FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Nasym?
Maltese: X'inhuma r-riskji assoċjati ma' Nasym?
English: The effectiveness of Nasym has been shown in 7 laboratory studies in which vaccination of cattle with Nasym, either using the nasal spray route or injection into the muscle, reduced both shedding of virus and signs of respiratory disease, such as increased rate of breathing, difficulty in breathing and watery or mucky eyes.
Maltese: L-effettività ta' Nasym intweriet f'7 studji tal-laboratorju fejn it-tilqim tal-frat b'Nasym, jew permezz ta' sprej nażali jew b'injezzjoni ġol-muskolu, naqqas kemm it-tixrid tal-virus kif ukoll is-sinjali ta' mard respiratorju, bħal żieda fir-rata ta' teħid tan-nifs, diffikultà fit-teħid tan-nifs u għajnejn idemmgħu jew iwaħħlu.
English: Nasym reduces shedding of virus and respiratory signs such as raised breathing rate, difficulty breathing, watery eyes and runny nose.
Maltese: Nasym inaqqas it-tixrid tal-virus u sinjali respiratorji bħal rata għolja ta' teħid tan-nifs, diffikultà fit-teħid tan-nifs, għajnejn idemmgħu u mnieħer iqattar.
English: For the full list of side effects and restrictions of Nasym, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Nasym, ara l-fuljett ta' tagħrif.
English: These studies involved non-vaccinated animals given a dummy vaccination and all animals were artificially exposed to bovine respiratory syncytial virus.
Maltese: Dawn l-istudji involvew annimali mhux imlaqqma li ngħataw tilqima finta u l-annimali kollha ġew esposti b'mod artifiċjali għall-virus sinktjali respiratorju bovin.
English: Why is Nasym authorised in the EU?
Maltese: Għaliex Nasym huwa awtorizzat fl-UE?
English: Other information about Nasym
Maltese: Informazzjoni oħra dwar Nasym
English: When the animal comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Maltese: Meta l-annimal jerġa' jiġi f'kuntatt ma' dan il-virus jew wieħed simili, dawn l-antikorpi flimkien ma' komponenti oħra tas-sistema immunitarja se jkunu kapaċi joqtlu l-virusis u jgħinu biex jipproteġu kontra l-marda.
English: Revaccination is given by injection into the muscle 2 months after the initial vaccination and then every 6 months.
Maltese: Il-vaċċin jibda jkun effettiv 3 ġimgħat wara t-tilqima ġolmuskolu u l-protezzjoni ddum 6 xhur.
English: For cattle from 9 days of age, the vaccine is sprayed into each of the animal's nostrils using an intranasal applicator.
Maltese: Għal frat mill-età ta' 9 ijiem, il-vaċċin jiġi sprejjat f'kull waħda mill-imnifsejn tal-annimal billi jintuża applikatur intranażali.
English: What is the withdrawal period in food-producing animals?
Maltese: X'inhu l-perjodu ta' tiżmim f'annimali li jipproduċu l-ikel?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi "jgħallmu" lis-sistema immunitarja (id-difiżi naturali talġisem) kif tiddefendi ruħha kontra marda.
English: The most common side effect with Nasym (which may affect up to 1 in 10 animals) is a slight change in the consistency of the faeces.
Maltese: L-effett sekondarju l-aktar komuni b'Nasym (li jista' jaffettwa sa annimal 1 minn kull 10) huwa bidla żgħira fil-konsistenza tal-ippurgar.
English: How does Nasym work?
Maltese: Kif jaħdem Nasym?
English: The studies confirmed the vaccine starts to be effective 3 weeks after both nasal vaccination and injection into the muscle, with effectiveness lasting 2 months after nasal vaccination and 6 months after injection into the muscle.
Maltese: L-istudji kkonfermaw li l-vaċċin jibda jkun effettiv 3 ġimgħat kemm wara t-tilqima nażali kif ukoll wara l-injezzjoni ġol-muskolu, bleffettività li ddum xahrejn wara t-tilqima nażali u 6 xhur wara l-injezzjoni ġol-muskolu.
English: 5531 AE Bladel THE NETHERLANDS
Maltese: 5531 AE Bladel, L-OLANDA
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Maltese: Meloxicam jiġi eliminat b'half-life terminali ta' 7.7 sigħat.
English: 6.1 List of excipients - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Sodium hydroxide - Hydrochloric acid, concentrated - Meglumine - Water for injections
Maltese: - Ethanol (96%) - Poloxamer 188 - Macrogol 400 - Glycine - Sodium hydroxide - Hydrochloric acid - Meglumine - Ilma għall-injezzjoni
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Zoetis Belgium SA
English: PHARMACEUTICAL FORM Oral suspension
Maltese: Suspensjoni orali
English: Saccharin sodium Carmellose sodium Silica, colloidal anhydrous Citric acid monohydrate Sorbitol, liquid (non-crystallising) Disodium phosphate dodecahydrate Sodium benzoate
Maltese: Saccharin Sodium Sodium Carboxyl Methyl Cellulose Colloidal Silicon Dioxide Citric Acid Monohydrate Sorbitol Solution
English: This was observed in less than 10% of the cattle treated in clinical studies.
Maltese: Dan ġie osservat f'inqas minn 10% tal-baqar ikkurati fi studji kliniċi.
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite.
Maltese: 5-hydroxy- u 5-carboxy u l-metabolit oxalyl.
English: BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT Lot{numru}
English: See also section 4.7.
Maltese: 4.3 Kontraindikazzjonijiet Ara wkoll sezzjoni 4.7.
English: For Contacera 20 mg/ml only: Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, THE NETHERLANDS
Maltese: Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, L-OLANDA
English: The active substance in Contacera is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Maltese: Is-sustanza(i) attiva(i) f'Contacera hija sustanza(i) ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15/02/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 15/02/2014
English: For example, a horse weighing 400 kg will receive 16 ml of Contacera, a horse weighing 500 kg will receive 20 ml of Contacera, and a horse weighing 600 kg will receive 24 ml of Contacera.
Maltese: Per eżempju, żiemel li jiżen 400 kg se jirċievi 16 ml ta' Contacera, żiemel li jiżen 500 kg se jirċievi 20 ml ta' Contacera, u żiemel li jiżen 600 kg se jirċievi 24 ml ta' Contacera.
English: Meloxicam 20 mg Ethanol (96%) 159.8 mg Clear, yellow solution.
Maltese: Meloxicam 20 mg Ethanol (96%) 159.8 mg
English: Milk: 5 days
Maltese: Ħalib: 5 ijiem
English: Date of last renewal: {DD/MM/YYYY}
Maltese: Data tal-aħħar tiġdid: {JJ/XX/SSSS}
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/12/2012
Maltese: Data tal-ewwel awtorizzazzjoni: 06/12/2012 Data tal-aħħar tiġdid: {JJ/XX/SSSS}
English: All major metabolites have been shown to be pharmacologically inactive.
Maltese: Intwera li l metaboliti prinċipali kollha huma farmakoloġikament inattivi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle:
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Baqar:
English: Sodium benzoate
Maltese: Sodium benzoate 5 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses meloxicam
Maltese: VETERINARJU Contacera 15 mg/ml suspensjoni orali għaż-żwiemel meloxicam
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritisagalactia syndrome) with appropriate antibiotic therapy.
Maltese: Għal terapija addizzjonali fit-trattament ta' settiċemija puwerperali u tossemija (sindromu mastite-metrite agalaktja) flimkien ma' terapija antibijotika adattata.
English: Eurovet Animal Health B.V. Handelsweg 25
Maltese: Għal Contacera 20 mg/ml biss: Eurovet Animal Health B.V. Handelsweg 25,
English: This is equivalent to 1 ml of Contacera per 25 kg body weight of horse.
Maltese: Dan huwa ekwivalenti għal 1 ml ta' Contacera għal kull 25 kg ta' piż tal-ġisem taż-żwiemel.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Meloxicam 20 mg/ml
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
Maltese: Prodotti antiinfjammatorji u antirewmatiċi, mhux sterojdiċi (oxicams).
English: Muscle Liver Kidney
Maltese: Is-sintomi kienu riversibbli.
English: Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.
Maltese: Numru massimu ta' fetħiet huwa ta' 14 għal tappijiet tal-20 ml, 50 ml u 100 ml u 20 għal tapp tal-250 ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses
Maltese: VETERINARJU Contacera 15 mg/ml suspensjoni orali għaż-żwiemel
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Maltese: Baqar: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem
English: Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Maltese: Suspensjoni orali biex tingħata f'dożaġġ ta' 0.6 mg / kg ta' piż tal-ġisem, darba kuljum, sa 14-il jum.
English: STATEMENT OF ACTIVE SUBSTANCES Meloxicam 15 mg/ml
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI Meloxicam 15 mg/ml
English: Horses:
Maltese: Teл:
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Maltese: thromboxane B2 ikkaġunata mill-għoti ġol-vina ta' E. coli endotoxin fl-għoġġiela u fil-majjali.
English: IM injection.
Maltese: Injezzjoni ġol-vini.
English: TARGET SPECIES Horses.
Maltese: Kodici ATC veterinarja:
English: Meloxicam is a NSAID of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Maltese: Meloxicam hu NSAID tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, kontra t-tnixxija, analġesiċi u antipiretiċi.
English: 4.9 Amounts to be administered and administration route Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.
Maltese: 4.9 Ammont li jingħata u l-metodu ta' amministrazzjoni Numru massimu ta' fetħiet huwa ta' 14 għat-tapp tal-20 ml, 50 ml u 100 ml u 20 għat-tapp tal-250 ml.
English: Laboratory studies in cattle have not produced any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Maltese: Studji fil-laboratorju fil-baqar ma pproduċew l-ebda evidenza ta' effetti teratoġeniċi, fetotossiċi jew maternotossiċi.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values 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.
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
Maltese: F'każijiet rari ħafna ġew irrappurtati nuqqas ta' aptit, letarġija, uġigħ addominali u kolite.
English: 15 μg/kg Milk
Maltese: 15 mg/ml
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan liskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effett(i) mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: PACKAGE LEAFLET: Contacera 15 mg/ml oral suspension for horses
Maltese: Contacera 15 mg/ml suspensjoni orali għaż-żwiemel
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodi ta' tiżmim
English: STATEMENT OF ACTIVE SUBSTANCES Meloxicam 20 mg/ml
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI Meloxicam 20 mg/ml
English: Honey flavoured, off-white to yellow viscous oral suspension.
Maltese: Offwajt għal isfar, għasel togħma, suspensjoni orali viskużi
English: MANUFACTURER'S BATCH NUMBER Lot:{number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Maltese: Wara l-għoti ta' żewġ dożi fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.9 μg/ml fi żmien siegħa fil-majjali.
English: 5 mg. For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Treatment of calves with Contacera 20 minutes before dehorning reduces post-operative pain.
Maltese: Trattament ta' għoġġiela b'Contacera 20 minuta qabel it-tneħħija tal-qrun tnaqqas l-uġigħ ta' wara loperazzjoni.
English: IV injection.
Maltese: Injezzjoni ġol-vina.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'dożaġġ ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.5 ml / 100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skont kif ikun xieraq.
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm reazzjonijiet mhux mixtieqa, it-trattament għandu jitwaqqaf u għandu jittieħed il-parir ta' veterinarju.
English: Meat and offal: 5 days
Maltese: Majjali: Laħam u ġewwieni tal-annimali: 5 ijiem
English: In very rare cases, adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Maltese: F'każijiet rari ħafna reazzjonijiet avversi li ġeneralment huma assoċjati ma' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Excipient: Sodium benzoate
Maltese: PARIR SABIEX
English: 4.8 Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other Non-Steroidal Anti-Inflammatory Drugs or with anticoagulant agents.
Maltese: .8 Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni M'għandux jingħata flimkien ma' glukokortikosterojdi, sustanzi oħrajn mhux sterojdiċi u antiinfjammatorji jew ma' mediċini antikoagulanti.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolemiku jew ipotensiv, għax hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: Cardboard box containing one colourless glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett tal-ħġieġ bla kulur wieħed għall-injezzjoni, li jkun fih 20 ml, 50 ml, 100 ml jew 250 ml.
English: Pharmacologically active substance
Maltese: farmakoloġika ment attiva(i)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses
Maltese: VETERINARJU Contacera 20 mg/ml soluzzjoni għall-injezzjoni għal baqar, majjali u żwiemel.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: FIL-PAKKETT Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu).
English: België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.
Maltese: Suomi/Finland Zoetis Finland Oy Puh/Tel:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/144/005 100 ml
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/12/144/005 100 ml
English: Shelf- life after first opening the container: 3 months.
Maltese: Laħam u ġewwieni tal-annimali: 3 ijiem.
English: Antiinflammatory agents/Nonster oidal antiinflammatory agents
Maltese: Prodotti antiinfjammatorji u anti-rewmatiċi, mhux sterojdiċi
English: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve,
English: Equidae
Maltese: Żwiemel
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label for 50 ml, 100 ml and 250 ml
Maltese: Tikketta għal fliexken ta' 50 ml, 100ml u 250ml
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Maltese: Injezzjoni waħda fil-muskolu b'dożaġġ ta' 0.4 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 100 ml or 250 ml bottle
Maltese: Tikketta għal flixkun ta' 100ml u 250ml
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 colourless glass vial containing 20 ml, 50 ml, 100 ml or 250 ml.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mall-prodott Kaxxa tal-kartun b'kunjett tal-ħġieġ bla kulur wieħed għall-injezzjoni, li jkun fih 20 ml, 50 ml, 100 ml jew 250 ml.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose, symptomatic treatment should be initiated.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn
English: Bovine, caprine
Maltese: Baqar Kaprini
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 20 ml, 50 ml, 100 ml and 250 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna għal fliexken 20 ml, 50 ml, 100 ml jew 250 ml
English: Cardboard box containing one HDPE bottle of 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Maltese: Kaxxa tal-kartun fiha flixkun HDPE waħda ta' 100 jew 250 ml u tapp li jirreżisti tbagħbis u l-ftuħ mit-tfal żgħar u siringa tal-kejl tal-polypropylene.
English: The volume of distribution is 0.12 l/kg.
Maltese: 12 l/kg.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Maltese: Meloxicam Meloxicam Baqar Kaprini
English: Manufacturers responsible for batch release:
Maltese: MOD(I) TA' AMMINISTRAZZJONI Baqar:
English: Via della Chimica, 9 I-36100 Vicenza(VI) Italy
Maltese: Via della Chimica, 9 I-36100 Vicenza(VI) L-Italja
English: paroxetine, venlafaxine, St. John's Wort)
Maltese: (bħal fluoxetine, paroxetine, venlafaxine, St John's Wort)
English: Contains fructose, sucrose, E218, and E216.
Maltese: Għandu fructose, sucrose, E218, u E216.
English: Extrapyramidal symptoms (EPS)
Maltese: Sintomi ekstrapiramidali (EPS)
English: The absolute oral bioavailability of the tablet formulation is 87 %.
Maltese: Il bijodisponibbilità orali assoluta tal-formolazzjoni tal-pillola hija ta' 87 %.
English: 14 × 1 tablets 28 × 1 tablets 49 × 1 tablets 56 × 1 tablets 98 × 1 tablets
Maltese: 14 × 1 pilloli 28 × 1 pilloli 49 × 1 pilloli 56 × 1 pilloli 98 × 1 pilloli
English: • nervousness,
Maltese: • nervożiżmu,
English: ABILIFY contains parahydroxybenzoates
Maltese: ABILIFY fih parahydroxybenzoates
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate
Maltese: Hydroxypropyl cellulose Magnesium stearate
English: Vistor hf. Sími: +354 (0) 535 7000
Maltese: Sími: +354 (0) 535 7000
English: Oral solution 50 mL oral solution 150 mL oral solution 480 mL oral solution
Maltese: Soluzzjoni orali 50 mL soluzzjoni orali 150 mL soluzzjoni orali 480 mL soluzzjoni orali
English: Lactose monohydrate Maize starch
Maltese: Il-qalba tal-pillola Lactose monohydrate Maize starch
English: ABILIFY contains fructose and sucrose
Maltese: ABILIFY fih fructose u sucrose
English: Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
Maltese: aripiprazole + lithium; aripiprazole + valproate, plaċebo + lithium; plaċebo + valproate.
English: Vanilla flavour (including vanillin, ethyl vanillin and lactose) Tartaric acid
Maltese: Togħma ta' vanilla (inklużi vanillin, ethyl vanillin u lactose)
English: Agitation
Maltese: Disturbi
English: • selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
Maltese: • inibituri selettivi tat-teħid mill-ġdid ta' serotonin (SSRIs) (bħal paroxetine u fluoxetine) użati għal depressjoni, OCD, paniku u ansjetà
English: ABILIFY contains aspartame
Maltese: ABILIFY fih aspartame
English: Hyponatremia Anorexia
Maltese: Iponatremija Anoreksja
English: Rhabdomyolysis Myalgia
Maltese: Rabdomijoliżi Mijalġja
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1 %; 30 mg, 28.8 %; placebo, 1.7 %); and akathisia (incidences were 10 mg, 12.1 %; 30 mg, 20.3 %; placebo, 1.7 %).
Maltese: Dawn ir-reazzjonijiet avversi kellhom relazzjoni possibbli mar-rispons tad-doża; disturb ekstrapiramidali (l-inċidenzi kienu 10 mg, 9.1 %; 30 mg, 28.8 %; plaċebo, 1.7 %); u akatisija (linċidenzi kienu 10 mg, 12.1 %; 30 mg, 20.3 %; plaċebo, 1.7 %).