FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 bottle containing 42 hard capsules 1 bottle containing 60 hard capsules 1 bottle containing 84 hard capsules 1 bottle containing 90 hard capsules 1 bottle containing 120 hard capsules
Maltese: Flixkun wieħed li fih 42 kapsula iebsa Flixkun wieħed li fih 60 kapsula iebsa Flixkun wieħed li fih 84 kapsula iebsa Flixkun wieħed li fih 90 kapsula iebsa Flixkun wieħed li fih 120 kapsula iebsa
English: - Do not take more than 3 tablets a day.
Maltese: - Tieħux aktar minn 3 pilloli kuljum.
English: Package leaflet: Information for the user alli 60 mg hard capsules Orlistat
Maltese: Informazzjoni għall-utent alli 60 mg kapsuli ibsin Orlistat
English: - Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate,
Maltese: - Qoxra tal-kapsula: ġelatina, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate, sorbitan monolaurate, linka sewda (shellac, iron oxide iswed (E172), propylene glycol).
English: Women Low activity
Maltese: Nisa Attività baxxa
English: Below 68.1 kg
Maltese: Taħt 68.1 kg
English: High-density polyethylene (HDPE) bottle with child resistant closure containing 42, 60, 84, 90 or 120 tablets.
Maltese: Fliexken tal-polyethylene ta' densità għolja (HDPE) b'għatu reżistenti għat-tfal li fihom 42, 60, 84, 90 jew 120 pillola.
English: Capsule band Gelatin
Maltese: Faxxa tal-kapsula
English: • you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.
Maltese: • għandek tieħu multivitamina (li jkun fiha l-vitamini A, D, E u K) darba kuljum, qabel l-irqad.
English: 1.85 m 95.75 kg 6 ' 0 ''
Maltese: 75 kg 1.80 m 90.75 kg 1.85 m 95.75 kg 1.90 m 101 kg
English: The primary parameter, change in body weight from baseline (time of randomisation), was assessed for body weight over time (Table 1) and the percentage of subjects who lost ≥5% or ≥10% of body weight (Table 2).
Maltese: Il-parametru primarju, bidla fil-piż tal-ġisem mil-linja bażi (ħin ta' randomisation), kien stmat għall-piż tal-ġisem fuq medda ta' żmien (Tabella 1) u l-persentaġġ ta' individwi li tilfu ≥5% jew ≥10% tal-piż tal-ġisem (Tabella 2).
English: 84.0 kg and over
Maltese: 84.0 kg u aktar
English: Do not take alli
Maltese: X'fih alli
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Maltese: Studji f'voluntiera ta' piż normali u oħrajn ħoxnin iżżejjed urew li l-ammont ta' assorbiment ta' orlistat kien minimu.
English: Use an extra method of contraception if you get severe diarrhoea.
Maltese: Uża metodu addizzjonali ta' kontraċezzjoni jekk ikollok dijarea severa.
English: Eating fewer than 1200 calories per day is not recommended.
Maltese: Teħid ta' inqas minn 1200 kalorija kuljum mhux irrakkomandat.
English: 4.5 Interaction with other medicinal products and other forms of interaction Ciclosporin
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Orlistat may decrease the absorption of antiepileptic medicinal products, leading to convulsions.
Maltese: Orlistat jista' jnaqqas l-assorbiment ta' prodotti mediċinali kontra l-epilessija, u b'hekk iwassal għall-konvulżjonijiet.
English: Cholelithiasis
Maltese: Orlistat
English: EXPIRY DATE
Maltese: Għażel data meta se tibda
English: Other serious side effects - Bleeding from the back passage (rectum) - Diverticulitis (inflammation of the large intestine).
Maltese: Effetti sekondarji serji oħra - Fsada mill-passaġġ ta' wara (rektum) - Divertikulite (infjammazzjoni tal-musrana l-kbira).
English: • Cholestasis
Maltese: - Osteoartrite
English: Sodium stearyl fumarate
Maltese: Gass fl-istonku Purgar artab
English: In vitro, orlistat is >99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Maltese: marbut ma' proteini tal-plażma (lipoproteini u albumini kienu l-aktar proteini li jwaħħlu).
English: Hepatic and renal impairment
Maltese: Reazzjonijiet allerġiċi severi
English: alli is contraindicated in pregnancy (see section 4.3).
Maltese: alli m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: 59.0 kg and over
Maltese: 59.0 kg u aktar
English: However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases.
Maltese: Madankollu, orlistat jista' indirettament inaqqas id-disponibiltà ta' kontraċettivi orali u jwassal għal tqala mhux mistennija f'xi każijiet individwali.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall- Mediċini http://www.ema.europa.eu.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu dan il-prodott mediċinali.
English: The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.
Maltese: Il-kapsuli jaħdmu biss fis-sistema diġestiva tiegħek biex iwaqqfu madwar kwart tax-xaħam fl-ikliet tiegħek milli jiġi assorbit.
English: For adults with a BMI of 28 or above
Maltese: Għall-adulti li għandhom BMI ta' 28 jew aktar
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Holds 3 capsules.
Maltese: Tieħux aktar minn 3 kapsuli kuljum.
English: INFORMATION IN BRAILLE alli 27 mg chewable tablets
Maltese: Informazzjoni għall-utent alli 27 mg pilloli li tomgħodhom
English: Date of first authorisation: 23rd July 2007.
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Lulju 2007
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: For every 2 kg (4 lb) you lose from dieting alone, alli might help you lose up to 1 kg (2 lb) more.
Maltese: Għal kull 2 kg (4 lb) li inti titlef bid-dieta waħedha, alli jista' jgħinek titlef sa 1 kg (2 lb) aktar.
English: GlaxoSmithKline Consumer Healthcare s.a./n.v.
Maltese: GlaxoSmithKline Consumer Healthcare S.p.A.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Holds 3 tablets.
Maltese: Tieħux aktar minn 3 pilloli kuljum.
English: “EXP”.
Maltese: “JIS”.
English: Soft stools
Maltese: Purgar żejtni
English: M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1,000and 2,500-fold less than orlistat, respectively).
Maltese: M1 u M3 għandhom ċirku beta-lactone miftuħ u attività li tinibixxi l-lipase dgħajfa ħafna
English: A realistic goal is to lose between 5 % to 10 % of your starting weight.
Maltese: Mira realistika hija li titlef bejn 5% sa 10% tal-piż tal-bidu tiegħek.
English: A decrease in ciclosporin plasma levels has been observed in a drug-drug interaction study and also reported in several cases, when orlistat was administered concomitantly.
Maltese: Ciclosporin Fi studju dwar l-interazzjoni bejn mediċina u oħra, kien osservat tnaqqis fil-livelli ta' ciclosporin fil- plażma u dan kien irrapportat ukoll f'diversi każijiet meta orlistat ingħata fl-istess waqt.
English: Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are co-administered (see section 4.5).
Maltese: Meta orlistat u levothyroxine jingħataw flimkien, jista' jkun hemm ipotirojdiżmu u/jew kontroll imnaqqas ta' ipotirojdiżmu (ara sezzjoni 4.5).
English: Below 65.7 kg
Maltese: Taħt 65.7 kg
English: Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Adverse reactions to orlistat are largely gastrointestinal in nature and related to the pharmacologic effect of the medicinal product on preventing the absorption of ingested fat.
Maltese: Reazzjonijiet avversi għal orlistat fil-biċċa l-kbira huma ta' natura gastro-intestinali u huma relatati ma' l-effett farmakoloġiku tal-prodott mediċinali fuq il-prevenzjoni ta' l-assorbiment ta' xaħam li jkun ittiekel.
English: 1.85 m 95.75 kg 6' 0''
Maltese: 1.50 m 63 kg 1.55 m 67.25 kg 1.60 m 71.75 kg 1.65 m 76.25 kg 1.70 m 81 kg 1.75 m 85.
English: Based on reports from literature and post-marketing experience orlistat may potentially reduce the absorption of antiretroviral medicinal treatments for HIV and could negatively affect the efficacy of antiretroviral medicinal treatments for HIV (see section 4.4).
Maltese: jnaqqas l-assorbiment ta' trattamenti mediċinali antiretrovirali għall-HIV u jista' jaffettwa b'mod negattiv l-effikaċja ta' trattamenti mediċinali antiretrovirali għall-HIV (ara sezzjoni 4.4).
English: • Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8) 4.4 Special warnings and precautions for use
Maltese: • Kura fl-istess waqt b'warfarin jew b'sustanzi orali oħra kontra il-koagulazzjoni tad-demm (ara sezzjonijiet 4.5 u 4.8)
English: Abdominal pain Faecal incontinence Liquid stools Increased defaecation
Maltese: - Inkontinenza (purgar) - Purgar likwidu - Purgar aktar ta' spiss - Ansjetà
English: Do not take alli with these medicines - Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.
Maltese: Tiħux alli ma' dawn il-mediċini - Ciclosporin: ciclosporin jintuża wara trapjanti ta' organi, għall-artrite rewmatojda severa u għal xi kundizzjonijiet severi tal-ġilda.
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Maltese: Id-dispożizzjoni ta' orlistat dehret li hija simili bejn voluntiera b'piż normali u dawk ħoxnin iżżejjed.
English: alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight (BMI 28 or above) adults, aged 18 or over.
Maltese: alli huwa wżat biex jitnaqqas il-piż flimkien ma' ikliet b'kaloriji mnaqqsa u b'inqas xaħam, f'adulti b'piż żejjed (BMI ta' 28 jew aktar), b'età minn 18-il sena 'l fuq.
English: Effects seen in blood tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: 9 st 4 lb and over
Maltese: Kif għandek tieħu alli
English: 10 st 10 lb to 11 st 11 lb 1400 calories
Maltese: Kif tistabilixxi il-mira tiegħek ta' kaloriji
English: As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast-feeding (see section 4.3).
Maltese: Peress li mhux magħruf jekk orlistat jgħaddix fil-ħalib tas-sider uman, alli huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Height Weight
Maltese: imnaqqxa fuqhom.
English: - The calorie target is the maximum number of calories you will eat each day.
Maltese: - Il-mira ta' kaloriji hija n-numru massimu ta' kaloriji li se tiekol kuljum.
English: Hepatitis that may be serious.
Maltese: Epatite li tista' tkun serja.
English: The frequencies of adverse reactions identified during post-marketing use of orlistat are not known as these reactions were reported voluntarily from a population of uncertain size.
Maltese: Il-frekwenza ta' reazzjonijiet avversi identifikati waqt l-użu ta' wara t-tqegħid fis-suq ta' orlistat mhux magħrufa peress li dawn ir-reazzjonijiet kienu rrapportati b'mod volontarju minn popolazzjoni ta' daqs mhux ċert.
English: NAME OF THE MEDICINAL PRODUCT alli 27 mg chewable tablets
Maltese: IL-PRODOTT MEDIĊINALI alli 27 mg pilloli li tomgħodhom
English: 12 st 5 lbs
Maltese: Sib it-tul tiegħek fit-tabella.
English: 70.3 kg and over
Maltese: 70.3 kg u aktar
English: - Do not store above 25°C.
Maltese: - Taħżinx f'temperatura 'l fuq minn 25°C.
English: Orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal productsfor HIV (see section 4.5).
Maltese: jnaqqas l-assorbiment ta' prodotti mediċinali antiretrovirali għall-HIV u jista' jaffettwa b'mod negattiv l-effikaċja ta' prodott mediċinali antiretrovirali għall-HIV (ara sezzjoni 4.4).
English: - you should not take alli for more than six months.
Maltese: - Kemm għandi ndum nieħu alli?
English: See the chart further on in this section.
Maltese: Ara t-tabella aktar l-isfel f'din is-sessjoni.
English: - The bottle contains two sealed canisters containing silica gel to keep the capsules dry.
Maltese: - Il-flixkun fih żewġ kontenituri ssiġillati li fihom silica gel biex iżommu l-kapsuli xotti.
English: Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical findings.
Maltese: Dożi waħedhom ta' 800 mg orlistat u dożi multipli sa 400 mg tliet darbiet kuljum għal 15-il ġurnata ġew studjati f'individwi b'piż normali u f'oħrajn bi ħxuna żejda mingħajr sejbiet kliniċi ta' sinifikanza.
English: - you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.
Maltese: - għandek tieħu multivitamina (li jkun fiha l-vitamini A, D, E u K) darba kuljum, qabel l-irqad.
English: Lactose
Maltese: Kolelitjasi
English: The chewable tablets also contain sucrose.
Maltese: Il-pilloli li tomgħodhom fihom ukoll sucrose.
English: Chewable tablet.
Maltese: Tesa' 3 pilloli.
English: The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Maltese: Iż-żmien biex tintlaħaq tneħħija totali (purgar u awrina) kien 3 sa 5 ijiem.
English: 4.1 Therapeutic indications alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. 4.2 Posology and method of administration
Maltese: 4.1 Indikazzjonijiet terapewtiċi alli huwa ndikat għal użu minn adulti b'piż żejjed (indiċi tal-massa tal-ġisem, BMI ≥28 kg/m²) biex jitnaqqas il-piż u għandu jittieħed flimkien ma' dieta ta' kaloriji kemmxejn baxxi u b'inqas xaħam.
English: Stop taking the capsules.
Maltese: Waqqaf it-teħid tal-kapsuli.
English: Τ.Θ.
Maltese: KG,
English: NAME OF THE MEDICINAL PRODUCT alli 60 mg hard capsules
Maltese: L- UŻU alli 60 mg kapsuli iebsa:
English: Blood and lymphatic system disorders Not known
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: The medicinal use of orlistat is unlikely to represent a risk to the aquatic or terrestrial environment.
Maltese: L-użu mediċinali ta' orlistat mhux probabbli li jirrappreżenta riskju għall-ambjent akkwatiku jew terrestri.
English: The chewable tablets contain lactose.
Maltese: TA' EĊĊIPJENTI Fih lactose u sucrose.
English: Printing ink Shellac
Maltese: .8 Effetti mhux mixtieqa
English: Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal reactions (see section 4.4).
Maltese: reazzjonijiet avversi gastro-intestinali (ara sezzjoni 4.4).
English: Possible side effects - Serious side effects - Very common side effects - Common side effects - Effects seen in blood tests - Learn to deal with diet-related treatment effects How to store alli
Maltese: - Effetti sekondarji komuni - Effetti osservati fit-testijiet tad-demm - Tgħallem ħu ħsieb l-effetti tal-kura relatati mad-dieta
English: - Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Maltese: - Jekk għandek kolestasi (kundizzjoni fejn in-nixxija tal-bili mill-fwied hija mblukkata).
English: Adults 18 and over
Maltese: Adulti ta' 18-il sena jew aktar
English: - a medicine for epilepsy as any changes in the frequency and severity of your convulsions should be discussed with your doctor.
Maltese: - mediċina għall-epilessija peress li kull bidla fil-frekwenza u fis-severità tal-konvulżjonijiet tiegħek għandha tiġi diskussa mat-tabib tiegħek.
English: - medicines to treat HIV.
Maltese: Staqsi għall-għajnuna medika minnufih.
English: Tel:+385 1 6051 999
Maltese: GlaxoSmithKline d.o.o. Tel:+385 1 6051 999
English: Risk of being overweight
Maltese: Twissijiet u prekawzjonijiet
English: Bullous eruption
Maltese: - Purgar artab
English: When warfarin or other oral anticoagulants are given in combination with orlistat, international normalised ratio (INR) values could be affected (see section 4.8).
Maltese: Meta warfarin jew sustanzi orali oħra kontra l-koagulazzjoni tad-demm jingħataw flimkien ma' orlistat, il-valuri tal-proporzjon normalizzat internazzjonali (INR) jistgħu jiġu affettwati (ara sezzjoni 4.8).
English: 190 11 Avlona, Greece
Maltese: Famar S.A., 49 KM Athens-Lamia, 190 11 Avlona, Il-Greċja
English: The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body.
Maltese: Jekk ħadt aktar kapsuli milli suppost, kellem tabib malajr kemm jista' jkun.
English: Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken at the same time (see section 4.4).
Maltese: Meta orlistat u levothyroxine jingħataw fl-istess waqt jista' jkun hemm ipotirojdiżmu u/jew kontroll imnaqqas ta' ipotirojdiżmu (ara sezzjoni 4.4).
English: alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight adults, aged 18 or over.
Maltese: alli huwa wżat biex jitnaqqas il-piż flimkien ma' ikliet b'kaloriji mnaqqsa u b'inqas xaħam, f'adulti b'piż żejjed, b'età ta' 18-il sena jew aktar.
English: Sodium starch glycolate (Type A)
Maltese: Antidepressanti, antipsikotiċi (li jinkludu l-lithium) u benzodiazepines
English: 601 Cornhusker Highway 68521 Lincoln, Nebraska UNITED STATES
Maltese: 601 Cornhusker Highway 68521 Lincoln, Nebraska
English: ATC vet code: QD11AH91
Maltese: Kodiċi ATC veterinarja: QD11AH91
English: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Rue Laid Burniat 1
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
English: Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate
Maltese: Histidine hydrochloride monohydrate
English: EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 vials EU/2/17/205/002 10 mg/ml 6 vials EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 vials EU/2/17/205/004 20 mg/ml 6 vials EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 vials EU/2/17/205/006 30 mg/ml 6 vials
Maltese: EU/2/17/205/009 10 mg/ml kunjett 1 EU/2/17/205/001 10 mg/ml 2 kunjetti EU/2/17/205/002 10 mg/ml 6 kunjetti EU/2/17/205/010 20 mg/ml kunjett 1 EU/2/17/205/003 20 mg/ml 2 kunjetti EU/2/17/205/004 20 mg/ml 6 kunjetti EU/2/17/205/011 30 mg/ml kunjett 1 EU/2/17/205/005 30 mg/ml 2 kunjetti EU/2/17/205/006 30 mg/ml 6 kunjetti
English: EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 vials EU/2/17/205/008 40 mg/ml 6 vials
Maltese: EU/2/17/205/012 40 mg/ml kunjett 1 EU/2/17/205/007 40 mg/ml 2 kunjetti EU/2/17/205/008 40 mg/ml 6 kunjetti
English: Agents for dermatitis, excluding corticosteroids.
Maltese: Aġenti għad-dermatite, esklużi l kortikosterojdi.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/205/001-012
Maltese: EU/2/17/205/001-012
English: These final reports should be provided by April 2018 and November 2019, for the ongoing 300 L and 2000 L stability studies, respectively.
Maltese: Dawn ir-rapporti finali għandhom jingħataw sa' April 2018 u Novembru 2019 għall-istudji ta' stabilità li huma għaddejin għal 300 L u 2000 L rispettivament.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/04/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 25/04/2017
English: CYTOPOINT strength (mg) to be administered
Maltese: CYTOPOINT saħħa (mg) li għandha tkun amministrata
English: Administer the entire contents (1 ml) of the vial.
Maltese: Amministra l-kontenut kollu (1 ml) tal-kunjett.
English: Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31.
Maltese: Lokivetmab huwa antikorp monoklonali (mAb) kanin immirat speċifikament għal canine interleukin
English: Store in the original package.
Maltese: Żomm fil-pakkett oriġinali.
English: Active substances:
Maltese: Stabilità tas-sustanza attiva:
English: Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product.
Maltese: Sinjali newroloġiċi (aċċessjoni, konvulżjoni jew atakksja) rari ġew osservati f'rapporti spontanji wara l-użu tal-prodott mediċinali veterinarju.
English: Avoid excessive shaking.
Maltese: Evita taħlit eċċessiv.
English: Secondary packaging: cardboard box.
Maltese: Ippakkjar skondarju: kaxxa tal-kartun.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: TAL-PRODOTT MEDIĊINALI VETERINARJU
English: PACKAGE SIZE 1 x 1 ml
Maltese: DAQS TAL-PAKKETT 1 x 1 ml
English: No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials antiinflammatories and vaccines.
Maltese: prodotti mediċinali veterinarji bħal endo- u ekto-parasitiċidi, antimikrobiċi, anti-infjammatorji u vaċċini.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Methionine
Maltese: KWANTITÀ
English: Do not use in dogs less than 3 kg bodyweight.
Maltese: Tużax fi klieb ta' anqas minn 3 kg piż.
English: 2 vials 1 vial
Maltese: Kunjett 1 Kunjett 1
English: 4.8 Interaction with other medicinal products and other forms of interaction No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, anti-inflammatories and vaccines.
Maltese: Ma dehret l-ebda interazzjoni fi studji fuq il-post fejn lokivetmab ġie amministrat fl-istess ħin ma' prodotti mediċinali veterinarji bħal endo- u ekto-parasitiċidi, antimikrobiċi, anti-infjammatorji u vaċċini.
English: The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from Atopic Dermatitis-related pruritus and anti-inflammatory activity.
Maltese: L-imblukkar ta' IL-31 bil-lokivetmab ma jħallix lill-IL-31 jabbina mal-ko-riċettur tiegħu u b'hekk ma jħallix issenjalar ta' ċelloli mmedjat minn IL-31, li jwassal għal ħelsien minn ħakk relatat ma'
English: Bodyweight (kg) of dog
Maltese: Piż korporju (kg) talkelb
English: Dog.
Maltese: D.
English: *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells
Maltese: *Lokivetmab huwa antikorp monoklonali kanin magħmul permezz ta' teknika rikombinanti minn ċelloli ovarji (CHO) tal-ħamster Ċiniż Sustanzi mhux attivi:
English: VIAL - 1 ml
Maltese: KUNJETT - 1 ml ISEM
English: Pack sizes:
Maltese: Qisien tal-pakketti:
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufattur tas-sustanzi bijoloġiċi attivi
English: Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports.
Maltese: Ġew rappurtati f'rapporti spontanji, każijiet rari ta' reazzjonijiet ipersensittivi (anafilassi, edema talwiċċ, urtikarja).
English: Refer also to section 4.5 of the SPC.
Maltese: Irreferi ukoll għal sezzjoni 4.5 tal-KPQ.
English: SPECIAL WARNING(S)
Maltese: U INGREDJENT(I)