FrancophonIA/ELRC3.0 huggingface dataset:
English: Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia.
Maltese: L-iloperidon huwa maħsub li jimblokka riċetturi għan-newrotrażmettituri dopamina u 5-idrossitriptamina (imsejħa wkoll serotonin), li huma involuti fl-iskiżofrenja.
English: The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment).
Maltese: L-istudju ta' perjodu qasir, li involva 567 pazjent, qabbel Fanaptum mal-mediċina tal-iskiżofrenja ziprasidone u mal-plaċebo (kura finta).
English: What was Fanaptum expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Fanaptum?
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia.
Maltese: Fl-20 ta' Lulju 2017, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Fanaptum, maħsub għall-kura tal-iskiżofrenja.
English: The company presented the results of 2 main studies of 4 and 26 weeks' duration.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' 2 studji ewlenin b'durata ta' 4 ġimgħat u 26 ġimgħa.
English: In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm.
Maltese: Fanaptum jikkawża ttitwil tal-QT, bidla fl-attività elettrika tal-qalb li tista' tikkawża anormalità ta' periklu għall-ħajja tarritmu tal-qalb.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: L-iskiżofrenja hija marda tal-moħħ li għandha għadd ta' sintomi, inkluż ħsibijiet u diskors diżorganizzati, alluċinazzjonijiet (jisimgħu jew jaraw affarijiet li ma jkunux hemm), suspetti u delużjonijiet (twemmin falz).
English: The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia.
Maltese: Is-CHMP innota wkoll li l-mediċina jibda jkollha l-effetti tagħha wara ġimagħtejn sa 3 ġimgħat ta' kura, u dan huwa ta' tħassib meta jiġu kkurati episodji f'daqqa (akuti) tal-iskiżofrenja.
English: Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines.
Maltese: Finalment, is-CHMP kellu tħassib li Fanaptum jitkisser fil-ġisem mill-enzimi tal-fwied li l-attività tagħhom titnaqqas f'ċerti pazjenti u minn ċerti mediċini oħra.
English: During the re-examination the CHMP looked again at the data submitted by the company and the company's proposal to introduce several new measures to manage the risk of QT prolongation.
Maltese: Matul l-eżaminazzjoni mill-ġdid is-CHMP reġa' ħares lejn id-data sottomessa mill-kumpanija u lproposta tal-kumpanija li tipproduċi diversi miżuri ġodda biex tiġġestixxi r-riskju ta' titwil tal-QT.
English: At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest.
Maltese: Meta saret ir-rakkomandazzjoni inizjali, is-CHMP kien tal-opinjoni li l-effikaċja ta' Fanaptum fl-istudji kienet modesta.
English: The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines.
Maltese: Barra minn hekk, ilKumitat kien għadu kkonċernat minħabba l-effikaċja modesta ta' Fanaptum u tal-bidu imdewwem talazzjoni.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw maċ-ċelloli tal-qrib.
English: Fanaptum was expected to be used to treat schizophrenia in adults.
Maltese: Fanaptum kien mistenni li jintuża biex jikkura l-iskiżofrenja fl-adulti.
English: The company informed the CHMP that there are no ongoing clinical studies with Fanaptum in the EU at the present time.
Maltese: Il-kumpanija infurmat lis-CHMP li bħalissa m'hemm l-ebda studju kliniku li għadu għaddej b'Fanaptum fl-UE.
English: Date of first authorisation: 23/02/2012
Maltese: Data tal-ewwel awtorizazzjoni : 23/02/2012
English: Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Water, purified
Maltese: Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Ilma, ppurifikat
English: Excipients: Ethyl alcohol 150 mg
Maltese: Ethyl alcohol 150 mg
English: A clinical response is normally seen within 3-4 days.
Maltese: Rispons kliniku ġeneralment jiġi osservat fi żmien 3-4 ijiem.
English: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Maltese: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, L-OLANDA
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Maltese: Madwar 97 % ta' meloxicam jeħel mal-proteini tal-plażma.
English: EU/2/12/138/001 6 ml/10 ml vial EU/2/12/138/002 11 ml/20 ml vial EU/2/12/138/003 33 ml/50 ml vial EU/2/12/138/004 3 ml/10 ml vial EU/2/12/138/005 3 ml/20 ml vial EU/2/12/138/006 8 ml/50 ml vial
Maltese: EU/2/12/138/001 6 ml/10 ml kunjett tal-ħġieġ EU/2/12/138/002 11 ml/20 ml kunjett tal-ħġieġ EU/2/12/138/003 33 ml/50 ml kunjett tal-ħġieġ EU/2/12/138/004 3 ml/10 ml kunjett tal-ħġieġ EU/2/12/138/005 3 ml/20 ml kunjett tal-ħġieġ EU/2/12/138/006 8 ml/50 ml kunjett tal-ħġieġ
English: Maintenance dosage range meloxicam delivered (mg/kg)*
Maltese: Medda taddożaġġ ta' manteniment ta' meloxicam fornut (mg/kg)*
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Maltese: Studji in vitro u in vivo wrew li meloxicam jinibixxi cyclooxygenase-2 (COX-2) b'mod iktar qawwi minn cyclooxygenase-1 (COX-1).
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu mediċina antiinfjammatorja mhux sterojd (NSAID) tal-klassi oxicam li taġixxi blinibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti antiinfjammatorji, analġesiċi, kontra t-tnixxja u antipiretiċi.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet Code:
Maltese: Prodotti antiinfjammatorji u antirewmatiċi, mhux sterojdi (oxicams)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam
Maltese: RevitaCAM 5 mg/ml Sprej għall-Mukuża tal-Ħalq għall-Klieb Meloxicam
English: People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
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 mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Oromucosal use.
Maltese: Mhux Applikabbli.
English: Marketing authorisation holder: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Maltese: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, IL-BELĠJU Manifattur responsabbli għall-ħrug tal-lott:
English: VIAL
Maltese: Klieb
English: Zoetis Lietuva UAB Tel: +370 5 2683634
Maltese: Tel: +370 5 2683634
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Maltese: Sustanza Attiva:
English: Oromucosal spray Yellow colloidal dispersion
Maltese: Sprej għall-mukuża tal-ħalq Dispersjoni kollojdjali safra
English: Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Maltese: Meloxicam jiġi assorbit kompletament wara l-għoti fil-mukuża tal-ħalq u l-ogħla konċentrazzjonijiet fil-plażma jinkisbu wara madwar 4.5 sigħat.
English: Gently shake vial
Maltese: Ċaqlaq il-kunjett bil-mod
English: Oromucosal Spray
Maltese: U LUŻU
English: Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) bħal telf ta' aptit, rimettar, dijarea, demm moħbi fl-ippurgar, apatija u insuffiċjenza tal-kliewi, kienu rrappurati xi kultant.
English: Treatment should be continued once daily by application of the spray to the oral mucosa (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).
Maltese: Il-kura għanda titkompla darba kuljum bl-applikazzjoni tal-isprej lill-mukuża orali (f'intervalli ta' 24 siegħa) b'doża ta' manteniment ta' 0.1 mg ta' meloxicam/kg ta' piż tal-ġisem (ara t-tabella ta' għoti tad-dożi).
English: Use during pregnancy and lactation: See section "Contraindications".
Maltese: Użu fit-tqala u fi żmien il-ħalib: Ara s-sezzjoni "Kontra indikazzjonijiet".
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjonijiet ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Maltese: Madwar 75 % tad-doża li tingħata titneħħa flippurgar, u l-bqija fl-awrina.
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Maltese: Hemm relazzjoni lineari bejn id-doża mogħtija u l-konċentrazzjoni fil-plażma osservata fil-medda taddoża terapewtika.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidrat, ipovolemiku jew ipotensiv, għax hemm riskju potenzjali ta' żieda ta' tossiċità tal-kliewi.
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs
Maltese: RevitaCAM 5 mg/ml Sprej għall-Mukuża tal-Ħalq għall-Klieb
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Not all pack sizes may be marketed.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mall-prodott kunjett tal-ħġieġ ta' 10 ml fih jew 3 ml jew 6 ml kunjett tal-ħġieġ ta' 20 ml fih jew 3 ml jew 11 ml kunjett tal-ħġieġ ta' 50 ml fih jew 8 ml jew 33 ml Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Care should be taken to select the correct size vial depending on the bodyweight of the dog.
Maltese: RevitaCAM hu ppreżentat f': kunjett tal-ħġieġ ta' 10 ml fih jew 3 ml jew 6 ml pompa ta' 50 µl kunjett tal-ħġieġ ta' 20 ml fih jew 3 ml jew 11 ml pompa ta' 100 µl kunjett tal-ħġieġ ta' 50 ml fih jew 8 ml jew 33 ml pompa ta' 215 µl Għandha tingħata attenzjoni biex jintgħażel id-daqs korrett tal-kunjett skont il-piż tal-ġisem tal-kelb.
English: Oromucosal use
Maltese: FARMAĊEWTIKU
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) matul il-perjodu ta' kura waħda)
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' NSAIDs bħal telf ta' aptit, rimettar, dijarea, demm moħbi fl-ippurgar, apatija u insuffiċjenza tal-kliewi, kienu rrappurati xi kultant.
English: To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums.
Maltese: Biex tagħti RevitaCAM, ix-xoffa ta' fuq tal-kelb għandha tinqabad u tinġibed lil hemm bil-mod biex tesponi l-ħanek.
English: * For the initial treatment of a single dose of 0.2 mg meloxicam/kg body weight, the above maintenance doses should be doubled.
Maltese: * Għall-kura inizjali ta' doża waħda ta' 0.2 mg ta' meloxicam/kg ta' piż tal-ġisem, id-dożi ta' manteniment t'hawn fuq għandhom jiġu rduppjati.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: Ħtieġijiet ta' farmakoviġilanza
English: 90 (3 x 30) tablets (multipack)
Maltese: 90 (3 × 30) pillola (pakkett multiplu)
English: 30 x 1 tablets (unit dose)
Maltese: 30 × 1 pillola (doża waħda)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Qawwa Forma Farmaċewtika
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-proċedura tal-EU Isem inventat
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93').
Maltese: Fih virus sħiħ diżattivat (maqtul) ta' żewġ razez tal-influwenza ekwina (‘A/equine-2/South Africa/4/03' u ‘A/equine-2/Newmarket/2/93').
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza on 8 July 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Equilis Prequenza fit-8 ta' Lulju 2005.
English: Most of the studies used Equilis Prequenza Te, a vaccine which protects against tetanus as well as the strains of equine influenza included in Equilis Prequenza.
Maltese: Il-biċċa l-kbira tal-istudji użaw Equilis Prequenza Te, vaċċin li jipproteġi kontra t-tetnu kif ukoll kontra r-razez tal-influwenza ekwina inklużi f'Equilis Prequenza.
English: The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Maltese: Il-kejl ewlieni tal-effikaċja kien ilproduzzjoni ta' livelli protettivi ta' antikorpi kontra l-komponenti tal-influwenza.
English: The initial studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
Maltese: L-istudji inizjali wrew li Equilis Prequenza huwa vaċċin effettiv kontra l-influwenza ekwina biex inaqqas is-sinjali kliniċi u l-eskrezzjoni tal-virus wara l-infezzjoni, fiż-żwiemel ta' 6 xhur jew aktar.
English: The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Maltese: Il-vaċċin inaqqas is-sinjali tal-influwenza ekwina u tal-eskrezzjoni (tneħħija) tal-virus wara l-infezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza exceed the risks for the approved indications and recommended that Equilis Prequenza be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equilis Prequenza huma akbar r-riskji tiegħu għall-indikazzjonijiet approvati u rrakkomanda li Equilis Prequenza jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Equilis Prequenza?
Maltese: X'hinu Equilis Prequenza?
English: Why has Equilis Prequenza been approved?
Maltese: Għaliex ġie approvat Equilis Prequenza?
English: The effectiveness of the current formulation of the vaccine has been assessed in additional laboratory studies.
Maltese: L-effikaċja tal-għamla attwali tal-vaċċin ġiet evalwata fi studji addizzjonali fil-laboratorju.
English: Other information about Equilis Prequenza:
Maltese: Tagħrif ieħor dwar Equilis Prequenza:
English: How has Equilis Prequenza been studied?
Maltese: Kif ġie studjat Equilis Prequenza?
English: Equilis Prequenza is a vaccine for use in horses.
Maltese: Equilis Prequenza Vaċċin kontra l-influwenza ekwina
English: The vaccine is available as a suspension for injection.
Maltese: Il-vaċċin jiġi bħala sospensjoni għall-injezzjoni.
English: Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
Maltese: Jista' jkun hemm uġigħ fis-sit tal-injezzjoni, iżda dan huwa rari.
English: Equilis Prequenza contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Maltese: Equilis Prequenza fih virus sħiħ diżattivat tar-razez tal-influwenza li l-vaċċin hu indikat kontrihom.
English: What is the risk associated with Equilis Prequenza?
Maltese: X'inhu r-riskju assoċjat ma' Equilis Prequenza?
English: The viruses included in the current formulation of Equilis Prequenza are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Maltese: Il-virusis inklużi fl-għamla attwali ta' Equilis Prequenza jikbru f'ċelloli mammiferi, mhux bħal dawk fl-għamla inizjali, li kienu kibru fil-bajd tat-tiġieġ.
English: The safety of the initial formulation of Equilis Prequenza was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Maltese: Is-sigurtà tal-għamla inizzjali ta' Equilis Prequenza ġiet studjata f'diversi studji f'kundizzjonijiet ta' laboratorju u fuq il-post f'għadd kbir ta' żwiemel, mill-età ta' xahrejn.
English: When a horse is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against them.
Maltese: Meta żiemel jingħata l-vaċċin, is-sistema immunitarja tagħraf lill-virus bħala “barrani” u tipproduċi antikorpi kontrih.
English: 5 April 2016 EMA/152385/2016
Maltese: 5 ta' April 2016 EMA/543482/2016
English: 1 Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V).
Maltese: 1 Estratt niexef (DER 3-7.4:1), estratt solventi:
English: For dry extracts, the solvent is then evaporated off.
Maltese: Għal estratti nixfin, is-solvent imbagħad jiġi evaporat.
English: Valerian root is the common name for the underground parts of the plant Valeriana officinalis L.
Maltese: L-għerq tal-valerjana huma l-isem komuni għall-partijiet ta' taħt l-art tal-pjanta Valeriana officinalis L.
English: Valerian root
Maltese: Għerq tal-Valerjana
English: Side effects have been reported with valerian root.
Maltese: Ġew irrapportati effetti sekondarji bl-għerq tal-valerjana.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian root medicines.
Maltese: Pazjenti bi ġrieħi miftuħin, problemi tal-ġilda, deni għoli, infezzjonijiet severi u problemi severi tal-qalb u taċ-ċirkolazzjoni ma għandhomx jieħdu banjijiet bil-mediċini li fihom l-għerq tal-valerjana.
English: The HMPC concluded that a specific valerian root preparation obtained as dry ethanol extract1 can be used for the relief of mild nervous tension and sleep disorders.
Maltese: L-HMPC ikkonkluda li preparazzjoni speċifika tal-għerq tal-valerjana miksuba bħala estratt xott taletanol1 tista' tintuża għas-serħan ta' tensjoni nervuża ħafifa u disturbi tal-irqad.
English: Valerian root medicines should be used only in adults and adolescents over the age 12 years.
Maltese: Il-mediċini li fihom l-għerq tal-valerjana għandhom jintużaw biss f'adulti u adoloxxenti li għandhom 'il fuq minn 12-il sena.
English: Extracts are prepared using a technique to extract compounds by putting the plant material in a solvent (such as ethanol, methanol or water) to dissolve compounds and form a liquid extract.
Maltese: L-estratti huma mħejjija bl-użu ta' teknika għall-estrazzjoni ta' komponenti billi tpoġġi il-materjali tal-pjanta f'solvent) (bħall-etanol, bħall-metanol jew bħall-ilma), biex jinħallu l-komponenti u jiffurmaw estratt likwidu.
English: In its assessment, the HMPC also considered clinical studies involving patients with mild symptoms of mental stress and insomnia (difficulty sleeping).
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra wkoll studji kliniċi li jinvolvu pazjenti b'sintomi ħfief ta' stress mentali u insomnija (diffikultà sabiex torqod).
English: Further information on the HMPC assessment of valerian root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with valerian root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom l-għerq tal-valerjana, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini tal-ħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: The HMPC conclusions only cover valerian root preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the underground parts of the plant, by expressing the juice of the fresh root, and as dry or liquid extracts.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss preparazzjonijiet tal-għerq tal-valerjana li jinkisbu billi l-partijiet ta' taħt l-art tal-pjanta jindaħnu (f'biċċiet iżgħar) jew isiru trab, billi jingħasar il-meraq tal-għerq frisk ta' fuq u bħala estratti nexfin jew likwidi.
English: What are the risks associated with valerian root medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-għerq tal-valerjana?