FrancophonIA/ELRC3.0 huggingface dataset:
English: - certain antiretrovirals (used to treat HIV infection) such as ritonavir, nelfinavir or indinavir as they may increase the effects of this medicine.
Maltese: - ċertu antiretrovirali (jintużaw biex jittrattaw infezzjonijiet tal-HIV) bħal ritonavir, nelfinavir, indinavir, għax jistgħu jżidu l-effetti ta' din il-mediċina.
English: Buvidal contains the active substance buprenorphine, which is a type of opioid medicine.
Maltese: Buvidal fih is-sustanza attiva buprenorphine, li hija tip ta' mediċina tal-opjojdi.
English: Erythema
Maltese: Rinite
English: Sweden
Maltese: Deni
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: Medja LS (%) (SE)
English: QT prolongation
Maltese: Titwil tal-QT
English: Uncommon Not known
Maltese: Komuni ħafna Komuni
English: Buvidal is intended for subcutaneous administration only.
Maltese: Buvidal hu biex jintuża darba biss.
English: Dysmenorrhoea
Maltese: N-Methylpyrrolidone
English: Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or thromboembolic events.
Maltese: Intravaskulari bħal injezzjoni ġol-vini toħloq riskju ta' ħsara serja għax Buvidal jifforma massa solida hekk kif imiss ma' fluwidi tal-ġisem, li jista' potenzjalment jikkawża ħsara fil-vina/arterja tad-demm, okklużjoni, jew avvenimenti tromboemboliċi.
English: Lacrimal disorder Mydriasis Miosis
Maltese: Jekk tuża buprenorphine aktar milli suppost
English: Vascular disorders
Maltese: Problemi fid-diskors
English: 1.2-fold increase
Maltese: Żieda ta' 1.2 darbiet iktar
English: diarrhoea - Rash, itching, hives - Joint pain, back pain, muscle pain, muscle spasms, neck pain, bone pain - Painful period - Injection site reactions e.g. pain, itching, red skin, swelling and hardening of skin, swelling of the ankles, feet or fingers, weakness, feeling unwell, fever, chills, drug withdrawal syndrome in the new-born, chest pain - Abnormal liver test results
Maltese: Buprenorphine għandu jintuża b'kawtela f'pazjenti b'insuffiċjenza respiratorja (eż. mard pulmonari ostruttiv kroniku, ażżma, cor pulmonale, tnaqqis fir-riserva respiratorja, ipossija, iperkapnija, tnaqqis respiratorju li kien jeżisti minn qabel jew kifoskoljożi).
English: Buvidal avoids first-pass effects and CYP3A4 inducers (e.g. phenobarbital, carbamazepine, phenytoin or rifampicin) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.
Maltese: - ċertu mediċini antiepilettiċi (jintużaw biex jittrattaw l-epilessija) bħal phenobarbital, carbamazepine u phenytoin, għax jistgħu jnaqqsu l-effett ta' Buvidal. - rifampicin (jintuża biex jittratta t-tuberkulożi).
English: 2.8-fold increase
Maltese: GĦALL-ĦRUĠ TAL
English: Efficacy variables in a pivotal phase 3, randomised, double-blind, doubledummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence
Maltese: L-elementi varjabbli tal-effikaċja fi studju kruċjali ta' fażi 3 b'doża flessibbli, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, double-dummy, ikkontrollat b'mod attiv, li sar fuq pazjenti b'dipendenza fuq l-opjojdi moderata sa severa
English: Injection site mass Oedema peripheral Asthenia
Maltese: Edema periferali
English: Pre-filled syringes containing 8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg and 128 mg solution for injection.
Maltese: Buvidal 8 mg, 16 mg, 24 mg u 32 mg jingħataw kull ġimgħa.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) (see section 4.5) or other opioids.
Maltese: Ġew irrappurtati wkoll imwiet b'rabta mal-għoti fl-istess ħin ta' buprenorphine u depressanti oħrajn bħallalkoħol, gabapentinoids (bħal pregabalin u gabapentin) (ara sezzjoni 4.5) jew opjojdi oħrajn.
English: After
Maltese: ISEM
English: Cough Dyspnoea Yawning Asthma Bronchitis
Maltese: Jekk tieqaf tuża Buvidal
English: Buvidal 16 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 16 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
English: Rash Pruritus Urticaria
Maltese: Dispepsja Ħalq xott Dijarea
English: The needle shield of the safety syringe may contain rubber latex that may cause allergic reactions in latexsensitive individuals.
Maltese: Il-protezzjoni tal-labra tas-siringa tas-sigurtà jista' jkun fiha lastku tat-tip latex li jista' jikkawża reazzjonijiet allerġiċi f'individwi sensittivi għal-latex.
English: Buvidal 32 mg prolonged-release solution for injection buprenorphine
Maltese: IL-PRODOTT MEDIĊINALI Buvidal 32 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
English: - Drowsiness: This medicine may cause drowsiness especially when used with alcohol or other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, other medicines that reduce anxiety or cause sleepiness, pregabalin or gabapentin.
Maltese: - Ngħas: Din il-mediċina tista' tikkawża n-ngħas speċjalment meta tintuża mal-alkoħol jew depressanti oħrajn tas-sistema nervuża (sustanzi li jnaqqsu r-rata tal-attività tal-moħħ) bħal benzodiazepines, mediċini oħra li jnaqqsu l-ansjetà jew iqabbduk in-ngħas, pregabalin jew gabapentin.
English: • For patients receiving methadone, the methadone dose should be reduced to a maximum of 30 mg/day before starting treatment with Buvidal which should not be administered until at least 24 hours after the patient last received a methadone dose.
Maltese: • Għal pazjenti li jkunu qed jirċievu l-methadone, id-doża ta' methadone għandha titnaqqas għal massimu ta' 30 mg/jum qabel ma jinbeda t-trattament b'Buvidal, li m'għandux jingħata sa millinqas 24 siegħa wara li l-pazjent ikun irċieva l-aħħar doża ta' methadone.
English: Overall, buprenorphine plasma exposure increased approximately 3-fold in subjects with severely impaired hepatic function (see sections 4.2, 4.3 and 4.4).
Maltese: B'kollox, l-esponiment ta' buprenorphine fil-plażma żdied b'madwar 3 darbiet f'pazjenti b'funzjoni tal-fwied li kienet indebolita b'mod sever (ara sezzjoni 4.2, 4.3 u 4.4).
English: Lymphadenopathy
Maltese: Artralġja
English: Undesirable effects were based on the known pharmacological activity of buprenorphine.
Maltese: L-effetti mhux mixtieqa kienu bbażati fuq l-attività farmakoloġika magħrufa ta' buprenorphine.
English: Conversely, if a patient who is concomitantly treated with Buvidal and a CYP3A4 inducer stops treatment with the CYP3A4 inducer, the patient should be monitored for symptoms of overtreatment.
Maltese: Min-naħa l-oħra, jekk pazjent li jkun qed jiġi ttrattat b'Buvidal u induttur ta' CYP3A4 fl-istess ħin iwaqqaf it-trattament bl-induttur ta' CYP3A4, il-pazjent għandu jkun immonitorjat għal sintomi ta' trattament żejjed.
English: Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse.
Maltese: Għalhekk, id-dożaġġi jridu jiġu mmonitorjati mill-qrib, u din il-kombinazzjoni trid tiġi evitata f'każijiet fejn ikun hemm riskju ta' użu ħażin.
English: When initiating treatment with buprenorphine, it is important to be aware of the partial agonist profile of buprenorphine.
Maltese: Meta jinbeda t-trattament b'buprenorphine, huwa importanti li wieħed ikun konxju mill-profil talagonist parzjali ta' buprenophine.
English: Supplemental dosing
Maltese: Disturbi epatobiljari
English: Buprenorphine is extensively metabolised in the liver.
Maltese: Buprenorphine huwa metabolizzat b'mod estensiv fil-fwied.
English: Use of an opioid antagonist (i.e. naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioids.
Maltese: Hu rakkomandat l-użu ta' antagonist talopjojdi (i.e. naloxone), minkejja l-effett modest li jista' jkollu biex ireġġa' lura s-sintomi respiratorji ta' buprenorphine meta mqabbel mal-effetti tiegħu fuq sustanzi li huma agonisti kompleti tal-opjojdi.
English: The 8 mg, 16 mg, 24 mg and 32 mg strengths contain small amounts of ethanol (alcohol), less than 100 mg per dose.
Maltese: Il-qawwiet ta' 8 mg, 16 mg, 24 mg u 32 mg fihom ammonti żgħar ta' etanol (alkoħol), anqas minn 100 mg għal kull doża.
English: Rash macular
Maltese: kull xahar biss).
English: 2040 / Budaörs Hungary
Maltese: 2040 / Budaörs
English: Roche Hungary Ltd Edison ut 1
Maltese: L-Ungerija Roche Hungary Ltd Edison ut 1
English: Domaniewska 39B 02-672 / Warsaw Poland
Maltese: Ul. Domaniewska 39B 02-672 / Warsaw Poland
English: Roche (Hellas) SA 4, Alamanas & Delfon Str. Maroussi 15125
Maltese: Roche (Hellas) SA 4, Alamanas & Delfon Str.
English: Czech Republic Roche s.r.o.
Maltese: Roche s.r.o.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Germany
Maltese: Il-Ġermanja Roche Pharma AG Emil-Barell-Strasse 1
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT(I), ID-DETENTUR TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID
English: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna Austria
Maltese: A - 1211 Vienna
English: Ul.
Maltese: L-Italja
English: Protection lasts for one year.
Maltese: Il-protezzjoni ddum isservi sena.
English: Vaccination may be followed by a small local swelling at the injection site (up to 24 cm2) for a short period (up to two weeks).
Maltese: Wara t-tilqima jista' jkun hemm nefħa lokali żgħira fis-sit tal-injezzjoni (sa 24 cm2) għal perjodu qasir (sa ġimagħtejn).
English: In 2014 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR Alsap 2-4 to convert to a normal status.
Maltese: Fl-2014 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' BTVPUR AlSap 2-4 ikollha status normali.
English: Bluetongue vaccine serotype 2 and 4
Maltese: Vaċċin kontra l-Ilsien Blu (Bluetongue) serotipi 2 u 4
English: Animals may show a slight rise in body temperature, normally no more than 1.1°C on average, in the 24 hours following vaccination.
Maltese: L-annimali jistgħu juru żieda żgħira fit-temperatura tal-ġisem, normalment mhux aktar minn 1.1°C bħala medja, fl-24 siegħa ta' wara t-tilqima.
English: BTVPUR AlSap 2-4 contains bluetongue viruses of two types (serotypes 2 and 4).
Maltese: BTVPUR AlSap 2-4 fih ukoll virusijiet tal-ilsien blu ta' żewġ tipi (serotipi 2 u 4).
English: The virus exists in several forms (serotypes) throughout the world; the types used in BTVPUR Alsap 2-4 are serotypes 2 and 4.
Maltese: Il-virus jeżisti f'diversi forom (serotipi) fid-dinja kollha; it-tipi użati f'BTVPUR Alsap 2-4 huma s-serotipi 2 u 4.
English: The CVMP concluded that the benefits of BTVPUR AlSap 2-4 exceed the risks for active immunisation of sheep to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotypes 2 and 4, and recommended that BTVPUR AlSap 2-4 be given marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' BTVPUR AlSap 2-4 jisbqu r-riskji għal immunizzazzjoni attiva tannagħaġ għall-prevenzjoni ta' infezzjoni, viremija u sinjali kliniċi kkawżati mill-virus tal-ilsien blu serotipi 2 u 4, u rrakkomanda li BTVPUR AlSap 2-4 għandu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 2-4 on 5 November 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal BTVPUR Alsap 2-4 valida flUnjoni Ewropea kollha fil-5 ta' Novembru 2010.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (idrossidu tal-aluminju u saponin) biex jistimula rispons aħjar.
English: BTVPUR ALSap 2-4 is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: BTVPUR AlSap 2-4 jintuża fin-nagħaġ sabiex jipproteġihom kontra l-marda tal-ilsien blu, infezzjoni kkawżata mill-virus tal-ilsien blu trażmess mill-insetti dipteri.
English: Other information about BTVPUR AlSap 2-4:
Maltese: Informazzjoni oħra dwar BTVPUR AlSap 2-4:
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Ilbilanċ ta' benefiċċju-riskju jista' jinsab fil-modulu tad-diskussjoni xjentifika f'dan l-EPAR.
English: In the future, if the animals are exposed to bluetongue virus, the immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-virus tal-ilsien blu, is-sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
English: Results also from a series of laboratory safety trials performed with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 or different bluetongue serotypes were presented in order to extrapolate safety conclusions.
Maltese: Ġew ippreżentati wkoll riżultati minn serje ta' provi fil-laboratorju dwar is-sigurtà li saru b'vaċċini ta' kompożizzjoni simili iżda li inkludew serotip wieħed biss mit-tnejn ta' BTVPUR AlSap 2-4 jew serotipi differenti tal-ilsien blu sabiex jiġu estrapolati konklużjonijiet dwar is-sigurtà.
English: The injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal is likely to have inherited antibodies against the virus from a mother that is already immune to the disease.
Maltese: L-injezzjoni tingħata minn età ta' xahar f'annimali li qatt ma jkunu ġew esposti għall-marda, u minn età ta' xaharejn u nofs jekk lannimal ikun wiret antikorpi kontra l-virus minn omm li tkun diġà immuni għall-marda.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni dwar ir-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is BTVPUR AlSap 2-4?
Maltese: X'inhu BTVPUR AlSap 2-4?
English: It is available as a suspension for injection that contains inactivated (killed) bluetongue serotype 2 and 4 viruses.
Maltese: Jiġi bħala sospensjoni għal injezzjoni li fiha virusijiet inattivati (maqtulin) tal-ilsien blu serotipi 2 u 4.
English: The safety and effectiveness studies showed that the vaccine is safe for sheep and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 2 and 4.
Maltese: L-istudji dwar is-sigurtà u l-effikaċja wrew li l-vaċċin huwa sigur għan-nagħaġ u li jnaqqas is-sinjali talmarda u jipprevjeni l-viremija fl-annimali minn età ta' xahar li jkunu infettati bil-virus tal-ilsien blu serotipi 2 u 4.
English: The safety of the vaccine was studied in an overdose laboratory safety study carried out with BTVPUR AlSap 2-4 in sheep.
Maltese: Is-sigurtà tal-vaċċin ġiet studjata fi studju fil-laboratorju dwar is-sigurtà f'dożi eċċessivi li sar b'BTVPUR AlSap 2-4 fin-nagħaġ.
English: BTVPUR ALSap 2-4 is a vaccine.
Maltese: BTVPUR ALSap 2-4 huwa vaċċin.
English: BTVPUR AlSap 2-4 is a vaccine.
Maltese: BTVPUR AlSap 2-4 huwa vaċċin.
English: BTVPUR AlSap 2-4 was initially authorised under ‘exceptional circumstances'.
Maltese: Għall-ewwel BTVPUR AlSap 2-4 ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: What is the risk associated with BTVPUR AlSap 2-4?
Maltese: X'riskji huma assoċjati ma' BTVPUR AlSap 2-4?
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan ilprodott tinsab fuq it-tikketta/il-pakkett ta' barra.
English: Two more laboratory studies with BTVPUR AlSap 2-4 were presented to support the efficacy of the vaccine.
Maltese: Ġew ippreżentati żewġ studji oħra fil-laboratorju b'BTVPUR AlSap 2-4 biex jappoġġaw l-effikaċja tal-vaċċin.
English: In both studies lambs were exposed to either bluetongue virus serotype 2 or bluetongue virus serotype 4, 12 months after vaccination.
Maltese: Fiż-żewġ studji, il-ħrief kienu esposti għas-serotip 2 jew għas-serotip 4 tal-virus tal-ilsien blu, 12-il xahar wara t-tilqima.
English: How has BTVPUR AlSap 2-4 been studied?
Maltese: Kif ġie studjat BTVPUR AlSap 2-4?
English: ATC-vet: QM01AC06.
Maltese: QM01AC06.
English: Sodium benzoate (E 211)
Maltese: Benżoat tas-Sodju (E 211)
English: See also section 4.7.
Maltese: Ara ukoll sezzjoni 4.7.
English: Date of first authorisation: 15.01.2007 Date of last renewal: 19.12.2011
Maltese: Data tal-aħħar tiġdid: 19.12.2011
English: Five major metabolites have been identified.
Maltese: Ħames metaboliti ġew identifikati.
English: Lot {number}
Maltese: NUMRU TA' LOTT Lot {numru}
English: Chronic musculo-skeletal disorders:
Maltese: Disturbi muskoluskeletrali kroniċi:
English: Horses: See section "Contraindications".
Maltese: Ara sezzjoni “Kontraindikazzjonijiet”.
English: Overdose (symptoms, emergengy procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: Ethanol, anhydrous Poloxamer 188
Maltese: Alkoħol etiliku anidru Poloxamer 188
English: Très le Bois - 22600 Loudéac - France Vetem SpA - Lungomare Pirandello, 8 - 92014 Porto Empedocle (AG) - Italy
Maltese: Loudéac - Franza Vetem SpA - Lungomare Pirandello, 8 - 92014
English: The active substance in Meloxidyl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Meloxidyl hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Reduction of post-operative pain (over a period of 24 hours):
Maltese: Tnaqqis ta' wġigħ ta' wara l-operazzjoni (tul perjodu ta' 24 siegħa):
English: Sodium chloride Sodium hydroxide Water for injection
Maltese: Sodium Chloride Sodium hydroxide Ilma għall-injezzjoni
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Maltese: Meloxicam hi metabolizzata għal alkoħol, derivattiv tal-aċidu u għal diversi metaboliti polari.
English: 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).
Maltese: L-iskoperta tal-metaboliti mill-kompost prinċipali tal-awrina u ħmieġ tal-imsaren, imma mhux fil-plażma hi indikattiva għall-eliminazzjoni rapida. 21% tad-doża irkuprata hi eliminate fl-awrina (2% bħala meloxicam mhux mibdul, 19% bħala metaboliti) u 79% fil-ħmieġ tal-imsaren (49% bħala meloxicam mhux mibdul, 30% bħala metabolites).
English: Ceva Santé Animale - Z.I Très le Bois - 22600 Loudéac - France
Maltese: Ceva Santé Animale - Z.I Très le Bois - 22600
English: Meloxidyl 1.5 mg/ml - Meloxidyl 5 mg/ml - Meloxidyl 0.5 mg/ml Not applicable
Maltese: Meloxidyl 1.5 mg/ml - Meloxidyl 5 mg/ml - Meloxidyl 0.5 m/l Mhux applikabbli
English: Meloxidyl 1.5 mg/ml oral suspension for dogs.
Maltese: VETERINARJU Meloxidyl 1.5 mg/ml oral suspension for dogs.
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritisagalactia syndrome) with appropriate antibiotic therapy.
Maltese: Għall-terapija miżjuda fil-kura ta' septiċimja puerpera u tossemija (sindrome ta' mastite-metrititeagalaktja) flimkien ma' terapija antibijotika addattata.
English: A clinical response is normally seen within 3 - 4 days.
Maltese: Rispons kliniku ġeneralment jidher fi żmien 3 - 4 ijiem.
English: Lungomare Pirandello, 8 92014 Porto Empedocle (AG) Italy
Maltese: Lungomare Pirandello, 8 92014
English: Silica colloidal anhydrous Sorbitol liquid non-crystallising Glycerol, xylitol Sodium benzoate Citric acid anhydrous Purified water.
Maltese: Silica colloidal anhydrous Sorbitol liquid non-crystallising Glycerol
English: Do not store above 25°C.
Maltese: Żomm il-prodott f'temperatura taht 25°C.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn)
English: Meloxicam is eliminated with a half-life of 24 hours.
Maltese: Meloxicam huwa eliminat b'half-life ta' 24 siegħa.
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 vitro u in vivo urew li meloxicam jinpedixxi cyclooxygenase-2 (COX-2) fuq medda akbar minn cyclooxygenase-1 (COX-1).
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Meglumine
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Sodium chloride (għall-aġġustament tal-pH) Meglumine
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: KWANTITÀ TA' SUSTANZA(I) ATTIVA(I)
English: INDICATION(S)
Maltese: INDIKAZZJONI(IJIET)
English: 5.2 Pharmacokinetic particulars
Maltese: 5.1 Kwalitajiet farmakodinmiċi
English: Ethanol anhydrous Poloxamer 188 Glycofurol Meglumine Glycine
Maltese: Glycofurol Meglumine Glycine
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC-vet code: QM01AC06
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, (oksikami) Kodici ATC veterinarja:
English: Pharmacologically active substance(s)
Maltese: Sustanza(i) farmakoloġikament attiva(i)
English: The volume of distribution is 0.3 l/kg.
Maltese: Il-volum ta' distribuzzjoni hu ta' 0.3 l/kg.
English: Each ml contains: - 1.5 mg of meloxicam - 2 mg of sodium benzoate
Maltese: U INGREDJENT(I) OĦRA Kull ml fih - 1.5 mg ta' meloxicam - 2 mg ta' sodium benzoate
English: PACKAGE LEAFLET: Meloxidyl 20 mg/ml solution for injection for cattle, pigs, horses 50, 100, & 250 ml
Maltese: Meloxidyl 20 mg/ml soluzzjoni għall-injezzjoni għall-baqar, majjali, żwiemel 50, 100 & 250 ml
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 li tingħata taħt il-ġilda, meloxicam hi kompletament bijodisponibbli, u l-ogħla medja ta' konċentrazzjonijiet fil-plażma ta' 0.73 µg/ml fil-klieb u 1.1 µg/ml fil-qtates intlaħqu wara madwar 2.5 sigħat u 1,5 sigħat wara l-għoti, rispettivament.
English: - Do not use in cats less than 6 weeks of age.
Maltese: - Tużax fi qtates li għandhom inqas minn età ta' 6 ġimgħat.
English: Equidae 20 μg/kg 65 μg/kg
Maltese: Taż-żwiemel 20 μg/kg 65 μg/kg
English: Composition for 1 ml
Maltese: U KWANTITATTIVA Kompożizzjoni għal 1 ml
English: Manufacturer responsible for batch release: Ceva Santé Animale - Z.I.
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Ceva Santé Animale - Z.I. Très le Bois - 22600
English: Meloxidyl 0.5 mg/ml oral suspension for cats Meloxicam
Maltese: VETERINARJU Meloxidyl 0.5 mg/ml suspensjoni orali għall-qtates Meloxicam
English: Pale yellow suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni orali.
English: Cattle: Meat and offal: 15 days; Milk: 5 days Pigs: Meat and offal: 5 days Horses: Meat and offal: 5 days.
Maltese: Laħam u ġewwieni: 15-il jum; Ħalib: 5 ijiem Majjali: Laħam u ġewwieni: 5 ijiem Żwiemel: Laħam u ġewwieni: 5 ijiem.
English: ADVERSE REACTIONS
Maltese: KONTRADIZZJONIJIET
English: - Xanthan gum - Silica colloidal anhydrous - Sorbitol liquid non-crystallising - Glycerol - Xylitol - Sodium benzoate (E 211) - Citric acid anhydrous - Purified water
Maltese: -Xanthan gum -Silica kollojdjali anidru -Likwidu tas-Sorbitol mhux kristalizzat -Glycerol -Xylitol
English: Z.I.
Maltese: NUMRU/I
English: Avoid introduction of contamination during use.
Maltese: Evita li tintroduċi l-kontaminazzjoni waqt l-użu.