FrancophonIA/ELRC3.0 huggingface dataset:
English: The administration of Respreeza increases and maintains serum levels and lung epithelial lining fluid (ELF) levels of alpha1-proteinase inhibitor leading to a slowdown of the progression of emphysema.
Maltese: L-għoti ta' Respreeza iżid u jżomm il-livelli fis-serum u l-livelli fil-fluwidu tal-kisja tal-epitelju (ELFepithelial lining fluid) tal-pulmun ta' inibitur alpha1 ta' proteinase u jwassal għal tnaqqis filprogressjoni tal-emfisema.
English: Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Maltese: Infużjonijiet sussegwenti jistgħu jingħataw minn persuna li qed tieħu ħsieb il-pazjent jew mill-pazjent (ara sezzjoni 4.4).
English: Normal healthy individuals produce sufficient alpha1-proteinase inhibitor to control the NE produced by activated neutrophils and are thus able to prevent inappropriate proteolysis of lung tissue by NE.
Maltese: Individwi normali f'saħħithom jipproduċu biżżejjed inibitur alpha1 ta' proteinase biex jikkontrolla NE magħmul minn newtrofili attivati u b'hekk huma kapaċi jipprevjenu proteolisi mhux xierqa tat-tessut tal-pulmun minn NE.
English: Post authorisation efficacy study (PAES): A randomized, long-term PAES has been agreed to study the dose-relationship if the higher API levels achieved in the blood might influence the rate of lung density decline and whether that would support an increased dose of 120mg/kg the MAH should conduct and submit the results of a randomized, long term, efficacy study conducted according to an agreed protocol.
Maltese: Kien hemm ftehim dwar PAES randomised, fit-tul biex tiġi studjata r-relazzjoni mad-doża biex isir magħruf jekk l-ogħla livelli ta' API miksuba fiddemm jistgħux jinfluwenzaw ir-rata ta' tnaqqis fid-densità tal-pulmun u jekk dan jappoġġax doża akbar ta' 120 mg/kg.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MELOXIDYL EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) MELOXIDYL Sommarju tal-EPAR għall-pubbliku
English: Meloxidyl is a medicinal product that contains the active substance meloxicam.
Maltese: Meloxidyl huwa prodott mediċinali li fih is-sustanza attiva meloxicam.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Ilbilanċ bejn il-benefiċċju-riskju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: Meloxidyl is a ‘generic': this means that Meloxidyl is similar to a ‘reference veterinary medicinal product' already authorised in the EU (Metacam).
Maltese: Meloxidyl huwa ‘ġeneriku': dan ifisser li Meloxidyl huwa simili għal ‘prodott mediċinali veterinarju ta' referenza' li huwa diġà awtorizzat fl-UE.
English: Meloxidyl is a pale green oral suspension (1.5 mg/ml) for dogs and (0.5 mg/ml) for cats, which is mixed into the food, and a yellow solution for injection (5 mg/ml) for dogs and cats as well as solution for injection (20 mg/ml) for cattle, pigs and horses.
Maltese: Meloxidyl huwa sospensjoni orali ta' lewn aħdar ċar (1.5 mg/ml) għall-klieb u (0.5 mg/ml) għall-qtates, li jitħallat mal-ikel, u soluzzjoni safra għal injezzjoni (5 mg/ml) għall-klieb u l-qtates kif ukoll soluzzjoni għal injezzjoni (20 mg/ml) għall-frat, il-ħnieżer u ż-żwiemel.
English: In pigs Meloxidyl injection is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders and for supportive therapy in the treatment of puerperal septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotics.
Maltese: Fil-ħnieżer l-injezzjoni ta' Meloxidyl tintuża biex jitnaqqsu s-sintomi ta' zappip u infjammazzjoni f'disturbi lokomotorji mhux infettivi u bħala terapija ta' appoġġ flimkien ma' terapija antibijotika xierqa fit-trattament tas-settiċemija (septicaemia) u tossjemija fit-tifrigħ (toxaemia around farrowing) (sindromu tal-mastite-metrite-agalassija [mastitis-metritisagalactia syndrome]).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: In cattle Meloxidyl injection is used to reduce clinical signs in case of acute respiratory infection with appropriate antibiotic therapy, to reduce clinical signs in case of diarrhoea in combination with oral re-hydration therapy in calves over one week of age and young, nonlactating cattle and as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.
Maltese: Fil-ifrat l-injezzjoni ta' Meloxidyl tintuża biex jitnaqqsu sinjali kliniċi f'każ ta' infezzjoni respiratorja akuta b'terapija antibijotika adatta, biex jitnaqqsu sinjali klinii f'każ ta' dijarrea flimkien ma' terapija ta' idratazzjoni mill-ġdid orali fl-għoġiela ta' età 'l fuq minn ġimgħa u baqar żgħar li ma jkunux qegħdin ireddgħu u bħala terapija ta' appoġġ fit-trattament ta' mastite akuta, flimkien ma' antibijotiċi.
English: Why has Meloxidyl been approved?
Maltese: Għaliex ġie approvat Meloxidyl?
English: They include loss of appetite, vomiting, diarrhoea, blood in the stools and apathy (lack of vitality).
Maltese: Dawn jinkludu telf ta' aptit, remettar, dijarrea, demm fil-feċi u apatija (nuqqas ta' vitalità).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Meloxidyl to Ceva Santé Animal on 15 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Meloxidyl lil Ceva Santé Animal fil-15 ta' Jannar 2007.
English: What is Meloxidyl?
Maltese: Għal xiex jintuża Meloxidyl?
English: They usually occur during the first week of treatment and tend to be temporary.
Maltese: Normalment iseħħu waqt l-ewwel ġimgħa ta' trattament u normalment ikunu għal perjodu temporanju.
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Maltese: L-għoti minn taħt il-ġilda, dak intramuskolari kif ukoll fil-vina huwa tollerat sew fil-frat u filħnieżer; ġiet osservata biss nefħa proviżorja fis-sit tal-injezzjoni wara l-għoti minn taħt il-ġilda f'inqas minn 10% tal-frat ittrattati fi studji kliniċi.
English: Other information about Meloxidyl:
Maltese: Aktar tagħrif dwar Meloxidyl:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Meloxidyl has been shown to be bioequivalent to Metacam.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li, skont irrekwiżiti tal-UE, Meloxidyl wera ruħu bijoekwivalenti għal Metacam.
English: What is the risk associated with Meloxidyl?
Maltese: X'inhu r-riskju assoċjat ma' Meloxidyl?
English: How has Meloxidyl been studied?
Maltese: Kif ġie studjat Meloxidyl?
English: In dogs and cats the side effects seen with Meloxidyl are similar to those seen with other NSAIDs and occur only occasionally.
Maltese: Fil-klieb u l-qtates l-effetti sekondarji osservati b'Meloxidyl huma simili għal dawk b'NSAIDs oħra u jseħħu biss okkażjonalment.
English: Studies have been carried out to prove that Meloxidyl is ‘bioequivalent' to the reference veterinary medicinal product: this means that Meloxidyl is equivalent to Metacam in the way it is absorbed and used by the body.
Maltese: Twettqu studji sabiex juru li Meloxidyl huwa ‘bijoekwivalenti' għall-prodott mediċinali veterinarju ta' referenza: dan ifisser li Meloxidyl huwa ekwivalenti għal Metacam fil-mod ta' kif jiġi assorbit u użat millġisem.
English: In dogs, Meloxidyl is used as an oral suspension to relieve inflammation and pain in musculoskeletal disorders.
Maltese: Meloxidyl jintuża fil-klieb bħala sospensjoni orali sabiex jittaffew l-infjammazzjoni u l-uġigħ f'disturbi muskuloskelettriċi.
English: As an injection, Meloxidyl is also used to reduce the pain and inflammation after an operation, such as orthopaedic or soft tissue surgery.
Maltese: Bħala injezzjoni, Meloxidyl jintuża wkoll biex inaqqas l-uġigħ u l-infjammazzjoni wara operazzjoni, bħal intervent kirurġiku ortopediku jew tat-tessut artab.
English: Meloxidyl contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Meloxidyl fih meloxicam li jappartjeni għal klassi ta' mediċini msejħa mediċini antiinfjammatorji mhux sterojdi (NSAIDs). Meloxicam jaġixxi billi jinibixxi s-sinteżi talprostaglandini.
English: In cats, Meloxidyl is used as an oral suspension to relieve inflammation and pain in chronic musculo-skeletal disorders as well as to relieve mild to moderate pain after an operation, such as spaying or soft tissue surgery.
Maltese: Fil-qtates, l-injezzjoni ta' Meloxidyl tintuża għat-tnaqqis ta' wġigħ wara operazzjoni, bħal fi sterilizzazzjoni jew intervent kirurġiku minuri tat-tessut artab.
English: Titration and maintenance *Adults
Maltese: Tittrazzjoni u manteniment *Adulti
English: ATC code: V03A E02.
Maltese: V03A E02.
English: Digoxin, warfarin, enalapril or metoprolol
Maltese: Digoxin, warfarin, enalapril jew metoprolol
English: Bioavailability
Maltese: Bijodisponibilità
English: Oral use.
Maltese: Użu oral.
English: Titration and maintenance
Maltese: Tittrazzjoni u manteniment
English: The potential risk to humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali ta' Renvela waqt it-tqala umana.
English: - The active substance is sevelamer carbonate.
Maltese: - Is-sustanza attiva hi sevelamer carbonate.
English: 90 sachets
Maltese: 90 qartas
English: gastrointestinal necrosis*1, colitis*1,
Maltese: nekrożi gastrointestinali*1, kolite*1,
English: Pharmacodynamic effect
Maltese: Effetti farmakodinamiċi
English: intestinal ulceration*1,
Maltese: Ulċerazzjoni intestinali*1,
English: In clinical trials of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%.
Maltese: Fi provi kliniċi b'sevelamer, kemm il-kolesterol totali medju u l-kolesterol-LDL naqas bi 15-39%.
English: intestinal mass*1
Maltese: massa intestinali*1
English: Immune system disorders
Maltese: Disturbi fissistemi immuni
English: Paediatric dose based on BSA (m2)
Maltese: Dożaġġ pedjatriku skont BSA (m2)
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see section 4.8).
Maltese: Ġew irrapportati każijiet ta' disturbi infjammatorji serji f'partijiet differenti tal-passaġġ gastrointestinali (inkluż komplikazzjonijiet serji bħal emorraġija, perforazzjoni, ulċerazzjoni, nekrozi, kolite u massa kolonika/tal-musrana l-għamja -caecal) assoċjati mal-preżenza ta' kristalli ta' sevelamer (ara sezzjoni 4.8).
English: Renvela 800 mg
Maltese: 800 mg
English: Powder for oral suspension.
Maltese: Trab għal suspensjoni orali.
English: Hypocalcaemia/hypercalcaemia
Maltese: Ipokalċemija/iperkalċemija
English: Inflammatory gastrointestinal disorders
Maltese: Disturbi infjammatorji gastrointestinali
English: • Hypophosphataemia
Maltese: • Ipofosfatemja
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Maltese: Ir-rata ta' rapportaġġ hi klassifikata bħala komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1,000, <1/100), rari (≥1/10,000, <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid data disponibbli).
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħtif farmakokinetiku
English: These figures were 23% and 15% in the subgroup of patients on hemodialysis and peritoneal dialysis, respectively.
Maltese: Dawn il-figuri kienu 23% u 15% fis-sottogrupp ta' pazjenti fuq emodijalisi u dijalisi peritoneali, rispettivament.
English: The effects may be secondary to vitamin D depletion.
Maltese: L-effetti jistgħu jkunu sekondarji għal żbilanċ ta' vitamina D.
English: The oral suspension must be administered within 30 minutes.
Maltese: Is-suspensjoni orali għandha tingħata fi żmien 30 minuta.
English: Only for bottle label of 180 tablets: PC:
Maltese: Għat-tikketta biss tal-flixkun ta' 180 pillola: PC:
English: gastrointestinal hemorrhage*1,
Maltese: emorraġija gastrointestinali*1,
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Intestinal obstruction, ileus/subileus, intestinal perforation1,
Maltese: Sadd intestinali, ileju/sottileju, perforazzjoni talimsaren1,
English: Proton pump inhibitors
Maltese: Inibituri tal-proton pump
English: Date of first authorisation: 10 June 2009 Date of latest renewal: 20 February 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Ġunju, 2009 Data tal-aħħar tiġdid: 20 ta 'Frar 2019
English: Each carton contains 60 or 90 sachets.
Maltese: Kull kartuna fiha 60 jew 90 qartas.
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft rejection).
Maltese: Ciclosporin, mycophenolate mofetil u tacrolimus f'pazjenti li fuqhom sar trapjant Livelli mnaqqsa ta' ciclosporin, mycophenolate mofetil u tacrolimus ġew rapportati f'pazjenti li fuqhom sar trapjant meta ngħataw sevelamer hydrochloride ma dawn mingħajr konsegwenzi kliniċi (eż. riġetazzjoni tal-graft).
English: Renvela 0.8 g
Maltese: 0.8 g
English: In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations.
Maltese: F'test ċitoġeniku f'mammiferi b'attivazzjoni metabolika in vitro, sevelamer hydrochloride kkaġuna żieda statistikament sinifikanti fl-għadd ta' aberrazzjonijiet strutturali tal-kromosomi.
English: Renvela is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.
Maltese: Renvela huwa indikat għall-kontroll ta' iperfosfatemija f'pazjenti pedjatriċi (>6 snin ta' età u erja tas superfiċje tal-ġisem (Body Surface Area- BSA) ta' >0.75 m2) b'mard kroniku tal-kliewi.
English: Each tablet contains 800 mg sevelamer carbonate.
Maltese: Kull pillola fiha 800 mg sevelamer carbonate.
English: *Plus subsequent titrating, see section “Titration and maintenance”
Maltese: **Flimkien ma' tittrazzjoni sussegwenti, ara sezzjoni “Tittrazzjoni u manteniment”
English: Renvela 1.6 g
Maltese: 1.6 g
English: Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment.
Maltese: Livelli ta' trigliċeridi, kolesterol-HDL u albumina ma nbiddlux wara trattament b'sevelamer.
English: Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Maltese: Pakketti ta' flixkun 1 ta' 30 jew 180 pillola (mingħajr il-kartuna ta' barra) u pakkett multiplu li fih 180 (6 fliexken ta' 30) pillola.
English: Crystal deposit intestine*1
Maltese: kristalli fl-intestin*1
English: In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile for adults.
Maltese: B'mod ġenerali, il-profil ta' sigurtà għat-tfal u l-adolexxenti ( 6 sa 18-il sena ta' età) huwa simili għall-profil ta' sigurtà għall-adulti.
English: The printing ink contains iron oxide black (E172), isopropyl alcohol and propylene glycol.
Maltese: Il-linka tal-istampar fiha iron oxide black (E172), isopropyl alcohol u propylene glycol.
English: The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
Maltese: Il-kisi tal-pillola jikkonsisti minn hypromellose (E464) u diacetylated monoglycerides.
English: • dysphagia
Maltese: • disfaġja
English: Special note for patients on peritoneal dialysis
Maltese: Nota speċjali għal pazjenti fuq dijalisi peritoneali
English: The second study demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus levels ≥ 1.78 mmol/l) haemodialysis patients over two randomised 4 week treatment periods (mean serum phosphorus time-weighted averages were 1.6 ± 0.5 mmol/l for sevelamer carbonate powder and 1.7 ± 0.4 mmol/l for sevelamer hydrochloride tablets).
Maltese: It-tieni studju wera li t-trab ta' sevelamer carbonate ddożat tliet darbiet kien ekwivalenti għal pilloli ta' sevalamer hydrochloride ddożati tliet darbiet kuljum f'31 pazjent iperfosfatemiku (imfisser f'livelli ta' fosforu fis-serum≥ 1.78 mmol/l) u emodijalisi fuq żewġ perijodi ta' trattament każwali ta' 4 ġimgħat (foforu fis-serum medju, b'medji piżati bil-ħin ikunu ta' 1.6 ± 0.5 mmol/l għal trab ta' sevelamer carbonate u 1.7 ± 0.4 mmol/l għal pilloli ta' sevelamer hydrochloride).
English: Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.
Maltese: Qartas ta' ethylene methacrylic acid copolymer, polyester, LDPE u laminat tal-fojl tal-aluminju, b'siġill magħmul mis-sħana.
English: The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Maltese: Is-sigurtà ta' sevelamer (bħala jew carbonate jew mluħa ta' hydrochloride) ġiet mistħarrġa f'diversi provi kliniċi li jinvolvu total ta' 969 pazjent fuq emodijalisi b'tul ta' trattament ta' bejn 4 sa 50 ġimgħa, (724 pazjent ittrattat b'sevelamer hydrochloride u 245 b'sevelamer carbonate), 97 pazjent fuq dijalisi peritoneali b'tul ta' trattament ta' 12-il ġimgħa (kollha ttrattati b'sevelamer hydrochloride) u 128 pazjent b'mard tal kliewi kroniku li mhumiex fuq dijalisi b'tul ta' trattament ta' bejn 8 u 12-il ġimgħa (79 pazjent ittrattat b'sevelamer hydrochloride u 49 b'sevelamer carbonate).
English: Pack size: 90 sachets per carton
Maltese: Daqs tal-pakkett: 90 qartas f'kull kartuna
English: Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day).
Maltese: Studji ta' karċinoġeniċità b'sevelamer hydrochloride li jittieħed mill-ħalq saru fuq ġrieden (dożi sa 9 g/kg/jum) u firien (0.3, 1, jew 3 g/kg/jum).
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions.
Maltese: Sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamer carbonate, ingħata lil voluntieri normali b'saħħithom f'dożi sa 14-il gramma kuljum għal 8 ijiem mingħajr ebda reazzjonijiet avversi.
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Maltese: *esperjenza wara li l-prodott tqiegħed fis-suq 1Ara twissija ta' disturbi infjammatorji gastrointestinali f'sezzjoni 4.4
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela.
Maltese: • L-effetti ta' mediċini bħal ciclosporin, mycophenolate mofetil u tacrolimus (mediċini użati biex irażżnu s-sistema immuni) jistgħu jkunu mnaqqsa b'Renvela.
English: 2.4 g** 4.8 g**
Maltese: 2.4 g**
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 TABLETS (MULTIPACK PRESENTATION)
Maltese: TIKKETTA - FLIXKUN TA' 30 PILLOLA ( FORMAT TAL-PAKKETT MULTIPLU)
English: Metabolic acidosis
Maltese: Indeboliment epatiku
English: Renvela 1.6 g powder for oral suspension sevelamer carbonate
Maltese: Renvela 1.6 g trab għal suspensjoni orali sevelamer carbonate
English: • Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Renvela.
Maltese: • Mediċini għat-trattament ta' ħruq ta' stonku u rifluss mill-istonku jew esofagu tiegħek, bħal omeprazole, pantoprazole, jew lansoprazole, magħrufa bħala “inibituri tal-proton pump”, jistgħu jnaqqsu l-effikaċja ta' Renvela.
English: Nausea, vomiting, upper abdominal pain, constipation
Maltese: Dijarea, dispepsja, gass, uġigħ addominali,
English: 0.8 g three times daily Titrate up/down by 0.4 g three times daily 1.6 g three times daily Titrate up/down by 0.8 g three times daily
Maltese: 0.8 g tliet darbiet kuljum Ittitra 'l fuq/'l isfel b'0.4 g tliet darbiet kuljum 1.6 g tliet darbiet kuljum Ittitra 'l fuq/'l isfel b'0.8 g tliet darbiet kuljum
English: 180 (6 bottles of 30) film-coated tablets
Maltese: 180 (6 fliexken ta' 30) pillola miksija b'rita
English: Renvela 2.4 g powder for oral suspension sevelamer carbonate
Maltese: Renvela 2.4 g trab għal suspensjoni orali sevelamer carbonate
English: • severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion
Maltese: • disturbi ta' motilità gastrointestinali severi li jinkludu gastroparesi mhux ittrattata, iż-żamma tal kontenut gastriku u caqlieq irregolari tal-imsaren • mard infjammatorju attiv tal-imsaren
English: flatulence,
Maltese: Nawsea,
English: 30 film-coated tablets 180 film-coated tablets
Maltese: Kull flixkun fih 30 pillola jew 180 pillola
English: EU/1/09/521/001 30 film-coated tablets EU/1/09/521/003 180 film-coated tablets
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/521/001 30 pillola miksijin b'rita EU/1/09/521/003 180 pillola miksijin b'rita
English: Renvela 0.8 g powder for oral suspension sevelamer carbonate
Maltese: Renvela 0.8 g trab għal suspensjoni orali sevelamer carbonate
English: Renvela contains sevelamer carbonate as the active substance.
Maltese: Renvela fiha sevelamer carbonate bħala s-sustanza attiva.
English: EU/1/09/521/008 90 sachets EU/1/09/521/009 90 sachets (with dosing spoon)
Maltese: EU/1/09/521/009 90 qartas (b'kuċċarina għad-dożaġġ)
English: 60 sachets per carton 90 sachets per carton
Maltese: 60 qartas 90 qartas
English: Each sachet of 1.6 g of powder is to be dispersed in 40 mL of water prior to administration (see section 6.6).
Maltese: Kull qartas ta' 1.6 g ta' trab għandu jiġi maħlul f'40 ml ilma qabel ma jingħata (ara sezzjoni 6.6) .
English: Renvela 1.6 g powder for oral suspension
Maltese: Renvela 1.6 g trab għal suspensjoni orali.
English: Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Maltese: Renvela hi indikata wkoll għal kontroll ta' iperfosfatemja f'pazjenti adulti b'mard tal-kliewi kroniku (CKD) mhux fuq dijalisi b'livell ta' fosforu fis-serum ta' ≥ 1.78 mmol/l.
English: Only for bottle label of 180 tablets: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: The white to off-white tablets are imprinted with “RENVELA 800” on one side.
Maltese: Pilloli bojod għal ofwajt li fuqhom hemm stampat “RENVELA 800” fuq naħa waħda.
English: (blood) phosphorus level equal to or above 1.78 mmol/l.
Maltese: fosforu fis-serum (demm) ugwali għal jew ogħla minn 1.78 mmol/l.
English: How to store Renvela
Maltese: X'fih Renvela
English: Each sachet contains 1.6 g sevelamer carbonate.
Maltese: Kull qartas fih 1.6 g sevelamer carbonate.
English: Renvela 2.4 g
Maltese: 2.4 g