FrancophonIA/ELRC3.0 huggingface dataset:
English: Nespo (SureClick) is available in packs containing 1 or 4 pre-filled pens (not all pack sizes may be marketed).
Maltese: Nespo (SureClick) jinstab f' pakketti ta' pinna mimlija għal-lest waħda jew f' pakketti ta' 4 pinen mimlija għal-lest (jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Dompé Biotec S.p.A.
Maltese: Żommu fil-pakkett oriġinali biex tilqa' mid-dawl.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 ml (40 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 20 mikrogramma ta' darbepoetin alfa f' 0.5 ml (40 µg/ml).
English: Nespo 150 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Maltese: Nespo 150 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 15 micrograms darbepoetin alfa.
Maltese: Kull kunjett ta' 1 ml fih 15-il mikrogramma darbepoetin alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 ml pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/ml).
Maltese: Kull siringa mimlija għal-lest fiha 50 mikrogramma ta' darbepoetin alfa f' 0.5 ml (100 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 ml pre-filled pen contains 150 micrograms darbepoetin alfa (500 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest fiha 150 mikrogramma ta' darbepoetin alfa f' 0.3 ml (500 µg/ml).
English: • if you are allergic to Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Take special care with Nespo
Maltese: • jekk għandek sensittività eċċessiva (allerġija) għal Nespo (darbepoetin alfa), għal r-HuEPO jew għal xi waħda mis-sustanzi l-oħra ta' Nespo.
English: In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in patients with CRF treated subcutaneously.
Maltese: Kien hemm żjieda moderata mistennija (< darbtejn) fil-konċentrazzjoni fis-serum hekk kif qagħda stabbli kienet avviċinata, iżda l-ebda akkumulazzjoni mhux mistennija ma seħħet meta ngħataw aktar dożi.
English: Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
Maltese: Il-farmakokinetika ta' darbepoetin alfa ġiet studjata klinikament f'pazjenti b' insuffiċjenza renali kronika wara l-għoti ġol vina u taħt il-ġilda.
English: In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
Maltese: F' pazjenti b' insuffiċjenza renali kronika u b'evidenza klinika ta' mard iskemiku tal-qalb jew ta' insuffiċjenza tal-qalb konġestiva, it-targit ta' l-emoglobina jrid jiġi determinat individwalment.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 20 micrograms of darbepoetin alfa in 0.5 ml (40 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 20 mikrogramma ta' darbepoetin alfa f' 0.5 ml (40 µg/ml).
English: There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
Maltese: Kien hemm rapporti ta' reazzjonijiet ta' sensittività eċċessiva serji li jinkludu reazzjonijiet anafilattiċi, anġioedema, qtugħ ta' nifs, raxx tal-ġilda u urtikarja, assoċjati ma' darbapoetin alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 40 micrograms darbepoetin alfa.
Maltese: Kull kunjett ta' 1 ml fih 40 mikrogramma darbepoetin alfa.
English: Check the expiry date on the pre-filled syringe label (EXP:).
Maltese: Iċċekkja d-data ta' skadenza fuq it-tikketta tas-siringa mimlija għal-lest (JIS:).
English: Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
Maltese: L-inċidenza ta' effetti mhux mixtieqa meqjusa bħala relatati ma' kura b'Nespo fi studji kliniċi kontrollati huma dawn:
English: HOW TO USE THE NESPO PRE-FILLED PEN (SURECLICK)
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni) ġo pinna mimlija għal-lest (SureClick).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 50 micrograms of darbepoetin alfa in 0.5 ml (100 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 50 mikrogramma ta' darbepoetin alfa f' 0.5 ml (100 µg/ml).
English: INSTRUCTIONS ON USE
Maltese: Aċċessjonijiet ġew rrappurtati
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Maltese: L-għejxien u l-progressjoni tat-tumur ġew eżaminati f' ħames studji kkontrollati kbar li involvew total ta' 2833 pazjent, liema minnhom erba' studji kieku studji double blind kkontrollati bil-placebo u l istudju l-ieħor kien studju open-label.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 100 micrograms of darbepoetin alfa in 0.5 ml (200 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 100 mikrogramma ta' darbepoetin alfa f' 0.5 ml (200 µg/ml).
English: 0.4 ml
Maltese: Nespo 40 µg
English: DO NOT use Nespo:
Maltese: Data ta' l-ewwel awtorizzazzjoni:
English: The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Maltese: Id-deċiżjoni li jingħataw eritropojetins rikombinanti għandha tkun ibbażata fuq evalwazzjoni tal-benefiċju-riskju bil-parteċipazzjoni tal-pazjent, li għandha tikkunsidra lkuntest kliniku speċifiku.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 10 mikrogramma ta' darbepoetin alfa f' 0.4 ml (25 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 300 micrograms of darbepoetin alfa in 0.6 ml (500 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 300 mikrogramma ta' darbepoetin alfa f' 0.6 ml (500 µg/ml).
English: • an allergy to latex (the needle cover on the pre-filled pen contains a derivative of latex).
Maltese: • allerġija għall-latex (l-għatu tal-labra tal-pinna mimlija għal-lest fih sustanza mnissla milllatex)
English: EU/1/01/184/013 1 Pack Blister EU/1/01/184/- 014 4 Pack Blister EU/1/01/184/039 1 Pack Unblistered
Maltese: EU/1/01/184/012 Pakkett Folja ta' 4 EU/1/01/184/038 Pakkett ta' 1 (mhux ġo folja)
English: FRONT- Nespo getting started guide:
Maltese: QUDDIEM- Nespo gwida biex tibda:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 ml (100 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 30 mikrogramma ta' darbepoetin alfa f' 0.3 ml (100 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 80 mikrogramma ta' darbepoetin alfa f' 0.4 ml (200 µg/ml).
English: Annex I List of medicinal products affected by the procedure
Maltese: TA' PRODOTTI MEDIĊINALI
English: Bulgaria биопарокс Fusafungine 50mg/10 Ml
Maltese: Il-Bulgarija биопарокс Fusafungine 50 mg/10 mL Sprej għall-Mukuża tal-Imnieħer/Ħalq, Soluzzjoni
English: Fusafungine, 0.125 Mg/Dose
Maltese: Fusafungine, 0.125 mg/Doża Sprej għall-Mukuża tal-Imnieħer/Ħalq, Soluzzjoni
English: Belgium Servier Benelux N.V.-S.A.
Maltese: Servier Benelux N.V.-S.A.
English: Luxembourg Servier Benelux N.V.-S.A.
Maltese: Il-Lussemburgu Servier Benelux N.V.-S.A.
English: Date of latest renewal: 18 December 2018.
Maltese: Data tal-aħħar tiġdid: 18 Diċembru 2018
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Maltese: Lucane Pharma, 172 rue de Charonne 75011 Paris
English: 1244 RL Ankeveen The Netherlands
Maltese: RL Ankeveen I-Olanda
English: Common Giddiness, vestibular syndrome.
Maltese: Mejt, sindrome vestibulari
English: In a single dose (4 grams) pharmacokinetic study in healthy adult volunteers (N=11) the initial time to a 2 µg/mL serum level of aminosalicylic acid was 2 hours with a range of 45 minutes to 24 hours; the median time to peak was 6 hours with a range of 1.5 to 24 hours; the mean peak level was 20 µg/mL with a range of 9 to 35µg/mL: a level of 2 µg/mL was maintained for an average of 8 hours with a range of 5 to 9.5 a level of 1 µg/mL was maintained for an average of 8.8 hours with a range of 6 to 11.5 hours.
Maltese: Fi studju farmakokinetiku b'doża waħda (4 gramma) f'voluntiera adulti b'saħħithom (N=11), il-ħin inizjali għal livell ta' aminosalicylic acid fis-serum ta' 2 µg/mL kien ta' sagħtejn b'medda ta' 45 minuta sa 24 siegħa; il-ħin medjan sal-ogħla livell kien ta' 6 sigħat b'medda ta' 1.5 sigħat sa 24 siegħa; il-livell massimu medju kien ta' 20 µg/mL b'medda ta' 9 sa 35µg/mL: livell ta' 2µg/mL inżamm għal medja ta' 8 sigħat b'medda ta' 5 sa 9.5 sigħat; livell ta' 1 µg/mL inżamm għal medja ta' 8.8 sigħat b'medda ta' 6 sa 11.5 sigħat.
English: Uncommon Anorexia.
Maltese: Mhux komuni anoressija,
English: Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis.
Maltese: L-aminosalicylic acid huwa batterjostatiku kontra l-Mycobacterium tuberculosis.
English: • thyroid gland problems*,
Maltese: • problemi fil-glandola tat-tirojde*,
English: Desensitization
Maltese: Desensitizzazzjoni
English: • Antituberculosis medicines or ethionamide (other treatments against tuberculosis)
Maltese: • Mediċini għal kontra t-tuberkulosi jew ethionamide (trattamenti oħra għal kontra t-tuberkulosi)
English: No data are available.
Maltese: M'hemmx data disponibbli.
English: Reactions are rare after a total dosage of 1.5 g.
Maltese: Ir-reazzjonijiet huma rari wara dożaġġ totali ta' 1.5 g.
English: Vitamin B12
Maltese: B12
English: EU/1/13/896/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/896/001
English: Methacrylic acid - Ethyl acrylate copolymer (1:1) Dispersion 30 per cent Hypromellose
Maltese: Silica, colloidal hydratedDibutyl sebacate Methacrylic acid - Ethyl acrylate copolymer (1:1) Dispersion 30 fil-mija Hypromellose
English: The other ingredients are silica, colloidal hydrated, dibutyl sebacate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, hypromellose, cellulose, microcrystalline, talc.
Maltese: Is-sustanzi l-oħra huma silica, colloidal hydrated, dibutyl sebacate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30fil-mija, hypromellose, cellulose, microcrystalline, talc.
English: Very rare Thrombocytopenia, purpura, leukopenia, anemia, methemoglobinemia, agranulocytosis.
Maltese: Tromboċitopenija, purpura, lewkopenija, anemija, metemoglobinemija, agranuloċitosi
English: In human lymphocyte cultures in-vitro clastogenic effects of achromatic, chromatid, isochromatic breaks or chromatid translocations were not seen at 153 or 600 µg /mL but at 1500 and 3000 µg /mL there was a dose related increase in chromatid aberrations.
Maltese: F'kulturi ta' limfoċiti umani in vitro, ma dehrux effetti klastoġeniċi ta' ksur akromatiku, kromatidu, isokromatiku jew traslokazzjonijiet kromatidi bid-doża ta' 153 jew 600 µg /mL iżda bid-doża ta' 1500 u 3000 µg/mL kien hemm żieda relatata mad-doża fl-aberrazzjonijiet kromatidi.
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AA01
Maltese: Kategorija farmakoterapewtika: Antimikobatteriċi, mediċini għat-trattament tat-tuberkulosi, Kodiċi ATC:
English: Triglyceride absorption is always normal.
Maltese: L-assorbiment tat-trigliċeridi dejjem ikun normali.
English: Date of first authorisation: 07 April 2014.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 07 ta' April 2014
English: Malabsorption syndrome*, peptic ulcer, gastrointestinal bleeding, jaundice, metallic taste.
Maltese: Sindrome ta' assorbiment ħażin*, ulċera peptika, fsada gastrointestinali, suffejra, togħma metallika
English: Plasma protein binding is about 50 to 60%, the kinetic distribution has a half-life of 0.94 hours and a volume of distribution of 1.001 L/kg.
Maltese: Il-twaħħil mal-proteini tal-plażma huwa ta' madwar 50 sa 60%, id-distribuzzjoni kinetika għandha ħalf-life ta' 0.94 sigħat u volum ta' distribuzzjoni ta' 1.001 L/kg.
English: • visual abnormalities,
Maltese: • abnormalitajiet fil-vista,
English: The cumulative excretion of para-aminosalicylic after 24 hours is 84% of an oral dose of 4 g, 21% as para-aminosalicylic acid and 63% as the acetylated form.
Maltese: It-tneħħija kumulattiva tal-para-aminosalicylic wara 24 siegħa hija 84% ta' doża orali ta' 4 g, 21% bħala aċidu para-aminosaliċiliku u 63% bħala l-forma aċetilata.
English: Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.
Maltese: Qratas magħmulin minn karta/polyethylene ta' densità baxxa/folja tal-aluminju/primer/polyethylene ta' densità baxxa.
English: The major metabolites of PAS are produced by conjugation to glycine in para-aminosalicyluric acid (PASU) for up to 25% of the dose and to N-acetyl in N-acetyl para-aminosalicylic acid (Ac-PAS) for up to 70% of the dose.
Maltese: Il-metaboliti prinċipali tal-PAS huma prodotti permezz ta' konjugazzjoni: għall-glycine fil-paraaminosalicyluric acid (PASU) sa 25% tad-doża u għall-N-aċetil fl-N-aċetil aċidu para-aminosaliċiliku (Ac-PAS) sa 70% tad-doża.
English: Pack size of 30 sachets.
Maltese: Kull kaxxa fiha 30 qartas.
English: • disturbance of gait and equilibrium.
Maltese: • disturb fil-mixja u l-bilanċ.
English: How to store GRANUPAS Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: 172 rue de Charonne 75011 Paris France
Maltese: 75011 Paris Franza
English: Gastro-resistant granules The granules are small off white/ light brown coloured approximately 1.5 mm diameter.
Maltese: Il-granijiet huma żgħar ta' lewn off white/kannella ċar b'dijametru ta' 1.5 mm.
English: Frequency is defined as very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000
Maltese: Il-frekwenza hija definita bħala komuni ħafna (≥1/10), 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The data available from a rat embryofoetal development study, where animals were given sodium aminosalicylate (3.85 to 385 mg/kg) were limited.
Maltese: Id-data disponibbli minn studju dwar l-iżvilupp tal-embriju u l-fetu fil-firien, fejn l-annimali ngħataw sodju aċidu para-aminosaliċiliku (3.85 sa 385 mg/kg) kienet limitata.
English: Most frequent adverse reactions were related to the gastrointestinal system.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi l-aktar frekwenti kienu relatati mas-sistema gastrointestinali.
English: Gastro-resistant granules 30 sachets
Maltese: Granijiet gastro-reżistenti 30 qartas
English: • giddiness,
Maltese: • sturdament,
English: • Diphenylhydramine (for allergic reactions)
Maltese: • Digoxin (għal mard tal-qalb) • Diphenylhydramine (għal reazzjonijiet allerġiċi)
English: Thyroid function should be monitored in HIV co-infected patients before commencing treatment and regularly during treatment, in particular when para-aminosalicylic acid is co-administered with ethionamide/prothionamide.
Maltese: Il-funzjoni tat-tirojde għandha tkun immonitorjata f'pazjenti ko-infettati bl-HIV qabel ma jibda t-trattament u waqt it-trattament regolarment, b'mod partikolari meta l-aċidu paraaminosaliċiliku huwa ko-amministrat ma' ethionamide/prothionamide.
English: Maximum daily dose is 12 g. Usual duration of treatment is 24 months.
Maltese: Id-doża massima ta' kuljum hija 12 g.
English: See section 4.2 for posology adjustments for desensitization.
Maltese: Ara sezzjoni 4.2 għall-aġġustamenti tal-pożoloġija għal desensitizzazzjoni.
English: • stomach ache (abdominal pain),
Maltese: • uġigħ fl-istonku (uġigħ addominali),
English: Limited pharmacokinetic data suggest no substantial difference between adults and children.
Maltese: Data farmakokinetika limitata ma tissuġġerixxi l-ebda differenza sostanzjali bejn l-adulti u t-tfal.
English: Urticaria.
Maltese: Ipotirojdiżmu
English: Very rare Crystalluria.
Maltese: Rari ħafna kristalli fl-awrina
English: • reduced ability to absorb nutrients from food ulcer,
Maltese: • tnaqqis fl-abilità ta' assorbiment tan-nutrijenti mill-ikel,
English: Para-aminosalicylic acid is distributed in various tissues and fluids including the lungs, kidneys, liver and peritoneal fluid.
Maltese: L-aċidu para-aminosaliċiliku jiġi distribwit f'diversi tessuti u fluwidi fosthom il-pulmuni, il-kliewi, ilfwied u l-fluwidu peritoneali.
English: Sodium aminosalicylic acid was not mutagenic in Ames test strain TA 100.
Maltese: Is-sodju aċidu para-aminosaliċiliku acid ma kienx mutaġeniku fir-razza TA 100 tat-test Ames.
English: In a single dose study the plasma half-life of para-aminosalicylic acid administered as GRANUPAS was 1.62 ± 0.85 h.
Maltese: Fi studju b'doża unika, il-half-life fil-plażma tal-aċidu para-aminosaliċiliku mogħti bħala GRANUPAS kienet ta' 1.62±0.85 sigħat.
English: The complete syndrome includes steatorrhoea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption.
Maltese: Is-sindrome komplet jinkludi steatorrea, mudell abnormali tal-musrana ż-żgħira fuq x-ray, atrofija tal-villus, depressjoni tal-kolesterol, tnaqqis fl-assorbiment tad-D-xylose u tal-ħadid.
English: Hypothyroidism*.
Maltese: Ipotirojdiżmu*
English: Very rare side effects (may affect less than 1 in 10,000 people):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw inqas minn persuna 1 minn kull 10,000):
English: The Netherlands
Maltese: I-Olanda
English: How to store GRANUPAS
Maltese: Tiħux GRANUPAS
English: Overpharma Tel: +351 214 307 760 info@overpharma.pt
Maltese: 307 760 info@overpharma.pt
English: Hypothyroidism
Maltese: Ipogliċemija
English: GRANUPAS is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Maltese: GRANUPAS huwa indikat għall-użu bħala parti minn terapija kombinata xierqa għal tuberkulosi reżistenti għal ħafna mediċini fl-adulti u pazjenti pedjatriċi mill-età ta' 28 jum 'il fuq meta ma jkunx jista' jiġi kompost reġimen ta' trattament effettiv għal raġunijiet ta' reżistenza jew tollerabbiltà.
English: During the first 3 months of your treatment with GRANUPAS, you must be attentive to any sign of allergic reaction (for example skin eruption, itchy red spots on the skin, itching, rash, watery or itchy eyes or stuffy nose) or hepatitis (for example fever, fatigue, dark urine, pale stool, abdominal pain, yellow skin and eyes).
Maltese: Matul l-ewwel 3 xhur tat-trattament tiegħek bl-GRANUPAS, għandek toqgħod attent għal kwalunkwe sinjal ta' reazzjoni allerġika (per eżempju tfaqqigħ ta' raxx fil-ġilda, tikek ħomor u ħakk fil-ġilda, ħakk, raxx, għajnejn idemmgħu jew ħakk fl-għajnejn jew imnieħer misdud) jew epatite (per eżempju deni, għeja, awrina skura, ippurgar pallidu, uġigħ addominali, ġilda safra u għajnejn sofor).
English: Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.
Maltese: B12 jista' jitnaqqas mill-aċidu para-aminosaliċiliku li jwassal għalliżvilupp ta' abnormalitajiet klinikament sinifikanti fl-eritroċiti wara t-tnaqqis; pazjenti fuq terapija ta' iżjed minn xahar għandhom jiġu kkunsidrati għaż-żamma tal-vitamina B12.
English: The recommended total dose per day is 150 mg for each kg of body weight.
Maltese: Id-doża totali rakkomandata għal kull ġurnata hija 150 mg għal kull kg tal-piż tal-ġisem.
English: GRANUPAS 4 g gastro-resistant granules
Maltese: GRANUPAS 4 g granijiet gastro-reżistenti
English: Common Cutaneous hypersensitivity, skin rash.
Maltese: Sensittività eċċessiva tal-ġilda, raxx fil-ġilda
English: The recommended schedule is 4 g every 8 hours.
Maltese: L-iskeda rakkomandata hija 4 g kull 8 siegħat.
English: In the table below all adverse reactions are listed by system organ class and by frequency.
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi kollha huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza.
English: GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Maltese: GRANUPAS 4 g granijiet gastro-reżistenti aċidu para-aminosaliċiliku
English: • dizziness,
Maltese: • nefħa,
English: Dibutyl sebacate
Maltese: Twissijiet u prekawzjonijiet
English: Regular monitoring of the thyroid function is indicated for all people living with HIV.
Maltese: Monitoraġġ regolari tal-funzjoni tat-tirojde huwa indikat għannies kollha li għandhom l-HIV.
English: Medical Need Europe AB Puh/Tel: + 46 8 533 39 500 info@medicalneed.com
Maltese: Suomi/Finland Medical Need Europe AB Puh/Tel: + 46 8 533 39 500 info@medicalneed.com
English: • elevated liver enzymes,
Maltese: • żieda fl-enzimi tal-fwied,
English: • crystals in urine.
Maltese: • kristalli fl-awrina,
English: It inhibits the onset of bacterial resistance to streptomycin and isoniazid.
Maltese: Huwa jinibixxi lbidu tar-reżistenza batterika għal streptomycin u isoniazid.
English: Given that the metabolites of para-aminosalicylic acid are largely excreted via glomerular filtration, caution is warranted in patients with mild to moderate renal impairment (see also section 4.3).
Maltese: Minħabba li l-metaboliti tal-aċidu para-aminosaliċiliku jitneħħew prinċipalment permezz ta' filtrazzjoni glomerulari, hija meħtieġa kawtela f'pazjenti li jkollhom indeboliment tal-kliewi ħafif sa moderat (ara wkoll sezzjoni 4.3).
English: • if you are infected with HIV
Maltese: • jekk int infettat bl-HIV
English: Para-aminosalicylic acid and its metabolites are excreted by glomerular filtration and tubular secretion.
Maltese: L-aċidu para-aminosaliċiliku u l-metaboliti tiegħu jiġu mneħħija permezz ta' filtrazzjoni glomerulari u sekrezzjoni tubulari.
English: Mild to moderate renal impairment
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: Co-administration of para- aminosalicylic acid and ethionamide may intensify adverse reactions of para-aminosalicylic acid, mainly the gastrointestinal effects, including jaundice, hepatitis, nausea, vomiting, diarrhoea, abdominal pain or anorexia.
Maltese: L-għoti fl-istess ħin tal-para- aminosalicylic acid u ethionamide jista' jħarrax ir-reazzjonijiet avversi tal-aċidu para-aminosaliċiliku , l-aktar l-effetti gastrointestinali, fosthom is-suffejra, l-epatite, iddardir, ir-rimettar, id-dijarea, l-uġigħ addominali jew l-anoressija.
English: How to take GRANUPAS
Maltese: Mediċini oħra u l-GRANUPAS
English: It is unknown whether it passes through the placental barrier.
Maltese: Mhux magħruf jekk jgħaddix mill-barriera tal-plaċenta.
English: There is no evidence available on the effect of para-aminosalicylic acid on fertility.
Maltese: Ma hemm ebda evidenza disponibbli dwar l-effett tal-aċidu para-aminosaliċiliku fuq il-fertilità.
English: Together they constitute more than 90% of the total metabolites of PAS found in urine.
Maltese: Flimkien huma jikkostitwixxu aktar minn 90% tal-metaboliti totali talPAS li jinstabu fl-awrina.
English: GRANUPAS 4g gastro-resistant granules para aminosalicylic acid Oral use
Maltese: GRANUPAS 4g granijiet gastro-reżistenti aċidu para-aminosaliċiliku Użu orali