FrancophonIA/ELRC3.0 huggingface dataset:
English: The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV. After a single dose, the duration of analgesia was dose and clinical pain model dependent, and ranged from 6 to greater than 12 hours.
Maltese: Id-daqs ta' l-effett analġeżiku taddoża ta' 40 mg kien komparabbli ma' dak ta' ketorolac 60 mg IM jew ketorolac 30 mg IV.
English: How to store Dynastat
Maltese: X'fih Dynastat
English: Thrombocytopenia
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: ▪ Dry mouth ▪ Muscle weakness ▪ Ear ache ▪ Unusual abdominal sounds
Maltese: • Taħbit tal-qalb mgħaġġel ħafna jew irregolari
English: After reconstitution, the concentration of parecoxib is 20 mg/ml.
Maltese: Wara r-rikostituzzjoni, l-konċentrazzjoni finali ta' parecoxib hija ta' 20 mg/ml.
English: • glucose 50 mg/ml (5%) solution for infusion;
Maltese: • soluzzjoni ta' glukosju għall-infużjoni 50 mg/ml (5%);
English: In young subjects, Dynastat 40 mg twice daily had no clinically significant effect on acetylsalicylic acid-mediated inhibition of platelet function (see section 4.5).
Maltese: F'persuni żgħar fl-eta, it-teħid ta' 40 mg Dynastat darbtejn kuljum, ma kellu l-ebda effett kliniku ta' ċerta importanza fuq linibizzjoni tal-funzjoni tal-plejtlets li jkun hemm bl-acetylsalicylic acid (ara sezzjoni 4.5)
English: In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
Maltese: Fil-bniedem, studji wrew li l-metaboliżmu ta' valdecoxib huwa l-aktar medjat permezz ta' isożemi CYP3A4 u 2C9.
English: In patients with moderate hepatic impairment (Child-Pugh score 7-9), treatment should be initiated with half the usual recommended dose of Dynastat and the maximum daily dose should be reduced to 40 mg since valdecoxib exposures were more than doubled (130%) in these patients.
Maltese: F'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh skala 7-sa 9), Dynastat għandu jinbeda b'nofs id-doża normalment rakkomandata u d-doża massima ta' kuljum għandha tiġi mnaqqsa għal 40 mg, peress li l-esponimenti ta' valdecoxib żdiedu b'aktar mid-doppju (130%) f'dawn ilpazjenti.
English: Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Maltese: Parecoxib għandu jitwaqqaf ma' l-ewwel feġġa ta' raxx tal-ġilda, feriti bil-mukus, jew ma' kwalunkwe sinjal ieħor ta' sensittività eċċessiva.
English: Coadministration of parecoxib and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
Maltese: L-amministrazzjoni flimkien ta' parecoxib u heparin m' affettwawx il-farmakodinamika ta' heparin (ħin tat-tromboplastina parzjalment attivata) kif imqabbla ma' heparin waħidha.
English: There is limited clinical experience with Dynastat treatment beyond three days (see section 5.1).
Maltese: L-esperjenza klinika ta' kura b' Dynastat għal aktar minn tliet ijiem, hija limitata (ara sezzjoni 5.1).
English: When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mmol of sodium per vial.
Maltese: Meta rikostitwit f'soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride, Dynastat ikun fih bejn wieħed u ieħor 0.44 mmol ta' sodium f' kull fjala.
English: Dynastat 40 mg powder and solvent for solution for injection Parecoxib
Maltese: Dynastat 40 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medicinal products.
Maltese: Reazzjonijiet serji tal-ġilda huma magħrufin li jseħħu b'NSAIDs inkluż inibituri selettivi ta' COX-2 kif ukoll prodotti mediċinali oħra.
English: ▪ If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
Maltese: • Jekk fil-passat kellek xi ulċera, tisfija tad-demm jew perforazzjoni tal-passaġġ gastro-intestinali.
English: Cerebrovascular disorder
Maltese: Disturbi ċerebrovaskolari
English: Valdecoxib is a selective COX-2 inhibitor within the clinical dose range.
Maltese: Fil-firxa tad-dożi kliniċi, valdecoxib huwa impeditur selettiv COX-2. Cyclooxygenase hu responsabbli għall-ġenerazzjoni tal-prostaglandini.
English: Hypertension (aggravated), orthostatic hypotension Respiratory, thoracic and mediastinal disorders Respiratory insufficiency
Maltese: Pressjoni għolja (aggravata), pressjoni baxxa hekk kif wieħed iqum Disturbi respiratorju, toraċiku u medjastinali Insuffiċjenza respiratorja
English: No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Maltese: Ġeneralment ma jkunx hemm bżonn ta' l-ebda aġġustament fid-doża f'pazjenti li għandhom indeboliment ħafif tal-fwied (Child-Pugh skala 5-6).
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including Dynastat should be considered.
Maltese: F'nisa li għandhom diffikultajiet biex jikkonċepixxu jew li jkunu għaddejjin minn investigazzjoni tal-infertilità, għandu jiġi kkunsidrat it-twaqqif ta' NSAIDs, inkluż Dynastat.
English: Opioid-sparing effects
Maltese: Effetti ta' tnaqqis fl-użu ta' opioids
English: What Dynastat looks like and contents of the pack Dynastat is available as a white to off-white powder.
Maltese: Dynastat huwa disponibbli bħala trab abjad għal offwajt.
English: The NSAIDs class is also associated with increased GI complications when coadministered with glucocorticoids, selective serotonin reuptake inhibitors, other antiplatelet drugs, other NSAIDs or patients ingesting alcohol.
Maltese: Il-klassi tal-NSAIDs hija wkoll assoċjata ma' żieda fil-komplikazzjonijiet GI meta jingħataw flimkien ma' glukokortikojdi, inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin, mediċini kontra l-plejtlits oħrajn, NSAIDS oħrajn jew pazjenti li jinġestu l-alkoħol.
English: In two pharmacokinetic interaction studies in rheumatoid arthritis patients receiving a stable weekly methotrexate dose (5-20 mg/week, as a single oral or intramuscular dose), orally administered valdecoxib (10 mg twice daily or 40 mg twice daily) had little or no effect on the steady-state plasma concentrations of methotrexate.
Maltese: F'żewġ studji ta' interazzjonijiet farmakokinetiċi li saru f'pazjenti li jbatu minn artrite rewmatika, li kienu qed jingħataw doża stabbli ta' methrotrexate fil-muskolu darba fil-ġimgħa (5-20 mg/ġimgħa, bħala doża waħda orali jew ġol-muskoli), valdecoxib mogħti mil-ħalq (10 mg darbtejn kuljum jew 40 mg darbtejn kuljum) kellu ftit jew l-ebda effett fuq il-konċentrazzjonijiet fil-plażma fl-istat fiss ta' methotrexate.
English: ▪ Low blood pressure on standing ▪ Blood tests may show abnormal liver function ▪ You may bruise easily due to a low blood platelet count ▪ Surgical wounds may become infected, abnormal discharge from surgical wounds ▪ Skin discolouration or bruising ▪ Complications with skin healing after operations ▪ High sugar levels in blood tests ▪ Injection site pain or injection site reaction ▪ Rash, or raised itchy rash (hives) ▪ Anorexia (loss of appetite) ▪ Joint pain ▪ High levels of blood enzymes in blood tests that indicate injury or stress to the heart, the brain,
Maltese: Kumplikazzjonijiet fil-parti gastro-intestinali ta' fuq (GI) (tiċrit, ulċeri jew fsada [PUBs]), li xi wħud minnhom wasslu għall-mewt seħħew fuq pazjenti li kienu qed jiġu kkurati b'parecoxib.- Għandha tintuża l-attenzjoni meta tingħata kura lil pazjenti li huma l-aktar f'riskju li jiżviluppaw komplikazzjonijiet gastro-intestinali b'NSAIDs; l-anzjani, jew pazjenti li għandhom passat mediku ta' mard gastro-intestinali, bħal ulċeri u fsada GI, jew pazjenti li jużaw acetylsalicylic acid fl-istess żmien tal-kura.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is therefore considered essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, u għalhekk huwa essenzjalment ikkunsidrat ‘mingħajr sodium'.
English: It represents approximately 10% of the concentration of valdecoxib; because of this metabolite's low concentration, it is not expected to contribute a significant clinical effect after administration of therapeutic doses of parecoxib.
Maltese: Hija tirrapreżenta bejn wieħed u ieħor 10% tal-konċentrazzjoni ta' valdecoxib: minħabba l-konċentrazzjoni baxxa ta' dan il-metabolu, mhuwiex mistenni li din tikkontribwixxi effett kliniku importanti wara l-amministrazzjoni ta' doża terapewtika ta' parecoxib.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Maltese: COX-2 ġiet identifikata fit-tessuti ta' madwar ulċeri fl-istonku fil-bniedem, iżda r-relevanza tagħha fil-fejqan ta' dawn l-ulċeri għadha ma ġietx stabbilita.
English: For more information on storage see the package leaflet.
Maltese: Jista jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: Dynastat should be introduced with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and the maximum daily dose should be reduced to 40 mg.
Maltese: F'pazjenti li għandhom indeboliment moderat talfwied l-kura b'Dynastat għandha tinbeda b'ċerta kawtela u b'nofs id-doża normalment rakkomandata (Child-Pughs Skala 7 - 9) u d-doża massima ta' kuljum għandha titnaqqas għal 40 mg.
English: White to off-white powder.
Maltese: Trab abjad ikanġi fl-offwajt.
English: For the short-term treatment of postoperative pain in adults.
Maltese: Għal kura mhux fit-tul kontra l-uġigħ ta' wara operazzjoni fl-adulti.
English: Withdraw with a sterile needle and syringe, 2 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 40 mg vial.
Maltese: Iġbed permezz ta' labra sterili u siringa, 2ml ta' solvent xieraq u daħħal il-labra ġol-parti ċentrali tat-tapp tal-gomma, b'mod li s-solvent jiġi trasferit ġol-fjala ta' 40 mg.
English: ▪ Lithium - used to treat depression ▪ Rifampicin - used for bacterial infections ▪ Antiarrhythmics - used to treat an irregular heartbeat ▪ Phenytoin or Carbamazepine - used for epilepsy ▪ Methotrexate - used for rheumatoid arthritis and cancer ▪ Diazepam - used for sedation and anxiety ▪ Omeprazole - used for treating ulcers
Maltese: Madankollu, ir-rata rrapportata ta' episodji serji tal-ġilda tidher li hija ikbar għal valdecoxib (il-metabolit attiv ta' parecoxib) hekk kif imqabbel ma' inibituri selettivi oħra ta' COX-2.
English: 3 x (1 vial + 1 prefilled syringe + 1 plunger rod + 1 vial adapter + 1 needle) (multipack)
Maltese: 3 x (1 kunjett + 1 siringa mimlija għal-lest + 1 lasta talplanġer + 1 adapter tal-kunjett + 1 labra (pakkett multiplu)
English: 2 vials +2 pre-filled syringes +2 plunger rods + 2 vial adapters + 2 needles
Maltese: 2 kunjetti + 2 siringi mimlija għal-lest + 2 lasti tal-planġer + 2 adapters tal-kunjett + 2 labriet
English: 1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 needle
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 1 lasta tal-planġer + 1 adapter tal-kunjett + 1 labra
English: MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: EMA/475235/2015 EMEA/H/C/001224
Maltese: EMEA/H/C/001224
English: Twynsta telmisartan / amlodipine
Maltese: Twynsta telmisartan / amlodipina
English: It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Maltese: Tiġi bħala pilloli (40 mg telmisartan/10 mg amlodipina, 40 mg telmisartan/5 mg amlodipina, 80 mg telmisartan/10 mg amlodipina u 80 mg telmisartan/5 mg amlodipina).
English: Other information about Twynsta:
Maltese: Informazzjoni oħra dwar Twynsta:
English: The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Twynsta jinstab fis-sit web tal-Aġenzija EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Amlodipine is a calcium channel blocker.
Maltese: L-amlodipina hija imblokkatur tal-kanal tal-kalċju.
English: This is a summary of the European public assessment report (EPAR) for Twynsta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Twynsta.
English: The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Maltese: L-effetti sekondarji l-aktar komuni bi Twynsta (li dehru f'aktar minn pazjent 1 minn kull 10) huma sturdament u edema periferali (nefħa, speċjalment fl-għekiesi u fis-saqajn).
English: Why has Twynsta been approved?
Maltese: Għaliex ġie approvat Twynsta?
English: The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Maltese: Id-doża massima hija pillola waħda tal-akbar qawwa (80/10 mg) darba kuljum.
English: The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Twynsta valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2010.
English: What is the risk associated with Twynsta?
Maltese: X'inhu r-riskju assoċjat ma' Twynsta?
English: For the full list of all side effects reported with Twynsta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rapportati bi Twynsta, ara l-fuljett ta' tagħrif.
English: Twynsta contains two active substances, telmisartan and amlodipine.
Maltese: Twynsta fih żewġ sustanzi attivi, it-telmisartan u l-amlodipina.
English: In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
Maltese: Fi studju ewlieni wieħed , 1,461 adult bi pressjoni għolja ġew ikkurati b'kombinazzjonijiet ta' telmisartan u amlodipina, b'telmisartan jew b'amlodipina waħidhom, jew bi plaċebo (kura finta).
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II. Anġjotensin II huwa vażokostrittur qawwi (sustanza li traqqaq il-vini tad-demm).
English: What is Twynsta?
Maltese: X'inhu Twynsta?
English: How has Twynsta been studied?
Maltese: Kif ġiet studjat Twynsta?
English: In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.
Maltese: Fiż-żewġ studji l-oħra, Twynsta kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika milli bit-tkomplija tal-kura bl-amlodipina waħedha: skont il-qawwiet ta' Twynsta u amlodipina, il-waqgħa filpressjoni tad-demm dijastolika kienet ikbar f'pazjenti li jieħdu Twynsta b'bejn 1.4 mmHg u 4.9 mmHg.
English: Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Maltese: Twynsta m'għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan, amlodipine, mediċini oħrajn fil-klassi ta' ‘derivattivi ta' dihydropyridine' jew għal xi sustanza oħra tiegħu.
English: Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Maltese: Twynsta lanqas ma għandha tintuża f'pazjenti li kellhom problemi serji bil-fwied jew biljari, xokk (waqa' qawwija fil-pressjoni tad-demm), ostruzzjoni għall-fluss tad-demm min-naħa tax-xellug ta' qalbhom jew f'pazjenti b'indeboliment talqalb wara li kellhom infart mijokardijaku (attakk tal-qalb).
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Din timblokka l-kanali speċjali preżenti fuq il-wiċċ taċ-ċelluli magħrufa bħala kanali tal-kalċju, li minnhom normalment il-joni tal-kalċju jidħlu fiċ-ċelluli.
English: Twynsta is a medicine that contains two active substances, telmisartan and amlodipine.
Maltese: Twynsta hija mediċina li fiha żewġ sustanzi attivi, it-telmisartan u l-amlodipina.
English: Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Maltese: Twynsta jintuża biex jikkura ipertensjoni (pressjoni tad-demm għolja) essenzjali fl-adulti (minn 18-il sena 'l fuq). ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Maltese: Bittnaqqis tal-pressjoni tad-demm, jitnaqqsu r-riskji assoċjati ma' pressjoni għolja tad-demm, bħallpuplesija.
English: By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Maltese: Billi jimblokka r-riċetturi li magħhom normalment jeħel l-anġjotensin II, telmisartan iwaqqaf lill-ormon milli jkollu effett, u dan jippermetti lill-vini tad-demm sabiex jitwessgħu.
English: How does Twynsta work?
Maltese: Għalxiex jintuża Twynsta?
English: Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Maltese: Twynsta ma għandux jintuża wkoll flimkien ma' mediċini li fihom l-aliskiren (użati wkoll fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete tat-tip 2, jew f'pazjenti li jbatu minn insuffiċjenza moderata jew gravi fil-kliewi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Twynsta.
Maltese: It-tnejn huma mediċini sabiex inaqqsu l-pressjoni tad-demm li ilhom disponibbli fl-Unjoni Ewropea (UE) sa mis-snin disgħin.
English: Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Maltese: Twettqu wkoll studji sabiex juru li l-pilloli ta' Twynsta jiġu assorbiti bl-istess mod fil-ġisem bħal pilloli separati ta' amlodipina u telmisartan.
English: ATCvet code: QI06AH09.
Maltese: Q106AH09
English: 1 cell culture infective dose 50%.
Maltese: 1: doża infettiva tas-cell culture 50%
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Maltese: Lijofiliżat (doża 10x1 ) + solvent ( 10x1 ml) Lijofiliżat (doża 50x 1) + solvent ( 50x1 ml)
English: Date of first authorisation: 23/02/2005 Date of last renewal: 25/01/2010
Maltese: Data tal-aħħar tiġdid: 25/01/2010
English: EU/2/04/052/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/052/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: EU/2/04/052/001 Lijofiliżat (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) EU/2/04/052/002 Lijofiliżat (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Maltese: Immunizzazzjoni attiva tal-qtates ta' 8 ġimgħat u akbar: - kontra r-rinotrakeite virali fil-qtates biex tnaqqas sinjali kliniċi, - kontra l-infezzjoni tal-calcivirus biex tnaqqas sinjali kliniċi
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 °C) Ipproteġi mid-dawl.
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, and feline panleucopenia virus.
Maltese: Tistimola immunità attiva kontra l-ħerpesvajrus tar-rinotrakeite fil-qtates, kaliċivirus fil-qtates, u lvajrus tal-panlewkopenja fil-qtates.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Maltese: Herpesvajrus attenwat tar-rinotrakeite fil-qtates (FHV strejn F2) ................................... ≥ 104.9 CCID501 kalċivirus inattivat fil-qtates (strejn FCV 431 u G1) antiġeni ........................................ ≥ 2.0 ELISA U.
English: Laboratoire Porte des Alpes Rue de l'aviation
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
English: Purevax RCP lyophilisate and solvent for suspension for injection.
Maltese: VETERINARJU Purevax RCP, lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: Excipient:
Maltese: Lijofiliżat :
English: Purevax RCP lyophilisate and solvent for suspension for injection
Maltese: Purevax RCP lijofiliżat u solvent għal suspensjoni għall-injezzjoni
English: Gentamicin, at most ....................................................................................................................... 16.5 µg
Maltese: Ilma għal injezzjoni ........................................................................................................................ q.s. ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent
Maltese: Pakkett li għandu 10 fliexken ta' doża ta' lijofiliżat u 10 fliexken ta' ml ta' solvent Pakkett li għandu 50 flixkun ta' doża ta' lijofiliżat u 50 flixkun ta' ml ta' solvent
English: Manufacturer responsible for the batch release: MERIAL
Maltese: TAL-MANIFATTURA RESPONSABBLI MILL
English: CLINICAL PARTICULARS 4.1 Target species
Maltese: 4.5 Prekawzjonijiet Speċjali għall-Użu
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Maltese: F'kundizzjonijiet normali tal-użu, jista' jkun hemm apatija li tgħaddi u anoreksja, u wkoll żieda fittemperatura tal-ġisem (li ddum normalment għal ġurnata jew tnejn).
English: ................................................................................................................... 1 ml.
Maltese: Ilma għal injezzjoni ......................................................................................................................... q.s ml
English: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV) .................................................................................................................... ≥ 103.5 CCID50.
Maltese: Herpesvajrus attenwat tar-rinotrakeite fil-qtates (FHV strejn F2) ................................... ≥ 104.9 CCID501 kalicivirus inattivat fil-qtates (strejn FCV 431 u G1) antiġeni ...................................... ≥ 2.0 ELISA U.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for the rhinotracheitis, calicivirus and panleucopenia components.
Maltese: - tilqim sussegwenti għandhom jingħataw f'intervalli sa tliet snin għall-komponenti tarrinotrakeite, tal-kaliċivirosi u tal-panlewkopenja.