FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 5% of patients can be expected to experience adverse reactions.
Maltese: Madwar 5% tal-pazjenti huma mistennija li jkollhom reazzjonijiet avversi.
English: - Rare side effects: distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests).
Maltese: - Effetti sekondarji rari: sens ta' togħma distort jew jitlaq għal kollox, disturbi fil-vista bħal vista mċajpra; uġigħ fil-ġogi; uġigħ fil-muskoli; tibdil fil-piż; temperatura għolja tal-ġisem; nefħa tal-estremitajiet; depressjoni; żieda fil-livelli tal-bilirubina u x-xaħam fid-demm (kienu osservati f'testijiet tad-demm), sider li jikber fl-irġiel, deni għoli u tnaqqis f'daqqa f'ċelluli granulari tad-demm bojod fiċ-ċirkolazzjoni (kif jidher fit-testijiet tad-demm).
English: In a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure.
Maltese: Fi studju dwar ir-riproduzzjoni tal-firien qabel u wara t-twelid maħsub biex jevalwa l-iżvilupp tal-għadam, sinjali ta' tossiċità tal-frieħ (mortalità, piż medju tal-ġisem aktar baxx, żieda aktar baxxa fil-piż medju tal-ġisem u tnaqqis fit-tkabbir tal-għadam) kienu osservati f'esponimenti (Cmax) bejn wieħed u ieħor darbtejn (2x) tal-esponiment kliniku uman.
English: - Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema.
Maltese: - Reazzjonijiet allerġiċi serji (rari: jistgħu jaffettwaw sa persuna 1 f'1,000): Reazzjonijiet ta' sensittività eċċessiva, dawk hekk imsejħa reazzjonijiet anafilattiċi, xokk anafilattiku u anġjoedema.
English: - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints; feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhoea.
Maltese: - Frekwenza mhux magħrufa: alluċinazzjoni, konfużjoni (speċjalment f'pazjenti bi storja medika ta' dawn is-sintomi); tnaqqis fil-livell ta' sodium fid-demm, tnaqqis fil-livell ta' manjesju fid-demm, raxx, possibbilment b'uġigħ fil-ġogi, infjammazzjoni fil-musrana l-kbira, li tikkawża dijarea maħlula persistenti.
English: • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Maltese: • Ikunu fuq kura sintomatika kontinwa għal indiġestjoni jew qrusa fl-istonku għal 4 ġimgħat jew iktar.
English: See ‘Other medicines and PANTOLOC Control'.
Maltese: Ara “Mediċini oħra u PANTOLOC Control.
English: mm/yyyy
Maltese: U L-UŻU
English: Subacute cutaneous lupus erythematosus (see section
Maltese: Lupus erythematosus tal-ġilda subakut (ara sezzjoni 4.4).
English: Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Maltese: Partikolarment mediċini li fihom xi wieħed mis-sustanzi attivi li ġejjin: - impedituri tal-protease tal-HIV bħal atazanavir, nelfinavir (għat-trattament ta' infezzjoni ta' HIV).
English: If you take PANTOLOC Control for longer periods, this may cause additional risks, such as:
Maltese: Jekk ser tieħu PANTOLOC Control għal perijodi itwal, dan jista' jikkaġuna riskji addizzjonali, bħal:
English: Do not exceed this recommended dose of 20 mg pantoprazole daily.
Maltese: Taqbiżx din id-doża rakkomandata ta' 20 mg ta' pantoprazole kuljum.
English: Distribution Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%.
Maltese: Distribuzzjoni Il-volum tad-distribuzzjoni hu ta' madwar 0.15 l/kg u t-twaħħil tal-proteina fis-serum hu ta' madwar
English: What PANTOLOC Control is and what it is used for What you need to know before you take PANTOLOC Control How to take PANTOLOC Control Possible side effects
Maltese: X'għandek tkun taf qabel ma tieħu PANTOLOC Control Kif għandek tieħu PANTOLOC Control Effetti sekondarji possibbli
English: Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).
Maltese: Mhux rakkomandat l-għoti ta' pantoprazole flimkien ma' impedituri tal-protease ta' HIV bħal atazanavir u nelfinavir li għalihom l-assorbiment hu dipendenti fuq pH intragastriku aċiduż; minħabba tnaqqis sinjifikanti fil-bijodisponibilità tagħhom (ara sezzjoni 4.5).
English: - Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test; fracture in the hip, wrist or spine.
Maltese: - Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100): uġigħ ta' ras; sturdament; dijarea; dardir, rimettar; nefħa u gass fl-istonku; stitikezza; ħalq xott; uġigħ ta' żaqq u skonfort; raxx tal-ġilda jew urtikarja; ħakk; tħossok dgħajjef, għajjien jew ġeneralment ma tħossokx tajjeb; problemi biex torqod; żieda fl-enzimi tal-fwied f'test tad-demm; ksur fil-ġenbejn, il-polz jew l-ispina dorsali.
English: Although the main metabolite has a longer half-life (2-3h), excretion is still rapid and thus accumulation does not occur.
Maltese: Għalkemm il-metabolit ewlieni għandu half-life itwal (2-3 sigħat), it-tneħħija xorta hi mgħaġġla u għaldaqstant l-akkumulazzjoni ma sseħħx.
English: Pruritus
Maltese: Kisja
English: Arthralgia; Myalgia
Maltese: Artralġja;
English: Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements.
Maltese: Evidenza ppubblikata disponibbli tissuġġerixxi li inibituri tal-pompa tal-proton jenħtieġ li jitwaqqfu bejn 5 ijiem u ġimagħtejn qabel il-kejl ta' CgA.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: Fit-tabella reazzjonijiet avversi huma kklassifikati taħt il-klassifikazzjoni tal-frekwenza ta' MEDRA:
English: Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Maltese: B12 (cyanocobalamin) minħabba ipo- jew aklorħajdra.
English: The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients.
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod komuni huma dijarea u wġigħ ta' ras, li t-tnejn iseħħu f'madwar 1% tal-pazjenti.
English: Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Maltese: Ara ‘Tiħux PANTOLOC Control'. - ketoconazole (użat għal infezzjonijiet fungali). - warfarin u phenprocoumon (jintużaw biex iraqqu d-demm u għall-prevenzjoni tal-emboli).
English: As pantoprazole is extensively protein bound, it is not readily dialysable.
Maltese: Minħabba li pantoprazole jeħel b'mod estensiv mal-proteina, mhuwiex dijalizzabbli fil-pront.
English: As with healthy subjects, the half-life of pantoprazole is short.
Maltese: Bħal fil-każ ta' persuni b'saħħithom, il-half-life ta' pantoprazole hi qasira.
English: The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old.
Maltese: Iż-żieda fil-mortalità ġiet irrappurtata biss fi frieħ tal-firien qabel ma nfatmu (sa 21 jum) li huwa stmat li jikkorrispondi għal trabi sal-età ta' sentejn.
English: How to store PANTOLOC Control Contents of the pack and other information
Maltese: Kif taħżen PANTOLOC Control Kontenut tal-pakkett u informazzjoni oħra
English: You must not use PANTOLOC Control if you are taking HIV protease inhibitors.
Maltese: M'għandekx tuża PANTOLOC Control jekk qed tieħu impedituri tal-protease tal-HIV.
English: Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients.
Maltese: L-użu fl-istess waqt ta' doża għolja ta' methotrexate (eż. 300 mg), u impedituri tal-proton-pump ġie rapportat li jgħolli l-livelli ta' methotrexate f'xi pazjenti.
English: Concomitant intake of food had no influence on bioavailability (AUC or Cmax), but increased the variability of the lag-time (tlag).
Maltese: It-teħid fl-istess ħin tal-ikel ma kellu l-ebda influwenza fuq il-bijodisponibiltà (AUC jew Cmax), iżda żied il-varjabilità tal-lag-time (tlag).
English: Erythema multiforme;
Maltese: Sindrome ta' Lyell; Eritema multiforme;
English: Relieves heartburn.
Maltese: Iż-żieda fil-gastrin hi riversibbli.
English: Posology The recommended dose is 20 mg pantoprazole (one tablet) per day.
Maltese: Pożoloġija Id-doża rakkomandata hi ta' 20 mg ta' pantoprazole (pillola waħda) kuljum.
English: The following adverse reactions have been reported with pantoprazole.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati bi pantoprazole.
English: A previous peri-postnatal study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 5 mg/kg in this study.
Maltese: Studju preċedenti ta' qabel u wara t-twelid fil-firien f'dożi kemxejn aktar baxxi ma sab l-ebda effetti avversi f'doża ta' 3 mg/kg meta mqabbla ma' doża baxxa ta' 5 mg/kg f'dan l-istudju.
English: Packs containing 7 or 14 gastro-resistant tablets.
Maltese: Il-pakketti fihom 7 jew 14-il pillola gastro-reżistenti.
English: - reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12 - fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Maltese: B12 - ksur tal-ġenbejn, il-polz jew l-ispina dorsali jekk diġà tbati minn osteoporożi jew jekk qed tieħu kortikosterojdi (li jistgħu jżidu r-riskju ta' osteoporożi). - livelli tal-manjesju fid-demm tiegħek li jonqsu (sintomi potenzjali: għeja, kontrazzjonijiet muskolari involontarji, diżorjentazzjoni, konvulżjonijiet, sturdament, rata ta' taħbit aktar mgħaġġla tal-qalb).
English: Magyarország Takeda Pharma Kft. Tel: +361 2707030
Maltese: Takeda Pharma sp. z o.o. Tel.: + 48 22 608 13 00
English: There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Maltese: Ma kienx hemm evidenza ta' indeboliment tal-fertilità wara l-għoti ta' pantoprazole fi studji fuq l-annimali (ara sezzjoni 5.3).
English: If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Maltese: Jekk il-livelli ta' CgA u gastrin ma jkunux irritornaw għall-medda ta' referenza wara kejl inizjali, il-kejl jenħtieġ li jiġi ripetut 14-il jum wara l-waqfien tal-kura tal-inibitur tal-pompa tal-proton.
English: The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver.
Maltese: L-okkorrenza ta' dawn in-neoplażmi hi marbuta mat-tibdil ikkaġunat minn pantoprazole fit-tkissir ta' thyroxine fil-fwied tal-firien.
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għas-suq.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Maltese: Għid lit-tabib tiegħek immedjatament, qabel jew wara li tieħu din il-mediċina, jekk tinnota kwalunkwe mis-sintomi li ġejjin, li jistgħu jkunu sinjal ta' marda oħra li tkun iktar serja: - telf ta' piż mhux intenzjonat (mhux marbut ma' dieta jew programm ta' eżerċizzju) - rimettar, partikularment jekk ikun ripetut - tirremetti d-demm; dan jista' jidher bħala frak tal-kafè skur fir-rimettar tiegħek - tinnota d-demm fl-ippurgar tiegħek; li jista' jidher iswed jew qisu qatran - diffikultà biex tibla' jew uġigħ meta tibla' - tidher musfar u tħossok dgħajjef (anemija) - uġigħ fis-sider - uġigħ fl-istonku - dijarea severa u/jew persistenti, għax din il-mediċina kienet assoċjata ma' żieda żgħira ta' dijarea infettiva - jekk ikollok raxx fuq il-ġilda tiegħek, speċjalment f'postijiet li jiġu esposti għax-xemx kellem lit-tabib tiegħek kemm jista' jkun malajr, peress li jista' jkollok bżonn twaqqaf il-kura tiegħek
English: - Serious skin reactions (frequency not known: frequency cannot be estimated from the available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun. - Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.
Maltese: - Reazzjonijiet serji tal-ġilda (frekwenza mhux magħrufa: frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli): raxx flimkien ma' nefħa, infafet jew tqaxxir tal-ġilda, telf ta' ġilda u ħruġ ta' demm madwar l-għajnejn, imnieħer, ħalq jew fil-partijiet ġenitali, u deterjorament mgħaġġel tas-saħħa ġenerali tiegħek, jew raxx meta tkun espost/a għax-xemx.
English: Interstitial nephritis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg) in one 2-year study.
Maltese: Żieda żgħira ta' tibdil neoplastiku tat-tirojde kien osservat fil-grupp ta' firien li kienu qed jirċievu l-ogħla doża (200 mg/kg) fi studju wieħed li dam sentejn.
English: Since pantoprazole binds to the enzyme distal to the receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin).
Maltese: Minħabba li pantoprazole jeħel mal-enzima distali fil-livell tar-riċettur, jista' jinibixxi t-tnixxija ta' hydrochloric acid indipendentement mill-istimulazzjoni minn sustanzi oħrajn (acetylcholine, istamina, gastrin).
English: - Avoid large meals - Eat slowly - Stop smoking - Reduce alcohol and caffeine consumption - Reduce weight (if overweight) - Avoid tight-fitting clothing or belts - Avoid eating less than three hours before bedtime - Elevate bedhead (if you suffer from nocturnal symptoms) - Reduce intake of food that can cause heartburn.
Maltese: - Evita ikliet kbar - Kul bil-mod - Tpejjipx iżjed - Naqqas il-konsum tal-alkoħol u tal-kafeina - Naqqas il-piż (jekk inti oħxon/ħoxna) - Evita ħwejjeġ jew ċintorini ssikkati - Tikolx inqas minn tliet sigħat qabel tmur torqod - Tella' l-bedhead (jekk tbati minn sintomi ta' bil-lejl) - Naqqas l-ammont ta' ikel li tiekol li jista' jikkawża qrusa fl-istonku.
English: Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Maltese: Għalkemm ma kienet osservata l-ebda interazzjoni waqt l-għoti fl-istess ħin ta' phenprocoumon jew warfarin fi studji farmakokinetiċi kliniċi, ftit każijiet iżolati ta' tibdil fl-International Normalised Ratio (INR) kienu rrappurtati waqt il-kura fl-istess ħin fil-perjodu ta' wara l-bejgħ.
English: Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets.
Maltese: Folji Alu/Alu bi jew mingħajr rinforz tal-kartun li jkun fihom 7 jew 14-il pillola gastro-reżistenti.
English: PANTOLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Maltese: PANTOLOC Control jintuża għal kura għal żmien qasir ta' sintomi tar-rifluss (per eżempju qrusa fl-istonku, rigurġitazzjoni tal-aċidu) fl-adulti.
English: Takeda Pharma sp. z o.o.
Maltese: Takeda Pharma AB
English: Do not take PANTOLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Maltese: Tieħux PANTOLOC Control ma' mediċini oħrajn li jillimitaw l-ammont ta' aċidu li jiġi prodott fl-istonku tiegħek, bħal inibitur tal-pompa tal-proton ieħor (omeprazole, lansoprazole jew rabeprazole) jew antagonist ta' H2 (eż. ranitidine, famotidine).
English: Urticaria; Angioedema
Maltese: Anġjoedema
English: 7 syringes.
Maltese: 7 siringi.
English: Date of last renewal: 06/06/2013
Maltese: Data tal-aħħar tiġdid: 06/06/2013
English: EU/2/08/083/006 10 tablets EU/2/08/083/007 30 tablets EU/2/08/083/008 180 tablets EU/2/08/083/009 60 tablets
Maltese: EU/2/08/083/006 10 pilloli EU/2/08/083/007 30 pillola EU/2/08/083/008 180 pillola EU/2/08/083/009 60 pillola
English: Horses (450-600 kg)
Maltese: Żwiemel (450-600 kg)
English: Store in the original package.
Maltese: Aħżen fil-pakkett originali.
English: Merial Toulouse 4 Chemin du Calquet 31000 Toulouse France
Maltese: Merial Toulouse 4 Chemin de Calquet 31000
English: 14 syringes.
Maltese: 14-il siringa.
English: - 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
Maltese: - Kaxxa tal-kartun li fiha 60 pillola fi flixkun ta' 30 ml tal-high density polyethylene.
English: Lactose monohydrate Microcrystalline cellulose Chartor hickory smoke flavour Hydroxypropyl cellulose Croscarmellose sodium
Maltese: Lactose monohydrate Microcrystalline cellulose Chartor hickory smoke flavour Hydroxypropyl cellulose Croscarmellose sodium Magnesium stearate Caramel (E150d) Silica, colloidal anhydrous Yellow Iron Oxide (E172) Red Iron Oxide (E172)
English: The elimination half-life (t½) after a single dose is 38.7 (± 7.8) hours.
Maltese: Il-half-life tal-eliminazzjoni (t½) wara doża waħda hija ta' 38.7 (± 7.8) sigħat.
English: The elimination half-life (t½) after a single dose is 29.6 (± 7.5) hours and 50.6 hours after 14 days of dosing.
Maltese: Il-half-life tal-eliminazzjoni (t½) wara doża waħda hija ta' 29.6 (± 7.5) sigħat u 50.6 sigħat wara 14-il jum ta' dożaġġ.
English: Firocoxib Equidae 10 μg/kg
Maltese: Firocoxib Equidae 10 μg/kg 15 μg/kg
English: Firocoxib is approximately 97% bound to plasma proteins.
Maltese: Il-Firocoxib jeħel madwar 97% mal-proteini tal-plasma.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/06/2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:25/06/2008
English: The peak concentration (Cmax) is 0.075 (± 0.021) μg/ml, area under the curve (AUC0-inf) is 3.48 (± 1.15) μg x hr/ml.
Maltese: L-għola konċentrazzjoni (Cmax) hija ta' 0.075 (± 0.021) µg/ml l-erja taħt il-kurva (AUC 0-24) hija 3.48 (±1.15) µg hr/ml.
English: The peak concentration (Cmax) is 0.075 (± 0.033) µg/ml (equivalent to approximately 0.223 µM), area under the curve (AUC0-24) is 0.96 (± 0.26) µg x hr/ml, and oral bioavailability is 79 (± 31) percent.
Maltese: L-għola konċentrazzjoni (Cmax) hija ta' 0.075 (± 0.33) µg/ml (ekwivalenti għal bejn wieħed u ieħor 0.223 μM), l-erja taħt il-kurva (AUC 0-24) hija 0.96 (±0.
English: 15 μg/kg 60 μg/kg 10 μg/kg
Maltese: 60 μg/kg
English: Disodium edetate n-Propyl gallate
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI
English: Meat and offal: 26 days.
Maltese: Laħam u ġewwieni: 26 ġurnata
English: The terminal elimination half-life (t ½ el) values were not significantly different (p>0.05), with mean values of 31.5 hours and 33.0 hours for the oral paste and the intravenous solution, respectively.
Maltese: Il-valuri tal-eliminazzjoni terminali half-life ( t ½ el) ma kinux differenti ħafna (p>0.05), b'valuri medji ta' 31.5 siegħa u 33.0 siegħa għall-paste tal-ħalq u ssoluzzjoni għall-vina, rispettivament.
English: Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties.
Maltese: Għalhekk ilCoxibs juru kwalitajiet analġesiċi, anti-infjammatorji, u antipiretiċi.
English: The peak plasma levels observed one minute following firocoxib intravenous administration was approximately 3.7 fold greater than the observed peak plasma concentrations reached after administration of the oral paste (oral Tmax = 2.02 hours).
Maltese: Il-livelli massimi tal-plasma osservati minuta wara l-amministrazzjoni fil-vina tal-firocoxib kienu bejn wieħed u ieħor 3.7 aktar mill-konċentrazzjonijiet massimi tal-plasma milħuqa wara l-amministrazzjoni tal-paste tal-ħalq (Tmax tal-ħalq = 2.02 sagħtejn).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 60 tablets
Maltese: PIZ, VOLUM JEW NUMRU TA' DOŻI 60 pillola
English: Mode of action:
Maltese: Mod t'azzjoni:
English: Tablets are engraved on one side with “M” above the score and “57” below the score.
Maltese: Il-pilloli huma mnaqqxa fuq naħa waħda bl-ittra “M” 'l fuq mill-linja u “57” taħt il-linja.
English: - 1 cardboard box containing 180 tablets in transparent PVC /aluminium foil blisters.
Maltese: - Kaxxa tal-kartun li fiha 180 pillola fi blisters tal-PVC trasparenti/fojl tal-aluminju.
English: The active substance in EQUIOXX 8.2 mg/g oral paste for horses, EQUIOXX 20 mg/ml solution for injection for horses and EQUIOXX 57 mg chewable tablets for horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010 as follows:
Maltese: Is-sustanza attiva fil-paste tal-ħalq EQUIOXX 8.2 mg/g għaż-żwiemel, fis-soluzzjoni għal injezzjoni għaż-żwiemel EQUIOXX 20mg/ml, u EQUIOXX pilloli li jintmagħdu ta' 57mg għaż-żwiemel hija sustanza aċċettata kif deskritta f'Tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) n.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Ceva Santé Animale
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Ceva Santé Animale.
English: COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception, and cognitive function).
Maltese: Huwa wkoll maħsub li l-Cox-2 huwa involut fl-ovulazzjoni, it-twaħħil tal-embrijun, l-għeluq tad-ductus arteriosus, u l-funzjonijiet tas-sistema nervuża (induzzjoni tad-deni, perċezzjoni tal-uġigħ, u l-funzjoni konjittiva).
English: Drug accumulation occurs with repeated dose administrations and steady state concentrations are achieved after 6-8 days of treatment in the horse.
Maltese: Akkumulazzjoni tal-mediċina sseħħ meta d-doża tiġi mgħotija ripetutament u l-istat fiss jiġi milħuq wara 6-8 ijiem tal-kura fiż-żiemel.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ceva Santé Animale
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ Ceva Santé Animale
English: 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
Maltese: 12 μM,, mentri l-IC50 għal COX-1 hija ta' 20.
English: Glycerol triacetate
Maltese: TWISSIJIET SPEĊJALI
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 57 mg
Maltese: TAS-SUSTANZA(I) / ATTIVA(I) Firocoxib 57 mg