FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical stability for the diluted solution for infusion has been demonstrated at 15-25°C for up to 6 hours or in the refrigerator (2ºC-8ºC) for no more than 24 hours.
Maltese: L-istabbilità kimika u fiżika għas-soluzzjoni dilwita għall-infużjoni ntweriet f'temperatura ta' 15-25°C għal sa 6 sigħat jew fil-friġġ (2ºC-8ºC) għal mhux aktar minn 24 siegħa.
English: Forty-one percent (41%) of patients treated with ONIVYDE pegylated liposomal across the clinical program were ≥ 65 years.
Maltese: Wieħed u erbgħin fil-mija (41 %) tal-pazjenti kkurati b'ONIVYDE lipożomali pegilat fil-programm kliniku kellhom ≥ 65 sena.
English: One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Maltese: Millilitru wieħed ta' konċentrat fih 4.3 mg bażi ħielsa anidra ta' irinotecan (bħala melħ ta' irinotecan sucrosofate f'formulazzjoni lipożomali pegilata).
English: The population pharmacokinetic analysis in patients aged 28 to 87 years, of whom 11% were ≥75 years suggests that age had no clinically meaningful effect on the exposure to irinotecan and SN-38.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni f'pazjenti li kellhom minn 28 sa 87 sena, li minnhom 11% kellhom ≥75, tissuġġerixxi li l-età ma kellha l-ebda effett klinikament sinifikanti fuq l-esponiment għal irinotecan u SN-38.
English: Common: Colitis, Haemorrhoids
Maltese: Mhux komuni: Trombożi
English: Non-liposomal irinotecan and SN-38 were genotoxic in vitro in the chromosomal aberration test on CHO-cells as well as in the in vivo micronucleus test in mice.
Maltese: Irinotecan mhux lipożomali u SN-38 kienu ġenotossiċi in vitro fit-test tal-aberrazzjoni kromożomali fuq iċ-ċelluli CHO kif ukoll fittest tal-mikronukleu in vivo fil-ġrieden.
English: The trial was designed to assess the clinical efficacy and safety of ONIVYDE pegylated liposomal monotherapy or ONIVYDE pegylated liposomal +5-FU/LV compared to an active control arm of 5-FU/LV.
Maltese: Il-prova kienet maħsuba biex tevalwa l-effikaċja klinika u s-sigurtà ta' monoterapija b'ONIVYDE lipożomali pegilat jew ONIVYDE lipożomali pegilat+5-FU/LV meta mqabbla mal-parti tal-istudju ta' kontroll attiv ta' 5-FU/LV.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ONIVYDE pegylated liposomal in all subsets of the paediatric population in treatment of adenocarcinoma of the pancreas (see section 4.2 for information on paediatric use).
Maltese: Għandha tingħata kunsiderazzjoni biex jiġu sostitwiti terapiji li jinduċu mhux bl-enzimi mill-inqas ġimagħtejn qabel ilbidu tat-terapija b'ONIVYDE lipożomali pegilat (ara sezzjoni 4.5).
English: Common: Pulmonary embolism, Embolism, Deep vein thrombosis Uncommon: Thrombosis
Maltese: Komuni: Emboliżmu pulmonarji, Emboliżmu, Trombożi tal-vini profondi
English: No dose adjustment is recommended in patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Maltese: Lebda aġġustament fid-doża mhu rakkomandat f'pazjenti b'indeboliment ħafif sa moderat tal-kliewi (ara sezzjonijiet 4.4 u 5.2).
English: Talk to your doctor or nurse before you are given ONIVYDE pegylated liposomal - if you have ever had any liver problems or jaundice - if you have ever had lung disease or have previously received medicines (colony stimulating factors) to increase your blood count or radiation therapy - if you are taking other medicines (see section “Other medicines and ONIVYDE pegylated liposomal”) - if you are planning to have a vaccination as many vaccinations must not be given during chemotherapy - if you are on a controlled sodium diet as this medicine contains sodium.
Maltese: Kellem lit-tabib jew lill-infermier tiegħek qabel tieħu ONIVYDE lipożomali pegilat - jekk qatt kellek xi problemi fil-fwied jew suffejra - jekk qatt kellek mard tal-pulmun jew fil-passat kont irċivejt mediċini (fatturi li jistimulaw il kolonji) biex jiżdied l-għadd tad-demm tiegħek, jew terapija ta' radjazzjoni - jekk qed tieħu xi mediċini oħra (ara sezzjoni “Mediċini oħra u ONIVYDE lipożomali pegilat”) - jekk qed tippjana li titlaqqam peress li ma jistax jingħata ħafna tilqim waqt il-kimoterapija - jekk qiegħed/qiegħda fuq dieta bl-ammont ta' teħid ta' sodium kkontrollat peress li din il mediċina fiha s-sodium.
English: Uncommon (may affect up to 1 in 100 people) - Systemic body inflammation, caused by infection of the gall bladder and bile ducts (biliary sepsis) - Allergic reaction to ONIVYDE pegylated liposomal (the active substance or the excipients) - Diminished availability of oxygen to the body tissues - Inflammation of the oesophagus (food pipe) - Formation or presence of a blood clot within a blood vessel - vein or artery (thrombosis) - Inflammation of the lining of the rectum (the end of the large intestine) - Type of rash, characterised by appearance of a flat, red area on the skin covered with bumps
Maltese: (sepsis biljari) - Reazzjoni allerġika għal ONIVYDE lipożomali pegilat (is-sustanza attiva jew l-eċċipjenti) - Disponibbiltà mnaqqsa ta' ossiġnu lit-tessuti tal-ġisem - Infjammazzjoni tal-esofagu (passaġġ tal-ikel) - Il-formazzjoni jew il-preżenza ta' embolu tad-demm f'vina jew arterja (trombożi) - Infjammazzjoni tal-kisja tal-rektum (it-tarf tal-musrana l-kbira) - Tip ta' raxx, ikkaratterizzat minn dehra ta' żona ċatta u ħamra fuq il-ġilda, miksija bil-ħafas
English: ONIVYDE pegylated liposomal must not be administered as a bolus injection or an undiluted solution.
Maltese: Għandha tiġi stabbilita kura massima ta' appoġġ biex tiġi evitata d-deidratazzjoni minħabba d-dijarea u biex tiġi kkurata kwalunkwe kumplikazzjoni infettiva.
English: UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism.
Maltese: L-attività ta' UGT1A1 titnaqqas f'individwi b'polimorfiżmi ġenetiċi li twassal għal attività enżimatika mnaqqsa bħall-polimorfiżmu UGT1A1*28.
English: Uncommon: Oesophagitis, Proctitis
Maltese: Infużjoni akuta u reazzjonijiet relatati
English: Irinotecan released from liposome encapsulation follows a similar metabolic pathway reported with non-liposomal irinotecan.
Maltese: Irinotecan li joħroġ mill-inkapsulazzjoni lipożomali jsegwi passaġġ metaboliku simili rrappurtat b'irinotecan mhux lipożomali.
English: Each pack contains one vial.
Maltese: Kull pakkett fih kunjett wieħed.
English: Therefore, co-administration of ONIVYDE pegylated liposomal with inducers of CYP3A4 may reduce systemic exposure of ONIVYDE pegylated liposomal.
Maltese: Għalhekk, l-għoti ta' ONIVYDE lipożomali pegilat flimkien ma' indutturi ta' CYP3A4 jista' jnaqqas l-esponiment sistemiku ta' ONIVYDE lipożomali pegilat.
English: Blood tests and medical examinations
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Maltese: Ġie osservat disinn retikulonodulari fuq X-rays tas-sider f'perċentwal żgħir ta' pazjenti rreġistrati fi studju kliniku b'irinotecan.
English: Loperamide should not be used for more than 48 consecutive hours due to risk of paralytic ileus.
Maltese: Loperamide m'għandux jintuża għal iktar minn 48 siegħa konsekuttivi minħabba r-riskju ta' ileus paralitiku.
English: STATEMENT OF ACTIVE SUBSTANCE One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 10 mL ta' konċentrat fih 43 mg bażi ħielsa anidra ta' irinotecan (bħala melħ ta' irinotecan sucrosofate f'formulazzjoni lipożomali pegilata).
English: • Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Maltese: • Għandha tingħata attenzjoni biex jiġi evitat ħruġ ta' likwidu mill-vini, u s-sit tal-infużjoni għandu jiġi mmonitorjat għal sinjali ta' infjammazzjoni.
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Maltese: U KWANTITATTIVA Kunjett wieħed ta' 10 mL ta' konċentrat fih 43 mg bażi ħielsa anidra ta' irinotecan (bħala melħ ta' irinotecan sucrosofate f'formulazzjoni lipożomali pegilata).
English: ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
Maltese: ONIVYDE lipożomali pegilat (irinotecan) għandu jiġi preskritt u amministrat biss lill-pazjenti minn professjonisti fil-kura medika li huma esperjenzati fl-użu tat-terapiji kontra l-kanċer.
English: In animal models, ONIVYDE pegylated liposomal has been shown to extend plasma levels of irinotecan and prolong the exposure to the active metabolite SN-38 at the site of the tumour.
Maltese: Fil-mudelli tal-annimali, ONIVYDE lipożomali pegilat wera li jestendi l-livelli tal-plażma ta' irinotecan u jtawwal l-esponiment għall-metabolit attiv SN-38 fis-sit tat-tumur.
English: Lot:
Maltese: /Tel:
English: Prior Whipple procedure
Maltese: Proċedura ta' Whipple minn qabel
English: • ONIVYDE pegylated liposomal is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration.
Maltese: • ONIVYDE lipożomali pegilat huwa fornut bħala tixrid lipożomali sterili f'konċentrazzjoni ta' 4.3 mg/mL u għandu jiġi dilwit qabel ma jingħata.
English: ONIVYDE pegylated liposomal and do not dose escalate to 70 mg/m 2, the recommended first dose reduction is to 43 mg/m and the second dose reduction is to 35 mg/m 2.
Maltese: ONIVYDE lipożomali pegilat u ma jeskalawx id-doża għal 70 mg/m 2, l-ewwel tnaqqis tad-doża rakkomandat huwa għal 43 mg/m u t-tieni tnaqqis tad-doża huwa għal 35 mg/m 2.
English: White to slightly yellow opaque isotonic liposomal dispersion.
Maltese: GĦAMLA FARMAĊEWTIKA Konċentrat għal soluzzjoni għall-infużjoni Tixrid lipsomali isotonika opaka bajda li tagħti ftit fl-isfar.
English: No reproductive and developmental toxicity studies have been performed with ONIVYDE pegylated liposomal.
Maltese: Ma sarux studji dwar it-tossiċità riproduttiva u tal-iżvilupp b'ONIVYDE lipożomali pegilat.
English: In rats, pups born from treated animals and having external abnormalities showed a decrease in fertility.
Maltese: Fil-firien, il-frieħ imwielda minn annimali kkurati u li kellhom anormalitajiet esterni urew tnaqqis fil-fertilità.
English: Uncommon: Hypoxia
Maltese: Mhux komuni: Sepsis biljari
English: Non-liposomal irinotecan caused atrophy of male reproductive organs both in rats and dogs after multiple daily doses of 20 mg/kg and 0.4 mg/kg, respectively.These effects were reversible upon cessation of treatment.
Maltese: Irinotecan mhux lipożomali kkważa atrofija tal-organi riproduttivi tal-irġiel kemm fil-firien kif ukoll fil-klieb wara dożi multipli kuljum ta' 20 mg/kg u 0.4 mg/kg, rispettivament.
English: Genotoxic and carcinogenic potential
Maltese: Potenzjal ġenotossiku u karċinoġeniku
English: One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as sucrosofate salt in a pegylated liposomal formulation).
Maltese: Kunjett wieħed ta' 10 mL ta' konċentrat fih 43 mg bażi ħielsa anidra ta' irinotecan (bħala melħ ta' sucrosofate f'formulazzjoni lipożomali pegilata).
English: Additional outcome measures included Progression Free Survival (PFS) and Objective Response Rate (ORR).
Maltese: Il-miżura primarja tal-eżitu kienet is-Sopravivenza Globali (OS). Miżuri addizzjonali tar-riżultat kienu jinkludu Sopravivenza Mingħajr Progressjoni (PFS, Progression Free Survival) u Rata ta' Rispons Oġġettiv (ORR, Objective Response Rate).
English: The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' ONIVYDE lipożomali pegilat fi tfal u adoloxxenti li għandhom ≤ 18 sena ma ġewx determinati s'issa.
English: The use of ONIVYDE pegylated liposomal in patients with significant renal impairment has not been established (see section 5.2).
Maltese: L-użu ta' ONIVYDE lipożomali pegilat f'pazjenti b'indeboliment tal-kliewi sinifikanti ma ġiex stabbilit (ara sezzjoni 5.2).
English: Uncommon: Rash maculo-papular, Nail discolouration Renal and urinary disorders Common: Acute renal failure General disorders and administration site conditions
Maltese: Komuni ħafna: Alopeċija Mhux komuni: Raxx makulopapulari, Tibdil fil-kulur tad-dwiefer
English: Should extravasation occur, flushing the site with sodium chloride 9 mg/ml (0.9%) solution for injection and/or sterile water and applications of ice are recommended.
Maltese: Jekk iseħħ ħruġ ta' likwidu mill-vini, huwa rakkomandat li s-sit jitlaħlaħ b'soluzzjoni għall-injezzjoni ta' sodium chloride ta' 9 mg/mL (0.9%) u/jew b'ilma sterili u għandu jiġi applikat is-silġ.
English: Non-liposomal irinotecan was teratogenic in rats and rabbits at doses below the human therapeutic dose.
Maltese: Irinotecan mhux lipożomali kien teratoġeniku fil-firien u fil-fniek f'dożi inqas mid-doża terapewtika umana.
English: Common: Hypoalbuminaemia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: It is also especially important that you tell your doctor if you are also taking the following medicines, since they reduce the availability of irinotecan in your body: - phenytoin, phenobarbital or carbamazepine (medicines used to treat convulsions and falls) - rifampicin and rifabutin (medicines used to treat tuberculosis) - St. John´s wort (a plant based medicine used to treat depression and low mood) - as ONIVYDE pegylated liposomal should not be given to you together with these medicines.
Maltese: Huwa importanti b'mod speċjali wkoll li tgħid lit-tabib tiegħek jekk tkun qed tieħu wkoll il-mediċini li ġejjin, peress li dawn inaqqsu d-disponibbiltà ta' irinotecan f'ġismek: - phenytoin, phenobarbital jew carbamazepine (mediċini użati biex jikkuraw il-konvulżjonijiet u l-waqgħat)
English: After dilution
Maltese: Disturbi vaskulari
English: 280 capsules + 2 inhalers
Maltese: 280 kapsuli + 2 inalatorju
English: Initiation Pack:10 capsules + 1 inhaler
Maltese: Pakkett ta 'inizjazzjoni: 10 kapsuli + 1 inalatur
English: Packaging Package size
Maltese: Daqs tal-pakkett
English: Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: Route of Administration
Maltese: Ippakkjar
English: Evicto (selamectin)
Maltese: Evicto (selamektina)
English: The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various sizes (15, 30, 45, 60, 120, 240 and 360 mg).
Maltese: Il-mediċina tiġi bħala soluzzjoni għal użu lokalizzat f'2 konċentrazzjonijiet differenti (6 % u 12 %) u f'tubi ta' diversi daqsijiet (15, 30, 45, 60, 120, 240 u 360 mg).
English: Further information on Evicto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/evicto.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/evicto.
English: Evicto received a marketing authorisation valid throughout the EU on 19 July 2019.
Maltese: Evicto ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 19/07/2019.
English: Other information about Evicto
Maltese: Informazzjoni oħra dwar Evicto
English: Evicto contains the active substance selamectin and is a ‘generic medicine'.
Maltese: Evicto fih is-sustanza attiva selamektina u huwa ‘mediċina ġenerika'.
English: This overview was last updated in May 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Mejju 2019.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Maltese: Isselamektina tattiva proteini speċjali msejħa ‘kanali tal-klorur' fuq il-wiċċ taċ-ċelloli tan-nervituri u talmuskoli tal-parassita u b'hekk tippermetti l-partikoli ċċarġjati tal-klorur jidħlu fiċ-ċelloli tan-nervituri u jfixklu l-attività elettrika normali tagħhom.
English: Evicto contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Maltese: Evicto fih is-selamektina, li hija mediċina antiparassitika li tappartjeni għall-klassi ‘avermektina'.
English: What are the benefits and risks of Evicto?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Evicto?
English: How has Evicto been studied?
Maltese: Kif ġie studjat Evicto?
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà għal Evicto, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti filqasam tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: Evicto is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worms that live inside the body.
Maltese: Evicto huwa mediċina antiparassitika li tintuża għall-kura u l-prevenzjoni ta' infestazzjonijiet ta' parassiti li jgħixu fuq il-ġilda jew fil-pil tal-qtates u l-klieb, bħall-briegħed u d-dud, kif ukoll li jikkuraw id-dud li jgħixu fil-ġisem.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Evicto.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati bil-mediċina ta' referenza, Stronghold, u ma għandhomx għalfejn jiġu ripetuti għal Evicto.
English: There was no need for ‘bioequivalence' studies to investigate whether Evicto is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' ‘bijoekwivalenza' biex jiġi investigat jekk Evicto jiġix assorbit b'mod simili għallmediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: This means that Evicto contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold.
Maltese: Dan ifisser li Evicto fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Stronghold.
English: Betula pendula Roth and/or Betula pubescens Ehrh., folium
Maltese: Betula pendula Roth u/jew Betula pubescens Ehrh., folium
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom healthcare practitioner should be consulted.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ottubru 2015
English: Birch leaf
Maltese: Werqa tal-betulla
English: Birch leaf medicines should only be used in adults and adolescents above 12 years of age.
Maltese: Mediċini li fihom il-werqa tal-betulla għandhom jintużaw biss fuq adulti u adolexxenti li għandhom aktar minn 12-il sena.
English: Other information about birch leaf medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-werqa tal-betulla
English: What are the risks associated with birch leaf medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-werqa tal-betulla?
English: The HMPC conclusions on the use of birch leaf medicines to increase the production of urine are based on their ‘traditional use' in minor urinary tract problems.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini li fihom il-werqa tal-betulla biex tiżdied ilproduzzjoni tal-awrina huma bbażati fuq l-'użu tradizzjonali' tagħhom fi problemi minuri tal-apparat urinarju.
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 erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod b'mod sigur għal millinqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Further information on the HMPC assessment of birch leaf 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 tal-werqa tal-betulla, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab "Id-dokumenti kollha" fis-sit web tal-Aġenzija:
English: What is birch leaf?
Maltese: X'inhi l-werqa tal-betulla?
English: Further information on the risks associated with birch leaf 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 mal-mediċini tal-werqa tal-betulla, inkluż il-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab "Id-dokumenti kollha" fis-sit elettroniku tal-Aġenzija:
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as water or alcohol).
Maltese: L-estratti jiġu ppreparati permezz ta' teknika għall-estrazzjoni tal-komposti mill-materjal tal-pjanti bit-taħlil tagħhom f'solvent (bħall-ilma jew l-alkoħol).
English: Side effects that have been reported with birch leaf medicines include diarrhoea, feeling or being sick, and allergic reactions such as itching, rash and stuffy and runny nose.
Maltese: Effetti sekondarji li ġew irrapportati b'mediċini tal-werqa tal-betulla jinkludu dijarea, tħossok jew tkun ma tiflaħx, u reazzjonijiet allerġiċi bħal ħakk, raxx u imnieħer misdud u iqattar.
English: The HMPC concluded that, on the basis of its long-standing use, birch leaf medicines can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine, in order to achieve flushing of the urinary tract.
Maltese: Għalkemm hemm ftit studji kliniċi, inkluż studju fuq 15-il pazjent b'infezzjonijiet fl-apparat urinarju li ssuġġerew effett pożittiv fuq l-infezzjoni urinarja, id-dejta hija limitata wisq biex tintuża bħala evidenza.
English: For dry extracts the solvent is then evaporated to obtain the extract.
Maltese: Fil-każ ta' estratti nixfin, is-solvent imbagħad jiġi evaporat sabiex jinkiseb l-estratt.
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użi mediċinali tagħha?
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of birch leaf.
Maltese: Dan huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti Mediċinali Erbali (HMPC) dwar l-użi mediċinali tal-werqa tal-betulla.
English: How are birch leaf medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini tal-werqa tal-betulla?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing birch leaf.
Maltese: Il-konklużjonijiet tal-HMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt l-evalwazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini erbali li fihom il-werqa tal-betulla.
English: Birch leaf is the common name for the leaves of the tree Betula pendula Roth and/or Betula pubescens Ehrh.
Maltese: Dan is-sommarju mhux intiż biex jipprovdi pariri prattiċi dwar l-użu ta' mediċini li fihom il-werqa talbetulla.
English: They are used over a period of 2 to 4 weeks.
Maltese: Jintużaw fuq perjodu ta' ġimagħtejn sa 4 ġimgħat.