FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of the vaccine has been adequately demonstrated in the laboratory, sufficient to confirm prevention of mortality and reduction of bursal lesions caused by vvIBDV using SPF chickens.
Maltese: L-effikaċja tal-vaċċin diġà ntweriet b'mod adegwat fil-laboratorju, u dan kien biżżejjed sabiex tiġi kkonfermata l-prevenzjoni tal-mortalità u t-tnaqqis ta' leżjonijiet bursali kkawżati mill-vvIBDV permezz ta' tiġieġ SPF.
English: Romania Fort Dodge Animal Health
Maltese: Ir-Rumanija Fort Dodge Animal Health
English: • Poulvac Bursa Plus has a negative impact on the serological response induced by vaccination against NDV.
Maltese: • Twettaq studju biex jivvaluta l-immunosuppressjoni potenzjali relatata mal-amministrazzjoni talvaċċin skont ir-rakkomandazzjonijiet tal-Ph.
English: The vaccine has a negative effect on the level of the serological response to NDV vaccination, however there was no affect on the ability of NDV vaccine to induce a protective response capable of resisting challenge with virulent NDV.
Maltese: Tqies li r-riskji assoċjati ma' din l-immunosuppressjoni ma kinux indirizzati biżżejjed fl-applikazzjoni.
English: Safety
Maltese: 2.1. Sigurtà
English: Greece Fort Dodge Animal Health
Maltese: Il-Greċja Fort Dodge Animal Health
English: SCIENTIFIC CONCLUSIONS
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: • Under field conditions it was shown that Poulvac Bursa Plus was able to restore performance lost due to vvIBD which had broken through the protection provided by classical vaccines containing mild or intermediate strains.
Maltese: • Taħt kundizzjonijiet prattiċi, intwera li Poulvac Bursa Plus kien kapaċi jerġa' jġib il-prestazzjoni mitlufa minħabba vvIBD li kien nifed fil-protezzjoni pprovduta minn vaċċini klassiċi li fihom razez ħfief jew intermedji.
English: Strength
Maltese: Infettiva.
English: Under laboratory conditions, efficacy against vvIBDV was shown using SPF chickens.
Maltese: Taħt kundizzjonijiet tal-laboratorju, l-effikaċja kontra vvIBDV intweriet bl-użu ta' tiġieġ SPF.
English: Until the emergence of those strains the common practice in broiler production was to vaccinate hens just before laying in order to induce a high level of passive immunity in the chicks which could protect them up to an age when infection by IBDV was less detrimental with regards to immunosuppression.
Maltese: o Ġie aċċettat li l-immunosuppressjoni li ntweriet kienet riskju rikonoxxut assoċjat mal-prodott, li huwa kontrobilanċjat bl-abbiltà murija li jipprovdi protezzjoni kontra vvIBD quddiem livelli
English: There is no requirement to demonstrate better protection than existing products, nevertheless it has been shown under field conditions that Poulvac Bursa Plus is able to restore performance lost due to vvIBD which has broken through the protection provided by classical vaccines containing mild or intermediate strains.
Maltese: Ma hemm ebda rekwiżit sabiex tintwera protezzjoni aħjar minn prodotti eżistenti, madankollu ntwera taħt kundizzjonijiet prattiċi li Poulvac Bursa Plus huwa kapaċi jerġa' jirristawra l-prestazzjoni mitlufa minħabba vvIBD li kienet nifdet il-protezzjoni pprovduta mill-vaċċini klassiċi li fihom razez ħfief jew intermedji.
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott, Tikketta u Fuljett ta' Tagħrif huma l-verżjonijiet finali miksubin matul il-proċedura tal-grupp ta' Koordinament.
English: • These types of product are for use in specific cases where there is evidence of vvIBD and where the level of bursal damage incurred is a necessary risk to achieve the protection provided against vvIBD.
Maltese: • Dawn it-tipi ta' prodotti huma għal użu f'każijiet speċifiċi fejn hemm evidenza ta' vvIBD u fejn il-livell ta' ħsara bursali mġarrba hija riskju neċessarju sabiex tinkiseb il-protezzjoni pprovduta kontra vvIBD.
English: Although the oral route is recommended, some safety studies have been carried out using the intraocular route.
Maltese: Għalkemm ir-rotta orali hija rrakkomandata, twettqu xi studji tas-sigurtà permezz tar-rotta intraokulari.
English: United Kingdom
Maltese: IsSlovakkja
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF POULVAC BURSA PLUS
Maltese: Poulvac Bursa Plus huwa vaċċin ħaj kontra l-Virus tal-Marda Bursali
English: There are no risks for the user, the consumer or the environment.
Maltese: Ma hemm ebda riskju għall-utent, għall-konsumatur jew għall-ambjent.
English: 6.2 Incompatibilities
Maltese: 6.2 Inkompatibbilitajiet
English: No evidence of toxic effects was found.
Maltese: Ma nstabet ebda evidenza t'effetti tossiċi.
English: Italia Sanofi S.p.A. Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
Maltese: Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande e chiamate dall'estero)
English: • Oedema
Maltese: • Edima
English: MedDRA system organ classes
Maltese: Sistema talKlassifika talOrgani fid-Database MedDRA
English: EXPIRY DATE
Maltese: DATA SKADENZA
English: D-65926 Frankfurt / Main Germany
Maltese: D-65926 Frankfurt / Main
English: Hepatic impairment
Maltese: Indeboliment Epatiku
English: Examples include:
Maltese: Attent:
English: Magyarország SANOFI-AVENTIS Zrt.
Maltese: Magyarország sanofi-aventis zrt., Tel.:
English: 5 cartridges of 3.15 ml
Maltese: 5 skartoċċi ta' 3.15 ml
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Maltese: Episodji ħfief ta' ipogliċemja jistgħu normalment ikunu ittrattati bil-karboidrati oralment.
English: 3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Maltese: 3 skartoċċi ta' 3 ml 4 skartoċċi ta' 3 ml 5 skartoċċi ta' 3 ml 6 skartoċċi ta' 3 ml 9 skartoċċi ta' 3 ml 10 skartoċċi ta' 3 ml
English: Maintenance
Maltese: Manutenzjoni
English: Lipodystrophy
Maltese: Skartoċċi
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 40 IU (1.4 mg) insulin human.
Maltese: ATTIVA(I) 1 ml fih 40 IU (1.4 mg) insulina umana.
English: Fur further details on handling, see section 6.6.
Maltese: Għal aktar informazzjoni dwar immaniġġar, ara sezzjoni 6.6.
English: Human insulin is produced by recombinant DNA technology in Escherichia coli.
Maltese: Insulina umana hija magħmula bit-teknoloġija rikombinanti tad-DNA ġo Escherichia coli.
English: D-65926 Frankfurt am Main, Germany
Maltese: D-65926 Frankfurt am Main,
English: Special populations Elderly population (≧65 years old)
Maltese: Popolazzjoni Anzjana (≧65 sena)
English: Insulin Human Winthrop Infusat is supplied in cartridges containing 3.15 ml solution (315 IU).
Maltese: Insulin Human Winthrop Infusat huwa fornut f'skartoċċi li fihom 3.15 ml ta' soluzzjoni (315 IU).
English: Insulin Human Winthrop Rapid").
Maltese: Human Winthrop Rapid”).
English: 2 years.
Maltese: sa 3 ijiem).
English: Select a dose of 2 units.
Maltese: 30 f'żidiet fid-doża ta' unità 1.
English: Insulin Human Winthrop Basal is an isophane insulin suspension.
Maltese: Insulin Human Winthrop Basal hija suspensjoni ta' insulina isophane.
English: Date of latest renewal: 17 January 2012
Maltese: Data tal-aħħar tiġdid: 17 Jannar 2012
English: Special populations Elderly population (≧65 years old) In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Maltese: Popolazzjoni Anzjana (≧65 sena) Fl-anzjani, l-aggravament progressiv tal-funzjoni tal-kliewi jista' jwassal għat-tnaqqis sostanzjali fil bżonn ta' l-insulina.
English: It comes in cartridges designed for use in Hoechst Infusor and H-Tron (insulin pumps).
Maltese: Huwa fornut f'skartoċċi magħmulin għall-użu ma' Hoechst Infusor u H-Tron (pompi ta' l-insulina).
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà 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 Ewropew tal-mediċini.
English: Step 1.
Maltese: Pass Nru. 1
English: Insulin Human Winthrop Infusat is supplied in vials containing 10 ml solution (1000 IU).
Maltese: Insulin Human Winthrop Infusat huwa fornut f'kunjetti ta' 10 ml ta' soluzzjoni (1000 IU).
English: Packs of 1 and 5 vials are available.
Maltese: Pakketti ta' 1 u 5 kunjetti huma disponibbli.
English: Problems with the pen?
Maltese: Diffikultajiet bil-pinna ?
English: Cartridges
Maltese: Treddigħ
English: Step 3.
Maltese: Pass Nru. 3
English: SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit.
Maltese: SoloStar tagħti insulina f'ammonti minn 1 sa 80 unitajiet f'qabżiet ta' Unita' waħda (1).
English: Each cartridge contains 3.15 ml of solution for injection, equivalent to 315 IU insulin.
Maltese: Kull skartoċċ fih 3.15 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 315 IU insulina.
English: PHARMACEUTICAL PARTICULARS
Maltese: IL-PRODOTTI MEDIĊINALI
English: - Keep this leaflet.
Maltese: tal pinna.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni
English: EXP
Maltese: Safar
English: Phenol, zinc chloride, trometamol, poloxamer 171,
Maltese: - Is-sustanzi l-oħra huma: phenol, zinc chloride, trometamol, poloxamer 171, glycerol,
English: 40 IU (International Units) of the active substance insulin human.
Maltese: 40 UI (Unita Internazzjonali) tas-sustanza attiva insulina umana.
English: It should be handled with care.
Maltese: Trid timmaniġġha b'attenzjoni.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Avoid situations where SoloStar might be damaged.
Maltese: Evita sitwazzjonijiet fejn is-SoloStar jista' jiġrilha l-ħsara.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Maltese: Data ta' l-ewwel awtorizzazzjoni: 17 Jannar 2007 Data tal-aħħar tiġdid: 17 Jannar 2012
English: Following subcutaneous injection, onset of action is within 30 minutes, the phase of maximum action is between 1.5 and 4 hours after injection and the duration of action is 12 to 16 hours.
Maltese: Wara linjezzjoni fit-tessut ta' taħt il-ġilda, tibda taħdem fi żmien 30 minuta, tilħaq ħidma massima ta' bejn 1.5 u 4 sigħat mill-injezzjoni, u ddum taħdem minn 12 sa 16 sigħat.
English: Insulin Human Winthrop Comb 25").
Maltese: Human Winthrop Comb 25”).
English: z o.o.
Maltese: ‘JIS'.
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Maltese: IU (Unita Internazzjonali) waħda hija ekwivalenti għal 0.035 mg insulina umana anidru.
English: Schematic diagram of the pen
Maltese: Dijagramma skematika tal-pinna
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 IU (3.5 mg) insulin human.
Maltese: ATTIVA(I) 1 ml fih 100 Unità (3.5 mg) insulina umana.
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: Insulin Human Winthrop Infusat has been developed for use in Hoechst Infusor and H-Tron.
Maltese: Insulin Human Winthrop Infusat kien żviluppat għall-użu ma' Hoechst Infusor u H-Tron.
English: Insulin Human Winthrop Infusat is a neutral insulin solution (regular insulin).
Maltese: Insulin Human Winthrop Infusat hija soluzzjoni newtrali ta' insulina (insulina regolari).
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, are sezzjoni 6.1.
English: Perform a safety test
Maltese: TA'REVIŻJONI TAT-TEST
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 January 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZJONI Data tal-ewwel awtorizzazzjoni: 17 Jannar 2007
English: MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Maltese: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main,
English: Packs of 5 cartridges are available.
Maltese: Pakketti ta' 5 skartoċċi huma disponibbli.
English: In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Maltese: F'suġġetti b'saħħithom, il-half-life ta' l-insulina fis-seru huwa ta' madwar 4 sa 6 minuti.
English: Step 4.
Maltese: Pass Nru. 4
English: The injection button colour will vary based on the formulation of Insulin Human Winthrop insulin used.
Maltese: Il-kulur tal-buttun ta' l-injezzjoni jista' jvarja skond il-formulazzjoni tal-insulina Insulin Human Winthrop.
English: Other source of information
Maltese: Sorsi oħra ta' informazzjoni
English: Insulin Human Winthrop Comb 50").
Maltese: Human Winthrop Comb 50”).
English: 15% dissolved insulin, 85% crystalline protamine insulin
Maltese: 15% insulina maħlula, 85% insulina kristallina protamine
English: Insulin Human Winthrop Comb 30 is a biphasic isophane insulin suspension consisting of 30% dissolved insulin and 70% crystalline protamine insulin.
Maltese: Insulin Human Winthrop Comb 30 hija suspensjoni ta' insulina isophane f'żewġ fażijiet li tikkonsisti f'30% ta' insulina maħlula u 70% ta' insulina protamine taħt għamla ta' kristalli.
English: The Insulin Human Winthrop Comb 15 cartridges are to be used only with the pens: OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar, JuniorSTAR.
Maltese: L-skartoċċi ta' Insulin Human Winthrop Comb 15 għandhom jintużaw biss flimkien mal-pinen; OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar, JuniorSTAR.
English: 30% dissolved insulin, 70% crystalline protamine insulin
Maltese: 30% insulina maħlula, 70% insulina kristallina protamine
English: Insulin Human Winthrop Rapid is a neutral insulin solution (regular insulin).
Maltese: Insulin Human Winthrop Rapid hija soluzzjoni newtrali ta' insulina (insulina regolari).
English: Intercurrent illness requires intensified metabolic monitoring.
Maltese: Il-mard kurrenti jeħtieġ l-immoniterjar metaboliku intensifikat.
English: Illnesses and injuries
Maltese: Mard u feriti
English: Insulin - lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
Maltese: L-insulina - tnaqqas il-livell tal-glucose fid-demm u tinkoraġixxi l-effetti anaboliċi, kif ukoll tnaqqas l effetti kataboliċi,
English: Open here
Maltese: Tista'
English: Oedema
Maltese: Sentejn
English: Following subcutaneous injection, onset of action is within 30 to 60 minutes, the phase of maximum action is between 2 and 4 hours after injection and the duration of action is 12 to 19 hours.
Maltese: Wara linjezzjoni fit-tessut ta' taħt il-ġilda, tibda taħdem minn 30 sa 60 minuta, tilħaq ħidma massima ta' bejn 2 u 4 sigħat mill-injezzjoni, u ddum taħdem minn 12 sa 19 sigħat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTONS / FOR 100 IU/ml: 5 ml and 10 ml VIAL
Maltese: KARTUN TA' BARRA / GĦAL 100 IU/ml: KUNJETT TA' 5 ml u 10 ml
English: Pack of 3 vials of 10 ml is available.
Maltese: Issibu f'pakketti ta' 3 kunjetti ta' 10 ml.
English: Step 6.
Maltese: Pass Nru. 6
English: Do not use Insulin Human Winthrop Infusat in peristaltic pumps with silicone tubing.
Maltese: Tużax Insulin Human Winthrop Infusat f'pompi peristaltiċi b'tubi tas-silikown.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċ
English: 3.15 ml solution in a cartridge (type 1 colourless glass) with a plunger (fluoropolymer coated rubber (type 1, mixture of chlorobutyl and natural rubber)), a flanged cap (aluminium) and a stopper with hole (bromobutyl rubber (type 1), a Luer cone attachment (colourless polyethylene) and a Luer cap (colourless polyethylene).
Maltese: 3.15 ml soluzzjoni f'skartoċċ (ħġieġ tip 1 mingħajr kulur), bi planġer (lastku (tip 1, taħlita ta' lastku chlorobutyl u dak naturali) miksi b'fluoropolymer), b'għatu bi flanġ (aluminju), tapp b'toqba fih (lastku tal-bromobutyl (tip 1)), b'kon razza Luer bħala aċċessorju (polyethylene mingħajr kulur) u kappa tat-tip Luer (polyethylene mingħajr kulur).
English: Insulin Human Winthrop Comb 15 is a biphasic isophane insulin suspension consisting of 15% dissolved insulin and 85% crystalline protamine insulin.
Maltese: Insulin Human Winthrop Comb 15 hija suspensjoni ta' insulina isophane f'żewġ fażijiet li tikkonsisti f'15% ta' insulina maħlula u 85% ta' insulina protamine taħt għamla ta' kristalli.
English: Insulin Human Winthrop Infusat comes in cartridges designed for use in Hoechst Infusor and H-Tron.
Maltese: Insulin Human Winthrop Infusat huwa fornut f'skartoċċi magħmulin għall-użu ma' Hoechst Infusor u H-Tron.
English: Phenol, zinc chloride, trometamol, poloxamer 171, glycerol, hydrochloric acid (for pH adjustment), water for injections.
Maltese: Phenol, zinc chloride, trometamol, poloxamer 171, glycerol, hydrochloric acid (għall-agġustament tal-pH), ilma għall-injezzjonijiet.
English: Shock
Maltese: Żomm
English: Pack of 5 cartridges of 3.15 ml is available.
Maltese: Issibu f'pakkett ta' 5 skartoċċi ta' 3.15 ml.
English: Insulin Human Winthrop Basal is injected subcutaneously 45 to 60 minutes before a meal.
Maltese: Insulin Human Winthrop Basal huwa injettat taħt il-ġilda 45 sa 60 minuta qabel ikla.
English: Do not mix insulins of different strengths (for example 100 IU per ml and 40 IU per ml).
Maltese: Tħallatx l-insulini ta' qawwa differenti (per ezempju 100 IU kull ml ma' 40 IU kull ml).
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), not known (cannot be estimated from the available data).
Maltese: L-effetti avversi relatati u imniżżlin hawn taħt, miġbura minn studji kliniċi, huma elenkati skond 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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The basal metabolic requirement is 40% to 60% of the total daily requirement.
Maltese: Il-ħtieġa bażika metabolika hija minn 40% sa 60% tal-bżonn sħiħ kuljum.
English: Insulin Human Winthrop Rapid is injected subcutaneously 15 to 20 minutes before a meal.
Maltese: Insulin Human Winthrop Rapid huwa injettat taħt il-ġilda 15 sa 20 minuta qabel ikla.
English: Step 5.
Maltese: Pass Nru. 5
English: Insulin Human Winthrop Comb 25 is a biphasic isophane insulin suspension consisting of 25% dissolved insulin and 75% crystalline protamine insulin.
Maltese: Insulin Human Winthrop Comb 25 hija suspensjoni ta' insulina isophane f'żewġ fażijiet li tikkonsisti f'25% ta' insulina maħlula u 75% ta' insulina protamine taħt għamla ta' kristalli.
English: Pregnancy
Maltese: Maniġġar
English: BRAILLE Insulin Human Winthrop Rapid SoloStar
Maltese: INFORMAZZJONI BIL-BRAILLE Insulin Human Winthrop Rapid SoloStar
English: Following subcutaneous injection, onset of action is within 30 to 60 minutes, the phase of maximum action is between 2 and 4 hours after injection and the duration of action is 11 to 20 hours.
Maltese: Wara linjezzjoni fit-tessut ta' taħt il-ġilda, tibda taħdem fi żmien 30 sa 60 minuta, tilħaq ħidma massima ta' bejn 2 u 4 sigħat mill-injezzjoni, u ddum taħdem minn 11 sa 20 sigħat.
English: BRAILLE Insulin Human Winthrop Basal SoloStar
Maltese: Insulin Human Winthrop Basal SoloStar 100
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).
Maltese: Is-sustanzi li jistgħu jnaqqsu l-effett fuq it-tnaqqis fil-livell tal-glucose fid-demm jinkludu l kortikosterojdi , danazol, diazoxide, id-dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f'kontraċettivi orali), derivattivi ta'phenothiazine, somatropin, prodotti mediċinali simpatomimetiċi (e.ż. epinephrine[adrenalin], salbutamol u terbutaline), l-ormoni tat-tirojde, inibituri tal-protease u lprodotti mediċinali antipsikotiċi atipiċi (e.ż. clozapine u olanzapine).
English: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Maltese: F'pazjenti b'indeboliment renali , il-ħtieġa ta' l-insulina tista' tonqos dovut għat-tnaqqis fil-livell metaboliku ta' l-insulina.
English: Only tetrafluoroethylene or polyethylene catheters must be used for infusion.
Maltese: Kateters tat-tetrafluoroethylene jew polyethylene biss għandhom jintużaw għall-infuzzjoni.
English: 50% dissolved insulin, 50% crystalline protamine insulin
Maltese: 50% insulina maħlula, 50% insulina kristallina protamine
English: The specific frequency cannnot be estimated from available data (frequency not known).
Maltese: Il frekwenza speċifika ma tistax tittieħed stima mid-data disponibbli (frekwenza mhux magħrufa).
English: Insulin Human Winthrop Rapid contains 40 IU insulin per ml.
Maltese: Insulin Human Winthrop Rapid fih 40 IU t'insulina kull ml.
English: Needles mut not be re-used.
Maltese: Għandha tkun immaniġġata bir-reqqa.
English: Insulin Human Winthrop Rapid is supplied in pre-filled pens, SoloStar, containing 3 ml solution (300 IU).
Maltese: Insulin Human Winthrop Rapid huwa fornut f'pinen mimlija għal-lest, SoloStar li fihom 3 ml ta' soluzzjoni (300 IU).
English: Tel: +49 (0)180 20 200 10
Maltese: Winthrop Arzneimittel GmbH Tel: +49 (0)180 20 200 10
English: Insulin Human Winthrop Rapid contains 100 IU insulin per ml.
Maltese: Insulin Human Winthrop Rapid fih 100 IU t'insulina kull ml.
English: Excipients: phenol, zinc chloride, trometamol, glycerol, poloxamer 171, hydrochloric acid (for pH adjustment), water for injections.
Maltese: Eċċipjenti: phenol, zinc chloride, trometamol, glycerol, poloxamer 171, hydrochloric acid (għallaġġustament tal-pH), ilma għall-injezzjonijiet.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Maltese: Fl-anzjani, l-aggravament progressiv tal-funzjoni tal-kliewi jista' jwassal għat-tnaqqis sostanzjali fil bżonn ta' l-insulina.
English: 25% dissolved insulin, 75% crystalline protamine insulin
Maltese: 25% insulina maħlula, 75% insulina kristallina protamine
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: EU/1/06/368/140 EU/1/06/368/141 EU/1/06/368/142
Maltese: EU/1/06/368/141 EU/1/06/368/142
English: BRAILLE Insulin Human Winthrop Infusat
Maltese: Tużax Insulin Human Winthrop Infusat