FrancophonIA/ELRC3.0 huggingface dataset:
English: 56% of patients treated with Kevzara 150 mg and 61% of those treated with 200 mg had a reduction in symptoms of 20% or more, compared with 34% of patients on placebo.
Maltese: It-tieni studju involva 546 pazjent li l-kundizzjoni tagħhom ma rrispondietx b'mod adegwat għal inibitur ta' TNF-α (tip ieħor ta' mediċina għall-artrite rewmatojde) jew li ma setgħux jieħduh; il-pazjenti kollha rċevew Kevzara jew plaċebo flimkien ma' DMARD. 56 % tal-pazjenti kkurati b'Kevzara 150 mg u 61 % ta' dawk ikkurati b'200 mg raw tnaqqis fis-sintomi ta' 20 % jew aktar, meta mqabbla ma' 34 % tal-pazjenti fuq il-plaċebo.
English: Increased blood levels of a liver enzyme called ALT (a sign of liver problems), reddening of the skin at the site of injection, nose and throat infections, and infections of the structures that carry urine (such as the bladder) are also common side effects which may affect up to 1 in 10 people.
Maltese: Żidiet tal-livelli fid-demm ta' enzima tal-fwied li tissejjaħ ALT (sinjal ta' problemi ful-fwied), ħmura tal-ġilda fissit tal-injezzjoni, infezzjonijiet tal-imnieħer u tal-griżmejn, u infezzjonijiet tal-istrutturi li jġorru l-awrina (bħall-bużżieqa tal-awrina) huma wkoll effetti sekondarji komuni li jistgħu jaffettwaw sa 1 minn kull 10.
English: Kevzara sarilumab
Maltese: Sommarju tal-EPAR għall-pubbliku sarilumab
English: The safety profile of Kevzara was considered acceptable and in line with that of other similar medicines.
Maltese: Il-profil tas-sigurtà ta' Kevzara ġie kkunsidrat bħala aċċettabbli u konformi ma' dak ta' mediċini simili oħra.
English: Three studies involving over 2,100 adults with rheumatoid arthritis showed that Kevzara is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage after 24 weeks of treatment.
Maltese: Tliet studji li involvew aktar minn 2,100 adult b'artirte rewmatojde wrew li Kevzara huwa effikaċi biex inaqqas l-uġigħ u n-nefħa fil-ġogi, itejjeb il-moviment tal-ġogi u jdewwem il-proċess tal-ħsara fil-ġogi wara 24 ġimgħa ta' kura.
English: The active substance in Kevzara, sarilumab, is a monoclonal antibody, a type of protein which has been designed to attach to and block the receptor (target) for a molecule called interleukin-6.
Maltese: ' proteina li tfas biex tagħraf u timblokka riċettur (mira) għal molekula msejħa interleukin-6.
English: Kevzara is used when treatment with one or more medicines known as disease-modifying antirheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Maltese: 'mediċina waħda je jimmodifikaw il-marda (DMARDs, disease-modifying anti-rheumatic drugs) ma tkunx ħadmet biżżejjed jew tkun wasslet għal effetti sekondarji inkwetanti.
English: The company that markets Kevzara will provide an alert card for patients, highlighting the risk of serious infections, neutropenia and intestinal perforation (a hole that develops in the wall of the gut), and listing the symptoms for which patients should seek immediate medical attention.
Maltese: Il-kumpanija li tqiegħed Kevzara fis-suq se tipprovdi kard ta' twissija għall-pazjenti, b'deskrizzjoni tarriskju ta' infezzjonijiet serji, newtropenija u perforazzjoni intestinali (toqba li tiżviluppa fil-ħajt talmusrana) u b'lista ta' sintomi li għalihom il-pazjenti għandhom ifittxu attenzjoni medika immedjatament.
English: This is a summary of the European public assessment report (EPAR) for Kevzara.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: Most side effects were mild to moderate in severity, and the more severe side effects were considered manageable with dose reduction or treatment interruption.
Maltese: Il-biċċa l-kbira tal-effetti sekondarji kienu ħfief sa moderati fis-severità, u l-effetti sekondarji aktar severi ġew ikkunsidrati bħala ġestibbli bi tnaqqis fid-doża jew b'interruzzjoni tal-kura.
English: Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Maltese: Billi jevita milli interleukin-6 jeħel mar-riċetturi tiegħu, sarilumab inaqqas l-infjammazzjoni u sintomi oħra assoċjati mal-artrite rewmatojde.
English: How does Kevzara work?
Maltese: Kif jintuża Kevzara?
English: The recommended dose is 200 mg given as an injection under the skin, once every 2 weeks.
Maltese: Iddoża rakkomandata hija ta' 200 mg li tingħata bħala injezzjoni taħt il-ġilda, darba kull ġimagħtejn.
English: Kevzara was shown to be of benefit to patients with moderate to severe rheumatoid arthritis whose condition did not improve adequately or who were intolerant to one or more DMARD medicines.
Maltese: Kevzara ntwera li huwa ta' benefiċċju għall-pazjenti b'artrite rewmatojde moderata sa severa li lkundizzjoni tagħhom ma tjibitx b'mod adegwat jew li kienu intolleranti għal mediċina DMARD waħda jew aktar.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kevzara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Kevzara huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Maltese: * Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fil-baqar.
English: Route of administration
Maltese: Speċi Metodu ta' Amministraz zjoni
English: EU Number
Maltese: Numru tal-UE Isem talProdott
English: Content Package size
Maltese: Kontenut Daqs ta' lIppakkjar
English: Withdraw al period
Maltese: Saħħa
English: DC5, Campona utca 1., Budapest, 1225, Hungary
Maltese: DC5, Campona utca 1., Budapest, 1225, L-Ungerija
English: Systemic allergy
Maltese: Allerġija sistemika
English: However, a consistent routine must be followed.
Maltese: Madankollu, għandha tiġi segwita rutina konsistenti.
English: Industriepark Höchst 65926 Frankfurt am Main Germany
Maltese: Industriepark Höchst 65926 Frankfurt am Main
English: • sulpha antibiotics,
Maltese: • antibijotiċi sulpha,
English: • the contraceptive pill,
Maltese: • il-pillola kontraċettiva,
English: STEP 3: Do a safety test
Maltese: PASS 3: Agħmel test ta' sigurtà
English: Special populations Renal impairment
Maltese: Popolazzjonijiet speċjali Indeboliment renali
English: Sanofi-Aventis Private Co. Ltd., Budapest Logistics and Distribution Platform Bdg.
Maltese: Ltd., Budapest Logistics and Distribution Platform Bdg.
English: MedDRA system organ classes
Maltese: Klassijiet tas-sistemi u tal-organi MedDRA
English: sanofi-aventis groupe 54 rue La Boétie F - 75008 Paris France
Maltese: sanofi-aventis groupe 54 rue La Boétie F - 75008 Paris Franza
English: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Maltese: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Il-Ġermanja.
English: • a new sterile needle (see STEP 2).
Maltese: • labra sterili ġdida (ara PASS 2).
English: • no appetite
Maltese: • bla aptit
English: Preparing a dose
Maltese: Preparazzjoni ta' doża
English: • “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),
Maltese: • “stimulanti tar-riċetturi beta 2” (per eżempju ritodrine, salbutamol jew terbutaline),
English: • Your pen contains a total of 300 units of insulin.
Maltese: • Il-pinna tiegħek fiha total ta' 300 unità ta' insulina.
English: • some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
Maltese: • ċerti antidipressanti (inibituri ta' monoamine oxidase jew inibituri selettivi tal-assorbiment millġdid ta' serotonin),
English: • some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and
Maltese: • ċerti inibituri tal-enzima li tbiddel l-anġjotensin (ACE, angiotensin converting enzyme) (per eżempju captopril, enalapril), u
English: • The active substance is insulin lispro.
Maltese: • Is-sustanza attiva hija insulin lispro.
English: Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours.
Maltese: Sistemi tal-infużjoni f'konċentrazzjonijiet minn 0.1 unità/ml sa 1.0 unità/ml ta' insulina lispro f'0.9% sodium chloride jew 5% dextrose huma stabbli f'temperatura ambjentali ta' ġewwa għal 48 siegħa.
English: • steroids,
Maltese: • sterojdi,
English: The cartridges are to be used only with the pens: Tactipen, AllStar, AllStar PRO, JuniorSTAR.
Maltese: L-iskrataċ għandhom jintużaw biss mal-pinen: Tactipen, AllStar, AllStar PRO, JuniorSTAR.
English: Solution for injection 1 x 10 ml
Maltese: Soluzzjoni għall-injezzjoni 1 x 10 ml
English: Pack sizes: 1, 3, 5 or 10 pre-filled pens.
Maltese: Daqsijiet tal-pakkett: pinna 1, 3, 5 jew 10 pinnen mimlija għal-lest.
English: Excipients: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Maltese: Eċċipjenti: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric acid u sodium hydroxide (għal aġġustment tal-pH), ilma għall-injezzjonijiet
English: • oral hypoglycaemics,
Maltese: • mediċini ipogliċemiċi orali,
English: (see also section “Warnings and precautions”).
Maltese: (ara wkoll is-sezzjoni “Twissijiet u prekawzjonijiet”).
English: 21 units selected
Maltese: Intagħżlu 21 unità
English: Solution for injection 5 x 3 ml
Maltese: Soluzzjoni għall-injezzjoni 5 x 3 ml
English: Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin.
Maltese: Allerġija sistemika, li hi rari iżda li tista' tkun aktar serja, hija allerġija mifruxa għall-insulina.
English: • fever, infection or emotional stress.
Maltese: • ikollok deni, infezzjoni jew stress emozzjonali.
English: Local allergy
Maltese: Allerġija lokali
English: Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin.
Maltese: Provi kliniċi saru fuq tfal (61 pazjent li kellhom minn 2 sa 11-il-sena) u tfal u adolexxenti (481 pazjenti li kellhom minn 9 sa 19-il sena), fejn tqabblu l-insulin lispro mal-insulina umana li tinħall.
English: Rubber seal
Maltese: Siġill tallastku
English: In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
Maltese: Fi studju double-blind u crossover, it-tnaqqis fil-livelli tal-emoglobina glikosilata wara għoti tad-dożaġġ għal 12-il ġimgħa kien 0.37 punti ta' perċentwal bl-insulina lispro, meta imqabbel ma' 0.03 punti ta' perċentwal għall-insulina li tinħall (p=0.004).
English: • Keep your pen at room temperature, below 30°C.
Maltese: • Żomm il-pinna tiegħek f'temperatura ambjentali, inqas minn 30°C.
English: Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Maltese: Il-ħtiġijiet għall-insulina jistgħu jonqsu fil-preżenza ta' prodotti mediċinali li għandhom attività ipogliċemika, bħal ma huma l-ipogliċemiċi orali, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (inibituri ta' monoamine oxidase, inibituri selettivi talassorbiment mill-ġdid ta' serotonin), ċerti inibituri tal-enżimi li jibdlu l-anġjotensina (captopril, enalapril), l-imblokkaturi tar-riċetturi ta' anġjotensin II, l-imblokkaturi tar-riċetturi beta, octreotide jew l-alkoħol.
English: Systemic allergy is rare (may affect up to 1 in 1,000 people).
Maltese: Allerġija sistemika hija rari (tista' taffettwa sa persuna 1 minn kull 1,000).
English: Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as ritodrine, salbutamol, terbutaline).
Maltese: Il-ħtiġijiet għall-insulina jistgħu jiżdiedu bi prodotti mediċinali li għandhom attività ipergliċemika, bħal ma huma l-kontraċettivi orali, il-kortikosterojdi, jew terapija b'sostituzzjoni tal-ormoni tat-tirojde, danazol, l-istimulanti beta2 (bħal ma huma ritodrine, salbutamol, terbutaline).
English: The primary activity of insulin lispro is the regulation of glucose metabolism.
Maltese: L-attività primarja tal-insulina lispro hija li tirregola l-metaboliżmu tal-glukożju.
English: Pack sizes: 5 or 10 cartridges
Maltese: Daqsijiet tal-pakkett: 5 jew 10 skrataċ.
English: Injecting a dose
Maltese: Injezzjoni ta' doża
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIK ATTIVA U MANIFATTURI
English: • sweating
Maltese: Uża sa
English: Each vial contains 10 ml equivalent to 1,000 units insulin lispro.
Maltese: Kull kunjett fih 10 ml ekwivalenti għal 1,000 unità insulin lispro.
English: Insulin scale
Maltese: Skala talinsulina
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment).
Maltese: Ilma għall-injezzjonijiet Hydrochloric acid (għal aġġustament fil-pH) Sodium hydroxide (għal aġġustament fil-pH).
English: Mixing Insulin lispro Sanofi with longer-acting human insulins (see section 6.2)
Maltese: Meta tħallat Insulin lispro Sanofi ma' insulini umani li jaħdmu aktar fit-tul (ara sezzjoni 6.2)
English: Hypoglycaemia
Maltese: Attività Ipogliċemika
English: You can give from 1 to 80 units in a single injection.
Maltese: Tista' tagħti minn unità 1 sa 80 unitá f'injezzjoni waħda.
English: Insulin lispro Sanofi is a biosimilar medicinal product.
Maltese: Insulin lispro Sanofi huwa prodott mediċinali bijoloġiku simili.
English: Clean the skin as instructed.
Maltese: Uża pinna ġdida.
English: • You should normally inject Insulin lispro Sanofi within 15 minutes of a meal.
Maltese: • Normalment għandek tinjetta Insulin lispro Sanofi fi żmien 15-il minuta minn ikla.
English: The pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.
Maltese: Il-profil farmakodinamiku tal-insulin lispro fit-tfal huwa simili għal dak li deher fl-adulti.
English: Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
Maltese: Insulin lispro ma kkaġunax indeboliment fil-fertilità, tossiċità tal-embriju jew teratoġeniċità fl-studji fl-annimali.
English: Dose selector Injection button
Maltese: Buttuna tal-injezzjoni
English: STEP 4: Select the dose
Maltese: PASS 4: Agħżel id-doża
English: EU/1/17/1203/001 5 cartridges EU/1/17/1203/002 10 cartridges.
Maltese: EU/1/17/1203/001 5 skrataċ EU/1/17/1203/002 10 skrataċ
English: Illness
Maltese: KLINIKU
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) and not known: cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi relatati li ġejjin miksuba minn investigazzjoniijiet kliniċi huma elenkati taħt skont il-klassi tas-sistemi u tal-organi u skont l-inċidenza tagħhom b'dawk li jseħħu l-aktar imniżżlin lewwel (komuni ħafna: ≥1/10; komuni: ≥1/100 sa <1/10; mhux komuni: ≥1/1,000 sa <1/100; rari:
English: Only use needles that are compatible for use with Insulin lispro Sanofi (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).
Maltese: Uża biss labar li huma kompatibbli mal-użu tal-pinna Insulin lispro Sanofi (eż. labar ta' BD, Ypsomed, Artsana jew Owen Mumford).
English: The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.
Maltese: Il-farmakokinetika tal-insulin lispro tirrifletti sustanza li hija assorbita malajr, u tikseb l-ogħla livelli fid-demm minn 30 sa 70 minuta wara injezzjoni taħt il-ġilda.
English: Insulin lispro Sanofi (insulin lispro 100 units/ml) and another insulin lispro medicinal product (200 units/ml) in a pre-filled pen
Maltese: Insulin lispro Sanofi (insulin lispro 100 unità/ml) u prodott mediċinali ieħor ta' insulin lispro (200 unità/ml) f'pinna mimlija għal-lest
English: In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
Maltese: Barra minn hekk, l-insulini għandhom diversi effetti anaboliċi u antikataboliċi fuq varjetà ta' tessuti differenti.
English: Insulin lispro Sanofi can be used in adolescents and children (see section 5.1).
Maltese: Insulin lispro Sanofi jista' jintuża fl-adolexxenti u fit-tfal (ara sezzjoni 5.1).
English: It is not for use in 1.5 ml pens.
Maltese: Mhuwiex qiegħed biex jintuża fil-pinen ta' 1.5 ml.
English: • beta-blockers, or
Maltese: • imblokkaturi tar-riċetturi beta, jew
English: • Inject Insulin lispro Sanofi under the skin (subcutaneous use or “SC”).
Maltese: • Injetta Insulin lispro Sanofi taħt il-ġilda (użu għal taħt il-ġilda jew “SC”, subcutaneous).
English: See the section below for help.
Maltese: Jekk jogħġbok segwi l-istruzzjonijiet b'attenzjoni.
English: Get to know your pen
Maltese: DATA TA' SKADENZA
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 july 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 19 Lulju 2017
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC code: A10AB04
Maltese: Mediċini użati fid-dijabete, insulini u analogi għall-injezzjoni, jaħdmu malajr, Kodiċi ATC:
English: • The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc oxide and water for injection.
Maltese: • Is-sustanzi l-oħra huma: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc oxide u ilma għall-injezzjoni.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn mmol 1 ta' sodium (23 mg) f'kull doża, i.e. huwa essenzjalment “ħieles mis-sodium”.
English: Always perform a safety test
Maltese: Dejjem agħmel test ta' sigurtà.
English: Hypoglycaemia.
Maltese: Ipogliċemija.
English: Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
Maltese: L-insulina lispro għandha l-bidu tal-azzjoni mgħaġġel (bejn wieħed u ieħor 15-il minuta), għalhekk tista' tingħata aktar viċin ta' ikla (bejn żero sa 15-il minuta mill-ikla) meta mqabbla ma' insulina regolari (30 sa 45 minuta qabel).
English: Disinfect the rubber membrane of the cartridge.
Maltese: Dejjem uża labra sterili ġdida għal kull injezzjoni.
English: OTHER SoloStar
Maltese: OĦRAJN SoloStar
English: You should normally use Insulin lispro Sanofi within 15 minutes of a meal.
Maltese: Normalment għandek tuża Insulin lispro Sanofi fi żmien 15-il minuta minn ikla.
English: Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.
Maltese: Bit-terapija tal-insulina ġew irrappurtati każijiet ta' edima, b'mod partikulari jekk kien hemm kontroll metaboliku batut u dan tjieb permezz ta' terapija intensiva ta' insulina.
English: Each vial contains 10 ml of solution for injection, equivalent to 1,000 units.
Maltese: Kull kunjett fih 10 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 1,000 unità.
English: Insulin lispro Sanofi SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.
Maltese: Insulin lispro Sanofi Solostar hija pinna mimlija għal-lest li tintrema wara l-użu u fiha 3 ml (300 unità, 100 unit/ml) ta' insulin lispro.
English: • Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
Maltese: • Ibdel il-labra (ara PASS 6 u PASS 2) imbagħad agħmel test ta' sigurtà (ara PASS 3).
English: Pack sizes: 1 or 5 vials.
Maltese: Daqsijiet tal-pakkett: kunjett 1 jew 5 kunjetti.
English: Store below 30°C and protect from direct heat and light.
Maltese: Aħżen f'temperatura taħt 30°C u pproteġi minn sħana u dawl diretti.
English: OUTER CARTON (cartridge)
Maltese: KARTUNA TA' BARRA (skartoċċ)
English: Insulin lispro Sanofi cartridges are to be used with JuniorSTAR, Tactipen, AllStar or AllStar PRO pens as recommended in the user manual (see section 4.2 and 4.4).
Maltese: L-iskrataċ Insulin lispro Sanofi għandhom jintużaw mal-pinen JuniorSTAR, Tactipen, AllStar jew AllStar PRO kif inhu rrakkomandat fit-tagħrif għall-utent (ara sezzjoni 4.2 u 4.4).
English: Solution for injection SoloStar 1 pen of 3 ml
Maltese: Soluzzjoni għall-injezzjoni SoloStar Pinna 1 ta' 3 ml
English: OUTER CARTON (10 ml vial)
Maltese: KARTUNA TA' BARRA (kunjett ta' 10 ml)
English: Local allergy in patients is common.
Maltese: Allerġija lokali fil-pazjenti hija komuni.
English: • wheezing
Maltese: • għeja
English: Each cartridge contains 3 ml equivalent to 300 units insulin lispro.
Maltese: Kull skartoċċ fih 3 ml ekwivalenti għal 300 unità insulin lispro.
English: These measures will help to protect the environment.
Maltese: A Ħu labra ġdida u qaxxar is-siġill protettiv.
English: Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medications such as beta-blockers.
Maltese: Il-kundizzjonijiet li jistgħu jagħmlu s-sintomi ta' twissija tal-bidu ta' ipogliċemija differenti jew jidhru anqas jinkludu dijabete għal żmien twil, terapija intensifikata bl-insulina, mard tan-nervituri fiddijabete jew mediċini bħal imblokkaturi tar-riċetturi beta.
English: Traceability
Maltese: Lipodistrofija
English: 5 pens of 3 ml
Maltese: 5 pinen ta' 3 ml
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
Maltese: Bidliet fil-qawwa, marka (manifattur), tip (regolari, NPH, lente, eċċ), l-ispeċi (annimal, bniedem, analogu tal-insulina tal-bniedem), u/jew il-metodu tal-manifattura (rikombinanti mid-DNA versus linsulina li tiġi mill-annimali) jistgħu jwasslu għal ħtieġa ta' bidla fid-dożaġġ.
English: Each pre-filled pen delivers 1-80 units in steps of 1 unit.
Maltese: Inti tista' tagħżel id-dożi tiegħek minn unità 1 sa 80 unità fi gradi ta' unità 1.
English: Preparing Insulin lispro Sanofi
Maltese: Preparazzjoni ta' Insulin lispro Sanofi
English: Insulin lispro Sanofi 100 units/ml solution for injection in vial
Maltese: Insulin lispro Sanofi 100 unità/ml injezzjoni
English: Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin.
Maltese: Provi kliniċi f'pazjenti bid-dijabete tat-tip 1 u tat-tip 2 urew tnaqqis fin-numru ta' episodji ta' ipogliċemija matul il-lejl bl-insulin lispro mqabbla ma' insulina umana li tinħall.
English: Fertility Insulin lispro did not induce fertility impairment in animal studies (see section 5.3).
Maltese: Fertilità Fi studji fuq l-annimali, insulina lispro ma kkaġunatx indeboliment fil-fertilità (ara sezzjoni 5.3).
English: EU/1/17/1203/007 1 vial EU/1/17/1203/008 5 vials.
Maltese: EU/1/17/1203/007 kunjett 1 EU/1/17/1203/008 5 kunjetti