FrancophonIA/ELRC3.0 huggingface dataset:
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Maltese: Telf notevoli ta' xagħar ta' ≥ 50% hu mistenni għall-maġġoranza ta' pazjenti li jkollhom alopeċja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with human serum albumin-paclitaxel nanoparticles in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel f'kull sett tal-popolazzjoni pedjatrika fit trattament ta' kanċer metastatiku tas-sider, adenokarċinoma tal-frixa u kanċer tal-pulmun ta' ċelluli mhux żgħar (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving human serum albumin-paclitaxel nanoparticles.
Maltese: Rapporti rari ta' insuffiċjenza konġestiva tal-qalb u disfunzjoni tal-ventrikulu tax-xellug kienu osservati fost individwi li kienu qed jingħataw nanopartiċelli ta' albumina tas-serum uman-paclitaxel.
English: Treatment effects on OS favoured the human serum albumin-paclitaxel nanoparticles/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Maltese: L-effetti tat-trattament fuq l-OS iffavoriet il-parti tal-istudju dwar nanopartiċelli ta' albumina tas serum uman-paclitaxel/gemcitabine fil-maġġoranza tas-sottogruppi speċifikati minn qabel (li jinkludu s-sess tal-persuna, KPS, ir-reġjun ġeografiku, il-post primarju tal-kanċer tal-frixa, l-istadju meta tkun saret id-dijanjosi, il-preżenza ta' metastasi fil-fwied, il-preżenza ta' karċinomatożi peritoneali, proċedura Whipple fil-passat, il-preżenza ta' stent fil-marrara fil-linja bażi, il-preżenza ta' metastasi fil-pulmun, u numru ta' postijiet metastatiċi).
English: Paclitaxel belongs to a group of medicines called “taxanes” used in cancer.
Maltese: Paclitaxel jappartieni għal grupp ta' mediċini msejħa “taxanes” li jintużaw għat-trattament tal-kanċer.
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin enhances transport of paclitaxel across endothelial cells.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il mediċina.
English: Common: Interstitial pneumonitis3, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Maltese: imidazole, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir,
English: No patients treated with human serum albumin-paclitaxel nanoparticles and carboplatin experienced Grade 4 peripheral neuropathy.
Maltese: L-ebda pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel u carboplatin ma kellhom newropatija periferali ta' Grad 4.
English: Respiratory thoracic and mediastinal disorders
Maltese: Disturbi gastro-intestinali
English: Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Maltese: Komuni: Pnewmonja, bronkite, infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju, infezzjoni fil-passaġġ urinarju
English: 2031 GA Haarlem Netherlands
Maltese: Haarlem 2031 GA L-Olanda
English: General disorders and administration site conditions Asthenia/Fatigue was reported in 40% of the patients.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Astenja/għeja kbira kienu rrappurtati f'40% tal-pazjenti.
English: Use of filters with a pore size less than 15 µm may result in blockage of the filter.
Maltese: L-użu ta' filtri b'daqs ta' pori ta' inqas minn 15 µm jista' jwassal għall-imblukkar tal-filtru.
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Maltese: • Għajnejn irritati, uġigħ fl-għajnejn, għajnejn ħomor, ħakk fl-għajnejn, vista doppja, tnaqqis filvista, jew tara dwal bħal leħħa ta' berqa, vista mċajpra minħabba nefħa fir-retina (edima makulari ċistojde)
English: Febrile Neutropenia:
Maltese: Sensittività eċċessiva severa
English: Day 1
Maltese: Grad 3
English: Pazenir contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state.
Maltese: Pazenir fih nanopartiċelli b'daqs ta' madwar 130 nm, magħmula minn albumina tas-serum tal-bniedem u paclitaxel, fejn paclitaxel ikun preżenti fi stat mhux ikkristallizzat, amorfu.
English: There was no evidence for accumulation of paclitaxel with multiple treatment courses.
Maltese: Ma kien hemm l-ebda evidenza ta' akkumulazzjoni ta' paclitaxel b'korsijiet multipli ta' trattament.
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Maltese: • Nuqqas ta' koordinazzjoni fil-muskoli jew diffikultà biex taqra, żieda jew tnaqqis fid-dmugħ,
English: For treatment of non-small cell lung cancer Pazenir is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Pazenir dose has been given.
Maltese: Għat-trattament ta' kanċer tal-pulmun ta' ċelluli mhux żgħar, Pazenir jingħata darba fil-ġimgħa (i.e. f'jiem 1, 8 u 15 ta' ċiklu ta' 21 jum), b'carboplatin li jingħata darba kull tliet ġimgħat (i.e. f'jum 1 ta' kull ċiklu ta' 21 jum biss), immedjatament wara li tkun ingħatat id-doża ta' Pazenir.
English: • Indigestion, abdominal discomfort
Maltese: • Ħalq xott, diffikultà biex tibla'
English: The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period.
Maltese: Id-doaas-superfiċje tal-ġisem mogħtija fuq perjodu ta' 3ezz ta' ' 125 mg/m2 tal erja tas-superfiċje tal-ġisem mogħtija fuq perjodu ta' 30 minuta.
English: Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Kull kunjett fih 100 mg ta' paclitaxel ifformulat bħala nanopartiċelli mwaħħla mal-albumina.
English: Animal studies with human serum albumin-paclitaxel nanoparticles showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Maltese: Studji fuq l-annimali b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel urew effetti tossiċi mhux riversibbli fuq l-organi riproduttivi tal-irġiel f'livelli ta' espożizzjoni klinikament rilevanti.
English: In one study, human serum albumin-paclitaxel nanoparticles were administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Maltese: Studji ta' fergħa waħda open-label Fi studju wieħed, nanopartiċelli ta' albumina tas-serum uman-paclitaxel ingħataw bħala infużjoni fuq perjodu ta' 30 minuta b'doża ta' 175 mg/m2 lil 43 pazjent b'kanċer metastatiku tas-sider.
English: Myalgia occurred in 24% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 7% of cases.
Maltese: Il-majalġja seħħet f'24% tal-pazjenti li kienu fuq nanopartiċelli ta' albumina tas-serum uman-paclitaxel, u kienet severa f'7% tal-każijiet.
English: • medicine used for heartburn or stomach ulcers (e.g. cimetidine)
Maltese: • mediċina li jintużaw għal ħruq ta' stonku jew ulċeri fl-istonku (eż. cimetidine)
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Maltese: Ludwig-Merckle-Strasse 3
English: Very common: Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia
Maltese: Komuni ħafna: Newropatija periferali, newropatija, ipoestesija, parestesija
English: Hepatobiliary disorders Common: Cholangitis
Maltese: Mhux komuni: Paralisi tas-VII nerv
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Maltese: Jekk id-dispersjoni ta' Pazenir tmiss mal-ġilda, il-ġilda għandha tinħasel immedjatament u bir-reqqa bis-sapun u bl-ilma.
English: Very common: Alopecia, rash Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Maltese: Komuni ħafna: Alopeċja, raxx Komuni: Disturbi fid-dwiefer, ħakk, ġilda xotta, ġilda ħamra, tibdil fil kulur/pigmentazzjoni tad-dwiefer, il-ġilda tiskura, onikolisi, tibdil fiddwiefer
English: Patients received a median treatment duration of 3.9 months in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Maltese: 32% tal-pazjenti fil-parti tal-istudju b'nanopartiċelli ta' albumina tas-serum umanpaclitaxel/gemcitabine meta mqabbla ma' 15% tal-pazjenti fil-parti tal-istudju b'gemcitabine irċivew trattament ta' 6 xhur jew aktar.
English: Thus patients receiving Pazenir should be vigilantly monitored by physicians for the occurrence of cardiac events.
Maltese: Għaldaqstant, il-pazjenti li jkunu qed jingħataw Pazenir, għandhom ikunu mmonitorjati b'attenzjoni minn tabib għal xi avvenimenti kardijaċi.
English: MUPS and capsules
Maltese: MUPS u kapsuli
English: The MAH commits to update the document 'P3-03 Description of Manufacturing Process and Process Controls for Drug Product'
Maltese: Il-MAH jimpenja ruħu li jaġġorna d-dokument ‘P3-03 Deskrizzjoni tal-Proċess ta' Manifattura u Kontrolli tal-Proċess għall-Prodott Mediċinali'
English: Capsules and solution for injection and solution for infusion
Maltese: Kapsuli u soluzzjoni għal injezzjoni u soluzzjoni għal infużjoni
English: The MAH commits to update the dossier according to the various regulations and the EU Directive 2001/83/EC.
Maltese: Il-MAH jimpenja ruħu li jaġġorna l-fajl skont ir-regolamenti varji u d-Direttiva tal-UE 2001/83/EC.
English: The MAH commits to investigate, justify and introduce the limits for impurities in accordance with the guideline ICH Topic Q3B: Impurities in new Drug Products
Maltese: Il-MAH jimpenja ruħu li jinvestiga, jiġġustifika u jintroduċi l-limiti għal impuritajiet skont il-linji gwida ICH Topic Q3B: Impuritajiet f'Prodotti Mediċinali Ġodda
English: The MAH commits to provide the supporting documents regarding TSE (Transmissible Spongiform Encephalopathies) safety.
Maltese: Il-MAH jimpenja ruħu li jipprovdi d-dokumenti ta' appoġġ rigward is-sigurtà kontra t-TSE (Enċefalopatiji Sponġiformi Trasmissibbli - Transmissible Spongiform Encephalopathies).
English: The MAH commits to investigate, justify and introduce limits for a number of degradation products.
Maltese: Il-MAH jimpenja ruħu li jinvestiga, jiġġustifika u jintroduċi limiti għal numru ta' prodotti ta' degradazzjoni.
English: The MAH commits to provide the supporting documents and data regarding the stability of the modification of the drug substance omeprazole magnesium and omeprazole.
Maltese: Il-MAH jimpenja ruħu li jipprovdi d-dokumenti u d-dejta ta' appoġġ rigward listabbiltà tal-modifika tas-sostanza mediċinali omeprazole magnesium u omeprazole.
English: The MAH commits to develop and introduce a second identification method for the drug substance omeprazole.
Maltese: Il-MAH jimpenja ruħu li jiżviluppa u jintroduċi metodu ta' identifikazzjoni ieħor għas-sostanza mediċinali omeprazole.
English: The MAH commits to respond to the following unresolved quality issues by discussing and implementing as relevant in the context of an update of the CTD documentation in May 2010.
Maltese: Il-MAH jimpenja ruħu li jwieġeb għall-kwistjonijiet mhux solvuti dwar il-kwalità li ġejjin billi jiddiskuti u jimplimenta kif rilevanti fil-kuntest ta' aġġornament tad-dokumentazzjoni tasCTD f'Mejju 2010.
English: ANNEX IV
Maltese: ANNESS IV KUNDIZZJONIJIET TAL-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ
English: The MAH commits to conduct an epidemiological study on the risk of falls and fractures and to provide the results of this study by Q2 of 2011.
Maltese: Il-MAH jimpenja ruħu li jwettaq studju epidemjoloġiku dwar ir-riskji tal-waqgħat u ksur u li jipprovdi r-riżultati ta' dan l-istudju sal-Q2 tal-2011.
English: Solution for injection and solution for infusion
Maltese: Soluzzjoni għal injezzjoni u soluzzjoni għal infużjoni
English: The MAH commits to provide the supporting documents regarding the limits of quantifications of the drug product
Maltese: Il-MAH jimpenja ruħu li jipprovdi d-dokumenti ta' appoġġ rigward il-limiti ta' kwantifikazzjonijiet tal-prodott mediċinali
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali, kkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin huma ssodisfati mid-Detenturi tal-Awtorizzazzjonijiet għatTqegħid fis-Suq:
English: EU Number
Maltese: Numru tal-MA (EU)
English: Invented name
Maltese: Isem Qawwa
English: Syringe
Maltese: Siringa
English: 0.3 mL 100 UI insulin
Maltese: 0.3 mL 100 UI insulina
English: More information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine.
Maltese: ema.europa.eu/Find medicine.
English: For daily doses > 1.5 mg - 5 mg (0.3 - 1.0 mL)
Maltese: Għal dożi ta' kuljum ta' > 1.5 mg5 mg (0.3 - 1.0 mL)
English: Females > 40 kg
Maltese: Nisa > 40 kg
English: Males > 40 kg
Maltese: Irġiel > 40 kg
English: Dose of Myalepta in mL
Maltese: Doża ta' Myalepta f'mL
English: A 3 ml syringe (21 gauge and 40 mm) to draw up the water for injection and reconstitute the powder.
Maltese: Siringa ta' 3 ml (21 gejġ u 40 mm) biex jinġibed l-ilma għall-injezzjoni u biex jiġi rikostitwit it-trab.
English: Educational materials will be provided to patients and healthcare professionals to ensure that the medicine Myalepta (metreleptin) is prepared and injected correctly, and to prevent the risk of medication errors.
Maltese: Il-materjal edukattiv ser jiġi pprovdut lill-pazjenti u lill-professjonisti fil-qasam tal-kura tas-saħħa sabiex jiġi żgurat li l-mediċina Myalepta (metreleptin) tiġi ppreparata u injettata kif suppost, u sabiex jiġi evitat ir-riskju ta' żbalji fil-medikazzjoni.
English: Maximum daily dose (injection volume)
Maltese: Doża massima ta' kuljum (volum tal-injezzjoni)
English: Water for injection to reconstitute the powder (2.2 ml of water for injection are needed);
Maltese: Ilma għall-injezzjoni biex jiġi rikostitwit it-trab (huwa meħtieġ 2.2 ml ta' ilma għallinjezzjoni);
English: • Myalepta (metreleptin), used treat lipodystrophy, is given as a daily subcutaneous injection in the abdomen, thigh or upper arm.
Maltese: • Myalepta (metreleptin), li jintuża biex jikkura l-lipodistrofija, jingħata kuljum bħala injezzjoni taħt il-ġilda fl-addome, fil-koxxa jew fil-parti ta' fuq tad-driegħ.
English: With every prescription of Myalepta the pharmacist should dispense:
Maltese: Aktar informazzjoni dwar Myalepta tinstab fis-sit elettroniku tal-Aġenzija:
English: Myalepta is a medicine used to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Maltese: Myalepta huwa mediċina li tintuża biex tikkura l-lipodistrofija, fejn il-pazjenti jkollhom telf tat-tessut xaħmi taħt il-ġilda u akkumulazzjoni ta' xaħam x'imkien ieħor fil-ġisem bħal fil-fwied u fil-muskoli.
English: A second syringe to inject the dose.
Maltese: It-tieni siringa biex tiġi injettata d-doża.
English: Needle gauge and length
Maltese: Doża tal-bidu ta' kuljum
English: In order to convert the dose for the 0.3 mL U100 insulin syringe the following table should be used:
Maltese: Sabiex tiġi kkonvertita d-doża għas-siringa ta' 0.3 mL U100 tal-insulina, għandha tintuża ttabella li ġejja:
English: • Your pharmacist will also give you a second syringe (the size of syringe to use varies depending on the dose prescribed and is either 0.3 mL, 1.0 mL or 2.5 mL ) that you must use to give the injection.
Maltese: • L-ispiżjar tiegħek ser jagħtik ukoll it-tieni siringa (id-daqs tas-siringa li għandek tuża jvarja skont id-doża preskritta, u jkun jew 0.3 mL, 1.0 mL jew 2.5 mL ) li għandek tuża biex tagħti l-injezzjoni.
English: Rounded amount of solution
Maltese: Ammont imqarreb għalleqreb numru sħiħ tassoluzzjoni
English: Dose of Myalepta in mg
Maltese: Piż tal-wild Doża ta' Myalepta f'mg
English: ‘Unit' measurement volume in 0.3 mL syringe to inject
Maltese: Volum ta' kejl f'“Unità” f'siringa ta' 0.3 mL li għandu jiġi injettat
English: Starting daily dose
Maltese: Aġġustamenti fiddoża
English: Patients should be reviewed every 6 months to ensure that their injection technique is correct.
Maltese: Il-pazjenti għandhom jiġu rieżaminati kull 6 xhur sabiex jiġi żgurat li t-teknika tal-injezzjoni tagħhom hijiex korretta.
English: Educational material for patients and healthcare professionals to ensure Myalepta is used correctly
Maltese: Materjal edukattiv għall-pazjenti u l-professjonisti fil qasam tal-kura tas-saħħa sabiex jiġi żgurat li Myalepta jintuża kif suppost
English: The dose should be prescribed in both milligrams and milliliters:
Maltese: Id-doża għandha tiġi preskritta kemm f'milligrammi kif ukoll f'millilitri:
English: It may harm them,
Maltese: Purified water;
English: D-21465 Reinbek Germany
Maltese: D-21465 Reinbek
English: Ronda General Mitre, 151 08022 Barcelona Spain.
Maltese: Ronda General Mitre, 151 08022 Barcelona Spanja
English: Cream 15 g 30 g 60 g
Maltese: Krema 15 g 30 g 60 g
English: The active substance is eflornithine.
Maltese: Is-sustanza attiva hi eflornithine.
English: very rare
Maltese: rari ħafna
English: MedDRA conventions for frequency are very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data) including isolated reports.
Maltese: komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli) li jinkludu rapporti iżolati.
English: Almirall, S.A. Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
Maltese: Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
English: Vaniqa 11.5% cream Vehicle
Maltese: Vaniqa 11.5% krema Vehicle
English: Vaniqa 11.5% cream Eflornithine
Maltese: Vaniqa 11.5% krema Eflornithine
English: Date of first authorisation: 20 March 2001 Date of latest renewal: 07 March 2011
Maltese: Data tal-aħħar tiġdid: 07 ta' Marzu, 2011
English: Vaniqa 11.5% cream
Maltese: Vaniqa 11.5% krema
English: o acne
Maltese: o akne
English: Vaniqa contains the active substance eflornithine.
Maltese: Vaniqa fih is-sustanza attiva eflornithine.
English: The potential risk to humans is unknown.
Maltese: Irriskju potenzjali għall-bnedmin mhuwiex magħruf.
English: Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down's Syndrome to a 35 year old).
Maltese: Minn dawn id-19-il tqala, kien hemm 9 trabi b'saħħithom, 5 aborti elettivi, 4 aborti spontanji u difett 1 tattwelid (Sindromu ta' Down li seħħ lil omm ta' 35 sena).
English: Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Maltese: Eflornithine mhuwiex magħruf li jiġi metabolit, u hu eliminat primarjament fl-awrina.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: Cream.
Maltese: Krema
English: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, 0.8 mg of methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate.
Maltese: Kull gramma ta' krema fiha 47.2 mg ta' cetostearyl alcohol, 14.2 mg ta' stearyl alcohol, 0.8 mg ta' methyl parahydroxybenzoate u 0.
English: It is important to continue using the cream.
Maltese: Hu importanti li tkompli tuża l-krema.
English: Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water; stearyl alcohol and sodium hydroxide (to adjust pH).
Maltese: Fih ukoll: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water, stearyl alcohol, sodium hydroxide (biex jikontrollaw ilpH).
English: Outcome*
Maltese: Riżultat*
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Propyl parahydroxybenzoate (E216); Purified water;
Maltese: Propyl parahydroxybenzoate (E216);
English: It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.
Maltese: Tiġi fornuta f'tubi ta' 15 g, 30 g u 60 g, iżda jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali.
English: / Ελλάδα / España / Κύπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republika
Maltese: / Magyarország / Malta / România / Slovenija / Slovenská republika
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Mediċini http://www.ema.europa.eu/.
English: Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Maltese: Kull 1 g ta' krema fiha 115 mg ta' eflornithine (bħala hydrochloride monohydrate).
English: • If possible, do not wash these areas of skin for 4 hours after applying the cream
Maltese: • Jekk ikun possibbli, taħsilx dawn il-partijiet tal-ġilda sa 4 sigħat wara li tkun dlikt il krema.
English: (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Maltese: (jaffettwaw inqas minn utent 1 minn kull 10,000) mhux magħruf (il-frekwenza ma tistax tkun stmata mid-data disponibbli).
English: Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
Maltese: Kull gramma ta' krema fiha 115 mg ta' eflornithine (bħala hydrochloride monohydrate).
English: However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/kg/day or approximately 24 g/day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.
Maltese: aċċidentalment, għandha tingħata attenzjoni għall-effetti murija b'dożi terapewtiċi ta' eflornithine filvina (400 mg/kg/kuljum jew madwar 24 g/kuljum) użati fil-kura ta' infezzjoni bi Trypanosoma brucei gambiense (marda Afrikana ta' l-irqad): telf ta' xagħar, nefħa tal-wiċċ, puplesiji, indeboliment tassmigħ, disturbi gastrointestinali, nuqqas t'aptit, uġigħ ta' ras, indebboliment, sturdament, anemija, tromboċitopenja u lewkopenja.
English: Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Maltese: Minħabba l-penetrazzjoni minima fil-ġilda ta' eflornithine (ara sezzjoni 5.2), diffiċli ħafna li jkun hemm doża eċċessiva.