FrancophonIA/ELRC3.0 huggingface dataset:
English: OLANZAPINE CIPLA belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Maltese: OLANZAPINE CIPLA tappartjeni għall-grupp ta' mediċini msejħa antipsikotiċi antipsikotiċi u hija użata fil-kura ta' dawn il-kondizzjonijiet li ġejjin:
English: - Tablet coat: - 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets: Opadry white containing hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol 3000 and glycerol triacetate - 15 mg tablets: Opadry Blue containing hypromellose (E464), titanium dioxide (E171), polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and iron oxide black (E172)
Maltese: Opadry Blue li fih hypromellose (E464), titanium dioxide (E171), polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium
English: Excipient with known effect: Each coated tablet contains 315 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija fiha 315 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Olanzapine Cipla 2.5 mg coated tablets olanzapine
Maltese: Olanzapine Cipla 2.5 mg pilloli miksija olanzapine
English: Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Maltese: Wara espożizzjoni fit-tul (għallinqas 48 ġimgħa). ilpazjenti li żiedu ≥ 7 %, ≥ 15 % u ≥ 25 % mil-linja bażi tal-piż tal-ġisem tagħhom kienu komuni ħafna (64.4 %, 31.7 % u 12.3 % rispettivament).
English: In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Maltese: Fi studji kliniċi f'pazjenti anzjani bid-demenzja, trattament b'olanzapine kien assoċjat ma' inċidenza ogħla ta' mwiet u reazzjonijiet avversi ċerebro-vaskulari meta mqabbla mal-plaċebo (ara wkoll sezzjoni 4.4).
English: Olanzapine Cipla 5 mg coated tablets olanzapine
Maltese: Olanzapine Cipla 5 mg pilloli miksija olanzapine
English: During treatment with olanzapine in combination with lithium or divalproex, an increase of  7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6
Maltese: Waqt trattament b'olanzapine flimkien ma' lithium jew divalproex, żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem seħħet f' 17.4% tal-pazjenti waqt it-trattament akut (sa 6 ġimgħat).
English: Olanzapine Cipla 10 mg coated tablets olanzapine
Maltese: Olanzapine Cipla 10 mg pilloli miksija olanzapine
English: Olanzapine Cipla 15 mg coated tablets are blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side.
Maltese: OLANZAPINE CIPLA 15 mg pilloli miksija huma blu, ellitiċi, konvessi, pilloli miksija b''NEO' imnaqqxa fuq naħa waħda u xejn fuq in-naħa l-oħra.
English: Olanzapine Cipla 10 mg
Maltese: Olanzapine Cipla 10 mg pilloli miksija
English: The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Maltese: L-esperjenza fl-adolexxenti (minn 13 sa 17-il sena) hija limitata għal dejta dwar l-effikaċja għal żmien qasir fl-iskiżofrenja (6 ġimgħat) u manija assoċjata ma' mard bipolari tat-tip I (3 ġimgħat) u li involvew anqas minn 200 adolexxent.
English: Excipient with known effect: Each coated tablet contains 322.6 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija fiha 322.6 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Excipient with known effect: Each coated tablet contains 242 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija fiha 242 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Dysarthria
Maltese: Takikardija/
English: Olanzapine Cipla 5 mg
Maltese: Olanzapine Cipla 5 mg pilloli miksija
English: Olanzapine Cipla 15 mg coated tablets olanzapine
Maltese: Olanzapine Cipla 15 mg pilloli miksija olanzapine
English: What OLANZAPINE CIPLA looks like and contents of the pack Olanzapine Cipla 2.5 mg coated tablets are white, round, biconvex, coated tablets with ‘2.5' debossed on one side and ‘OLZ' on the other.
Maltese: Id-dehra ta' OLANZAPINE CIPLA u l-kontenuti tal-pakkett OLANZAPINE CIPLA 2.5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b'rita b''2.5' imnaqqxa fuq naħa waħda u ‘OLZ' fuq in-naħa l-oħra.
English: Medicinal product subject to medical prescription.
Maltese: ISEM PRODOTT MEDIĊINALI
English: EU/1/07/426/010 - Olanzapine Cipla - 15 mg - coated tablets - 28 tablets per box EU/1/07/426/011 - Olanzapine Cipla - 15 mg - coated tablets - 56 tablets per box
Maltese: EU/1/07/426/010 - Olanzapine Cipla - 15 mg - pilloli miksija - 28 pillola, kull kaxxa EU/1/07/426/011 - Olanzapine Cipla - 15 mg - pilloli miksija - 56 pillola, kull kaxxa
English: Cold-formed aluminium blisters in cartons of 7, 28 or 56 tablets per carton.
Maltese: Strixxi tal-folji ta' l-aluminju iffurmati fil-ksieħ f'kaxxi tal-kartun ta' 7, 28 jew 56 pillola f'kull kaxxa tal-kartun.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported 11Dystonia
Maltese: Aċċessjonijiet li filmaġġoranza tagħhom kien rrappurtat passat mediku ta' aċċessjonijiet jew fatturi tar-riskju għall- aċċessjonijiet11
English: OLANZAPINE CIPLA with alcohol
Maltese: OLANZAPINE CIPLA mal-alkohol
English: Glucosuria
Maltese: Alopeċja
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin (≥ 6.2 mmol/l).
English: Discontinuation symptoms7, 12
Maltese: Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif talkura7,12
English: EU/1/07/426/005 - Olanzapine Cipla - 7.5 mg - coated tablets - 28 tablets per box EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - coated tablets - 56 tablets per box
Maltese: EU/1/07/426/005 - Olanzapine Cipla - 7.5 mg - pilloli miksija - 28 pillola, kull kaxxa EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - pilloli miksija - 56 pillola, kull kaxxa
English: EU/1/07/426/001 - Olanzapine Cipla - 2.5 mg - coated tablets - 28 tablets per box EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - coated tablets - 56 tablets per box
Maltese: EU/1/07/426/001 - Olanzapine Cipla - 2.5 mg - pilloli miksija - 28 pillola, kull kaxxa EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - pilloli miksija - 56 pillola, kull kaxxa
English: Olanzapine Cipla 5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 5' debossed on one side and ‘NEO' on the other.
Maltese: OLANZAPINE CIPLA 5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b'rita b''OLZ 5' imnaqqxa fuq naħa waħda u ‘NEO' fuq in-naħa l-oħra.
English: EU/1/07/426/010, 28 coated tablets EU/1/07/426/011, 56 coated tablets
Maltese: EU/1/07/426/011 56 pillola miksija
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 7.5' debossing on one side and ‘NEO' on the other.
Maltese: Pilloli bojod, tondi, bikonvessi, miksija b' 'OLZ 7.5' imnaqqxa fuq naħa waħda u ‘NEO' fuq in-naħa l-oħra.
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Maltese: Epatite inkluż mard tal-fwied tat-tip epatoċellulari, kolestatiku jew tattnejn flimkien)11
English: EU/1/07/426/003 - Olanzapine Cipla - 5 mg - coated tablets - 28 tablets per box EU/1/07/426/004 - Olanzapine Cipla - 5 mg - coated tablets - 56 tablets per box
Maltese: EU/1/07/426/003 - Olanzapine Cipla - 5 mg - pilloli miksija - 28 pillola, kull kaxxa EU/1/07/426/004 - Olanzapine Cipla - 5 mg - pilloli miksija - 56 pillola, kull kaxxa
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t-temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija talġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: Patients treated with any antipsychotic agents, including Olanzapine Cipla, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Pazjenti kkurati b'sustanzi antipsikotiċi, inkluż OLANZAPINE CIPLA, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, polijurja, polifaġja u debbulizza) u pazjenti bid-dijabete mellitus jew li għandhom fatturi ta' riskju għad-dijabete mellitus għandhom jiġu segwiti b'mod regolari f'każ li l-kontroll tal-glukosju jmur għall-agħar.
English: Coated tablet White, round, biconvex, coated tablets with ‘2.5' debossing on one side and ‘OLZ' on the other.
Maltese: Pilloli bojod, tondi, bikonvessi, miksija b' '2.5' imnaqqxa fuq naħa waħda u ‘OLZ' fuq in-naħa l-oħra.
English: Manufacturer:
Maltese: Fax:
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Maltese: Aċċessjonijiet ġew irrapportati li seħħew b'mod mhux komuni f'pazjenti trattati b'olanzapine.
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥
English: Elevated glucose levels4
Maltese: GĦALL-ĦRUĠ TAL
English: Postural hypotension
Maltese: Min ipejjep
English: Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Maltese: L-effetti fit-tul assoċjati ma' dawn l-avvenimenti ma ġewx studjati u għadhom mhux magħrufa (ara sezzjonijiet 4.8 u 5.1).
English: Leukopenia10
Maltese: Deni10
English: Decreased bioavailability
Maltese: Biodisponibbiltà mnaqqsa
English: This leaflet was last revised in {month YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: The daily dose of OLANZAPINE CIPLA is between 5 and 20 mg.
Maltese: Id-doża ta' kuljum ta' OLANZAPINE CIPLA hija bejn 5 u 20 mg.
English: EU/1/07/426/007 - Olanzapine Cipla - 10 mg - coated tablets - 7 tablets per box EU/1/07/426/008 - Olanzapine Cipla - 10 mg - coated tablets - 28 tablets per box EU/1/07/426/009 - Olanzapine Cipla - 10 mg - coated tablets - 56 tablets per box
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/426/007 - Olanzapine Cipla - 10 mg - pilloli miksija - 7 pillola, kull kaxxa EU/1/07/426/008 - Olanzapine Cipla - 10 mg - pilloli miksija - 28 pillola, kull kaxxa
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Maltese: Studji f'pazjenti bejn it-13 u s-17-il sena wrew reazzjonijiet avversi varji, fosthom żieda fil-piż, tibdil fil-parametri metaboliċi u żieda fillivelli ta' prolactin.
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Maltese: Ġew rappurtati każijiet fatali b' dożi akuti u eċċessivi baxxi daqs 450 mg iżda kien hemm ukoll każ fejn pazjent baqa ħaj wara doża eċċessiva akuta ta' madwar 2 g ta' olanzapine meħud b'mod orali..
English: Coated tablet White, round, biconvex, coated tablets with ‘OLZ 10' debossing on one side and ‘NEO' on the other.
Maltese: Pilloli bojod, tondi, bikonvessi, miksija b' 'OLZ 10' imnaqqxa fuq naħa waħda u ‘NEO' fuq in-naħa l-oħra.
English: Each coated tablet contains 15 mg olanzapine.
Maltese: Kull pillola miksija fiha 15 mg ta' olanzapine.
English: Cytochromes P450
Maltese: Il-kisja tal-pillola
English: - sodium chloride
Maltese: - dextrose monohydrate - sodium chloride - sodium S-Lactate
English: The CHMP considers of extreme importance to retain coordination of the review of the conditions presently identified for the sites in Canada, Poland and Turkey.
Maltese: Is-CHMP iqis li huwa ta' importanza kbira li jżomm il-koordinament tal-eżami tal-kundizzjonijiet identifikati fil-preżent għas-siti fil-Kanada, il-Polonja u t-Turkija.
English: Suppliers of active substance listed below have not previously been used in EU product and active substance master files (ASMF's) or equivalent data packages should be submitted for these suppliers.
Maltese: Il-fornituri tas-sustanza attiva elenkati hawn isfel ma ntużawx qabel fil-prodott tal-UE u għalhekk għandhom jiġu sottomessi fajls prinċipali dwar is-sustanza attiva (ASMFs) jew pakketti ta' dejta ekwivalenti għal dawn il-fornituri.
English: The full description of manufacture (3.2.P.3) for all sites together with its critical review should be submitted.
Maltese: Għandha tiġi sottomessa deskrizzjoni sħiħa tal-manifattura (3.2.P.3) għas-siti kollha flimkien malvalutazzjoni kritika tagħha.
English: The excipients water for injections and sodium hydroxide are controlled according to the United States Pharmacopoeia.
Maltese: Is-sustanzi mhux attivi tal-ilma għall-injezzjonijiet u s-sodium hydroxide huma kkontrollati skont ilFarmakopea tal-Istati Uniti.
English: Annex IV
Maltese: B'mod partikolari
English: The following conditions (identified below per site) should be fulfilled by the marketing authorisation holder.
Maltese: Il-kundizzjonijiet li ġejjin (identifikati hawn taħt għal kull sit) għandhom jiġu ssodisfati middetentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: For glucose anhydrous the limit test for endotoxin in the drug substance should be tightened prior to the release of PD solutions to the EU market under the EU marketing authorisation.
Maltese: Għall-glukożju anidruż it-test tal-limitu għall-endotossini fis-sustanza tal-mediċina għandu jsir aktar strett qabel ir-rilaxx tas-soluzzjonijiet għall-PD lis-suq tal-UE skont l-awtorizzazzjoni għat-tqegħid fissuq tal-UE.
English: The maximum batch size at Lublin should be stated and the actual validation data for these batch sizes should be provided within three weeks of Commission Decision.
Maltese: Għandu jiġi ddikjarat id-daqs massimu tal-lott f'Lublin u d-dejta proprja ta' validazzjoni għal dawn id-daqsijiet tal-lott għandha tiġi pprovduta fi żmien tliet ġimgħat mid-Deċiżjoni tal-Kummissjoni.
English: Specifications for the excipients sodium hydroxide and hydrochloric acid should be stated along with the results of analysis.
Maltese: L-isterilizzazzjoni terminali trid tiġi espressa bħala ħin minimu ta' espożizzjoni għal temperatura minima skont il-Ph.
English: The coordinated review of the conditions by the CHMP will enable the appropriate harmonious adjustments with minimum impact on supply of PD solutions to the EU market.
Maltese: L-evalwazzjoni kkoordinata tal-kundizzjonijiet misCHMP se tippermetti l-aġġustamenti armonjużi xierqa bl-inqas impatt fuq il-provvista tas-soluzzjonijiet għall-PD lis-suq tal-UE.
English: Polish manufacturing site The MAH should address the following:
Maltese: Is-sit tal-manifattura Pollakk Il-MAH għandu jindirizza dan li ġej:
English: In addition, where applicable, they should be tested and shown to comply with the European Pharmacopoeia (Ph.Eur.
Maltese: Barra minn hekk, fejn applikabbli, huma għandhom jiġu ttestjati u murija li jikkonformaw mal-Farmakopea Ewropea (Ph.
English: A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Maltese: Mill-identifikazzjoni tat-tħassib f'Castlebar beda jintuża approċċ Ewropew armonizzat għall-provvista u l-proċedura skont l-Artikolu 31 tibqa' fis-seħħ sakemm jiġu solvuti l-kwistjonijiet pendenti.
English: The present opinion is the first of a series of entwined opinions, which may result subsequently in additional measures being requested for the sites subject of the current opinion.
Maltese: L-opinjoni preżenti hija l-ewwel waħda minn sensiela ta' opinjonijiet relatati, li sussegwentement jistgħu jwasslu sabiex jintalbu miżuri addizzjonali għas-siti soġġetti għall-opinjoni attwali.
English: Can Parellada Industrial 08228 Terrassa, Barcelona SPAIN
Maltese: Can Parellada Industrial 08228 Terrassa, Barcelona SPANJA
English: 7 tablets 84 tablets 252 tablets
Maltese: 7 pilloli 84 pillola 252 pillola
English: Water, purified
Maltese: Ilma, purifikat
English: Sodium citrate dihydrate Starch, pregelatinized Iron oxide brown Iron oxide yellow Cellulose, microcrystalline Meat Dry Flavour Silica, colloidal anhydrous Magnesium stearate
Maltese: Sodium citrate dihydrate Starch, Pregelatinized Iron oxide brown Iron oxide yellow Cellulose, microcrystalline Togħma Xotta ta' Laħam Silica, colloidal anhydrous Magnesium stearate
English: EXP {month/year} 3 ml:
Maltese: Jiskadi {xahar/sena} 3 ml:
English: 14 days
Maltese: 14-il jum
English: Dose scheme for the maintenance dose:
Maltese: Doża tal-manteniment:
English: The active substance in Metacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Metacam hi sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: The major metabolites found in all species were the 5-hydroxy- and 5-carboxymetabolites and the oxalyl-metabolite.
Maltese: Il-metaboliti ewlenin li jinsabu f'kull speċi kienu lmetaboliti 5-hydroxy- u 5-carboxy u l-metabolit oxalyl.
English: Excipient: Sodium benzoate 1.5 mg
Maltese: Sodium benzoate 1.5 mg
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Meglumine
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH) Meglumine
English: Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ (kunjetti ta' 20 ml, 50 ml, 100 ml jew 250 ml): 3 snin.
English: Metacam 2.5 mg chewable tablets for dogs Blisters: 7, 84 or 252 tablets.
Maltese: Metacam 2.5 mg pilloli li jintmagħdu għall-klieb Folji: 7, 84 jew 252 pillola.
English: Oral suspension, chewable tablet:
Maltese: Sospensjoni orali, pillola li tintmagħad:
English: Sodium hydroxide Glycofurol Meglumine Water for injections
Maltese: Sodium hydroxide Glycofurol Meglumine Ilma għall-injezzjoni
English: Metacam 1 mg chewable tablets for dogs Blisters: 7, 84 or 252 tablets.
Maltese: Metacam 1 mg pilloli li jintmagħdu għall-klieb Folji: 7, 84 jew 252 pillola.
English: Guinea pigs: No data available.
Maltese: M'hemm l-ebda data disponibbli.
English: Manufacturer responsible for batch realease Labiana Life Sciences S.A.
Maltese: Manifattur responsabbli għall-ħruġ tal-lott Labiana Life Sciences S.A.
English: Chronic musculoskeletal disorders in cats: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Maltese: Ir-rispons għat-terapija fit-tul għandu jkun immonitorjat f'intervalli regolari minn kirurgu veterinarju.
English: Excipient(s): Sodium benzoate 1.5 mg
Maltese: Sustanza(i) mhux attiva(i): Sodium benzoate 1.5 mg
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-MetritisAgalactia syndrome MMA) with appropriate antibiotic therapy.
Maltese: Għal terapija addizzjonali fit-trattament ta' settiċemija puwerperali u tossemija (sindrome mastitemetrite-agalaktja) flimkien ma' terapija antibijotika adattata.
English: Pharmacologically active substance
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Bottle, 3 ml, 10 ml, 15 ml, 30 ml
Maltese: Flixkun, 3 ml, 10 ml, 15 ml, 30 ml
English: A clinical response is normally seen within 7 days.
Maltese: Rispons kliniku ġeneralment ikun osservat wara 7 ijiem.
English: Post-operative pain associated with soft tissue surgery:
Maltese: Uġigħ wara operazzjoni assoċjat ma' kirurġija tat-tessut artab:
English: Meloxicam 1 mg/chewable tablet Meloxicam 2.5 mg/chewable tablet
Maltese: Meloxicam 1 mg / pillola li jintmagħdu Meloxicam 2.5 mg / pillola li jintmagħdu
English: EU/2/97/004/046 7 tablets EU/2/97/004/047 84 tablets EU/2/97/004/048 252 tablets
Maltese: EU/2/97/004/046 7 pilloli EU/2/97/004/047 84 pillola EU/2/97/004/048 252 pillola
English: EU/2/97/004/043 7 tablets EU/2/97/004/044 84 tablets EU/2/97/004/045 252 tablets
Maltese: EU/2/97/004/043 7 pilloli EU/2/97/004/044 84 pillola EU/2/97/004/045 252 pillola
English: MRL Target tissues
Maltese: MRL Tessuti mmirat i
English: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Maltese: għoti ta' darba ta' 0.3 mg meloxicam / kg ta' piż tal-ġisem (i.e. 0.06 ml/kg).
English: Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or "M25" on one side.
Maltese: Pillola tonda bikonvessa beige bit-tikek, b'qasma fuq in-naħa ta' fuq b'kodiċi mnaqqax jew "M10" jew "M25" fuq naħa waħda.
English: The volume of distribution is 0.09 l/kg.
Maltese: Il-volum tad-distribuzzjoni hu ta' 0.09 l/kg.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Maltese: Prodotti anti-infjammatorji u antirewmatiċi, mhux sterojdiċi (oxicams).
English: Excipients: Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)
Maltese: Sodium benzoate 1.5 mg (ekwivalenti għal 0.06 mg kull qatra)
English: Vial, 50 ml
Maltese: Kunjett, 50 ml
English: Carton for 10 ml, 32 ml, 100 ml and 180 ml
Maltese: Flixkun ta' 10 ml, 32 ml, 100 ml jew 180 ml.
English: Maintenance dose: 0.1 mg meloxicam/kg body weight once daily (1 chewable tablet per 10 kg body weight).
Maltese: Doża tal-manteniment: 0.1 mg ta' meloxicam / kg ta' piż tal-ġisem darba kuljum (1 pillola li tomgħodha għal kull 10 kilogrammi ta' piż tal-ġisem).
English: Excipient: Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)
Maltese: Sodium benzoate 1.5 mg (ekwivalenti għal 0.05 mg kull qatra)
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu mediċina mhux sterojdi kontra l-infjammazzjoni (NSAID, non-steroidal antiinflammatory drug) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra t-tnixxija u antipiretiċi.
English: Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Maltese: għoti ta' darba ta' 0.2 mg meloxicam / kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kg).
English: To obtain the best possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical intervention.
Maltese: Biex tikseb l-aħjar effett possibbli biex jittaffa l-uġigħ wara operazzjoni, Metacam għandu jingħata 30 minuta qabel intervent kirurġiku.
English: 3 drops/kg body weight.
Maltese: 3 qatriet/kg ta' piż tal-ġisem.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Maltese: Wara l-għoti ta' doża waħda taħt il-ġilda ta' 0.5 mg ta' meloxicam/kg, intlaħqu valuri Cmax ta' 2.1 µg/ml u 2.7 µg/ml wara 7.7 sigħat u 4 sigħat f'baqar żgħar u f'baqar li jkunu qed ireddgħu, rispettivament.