese: Viread 123 mg pilloli miksija b'rita huma indikati għat-trattament tal-epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena u li jiżnu minn 17-il kg sa inqas minn 22 kg, b':
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/200/001
English: Concomitant administration of sofosbuvir/velpatasvir and efavirenz is expected to decrease plasma concentrations of velpatasvir.
Maltese: sofosbuvir/velpatasvir/voxi laprevir u potenzjatur farmakokinetiku (eż.
English: Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years who weigh < 17 kg or who are unable to swallow film-coated tablets.
Maltese: Viread hu disponibbli wkoll bħala granijiet ta' 33 mg/g għat-trattament ta' infezzjoni bl-HIV-1 u epatite B kronika f'pazjenti pedjatriċi li għandhom minn sentejn sa < 12-il sena li jiżnu < 17 kg jew li mhumiex kapaċi jibilgħu pilloli miksija b'rita.
English: Viread 204 mg film-coated tablets are supplied in bottles containing 30 tablets.
Maltese: Ilpilloli miksija b'rita ta' Viread 204 mg huma pprovduti fi fliexken li fihom 30 pillola.
English: • For ½ scoop: • Fill the dosing scoop up to the “½ line” on the side (see Figure C).
Maltese: • Imla l-imgħarfa tad-dożaġġ sa “½ linja” mal-ġenb (ara Figura Ċ).
English: b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis score.
Maltese: B'mod rari, ġew irrappurtati pankreatite u aċidożi lattika li kultant kienu fatali.
English: • compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Maltese: • mard tal-fwied kumpensat u evidenza ta' mard immuni attiv, i.e. replikazzjoni virali attiva, u livelli ta' ALT fis-serum li jkunu għoljin b'mod persistenti, jew evidenza istoloġika ta'
English: • Adults and adolescents aged 12 to less than 18 years and weighing at least 35 kg: 245 mg, equivalent to 7.5 scoops of granules, once a day.
Maltese: 35 kg: 245 mg, ekwivalenti għal 7.5 mgħaref ta' granijiet, darba kuljum.
English: h 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Maltese: h 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 144 ġimgħa open label.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/006 30 film-coated tablets EU/1/01/200/007 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/01/200/007 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Viread 163 mg tablets are not suitable for the following groups:
Maltese: Il-pilloli Viread 163 mg mhumiex adatti għall-gruppi li ġejjin:
English: Viread 163 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:
Maltese: Viread 163 mg pilloli miksija b'rita huma indikati għat-trattament tal-epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena u li jiżnu minn 22 kg sa inqas minn 28 kg, b':
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Maltese: kienet simili bejn il-grupp ta' kura b'tenofovir disoproxil u l-grupp ta' kura bi stavudine jew zidovudine.
English: The recommended dose for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 22 kg to < 28 kg who are able to swallow film-coated tablets is one 163 mg tablet once daily taken orally with food.
Maltese: Id-doża rakkomandata għat-trattament ta' infezzjoni bl-HIV-1 u epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena li jiżnu minn 22 kg sa < 28 kg li huma kapaċi jibilgħu pilloli miksija b'rita hi ta' pillola waħda ta' 163 mg darba kuljum meħuda mill-ħalq mal-ikel.
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: tenofovir disoproxil, sofosbuvir/velpatasvir u atazanavir/ritonavir tista' żżid ir reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Maltese: L-istima ta' reazzjonijiet avversi hi bbażata fuq studju randomised (Studju GS-US-174-0115) f'106 pazjenti adolexxenti (b'età minn 12 sa < 18-il sena) b'epatite B kronika li kienu qed jirċievu trattament b'tenofovir disoproxil 245 mg (n = 52) jew plaċebo (n = 54) għal 72 ġimgħa u fuq studju randomised (Studju GS-US-174-0144) f'89 pazjent b'epatite B kronika (b'età minn sentejn sa < 12-il sena) li kienu qed jirċievu trattament b'tenofovir disoproxil (n = 60) jew plaċebo (n = 29) għal 48 ġimgħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/004 30 film-coated tablets EU/1/01/200/005 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/01/200/005 90 (3 fliexken ta' 30) pillola miksija b'rita
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001 30 film-coated tablets EU/1/01/200/002 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/01/200/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: For dosage see section 3, How to take Viread.
Maltese: Għad-dożaġġ ara sezzjoni 3, Kif gћandek tieћu Viread.
English: Thirteen percent (6/45) of the tenofovir disoproxil group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil group, and
Maltese: 18% (8/45) fil-grupp ta' tenofovir disoproxil, 7% (3/45) fil-grupp ta' emtricitabine u tenofovir disoproxil u 9% (2/22) fil-grupp ta' entecavir.
English: • Not for children who weigh under 17 kg or 22 kg and over.
Maltese: • Mhux għal tfal li jiżnu inqas minn 17 kg jew 22 kg u aktar.
English: • That use of Viread should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Maltese: • Li l-użu ta' Viread għandu jiġi evitat bl-użu konkomitanti jew riċenti ta' prodotti mediċinali nefrotossiċi.
English: + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.)
Maltese: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabine/Tenofovir disoproxil
English: Adefovir dipivoxil 10 mg n = 90
Maltese: 10 mg n = 90
English: Mean (± SD) Cmax and AUCtau are
Maltese: Popolazzjoni(jiet) speċjali oħrajn
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 Ż tal-BMD tas-sinsla tad-dahar, u -0.184
English: Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
Maltese: Il-ħin biex il livell ta' tenofovir diphosphate jonqos bin-nofs huwa ta' 10 sigħat ġewwa ċ-ċellula f'celluli mononukleari tad-demm periferali (peripheral blood mononuclear cells, PBMCs) attivati u 50 siegħa f'dawk li qed jistrieħu.
English: l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Maltese: l 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 240 ġimgħa open label.
English: Viread 163 mg film-coated tablets are supplied in bottles containing 30 tablets.
Maltese: Il-pilloli miksija b'rita ta' Viread 163 mg huma pprovduti fi fliexken li fihom 30 pillola.
English: + Atazanavir/Ritonavir (300 mg q.d./100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Atazanavir/Ritonavir (300 mg q.d./100 mg q.d.) + Emtricitabine/Tenofovir disoproxil
English: Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg .
Maltese: (minn età ta' 12 sa < 18-il sena) li kienu qed jirċievu dożi orali ta' kuljum ta' 245 mg tenofovir disoproxil kien simili għal esponimenti miksuba f'persuni adulti li kienu qed jirċievu doża waħda kuljum ta' 245 mg tenofovir disoproxil.
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Maltese: Tabella 6: Rispons istoloġiku (%) f'individwi kumpensati li kienu negattivi għal HBeAg u pożittivi għal HBeAg f'ġimgħa 240 meta mqabbla mal-linja bażi
English: Renal and bone effects in adult population
Maltese: Effetti renali u fuq l-għadam fil-popolazzjoni adulta Effetti renali
English: Viread 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Maltese: Viread 245 mg pilloli miksija b'rita huma indikati wkoll għat-trattament ta' adolexxenti infettati b'HIV-1 b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji,li jkollhom minn 12 sa < 18-il sena.
English: In study GS-US-174-0121, 141 patients with lamivudine resistance substitutions at baseline received tenofovir disoproxil for up to 240 weeks.
Maltese: Fi studju GS-US-174-0121, 141 pazjent b'sostituzzjonijiet ta' reżistenza għal lamivudine fil-linja bażi, irċivew tenofovir disoproxil għal mhux aktar minn 240 ġimgħa.
English: Very common: hypophosphataemia1
Maltese: Popolazzjoni pedjatrika HIV-1
English: (1 subject)
Maltese: (n = 1),
English: • Children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg:
Maltese: • Tfal li jkollhom minn 6 sa inqas minn 12-il sena li jiżnu minn 22 kg sa inqas minn 28 kg:
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Maltese: F'ġimgħa 72, total globali ta' 88% (46/52) tal-pazjenti fil-grupp tal-kura b'tenofovir disoproxil u 0% (0/54) ta' pazjenti fil-grupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml. Erba' u sebgħin fil-mija (26/35) tal-pazjenti fil-grupp ta' tenofovir disoproxil kellhom ALT normalizzat f'ġimgħa 72 meta mqabbla ma' 31%
English: Viread may affect your kidneys during treatment.
Maltese: iżda ma kienx ikkonfermat fl-istudji kliniċi.
English: Treatment of acute STEMI
Maltese: Trattament ta' STEMI akut
English: • increase in the risk of hepatic impairment;
Maltese: • żieda fir-riskju tal-indeboliment epatiku;
English: • the Committee considered the referral under Article 30 of Directive 2001/83/EC,
Maltese: • il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE,
English: Section 1 - Name of the medicinal product and Section 2 - Qualitative and quantitative composition
Maltese: Taqsima 1 - Isem tal-prodott mediċinali u Taqsima 2 - Kompożizzjoni kwalitattiva u kwantitattiva
English: Section 4.2 - Posology and method of administration
Maltese: Taqsima 4.2 - Pożoloġija u metodu ta' amministrazzjoni
English: Treatment of DVT and pulmonary embolism PE
Maltese: Trattament tad-DVT u l-emboliżmu pulmonari PE
English: Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
Maltese: Id-dożi studjati fl-istudji kliniċi jvarjaw minn 0.5 mg/kg sa 1.25 mg/kg.
English: The first marketing authorisation (MA) was granted in France on 03 April 1987.
Maltese: L-ewwel Awtorizzazzjoni għat-Tqegħid fis-Suq (MA) ngħatat fi Franza fit-3 ta' April 1987.
English: Treatment of acute ST-segment elevation myocardial infarction (STEMI)
Maltese: Trattament tal-infart mijokardjali b'elevazzjoni tas-segment ST (STEMI)
English: Direct Healthcare Provider Communication (DHPC)
Maltese: Komunikazzjoni Diretta mal-Fornitur tal-Kura tas-Saħħa (DHPC)
English: Vials of 100 mg/10 mL and a pen of 10 x 40 mg (equivalent to 10 x 4 000 IU anti Xa) are also authorised.
Maltese: Il-kunjetti ta' 100 mg/10 mL u pinna ta' 10 x 40 mg (ekwivalenti għal 10 x 4 000 IU anti Xa) huma awtorizzati wkoll.
English: • gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
Maltese: • ulċera gastrointestinali, preżenza ta' neoplażma malinna b'riskju għoli ta' emorraġija, kirurġija fil-moħħ, fis-sinsla jew oftalmika riċenti, variċi gastriċi magħrufa jew suspettati, malformazzjonijiet arterjovenużi, anewriżmi vaskolari jew anormalitajiet vaskolari maġġuri intraspinali jew intraċerebrali;
English: The CHMP adopted a wording, which is in agreement with the clinical data and treatment guidelines (grade IIbB in ESC guidelines 2012, American Heart Association (AHA) guideline 2011).
Maltese: Is-CHMP adotta test, li huwa konformi mad-data klinika u l-linji gwida għat-trattament (grad IIbB fillinji gwida tal-ESC tal-2012, il-linji gwida tal-American Heart Association (AHA) tal-2011).
English: Prophylaxis of venous thromboembolism (VTE) in surgical patients
Maltese: Profilassi tat-tromboemboliżmu venuż (VTE) fil-pazjenti kirurġiċi
English: The product is currently registered in the EU under concentrations of 100 mg/mL (equivalent to 10 000 IU anti Xa/mL) in prefilled syringes, multi-dose vials, ampoules, and 150 mg/mL (equivalent to 15 000 IU anti Xa/mL) in prefilled syringes.
Maltese: Il-prodott huwa attwalment irreġistrat fl-UE taħt konċentrazzjonijiet ta' 100 mg/mL (ekwivalenti għal 10 000 IU anti Xa/mL) f'siringi mimlija minn qabel, kunjetti b'ħafna dożi, ampolli, u 150 mg/mL (ekwivalenti għal 15 000 IU anti Xa/mL) f'siringi mimlija lesti.
English: • Enoxaparin strength will now be expressed both in international units (IU) of anti-Xa activity and in milligram (mg): One mg of enoxaparin sodium is equivalent to 100 IU anti-Xa activity.
Maltese: • Is-saħħa tal-enossaparin issa se tiġi espressa kemm f'unitajiet internazzjonali (IU) tal-attività anti-XA u f'milligrammi (mg): Milligramma ta' sodju tal-enossaparin hija ekwivalenti għal 100 IU ta' attività anti Xa.
English: o or as twice daily injections of 100 IU/kg (1 mg/kg): used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Maltese: o jew inkella bħala injezzjonijiet darbtejn kuljum ta' 100 IU/kg (1 mg/kg): użati filpazjenti l-oħra kollha bħal dawk obeżi, b'PE sintomatiku, kanċer, VTE rikorrenti jew trombożi prossimali (vena iliaca).
English: However, the CHMP considered that acetylsalicylic acid (ASA) should be recommended at dose from 75 mg to 325 mg in the SmPC to be in line with clinical data and clinical practice.
Maltese: Madankollu, is-CHMP ikkunsidra li laċidu aċetisaliċiliku (ASA) għandu jkun irrakkomandat fid-doża minn 75 mg sa 325 mg fl-SmPC biex dan ikun f'konformità mad-data klinika u l-prassi klinika.
English: Prophylaxis of venous thromboembolic disease
Maltese: Profilassi tal-marda tromboembolika venuża
English: Sections 4.5 to 6 have been harmonised based on relevant available information or amended according to the latest QRD template.
Maltese: It-taqsimiet 4.5 sa 6 ġew armonizzati skont l-informazzjoni disponibbli rilevanti jew emendati skont laktar mudell riċenti tal-QRD.
English: Enoxaparin sodium can be administered subcutaneously:
Maltese: Is-sodju tal-enossaparin jista' jiġi amministrat taħt il-ġilda:
English: • increased potential bleeding;
Maltese: • żieda fl-emorraġija potenzjali;
English: - Medically managed patients (not undergoing primarily invasive procedure such as percutaneous coronary intervention (PCI) or coronary bypass artery surgery (CABG);
Maltese: - Pazjenti mediċi (li mhumiex għaddejjin minn proċedura primarjament invażiva bħal intervent koronarju perkutanju (PCI) jew kirurġija koronarja tal-bajpass tal-arterja (CABG);
English: The harmonised indication is based on treatment guidelines (European Society of Cardiology (ESC), and ACCP), as well as clinical study and literature data presented by the MAH.
Maltese: L-indikazzjoni armonizzata hija bbażata fuq linji gwida tat-trattament (is-Soċjetà Ewropea tal-Kardjoloġija (ESC), u l-ACCP), kif ukoll studji kliniċi u data tal-letteratura ppreżentata mill-MAH.
English: • careful biological monitoring by anti-Xa activity measurement in renally impaired patients;
Maltese: • monitoraġġ bijoloġiku mill-qrib permezz tal-kejl tal-attività anti Xa f'pazjenti b'indeboliment renali;
English: • The Dosage in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) has been clarified as follows:
Maltese: • Id-dożaġġ fit-trattament tat-trombożi profonda fil-vini (FVT) u l-emboliżmu pulmonari (PE) ġie kjarifikat kif ġej:
English: For treatment of DVT and PE the CHMP considered, based on the data provided and available treatment guidelines, that the harmonised wording should include a once daily injection of 150 IU/kg (1.5 mg/kg) or a twice daily injections of 100 IU/kg (1 mg/kg) in DVT and PE patients.
Maltese: Għat-trattament tad-DVT u l-PE, is-CHMP, fuq il-bażi tad-data pprovduta u l-linji gwida għattrattament disponibbli, ikkunsidra li t-test armonizzat għandu jinkludi injezzjoni darba kuljum ta' 150 IU/kg (1.5 mg/kg) jew injezzjonijiet darbtejn kuljum ta' 100 IU/kg (1 mg/kg) għall-pazjenti DVT u PE.
English: Prophylaxis of VTE in medical patients
Maltese: Profilassi tal-VTE fil-pazjenti mediċi
English: For treatment of deep venous thromboembolism, the exact wording varied across Member States, and the CHMP considered harmonising the indication to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) excluding PE likely to require thrombolytic therapy or surgery.
Maltese: Għat-trattament tat-tromboemboliżmu profond venuż, it-test eżatt varja fost l-Istati Membri, u s-CHMP ikkunsidrat tarmonizza l-indikazzjoni sabiex tinkludi t-trattament tat-tromboemboliżmu profond fil-vini (DVT) u l-emboliżmu pulmonari (PE) minbarra PE li probabbilment jeħtieġ terapija jew kirurġija trombolitika.
English: On the other hand, other low molecular weight heparins (LMWHs) in most European MSs are mainly expressed in IU of activity anti Xa and not in mg, which is in line with the European Pharmacopoeia (Version 8.1, 2014), which expresses the strength of heparins, including LWMH in IU of activity anti Xa.
Maltese: Min-naħa l-oħra, eparini oħra b'piż molekulari baxx (LMWHs) f'ħafna SM Ewropej huma espressi prinċipalment f'IU ta' attività anti Xa u mhux f'mg, li huwa f'konformità mal-Farmakopea Ewropea (Verżjoni 8.1, 2014), li tesprimi s-saħħa tal-eparini, inkluż LWMH f'IU ta' attività anti Xa.
English: The strength of the product is expressed differently in the different MSs, either in mg or in activity IU anti-factor Xa.
Maltese: Is-saħħa tal-prodott hija espressa b'mod differenti fl-SM differenti, f'mg jew inkella f'attività IU talantifattur Xa.
English: On one hand, an expression and dosing in mg is consistent with the approvals in the majority of the EU and allows both identification and distinction between different presentations whilst favouring ease of prescribing, dosing, dispensing and administration.
Maltese: Minn naħa, espressjoni u dożaġġ f'mg huma konsistenti mal-approvazzjonijiet fil-maġġoranza tal-UE u jippermettu kemm l-identifikazzjoni kif ukoll id-distinzjoni bejn preżentazzjonijiet differenti filwaqt li jiffavorixxu l-faċilità tal-preskrizzjoni, id-dożaġġ, l-iddispensar u l-amministrazzjoni.
English: • The pen presentation (10 x 4,000 IU (10x 40 mg)) contains all approved indications except use in extracorporeal dialysis.
Maltese: • Il-preżentazzjoni f'pinna (10 x 4 000 IU (10x 40 mg)) tinkludi l-indikazzjonijiet approvati kollha minbarra l-użu fid-dijaliżi barra mill-ġisem.
English: • not to use perform spinal/epidural anaesthesia or lumbar puncture during treatment with enoxaparin;
Maltese: • ma għandhiex tintuża biex issir anesteżija spinali/epidurali jew titqib lumbari waqt ittrattament bl-enossaparin;
English: Treatment of deep venous thromboembolism
Maltese: Trattament tat-tromboemboliżmu venuż
English: The principal pharmacological properties of enoxaparin include antifactor Xa and antifactor IIa (antithrombin) activity, which are dependent on its binding affinity for antithrombin.
Maltese: Il-proprjetajiet farmakoloġiċi prinċipali tal-enossaparin jinkludu attività tal-antifattur Xa u lantifattur IIa (antitrombin), li huma dipendenti fuq l-affinità għall-irbit tagħha għall-antitrombin.