FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Maltese: Huwa jintuża f'pazjenti li kellhom trapjant, għall-prevenzjoni ta' rifjut (meta s-sistema immunitarja tattakka l-organu trapjantat).
English: Powder: 500 U; Solvent: 5 ml
Maltese: Trab: 500 U; Solvent: 5 ml
English: 2 disposable 10ml syringes 2 venipuncture sets
Maltese: trasferiment bil-filtru 2 siringi ta' 10 ml li jintremew wara li jintużaw 2 settijiet għal venipuntura 2 tvalji protettivi
English: Intravenous use powder: vial (glass); solvent: vial (glass)
Maltese: Użu għal ġol-vini trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
English: 2 powder vials 2 solvent vials 2 filter transfer devices
Maltese: 2 kunjetti bit-trab 2 kunjetti bis-solvent
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: 500 U Powder and solvent for solution for injection
Maltese: U Trab u solvent għal soluzzjoni għal injezzjoni
English: Further information on Bravecto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
Maltese: Aktar informazzjoni dwar Bravecto tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
English: Bravecto contains the active substance fluralaner.
Maltese: Bravecto fih is-sustanza attiva fluralaner.
English: Other information about Bravecto
Maltese: Informazzjoni oħra dwar Bravecto
English: This summary was last updated in September 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Settembru 2019.
English: Bravecto received a marketing authorisation valid throughout the EU on 11 February 2014.
Maltese: Bravecto ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-11 ta' Frar 2014.
English: It may be used:
Maltese: Dan jista' jintuża:
English: The active substance in Bravecto, fluralaner, acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva fi Bravecto, il-fluralaner, taġixxi bħala ‘ektoparassitiċida'.
English: What are the risks associated with Bravecto?
Maltese: X'inhuma r-riskji assoċjati ma' Bravecto?
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Maltese: Dan jimblokka l-moviment normali tal-partikoli ċċarġjati talklorur (joni) ġewwa u barra ċ-ċelloli tan-nervituri, speċjalment dawk assoċjati ma' aċidu gammaaminobutirriku (GABA) u glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn in-nervituri (newrotrażmettituri).
English: Effectiveness was 95% and 94% for Bravecto chewable tablets and Bravecto spot-on solution respectively based on the percentage of dogs free from live mites at days 56 and 84 after treatment.
Maltese: L-effikaċja kienet ta' 95 % u ta' 94 % għall-pilloli li jintmagħdu ta' Bravecto u s-soluzzjoni ta' taqtir fuq il-ġilda ta' Bravecto rispettivament fuq il-bażi talperċentwali ta' klieb ħielsa minn dud ħaj fil-jiem 56 u 84 wara l-kura.
English: • to treat demodectic and sarcoptic mange (skin infestation caused by two different mites) in dogs
Maltese: • biex jikkura l-iskabbja demodektika u sarkoptika (infestazzjoni tal-ġilda kkawżata minn żewġ dud differenti) fil-klieb
English: In an EU field study involving 561 dogs with flea and/or tick infestations, the effects of Bravecto tablets were compared with those of another product, fipronil, that kills fleas and ticks, applied as a spot-on solution to the skin of the dogs.
Maltese: Fi studju tal-UE fuq il-post li involva 561 kelb b'infestazzjonijiet tal-briegħed u/jew tal-qurdien, l-effetti tal-pilloli ta' Bravecto tqabblu ma' dawk ta' prodott ieħor, fipronil, li joqtol il-briegħed u l-qurdien, li jiġi applikat bħala soluzzjoni għal użu lokalizzat fuq il-ġilda tal-klieb.
English: For ear mite infestations, a veterinary check is advised 28 days after treatment.
Maltese: Għall-infestazzjonijiet tad-dud tal-widnejn, huwa meħtieġ kontroll veterinarju 28 jum wara l-kura.
English: Bravecto is a veterinary medicine used to treat parasitic infestations in dogs and cats.
Maltese: Bravecto huwa mediċina veterinarja użata biex tikkura infestazzjonijiet parassitiċi fil-klieb u l-qtates.
English: In a study conducted in the EU involving cats with ear mites, the effectiveness of Bravecto was >90% based on presence of live ear mites at day 28 after treatment.
Maltese: Fi studju li sar fl-UE li involva qtates b'dud tal-widnejn, l-effikaċja ta' Bravecto kienet ta' > 90 % ibbażata fuq il-preżenza ta' dud tal-widnejn ħaj f'jum 28 wara l-kura.
English: • as part of the management of flea allergy dermatitis (an allergic reaction to flea bites) in dogs and cats
Maltese: • bħala parti mill-ġestjoni ta' dermatite allerġika mill-briegħed (reazzjoni allergika għall-gdim talbriegħed) fil-klieb u l-qtates
English: Bravecto and the comparator medicine were both 100% effective as all treated dogs were free from live mites when skin scrapings were taken on days 56 and 84 after treatment.
Maltese: Bravecto u l-mediċina komparatur kienu t-tnejn 100 % effettivi peress li l-klieb kollha kkurati kienu ħielsa minn dud ħaj meta ammont mill-ġilda ttieħed f'jiem 56 u 84 wara l-kura.
English: After being given, its actions last for 12 weeks against fleas and 8 to 12 weeks against ticks.
Maltese: Wara li jingħata, l-azzjonijiet tiegħu jdumu għal 12-il ġimgħa kontra l-briegħed u minn 8 sa 12-il ġimgħa kontra l-qurdien.
English: The veterinarian will decide if additional treatment is needed.
Maltese: Il-veterinarju ser jiddeċiedi jekk ikunx hemm bżonn kura addizzjonali.
English: A study conducted in Europe involved dogs with sarcoptic mange and compared Bravecto chewable tablets and Bravecto spot-on solution to another medicine authorised to treat sarcoptic mange.
Maltese: Studju li sar fl-Ewropa involva klieb b'marda sarkoptika u qabbel il-pilloli li jintmagħdu ta' Bravecto u ssoluzzjoni għal użu lokalizzat ta' Bravecto ma' mediċina oħra awtorizzata li tikkura marda sarkoptika.
English: • to treat ear mite infestations in cats.
Maltese: • biex jikkura infestazzjonijiet tad-dud tal-widnejn fil-qtates.
English: The spot-on solution and tablets are available in different strengths for dogs and cats of different weights.
Maltese: Is-soluzzjoni għal użu lokalizzat u l-pilloli huma disponibbli f'qawwiet differenti għal klieb u qtates ta' piżijiet differenti.
English: The most common side effect of the spot-on solution (which may affect more than 1 in 100 animals) is a mild short-lived skin reaction at the application site, such as erythema (redness) and pruritus (itching) or hair loss.
Maltese: L-effett sekondarju l-aktar komuni tas-soluzzjoni għal użu lokalizzat (li jista' jaffettwa aktar minn annimal 1 minn kull 100) huwa reazzjoni ħafifa tal-ġilda għal żmien qasir fis-sit tal-applikazzjoni, bħal eritema (ħmura) u prurite (ħakk) jew telf ta' pil.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Maltese: Dan iwassal għal attività mhux ikkontrollata tas-sistema nervuża u l-paraliżi u lmewt tal-parassiti.
English: It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Maltese: Is-sit ta' applikazzjoni jdum sa 48 siegħa biex jinxef iżda jkun jista' jiġi nnutat aktar fit-tul.
English: How does Bravecto work?
Maltese: Kif jintuża Bravecto?
English: The field study showed that Bravecto was effective in reducing the number of fleas and ticks in dogs with existing flea or tick infestations and that its effects against fleas and most tick species persisted for 3 months.
Maltese: Listudju fuq il-post wera li Bravecto kien effettiv fit-tnaqqis tal-għadd ta' briegħed u qurdien fi klieb b'infestazzjonijiet eżistenti ta' briegħed jew ta' qurdien u li l-effetti tiegħu kontra l-briegħed u ħafna mill-ispeċi ta' qurdien damu għal 3 xhur.
English: Fluralaner kills fleas, ticks and mites that have ingested the dog's or cat's blood by acting on their nervous system.
Maltese: Fluralaner joqtol il-briegħed, il-qurdien u d-dud li jkunu belgħu d-demm tal-kelb jew tal-qattus billi jaġixxi fuq is-sistema nervuża tagħhom.
English: The effectiveness of Bravecto against fleas and ticks was investigated in both laboratory and field studies.
Maltese: L-effikaċja ta' Bravecto kontra l-briegħed u l-qurdien ġiet investigata kemm fi studji tal-laboratorju kif ukoll fuq il-post.
English: Date of last renewal: 21/06/2016
Maltese: Data tal-aħħar tiġdid: 21/06/2016
English: - 50 ml PET vials: 2 years.
Maltese: - 50 ml fjali PET: 2 snin.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Disodium phosphate dihydrate Potassium dihydrogen phosphate
English: Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Maltese: Strejn tal-virus ħaj myxoma vectored RHD 009: ≥103.0 u ≤106.1 FFU*
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/09/2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 07/09/2011
English: Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Maltese: Ġelatina idrolizzata Diġest pancrejatiku tal-kasejn Sorbitol
English: - PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
Maltese: Fjali PET (50ml): Aħżen fil-friġġ (2°C - 8°C).
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva hija fil-prinċipju ta' oriġini bijoloġika intenzjonata biex tipproduċi immunità attiva ma taqax taħt l-iskop tar-Regolament (EC) No 470/2009.
English: Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) vial of 50 ml closed with a halogenobutyl rubber stopper and aluminium cap.
Maltese: Fjala tal-ħġieġ ta' 1ml jew 10ml, jew fjala tal-polyethylene terephthalate (PET) ta' 50ml magħluq b' tapp tal-gomma (halogenobutyl) u kappa tal-aluminju.
English: NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Maltese: TAD-DILJUWENT Nobivac Myxo-RHD
English: Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Maltese: MILL-ĦRUĠ TALLOTT Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva Intervet International BV, site De Bilt Ambachtstraat 4 3732 CN De Bilt
English: Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
Maltese: Immunoloġiku għall-leporidae, vaċċin virali ħaj, Kodici ATC veterinarja:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Strejn tal-virus ħaj myxoma vectored RHD 009: ≥103.0
English: ml vial of solvent.
Maltese: Volum Solvent
English: Cardboard box with 10 x 10 ml solvent vials (glass)
Maltese: Kaxxa tal-kartun b` 10 x 10ml fjali(ħġieġ) tas-solvent
English: Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Maltese: Żid 1-2ml solvent tan-Nobivac Myxo-RHD mal-fjala(i) tal-50 doża u kun ċert li l-lijofiliżat inħall kompletament.
English: 5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine + 10 x 10 ml glass solvent vials 10 x 50 doses of vaccine + 2 x 50 ml PET solvent vials
Maltese: 5 x 1 doża tal-vaċċin li tinkludi s-solvent 25 x 1 doża tal-vaċċin li tinkludi s-solvent 10 x 50 dożi tal-vaċċin + 10 x 10 ml fjal tal-ħġieġ tas-solvent 10 x 50 dożi tal-vaċċin + 2 x 50 ml fjal PET tas-solvent
English: To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Maltese: Sabiex jistimula l-immunità kontra l-virus myxoma u l-marda virali emorraġika tal-fniek.
English: Rabbits.
Maltese: Fniek.
English: A transient temperature increase of 1 - 2° C can commonly occur.
Maltese: Żieda tranżitorja fit-temperatura ta' 1-20 C tistà sseħħ komunament.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Lijofiliżat u solvent għall-suspensjoni għall-injezzjoni
English: - 1 ml and 10 ml glass vials: 4 years.
Maltese: - 1 u 10ml fjal tal-ħġieġ: 4 snin
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Virus ħaj myxoma vectored RHD
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).Tiffriżax.
English: Cardboard box with 1 x 50 ml solvent vials (PET)
Maltese: Kaxxa tal-kartun b` 1 x 50ml fjali (PET) fjali
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Maltese: VETERINARJU Nobivac Myxo-RHD lijofiliżat u solvent għal suspensjoni għal injezzjoni għall-fniek
English: PACKAGE SIZE 1 x 50 ml
Maltese: 1 x 50ml
English: Plastic box with 5 x 1 dose of vaccine including 5 x 1 ml solvent vials (glass) Plastic box with 25 x 1 dose of vaccine including 25 x 1 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Maltese: Kaxxa tal-plastik b` 5 x 1 doża tal-vaċċin li tinkludi 5 x 1ml jfali(ħġieġ) ta s-solvent Kaxxa tal-plastik b` 25 x 1 doża tal-vaċċin li tinkludi 25 x 1ml fjali (ħġieġ) tas-solvent Kaxxa tal-kartun b` 10 x 50 dożi tal-vaċċin
English: Multi-dose vial
Maltese: TAL-PRODOTT MEDIĊINALI
English: After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Maltese: Wara infezzjoni minn myxomatosis virulenti xi annimali vaċċinati jistgħu jiżviluppaw ftit nefħiet, speċjalment f'partijiet tal-ġisem bla xagħar, li malajr jiffurmaw qoxra.
English: PACKAGE SIZE 10 x 10 ml
Maltese: 10 x 10ml
English: 4.2 Indications for use, specifying the target species For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
Maltese: Għall-immunità attiva tal-fniek ta' età minn 5 ġimgħat 'il fuq biex inaqqas l-imwiet u sintomi kliniċi tal-myxomatosis u biex jipprevjeni l-imwiet minħabba l-marda emorraġika tal-fniek (RHD) ikkawżat mill-strejn virali RHD klassiku.
English: Excipients:
Maltese: Ippakjar:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/001-004
Maltese: EU/2/11/132/001-004
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott{numru}
English: Injection volume
Maltese: U KWANTITATTIVA
English: Volume
Maltese: KWANTITÀ
English: Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Maltese: Iġbed il-konċentrat rikostitwit tal-vaċċin mill-fjala(i) u injetta lura fil-fjala tas-solvent Myxo-RHD.
English: In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur.
Maltese: Fil-fniek pets, f'każijiet rari ħafna, reazzjonijiet lokali bħall nekrożi, skorċa, qoxra jew telf ta' xagħar jistgħu jseħħu.
English: Intervet International B.V., site Boxmeer Wim de Körverstraat 35
Maltese: Intervet International BV
English: - Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Maltese: - Kaxxa tal-plastik b'25 x 1 doża fjala tal-vaċċin u 25 x 1ml fjala tas-solvent.
English: The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Maltese: L-istrejn tal-vaċċin huwa myxomatosis li juri l-ġene tal-proteina capsid tal-virus tal-marda emorraġika tal-fniek.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhux attivi msemijja f'sezzjoni 6.1 tal- KPQ huma jew sustanzi permessi li għalihom ittabella 1 tal-anness tar-Regolament tal-Kommissjoni (EU) No37/2010 tindika li m'hemmx bżonn MRLs jew huma kunsidrati li ma jaqawx taħt l-iskop tar-Regolament (EC) No 470/2009 meta użati f'dan il-prodott veterinarju mediċinali.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata fuq dan il-prodott veterinarju mediċunali jinstab fuq il-websajt tal-Aġenzija Ewropea tal-Mediċini http://www.emea.europa.eu
English: - Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Maltese: Kaxxa tal-kartun b' 10 x 50 dożi fjala tal-vaċċin + kaxxa tal-kartun b' 10 x 10ml fjali tas-solvent.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U TAL
English: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Maltese: - Kaxxa tal-plastik b'5 x 1 doża fjala tal-vaċċin u 5 x 1ml fjala tas-solvent.
English: In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
Maltese: In-nefħa tinżel kompletament fi żmien 3 ġimgħat mill-vaċċinazzjoni.
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Maltese: Kaxxa tal-kartun b' 10 x 50 dożi fjali tal-vaċċin + 2 x kaxxi tal-kartun kull waħda fiha 1 x 50ml fjala tas-solvent.
English: Solvent (50 ml PET vial):
Maltese: TIKETTA SOLVENT 50 ml FJALI
English: The manufacture, import, possession, sale, supply and/or use of Nobivac Myxo-RHD may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' Nobivac Myxo-RDH huwa pprojbit jew jista' jkun ipprojbit f'ċertu Stati Membri fit-territorju kollu tagħhom jew f'parti minnu taħt leġiżlazzjoni nazzjonali.
English: Onset of immunity: 3 weeks.
Maltese: Bidu tal-immunità: 3 ġimgħat Kemm iddum l-immunità: 1 sena
English: Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Maltese: Fjal tal-ħġieġ ta' 1 jew 50 doża b'tapp tal-gomma (halogenobutyl) u kappa tal-aluminju
English: Single-dose vial
Maltese: TA' PRODOTT MHUX
English: Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Maltese: Kaxxa tal -plastik b' 5 x 1 doża fjala tal-vaċċin u 5 x 1ml fjala tas-solvent.
English: In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination.
Maltese: F'każijiet rari ħafna, reazzjoniet serji ta' ipersensitività, li jistgħu jkunu fatali, jistgħu jseħħu wara l-vaċċinazzjoni.
English: PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Maltese: Nobivac Myxo-RHD lijofiliżat u solvent għall-suspensjoni għall-injezzjoni għall-fniek
English: Reconstituted product: off-pink or pink coloured suspension.
Maltese: Il-prodotti mħallat: suspensjoni kulur kważi roża jew roża.
English: Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Maltese: Solvent(1ml u 10ml fjal tal-ħġieġ)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Maltese: *Focus Forming Units
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: Solvent volume
Maltese: Volum talinjezzjoni
English: In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
Maltese: Apparti r-reazzjonijiet mhux mixtieqa osservati wara l-vaċċinazzjoni ta' doża waħda, nefħa mhux kbira tal-lymph nodes lokali tista' tiġi osservata wara 3 ijiem ta' doża eċċessiva ta' vaċċinazzjoni.
English: Subcutaneous use.
Maltese: ġimgħat tal-vaċċinazzjoni.
English: Lyophilisate: off-white or cream-coloured pellet.
Maltese: Solvent: soluzzjoni ċara u bla kulur.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
Maltese: EU/2/11/132/003
English: There are several metabolites identified.
Maltese: Hemm diversi metaboliti identifikati.
English: Infection including opportunistic infections
Maltese: Infezzjonijiet inklużi infezzjonijiet opportunistiċi
English: Gonzagagasse 16/16 1010 Wien Austria
Maltese: Gonzagagasse 16/16 1010
English: Stevens Johnson syndrome
Maltese: Sindrome ta' Stevens Johnson
English: Ostenfelder Strasse 51-61 D-59320 Ennigerloh Germany
Maltese: Ostenfelder Strasse 51-61 D-59320 Ennigerloh
English: • Envarsus 0.75 mg tablets: 41.7 mg
Maltese: • Envarsus 0.75 mg pilloli: 41.7 mg
English: <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000),
English: • Envarsus 1 mg tablets:
Maltese: • Envarsus 1 mg pilloli:
English: Hypersensitivity to other macrolides.
Maltese: Sensittività eċċessiva għal macrolides oħra.
English: • Envarsus 4 mg tablets:
Maltese: • Envarsus 4 mg pilloli:
English: The treatment difference (Envarsus-Prograf) was 0% (95% confidence interval [4.21%, 4.21%]).
Maltese: Id-differenza fil-kura (Envarsus-Prograf) kienet ta' 0% (intervall ta'kunfidenza ta' 95% [-4.21%, 4.21%]).
English: Other interactions leading to clinically detrimental effects
Maltese: Interazzjonijiet oħra li jwasslu għal effetti klinikament detrimentali
English: Conversion from ciclosporin to tacrolimus
Maltese: Bidla minn ciclosporin għal tacrolimus
English: The treatment difference (Envarsus-Prograf) was -1.35% (95% confidence interval [-7.94%, 5.27%]).
Maltese: Id-differenza fil-kura (Envarsus-Prograf) kienet ta' -1.35% (intervall ta' kunfidenza ta' 95% [-7.94%, 5.27%]).
English: Limited knowledge of interactions between tacrolimus and statins is available.
Maltese: Hemm disponibbli għarfien limitat ta' interazzjonijiet bejn tacrolimus u statins.
English: Via San Leonardo 96 43122 Parma Italy
Maltese: Via San Leonardo 96 43122 Parma L-Italja
English: In plasma, tacrolimus is highly bound (>98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Maltese: tacrolimus jintrabat ħafna (>98.8%) mal-proteini fil-plażma, l-aktar mal-albumina fis-serum u ma' α-1-acid glycoprotein.
English: Absorption is variable and the mean oral bioavailability of tacrolimus is in the range of 20%-25% (individual range in adult patients 6%-43%).
Maltese: L-assorbiment huwa varjabbli u l-bijodisponibiltà orali medja ta' tacrolimus hija fil-firxa ta' 20%-25% (firxa individwali f'pazjenti adulti ta' 6%-43%).
English: In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen and (triacetyl)oleandomycin.
Maltese: In vitro is-sustanzi li ġejjin intwerew li huma inibituri potenzjali tal-metaboliżmu ta' tacrolimus: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, u (triacetyl)oleandomycin.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Maltese: Hemm ukoll evidenza ta' metaboliżmu gastrointestinali minn CYP3A4 fil-ħajt intestinali.
English: In practice, tacrolimus-based therapy has been initiated 12 to 24 hours after discontinuation of ciclosporin.
Maltese: Fil-prattika, terapija ibbażata fuq tacrolimus tkun ġiet mibdija 12 sa 24 siegħa wara li jkun twaqqaf ciclosporin.