FrancophonIA/ELRC3.0 huggingface dataset:
English: In Li-Fraumeni cancer, where the p53 gene is defective, the p53 protein does not work properly and the cancer cells can continue to grow and divide.
Maltese: Il-kanċer Li-Fraumeni, meta l-ġene p53 ikun difettuż, il-proteina p53 ma taħdimx b'mod kif suppost u ċ-ċelloli tal-kanċer jistgħu ikomplu jikbru u jimmultiplikaw.
English: The CHMP was concerned that there was not enough evidence to show that the injection of Advexin into Li-Fraumeni tumours led to benefits for patients.
Maltese: Is-CHMP esprima tħassib li ma kienx hemm evidenza biżżejjed sabiex turi li l-injezzjoni ta' Advexin fit-tumuri Li-Fraumeni wasslu għal benefiċċji fil-pazjenti.
English: The application was at day 179 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 179 meta l-kumpanija rtiratha.
English: What was Advexin expected to be used for?
Maltese: Kif kien mistenni li jaħdem Advexin?
English: Questions and answers on the withdrawal of the marketing application for Advexin
Maltese: Mistoqsija u Tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Advexin
English: Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Maltese: Il-kanċer Li-Fraumeni jista' jseħħ f'bosta partijiet tal-ġisem iżda normalment jaffettwa s-sider, il-moħħ, l-għadam jew it-tessuti rotob (tessuti li jikkolegaw, idawru jew li jżommu stutturi oħrajn fil-ġisem).
English: Further information on Kymriah can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kymriah
Maltese: Informazzjoni oħra dwar Kymriah
English: The blood cancers that Kymriah is used to treat are rare, and Kymriah was designated an ‘orphan medicine' (a medicine used in rare diseases) for B-cell ALL on 29 April 2014 and DLBCL on 14 October
Maltese: Il-kanċers tad-demm li Kymriah jintuża biex jikkurahom huma rari, u Kymriah ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għal ALL taċ-ċellola B fid-29 ta' April 2014 u għal DLBCL fl-14 ta' Ottubru 2016.
English: Around 24% of patients had a complete response and 34% had at least a partial response after at least 3 months.
Maltese: Madwar 24 % tal-pazjenti kellhom rispons sħiħ u 34 % kellhom tal-inqas rispons parzjali wara tal-inqas 3 xhur.
English: This was better than results seen with the cancer medicines clofarabine, blinatumomab or a combination of clofarabine, cyclophosphamide and etoposide.
Maltese: Dan kien aħjar mir-riżultati li dehru bil-mediċini tal-kanċer clofarabine, blinatumomab jew kombinazzjoni ta' clofarabine, ċiklofosfamid u etoposide.
English: Kymriah contains the active substance tisagenlecleucel (consisting of genetically modified white blood cells).
Maltese: Kymriah fih is-sustanza attiva tisagenlecleucel (li tikkonsisti minn ċelloli bojod tad-demm modifikati ġenetikament).
English: The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure) and decreases in platelets (components that help the blood to clot), haemoglobin (the protein found in red blood cells that carries oxygen around the body) or white blood cells including neutrophils and lymphocytes.
Maltese: L-effetti sekondarji serji l-aktar komuni huma sindrome ta' rilaxx ta' ċitokina (kondizzjoni potenzjalment ta' periklu għall-ħajja li tista' tikkawża deni, rimettar, qtugħ ta' nifs, uġigħ u pressjoni tad-demm baxxa) u tnaqqis fil-pjastrini (komponenti li jgħinu d-demm jagħqad), emoglobina (il-proteina li tinsab fiċ-ċelloli ħomor tad-demm li ġġorr lossiġenu madwar il-ġisem) jew ċelloli bojod tad-demm inkluż newtrofili u limfoċiti.
English: What are the risks associated with Kymriah?
Maltese: X'inhuma r-riskji assoċjati ma' Kymriah?
English: As for all medicines, data on the use of Kymriah are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Kymriah hija ssorveljata kontinwament.
English: The main study of Kymriah in DLBCL involved 165 patients who had at least 2 previous treatments and could not have a stem cell transplant.
Maltese: L-istudju ewlieni ta' Kymriah f'DLBCL involva 165 pazjent li rċivew tal-inqas 2 kuri preċedenti u li ma setax isirilhom trapjant taċ-ċelloli staminali.
English: The main study of Kymriah in B-cell ALL involved 92 children and young adults (3-25 years of age) whose cancer had come back after previous treatment or did not respond to treatment.
Maltese: L-istudju ewlieni ta' Kymriah f'ALL taċ-ċellola B involva 92 wild u żagħżugħ (ta' età ta' 3-25 sena) li lkanċer tagħhom irritorna wara kura preċedenti jew li ma rrispondiex għall-kura.
English: B-cell ALL
Maltese: ALL taċ-ċellola B
English: Kymriah contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Maltese: Kymriah fih iċ-ċelloli T tal-pazjent stess (tip ta' ċellola bajda tad-demm) li ġew modifikati ġenetikament fil-laboratorju sabiex jagħmlu proteina msejħa riċettur ta' antiġen kimeriku (CAR). CAR jista' jeħel ma' proteina oħra fuq il-wiċċ taċ-ċelloli tal-kanċer imsejħa CD19.
English: • Diffuse large B-cell lymphoma (DLBCL) in adults whose cancer has come back or did not respond after two or more previous treatments.
Maltese: • Limfoma taċ-ċellola B kbira diffuża (DLBCL) f'adulti li l-kanċer tagħhom irritorna jew li ma rrispondiex wara żewġ kuri preċedenti jew aktar.
English: • B-cell acute lymphoblastic leukaemia (ALL), in children and young adults up to 25 years of age whose cancer did not respond to previous treatment, has come back two or more times, or has come back after a transplant of stem cells;
Maltese: • Lewkimja limfoblastika akuta (ALL) taċ-ċellola B, fi tfal u żgħażagħ sa età ta' 25 sena li l-kanċer tagħhom ma rrispondiex għal kura preċedenti, irritorna darbtejn jew aktar, jew irritorna wara trapjant ta' ċelloli staminali;
English: Kymriah is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Kymriah huwa tip ta' mediċina terapewtika avvanzata msejħa “prodott terapewtiku ta' ġene”.
English: Twelve months after treatment, the likelihood of survival was 40%.
Maltese: Tnax-il xahar wara l-kura, il-probabbiltà ta' sopravivenza kienet 40 %.
English: How is Kymriah used?
Maltese: Kif jaħdem Kymriah?
English: Serious infections occur in around 3 in 10 DLBCL patients.
Maltese: Iseħħu infezzjonijiet serji f'madwar 3 pazjent b'DLBCL minn kull 10.
English: Twelve months after treatment, the likelihood of survival was 70%.
Maltese: Tnax-il xahar wara l-kura, il-probabbiltà ta' sopravivenza kienet 70 %.
English: A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
Maltese: Mediċina msejħa tocilizumab u tagħmir tal-emerġenza għandhom ikunu disponibbli f'każ li l-pazjent ikollu effett sekondarju potenzjalment serju msejjaħ sindrome ta' rilaxx ta' ċitokina (ara s-sezzjoni dwar ir-riskji taħt).
English: For the full list of side effects and restrictions with Kymriah, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Kymriah, ara l-fuljett ta' tagħrif.
English: How does Kymriah work?
Maltese: Kif jintuża Kymriah?
English: Patients should be closely monitored for 10 days after treatment for side effects and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal 10 ijiem wara l-kura għall-effetti sekondarji u huma rakkomandati li jibqgħu qrib sptar speċjalista għal tal-inqas 4 ġimgħat wara l-kura.
English: Serious side effects, occur in most patients, and can include cytokine release syndrome.
Maltese: F'ħafna mill-pazjenti jseħħu effetti sekondarji serji, u jistgħu jinkludu sindrome ta' rilaxx ta' ċitokina.
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Kymriah, the patient should have a short course of chemotherapy to clear away their white blood cells and just before the infusion, they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Maltese: Qabel ma jieħu Kymriah, il-pazjent għandu jirċievi kors qasir ta' kimoterapija sabiex jitneħħew iċ-ċelloli bojod tad-demm tiegħu u eżatt qabel l-infużjoni, jingħata paracetamol u mediċina antistamina sabiex jitnaqqas ir-riskju ta' reazzjonijiet għall-infużjoni.
English: Tocilizumab must be available in case of cytokine release syndrome.
Maltese: Aktar informazzjoni fuq Kymriah tinstab fis-sit elettroniku tal-Aġenzija:
English: The company must carry out several studies to obtain more information on Kymriah including its safety and effectiveness in the long term and in B-cell ALL patients under 3 years of age.
Maltese: Il-kumpanija għandha twettaq diversi studji sabiex tikseb aktar informazzjoni dwar Kymriah inkluż issigurtà u l-effikaċja tiegħu fit-tul u f'pazjenti b'ALL taċ-ċellola B taħt l-età ta' 3 snin.
English: (Invented)name Strength Pharmaceutical form
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: ATC Code: A10AE04.
Maltese: Kodiċi ATC: A10AE04.
English: Via Valcanello, 4 03012 Anagni (FR) Italy
Maltese: Via Valcanello, 4 03012 Anagni (FR)
English: MedDRA system organ classes
Maltese: Sistema talklassifika talorgani
English: - The active substance is insulin glargine.
Maltese: - Is-sustanza attiva hi insulina glargine.
English: Tel: 800 13 12 12 (domande di tipo tecnico) 800.536389 (altre domande)
Maltese: Tel: 800 13 12 12 (domande di tipo tecnico) 800.
English: Pack of 1 vial.
Maltese: Pakkett ta' kunjett wieħed.
English: Participants were randomised (1:1) to receive insulin glargine (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Maltese: B'mod arbitrarju (1:1), il-parteċipanti rċevew insulin glargine (n=6264), mogħti b'mod biex jilħaq FPG ≤95 mg/dl (5.3 mM) jew kura standard (n=6273).
English: *Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Maltese: *Insulin glargine huwa magħmul bit-teknoloġija rikombinanti tad-DNA ġo Escherichia coli .
English: Hydrochloric acid (for pH adjustment) Polysorbate 20
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Polysorbate 20
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (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; very rare: <1/10,000).
Maltese: L-effetti avversi relatati u imniżżlin hawn taħt, miġbura minn studji kliniċi, huma elenkati skont is-sistema tal-klassifika ta' l-organi u f'ordni fejn l-inċidenza dejjem tonqos (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; rari ħafna: < 1/10,000).
English: 5 ml vial, cartridge, SoloStar pre-filled pen Zinc chloride
Maltese: Kunjett ta' 5 ml, skatoċċ, pinna mimlija għal-lest SoloStar Zinc chloride
English: After subcutaneous injection of Lantus in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Maltese: Wara l-injezzjoni minn taħt il-ġilda ta' Lantus f'pazjenti dijabetiċi, insulin glargine malajr jiġi mmetabolizzat fil-carboxyl terminus tal-ħolqa tal-Beta bil-formazzjoni ta' żewġ metaboliti attivi, M1 (21A-Gly-insulin) u M2 (21A-Gly-des-30B-Thr-insulin).
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Höchst,
English: 1 ml contains 100 units (3.64 mg) insulin glargine.
Maltese: 1 ml fih 100 unità (3.64 mg) insulin glargine
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u tattessuti konnettivi
English: Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine / lispro group versus 52% in the NPH / regular group.
Maltese: B'mod simili, l-inċidenza ta' ipogliċemija ta' matul il-lejl kienet ta' 32% fil-grupp ta' insulin glargine/ lispro kontra 52% fil-grupp ta' NPH/ normali.
English: 3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 8 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
Maltese: Soluzzjoni għall-injezzjoni Pinna 1 ta' 3 ml 3 pinen ta' 3 ml 4 pinen ta' 3 ml 5 pinen ta' 3 ml 6 pinen ta' 3 ml 8 pinen ta' 3 ml 9 pinen ta' 3 ml 10 pinen ta' 3 ml
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Maltese: L-attività primarja ta' l-insulina, inkluża dik ta' insulin glargine, hija li tirregola l-metaboliżmu tal-glukożju.
English: Each pen contains multiple doses.
Maltese: Kull pinna fiha diversi dożi.
English: Lantus contains insulin glargine.
Maltese: Lantus fih insulin glargine.
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Maltese: Fil-linja bażi, il-parteċipanti kellhom valur medjan ta' HbA1c ta' 6.4% u l-valuri medjani ta' HbA1c waqt il-kura varjaw minn 5.9 sa 6.4% fil-grupp ta' insulin glargine u 6.2% sa 6.6% fil-grupp ta' kura standard matul iż-żmien kollu ta'
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: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar issigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku
English: Lantus with alcohol
Maltese: Lantus ma' alkoħol
English: Date of first authorisation: 9 June 2000 Date of latest renewal: 17 February 2015
Maltese: Data tal-aħħar tiġdid: 17 Frar 2015
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Maltese: Rabta mar-riċettur ta' IGF-1: L-affinità ta' insulin glargine għar-riċettur uman ta' IGF-1 hija madwar 5 sa 8 darbiet aktar minn dik tal-insulina umana (iżda madwar 70 sa 80 darba inqas minn dik ta' IGF-1), filwaqt li l-affinità tar-rabta ta' M1 u M2 mar-riċettur IGF-1 huwa daqsxejn inqas meta mqabbel mal-insulina umana.
English: Unopened:
Maltese: Attent:
English: EU/1/00/134/001-004 EU/1/00/134/005-007 EU/1/00/134/012 EU/1/00/134/013-017 EU/1/00/134/030-037
Maltese: EU/1/00/134/013-017 EU/1/00/134/030-037
English: Other medicines and Lantus
Maltese: Mediċini oħra u Lantus
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants).
Maltese: L-istudju ORIGIN (Outcome Reduction with Initial Glargine INtervention) kien studju multiċentriku, magħmul b'mod arbitrarju u tat-tip 2x2 factorial fejn ħadu parti f'12,537 parteċipant b'riskju għoli kardjovaskulari(CV) u b'indeboliment fil-kontroll taz-zokkor fl-istat ta' sawm (IFG) jew b'indeboliment fittolleranza taz-zokkor (IGT) (12% tal-parteċipanti) jew bid-dijabete mellitus tat-tip 2 ikkurata b' ≤1 sustanza antidijabetika orali (88% tal-parteċipanti).
English: EU/1/00/134/031 3 pens of 3 ml EU/1/00/134/032 4 pens of 3 ml EU/1/00/134/033 5 pens of 3 ml EU/1/00/134/034 6 pens of 3 ml EU/1/00/134/035 8 pens of 3 ml EU/1/00/134/036 9 pens of 3 ml EU/1/00/134/037 10 pens of 3 ml
Maltese: EU/1/00/134/030 pinna 1 ta' 3 ml EU/1/00/134/031 3 pinen ta' 3 ml EU/1/00/134/032 4 pinen ta' 3 ml EU/1/00/134/033 5 pinen ta' 3 ml EU/1/00/134/034 6 pinen ta' 3 ml EU/1/00/134/035 8 pinen ta' 3 ml EU/1/00/134/036 9 pinen ta' 3 ml EU/1/00/134/037 10 pinen ta' 3 ml
English: The graph above shows the activity profiles over time of insulin glargine and NPH insulin.
Maltese: Il-graff hawn fuq turi il-profili ta'attività kontra l-ħin ta' Insulin glargine u l-NPH insulin.
English: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups.
Maltese: Varjabilitajiet ta' glycohaemoglobin u glucose kienu komparabbli fiż-żewġ gruppi ta' kura.
English: The Lantus cartridges are to be used only with the pens: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.
Maltese: L-iskartoċċi ta' Lantus għandhom jintużaw biss flimkien mal-pinen: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.
English: EU/1/00/134/013 1 cartridge of 3 ml EU/1/00/134/014 3 cartridges of 3 ml EU/1/00/134/005 4 cartridges of 3 ml EU/1/00/134/006 5 cartridges of 3 ml EU/1/00/134/015 6 cartridges of 3 ml EU/1/00/134/016 8 cartridges of 3 ml EU/1/00/134/017 9 cartridges of 3 ml EU/1/00/134/007 10 cartridges of 3 ml
Maltese: EU/1/00/134/013 skartoċċ 1 ta' 3 ml EU/1/00/134/014 3 skartoċċi ta' 3 ml EU/1/00/134/005 4 skartoċċi ta' 3 ml EU/1/00/134/006 5 skartoċċi ta' 3 ml EU/1/00/134/015 6 skartoċċi ta' 3 ml EU/1/00/134/016 8 skartoċċi ta' 3 ml EU/1/00/134/017 9 skartoċċi ta' 3 ml EU/1/00/134/007 10 skartoċċi ta' 3 ml
English: EU/1/00/134/001 1 vial of 5 ml EU/1/00/134/002 2 vials of 5 ml EU/1/00/134/003 5 vials of 5 ml EU/1/00/134/004 10 vials of 5 ml
Maltese: EU/1/00/134/002 2 kunjetti ta' 5 ml EU/1/00/134/003 5 kunjetti ta' 5 ml EU/1/00/134/004 10 kunjetti ta' 5 ml
English: Pack sizes of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Maltese: Daqsijiet tal-pakkett 1, 2, 5 u 10 kunjetti ta' 5 ml jew kunjett 1 ta' 10 ml.
English: Insulin antibodies
Maltese: Insulin glargine
English: Suomi/Finland
Maltese: België/Belgique/Belgien
English: EU/1/00/134/030 1 pen of 3 ml.
Maltese: EU/1/00/134/001 kunjett 1 ta' 5 ml
English: • Adolescents and children aged 2 years and older patients Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older (see section 5.1).
Maltese: • Adolexxenti u tfal ta' sentejn u pazjenti akbar fl-età Is-sigurtà u l-effikaċja ta' Lantus ġew stabbiliti fl-adolexxenti u fit-tfal minn sentejn 'il fuq (ara sezzjoni 5.1).
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group.
Maltese: Ir-rati ta' ipogliċemija severa (parteċipanti affettwati għal kull 100 parteċipant ta' snin ta' espożizzjoni) kienu ta' 1.05 għal insulin glargine u 0.30 għall-grupp ta' kura standard, u r-rati ta' ipogliċemija kkonfermata li ma kinitx severa kienu ta' 7.71 għal insulin glargine u 2.44 għall-grupp ta' kura standard.
English: Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study (see section 5.1).
Maltese: Il-farmakokinetika fi tfal b'età ta' sentejn sa inqas minn 6 snin b'dijabete mellitus tat-tip 1 kienet evalwata fi studju kliniku (ara sezzjoni 5.1).
English: Date of first use:……………
Maltese: JIS: Data ta' l-ewwel użu:..............
English: Sanofi A/S Tlf: +45 45 16 70 00
Maltese: Tlf: +45 45 16 70 00
English: 2 years.
Maltese: 10 sek
English: Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Maltese: U KWANTITATTIVA Kull ml fih 100 unità insulin glargine* (ekwivalenti għal 3.64 mg).
English: 8 cartridges of 3 ml.
Maltese: 8 skartoċċi ta' 3 ml.
English: You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Maltese: Tista' tissettja d-doża f'qabżiet ta' unità l-waħda, minn minimu ta' Unità waħda sa massimu ta' 80 unità.
English: Perform a Safety test
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Solution for injection 1 cartridge of 3 ml.
Maltese: Soluzzjoni għall-injezzjoni Skartoċċ 1 ta' 3 ml.
English: Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
Maltese: Studji in vitro jindikaw li l-affinità tal-insulin glargine u l-metaboliti tiegħu M1 u M2 għar-riċettur tal-insulina umana hija simili għal dik tal-insulina umana.
English: The Lantus cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Maltese: L-skartoċċi ta' Lantus għandhom jintużaw biss flimkien mal-pinen: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO jew JuniorSTAR (ara sessjonijiet 4.2 u 4.4).
English: Lantus 100 units/ml solution for injection in a vial Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units.
Maltese: Lantus 100 unità/ml soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 5 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 500 unità, jew 10 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 1000 unità.
English: Switch from insulin glargine 300 units/ml to Lantus Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable.
Maltese: Il-bidla minn insulin glargine 300 unità/ml għal Lantus Lantus u Toujeo (insulin glargine 300 unità/ml) mhumiex bijoekwivalenti u ma jistgħux jinbidlu b'mod dirett ma' xulxin.
English: Luxembourg/Luxemburg Sanofi Belgium
Maltese: Luxembourg/Luxemburg
English: The safety and efficacy of Lantus have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lantus ma ġewx stabbiliti.
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Maltese: Meta jingħataw fil-vina, il-half-life ta' l-eliminazzjoni ta' insulin glargine u l-insulina umana huma komparabbli.
English: United Kingdom Sanofi
Maltese: T/A SANOFI
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Maltese: Sustanzi li jistgħu jnaqqsu l-effett tat-tnaqqis fil-livell tal-glukożju fid-demm jinkludu l-corticosteroids, danazol, diazoxide, id-dijuretiċi, glucagon, isoniazid, oestrogens u progestogens, id-derivattivi ta' phenothiazine , somatropin, prodotti mediċinali simpatomimetiċi (e.ż. epinephrine [adrenaline], salbutamol u terbutaline), l-ormoni tat-tirojde, il-prodotti mediċinali antipsikotiċi atipiċi (e.ż clozapine u olanzapine) u linibituri tal-protease.
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Maltese: Fi studju kliniku kkontrollat b'mod arbitrarju, pazjenti tfal (etajiet li jvarjaw minn 6 sa 15-il sena) biddijabete tat-tip I (n=349) ġew ikkurati għal 28 ġimgħa bi skeda ta' insulina basal-bolus fejn ġiet użata insulina umana regolarment qabel kull ikla.