FrancophonIA/ELRC3.0 huggingface dataset:
English: 1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
Maltese: 1060 pazjent ġew magħżula b'mod arbitrarju biex jirċievu jew Docetaxel Zentiva 75 mg/m2 mogħti siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclosphosphamide 500 mg/m2 (521
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Maltese: Wara 10 snin ta' osservazzjoni ta' wara t-trattament fl-istudju TAX316, il-lewkimja akuta ġiet irrappurtata f'43 minn 744 pazjent fuq TAC (0.4%) u f'1 minn 736 pazjent fuq FAC(0.1 %).
English: România S.C. ZENTIVA S.A.
Maltese: ZENTIVA S.A.
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilita
English: In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' Docetaxel Zentiva 160 mg/8 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Maltese: Docetaxel Zentiva 20 mg/1ml konċentrat sterili docetaxel
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: Ir-reazzjonijiet avversi l-aktar komunement irrapportati ta' docetaxel innifsu huma: newtropenija (li kienet riversibbli u mhux kumulattiva: il-jum medjan biex jintlaħaq in-nadir kien ta' 7 ijiem u ż-żmien medju ta' dewmien tan-newtropenija severa (< 500 ċelluli/mm3) kien ta' 7 ijiem), anemija, alopeċja,
English: A. LABELLING
Maltese: III (TAX
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Maltese: (żmien medjan attwali ta' osservazzjoni ta' 8 snin), l-edima periferika kienet għada għaddejja f'19-il pazjent TAC (2.6%) u f'4 pazjenti (0.5%) fil-fergħa FAC.
English: Vomiting (G3/4: 1.2%)
Maltese: Deni (G3/4: 1.2%)
English: Tel: +40 021 304 7597
Maltese: Τηλ: +357 240 30 144
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX prodotti oħra mediċinali ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan il-prodott mediċinali (Docetaxel Zentiva 20 mg/1 ml konċentrat għal soluzzjoni għallinfużjoni, li jkun fih biss kunjett wieħed).
English: Asthenia (severe:
Maltese: Astenja (severa:
English: Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Maltese: Parasteżija; Ugigħ ta' ras; Disgewżja;
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX prodotti oħra mediċinali ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan il-prodott mediċinali (Docetaxel Zentiva 160 mg/8 ml konċentrat għal soluzzjoni għallinfużjoni, li jkun fih biss kunjett wieħed).
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Maltese: It-total ta' 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/m2 li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/m2
English: For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Maltese: Għal aġġustamenti fid-dożi, fil-każ ta' cisplatin u 5-fluorouracil, ara s-sommarji tal-karatteristiċi tal prodotti .
English: Docetaxel Zentiva will be administered to you by a healthcare professional.
Maltese: Docetaxel Zentiva sejjer jingħatalek minn professjonist fil-qasam tas-saħħa.
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Docetaxel Zentiva 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil
English: The recommended dose of docetaxel is 75 mg/m2 every 3 weeks for 6 cycles.
Maltese: doxorubicin (75 mg/m2 kull 3 ġimgħat).
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Maltese: L-użu flinkien ma' cisplatin u 5-fluorouracil għat-trattament ta'pazjenti b'adenokarċinoma ta' l istonku, l-istudju tal-pern eskluda pazjenti b'ALT u/jew AST > 1.5 x ULN, assoċjat ma' alkaline phosphatase ta' > 2.5 x ULN, u bilirubin > 1 x ULN; għal dawn il-pazjenti, tnaqqis fid-dożi ma jistgħux ikunu irrakkomandati u docetaxel m'għandux jintuża, sakemm hu strettament indikat.
English: Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Maltese: docetaxel titqabbel ma' pacilitaxel fit-trattament ta' kanċer tas-sider avvanzat, f'pazjenti li t-terapija preċedenti kellha tinkludi xi anthracycline.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² single agent
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel Zentiva 75 mg/m²
English: 1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
Maltese: F'dan l-istudju, 255 pazjent kienu mqassmin, mingħajr għażla, għall-kura b'docetaxel (75 mg/m2 bħala infużjoni fil-vini fuq perijodu ta' siegħa, kull 3 ġimgħat) u capecitabine (1250 mg/m2 darbtejn kuljum għal ġimgħatejn, segwit b'perijodu ta' waqfien għal ġimgħa). 256 pazjent kienu mqassmin, mingħajr għażla, għall-kura b'docetaxel biss (100 mg/m2 bħala infużjoni filvini fuq perjodu ta' siegħa kull 3 ġimgħat).
English: Others
Maltese: L
English: In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' Docetaxel Zentiva 20 mg/1 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Żieda fil-bilirubin fiddemm (9%)
English: In Docetaxel Zentiva 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' Docetaxel Zentiva 80 mg/4 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Maltese: Docetaxel Zentiva flimkien ma' prednisone jew prednisolone huwa indikat għat-trattament tal-kanċer metastatiku tal-prostata, reżistenti għall-kastrazzjoni.
English: Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study (TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Maltese: Twissijiet dwar l-użu f'kanċer tal-prostata reżistenti għall-kastrazzjoni Minn 333 pazjent ittrattati b'docetaxel kull tliet ġimgħat fi studju fiq il-kanċer tal-prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
English: Efficacy of docetaxel in combination with prednisone or prednisolone and standard of care in the treatment of patients with metastatic hormone-sensitive prostate cancer (STAMPEDE)
Maltese: L-effikaċja ta' docetaxel flimkien ma' prednisone jew prednisolone u kura standard fit-trattament ta' pazjenti b'kanċer tal-prostata metastatiku sensittiv għall-ormon (STAMPEDE).
English: • dizziness
Maltese: ċikli..
English: Tabulated summary of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal Docetaxel 100 mg/m2 flimkien ma' trastuzumab
English: Docetaxel Zentiva in combination with capecitabine
Maltese: 2Is-sopravivenza medjana u stmata Docetaxel Zentiva użat flimkien ma' capecitabine
English: The required volume of Docetaxel Zentiva concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: 5% soluzzjoni tal-glukosju jew ta' kloridu tas-sodju 9 mg/ml (0.9%) għall-infużjoni.
English: • ADT alone
Maltese: • ADT waħdu
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hija probabbli stima baxxa għax docetaxel waħdu f'doża ta'100 mg/m2 hu magħruf li jġib in-newtropenija f'97%tal-pazjenti, 76% fi grad 4, meta ibbażata fuq in-nadir ta' l-għadd taċ ċelluli fid-demm.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: Docetaxel Zentiva użat flimkien ma' doxorubicin Studju wieħed kbir fil-fażi
English: Conjunctivitis (G3/4:
Maltese: Konġuntivite (G3/4:
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Maltese: Anemija (G3/4: 20.9%); Newtropenija (G3/4: 83.2%);
English: Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari għat-terapija miżjuda b'DOCETAXEL 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: Epistaxis (G3/4: < 1%)
Maltese: Uġigħ ta' ras (G3/4: < 1%);
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Maltese: Kull ml ta' konċentrat fih 20mg docetaxel li huwa trihydrate.
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-edima periferika li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjoni f'4 pazjenti (0.8 %) fil-fergħa TAC u f'2 pazjenti (0.4 %) fil fergħa FAC.
English: • Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.)
Maltese: • Pustullożi Eksantematuża Akuta Mifruxa (AGEP, Acute Generalized Exanthematous
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Docetaxel Zentiva 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Maltese: Kull ml tal-konċentrat għal soluzzjoni għall infużjoni ta' docetaxel fih 20 mg ta' docetaxel .
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Fġir l-imnieħer; Uġigh fil farinġi u llarinġi; Farinġite tal-parti nażali; Qtugħ ta' nifs; Sogħla; Tnixxija mill-imnieħer
English: Docetaxel Zentiva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Maltese: Docetaxel Zentiva flimkien ma' cisplatin u 5-fluorouracil huwa indikat fit-trattament ta' pazjenti li għandhom adenokarċinoma metastatika ta' l-istonku, inkluż l-adenokarċinoma tal-parti fejn l-istonku jingħaqad ma' l-esofagu, u li ma kienux ħadu l-kimoterapija qabel, għal mard metastatiku.
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Maltese: Newropatija periferika tassensazzjoni (G3/4: 1.2%); Disgewzja (G3/4: 0%)
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Maltese: Fil-qasam ta' l-istudji fejn Docetaxel Zentiva intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: • oesophagitis
Maltese: Uġigh
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Docetaxel Zentiva 80 mg/4 ml konċentrat u solvent għal soluzzjoni għall-infużjoni
English: Package leaflet: Information for the patient Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: Informazzjoni għall-pazjent Docetaxel Zentiva 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni docetaxel
English: Nausea (G3/4: 9.6%);
Maltese: Disgewżja (G3/4: 0.6%);
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Maltese: Pressjoni baxxa (G3/4: 0%); Flebite (G3/4: 0%);
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Maltese: Docetaxel Zentiva 75 mg/m² bħala sustanza użata waħedha:
English: Package leaflet: Information for the patient Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: Informazzjoni għall-pazjent Docetaxel Zentiva 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni docetaxel
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Maltese: Għalhekk, id-doża irrakkomandata ta' docetaxel f'dawk il-pazjenti li għandhom livelli għolja fit-testijiet tal-funzjoni tal-fwied (LFTs) huwa 75 mg/m2 u l-LFTs irid jiġi meqjus fil-bidu u qabel kull ċiklu ta' trattament (arasezzjoni 4.2).
English: Anaemia (G3/4: 20.9%);
Maltese: Letarġija (G3/4: 19.0%);
English: How to store Docetaxel Zentiva
Maltese: X'fih Docetaxel Zentiva
English: Anaemia (G3/4: 9.4%); Febrile neutropenia;
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Anorexja (G3/4: 0.6%) Disturbi fis-sistema nervuża
English: 1 dose 50 doses
Maltese: 50 dożi
English: EU/2/19/244/001 EU/2/19/244/002 EU/2/19/244/003
Maltese: EU/2/19/244/002
English: Zero days.
Maltese: Injetta 0.
English: The frequency of adverse reactions is defined using the following convention:
Maltese: Il-frekwenza tal-effeti mhux mixtieqa hija definita bil-konvenzjoni li ġejja:
English: Solvent for Nobivac Myxo-RHD PLUS
Maltese: Solvent Nobivac Myxo-RHD PLUS
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate
Maltese: Disodium phosphate dihydrate Potassium dihydrogen phosphate Ilma għall-injezzjoni
English: Date of first authorisation: 19/11/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 19/11/2019
English: 0.5 ml 10 ml
Maltese: 0.5ml
English: Name and address of the manufacturer of the biological active substances Intervet International B.V.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva Intervet International BV
English: Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
Maltese: VETERINARJU Nobivac Myxo-RHD PLUS lijofiliżat u solvent għal suspensjoni għal injezzjoni għall-fniek
English: Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Maltese: Immunoloġiku għall-leporidae, vaċċin virali ħaj, Kodici ATC veterinarja:
English: The active substances 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: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U TAL
English: Plastic box with 5 x 1 dose vials of vaccine and 5 x 0.5 ml solvent vials (glass) Plastic box with 25 x 1 dose vials of vaccine and 25 x 0.5 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Maltese: Kaxxa tal-plastik b`5 x 1 doża tal-vaċċin u 5 x 0.5ml jfali(ħġieġ) ta s-solvent Kaxxa tal-plastik b` 25 x 1 doża tal-vaċċin u 25 x 0.5ml fjali (ħġieġ) tas-solvent Kaxxa tal-kartun b`10 x 50 dożi tal-vaċċin
English: For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
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 (RHDV1) u RDH tip 2 (RDHV2).
English: Intervet International B.V. Wim de Körverstraat 35
Maltese: Intervet International BV
English: Solvent: Type I clear glass vial of 0.5 ml or 10 ml closed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Solvent Fjala tal-ħġieġ trasparenti tip I ta' 0.5ml jew 10ml, magħluq b' tapp tal-gomma (bromobutyl) u kappa tal-aluminju.
English: *Focus Forming Units For the full list of excipients, see section 6.1.
Maltese: *Focus Forming Units
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: Lyophilisate and solvent for suspension for injection
Maltese: Lijofilizat u solvent għall-suspensjoni għall-injezzjoni
English: Add 1 -2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
Maltese: Żid 1-2ml solvent mal-fjala(i) tal-50 doża u kun ċert li l-lijofiliżat inħall kompletament.
English: High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Maltese: Livelli għoljin ta` antikorpi ġejjin mill-omm kontra l-virus myxoma u/jew RHD virus jistgħu potenzjaliment inaqqsu l-effikaċja ta`dan il-prodott.
English: Live myxoma vectored RHD viruses
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Virus ħaj myxoma vectored RHD
English: Lot {number}
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Maltese: Kull doża (0.2 ml jew 0.5ml) tal-vaċċin rikostitwit fiha:
English: Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU * Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU* *Focus Forming Units
Maltese: Strejn tal-virus ħaj myxoma vectored RHD 009:103.0 -105.8 FFU* Strejn tal-virus ħaj myxoma vectored RHD MK1899: 103.0 -105.8 FFU* *Focus Forming Units
English: The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
Maltese: Sabiex jistimula l-immunità kontra l-virus myxoma u l-marda virali emorraġika tal-fniek.
English: Lyophilisate: Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Fjal tal-ħġieġ trasparenti tip I ta' 1 jew 50 doża b'tapp tal-gomma (chloronobutyl) u kappa tal aluminju
English: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU* Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU*
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Strejn tal-virus ħaj myxoma vectored RHD 009:103.0 -105.8 FFU* Strejn tal-virus ħaj myxoma vectored RHD MK1899: 103.0 -105.8 FFU*
English: - Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Maltese: - Kaxxa tal-plastik b'5 x 1 doża fjala tal-vaċċin u 5 fjali li fihom 0.5ml f tas-solvent.
English: - Plastic box with 25 x 1 dose vial of vaccine and 25 vials containing 0.5 ml of solvent.
Maltese: - Kaxxa tal-plastik b'25 x 1 doża fjala tal-vaċċin u 25 fjali li fihom 0.5ml tas-solvent.
English: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU/dose.
Maltese: Strejn tal-virus ħaj myxoma vectored RHD 009:103.0 - 105.
English: 0.5 ml and 10 ml glass vial
Maltese: TIKETTA SOLVENT 0.5ml u 10ml fjali tal-ħġieġ
English: The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses.
Maltese: L-istrejn tal-vaċċin huwa myxomatosis li juri l-ġene tal-proteina capsid tal-virus klassiku jew virus tip 2 RHD.
English: 5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine
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
English: Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU/dose.
Maltese: FFU* Strejn tal-virus ħaj myxoma vectored RHD MK1899: 103.0 -105.8 FFU*
English: - Cardboard box with 10 x 50 doses vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Maltese: - Kaxxa tal-kartun b' 10 x 50 dożi fjala tal-vaċċin ; u kaxxa tal-kartun b' 10 x 10 ml fjala tas solvent
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: − rari ħafna (anqas minn 1 annimal kull 10,000 annimal, inkluż rapporti iżolati).