FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are 75 years old or older as starting this medicine above 75 years is not recommended .
Maltese: • jekk għandek 75 sena jew iktar minħabba li mhux irrakkomandat li tibda tieħu din il-mediċina wara l-75 sena.
English: The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3 %) or empagliflozin 25 mg (4.3 %) compared to placebo (2.1 %).
Maltese: Il-frekwenza ta' żvojtar tal-volum kienet ogħla f'pazjenti li għandhom 75 sena jew akbar ittrattati b'empagliflozin 10 mg (2.3%) jew empagliflozin 25 mg (4.3 %) meta mqabbla ma' plaċebo (2.1%).
English: Based on very limited experience in patients 75 years and older, initiation of Glyxambi therapy is not recommended in this population (see sections 4.4 and 5.2).
Maltese: Minħabba l-esperjenza limitata ħafna f'pazjenti li għandhom 75 sena jew iktar, mhux irrakkomandat li tinbeda terapija b'Glyxambi f'din il-popolazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: Glyxambi 10 mg/5 mg film-coated tablets
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita
English: The mode of action for these tumours is dependent on the natural predisposition of the male mouse to renal pathology and a metabolic pathway not reflective of humans.
Maltese: Il-mod t'azzjoni ta' dawn it-tumuri huwa dipendenti fuq il-predisposizzjoni naturali tal-ġurdien raġel għal patoloġija tal-kliewi u għal rotta tal-kliewi li mhix riflettiva għall-bniedem.
English: What Glyxambi contains - The active substances are empagliflozin and linagliptin.
Maltese: X'fih Glyxambi - Is-sustanzi attivi huma empagliflozin u linagliptin.
English: Your doctor may limit your dose or decide to use an alternative medicine.
Maltese: Glyxambi mhuwiex irrakkomandat u t-tabib tiegħek jista' jiddeċiedi li juża mediċina alternattiva.
English: see section 4.4 see subsection below for additional information
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function (see sections 4.2, 5.1 and 5.2).
Maltese: Minħabba l-mekkaniżmu ta' azzjoni, l-effikaċja gliċemika ta' empagliflozin huwa dipendenti fuq il-funzjoni tal-kliewi (ara sezzjonijiet 4.2, 5.1 u 5.2).
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37 % and plasma protein binding was
Maltese: C]-empagliflozin lil voluntiera b'saħħithom, it-tqassim ta' ċelluli ħomor tad-demm kien madwar 37% u t-twaħħil mal-proteini fil-plażma kien ta' 86%.
English: Glyxambi 10 mg/5 mg film-coated tablets Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Maltese: Kull pillola miksija b'rita fiha 10 mg empagliflozin u 5 mg linagliptin.
English: Glyxambi 25 mg/5 mg film-coated tablets Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Maltese: Kull pillola miksija b'rita fiha 25 mg empagliflozin u 5 mg linagliptin.
English: Zero days
Maltese: Qawwa
English: 100 ml vial
Maltese: U* adhesin F5, at mill-inqas 1.7
English: Target species
Maltese: Isem talprodott filkummerċ
English: EU Number Tradename Strength
Maltese: Numru ta' l'Unjoni Ewropea
English: Packaging Content Package size
Maltese: Għamla farmaċewtika Speċi t'amministrazzjoni Ippakkjar Kontenut Daqs talpakkett
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Maltese: Distribuzzjoni Desloratadine jintrabat b'mod moderat (83 % - 87 %) mal-proteini tal-plażma.
English: Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Maltese: Pakketti ta' 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 u 105 pillola miksija b'rita.
English: Microcrystalline cellulose Pregelatinised maize starch Talc
Maltese: Qalba tal-pillola Microcrystalline cellulose Pregelatinised maize starch Talc
English: Tablet coating Lactose monohydrate Hypromellose Titanium dioxide (E171) Macrogol 400
Maltese: Kisja tal-pillola Lactose monohydrate Hypromellose Titanium dioxide (E171) Macrogol 400
English: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren
English: - The other ingredients are microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal anhydrous, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132), shellac and propylene glycol.
Maltese: - Is-sustanza attiva hi desloratadine 5 mg - Is-sustanzi l-oħra huma microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal anhydrous lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132), shellac u propylene glycol.
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands or
Maltese: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, L-Olanda jew
English: Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola miksija b'rita fiha 1.2 mg lactose monohydrate (ara sezzjoni 4.4).
English: It also contains lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Jinkludi wkoll il-lactose monohydrate.
English: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Maltese: Sturdament , sonnolenza, nuqqas ta' rqad, iperattività psikomotorjali,
English: EU/1/11/732/001 EU/1/11/732/002 EU/1/11/732/003 EU/1/11/732/004 EU/1/11/732/005 EU/1/11/732/006 EU/1/11/732/007 EU/1/11/732/008 EU/1/11/732/009 EU/1/11/732/010 EU/1/11/732/011 EU/1/11/732/012 EU/1/11/732/013 EU/1/11/732/014
Maltese: EU/1/11/732/005 EU/1/11/732/006 EU/1/11/732/007 EU/1/11/732/008 EU/1/11/732/009 EU/1/11/732/010
English: 4042 Debrecen,
Maltese: 4042 Debrecen, L-Ungerija jew
English: Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren
English: OPA/Alu/PVC - Aluminium blisters.
Maltese: Folji tal-aluminju - OPA/Alu/PVC.
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Maltese: Data tal-aħħar tiġdid: 8 ta' Awwissu 2016
English: Pack of 50 x 1 film-coated tablet (unit dose).
Maltese: Pakkett ta' 50 x 1 pillola miksija b'rita (doża waħda).
English: The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.
Maltese: desloratadine kienet proporzjonali mad-doża fuq medda ta' 5 mg sa 20 mg.
English: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Maltese: Hemm esperjenza limitata dwar l-effikaċja fil-provi kliniċi bl-użu ta' desloratadine fl-adoloxxenti li għandhom bejn 12 u 17-il sena (ara sezzjonijiet 4.8 u 5.1).
English: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tiġi stmata mid-dejta disponibbli).
English: There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.
Maltese: akkumulu tal-mediċina li jista' jkollu rilevanza klinika wara li jingħata dożaġġ ta' desloratadine darba kuljum (5 mg sa 20 mg) għal 14-il ġurnata.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1, jew għal loratadine.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi erditarji rari ta' intolleranza għal galactose, deffiċjenza ta' Lapp lactase jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: How to store Desloratadine Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Desloratadine Teva contains lactose.
Maltese: Desloratadine Teva fih il-lactose.
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 għallMediċini. http://www.ema.europa.eu
English: How to take Desloratadine Teva
Maltese: Tiħux Desloratadine Teva
English: Desloratadine Teva is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Maltese: Desloratadine Teva jintuża fl-adulti u fl-adolexxenti minn 12-il sena 'l fuq biex jittaffew is-sintomi assoċjati ma': - rajnajtis allerġiku (ara sezzjoni 5.1)
English: EU/1/11/732/010 60 film-coated tablets
Maltese: EU/1/11/732/014 105 pillol miksija b'rita
English: Desloratadine Teva 5 mg film-coated tablets Desloratadine
Maltese: Desloratadine Teva 5 mg pilloli miksija b'rita Desloratadine
English: In a clinical pharmacology trial, desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Maltese: Fi prova farmakoloġika klinika, pilloli desloratadine li ttieħdu flimkien mal-alkoħol ma żidux l-effetti li jxekklu l-prestazzjoni tal-alkoħol (ara sezzjoni 5.1).
English: The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Maltese: Il-grad ta' akkumulu ta' desloratadine kien jaqbel mal half-life tiegħu (madwat 27 siegħa) u l-frekwenza ta' dożaġġ ta' darba kuljum.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo.
Maltese: bid-doża rakkomandata ta' 5 mg kuljum, l-effetti mhux mixtieqa b'desloratadine kien rappurtati fi 3 % tal-pazjenti aktar minn dawk fuq plaċebo.
English: Other medicines and Desloratadine Teva
Maltese: Mediċini oħra u Desloratadine Teva
English: Tablet core
Maltese: Linka użata
English: Blue, round, biconvex film-coated tablet - printed in with ink: “D5” on one side and plain on the other.
Maltese: Pillola blu, tonda u bikonvessa miksija b'rita - bl-ittri “D5” stampati bil-linka fuq naħa waħda u b'xejn stampat fuq in-naħa l-oħra.
English: In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of desloratadine.
Maltese: Fi studju farmakokinetiku fejn il-karatteristiċi demografiċi tal-pazjenti kienu jaqblu ma' dawk tal popolazzjoni ġenerali b'rajnajtis allerġiku ta' l-istaġun, 4 % tas-suġġetti akkwistaw konċentrazzjoni ogħla ta' desloratadine.
English: In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
Maltese: Fi prova klinika farmakoloġika, li fiha ingħata desloratadine b'doża ta' 45 mg kuljum (disa' darbiet id-doża klinika) għal għaxart ijiem, ma kienx hemm żieda fit-tul ta' l-intervall QTc.
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Maltese: Żjieda fl-enżimi tal-fwied, żieda fil bilirubin, epatite Suffejra
English: Merckle GmbH
Maltese: taħt il-ġilda
English: Headache
Maltese: Bijotraformazzjoni
English: ● stomach ache
Maltese: ● żieda fl-aptit
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Informazzjoni li mhiex klinika magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma turi l-ebda periklu speċjali għall-bnedmin.
English: Desloratadine Teva contains desloratadine which is an antihistamine.
Maltese: Fi studji in vitro, desloratadine wera karatteristiċi kontra l-allerġiji.
English: In clinical studies in adults, side effects were about the same as with a dummy tablet.
Maltese: Fil-provi kliniċi fl-adulti, l-effetti sekondarji kienu rrapportati kważi daqs kemm ikun hemm b'pillola finta.
English: Desloratadine Teva relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Maltese: Desloratadine Teva jtaffi s-sintomi assoċjati ma' rajnajtis allerġiku (infjammazzjoni tal-passaġġi flimnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad-dust mites) fl-adulti u fladolexxenti minn 12-il sena 'l fuq.
English: EU/1/11/732/013 50 x 1 film-coated tablet (unit dose) EU/1/11/732/014 105 film-coated tablets
Maltese: EU/1/11/732/013 50 x 1 pillola miksija b'rita (doża waħda)
English: 50 film-coated tablets
Maltese: ● żieda fil-piż
English: Since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
Maltese: Fi provi kliniċi ta' medda ta' indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika,
English: During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Maltese: Meta Desloratadine Teva tqiegħed fis-suq, ġew irrapportati b'mod rari ħafna każijiet ta' reazzjonijiet allerġiċi serji (affann, ħakk, ħorriqija u nefħa).
English: Adults During the marketing of Desloratadine Teva, the following side effects were reported as:
Maltese: Matul it-tqegħid fis-suq ta' Desloratadine Teva, l-effetti sekondarji li ġejjin ġew irrappurtati bħala:
English: Adults and adolescents 12 years of age and over
Maltese: Adulti u adolexxenti (minn tnax-il sena 'l fuq)
English: 100 film-coated tablets
Maltese: Zieda fil-piż
English: ● slow heartbeat
Maltese: ● infjammazzjoni tal-fwied
English: The efficacy of desloratadine tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Maltese: L-effikaċja tal-pilloli desloratadine ma ntwerietx b'mod ċar fi provi bi pazjenti adolexxenti minn 12 sa
English: ● dizziness
Maltese: ● aċċessjonijiet
English: Desloratadine Teva 5 mg film-coated tablets
Maltese: Desloratadine Teva 5 mg pilloli miksija b'rita
English: The safety and efficacy of Desloratadine Teva 5 mg film-coated tablets in children below the age of 12 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Desloratadine Teva 5 mg pilloli miksija b'rita fit-tfal ta' inqas minn 12-il sena ma ġewx determinati s'issa.
English: Adverse reactions seen with desloratadine
Maltese: Reazzjonijiet avversi osservati b' desloratadine
English: How to store Desloratadine Teva
Maltese: Meta għandu jintuża Desloratadine Teva
English: Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours.
Maltese: Desloratadine jiġi assorbit tajjeb u l-ogħla konċentrazzjoni tinkiseb wara madwar 3 sigħat; il half-life fl-aħħar fażi hija madwar 27 siegħa.
English: OPA/Alu/PVC - Aluminium perforated unit dose blisters.
Maltese: Aqra sew dan il-fuljett kollu qabel tibda tuża din il-mediċina peress li fih informazzjoni importanti għalik.
English: Package leaflet: Information for the patient Desloratadine Teva 5 mg film-coated tablets
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta tat-tabib
English: Jaundice
Maltese: Teva
English: In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms.
Maltese: Minbarra l-klassifikazzjonijiet stabbiliti ta' l-istaġun u perenni, rajnajtis allerġiku jista' minflok ikun klassifikat bħala rajnajtis allerġiku intermittenti u rajnajtis allerġiku persistenti skond kemm idumu ssintomi.
English: In the multiple-dose study, steady state was reached after Day 11, and compared to healthy subjects the exposure to desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in subjects with severe CRI.
Maltese: Jum 11, u mqabbel ma' dak f'individwi f'saħħithom l-esponiment għal desloratadine kien ~1.5 drabi ikbar f'individwi b'CRI minn ħafifa sa moderata u ~2.5 drabi iktar f'individwi b'CRI severa.
English: In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
Maltese: Effikaċja klinika u sigurtà Fi prova klinika b'ħafna dożi, li fiha sa 20 mg desloratadine ingħata kuljum għal 14-il ġurnata, ma kienx hemm effett kardjovaskulari klinikament jew statistikament rilevanti.
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Maltese: Il-frekwenza tar-reazzjonijiet avversi tal-provi kliniċi rrapportati aktar minn dawk ta' plaċebo u effetti mhux mixtieqa oħrajn li ġew rappurtati fil-perijodu ta' wara t-tqegħid fis-suq huma elenkati fit-tabella li ġejja.
English: Desloratadine Teva is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Maltese: Desloratadine Teva jintuża wkoll biex itaffi s-sintomi assoċjati ma' urtikarja (kundizzjoni tal-ġilda ikkawżata minn allerġija).
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine.
Maltese: Tqala Ammont kbir ta' dejta dwar l-użu waqt it-tqala (iktar minn 1,000 riżultat ta' tqala) juri li m'hemm l ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-użu ta' desloratadine.
English: No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Maltese: Ma kienx hemm differenzi sinjifikanti bejn ir-riżultati ta' testijiet psikomotorjali fil-gruppi ta' desloratadine u plaċebo, kemm meta kien mogħti waħdu kif ukoll ma' l-alkoħol.
English: DK-7171 Uldum Denmark
Maltese: DK-7171 Uldum
English: EXP: {MM/YYYY}
Maltese: EXP: {xx/ssss}
English: Musculo-skeletal disorders:
Maltese: Disturbi muskolo-skeletriku :
English: More than 97% of meloxicam is bound to plasma proteins.
Maltese: Iktar minn 97% ta' meloxicam jeħel mal-proteini tal-plażma.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdi (oxicams).
English: 1 ml of solution for injection contains 5 mg of meloxicam.
Maltese: I ml ta' soluzzjoni għall-injezzjonijiet fih 5 mg ta' meloxicam.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi mhux attivi, ara s-sezzjoni 6.1.
English: Lot: {number}
Maltese: {numru}
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 anti-infjammatorja mhux sterojdi (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra t-tnixxija u kontra d-deni.
English: If side effects occur, treatment should be discontinued.
Maltese: Jekk ikun hemm effetti oħra , it-trattament għandu jitwaqqaf.
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Maltese: Studji in vivo u in vitro urew li meloxicam jinibixxi cyclooxygenase-2 (COX-2) b'mod iktar qawwi minn
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (European Medicines Agency) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (European Medicines Agency) http://www.ema.europa.eu/.
English: Flexicam 5 mg/ml solution for injection for dogs and cats
Maltese: Flexicam 5 mg/ml soluzzjoni għall-injezzjoni għal klieb u qtates
English: Dogs:
Maltese: Qtates:
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Maltese: Wara l-għoti taħt il-ġilda, meloxicam hu kompletament bijodisponibbli, u l-ogħla medja ta' konċentrazzjonijiet fil-plażma ta' 0.73 g/ml, fil-klieb u 1.1 g/ml fil-qtates intlaħqu wara madwar 2.5 sigħat u 1.5 sigħat wara l-għoti rispettivament.
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi tal-mediċini NSAIDs bħal nuqqas t'aptit, rimettar, dijarea, demm moħbi fl-ippurgar u apatija kienu rrappurtati.
English: Musculo-skeletal disorders: single subcutaneous injection.
Maltese: Disturbi muskolu-skeletriku: injezzjoni waħda taħt il-ġilda.
English: SPECIAL STORAGE PRECAUTIONS
Maltese: Kategorija farmakoterapewtika:
English: Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Maltese: Madwar 75% tad-doża li tingħata titneħħa fl-ippurgar, u l-bqija fl-awrina.
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
Maltese: Biex itaffi l-uġigħ ta' wara l-operazzjoni fil-qtates, is-sigurtà kienet dokumentata biss wara loppju b'thiopental/halothane.
English: When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Maltese: Meta l-loppju u NSAID jingħataw flimkien, ma jistax jiġi eskluż li jista' jkun hemm riskju għall-funzjoni
English: Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip-off aluminium violet seal.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġietx stabbilita waqt it-tqala u fi żmien il-ħalib.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
Maltese: U L-UŻU, jekk applikabbli
English: Name and address of the manufacturers responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott