FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedure started in November 2009 and the indications applied for are the “treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures” and the “treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures”.
Maltese: Il-proċedura bdiet f'Novembru 2009 u l-indikazzjonijiet li għalihom iddaħħlet applikazzjoni huma l-“kura ta' osteoporożi postmenopawżali, sabiex jitnaqqas ir-riskju ta' ksur vertebrali” u l-“kura ta' osteoporożi postmenopawżali stabbilita, sabiex jitnaqqas ir-riskju ta' ksur tal-għadam tal-ġenbejn”.
English: Treatment with bisphosphonates generally also includes treatment with calcium, to support the remineralisation of the skeleton and with colecalciferol (vitamin D3) which increases calcium absorption.
Maltese: Ġeneralment, il-kura b'bisfosfonati tinkludi wkoll kura bil-kalċju, sabiex tappoġġja r-rimineralizzazzjoni tal-iskeletru u b'colecalciferol (vitamina D3) li żżid l-assorbiment tal-kalċju.
English: The CHMP considered this to be a clear public health benefit.
Maltese: Is-CHMP qies li dan huwa ta' benefiċċju ċar għas-saħħa pubblika.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant and marketing authorisation holders in the Member States
Maltese: TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, DETENTURI
English: film-coated tablets + effervescent granules
Maltese: pilloli miksija b'rita + grani li jfexfxu
English: • the data submitted in the initial authorisation application product file was considered to sufficiently support the marketing authorisation application,
Maltese: • id-dejta sottomessa fil-fajl tal-prodott tal-applikazzjoni tal-awtorizzazzjoni inizjali kienet meqjusa bħala li tappoġġja biżżejjed l-applikazzjoni tal-awtorizzazzjoni għat-tqegħid fis-suq,
English: • the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Fortipan Combi D and associated names (see Annex I).
Maltese: • is-CHMP kien konvint mill-benefiċċji ċari għas-saħħa pubblika u mill-konformità mtejba li jirriżultaw minn dan il-prodott, is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li, is-sommarju talkaratteristiċi tal-prodott, it-tikketta u l-fuljett ta' tagħrif tiegħu jibqgħu skont il-verżjonjiet finali miksubin waqt il-proċedura tal-grupp ta' Koordinazzjoni kif imsemmi fl-Anness
English: The CHMP agreed that the pharmacology and toxicology of calcium and colecalciferol are well-established, that combinations of these two products have been used globally in clinical practice for many years, and that the human experience supersedes non-clinical data.
Maltese: Is-CHMP qabel li lfarmakoloġija u t-tossikoloġija ta' kalċju u colecalciferol huma stabbiliti sew, li l-kombinazzjonijiet ta' dawn iż-żewġ prodotti ntużaw globalment fil-prattika klinika għal bosta snin u li l-esperjenza umana tisboq id-dejta klinika.
English: Member State EU/EEA
Maltese: Mnejn jingħata Stat Membru
English: Overall summary of the scientific evaluation of Fortipan Combi D and associated names (see Annex I)
Maltese: III għal Fortipan Combi D u l-ismijiet assoċjati (ara l-Anness I).
English: Public health benefit and improved compliance
Maltese: Benefiċċju għas-saħħa pubblika u konformità mtejba
English: The CHMP was of the opinion that the combination pack will simplify the correct dosage regimen compared to the individual products, thereby reducing the risk of interactions.
Maltese: Is-CHMP kien tal-opinjoni li l-pakkett tal-kombinazzjoni jissimplifika r-reġimen tad-dożaġġ korrett meta mqabbel mal-prodotti individwali, b'hekk inaqqas ir-riskji ta' interazzjonijiet.
English: Risedronate sodium is a bisphosphonate that inhibits bone resorption and has been shown to increase bone mass and biomechanical skeletal strength.
Maltese: Risedronate sodium huwa bisfosfonat li jinibixxi r-risorbiment tal-għadam u ntwera li jżid il-massa tal-għadam u s-saħħa skeletali bijomekkanika.
English: The full EPAR for Zutectra 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: The recommended dose normally ranges from 500 IU to 1,000 IU, and exceptionally up to 1,500 IU.
Maltese: IU sa 1,000 IU, u eċċezzjonalment sa 1,500 IU.
English: This is a summary of the European public assessment report (EPAR) for Zutectra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zutectra.
English: The most common side effects with Zutectra (seen in between 1 and 10 patients in 100) are reactions at the injection site, such as pain, urticaria (itchy rash), haematoma (blood under the skin) and erythema (reddening of the skin).
Maltese: L-effetti sekondarji l-aktar komuni b'Zutectra (li ġew osservati f'bejn 1 u 10 pazjenti minn kull 100) huma reazzjonijiet fis-sit tal-injezzjoni, bħal uġigħ, urtikarja (raxx bil-ħakk), ematoma (demm taħt ilġilda) u eritema (ħmura tal-ġilda).
English: The European Commission granted a marketing authorisation valid throughout the EU for Zutectra on 30 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zutectra fit-30 ta' Novembru 2009.
English: Other information about Zutectra
Maltese: Informazzjoni oħra dwar Zutectra
English: Zutectra human hepatitis-B immunoglobulin
Maltese: Zutectra immunoglobulina tal-epatite B umana
English: Zutectra has been studied in one main study involving 30 adults who had undergone liver transplants.
Maltese: Zutectra ġie studjat fi studju wieħed ewlieni li kien jinvolvi 30 adult li riċentement kellhom trapjanti talfwied.
English: This summary was last updated in 12-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2015.
English: It is available as a prefilled syringe containing 500 international units (IU) of the active substance, human hepatitis B immunoglobulin.
Maltese: Dan jiġi f'siringi mimlijin minn qabel li fihom 500 unità internazzjonali (IU) tas-sustanza attiva, immunoglobulina tal-epatite B umana.
English: The active substance in Zutectra, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
Maltese: Is-sustanza attiva f'Zutectra, l-immunoglobulina tal-epatite B umana, hija antikorp purifikat estratt mid-demm uman.
English: Why has Zutectra been approved?
Maltese: Għaliex ġie approvat Zutectra?
English: Zutectra is used to prevent re-infection with the hepatitis B virus in patients without active infection (i.e. those who test negative for the presence of the hepatitis B protein (HBsAg) and for hepatitis B DNA (HBV-DNA)).
Maltese: Zutectra jintuża f'adulti li kellhom trapjant tal-fwied minħabba insuffiċjenza tal-fwied li kienet ikkawżata minn infezzjoni tal-epatite B. Zutectra jintuża biex jipprevjeni infezzjoni mill-ġdid bil-virus tal-epatite B f'pazjenti mingħajr infezzjoni attiva (jiġifieri dawk li t-test tagħhom jirriżulta negattiv għall-preżenza tal-proteina tal-epatite B (HBsAg) u għad-DNA tal-epatite B (HBV-DNA)).
English: What is Zutectra?
Maltese: Kif jintuża Zutectra?
English: In the second study, all of the 49 patients had antibody levels above 100 IU per litre and none of them was re-infected during the 24 weeks of treatment.
Maltese: Fit tieni studju, id-49 pazjent kollha kellhom livelli ta' antikorpi ogħla minn 100 IU għal kull litru u ħadd minnhom ma reġa' ġie infettat matul l-24 ġimgħa ta' kura.
English: The use of standard antiviral medicines to prevent hepatitis B re-infection should be considered together with Zutectra.
Maltese: L-użu ta' mediċini antivirali standard biex jipprevjenu l-infezzjoni mill-ġdid tal-epatite B jistgħu jintużaw flimkien ma' Zutectra.
English: The main measure of effectiveness was the number of patients in whom treatment failed, defined as blood levels of hepatitis B immunoglobulins falling below 100 IU per litre or reinfection by hepatitis B virus during the 24 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li l-kura tagħhom ma rnexxietx, definit bħala livelli tad-demm tal-immunoglobulini tal-epatite B li jinżlu taħt 100 IU għal kull litru jew l-infezzjoni mill-ġdid mill-virus tal-epatite B matul l-24 ġimgħa ta' kura.
English: What is the risk associated with Zutectra?
Maltese: Għal xiex jintuża Zutectra?
English: In the first study, all 23 of the patients who completed treatment had antibody levels above 100 IU per litre.
Maltese: Fl-ewwel studju, it-23 pazjent kollha li lestew il-kura kellhom livelli ta' antikorpi ogħla minn 100 IU għal kull litru.
English: Zutectra prevents the patient from being re-infected with hepatitis B by keeping the blood levels of human hepatitis B immunoglobulins high enough, so that they can attach to the virus and stimulate the immune system to destroy it.
Maltese: Zutectra jipprevjeni lill-pazjent milli jerġa' jiġi infettat bl-epatite B billi jżomm il-livelli tad-demm tal-immunoglobulini tal-epatite B umana għoljin biżżejjed, sabiex ikunu jistgħu jeħlu mal-virus u jistimulaw is-sistema immuni biex teqirdu.
English: The main measure of effectiveness was the number of patients who had a blood level of hepatitis B immunoglobulin above 100 IU per litre after 18 to 24 weeks.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-għadd ta' pazjenti li kellhom livell tad-demm tal-immunoglobulina tal-epatite B ogħla minn 100 IU għal kull litru wara 18 sa 24 ġimgħa.
English: Antibodies are proteins naturally found in the blood that help the body to fight infections and other diseases.
Maltese: L-antikorpi huma proteini li jinstabu b'mod naturali fid-demm li jgħinu lill-ġisem jiġġieled l-infezzjonijiet u mard ieħor.
English: Zutectra is used in adults who have had a liver transplant because of liver failure that was caused by hepatitis B infection.
Maltese: Il-livell huwa kkunsidrat xieraq biex jipproteġi kontra linfezzjoni mill-ġdid bil-virus tal-epatite B.
English: The dose is established based on the patient's blood levels of antibodies against the hepatitis B virus.
Maltese: Zutectra intwera li kien effettiv fiż-żamma tal-livelli tal-antikorpi meħtieġa biex jipproteġu kontra linfezzjoni mill-ġdid tal-epatite B.
English: For the full list of all side effects reported with Zutectra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zutectra, ara l-fuljett ta' tagħrif.
English: Zutectra is a solution for injection.
Maltese: Zutectra huwa soluzzjoni għal injezzjoni.
English: Before starting Zutectra, the patient will need to receive medicines that contain the same active substance as in Zutectra, but given into a vein.
Maltese: Qabel ma jibda jieħu Zutectra, ilpazjent ikollu bżonn jirċievi mediċini li fihom l-istess sustanza attiva bħal Zutectra, iżda mogħtija ġo vina.
English: 90 (3 x 30) tablets (multipack)
Maltese: 90 (3 x 30) pilloli (pakkett b'ħafna unitajiet)
English: Oral Suspension Oral use bottle (glass)
Maltese: Suspensjoni orali
English: Pack size
Maltese: Użu orali
English: Film-coated tablet Oral use
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: The full EPAR and risk management plan summary for Taltz 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: Taltz contains the active substance ixekizumab.
Maltese: Taltz fih is-sustanza attiva ixekizumab.
English: Other information about Taltz
Maltese: Informazzjoni oħra dwar Taltz
English: Interleukin 17A is involved in immune system effects, including inflammation, that cause psoriasis.
Maltese: Interleukin 17A hija involuta fl-effetti tas-sistema immunitarja, inkluża l-infjammazzjoni, li jikkawżaw il-psorjasi.
English: The active substance in Taltz, ixekizumab, is a monoclonal antibody, a protein designed to attach to interleukin 17A, a messenger molecule in the body's immune system (the body's natural defences).
Maltese: Is-sustanza attiva f'Talz, l-ixekizumab, hija antikorp monoklonali, proteina mfassla biex teħel ma' interleukin 17A, molekula messaġġiera fis-sistema immunitarja tal-ġisem (id-difiża naturali tal-ġisem).
English: This is a summary of the European public assessment report (EPAR) for Taltz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Taltz.
English: The first dose of 160 mg (two injections) is followed by an injection of 80 mg every two weeks for the first 12 weeks and every 4 weeks thereafter.
Maltese: L-ewwel doża ta' 160 mg (żewġ injezzjonijiet) hija segwita minn injezzjoni ta' 80mg kull ġimagħtejn għall-ewwel 12-il ġimgħa u kull 4 ġimgħat wara dan.
English: In 3 main studies involving over 3,800 patients with psoriasis, 89% of those treated every two weeks with Taltz attained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks.
Maltese: Fi 3 studji ewlenin li involvew 'il fuq minn 3,800 pazjent bi psorjasi, 89% minn dawk ikkurati kull ġimagħtejn b'Talz kisbu tnaqqis ta' 75% fil-punteġġi PASI (kejl tas-severità tal-marda u ż-żona talġilda affettwata) wara 12-il ġimgħa.
English: The medicine has been shown to be effective in moderate to severe plaque psoriasis and its side effects are in line with other similar psoriasis medicines.
Maltese: Din il-mediċina wriet li hija effettiva fi psorjasi bil-qoxra moderata għal severa u l-effetti sekondarji tagħha huma f'konformità ma' mediċini tal-psorjasi simili oħrajn.
English: This compares with 4% of those given placebo and with 48% of patients given etanercept in 2 of the main studies.
Maltese: Dan jitqabbel mal-4% ta' dawk li ngħataw plaċebo u mal-48% talpazjenti li ngħataw etanercept fi 2 mill-istudji ewlenin.
English: Why is Taltz approved?
Maltese: Għaliex ġie approvat Taltz?
English: The doctor may decide to stop treatment if the condition does not improve after 16 to 20 weeks.
Maltese: It-tabib jista' jiddeċiedi li jwaqqaf ilkura jekk il-kondizzjoni ma titjiebx wara 16 sa 20 ġimgħa.
English: Also, 82% of patients given Taltz had clear or nearly clear skin after 12 weeks, compared with 4% of patients given placebo and 39% of patients given etanercept
Maltese: Barra minn hekk, 82% tal-pazjenti li ngħataw Taltz kellhom ukoll ġilda ċara jew kważi ċara wara 12-il ġimgħa, meta mqabbla mal-4% tal-pazjenti li ngħataw il-plaċebo u mad-39% tal-pazjenti li ngħataw etanercept
English: How is Taltz used?
Maltese: Taltz?
English: Plaque psoriasis improved to a greater extent in patients treated with Taltz than with placebo (a dummy treatment) or with etanercept, another medicine used to treat psoriasis.
Maltese: Il-psorjasi bil-qoxra tjiebet b'mod iktar estensiv f'pazjenti kkurati b'Taltz milli bil-plaċebo (kura finta) jew b'etanercept, mediċina oħra użata biex tikkura l-psorjasi.
English: A risk management plan has been developed to ensure that Taltz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Taltz jintuża bl-aktar mod sigur possibbli.
English: Taltz must not be given to patients who have potentially serious infections such as tuberculosis.
Maltese: Taltz m'għandux jingħata lil pazjenti li għandhom infezzjonijiet potenzjalment serji bħal tuberkulożi.
English: By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system and thereby reduces the symptoms of psoriasis.
Maltese: Billi teħel ma' interleukin 17A, l-ixekizumab timblokka l-azzjoni tagħha u tnaqqas l-attività tas-sistema immunitarja u b'hekk tnaqqas is-sintomi ta' psorjasi.
English: What are the risks associated with Taltz?
Maltese: X'inhuma r-riskji assoċjati ma' Taltz?
English: What measures are being taken to ensure the safe and effective use of Taltz?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Taltz?
English: Studies show that Taltz is effective in treating plaque psoriasis in patients who required systemic treatment.
Maltese: L-istudji wrew li Taltz huwa effettiv biex jikkura psorjasi bil-qoxra f'pazjenti li kienu jeħtieġu kura sistemika.
English: It is used in adults who require systemic treatment (treatment with medicines affecting the whole body).
Maltese: Jintuża f'adulti li jeħtieġu kura sistemika (kura b'mediċini li jaffettwaw ilġisem kollu).
English: Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin.
Maltese: Taltz huwa mediċina użata biex tikkura psorjasi bil-qoxra moderata sa severa, marda li tikkawża rqajja' ħomor bil-qxur fuq il-ġilda.
English: It is not intended to provide practical advice on how to use Taltz.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Taltz.
English: 28 x 1tablets (unit dose) (calendar pack)
Maltese: 28x1 pillola (doża waħda) pakkett kalendarjani
English: 1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that prior to giving the injection, the HCP should determine that the patient will clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur 2) Recommendations for monitoring of patients for glucose, lipids, and weight.
Maltese: - Deskrizzjoni tas-sindromu ta' wara l-injezzjoni - Ir-rakkomandazzjoni ta' 3 sigħat ta' osservazzjoni fuq il-post wara l-injezzjoni - Ir-rakkomandazzjoni li qabel ma tingħata l-injezzjoni, il-PKS għandhom jiżguraw li l-pazjent mhuwiex sejjer lura lejn id-destinazzjoni tiegħu waħdu.
English: An education program to the health care professionals (HCP) (doctors-nurses-pharmacists) shall address,
Maltese: Programm edukattiv għall-professjonisti fil-kura tas-saħħa (PKS) għandu jindirizza:
English: - Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines.
Maltese: - Titqajjem kuxjenza dwar monitoraġġ metaboliku xieraq permezz tat-tqassim ta' linji gwida ppubblikati u utilizzati fil-kura antipsikotika.
English: ATCvet code: QA10AC01 Insulin (human).
Maltese: Kodiċi ATC veterinarja: QA10AC01 Insulina (umana).
English: Store upright in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen f'pożizzjoni wieqfa fil-friġġ (2°C - 8°C).
English: (73.5% on once daily and 59.3% on twice daily administration).
Maltese: (73.5% fuq għoti ta' darba kuljum u 59.3% fuq għoti ta' darbtejn kuljum).
English: *produced by recombinant DNA technology
Maltese: *prodotta minn teknoloġija ta' DNA rikombinanti.
English: There is a low possibility of an allergic reaction in sensitised individuals.
Maltese: Hemm possibbiltà żgħira ta' reazzjoni allerġika f'individwi sensittivi.
English: Hypoglycaemic reactions were very commonly reported in clinical studies: 13% (23 of 176) of treated cats and 26.5% (44 of 166) of treated dogs.
Maltese: Reazzjonijiet ipogliċemiċi ġew irrappurtati b'mod komuni ħafna fi l-istudjui klinikuċi: 13% (23 minn 176) tal-qtates ikkurati u 26.5% (44 minn 166) ta' klieb ittrattati.
English: Active substance: Insulin human*
Maltese: Insulina umana*
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux mixtieqa - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattati) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal trattati ) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal trattati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattati , inklużi rapporti iżolati).
English: One IU (International Unit) corresponds to 0.0347 mg of insulin human.
Maltese: 0347 mg ta' insulina umana.
English: Method of administration:
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Management
Maltese: TAMMINISTRA
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324
Maltese: Manifattur responsabbli mill-ħruġ tal-lott: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str.
English: SC
Maltese: A.
English: 40 IU as protamine zinc insulin.
Maltese: IU bħala insulina bi protamine zinc.
English: Dogs
Maltese: UŻU
English: A U-40 syringe must be used.
Maltese: U-40.
English: Dose reductions due to observed hypoglycaemia or suspected Somogyi effect (rebound hyperglycaemia) may be of 50% or higher (potentially including a temporary pause of insulin administration).
Maltese: Tnaqqis fid-doża minħabba l-ipogliċemija osservata jew effett issuspettat ta' Somogyi (ipogliċemija li tirkadi) jista' jkun ta' 50% jew ogħla (inkluż potenzjalment waqfien temporanju tal-għoti tal-insulina).
English: Target tissue organs are i.e. liver, muscle and adipose tissue.
Maltese: L-organi tat-tessut fil-mira huma: il-fwied, il-muskoli u t-tessut adipose.
English: Vial, 10 ml
Maltese: Kunjett, 10 ml
English: Major incompatibilities: In absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Degradation normally involves endocytosis of the insulin-receptor complex, followed by the action of insulin-degrading enzyme.
Maltese: Id-degradazzjoni normalment tinvolvi l-endoċitożi tal-kumpless insulina-riċettur, segwita mill-azzjoni tal-enzima li tiddregrada l-insulina.
English: Dogs:
Maltese: Dożaġġ:
English: QUANITITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: - Switching to twice daily dosing: In such cases, it is recommended to reduce the dose per injection by one third (e.g. 12 kg dog being treated once daily with 12 IU insulin/injection may be switched to 8 IU insulin/injection administered twice daily).
Maltese: F'każijiet bħal dawn, huwa rrakkomandat li tnaqqas id-doża ta' kull injezzjoni b'terz (eż. kelb ta' 12-il kg li qed jiġi kkurat darba kuljum bi 12 IU insulina/injezzjoni jista' jinqaleb għal 8 IU insulina/injezzjoni mogħtija darbtejn kuljum).
English: Vial, 20 ml
Maltese: Kunjett, 20 ml
English: Protamine zinc recombinant human insulin is an insulin whose absorption and onset of action is delayed by the addition of protamine and zinc leading to crystal formation.
Maltese: Protamine zinc insulina umana rikombinanti hi insulina li l-assorbiment tagħha u l-bidu tal-azzjoni jiġi ttardjat miż-żieda ta' protamine u zinc li jwassal għal formazzjoni ta' kristalli.
English: Median time to blood glucose nadir was approximately 16 and 12 hours following administration of 0.5 or 0.8 IU/kg bodyweight, respectively.
Maltese: Iż-żmien medju għall-iżjed ammont baxx ta' glucose fid-demm kien madwar 16 u 12-il siegħa wara l-għoti ta' 0.5 jew 0.8 IU/kg piż tal-ġisem, rispettivament.
English: Overall insulin influences the regulation of the carbohydrate and fat metabolism.
Maltese: L-insulina totali tinfluwenza r-regolazzjononi tal-metaboliżmu tal-karboidrati u tax-xaħam.
English: Cloudy, white, aqueous suspension.
Maltese: Suspensjoni bajda, akweja u mċajpra.