FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro data indicated a low potential for interaction with other antiepileptic medicinal products (see section 5.2).
Maltese: Prodotti mediċinali oħrajn għal kontra l-epilessija Dejta in vitro tindika possibbiltà żgħira ta' interazzjoni ma' prodotti mediċinali oħrajn għal kontra l epilessija (ara sezzjoni 5.2).
English: INFORMATION IN BRAILLE trobalt 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE trobalt 300 mg
English: Swallow the tablet whole.
Maltese: azzjoni ta' forma epilettika.
English: INFORMATION IN BRAILLE trobalt 400 mg
Maltese: INFORMAZZJONI BIL-BRAILLE trobalt 400 mg
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX21.
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika: mediċini għal kontra l-epilessija, mediċini oħrajn għal kontra l epilessija, Kodiċi ATC:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011, EU/1/11/681/012
Maltese: EU/1/11/681/011, EU/1/11/681/012
English: Risk related to Trobalt
Maltese: Riskju marbut ma' Trobalt
English: INFORMATION IN BRAILLE trobalt 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE trobalt 100 mg
English: Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Maltese: Abnormalitajiet fil-viżta (kostrizzjoni tal-kamp, telf tas-sensittività ċentrali, u akutezza viżiva mnaqqsa ) ġew irrapportati.
English: Across all studies, patients had a mean duration of epilepsy of 22 years and a median baseline seizure frequency ranging from 8 to 12 per 28 days.
Maltese: Fl-istudji kollha, il-pazjenti kellhom epilessija li kienet ilha fuqhom medja ta' 22 sena u linja bażi medjana bi frekwenza ta' aċċessjonijet fuq medda ta' 8 sa 12 kull 28 jum.
English: Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Maltese: Għad hemm inċertezzi dwar l-impatt ta' dan ir-riskju fuq il-pazjenti peress li hemm il-possibbiltà ta' anormalitajiet funzjonali assoċjati mar-retinopatija, inkluż indeboliment tal-vista potenzjalment sever.
English: 100 mg tablets:
Maltese: Pilloli ta' 100 mg:
English: Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Maltese: Trobalt 400 mg pilloli miksijin b'rita huma vjola, tawwalin u mmarkati b'“RTG-400”fuq naħa waħda.
English: Microcrystalline cellulose.
Maltese: pigmentazzjoni retinali.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Maltese: Kull pillola fiha 300 mg ta' retigabine
English: No signs of gall bladder dysfunction were seen clinically.
Maltese: Ma dehru lebda sinjali kliniċi ta' disfunzjoni fil-bużżieqa tal-marrara.
English: Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Maltese: Trobalt 200 mg pilloli miksijin b'rita huma sofor, tawwalin u mmarkati b'“RTG-200” fuq naħa waħda.
English: Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Maltese: Id-dejta farmakokinetika attwalment disponibbli hija deskritta fis-sezzjoni 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while
Maltese: jkollok bżonn visti aktar mis-soltu (inkluż elettrokardjogramm [ECG], li huwa test li jirrekordja lattività elettrika ta' qalbek) waqt li inti tkun qed tieħu Trobalt.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Maltese: Kull pillola fiha 50 mg ta' retigabine
English: Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Maltese: Trobalt 300 mg pilloli miksijin b'rita huma ħodor, tawwalin u mmarkati b'“RTG-300”fuq naħa waħda.
English: Clinical efficacy of adjunctive retigabine therapy in partial onset seizures
Maltese: Effikaċja klinika ta' terapija miżjuda b'retigabine f'aċċessjonijiet b'bidu parzjali
English: Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Maltese: Retigabine kien effettiv f'kura miżjuda f'adulti b'aċċessjonijiet b'bidu parzjali fi tliet studji kliniċi (Tabella 1).
English: Each tablet contains 200 mg retigabine
Maltese: Kull pillola fiha 200 mg ta' retigabine
English: Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Maltese: Pazjenti anzjani jistgħu jkunu f'riskju akbar ta' każijiet tas-sistema nervuża ċentrali, żamma tal-awrina u fibrillazzjoni tal-atriju.
English: Each tablet contains 100 mg retigabine
Maltese: Kull pillola fiha 100 mg ta' retigabine
English: Hepatobiliary disorders
Maltese: MakulopatijaVitelliformi
English: Opaque PVC-PVDC-aluminium foil blisters.
Maltese: Pilloli ta' 400 mg: Folji opaki tal-PVC-PVDC-fojl tal-aluminju.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets retigabine
Maltese: Kull pillola fiha 400 mg ta' retigabine
English: Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Maltese: Il-farmakokinetika ta' retigabine fi tfal li għandhom inqas minn 12-il sena kinitx investigata.
English: Hypromellose
Maltese: Nefrolitjasi
English: Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Maltese: Il-biodisponibbiltà orali assoluta ta' retigabine meta mqabbla ma' doża minn ġol-vina hija ta' madwar 60%.
English: The following convention has been used for the classification of adverse reactions: Very common: ≥1/10
Maltese: Komuni ħafna: ≥1/10
English: The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Maltese: Id-doża totali ta' kuljum tal-bidu hija ta' 150 mg/jum, u waqt il-perjodu ta' titrazzjoni, id doża totali ta' kuljum għandha tiżdied b'massimu ta' 150 mg kull ġimgħa, skont ir-rispons u t tollerabbiltà tal-pazjent individwali.
English: − The need for comprehensive ophthalmological examinations including visual acuity, slit-lamp examination, dilated fundus photography and macular optical coherence tomography (OCT) imaging at treatment initiation and at least every 6 months thereafter while treatment is ongoing.
Maltese: − Il-ħtieġa għal eżamijiet oftalmoloġiċi komprensivi li jinkludu akutezza tal-viżta, eżaminazzjoni b'dawl qawwi, fundoskopija dilatata u immaġni tat-tomografija tal koerenza ottika makulari (OCT - optical coherence tomography) fil-bidu tal-kura u millinqas kull 6 xhur minn hemm 'il quddiem filwaqt li l-kura tkun għadha għaddejja.
English: Very common: ≥1/10 Common:
Maltese: Mhux komuni: ≥1/1,000 sa <1/100 Rari:
English: − The need to inform patients that TROBALT may cause pigment changes in ocular tissues, including the retina, and also in the skin, lips and/or nails, as well as a distinct form of macular abnormality with features of vitelliform maculopathy;
Maltese: − Il-ħtieġa li li l-pazjenti jiġu infurmat li TROBALT jista' jikkawża tibdil fil-pigment tat tessuti okulari, inkluża r-retina, u anki fil-ġilda, ix-xofftejn u/jew id-dwiefer, kif ukoll bħala forma distinta ta' anormalità makulari mal-karatteristiċi ta' makulopatija vitelliformi.
English: Urinary hesitation
Maltese: Disurja Diffikultà biex tibda
English: Eye disorders caused by changes in the centre of the retina (maculopathy): this can be common in people taking Trobalt.
Maltese: Disturbi fl-għajnejn ikkawżati minn tibdil fiċ-ċentru tar-retina (makulopatija): dan jista' jkun komuni f'persuni li jieħdu Trobalt.
English: • constipation; feeling sick (nausea); indigestion; dry mouth
Maltese: • stitikezza; dardir (nawsja); indiġestjoni; ħalq xott • nefħa fil-parti t'isfel tar-riġel u fis-saqajn
English: Packs containing 21or 84 film-coated tablets.
Maltese: Pakketti li fihom 21 jew 84 pillola miksija b'rita.
English: Hypokinesia
Maltese: Amnesija
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trobalt in paediatric patients aged 2 to below 18 years with Lennox Gastaut Syndrome, and in paediatric patients aged 0 to below 18 years with partial onset seizures (see section 4.2 for information on paediatric use).
Maltese: u f'pazjenti pedjatriċi mit-twelid sal-età ta' 18-il sena b'aċċessjonijiet b'bidu parzjali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: Meta-analiżi ta' provi randomised ikkontrollati bi plaċebo ta' prodotti mediċinali għal kontra l-epilessija ukoll urew żieda żgħira fir-riskju ta' ħsieb u mġieba ta' suwiċidju.
English: Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Maltese: Pilloli ħodor, tondi, miksijin b'rita ta' 7.1 mm, immarkati b'“RTG 100” fuq naħa waħda.
English: Adverse event data from clinical trial subjects showed a rate of event of discolouration of the nails, lips, skin and/or mucosa per patient year of exposure of 3.6%.
Maltese: Dejta dwar avvenimenti avversi minn individwi ta' provi kliniċi uriet rata ta' avveniment ta' telf tal kulur tad-dwiefer, tax-xufftejn, tal-ġilda u/jew tal-mukoża għal kull sena pazjent ta' espożizzjoni ta' 3.6%.
English: In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis (n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine (100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
Maltese: F'tieni studju ta' doża singola, f'suġġetti b'mard tal-kliewi tal-aħħar stadju li kienu qegħdin jirċievu emodijaliżi kronika (n= 8), il-bidu tad-dijaliżi f'madwar 4 sigħat wara doża singola ta' retigabine (100 mg) irriżulta fi tnaqqis medjan fil-konċentrazzjonijiet ta' retigabine fil-plażma ta' 52% mill-bidu sat-tmiem tad-dijaliżi.
English: Posology
Maltese: Akkwiżita
English: Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Maltese: retigabine x'aktarx ma jaffettwax il-farmakokinetika tas-sottostrati tal-isoenżimi prinċipali taċ ċitokroma P450 permezz ta'mekkaniżmi impeditorji jew induttivi.
English: It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal (see section 4.2).
Maltese: Huwa rrakkomandat li d-doża ta' Trobalt titnaqqas fuq perijodu ta' millinqas 3 ġimgħat, sakemm tħassib dwar sigurtà ma jkunx jeħtieġ twaqqif immedjat (ara sezzjoni 4.2).
English: Increased liver function tests
Maltese: Żieda fir-riżultati tat testijiet tal-funzjoni talfwied
English: The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day).
Maltese: ogħla doża hija ta' 400 mg li tittieħed tliet darbiet kuljum (total ta' 1,200 mg kuljum).
English: Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
Maltese: Għandu jkun hemm kawtela meta Trobalt jiġi ordnat flimkien ma' prodotti mediċinali magħrufa li jtawlu l-intervall QT u f'pazjenti magħrufa li għandhom intervall QT mtawwal, insuffiċjenza konġestiva tal-qalb, ipertrofija ventrikulari, ipokalimja, jew ipomagnesimja, u f'pazjenti li għadhom kemm bdew il-kura u għandhom 65 sena jew aktar.
English: Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Maltese: jew 1,200 mg/jum (ara Tabella 1).
English: There was no meaningful change in digoxin Cmax.
Maltese: Ma kien hemm ebda bidla ta' valur fis-Cmax ta' digoxin.
English: Adjustment of the Trobalt dose is recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Maltese: Aġġustament fid-doża ta' Trobalt hija rrakkomandata f'pazjentib'indeboliment moderat jew qawwi tal-fwied (ara sezzjoni 4.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009, EU/1/11/681/010
Maltese: EU/1/11/681/009, EU/1/11/681/010
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trobalt in paediatric patients aged 2 to below 18 years with Lennox Gastaut Syndrome, and in paediatric patients aged 0 to below 18 years with partial onset seizures (see section 4.2 for information on paediatric use) .
Maltese: Trobalt huwa indikat biex jiżdied mal-kura ta' aċċessjonijiet b'bidu parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja reżistenti għall-mediċini f'pazjenti 'l fuq minn 18-il sena bl-epilessija, fejn ingħatat prova li kombinazzjonijiet xierqa ma' prodotti mediċinali oħrajn huma inadegwati jew ma ġewx ittollerati.
English: • hallucinations (seeing or hearing things that are not there).
Maltese: • alluċinazzjonijiet (tara jew tisma' affarijiet li mhumiex hemm).
English: Trobalt can affect the results of some tests.
Maltese: Trobalt jista' jaffettwa r-riżultati ta' xi testijiet.
English: Tell the person who orders the test that you are taking Trobalt.
Maltese: Għid lil persuna li tordnalek it-test li inti qed tieħu Trobalt.
English: Reversibility of retinal pigmentation after retigabine discontinuation has been reported in some subjects.
Maltese: Ir-riversibilità tal-pigmentazzjoni retinali wara t-twaqqif ta' retigabine ġiet irrapportata f'xi individwi.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
Maltese: Trobalt 300 mg pilloli miksijin b'rita
English: Eye disorders
Maltese: Disorjentament Ansjetà
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004, EU/1/11/681/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/681/004, EU/1/11/681/005
English: EXP
Maltese: Diplopja
English: Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems.
Maltese: Trobalt jista' jikkawża effetti sekondarji serji, inkluż li ma tkunx tista' tgħaddi l-awrina (żamma talawrina) u problemi ta' saħħa mentali.
English: Each pack contains blisters of 21or 84 film-coated tablets.
Maltese: Kull pakkett fih folji ta' 21 jew 84 pillola miksija b'rita.
English: In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Maltese: Barraminhekk, ġew identifikati każijiet ta' makulopatija tip ta' vitelliforma akkwiżita, kemm fi studji kliniċi kif ukoll bħala rapporti spontanji.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets retigabine
Maltese: Trobalt 200 mg pilloli miksijin b'rita retigabine
English: Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
Maltese: Terapija b'ħafna prodotti mediċinali għal kontra l-epilessija hija assoċjata ma' riskju akbar ta' deformazzjonijiet konġenitali minn monoterapija u għalhekk monoterapija għandha tintuża kull meta dan ikun possibbli.
English: Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in people taking Trobalt (see Section 4).
Maltese: Disturbi fl-għajnejn ikkawżati minn tibdil fiċ-ċentru tar-retina (makulopatija) ġew irrapportati f'persuni li jieħdu Trobalt (ara Sezzjoni 4).
English: Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Maltese: Trobalt 100 mg pilloli miksijin b'rita huma ħodor, tondi u mmarkati b'“RTG 100” fuq naħa waħda.
English: The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Maltese: Il-volum ta' distribuzzjoni ta' retigabine fl-istat fiss huwa bejn 2 u 3 l/kg wara għoti ta'
English: Other antiepileptic medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: The following convention has been used for the classification of adverse reactions:
Maltese: Il-konvenzjoni li ġejja ntużat għall-klassifikazzjoni tar-reazzjonijiet avversi:
English: The maximum total daily starting dose is 300 mg (100 mg three times daily).
Maltese: L-ogħla doża totali ta' kuljum tal-bidu hija ta' 300 mg (100 mg tliet darbiet kuljum).
English: Magnesium stearate
Maltese: Mhux applikabbli.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
Maltese: Trobalt 400 mg pilloli miksijin b'rita
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/007, EU/1/11/681/008
Maltese: EU/1/11/681/007, EU/1/11/681/008
English: In a single-dose study, there were no clinically significant effects on retigabine AUC in volunteers with mild hepatic impairment (Child-Pugh score 5 to 6).
Maltese: retigabine f'voluntiera f'saħħithom b'indeboliment ħafif tal-fwied (punteġġ Child-Pugh 5 sa 6).
English: Pigment changes (discolouration) of the skin, lips or nails have been reported in long-term clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of ocular tissues (see above paragraph and section 4.8).
Maltese: Tibdil fil-pigment (tibdil fil-kulur) tal-ġilda, tax-xufftejn jew tad-dwiefer ġie rrapportat fi studji kliniċi fit-tul b'retigabine, xi kultant iżda mhux dejjem flimkien ma' tibdil fil-pigment tat-tessuti okulari (ara l-paragrafu hawn fuq u sezzjoni 4.8).
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥ 2828 AU* Mycoplasma hyopneumoniae inactivated
Maltese: --1 Circovirus tal-ħnieżer tip 2 ORF2 subunit antiġen ≥ 2828 AU* Mycoplasma hyopneumoniae inattivat
English: ≥ 2.69 RPU** * Antigenic Units as determined in the in vitro potency test (ELISA).
Maltese: ≥ 2.69 RPU** * Units antiġeniċi kif determinati f'test tal-potenza in vitro (ELISA).
English: ** Relative Potency Unit defined against a reference vaccine
Maltese: ** Units ta' potenza relattiva kif imqabbla ma' vaċċin ta'refernza.
English: EU (MA) Number
Maltese: EU (MA) Numru Isem kummerċj ali
English: Package size l t o r
Maltese: Daqs tal-pakkett t x
English: 31 May 2016 EMA/269745/2016
Maltese: EMA/269745/2016
English: Sandy everlasting EMA/269745/2016
Maltese: Fjuri tas-Sempreviva safra EMA/269745/2016
English: Sandy everlasting is the common name for the flowers of the plant Helichrysum arenarium (L.) Moench.
Maltese: Sandy everlasting huwa l-isem komuni għall-fjuri tal-pjanta Helichrysum arenarium (L.) Moench.
English: What is Sandy everlasting?
Maltese: X'inhu Sandy everlasting?
English: In its assessment, the HMPC considered studies in laboratory tests which supported an effect in increasing the flow of bile (a fluid produced in the liver which helps to break down fats) and reducing muscle contractions of the gall bladder (a small organ where bile is stored).
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra studji f'testijiet tal-laboratorju li jappoġġjaw effett fiż-żieda tat-tnixxija tal-bila (fluwidu prodott fil-fwied li jgħin fit-tkissir tax-xaħam) u t-tnaqqis tal-kontrazzjonijiet tal-muskoli tal-bużżieqa tal-marrara (organu żgħir fejn tinħażen il-bila).
English: The HMPC noted a lack of clinical studies with sandy everlasting.
Maltese: L-HMPC innota nuqqas ta' studji kliniċi rigward sandy everlasting.
English: Other information about Sandy everlasting medicines
Maltese: Informazzjoni oħra dwar mediċini li fihom Sandy everlasting
English: Sandy everlasting medicines should only be used in adults.
Maltese: Mediċini ta' sandy everlasting għandhom jintużaw biss fl-adulti.
English: What are the risks associated with Sandy everlasting medicines?
Maltese: X'inhuma r-riskji assoċjati ma' mediċini li fihom Sandy everlasting?
English: Further information on the HMPC assessment of sandy everlasting 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: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom sandy everlasting, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (All Documents') filwebsajt tal-Aġenzija:
English: This means that, although there is insufficient evidence from clinical trials, 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 millinqas 15-il sena fl-UE).
English: Any applications for the licensing of medicines containing sandy everlasting have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom sandy everlasting għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Sandy everlasting preparations may also be found in combination with other herbal substances in some herbal medicines.
Maltese: Il-preparazzjonijiet ta' sandy everlasting jistgħu jinstabu wkoll f'kombinazzjoni ma' sustanzi tal-ħxejjex oħra f'xi mediċini tal-ħxejjex.
English: Further information on the risks associated with these sandy everlasting 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 sandy everlasting, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: The HMPC concluded, that on the basis of its long-standing use, this sandy everlasting preparation can be used for digestive disorders with a feeling of fullness and bloating.
Maltese: L-HMPC ikkonkluda li, abbażi tal-użu fit-tul tagħha, din il-preparazzjoni ta' sandy everlasting tista' tintuża għal disturbi diġestivi fejn tħossok imbulmat/a u minfuħ/a.
English: Sandy everlasting
Maltese: Fjuri tas-Sempreviva safra
English: What evidence supports the use of Sandy everlasting medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini li fihom sandy everlasting?
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of sandy everlasting.
Maltese: Dan is-sommarju mhux maħsub biex jipprovdi parir prattiku dwar l-użu ta' mediċini li fihom sandy everlasting.
English: Herbal medicines containing this sandy everlasting preparation is usually available as herbal teas to be drunk.
Maltese: Mediċini tal-ħxejjex li fihom din il-preparazzjoni ta' sandy everlasting normalment ikunu disponibbli bħala tejiet tal-ħxejjex biex jinxtorob.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing sandy everlasting.
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom Sandy everlasting?
English: The HMPC conclusions only cover a sandy everlasting preparation, which is obtained by drying and comminuting (reducing into tiny pieces) the flowers.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss preparazzjoni ta' sandy everlasting, li hija miksuba billi jitnixxfu u jindaħnu (f'biċċiet iżgħar) l-fjuri.