FrancophonIA/ELRC3.0 huggingface dataset:
English: For the suspension of the marketing authorisations of Numeta G13%E to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Maltese: Biex is-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Numeta G13%E titneħħa, l-Awtoritajiet nazzjonali kompetenti tal-Istati Membri għandhom jivverifikaw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mill-MAH:
English: Annex III Condition for lifting the suspension of the marketing authorisations
Maltese: Anness III Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għat tqegħid fis-suq
English: The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition.
Maltese: Il-MAH għandu jikkollabora mal-Istat Membru ta' Referenza biex ikun hemm ftehim dwar il-proċedura adegwata li għandha tintuża għat-twettiq ta' din il-kundizzjoni.
English: --1 Hydrocortisone aceponate: 1.11 mg/ml; Miconazole (as nitrate form): 15.1 mg/ml; Gentamicin (as sulphate form): 1,505 IU/ml.
Maltese: --1 Millilitru fih 1.11 mg idrokortiżon aċeponat, 15.1 mg mikonażol (bħala nitrat) u 1505
English: Auricular use Multi-dose container (PP)
Maltese: Kontenitur multidoża b'pompa
English: EU number
Maltese: Numru ta' l-UE
English: Packaging
Maltese: Kontenitur
English: Route of administration
Maltese: Mod ta' Amministrazzjoni Ippakkjar
English: Content Package size Withdrawal period
Maltese: Kontenut Daqs talpakkett
English: Invented name
Maltese: Ma japplikax
English: EMA/CHMP/761027/2012 EMEA/H/C/002506
Maltese: EMA/130138/2013 EMEA/H/C/002506
English: What is Solumarv?
Maltese: X'inhu Solumarv?
English: Solumarv is a medicine that contains the active substance human insulin.
Maltese: Solumarv hija mediċina li fiha s-sustanza attiva umana l-insulina.
English: For more information on biosimilar medicines, see the questions-and-answers document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument mistoqsija u tweġiba here
English: Solumarv was developed as a biosimilar medicine.
Maltese: Solumarv ġie żviluppat bħala mediċina bijosimili.
English: The reference medicine for Solumarv in this application was Humulin S.
Maltese: Il-mediċina ta' referenza għal Solumarv f'din l-applikazzjoni kienet Humulin M3.
English: The application was a joint application from Marvel LifeSciences for Solumarv and two other medicines (Isomarv medium and Combimarv, also developed as biosimilar medicines).
Maltese: L-applikazzjoni kienet applikazzjoni konġunta minn Marvel LifeSciences għal Solumarv u żewġ medicini oħra (Isomarv medium u Combimarv, żviluppati wkoll bħala mediċini bijosimili).
English: Withdrawal of the marketing authorisation application for Solumarv (human insulin)
Maltese: Irtirar tal-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Solumarv (insulina umana)
English: The insulin in Solumarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Maltese: Solumarv jiġi prodott b'metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': jiġi magħmul minn batterji li jkunu diġà rċevew ġene (DNA) li jagħmilhom kapaċi jipproduċu l-insulina.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solumarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Maltese: Fil-15 ta' Novembru 2012, Marvel LifeSciences Ltd uffiċjalment għarrfu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li jixtiequ jirtiraw l-applikazzjoni tagħhom għallawtorizzazzjoni tat-tqegħid fis-suq għal Solumarv, użat għat-trattament ta' pazjenti bid-dijabete li jeħtieġu l-insulina biex jikkontrollaw il-glukożju fid-demm.
English: Solumarv was intended as a replacement insulin that is similar to the insulin made by the body.
Maltese: Solumarv kien intiż li jintuża bħala sostitut tal-insulina li hija simili għall-insulina prodotta mill-ġisem.
English: What was Solumarv expected to be used for?
Maltese: Kif kien mistenni li jaħdem Solumarv?
English: How is Solumarv expected to work?
Maltese: Għal x'hiex kien mistenni li jintuża Solumarv?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Maltese: Fl-ittra tagħha lill-Aġenzija fejn għarrfitha li qed tirtira l-applikazzjoni, il-kumpanija saħqet li ddeċidiet li tirtira l-applikazzjonijiet biex terġa' twettaq l-istudji f'organizzazzjoni ta' riċerka kuntrattwali validata u biex tissottometti dejta addizzjonali.
English: The company presented the results of studies designed to show that Solumarv is similar to its reference medicine Humulin S in terms of its structure, biological activity and clinical performance.
Maltese: Il-kumpanija ppreżentat ir-riżultati tal-istudji ddiżinjati biex juru li Solumarv huwa simili għall-mediċina ta' referenza Humulin M3 għal dak li jirrigwarda l-istruttura, l-attività bijoloġika u l-prestazzjoni klinika.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Solumarv could not have been approved.
Maltese: Wara valutazzjoni inizjali, is-CHMP kellu tħassib sinifikanti u kien tal-opinjoni proviżorja li Solumarv ma jkunx jista' jiġi approvat.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Solumarv in clinical trials.
Maltese: Il-kumpanija informat lis-CHMP li fiż-żmien tal-irtirar ma kienx hemm pazjenti li kienu qed jirċievu Solumarv fi provi kliniċi.
English: • restriction to open surgery
Maltese: • restrizzjoni għal kirurġija miftuħa
English: • correct pressure and distance from tissue
Maltese: • il-pressjoni u d-distanza korretta mit-tessut
English: The Marketing Authorisation Holder shall agree the exact content and format of the educational material and educational program with the national competent authority.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jaqbel fuq il-kontenut u l-format eżatt tal-materjal edukattiv u l-programm edukattiv mal-awtorità nazzjonali kompetenti.
English: • use of pressurized CO2 only
Maltese: • l-użu biss ta' CO2 taħt pressjoni
English: • requirement to closely monitor blood pressure, pulse rate, oxygen saturation and end tidal CO2 when spraying the product, for the occurrence of gas embolism.
Maltese: • rekwiżit biex il-pressjoni tad-demm, ir-rata tal-polz, is-saturazzjoni tal-ossiġenu u l-end tidal CO2 jiġu mmonitorjati bir-reqqa meta l-prodott jiġi sprejjat, għall-okkorrenza ta' emboliżmu tal-gass.
English: • a warning card that informs about the correct pressure and distance for the spray application for open surgery
Maltese: • tabella ta' twissija li tinforma dwar il-pressjoni u d-distanza korretta għall-applikazzjoni bħala sprej għal kirurġija miftuħa
English: • labels for the pressure regulator that inform about the correct pressure and distance in open surgery
Maltese: • tikketti għar-regolatur tal-pressjoni li jinfurmaw dwar il-pressjoni u d-distanza korretta f'kirurġija miftuħa
English: • requirement to dry the wound using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices) prior to using the product
Maltese: • rekwiżiti biex il-ferita titnixxef permezz ta' tekniki standard (eż. l-applikazzjoni intermittenti ta' kompressi, tajjar, l-użu ta' apparat li jiġbed) qabel il-prodott jintuża
English: Annex IV Conditions to the marketing authorisations
Maltese: Anness IV Kundizzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq
English: • risk of life-threatening gas embolism if the product is sprayed incorrectly
Maltese: • ir-risk ta' periklu għall-ħajja ta' emboliżmu tal-gass jekk il-prodott jiġi sprejjat ħażin
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the product according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jissottometti lill-awtorità nazzjonali kompetenti, fi żmien xahar mid-deċiżjoni tal-Kummissjoni Ewropea dwar din ilproċedura (EMEA/H/A-31/1337), pjan għall-immaniġġjar tar-riskju tal-UE għall-prodott skont ilPrattiċi ta' Viġilanza Tajba tal-UE li jinkludi t-tħassib dwar is-sigurtà ta' emboliżmu tal-gass.
English: The MAH shall offer an educational program to all users of the spray application of this product.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu joffri programm edukattiv lill-utenti kollha tal-applikazzjoni ta' dan il-prodott bħala sprej.
English: The MAH shall ensure that, within two years of the European Commission decision on this procedure (EMEA/H/A-31/1337), the product can only be used with a pressure regulator that caps the maximum pressure at 2.5 bars.
Maltese: Jekk it-tikketta tiġi pprovduta bħala parti mill-prodott mediċinali, għandha tiġi inkorporata fl-informazzjoni dwar il-prodott permezz ta' proċedura ta' varjazzjoni Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, fi żmien sentejn middeċiżjoni tal-Kummissjoni Ewropea dwar din il-proċedura (EMEA/H/A-31/1337), il-prodott jista' jintuża biss b'regolatur tal-pressjoni li jillimita l-pressjoni massima għal 2.5 bars.
English: The MAH shall ensure that, at the time of the European Commission decision for this procedure (EMEA/H/A-31/1337), all users of the spray application of this product are provided with educational material.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, fil-ħin tad-deċiżjoni talKummissjoni Ewropea għal din il-proċedura (EMEA/H/A-31/1337), l-utenti kollha tal-applikazzjoni ta' dan il-prodott bħala sprej jiġu pprovduti b'materjal edukattiv.
English: • which regulator(s) should be used, in line with manufacturer recommendations and the SmPC instructions for use
Maltese: • liema regolatur(i) għandu(hom) jintuża(w), skont ir-rakkomandazzjonijiet tal-manifattur u l-istruzzjonijiet għall-użu tal-SmPC
English: • a yellow tag, to be placed on the device air hose, which provides instructions for use.
Maltese: • tikketta safra, li għandha titqiegħed fuq il-pajp tal-arja tal-apparat, li tipprovdi istruzzjonijiet għall-użu.
English: The full EPAR for Kisqali 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: Kisqali ribociclib
Maltese: Kisqali ribociklib
English: Kisqali is available as 200-mg tablets.
Maltese: Kisqali jiġi bħala pilloli ta' 200 mg.
English: Other information about Kisqali
Maltese: Informazzjoni oħra dwar Kisqali
English: This is a summary of the European public assessment report (EPAR) for Kisqali.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kisqali.
English: The usual recommended dose is 3 tablets (600 mg) once daily for 21 days followed by a 7-day break to complete a 28-day treatment course.
Maltese: Id-doża rakkomandata tas-soltu hija 3 pilloli (600 mg) darba kuljum għal 21 jum segwiti minn pawża ta' 7 ijiem biex il-kors ta' kura ta' 28 jum jiġi komplut.
English: The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide.
Maltese: Is-sustanza attiva f'Kisqali, ir-ribociklib, timblokka l-attività ta' enzimi magħrufin bħala kinases li jiddependu minn ċiklin (CDK, cyclin-dependent kinases) 4 u 6, li huma importanti biex jirregolaw ilmod ta' kif iċ-ċelluli jikbru u jinqasmu.
English: Kisqali contains the active substance ribociclib.
Maltese: Kisqali fih is-sustanza attiva ribociklib.
English: Kisqali was found to be effective in one main study involving 668 women with HR-positive, HER2negative breast cancer.
Maltese: Kisqali nstab li huwa effettiv fi studju ewlieni wieħed li involva 668 mara b'kanċer tas-sider pożittiv għall-HR u negattiv għall-HER2.
English: Why is Kisqali approved?
Maltese: Għaliex ġie approvat Kisqali?
English: The most common severe side effects with Kisqali (which may affect more than 1 in 50 people) are low levels of white blood cells, nausea, vomiting, tiredness, back pain, abnormal blood tests for liver function and low levels of phosphate in the blood (hypophosphataemia).
Maltese: L-effetti sekondarji severi l-aktar komuni b'Kisqali (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 50) huma livelli baxxi taċ-ċelluli bojod tad-demm, nawżja, remettar, għeja, uġigħ fid-dahar, testijiet tad-demm anormali għall-funzjoni tal-fwied u livelli baxxi ta' fosfat fid-demm (ipofosfatemija).
English: The most common side effects with Kisqali (which may affect more than 1 in 5 people) are low levels of white blood cells, headache, back pain, nausea (feeling sick), vomiting, diarrhoea, constipation, tiredness, hair loss and rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Kisqali (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma livelli baxxi taċ-ċelluli bojod tad-demm, uġigħ ta' ras, uġigħ fid-dahar, nawżja (tħossok ma tiflaħx), remettar, dijarea, stitikezza, għeja, telf ta' xagħar u raxx.
English: By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
Maltese: Billi jimblokka CDK4 u CDK6, Kisqali jnaqqas it-tkabbir taċċelluli tal-kanċer tas-sider pożittivi għall-HR
English: Kisqali is used with an aromatase inhibitor (a cancer medicine that reduces oestrogen).
Maltese: Kisqali jintuża ma' inibitur ta' aromatase (mediċina kontra l-kanċer li tnaqqas l-estroġenu.
English: The Agency considered that Kisqali's pattern of side effects has been fairly well established and the side effects appear manageable.
Maltese: L-Aġenzija kkunsidrat li t-tendenza ta' effetti sekondarji ta' Kisqali ġiet stabbilita pjuttost tajjeb u l-effetti sekondarji jidhru li huma ġestibbli.
English: Kisqali used with an aromatase inhibitor increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2negative breast cancer that is advanced or metastatic.
Maltese: Kisqali użat ma' inibitur ta' aromatase żied iż-żmien li ħadet il-marda biex tiggrava f'nisa li għaddew mill-menopawża b'kanċer tas-sider pożittiv għall-HR u negattiv għall-HER2 li kien avvanzat jew metastatiku.
English: Kisqali is a cancer medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women.
Maltese: Kisqali huwa mediċina kontra l-kanċer użata għall-kura ta' kanċer tas-sider avvanzat jew metastatiku (kanċer li jkun infirex għal partijiet oħra tal-ġisem) f'nisa li għaddew mill-menopawża.
English: Kisqali can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Maltese: Kisqali jista' jintuża biss meta ċ-ċelluli tal-kanċer ikollhom riċetturi għal ċerti ormoni fuq is-superfiċje tagħhom (pożittiv għall-HR) u ma jkollhomx kwantitajiet kbar ta' riċettur ieħor imsejjaħ HER2 (negattiv għall-HER2).
English: What are the risks associated with Kisqali?
Maltese: Kif jintuża Kisqali?
English: The European Medicines Agency decided that Kisqali's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Kisqali huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: - The active substance is glibenclamide.
Maltese: - Is-sustanza attiva hi glibenclamide.
English: Up to 10
Maltese: Sa 10
English: Date of first authorisation: 24th May 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Mejju 2018
English: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne France
Maltese: Centre Spécialités Pharmaceutiques 76-78 Avenue du midi 63800 Cournon d'Auvergne Franza
English: Biological analyses:
Maltese: Analiżi bijoloġika:
English: Benzoic acid and benzoates (sodium benzoate)
Maltese: Benzoic acid u benzoates (sodium benzoate)
English: Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANCE
Maltese: Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANZA
English: 1 oral syringe (1 mL) 1 oral syringe (5 mL) 1 syringe adaptor.
Maltese: Siringa orali 1 (1 mL) Siringa orali 1 (5 mL) Adapter 1 tas-siringa.
English: Potential risk
Maltese: Riskju potenzjali
English: In isolated cases, photosensitivity may occur.
Maltese: F'każijiet iżolati, jista' jkun hemm fotosensittività.
English: 1 x 30 mL bottle.
Maltese: Flixkun 1 x 30 mL.
English: Isoniazid used to treat tuberculosis
Maltese: Isoniazid użat għat-trattament tat tuberkulosi
English: Sulfamethoxazole with trimethoprim (Cotrimoxazole)
Maltese: Sulfamethoxazole bi trimethoprim (Cotrimoxazole)
English: For severe renal impairment see section 4.3.
Maltese: Għal insuffiċjenza severa tal-kliewi ara sezzjoni 4.3.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients hydroxyethylcellulose lactic acid purified water sodium benzoate (E211) sodium citrate xanthan gum
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti hydroxyethylcellulose lactic acid ilma ppurifikat sodium benzoate (E211) sodium citratexanthan gum
English: Glibenclamide is completely metabolised by the liver into 3 inactive metabolites excreted via bile (60%) and urine (40%); elimination is complete in 45 to 72 hours.
Maltese: Glibenclamide hu kompletament metabolizzat mill-fwied fi 3 metaboliti inattivi imneħħija permezz tal-bile (60%) u tal-awrina (40%); l-eliminazzjoni tkun kompleta f'45 sa 72 siegħa.
English: Each mL contains 2.8 mg of sodium and 5 mg of benzoate salt.
Maltese: Kull mL fih 2.8 mg sodju u 5 mg benzoate salt.
English: Pharmacotherapeutic group: Drugs used in diabetes, sulphonylureas, ATC code: A10BB01
Maltese: Mediċini użati fid-dijabete, sulphonylureas, kodiċi ATC: A10BB01 Mekkaniżmu ta' azzjoni
English: Rifampicin used to treat infections including tuberculosis
Maltese: Rifampicin użat għall-kura ta' infezzjonijiet inkluża t-tuberkulożi
English: G6PD is an enzyme evolved in sugar metabolism.
Maltese: G6PD hi enzima evoluta fil-metaboliżmu taz-zokkor.
English: Increased toxicity of ciclosporin
Maltese: Tossiċità miżjuda ta' ciclosporin
English: Potential effects
Maltese: Effetti potenzjali
English: Oestrogens (such as 17-beta oestradiol) used for hormonal treatment
Maltese: Estroġeni (bħal pereżempju 17-beta oestradiol) użati għal trattament ormonali
English: Other medicines and AMGLIDIA
Maltese: Mediċini oħra u AMGLIDIA
English: Adrenaline (epinephrine) and other sympathomimetic agents (used to treat serious allergic reaction, cardiovascular arrest, asthma)
Maltese: Adrenalina (epinefrina) u aġenti simpatomimetiċi oħra (użati għat-trattament ta' reazzjoni allerġika serja, arrest kardjovaskulari , ażma)
English: The plasma glibenclamide levels in the simulated paediatric population were approximately 30%-60% lower than the adult levels.
Maltese: Il-livelli ta' glibenclamide fil-plażma fil-popolazzjoni pedjatrika simulata kienu bejn wieħed u ieħor 30%-60% iktar baxxi mil-livelli tal-adulti.
English: AMGLIDIA with alcohol
Maltese: AMGLIDIA mal-alkoħol
English: In very rare cases, an intolerance to alcohol may occur.
Maltese: F'każijiet rari ħafna, jista' jkun hemm intolleranza għall-alkoħol.
English: Microvascular complications were reported in 7/81(9%) patients; there were no macrovascular complications.
Maltese: Ġew rappurtati kumplikazzjonijiet mikrovaskulari f'7/81(9%); ma kien hemm l-ebda kumplikazzjonijiet makrovaskulari.
English: Summary of the safety profile:
Maltese: Sommarju tal-profil tas-sigurtà
English: Cyclophosphamides used to treat different types of cancer
Maltese: Cyclophosphamides użati għat-trattament ta' tipi differenti ta' kanċer
English: AMGLIDIA contains sodium and benzoate salt
Maltese: AMGLIDIA fih is-sodium u benzoate salt
English: The values for maximum plasma concentrations (Cmax) were similar for the two suspensions (201.71 ± 71.43 ng/mL for the 6 mg/mL suspension and 206.93 ± 67.33 ng/mL for the 0.6 mg/mL suspension).
Maltese: Il-valuri għall-konċentrazzjonijiet massimi tal-plażma (Cmax) kienu simili għaż-żewġ suspensjonijiet (201.71 ± 71.43 ng/mL għas-suspensjoni 6 mg/mL u 206.
English: The same child had a transient and minimal ASAT 73 IU/L, and ALAT 42 IU/L increased (normal range below 60 and 40 respectively).
Maltese: L-istess wild kellu ASAT 73 IU/L tranżitorju u minimu, u ALAT 42 IU/L miżjud (medda normali taħt 60 u 40 rispettivament).
English: Adrenaline (epinephrine) and other sympathomimetic agents
Maltese: Adrenalina (epinefrina)
English: Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10); komuni (≥ 1/100 to < 1/10); mhux komuni (≥ 1/1,000 to < 1/100); rari (≥ 1/10,000 to < 1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Clinical data are not available.
Maltese: Data mhux klinika mhix disponibbli.
English: Patients with G6PD enzyme deficiency
Maltese: Pazjenti b'defiċjenza fl-enżima G6PD
English: Ten patients (7 boys/3 girls) with KCNJ11 mutation, with median age 2.7 years (0.3 to 16.2) andmedian duration of glibenclamide therapy 2.3 years (6 days to 11.3 years) were treated.
Maltese: Ġew ittrattati 10 pazjenti (7 subien/3 ibniet) b'mutazzjoni KCNJ11, b'eta medjana ta' 2.7 snin (0.3 sa 16.2) u d-dewmien medjan ta' terapija bi glibenclamide ta' 2.3 snin (6 ijiem sa 11.3 snin).
English: Barbiturates (such as phenobarbital used to treat epilepsy)
Maltese: Barbituriċi (bħal pereżempju phenobarbital użat fit-trattament tal-epilessija)
English: Alcohol (Alcohol present in medicines)
Maltese: Alkoħol (Alkoħol preżenti fil-mediċini)
English: Adverse reactions (diarrhoea/nausea/reduced appetite/abdominal pain) were reported in 10/81(12%); these were transient, and no patients discontinued sulphonylurea as a result.
Maltese: Reazzjonijiet avversi (dijarea/dardir/nuqqas ta' aptit/uġigħ addominali) kienu rappurtati f'10/81(12%); dawn kienu temporanji u l-ebda pazjent ma waqqaf sulphonylurea bħala riżultat ta' dan.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Aspetti ġenerali
English: AMMTeK 55 rue de Turbigo 75003 Paris France
Maltese: AMMTeK 55 rue de Turbigo 75003 Paris Franza
English: Overall, the safety profile of Glibenclamide is in line with the safety profile of others sulfonylureas.
Maltese: Globalment, il-profil tas-sigurtà ta' Glibenclamide hu konformi mal-profil tas-sigurtà ta' sulfonylureas oħra.
English: This must be followed by continuous infusion of more dilute glucose solution (10%) at the rate needed to maintain blood-glucose above 100 mg/dL (100 mg/dL = 5.5 mmol/L).
Maltese: Din trid tkun segwita b'infużjoni kontinwa ta' soluzzjoni ta' glucose dilwita aktar (10%) fir-rata meħtieġa biex il-glucose fid-demm jinżamm ogħla minn 100 mg/dL (100 mg/dL = 5.5 mmol/L).
English: Other side effects:
Maltese: Effetti sekondarji oħra:
English: Rare cases of agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia
Maltese: Każijiet rari ta' agranulocytosis, anemija emolitika, aplasija tal-mudullun u pancytopenia.
English: - one syringe adaptor.
Maltese: Neħħi s-siringa mill-adapter.