FrancophonIA/ELRC3.0 huggingface dataset:
English: Liquid light paraffin: 234.8 mg.
Maltese: Paraffina likwida ħafifa: 234.8mg
English: From 8 - 14 days old: administer 0.25 ml subcutaneously.
Maltese: Flieles li għandhom minn 8-14 il-ġurnata: amministra 0.25ml taħt il-ġilda Flieles li għandhom minn 14-il ġurnata sa 6 ġimgħat: amministra 0.25ml jew 0.5ml taħt il-ġilda jew filmuskolu.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll jew l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
English: Adjuvant: Liquid light paraffin 234.8 mg
Maltese: Adjuvant Paraffina likwida ħafifa 234.8mg/
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 0.5 ml contains:
Maltese: U INGREDJENT(I) OĦRA Doża ta' 0.5ml fiha:
English: Following the administration of a double dose, no adverse reactions other than those described in section 4.6 have been observed.
Maltese: Wara li ngħatat doża doppja, ma ġewx osservati reazzjonijiet mhux mixtieqa oħra, ħlief dawk imsemmija f'sezzjoni 4.6
English: Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Maltese: Tnaqqis ta' sinjali kliniċi, imwiet u tneħħija tal-virus wara tlaqqiegħ mal-vaċċin ġew murija fi żmien tliet ġimgħat wara t-tilqim.
English: Liquid light paraffin 234.8 mg
Maltese: Paraffina likwida ħafifa 234.8mg/
English: From 8 - 14 days old: 0.25 ml subcutaneously.
Maltese: Flieles li għandhom minn 8 -14-il ġurnata: 0.25ml taħt il-ġilda Flieles li għandhom minn 14-il ġurnata sa sitt ġimgħat: 0.25ml jew 0.5ml taħt il-ġilda jew fil-muskolu.
English: To the user:
Maltese: Aġġuvant:
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Maltese: Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta' dan ilprodott tista' tikkawża nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l-bżonn li jinqata' xi subgħa.
English: ADVERSE REACTIONS
Maltese: MANIFATTURI
English: None.
Maltese: IEĦOR
English: Nobilis Influenza H5N2 emulsion for injection for chickens
Maltese: VETERINARJU Nobilis Influenza H5N2 emulsjoni għal injezzjoni għal flieles
English: Spain
Maltese: KWANTITÀ
English: 4.8 Interactions with other medicinal products and other forms of interaction
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
English: TARGET SPECIES Chickens
Maltese: EFFETTI MHUX MIXTIEQA
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Maltese: b) il-marda li għaliha l-prodott huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju inkwestjoni.
English: A transient diffuse swelling may very commonly occur at the vaccination site, which persists for about 14 days.
Maltese: Nefħa mifruxa ta' natura temporanja tista' sseħħ komuni ħafna fil-post tat-tilqima li tippersisti għal madwar 14-il ġurnata.
English: 6 weeks and older: administer 0.5 ml subcutaneously or intramuscularly.
Maltese: amministra 0.5ml taħt il-ġilda jew fil-muskolu.
English: 2621 North Belt Highway,
Maltese: 2621 North Belt Highway, St.
English: Active substance:
Maltese: Sustanza Attiva:
English: Missouri, 64506-2002
Maltese: Joseph, Missouri, 64506-2002 L-ISTATI
English: Avoid multiple broaching.
Maltese: Evita titqib multiplu.
English: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Maltese: PR* 1.0-3.75 * Potenza Relattiva (test ELISA) permezz ta' paragun ma' tilqima ta' referenza
English: 1 mg
Maltese: IM ta' 1 ml.
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Maltese: Boehringer Ingelheim Vetmedica GmbH
English: INDICATIONS
Maltese: INDIKAZZJONIJIET
English: 10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses) 12 x 10 ml (12 x 10 doses) 12 x 50 ml (12 x 50 doses) 12 x 100 ml (12 x 100 doses) 12 x 250 ml (12 x 250 doses)
Maltese: 12 x 10 ml (12 x 10 dożi) 12 x 50 ml (12 x 50 doża) 12 x 100 ml (12 x 100 doża) 12 x 250 ml (12 x 250 doża)
English: When mixed with Ingelvac MycoFLEX:
Maltese: Meta mħallat ma' Ingelvac MycoFLEX:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: Store and transport refrigerated (2 °C-8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 ºC-8 ºC).
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer
Maltese: Doża waħda (1 ml) fiha: Circovirus tal-qżieqeż ta' tip 2 proteina ORF2 Carbomer
English: 100 ml (100 doses) 250 ml (250 doses)
Maltese: 100 ml (100 doża) 250 ml (250 doża)
English: Porcine circovirus type 2 ORF2 protein
Maltese: Ċircovirus tal-qżieqeż ta' tip 2 ORF2 proteina
English: at least 17 weeks.
Maltese: mill-inqas 17-il ġimgħa.
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Boehringer Ingelheim Animal Health USA
English: • Use a pre-sterilised transfer needle.
Maltese: • Uża labra sterilizzata minn qabel għat-trasferiment.
English: ROUTE OF ADMINISTRATION
Maltese: MOD TA' AMMINISTRAZZJONI
English: Carbomer Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: • Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Maltese: • Uża l-istess volumi ta' Ingelvac CircoFLEX u Ingelvac MycoFLEX.
English: Onset of immunity:
Maltese: Il-bidu tal-immunità:
English: METHOD AND ROUTE OF ADMINISTRATION
Maltese: METODU U MOD TA' AMMINISTRAZZJONI
English: 10 ml (10 doses) 50 ml (50 doses)
Maltese: 50 ml (50 doża)
English: Each dose (1 ml) contains:
Maltese: Doża waħda (1 ml) fiha:
English: Pigs
Maltese: UŻU
English: Avoid introduction of contamination during use.
Maltese: Evita li tintroduċi xi kontaminazzjoni waqt l-użu.
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: STATEMENT OF ACTIVE SUBSTANCES
Maltese: TAS-SUSTANZA ATTIVA
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml.
Maltese: Daqsijiet tal-pakkett ta' 1 jew 12-il flixkun ta' densità għolja tal-polyethylene ta' 10 ml, 50 ml, 100 ml jew 250 ml.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Ingelvac CircoFLEX suspension for injection for pigs
Maltese: VETERINARJU Ingelvac CircoFLEX suspensjoni għall-injezzjoni għal qżieqeż
English: The excipients (including adjuvants) 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: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: PACKAGE SIZES
Maltese: DAQSIJIET TAL-PAKKETT
English: ANNEX II
Maltese: ANNESS III
English: Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) Wara l-għoti ta' doża eċċessiva 4 darbiet ogħla tat-tilqima, l-ebda reazzjonijiet avversi ħlief dawk deskritti taħt sezzjoni “Effetti mhux mixtieqa” ma ġew osservati.
English: U.S.A.
Maltese: A.
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Boehringer Ingelheim Vetmedica GmbH 55216
English: For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Maltese: Għal tilqima attiva ta' qżieqeż mill-età ta' ġimagħtejn kontra circovirus tal-qżieqeż ta' Tip 2 (PCV2) biex titnaqqas il-mortalità, sinjali kliniċi - li jinkludu telf ta' piż - u leżjonijiet f'tessuti limfojdi assoċjati ma' marda marbuta ma' PCV2 (PCVD).
English: Ingelvac MycoFLEX may be not authorised to use in certain Member States.
Maltese: Ingelvac MycoFLEX jista' ma jkunx awtorizzat f'ċerti Stati Membri.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 10 ml; 50 ml, 100 ml, 250 ml cardboard box
Maltese: 10 ml, 50 ml, 100 ml, 250 ml kaxxa tal-kartun
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 dwar il-Mediċini http://www.ema.europa.eu/.
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' tiżmim
English: During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
Maltese: Waqt it-tilqim, l uniformità tat-taħlita kkulurita għandha tiġi mmonitorjata u tinżamm permezz ta' aġitazzjoni kontinwa.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.
Maltese: Din it-tilqima hi maħsuba biex tistimula l-iżvilupp ta' rispons ta' immunità attiva għal circovirus talqżieqeż ta' tip 2.
English: Each bottle is closed with a chlorobutyl stopper and lacquered aluminium seal.
Maltese: Kull flixkun huwa magħluq b'tapp tal-chlorobutyl u siġill tal-aluminju lacquered.
English: MANUFACTURER'S BATCH NUMBER
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.
Maltese: Labar sterilizzati minn qabel għattrasferiment (iċċertifikati bil-marka CE) ġeneralment ikunu disponibbli mingħand fornituri ta' tagħmir mediku.
English: - After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
Maltese: - Wara t-trasferiment tal-kontenut kollu ta' Ingelvac CircoFLEX, aqla' u armi l-labra tat trasferiment u battal il-flixkun vojt tat-tilqima Ingelvac CircoFLEX.
English: Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni Dejta disponibbli dwar il-kwalità, is-sigurtà u l-effikaċja turi li din it-tilqima tista' titħallat ma' Ingelvac MycoFLEX ta' Boehringer Ingelheim u tingħata f'sit wieħed tal-injezzjoni.
English: When mixed with Ingelvac MycoFLEX the following equipment should be used:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Maltese: 10 ml (10 dożi) 50 ml (50 doża) 100 ml (100 doża) 250 ml (250 doża)
English: QUANTITY OF THE ACTIVE SUBSTANCE
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
Maltese: Injezzjoni waħda ġol-muskoli ta' doża waħda (1 ml), irrispettivament mill-piż tal-ġisem.
English: Do not freeze.
Maltese: CircoFLEX.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour.
Maltese: Biex tiżgura t-taħlit tat-tilqim kif suppost, ċaqlaq bil-mod il-flixkun tat-tilqima ta' Ingelvac MycoFLEX sakemm it-taħlita ssir ta' kulur uniformi minn oranġjo sa aħmar.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin jista' jiħallat u jiġi amministrat ma' Ingelvac MycoFLEX ta' Boehringer Ingelheim u tingħata f'sit wieħed tal-injezzjoni.
English: Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine.
Maltese: Doża waħda (1 ml) fiha: circovirus tal-qżieqeż ta' tip 2 proteina ORF2:
English: Date of first authorisation: Date of last renewal:
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: - Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Maltese: - Ittrasferixxi t-tilqima Ingelvac CircoFLEX ġol-flixkun tat-tilqima ta' Ingelvac MycoFLEX.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml, 50 ml bottle
Maltese: JMISS MAL-PRODOTT Flixkun ta' 10 ml, 50 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: Kodici ATC veterinarja:
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07
Maltese: Id-deċiżjoni sabiex tintuża din it-tilqima qabel jew wara xi prodott mediċinali veterinarju ieħor, għaldaqstant għandha tittieħed skont il-każ.
English: Adjuvant:
Maltese: TAMMINISTRA
English: The full EPAR for Fampyra 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: It contains the active substance fampridine.
Maltese: Fih is-sustanza attiva fampridina.
English: (An 8-point improvement is considered clinically significant in this scale, which ranges from 0 to 100).
Maltese: (Titjib ta' 8 punti jitqies klinikament sinifikanti f'din l-iskala, li tvarja minn 0 sa 100).
English: Fampyra fampridine
Maltese: Informazzjoni oħra dwar Fampyra
English: This was switched to a full marketing authorisation on 22 May 2017.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fit22 ta' Mejju 2017.
English: This summary was last updated in 07-2017
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2017.
English: This is a summary of the European public assessment report (EPAR) for Fampyra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fampyra.
English: The active substance in Fampyra, fampridine, is a potassium channel blocker.
Maltese: Is-sustanza attiva f'Fampyra, il-fampridina, hija imblokkatur tal-kanal tal-potassju.
English: Why is Fampyra approved?
Maltese: Għaliex ġiet approvat Fampyra?
English: The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Maltese: L-effetti sekondarji li dehru b'Fampyra huma prinċipalment newroloġiċi (relatati mal-moħħ jew mannervituri) u jinkludu attakki ta' puplesija (aċċessjonijiet), insomnja (diffikultà fl-irqad), ansjetà, problemi fil-bilanċ, sturdament, parasteżija (sensazzjonijiet abnormali bħal tmewwit u tnemnim), rogħda, uġigħ ta' ras u astenja (dgħjufija).
English: Fampyra must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2' such as cimetidine.
Maltese: Fampyra ma għandux jintuża ma' mediċini oħra li fihom il-fampridina jew ma' mediċini magħrufa bħala "inibituri ta' trasportatur katjoniku organiku 2" bħal cimetidine.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku fampridina
English: The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
Maltese: L-effett sekondarju l-aktar komuni rrapportat fl-istudji kliniċi, li affettwa lil madwar 12 % tal-pazjenti, huwa l-infezzjoni fl-apparat urinarju.
English: With regard to the medicine's safety, serious side effects with Fampyra are rare.
Maltese: Fir-rigward tas-sigurtà talmediċina, effetti sekondarji serji b'Fampyra huma rari.
English: Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.
Maltese: Fampyra huwa disponibbli bħala pilloli ta' 10 mg li jittieħdu mingħajr ikel darbtejn kuljum, b'intervall ta' 12-il siegħa.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni kundizzjonali għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fampyra fl-20 ta' Lulju 2011.
English: A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs.
Maltese: It-tielet studju f'633 pazjent kejjel it-titjib fil-kapaċità tal-mixi fuq 24 ġimgħa permezz ta' skala ta' klassifikazzjoni magħrufa bħala skala ta' mixi tal-iskeloriżi multipla (MSWS), fejn il-pazjenti kkalkolaw kemm kienu kapaċi jagħmlu attivitajiet varji bħal jimxu, jiġru jew jitilgħu t-taraġ.
English: What are the risks associated with Fampyra?
Maltese: X'inhuma r-riskji assoċjati ma' Fampyra?
English: In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.
Maltese: Fit-tieni studju, ir-riżultati kienu simili bi 43 % tal-pazjenti fil-grupp Fampyra jaqbżu l-aħjar veloċità preċedenti tagħhom fi tlieta minn erba' okkażjonijiet, meta mqabbla ma' 9 % fil-grupp tal-plaċebo.
English: In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo.
Maltese: F'dan l-istudju, 43 % tal-pazjenti li kienu qed jieħdu Fampyra kellhom tal-anqas titjib ta' 8 punti fil-punteġġ MSWS tagħhom meta mqabbel ma' 34 % ta' dawk li kienu qed jieħdu plaċebo.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Maltese: Peress li l-kumpanija forniet l-informazzjoni addizzjonali meħtieġa, lawtorizzazzjoni minn kundizzjonali saret approvazzjoni sħiħa.
English: For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles.
Maltese: Sabiex il-muskoli tal-ġisem jinġibdu, jiġu trażmessi impulsi elettriċi tul in-nervituri lejn il-muskoli.
English: In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo .
Maltese: F'wieħed mill-istudji, 35 % tal-pazjenti li jieħdu Fampyra kellhom veloċità tal-mixi ogħla f'tal-anqas tlieta minn erba' okkażjonijiet mill-iktar veloċità mgħaġġla tagħhom qabel il-kura meta mqabbla ma' 8 % tal-pazjenti li jieħdu plaċebo.
English: Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed.
Maltese: Żewġ studji prinċipali f'540 pazjent bl-isklerożi multipla wrew li Fampyra kien aktar effettiv mill-plaċebo (kura finta) għat-titjib tal-veloċità tal-mixi.
English: MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Maltese: L-SM hija marda tan-nervituri, fejn l-infjammazzjoni teqred il-kisja protettiva madwar in-nervituri.
English: How is Fampyra used?
Maltese: Kif jintuża Fampyra?
English: Fampyra was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Maltese: Oriġinarjament Fampyra ngħata "approvazzjoni kundizzjonali" għax kien għad fadal iżjed evidenza x'toħroġ dwar il-mediċina.
English: In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
Maltese: FlSM, din it-trasmissjoni tal-impulsi elettriċi tiddgħajjef meta l-kisja protettiva ta' madwar in-nervituri tkun ġarrbet il-ħsara, u dan jista' jwassal għal dgħjufija fil-muskoli, ebusija fil-muskoli u diffikultà filmixi.
English: Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
Maltese: Fampyra jintuża biex itejjeb il-kapaċità tal-mixi fl-adulti bl-isklerożi multipla (SM) li għandhom diżabilità fil-mixi.
English: This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
Maltese: Dan huwa maħsub li għandu l-effett li jippermetti lill-impuls elettriku biex ikompli jivjaġġa tul in-nervituri biex jistimula lill-muskoli, u dan jagħmel il-mixi aktar faċli.