FrancophonIA/ELRC3.0 huggingface dataset:
English: Targocid and associated names (see Annex I) 100 mg powder and solvent for solution for injection/infusion or oral solution Targocid and associated names (see Annex I) 200 mg powder and solvent for solution for injection/infusion or oral solution Targocid and associated names (see Annex I) 400 mg powder and solvent for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (Ara Anness I) 100 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali Targocid u ismijiet assoċjati (Ara Anness I) 200 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali Targocid u ismijiet assoċjati (Ara Anness I) 400 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali [Ara Anness I -Biex timtela mill-pajjiż partikolari]
English: 400 mg intravenous or intramuscular (this equates to approximately 6 mg/kg body weight) every 12 hours for 3 administrations
Maltese: 400 mg minn ġol-vini jew minn ġolmuskoli (dan huwa daqs madwar 6 mg/kg piż tal-ġisem) kull 12-il siegħa għal 3 għotjiet
English: Coagulase-negative staphylococci a
Maltese: Staphylococci negattivi għall-coagulasea
English: Loading dose regimen
Maltese: Mekkaniżmu ta' reżistenza
English: Thrombocytopenia
Maltese: Suxxettibbli
English: • Ringer solution
Maltese: • soluzzjoni ta' Ringer
English: For Targocid, powder for solution for injection/infusion or oral solution - 1 powder vial - 5x1 powder vials - 10x1 powder vials - 25x1 powder vials
Maltese: Għal Targocid, trab għal soluzzjoni għall-injezzjoni/għall-infużjoni jew soluzzjoni orali - kunjett wieħed ta' trab - 5x1 kunjetti ta' trab - 10x1 kunjetti ta' trab - 25x1 kunjetti ta' trab
English: Patients in continuous ambulatory peritoneal dialysis (CAPD) After a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week and then 20 mg/L in the overnight bag in the third week.
Maltese: IE a L-MICs tal-glycopeptide huma dipendenti mill-metodu u għandhom jiġu determinati permezz ta' mikrodilwizzjoni ta' brodu (referenza ISO 20776). S. aureus b'valuri MIC ta' 2 mg/mL għal vancomycin qegħdin fid-demarkazzjoni tad-distribuzzjoni tal-MIC bħal dik li tinstab fin-natura u għalhekk jista' jkun hemm indeboliment fir-rispons kliniku.
English: Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.
Maltese: Prekawzjonijiet speċjali għandhom jittieħdu meta teicoplanin jingħata f'pazjenti li jeħtieġu kura konkomittanti bi prodotti mediċinali tossiċi għall-widnejn u/jew għall-kliewi li għalihom huwa rrakkomandat li jsiru testijiet regolari ematoloġiċi, tal-funzjoni tal-fwied u tal-kliewi.
English: • in a Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal.
Maltese: • f'kunjett tal-ħġieġ tat-Tip I, bla kulur b'volum siwi ta' 10 mL għal 200 mg magħluq b'tapp tallastku bromobutyl u għatu tal-plastik li jinfetaħ b'saba wieħed kollox magħluq b'siġill isfar talaluminju.
English: • in a Type I, colourless glass vial of useful volume of 8 mL for 100 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium red overseal.
Maltese: • f'kunjett tal-ħġieġ tat-Tip I, bla kulur b'volum siwi ta' 8 mL għal 100 mg magħluq b'tapp tal-lastku bromobutyl u għatu tal-plastik li jinfetaħ b'saba wieħed kollox magħluq b'siġill aħmar tal-aluminju.
English: Type I, colourless glass vial of useful volume of 22 mL for 400 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium green overseal.
Maltese: Kunjett tal-ħġieġ tat-Tip I, bla kulur b'volum ta' siwi ta' 22 mL għal 400 mg magħluq b'tapp tal-lastku bromobutyl u għatu tal-plastik li jinfetaħ b'saba wieħed kollox magħluq b'siġill aħdar tal-aluminju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 100 mg, 200 mg and 400 mg / powder for solution for injection/infusion or oral solution
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA GĦAL 100 mg, 200 mg u 400 mg / trab għal soluzzjoni għallinjezzjoni/infużjoni jew soluzzjoni orali
English: Teicoplanin has a low total clearance in the range of 10 to 14 mL/h/kg and a renal clearance in the range of 8 to 12 mL/h/kg indicating that teicoplanin is mainly excreted by renal mechanisms.
Maltese: Teicoplanin għandu tneħħija totali baxxa fil-medda bejn 10 u 14-il mL/siegħa/kg u tneħħija mill-kliewi fuq medda bejn 8 u 12-il mL/siegħa/kg li juri li l-biċċa l-kbira ta' teicoplanin tneħħa permezz ta' mekkaniżmi mill-kliewi.
English: The modification is based on exchange of the terminal D-alanine-D-alanine function of the aminoacid chain in a murein precursor with D-Ala-D-lactate, thus reducing the affinity to vancomycin.
Maltese: Il-bidla hija bbażata fuq skambju tal-funzjoni ta' D-alanine-D-alanine terminali tal-katina tal-aċidi amminiċi fi prekursur tal-murein b'D-Ala-D-lactate, u b'hekk tonqos l-affinità għal vancomycin.
English: Targocid and associated names (see Annex I) is also indicated as an alternative oral treatment for Clostridium difficile infection-associated diarrhoea and colitis.
Maltese: Targocid u ismijiet assoċjati (ara Anness I) huwa indikat ukoll bħala kura alternattiva mill-ħalq għal dijarea u kolite assoċjati ma' infezzjoni bi Clostridium difficile.
English: 12 mg/kg body weight intravenous or intramuscular once a day
Maltese: 12 mg/kg piż talġisem minn ġol-vini jew minn ġol-muskolu darba kuljum
English: A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).
Maltese: Ma tistax tiġi eskluża l-possibbiltà ta' riskju ta' ħsara fil-widna ta' ġewwa u fil-kliewi tal-fetu (ara sezzjoni 4.4).
English: Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.
Maltese: Sensittività eċċessiva għal teicoplanin jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.
English: For storage conditions of the reconstituted/diluted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita ppreparata kif rrakkomandat intweriet għal 24 siegħa f'temperatura bejn 2 u 8°C.
English: Type I, colourless glass vial of useful volume of 8 mL for 100 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium red overseal.
Maltese: Kunjett tal-ħġieġ tat-Tip I, bla kulur b'volum siwi ta' 8 mL għal 100 mg magħluq b'tapp tal-lastku bromobutyl u għatu tal-plastik li jinfetaħ b'saba wieħed kollox magħluq b'siġill aħmar tal-aluminju.
English: Each vial contains 200 mg teicoplanin equivalent to not less than 200,000 IU After reconstitution, the solutions will contain 200 mg teicoplanin in 3.0 mL
Maltese: Kull kunjett fih 200 mg teicoplanin ekwivalenti għal mhux anqas minn 200,000 UI
English: Patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known neurotoxic/ototoxic potential (aminoglycosides, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.
Maltese: Pazjenti li qed jirċievu teicoplanin flimkien jew konsekuttivament ma' prodotti mediċinali oħra magħrufa li għandhom possibbilità newrotossika/tossika għall-widnejn (aminoglycosides, ciclosporin, cisplatin, furosemide u ethacrynic acid) għandhom jiġu mmonitorjati b'attenzjoni u l-benefiċċju ta' teicoplanin għandu jiġi stmat jekk is-smigħ imur għall-agħar.
English: Teicoplanin can cause dizziness and headache.
Maltese: Teicoplanin ma jitneħħiex permezz tal-emodijalisi.
English: Targocid and associated names (see Annex I) 200 mg powder and solvent for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 200 mg trab u solvent għal soluzzjoni għallinjezzjoni/infużjoni jew soluzzjoni orali
English: Targocid and associated names (see Annex I) 400 mg powder and solvent for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 400 mg trab u solvent għal soluzzjoni għallinjezzjoni/infużjoni jew soluzzjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Targocid and associated names (see Annex I) 200 mg powder for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 200 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali
English: • For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
Maltese: • Għal persuni bi problemi minn ħfief sa moderati fil-kliewi - id-doża ta' manteniment tingħata kull jumejn, jew nofs id-doża ta' manteniment tingħata darba kuljum.
English: Studies to investigate the potential to cause ototoxicity in the guinea-pig indicate that a mild impairment of cochlear and vestibular function is possible, in the absence of morphological damage.
Maltese: Studji biex jinvestigaw il-potenzjal ta' kawża ta' tossiċità fil-widnejn fil-fenek tal-Indi juru li, fin-nuqqas ta' ħsara morfoloġika, huwa possibbli indeboliment ħafif fil-funzjoni ta' ħofret il-widna u tal-vestibolu.
English: Renal and Urinary disorders
Maltese: Disturbi filkliewi u fissistema urinarja
English: • Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein.
Maltese: • Doża ta' manteniment: 8 mg għal kull kilogramma ta' piż tal-ġisem, mogħtija darba kuljum, bħala infużjoni permezz ta' dripp ġo vina.
English: Targocid and associated names (see Annex I) 100 mg powder for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 100 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali
English: Babies (from birth to the age of 2 months)
Maltese: Tfal (minn xahrejn sa 12-il sena)
English: When administered by oral route at 250 or 500 mg single dose to healthy subjects, teicoplanin is not detected in serum or urine but only recovered in feces (about 45% of the administered dose) as unchanged medicinal product.
Maltese: Meta ngħata mill-ħalq b'doża waħda ta' 250 jew 500 mg lill-individwi f'saħħithom, teicoplanin ma jinstabx fis-serum jew flawrina iżda jiġi rkuprat biss mill-ippurgar (madwar 45% tad-doża mogħtija) bħala prodott mediċinali mhux mibdul.
English: Pain, pyrexia
Maltese: FULJETT TA' TAGĦRIF
English: Targocid and associated names (see Annex I) 400 mg powder for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 400 mg trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: • Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every
Maltese: • Doża tal-bidu (għall-ewwel tliet dożi): 10 mg għal kull kilogramma piż tal-ġisem, mogħtija kull
English: Abcess
Maltese: Targosid
English: Each vial contains 100 mg teicoplanin equivalent to not less than 100,000 IU After reconstitution, the solutions will contain 100 mg teicoplanin in 1.5 mL
Maltese: Kull kunjett fih 100 mg teicoplanin ekwivalenti għal mhux anqas minn 100,000 UI
English: • For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.
Maltese: • tieħu aktar infezzjonijiet mis-soltu - dawn jistgħu jkunu sinjali ta' tnaqqis fl-għadd taċ-ċelluli fid demm tiegħek.
English: Preparation of the diluted solution before infusion:
Maltese: Preparazzjoni tas-soluzzjoni ddilwita qabel l-infużjoni:
English: Teicoplanin distributed mainly in lung, myocardium and bone tissues with tissue/serum ratios superior to 1.
Maltese: Teicoplanin ġie ddistribwit l-aktar fil-pulmuni, fit-tessuti tal-mijokardju u tal-għadam bi proporzjonijiet fit-tessuti/serum ta' aktar minn 1.
English: Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal.
Maltese: Kunjett tal-ħġieġ tat-Tip I, bla kulur b'volum ta' siwi ta' 10 mL għal 200 mg magħluq b'tapp tal-lastku bromobutyl u għatu tal-plastik li jinfetaħ b'saba wieħed kollox magħluq b'siġill isfar tal-aluminju.
English: • decrease in platelet count.
Maltese: • Indeboliment tal-kliewi:
English: • sudden life-threatening allergic reaction - the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills
Maltese: • Reazzjoni allerġika f'daqqa ta' theddida għall-ħajja - is-sinjali jistgħu jinkludu: tbatija bit-teħid tannifs jew tħarħir, nefħa, raxx, ħakk, deni, tkexkix ta' bard
English: Targocid and associated names (see Annex I) 100 mg powder and solvent for solution for injection/infusion or oral solution
Maltese: Targocid u ismijiet assoċjati (ara Anness I) 100 mg trab u solvent għal soluzzjoni għallinjezzjoni/infużjoni jew soluzzjoni orali
English: In embryofetal development studies, no malformations were observed following subcutaneous administration of up to 200 mg/kg/day in the rat and intramuscular administration up to 15 mg/kg/day in the rabbit.
Maltese: Flistudji ta' żvilupp tal-embrju u tal-fetu, ma kienu osservati l-ebda formazzjonijiet difettużi wara għoti taħt il-ġilda sa 200 mg/kg/jum fil-far u għoti minn ġol-muskoli sa 15-il mg/kg/jum fil-fenek.
English: For Targocid, powder and solvent for solution for injection/ infusion or oral solution What Targocid contains
Maltese: Targocid huwa trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali.
English: If you forget to have Targocid
Maltese: X'għandek tkun taf qabel ma tingħata Targocid
English: Thrombocytopenia has been reported with teicoplanin.
Maltese: Ġiet irrappuratata tromboċitopenija b'teicoplanin.
English: • you have a decrease in platelet count (thrombocytopenia)
Maltese: • livelli tal-kreatinina fid-demm jogħlew (biex jimmonitorjaw il-kilwa tiegħek)
English: • It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
Maltese: • Hija tingħata permezz ta' injezzjoni ġo vina (użu minn ġol-vini) jew muskolu (użu minn ġol muskoli).
English: For Targocid, powder for solution for injection/infusion or oral solution What Targocid contains
Maltese: Għal Targocid, trab għal soluzzjoni għall-injezzjoni/infużjoni jew soluzzjoni orali X'fih Targocid
English: (Invented) name
Maltese: (multiplu)
English: Content (concentration)
Maltese: Kontenut (konċentrazz joni)
English: 6 (3 x 2) pre-filled pens (multipack)
Maltese: 6 (3x2) pinnen mimlijin lesti (multiplu)
English: 1 cartridge + 1 automated minidoser
Maltese: 1 skartoċċ + 1 automated mini-doser skartoċċ (plastik)
English: 3 (3 x 1) cartridges + 3 (3 x 1) automated minidosers (multipack)
Maltese: 3 (3 x 1) skrataċ + 3 (3
English: Pack size
Maltese: pinna mimlija lesta
English: Pre-filled syringe (glass)
Maltese: skartoċċ (plastic)
English: VIAL (1 ML SUSPENSION)
Maltese: KUNJETT (SOSPENSJONI 1 ML)
English: Canine parainfluenza virus Type 2
Maltese: Canine parainfluenza virus Tip 2
English: Store and transport refrigerated (2°C-8°C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: *** International units.
Maltese: *** Unitajiet internazzjonali.
English: ** Antibody micro agglutination-lytic reaction.
Maltese: * 50% doża infettiva tat-tessut ikkultivat. ** Antibody micro agglutination-lytic reaction.
English: Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
Maltese: Sospensjoni (inattivat): L.interrogans serovar Icterohaemorrhagiae
English: Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70
Maltese: Trometamol Edetic acid Sucrose
English: ATC vet code: QI07AJ.
Maltese: QI07AJ.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/173/001
Maltese: FIS-SUQ EU/2/14/173/001
English: None.
Maltese: IU
English: Dose and route of administration:
Maltese: Doża u metodu ta' amministrazzjoni:
English: Suspension (inactivated):
Maltese: Sospensjoni (inattivat):
English: Suspension: pink colour with fine sediment.
Maltese: Sospensjoni: kulur roża b'sediment fin.
English: Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Maltese: Canine parainfluenza virus Tip 2, strejn CPiV-2 Bio 15
English: Rabies virus
Maltese: Virus tar-rabja
English: However, in field studies 10% of sero-negative dogs did not show seroconversion (> 0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Maltese: Mandankollu, f'field studies 10% ta' klieb sero-negattivi ma wrewx serokonverżjoni (> 0.1 IU/ml) 3-4 ġimgħat wara doża primarja waħda kontra r-rabbja.
English: Two doses of Versican Plus Pi/L4R 3-4 weeks apart from 8-9 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus Pi/L4R 3 - 4 ġimgħat minn xulxin minn età ta' 8 - 9 ġimgħat.
English: Potassium chloride
Maltese: Klorur tal-potassju
English: Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension.
Maltese: Kaxxa tal-plastik b'25 kunjett (doża waħda) tal-lijofiliżat u 25 kunjett (1 ml) tas-sospensjoni.
English: Pack sizes:
Maltese: Ingredjent ieħor:
English: Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini virali ħajjin u inattivati u vaċċini batteriċi inattivati..
English: Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension.
Maltese: Kaxxa tal-plastik b'50 kunjett (doża waħda) tal-lijofiliżat u 50 kunjett (1 ml) tas-sospensjoni.
English: Disodium phosphate dodecahydrate
Maltese: Potassium dihydrogen phosphate Sodium dihydrogen phosphate dodecahydrate Ilma għall-injezzjonijiet
English: PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni.
English: Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml sospensjoni magħluqa b'tapp tal-chlorobutyl rubber u kappa talaluminju.
English: Adjuvant:
Maltese: Rabbja:
English: At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Maltese: Tal-anqas sena wara l-kors ta' tilqim primarju għall-komponenti tal-canine parainfluenza virus u Leptospira.
English: Therefore, the first dose may be given using Versican Plus Pi/L4.
Maltese: Għalhekk l-ewwel doża tista' tingħata bl-użu ta' Versican Plus Pi/L4.
English: Lyophilisate and suspension for suspension for injection.
Maltese: Lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Maltese: It-tilqima hija intenzjonata għall-immunizzazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-canine parainfluenza virus, mill-Leptospira interrogens serogrupp Australis serovar
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
Maltese: VETERINARJU Versican Plus Pi/L4R lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb.
English: Primary vaccination scheme:
Maltese: Kodici ATC veterinarju:
English: Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Maltese: Ħallat sew u immedjatament amministra lkontenut kollu (1 ml) tal-prodott rikostitwit.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate for dogs
Maltese: Versican Plus Pi/L4R lijofiliżat għall-klieb
English: PACKAGE LEAFLET: Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
Maltese: Versican Plus Pi/L4R lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb
English: Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.
Maltese: Sinjali kliniċi ta' mard immunitarju, bħal anemija ħimolitika, trombosajtopinja jew poliartrite ġew rappurtati f'każijiet rari ħafna.
English: Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Maltese: Il-kompetenza immunitarja tal-annimal tista' tiġi kompromessa minn varjetà ta' fatturi li jinkludu saħħa fqira, stat nutrizzjonali, fatturi ġenetiċi, kura b'mediċini fl-istess ħin u stress.
English: IU/ml after the primary vaccination.
Maltese: IU/ml).
English: Annual re-vaccination is required for canine parainfluenza and Leptospira components.
Maltese: Hemm bżonn ta' tilqima repetuta kull sena għall-Parainfluenza u għall-komponenti tal-Leptospira.
English: Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after completion of the primary course for Leptospira components.
Maltese: - Ġimagħtejn wara tilqima waħda minn età ta' 12-il ġimgħa għar-rabbja. - 3 ġimgħat wara li jintemm il-kors primarju għal CpiV, u - 4 ġimgħat wara li jintemm il-kors primarju għall-komponenti tal-Leptospira.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R suspension for dogs
Maltese: Versican Plus Pi/L4R sospensjoni għall-klieb
English: Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Maltese: Bratislava, Leptospira interrogens serogrupp Canicola servar Canicola, Leptospira kirschneri serogrupp Grippotyphosa serovar Grippotyphosa, Leptospira interrogens serogrupp
English: 6.5 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih doża waħda ta' lijofiliżat magħluqa b'tapp tal-bromobutyl rubber u kappa tal-aluminju.
English: Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age.
Maltese: Tul tal-immunità għar-rabbja ġie ddimostrat wara tilqima waħda f'età ta' 12-il ġimgħa.
English: OTHER INFORMATION
Maltese: DIFFERENTI
English: Adjuvant: Aluminium hydroxide
Maltese: EFFETTI MHUX MIXTIEQA
English: The procedure started in November 2010.
Maltese: Il-proċedura bdiet f'Novembru 2010.
English: Overall conclusion
Maltese: Konklużjonijiet ġenerali
English: Benefit-risk balance
Maltese: Il-bilanċ tal-benefiċċju-riskju
English: Limited clinically relevant efficacy has been demonstrated in the paediatric population.
Maltese: Intweriet effikaċja klinikament rilevanti limitata fil-popolazzjoni pedjatrika.
English: • The CHMP considered the totality of the available data, including the 2010 French safety review;
Maltese: • Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli, inkluż ir-reviżjoni
English: The overall therapeutic benefit was considered to be limited;
Maltese: Il-benefiċċju terapewtiku ġenerali tqies li huwa limitat;
English: When taking into account all system organ classes, the reported adverse drug reactions (ADRs) were mainly nervous system disorders.
Maltese: Meta titqies il-klassifika tas-sistema talorgani kollha, ir-reazzjonijiet avversi għall-mediċina (ADRs) rrappuratati kienu prinċipalment disturbi tas-sistema nervuża.