FrancophonIA/ELRC3.0 huggingface dataset:
English: Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme).
Maltese: Trattament għall-ħniex (Toxocara cati u Ancylostoma tubaeforme).
English: Advocate 250 mg + 62.5 mg spot-on solution for large dogs Imidacloprid, moxidectin
Maltese: VETERINARJU Advocate 250 mg + 62.5 mg taħlita likwida għal użu lokalizzat fuq klieb kbar
English: Advocate for small cats (≤ 4 kg) and ferrets
Maltese: Advocate għall-qtates żgħar (≤ 4 kg) u nimsa
English: Cats, ferrets
Maltese: Qtates, nimsa
English: Heartworm
Maltese: Imidakloprid
English: Advocate 80 mg + 8 mg spot-on solution for large cats Imidacloprid, moxidectin
Maltese: Advocate 80 mg + 8 mg taħlita likwida għal użu lokalizzat fuq qtates kbar
English: Advocate for extra-large dogs (> 25-40 kg)
Maltese: Advocate għal klieb kbar ħafna (> 25-40 kg)
English: Unit dose Imidacloprid Moxidectin
Maltese: Il-ħniex it-tondi tal-imsaren
English: Each 0.4 ml pipette contains: Active substances: 40 mg imidacloprid, 4 mg moxidectin
Maltese: 4ml fiha: Sustanzi attivi: 40 mg Imidakloprid, 4mg Moksidektin
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Maltese: Manifattur responsabbli għall-ħrug tal-lott: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str.
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Maltese: Resistenza tal-parassita għal xi klassi partikulari ta' sustanza kontra d-dud tista' tiżviluppa wara li jsir użu frekwenti u repetut ta' din is-sustanza ta' din il-klassi.
English: Flea larvae
Maltese: Dudu frosta
English: This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the product as described under the section “ADVICE ON CORRECT ADMINISTRATION”; in particular, oral uptake by the recipient and/or other animals in close contact should be prevented.
Maltese: Dan il-prodott fih il-moksidektin (laktonju makroċikliku), għalhekk, għandha tingħata attenzjoni speċjali fuq klieb tar-razza Collies jew Old English Sheep dogs u razez simili jew taħlit ta' razez simili; biex il-prodott jiġi amministrat kif spjegat fis-sezzjoni “TAGĦRIF FUQ APPLIKAZZJONI KORRETTA”¸ partikularment għandu jiġi evitat li annimali trattati /jew annimali oħra li jiġu f'kuntatt magħhom, jilgħaqu l-mediċina.
English: Each 0.4 ml pipette contains: Active substances: 40 mg imidacloprid, 10 mg moxidectin.
Maltese: 4ml fiha: Sustanzi attivi: 40 mg Imidakloprid, 10 mg Moksidektin
English: Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens)
Maltese: Għat-trattament ta' dirofilarjożi tal-ġilda (Dudu tal-ġilda) (stadji tal-adulti ta' Dirofilaria repens)
English: Do not use on canaries.
Maltese: Tużahx fuq il-kanarini.
English: For medium dogs weighing between 4 kg and 10 kg.
Maltese: SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT Għal klieb ta' daqs medju li jiżnu minn 4 kg sa 10kg
English: EU/2/03/039/011 3 pipettes EU/2/03/039/012 6 pipettes EU/2/03/039/018 4 pipettes EU/2/03/039/029 21 pipettes EU/2/03/039/030 42 pipettes EU/2/03/039/051 1 pipette EU/2/03/039/052 2 pipettes EU/2/03/039/053 9 pipettes EU/2/03/039/054 12 pipettes
Maltese: EU/2/03/039/011 3 pipetti EU/2/03/039/012 6 pipetti EU/2/03/039/018 4 pipetti EU/2/03/039/029 21 pipetti EU/2/03/039/030 42 pipetti EU/2/03/039/051 1 pipetta EU/2/03/039/052 2 pipetti EU/2/03/039/053 9 pipetti
English: • the treatment of biting lice (Trichodectes canis),
Maltese: • trattament tal-qamel li jigdem (Trichodectes canis),
English: The product has a persistent action and protects cats for 4 weeks after a single application against reinfection with Dirofilaria immitis.
Maltese: Il-prodott għandu azzjoni persistenti u jipproteġi lill-qtates għal 4 ġimgħat wara applikazzjoni waħda kontra infezzjoni mill-ġdid b'Dirofilaria immitis.
English: Each 4 ml pipette contains: Active substances: 400 mg imidacloprid, 100 mg moxidectin.
Maltese: Kull pipetta ta' 4 ml fiha: Sustanzi attivi: 400 mg Imidakloprid, 100 mg Moksidektin
English: For dogs suffering from, or at risk from, mixed parasitic infections:
Maltese: Għal qtates li jsofru, jew qegħdin fir-riskju ta' infezzjonijiet kawżati minn parassiti diversi:
English: The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for dogs.
Maltese: Id-dożi minimi rrikkmandati huma ta'10 mg Imidakloprid għal kull kg piż tal-ġisem, u 2.5 mg Moksidektin għal kull kg piż tal-ġisem, li jiġu ekwivalenti għal 0.1 ml Advocate għall-klieb, għal kull kg upiż tal-ġisem.
English: Advocate 400 mg + 100 mg spot-on solution for extra-large dogs Imidacloprid, moxidectin
Maltese: VETERINARJU Advocate 400 mg + 100 mg taħlita likwida għal użu lokalizzat fuq klieb kbar ħafna
English: • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
Maltese: L4, adulti immaturi u maturi tat-Toxocara cati u Ancylostoma tubaeforme).
English: EU/2/03/039/009 3 pipettes EU/2/03/039/010 6 pipettes EU/2/03/039/017 4 pipettes EU/2/03/039/027 21 pipettes EU/2/03/039/028 42 pipettes EU/2/03/039/047 1 pipette EU/2/03/039/048 2 pipettes EU/2/03/039/049 9 pipettes EU/2/03/039/050 12 pipettes
Maltese: EU/2/03/039/009 3 pipetti EU/2/03/039/010 6 pipetti EU/2/03/039/017 4 pipetti EU/2/03/039/027 21 pipetti EU/2/03/039/028 42 pipetti EU/2/03/039/047 1 pipetta EU/2/03/039/048 2 pipetti EU/2/03/039/049 9 pipetti
English: Advocate 40 mg + 4 mg spot-on solution for small cats and ferrets Imidacloprid, moxidectin
Maltese: VETERINARJU Advocate 40 mg + 4 mg taħlita likwida għal użu lokalizzat fuq il-friegħ tal-qtates u nimsa
English: Treatment of demodicosis (caused by Demodex canis)
Maltese: (ikkawżata minn Sarcoptes scabiei var canis), domodikosis (ikkawżata minn Demodex canis),
English: Advocate for small cats and ferrets (≤ 4 kg)
Maltese: Advocate għal klieb żgħar (≤ 4 kg)
English: Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
Maltese: Klieb infettati bid-dud tal-qalb adult, ittolleraw id-doża rrakkomandata sa 5 darbiet, kull ħmistax għal
English: Heartworm prevention (Dirofilaria immitis)
Maltese: Prevenzjoni tad-dudu tal-qalb (Dirofilaria immitis)
English: In endemic areas regular monthly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Maltese: F'żoni endemiċi, l-applikazzjoni regolari kull xahar ser tipprevjeni l-anġjostrongilożi u infezzjoni ovvja b'Angiostrogylus vasorum.
English: In case of accidental oral uptake, symptomatic treatment should be administered.
Maltese: Fil-każ li l-prodott jittieħed aċcidentalment b'mod orali, għandu jiġi amministrat trattament sintomatiku.
English: EU/2/03/039/007 3 pipettes EU/2/03/039/008 6 pipettes EU/2/03/039/016 4 pipettes EU/2/03/039/025 21 pipettes EU/2/03/039/026 42 pipettes EU/2/03/039/043 1 pipette EU/2/03/039/044 2 pipettes EU/2/03/039/045 9 pipettes EU/2/03/039/046 12 pipettes
Maltese: EU/2/03/039/007 3 pipetti EU/2/03/039/008 6 pipetti EU/2/03/039/016 4 pipetti EU/2/03/039/025 21 pipetti EU/2/03/039/026 42 pipetti EU/2/03/039/043 1 pipetta EU/2/03/039/044
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
Maltese: Pakkett ta' barra, pakkett ta' 1, 2, 3, 4, 6, 9, 12, 21 u 42 pipetti.
English: EU/2/03/039/001 3 pipettes EU/2/03/039/002 6 pipettes EU/2/03/039/013 4 pipettes EU/2/03/039/019 21 pipettes EU/2/03/039/020 42 pipettes EU/2/03/039/031 1 pipette EU/2/03/039/032 2 pipettes EU/2/03/039/033 9 pipettes EU/2/03/039/034 12 pipettes
Maltese: EU/2/03/039/001 3 pipetti EU/2/03/039/002 6 pipetti EU/2/03/039/013 4 pipetti EU/2/03/039/019 21 pipetti EU/2/03/039/020 42 pipetti EU/2/03/039/031 1 pipetta EU/2/03/039/032 2 pipetti EU/2/03/039/033 9 pipetti
English: EU/2/03/039/003 3 pipettes EU/2/03/039/004 6 pipettes EU/2/03/039/014 4 pipettes EU/2/03/039/021 21 pipettes EU/2/03/039/022 42 pipettes EU/2/03/039/035 1 pipette EU/2/03/039/036 2 pipettes EU/2/03/039/037 9 pipettes EU/2/03/039/038 12 pipettes
Maltese: EU/2/03/039/003 3 pipetti EU/2/03/039/004 6 pipetti EU/2/03/039/014 4 pipetti EU/2/03/039/021 21 pipetti EU/2/03/039/022 42 pipetti EU/2/03/039/035 1 pipetta EU/2/03/039/036 2 pipetti EU/2/03/039/037 9 pipetti
English: • the treatment and prevention of flea infestation (Ctenocephalides felis),
Maltese: • Għat-trattament u l-prevenzjoni ta' mard tal-briegħed (Ctenocephalides felis),
English: One treatment prevents future flea infestation for 3 weeks.
Maltese: Trattament wieħed jippreveni infestazzjoni futura tal-briegħed għal minn 3 ġimgħat.
English: In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Maltese: F'postijiet li mhumiex endemiċi għad-dudu tal-qalb, ilprodott jista' jiġi użat bħala programm ta' prevenzjoni kontra l-briegħed u ħniex gastrointestinali.
English: Alternative treatment should be administered.
Maltese: Għandu jiġi amministrat trattament alternattiv.
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 dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also sections 4.2 and 4.9).
Maltese: L-użu tal-prodott għandu jkun ibbażat fuq dijanjosi kkonfermata ta' infezzjoni mħallta (jew riskju ta' infezzjoni, fejn japplika prevenzjoni) fl-istess ħin (ara wkoll sezzjonijiet 4.2 u 4.9).
English: Weight of cat [kg]
Maltese: Piż tal qattus[kg]
English: • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
Maltese: Trattament għall-ħniex (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, Toxascaris leonina and Trichuris vulpis).
English: Treatment and prevention of Angiostrongylus vasorum A single dose should be administered.
Maltese: Trattament u prevenzjoni ta' Angiostrogylus vasorum Doża waħda għandha tiġi amministrata.
English: After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
Maltese: Jekk lannimal jilgħaq is-sit tal-applikazzjoni wara t-trattament, sinjali newroloġiċi (li ħafna minnhom huma temporanji) bħal atassja, rogħda ġeneralizzata, sinjali fl-għajnejn (twessigħ tal-pupilli, ftit rifless pupillari, nystagmus), respirazzjoni annormali, salivazzjoni u rimettar jistgħu jkunu osservati f'każi rari ħafna.
English: For ferrets suffering from, or at risk from, mixed parasitic infections:
Maltese: Għal nimsa li jsofru minn, jew jinsabu fir-riskju ta' infezzjonijiet imħallta parasitiċi:
English: Spot-on
Maltese: OĦRA
English: When 40 % of the unit dose was given orally, severe neurological signs were observed.
Maltese: Meta 40% taddoża ġiet mogħtija oralment, sinjali newroloġiċi ġew osservati.
English: • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
Maltese: • prevenzioni ta' mard tad-dudu tal-qalb ( larva L3 u L4 tad-Dirofilaria immitis),
English: • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis (roundworm), Ancylostoma caninum (hookworm) and Uncinaria stenocephala (hookworm), adults of Toxascaris leonina (roundworm) and Trichuris vulpis (whipworm)).
Maltese: L4, adulti mmaturi u maturi tatToxocara canis (Il-ħniex it-tondi tal-imsaren) u Ancylostoma caninum (Dudu parassita talintestini) u Unicinaria stenocephala (Dudu parassita tal-intestini), adulti tat- Toxascaris leonina (Il-ħniex it-tondi tal-imsaren) u Trichuris vulpis (Dudu li ġismu jixbah frosta)).
English: Dosage schedule for cats:
Maltese: Skeda tad-doża għall-qtates:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: For large dogs weighing between 10 kg and 25 kg.
Maltese: SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT Għal klieb kbar li jiżnu minn 10 kg sa 25 kg
English: Thelazia for ferrets
Maltese: ANNESS I KARATTERISTIĊI
English: For ferrets: Do not use Advocate for large cats (0.8 ml) or Advocate for dogs (any size).
Maltese: Tużax Advocate għall-qtates il-kbar (0.8 ml) jew Advocate għall-Klieb (kwalunkwe daqs).
English: Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
Maltese: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum.
English: • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm).
Maltese: L4, adulti immaturi u maturi tat-Toxocara cati (Il-ħniex it-tondi tal-imsaren) u Ancylostoma tubaeforme (Dudu parassita tal intestini)).
English: White polypropylene unit dose pipette with screw cap.
Maltese: Ma hemmx antidot specifiku magħruf.
English: INDICATION(S) For dogs suffering from, or at risk from, mixed parasitic infections:
Maltese: Għall-nimsa li jsofru minn, jew jinsabu fir-riskju ta' infezzjonijiet imħallta parasitiċi:
English: If the animal licks the application site after treatment, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.
Maltese: Jekk lannimal jilgħaq is-sit tal-applikazzjoni wara t-trattament, sinjali newroloġiċi (li ħafna minnhom huma temporanji) bħal atassja, rogħda ġeneralizzata, sinjali fl-għajnejn (twessigħ tal-pupilli, ftit rifless pupillari, nystagmus), respirazzjoni annormali, tbeżliq u rimettar jistgħu jkunu osservati f'każi rari ħafna.
English: • the treatment and prevention of flea infestation (Ctenocephalides felis), • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).
Maltese: • Għall-prevenzioni ta' mard tad-dudu tal-qalb (larva L3 u L4 tad-Dirofilaria immitis), • Għat-trattament tal-mikrofilariae ċirkulanti (Dirofilaria immitis),
English: A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnea and dyspnea) that may require prompt veterinary treatment.
Maltese: Studju li twettaq fuq il-post wera li fil-klieb pożittivi għad-dudu tal-qalb b'mikrofilaraemija hemm riskju ta' sinjali respiratorji severi (sogħla, takipnea u dispnea) li jistgħu jeħtieġu trattament veterinarju fil-pront.
English: Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs.
Maltese: Moksidektin jgħaddi minn ġol-ġilda, u jilħaq konċentrazzjoni massima fil-plasma, bejn wieħed u ieħor minn 4 sa 9 ijiem wara trattament fuq il-klieb.
English: The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for cats.
Maltese: Id-dożi minimi rakkomandati huma ta'10mg Imidakloprid għal kull kg piż tal-ġisem u 1.0 mg Moksidektin għal kull kg piż tal-ġisem, li jiġu ekwivalenti għal 0.1ml Advocate għall-qtates, għal kull kg piż tal-ġisem.
English: The full EPAR for Provenge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Provenge
Maltese: Informazzjoni oħra dwar Provenge
English: Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
Maltese: Provenge ċelloli mononukleari tad-demm periferali awtologu attivati b'PAP-GM-CSF
English: This is a summary of the European public assessment report (EPAR) for Provenge.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Provenge.
English: Provenge is available as a liquid dispersion for infusion (drip) into a vein.
Maltese: Provenge huwa disponibbli bħala dispersjoni likwida għal infużjoni (dripp) fil-vina.
English: Why is Provenge approved?
Maltese: Għal xiex ġiet approvat Provenge?
English: The most common side effects with Provenge (which may affect more than 1 in 10 people) include chills, fatigue (tiredness), pyrexia (fever), nausea (feeling sick), arthralgia (joint pain), headache and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni bi Provenge (li jistgħu jolqtu aktar minn 1 minn kull 10) jinkludu kesħa, għeja, piressija (deni), dardir (tħossok ma tiflaħx), artralġja (uġigħ fil-ġogi), uġigħ ta' ras u rimettar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Provenge on 6 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Provenge fis-6 ta' Settembru 2013.
English: Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells.
Maltese: Provenge huwa immunoterapija, jiġifieri mediċina li tistimula s-sistema immuni biex toqtol iċ-ċelloli talkanċer.
English: The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells.
Maltese: Il-proteina ta' fużjoni tikkonsisti minn phosphatase tal-aċidu prostatiku (PAP), molekula li tinstab fil-biċċa l-kbira taċ-ċelloli tal-kanċer tal-prostata, imwaħħal mal-fattur li jistimula l-kolonja tal-makrofaġi-granuloċiti (GM-CSF), molekula li tattiva ċ-ċelloli immuni.
English: What measures are being taken to ensure the safe and effective use of Provenge?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Provenge?
English: Serious side effects with Provenge include severe acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteraemia), heart attack and cerebrovascular events (related to the blood supply to the brain).
Maltese: L-effetti sekondarji serji bi Provenge jinkludu reazzjonijiet akuti severi għall-infużjoni, infezzjoni severa (sepsis minn kateter u batterimija stafilokokkali), attakk tal-qalb u avvenimenti ċerebrovaskulari (relatati mal-provvista tad-demm lejn il-moħħ).
English: In a main study involving 512 patients, the average overall survival for patients treated with Provenge was 25.8 months, compared with 21.7 months for patients given placebo.
Maltese: 8 xhur, meta mqabbla ma' 21.7 xhur għall-pazjenti mogħtija l-plaċebo.
English: Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Maltese: Provenge huwa tip ta' mediċina terapewtika avvanzata msejħa ‘prodott terapewtiku ta' ċellola somatika'.
English: The main risks included acute infusion reactions, toxicities associated with the leukapheresis procedure and infections, but the CHMP considered that these were manageable and adequately addressed by risk minimisation measures for this medicine.
Maltese: Ir-riskji prinċipali kienu jinkludu reazzjonijiet akuti għall-infużjoni, effetti tossiċi assoċjati mal-proċedura tal-lewkafereżi u infezzjonijiet, iżda s-CHMP ħass li dawn kienu maniġġibbli u indirizzati adegwatament bil-miżuri ta' minimizzazzjoni tar-riskju għal din il-mediċina.
English: Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge.
Maltese: Se jitwettqu wkoll aktar studji sabiex tkun ipprovduta dejta ta' sostenn addizzjonali dwar l-effikaċja ta' Provenge.
English: The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients.
Maltese: Is-CHMP ikkonkluda li t-titjib fissopravivenza globali li deher bi Provenge huwa importanti għall-pazjenti.
English: What are the risks associated with Provenge?
Maltese: X'inhuma r-riskji assoċjati ma' Provenge?
English: A risk management plan has been developed to ensure that Provenge is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Provenge jintuża bl-aktar mod sigur possibbli.
English: How is Provenge used?
Maltese: Kif jaħdem Provenge?
English: It is used when the cancer is metastatic (has spread to other parts of the body), and when medical or surgical castration (stopping the production of male hormones) has not worked or no longer works but treatment with chemotherapy (medicines that kill fast-growing cells like cancer cells) is not yet considered appropriate.
Maltese: Huwa jintuża meta l-kanċer ikun metastatiku (infirex għal partijiet oħra talġisem), u meta kastrazzjoni medika jew kirurġika (twaqqif tal-produzzjoni tal-ormoni maskili) ma tkunx ħadmet jew ma tkunx għadha taħdem iżda l-kura bil-kimoterapija (mediċini li joqtlu ċelloli li jikbru malajr bħaċ-ċelloli tal-kanċer) tkun għadha mhux ikkunsidrata bħala xierqa.
English: Provenge is used to treat adult men with cancer of the prostate (a gland of the male reproductive system) who have few or no symptoms.
Maltese: Provenge jintuża għall-kura ta' rġiel adulti b'kanċer tal-prostata (glandola tas-sistema riproduttiva maskili) li jkollhom ftit jew l-ebda sintomi.
English: Provenge was shown to improve overall survival (the average length of time the patients lived) of patients with castration-resistant metastatic prostate cancer, compared with placebo (a dummy treatment).
Maltese: Provenge huwa mediċina għall-kanċer li tiġi ppreparata speċifikament għal kull pazjent billi jintużaw ċelloli immuni (ċelloli li jiffurmaw parti mid-difiżi naturali tal-ġisem) tagħhom stess.
English: Further information on Bexsero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The second main study involved 1,631 adolescents aged between 11 and 17.
Maltese: It-tieni studju ewlieni involva 1,631 adolexxent ta' bejn il-11 u s-17-il sena.
English: Other information about Bexsero
Maltese: Informazzjoni oħra dwar Bexsero
English: Bexsero received a marketing authorisation valid throughout the EU on 14 January 2013.
Maltese: Bexsero ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fl-14 ta' Jannar 2013.
English: Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed])
Maltese: Bexsero (vaċċin meningokokkali grupp B [rDNA,
English: The most common side effects with Bexsero in children up to 10 years of age (seen in more than 1 patient in 10) are eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia (joint pain), fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site.
Maltese: L-effeti sekondarji l-aktar komuni b'Bexsero fi tfal sal-età ta' 10 snin (li dehru f'aktar minn 1 minn kull 10) huma disturbi tal-ikel, ngħas, biki mhux tas-soltu, uġigħ ta' ras, dijarea, rimettar, raxx, artralġja (uġigħ fil-ġogi), deni u irritabilità kif ukoll sensittività, nefħa, ebusija u ħmura tal-ġilda fis-sit talinjezzjoni.
English: Bexsero contains parts of the bacteria N. meningitidis group B.
Maltese: Bexsero fih partijiet tal-batterji N. meningitidis grupp B.