FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillGrupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati - Bniedem (CMDh), li adotta pożizzjoni.
English: Current formulations containing lactose will be replaced with lactose-free formulations
Maltese: Il-formulazzjonijiet attwali li fihom il-lattożju ser jiġu sostitwiti b'formulazzjonijiet mingħajr lattożju
English: It is considered that allergic conditions, such as asthma exacerbation, may increase susceptibility to allergic reactions to cow's milk proteins in methylprednisolone products containing lactose of bovine origin.
Maltese: Huwa meqjus li l-kundizzjonijiet allerġiċi, bħal aggravar tal-ażma, jistgħu jżidu s-suxxettibiltà għal reazzjonijiet allerġiċi għall-proteini tal-ħalib tal-baqra fi prodotti ta' methylprednisolone li fihom lattożju ta' oriġini bovina.
English: • Patients being treated for an allergic reaction with these products should have their treatment stopped if their symptoms worsen or they develop new symptoms as these could be signs of an allergic reaction to cow's milk proteins.
Maltese: • Jekk qed tingħata kura għal reazzjoni allerġika b'dawn il-prodotti u s-sintomi tiegħek jaggravaw, ittabib tiegħek ser iwaqqaf il-kura tiegħek.
English: CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms.
Maltese: L-injezzjonijiet b'methylprednisolone huma użati biex jikkuraw is-sintomi ta' reazzjonijiet allerġiċi severi u kundizzjonijiet oħra infjammatorji.
English: • Companies have been asked to take steps by 2019 to replace current formulations containing lactose with lactose-free formulations.
Maltese: • Ġew mitlubin kumpaniji biex sal-2019 jieħdu passi sabiex jissotitwixxu formulazzjonijiet attwali li fihom il-lattożju b'formulazzjonijiet mingħajr lattożju.
English: Tube (Alu) 60 g (0.1%)
Maltese: 60 g (0.1%)
English: 0.1% Gel
Maltese: 0.1% Ġell
English: Cutaneous use
Maltese: Panretin
English: EU number Invented name Strength Pharmaceutical formRoute of administration Packaging Content (concentration) Package size EU/1/00/149/001 Panretin
Maltese: EU/1/00/149/001
English: Difloxacin
Maltese: Difloxaċin
English: It is available as an oral solution for chickens and turkeys (100 mg/ml), as tablets for dogs (15 mg, 50 mg, 100 mg and 150 mg), and as a solution for injection for cattle and dogs (50 mg/ml).
Maltese: Jiġi bħala soluzzjoni orali għat-tiġieġ u d-dundjani (100 mg/ml), bħala pilloli għall-klieb (15 mg, 50 mg, 100 mg u 150 mg), u bħala soluzzjoni għall-injezzjoni għall-ifrat u l-klieb (50 mg/ml).
English: Dicural contains the active substance difloxacin, which is an antibiotic.
Maltese: Dicural fih is-sustanza attiva difloxacin, li hija antibijotiku.
English: In dogs, side effects from Dicural are rare, but include loss of appetite, vomiting, diarrhoea and anal irritation.
Maltese: Fil-klieb, l-effetti sekondarji minn Dicural huma rari, iżda jinkludu telf ta' aptit, remettar, dijarea u irritazzjoni anali.
English: Difloxacin works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Maltese: Difloxacin jaħdem billi jimblokka enzim magħruf bħala ‘DNA gyrase', li hu importanti għax jippermetti lill-batterji jagħmlu kopji tad-DNA tagħhom.
English: The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Dicural, difloxacin, tagħmel parti minn grupp ta' antibijotiċi magħrufin bħala ‘fluoroquinolones'.
English: Why has Dicural been approved?
Maltese: Għaliex ġie approvat Dicural?
English: • in dogs, Dicural is used to treat acute (short-lived) infections of the bladder and to treat pyoderma (a skin infection with a rash and raised lumps).
Maltese: • fil-klieb, Dicural jintuża fit-trattament ta' infezzjonijiet akuti (li ma jdumux) fil-borża talawrina u fit-trattament tal-pyoderma (infezzjoni tal-ġilda b'raxx u b'infafet).
English: Other information about Dicural:
Maltese: Tagħrif ieħor dwar Dicural:
English: Two of these studies compared Dicural with enrofloxacin and one compared it with the combination of amoxicillin and clavulanic acid (used together as an antibiotic).
Maltese: Tnejn minn dawn il-provi qabblu Dicural ma' enrofloxacin u waħda qabblitu ma' kombinazzjoni ta' amoxicillin u clavulanic acid (użati flimkien bħala antibijotiku).
English: This includes small- and medium-sized breeds up to and including eight months of age, large breeds up to one year of age and giant breeds up to 18 months of age.
Maltese: Razez kbar sa sena fl-età u razez ġganteski sa 18-il xahar.
English: Dicural must not be used in epileptic dogs.
Maltese: Dicural m'għandux jintuża fi klieb epilettiċi.
English: A further three trials looked at its effects in treating pyoderma: two compared it with enrofloxacin and one compared it with amoxicillin and clavulanic acid.
Maltese: Tliet provi oħra ħarsu lejn l-effetti tiegħu fit-trattament tal-pyoderma: tnejn qabbluh ma' enrofloxacin u waħda qabblitu ma' amoxicillin u clavulanic acid.
English: One of these trials compared Dicural-treated birds with untreated birds, and another compared Dicural with enrofloxacin (another veterinary fluoroquinolone).
Maltese: Waħda minn dawn il-provi qabblet għasafar ittrattati b'Dirural ma' għasafar mhux ittrattati, u oħra qabblet Dicural ma' enrofloxacin (fluoroquinolone veterinarju ieħor).
English: For full details, see the Summary of Product Characteristics (SPC, also part of the EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tasCVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: By blocking the production of DNA, difloxacin stops the bacteria that are causing an infection from growing and multiplying.
Maltese: Meta jimblokka lproduzzjoni tad-DNA, difloxacin iwaqqaf il-batterji li jkunu qed jikkawżaw infezzjoni milli jikbru u jimmultiplikaw.
English: How has Dicural been studied?
Maltese: Kif ġie studjat Dicural?
English: People who are hypersensitive (allergic) to quinolones (a group of antibiotics that includes the fluoroquinolones) should avoid any contact with Dicural.
Maltese: Persuni allerġiċi għal quinolones (grupp ta' antibijotiċi li jinkludu fluoroquinolones) għandhom jevitaw il-kuntatt ma' Dicural.
English: The itching tends to disappear within a few minutes and the swelling within a few days.
Maltese: Il-ħakk ġeneralment imur fi ftit minuti u n-nefħa fi żmien ftit jiem.
English: After the last administration of Dicural, chickens and turkeys should not be slaughtered for 24 hours and cattle should not be slaughtered for 46 days.
Maltese: Wara l-aħħar amministrazzjoni ta' Dicural, it-tiġieġ u d-dundjani m'għandhomx jinqatlu għal 24 siegħa u l-ifrat m'għandhomx jinqatlu għal 46 jum.
English: • in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
Maltese: • fl-ifrat, Dicural jintuża fit-trattament ta' infezzjonijiet li jaffettwaw il-pulmuni u n-nifs (shipping fever u pnewmonja fl-għoġliet).
English: What is Dicural?
Maltese: Kif jaħdem Dicural?
English: In all species, Dicural was effective in reducing the number of infected animals or reducing the severity of infection.
Maltese: Fl-ispeċi kollha, Dicural kien effettiv fit-tnaqqis fin-numru ta' annimali infettati jew fit-tnaqqis tasseverità tal-infezzjoni.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Tagħrif dwar l-istejtus tal-preskrizzjoni jista' jinstab fuq it-tikketta/pakkett ta' barra.
English: • in chickens and turkeys, Dicural is used to treat certain infections affecting the respiratory system (lungs and air sacs).
Maltese: • fit-tiġieġ u d-dundjani, Dicural jintuża fit-trattament ta' ċerti infezzjonijiet li jaffettwaw issistema respiratorja (il-pulmun u l-boroż tal-arja).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Dicural are greater than the risks for the treatment and recommended that Dicural be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Dicural huma ikbar mir-riskji tiegħu fit-trattament u rrakkomanda li Dicural jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: What is the risk associated with Dicural?
Maltese: X'inhu r-riskju assoċjat ma' Dicural?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural on 16 January 1998.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Dicural valida madwar lUnjoni Ewropea kollha, fis-16 ta' Jannar 1998.
English: All seven studies compared Dicural with enrofloxacin in calves.
Maltese: Dicural jingħata darba kuljum għal ħamest ijiem bħala injezzjoni taħt il-ġilda.
English: When handling Dicural oral solution for chickens and turkeys, use gloves and a face-protecting device to avoid irritation of the skin or eyes.
Maltese: Il-bilanċ bejn ir-riskji u l-benefiċċji jinsab fil-modulu tad-diskussjoni xjentifika modulu ta' dan l-EPAR.
English: No.1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor,
Maltese: No.1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200
English: INFORMATION IN BRAILLE Semglee
Maltese: INFORMAZZJONI BIL-BRAILLE Semglee
English: MedDRA system organ classes
Maltese: Sistema tal- klassifika tal- organi MedDRA
English: Multipack: 10 (2 packs of 5) pens of 3 ml.
Maltese: Pakkett multiplu: 10 (2 pakketti ta' 5) pinen ta' 3 mL.
English: E - Store the pen at room temperature (under 30°C).
Maltese: E - Aħżen il-pinna fit-temperatura tal-kamra (taħt 30°C).
English: Semglee contains insulin glargine.
Maltese: Semglee fih insulin glargine.
English: The needle sizes compatible with this pen are: - 31G, 5 mm, - 32G, 4-6 mm, - 34G, 4 mm.
Maltese: - 31G, 5 mm, - 32G, 4-6 mm, - 34G, 4 mm.
English: • It is the correct insulin type.
Maltese: • Hi t-tip ta' insulina korretta.
English: • Semglee pen
Maltese: • Pinna Semglee
English: Step 1.
Maltese: M1.
English: 5 pens of 3 ml.
Maltese: 5 pinen ta' 3 mL.
English: EXPIRY DATE
Maltese: Data meta tiskadi
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: Semglee is a biosimilar medicinal product.
Maltese: Semglee huwa prodott mediċinali bijoloġiku simili.
English: Packs of 1, 3, 5, 10 and multipack containing 10 (2 packs of 5) pens.
Maltese: Pakketti ta' 1, 3, 5, 10 u pakkett multiplu li fih 10 (2 pakketti ta' 5) pinen.
English: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 This leaflet was last revised in {month YYYY}.
Maltese: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000
English: Nervous system disorders
Maltese: Disturbi fis- sistema nervuża
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: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 units (3.64 mg) insulin glargine
Maltese: ATTIVA(I) 1 mL fih 100 unità (3.64 mg) insulin glargine.
English: After subcutaneous injection of Semglee 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' Semglee 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: F - Repeat steps 3B through 3E up to three more times until you see drops of insulin at the tip of the needle.
Maltese: F - Irrepeti passi 3B sa 3E sa tliet darbiet oħra sakemm tara qtar tal-insulina fit-tarf tal-labra.
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' HbA11c 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' follow-up.
English: • The expiration date has not passed.
Maltese: • Iċċekkja d-data ta' skadenza fuq it-tikketta tal-pinna.
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 2×2 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 fit- tolleranza taz-zokkor (IGT) (12% tal-parteċipanti) jew bid-dijabete mellitus tat-tip 2 ikkurata b'≤ 1 sustanza antidijabetika orali (88% tal-parteċipanti).
English: Semglee is available in pack sizes of 1, 3, 5, 10 pens and in a multipack compromising of 2 cartons, each containing 5 pens.
Maltese: Semglee hu disponibbli f'daqsijiet ta'-pakkett ta' 1, 3, 5 u 10 pinen u f'pakkett multiplu li jinkludi 2 kartun, kull wiehed Ikun fih 5 pinen.
English: Semglee with alcohol
Maltese: Semglee mal-alkoħol
English: Excipients: zinc chloride, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Maltese: Eċċipjenti: zinc chloride, metacresol, glycerol, hydrochloric acid u sodium hydroxide (għallaġġustament tal- pH), ilma għall-injezzjonijiet
English: Elderly population (≥ 65 years old)
Maltese: Popolazzjoni anzjana (≥ 65 sena)
English: A - Check that the dose window shows “0”.
Maltese: A - Iċċekkja li t-tieqa tad-doża tkun turi “0”.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 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: • Adolescents and children aged 2 years and older patients Safety and efficacy of Semglee 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' Semglee ġew stabbiliti fl-adolexxenti u fit-tfal minn sentejn 'il fuq (ara sezzjoni 5.1).
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 l- inibituri tal-protease.
English: Semglee pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.
Maltese: Il-pinna Semglee tagħti insulina f'inkrementi ta' 1 unità sa doża massima waħda ta' 80 unità.
English: You can inject 1 to 80 units in a single injection.
Maltese: Tista' tinjetta minn 1 sa 80 unità f'injezzjoni waħda.
English: *Insulin glargine is produced by recombinant DNA technology in Pichia pastoris.
Maltese: * Insulin glargine huwa magħmul bit-teknoloġija rikombinanti tad-DNA ġo Pichia pastoris.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis- sezzjoni 6.1.
English: Combination of Semglee with pioglitazone
Maltese: It-teħid flimkien ta' Semglee ma' pioglitazone
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Maltese: Ezempji ta' sintomi li jindikaw livell baxx taz-zokkor fil-moħħ:: uġigħ ta' ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl-irqad, nuqqas ta' kwiet, komportament aggressiv, nuqqas ta' attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid-diskors, (xi drabi it-telf komplet tad-diskors), indeboliment tal-vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir-reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis-sensi.
English: Semglee contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol (23 mg) ta' sodium f'kull doża jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
Maltese: Il-mediċini li jistgħu jgħollu l-livell taz-zokkor f'demmek (ipergliċemija) jinkludu: - l-kortikosterojdi (bħal “cortisone”, użat għall-kura ta' l-infjammazzjoni), - danazol (mediċina li taħdem fuq l-ovulazzjoni), - diazoxide (użat għall-kura ta' pressjoni għolja fid-demm), - id-dijuretiċi (użati għall-kura ta' pressjoni għolja fid-demm jew iż-żamma eċċessiva ta' fluwidi), - glukagon (ormon tal-frixa użat għall-kura ta' ipogliċemija severa), - isoniazid (użat għall-kura tat-tuberkulożi), - l-estroġeni u l-proġesteni (bħal fil-pillola kontraċettiva, użata għall-kontroll tat-twelid), - id-derivattivi ta' phenothiazine (użati għall-kura ta' disturbi psikjatriċi), - somatropin (ormon tat-tkabbir), - il-mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall- kura ta' l-ażma), - ormoni tat-tirojde (użati għall-kura ta' disturbi fil-glandola tat-tirojde), - l-mediċini hekk imsejħa atipiċi kontra l-psikożi (bħal olanzapine u clozapine), - l-inibituri ta' protease (użati għall-kura ta' l-HIV).
English: Switch from insulin glargine 300 units/ml to Semglee Semglee and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable.
Maltese: Il-bidla minn insulin glargine 300 unità/mL għal Semglee Semglee u insulin glargine 300 unità/mL mhumiex bijoekwivalenti u ma jistgħux jinbidlu b'mod dirett ma' xulxin.
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) bid- dijabete 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.
English: Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
Maltese: Kull mL ta' soluzzjoni fih 100 unità ta' insulina glargine (ekwivalenti għal 3.64 mg).
English: Select your dose
Maltese: DATA TA' SKADENZA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Packs of 1, 3, 5 and 10
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA - Pakketti ta' 1, 3, 5 u 10
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1270/005
Maltese: EU/1/18/1270/005
English: Semglee is a pre-filled disposable pen injector containing 300 units of insulin glargine in 3 mL of solution (100 units/mL).
Maltese: Semglee hu injettur ta' pinna mimlija għal-lest li jintrema wara li jinħela, li jkun fih 300 unità ta' insulin glargine f'soluzzjoni ta' 3 mL (100 unità/mL).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) multipack - 10 (2x5 pens)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA (mingħajr il-kaxxa blu) pakkett multiplu - 10 (2×5 pinen)
English: It is completely soluble at the acidic pH of the Semglee injection solution (pH 4).
Maltese: Hi tinħall għal kollox fil-pH aċiduża tas-soluzzjoni għall-injezzjoni ta' Semglee (pH 4).
English: Lipohypertrophy Lipoatrophy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • made of heavy duty plastic,
Maltese: • magħmul minn plastik b'saħħtu,
English: - In your brain
Maltese: U LUŻU
English: Semglee is administered subcutaneously.
Maltese: Semglee jingħata b'mod subkutanju.
English: - The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Semglee contains sodium”), hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: zinc chloride, metacresol, glycerol, sodium hydroxide (għall-aġġustament tal- pH) (ara sezzjoni 2 “Semglee fih is-sodium”), hydrochloric acid (għall- aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Maltese: Il-konċentrazzjonijiet, għalhekk, kienu konsisteni mal-profil tal- ħin ta' l-attività farmakodinamika ta' insulin glargine.
English: Other medicines and Semglee
Maltese: Mediċini oħra u Semglee
English: • Restart the process at step 2A to attach and prime a new needle.
Maltese: • Erġa' ibda l-proċess minn pass 2A biex twaħħal u tipprepara labra ġdida.