FrancophonIA/ELRC3.0 huggingface dataset:
English: Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Maltese: Carglumic acid hu strutturalment analogu għal N-acetylglutamate, li hu attivatur, preżenti b'mod naturali, ta' carbamoyl phosphate synthetase, l-ewwel enżima fiċ-ċiklu tal-urea.
English: The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
Maltese: Id-doża inizjali tal-bidu għandha tkun ta' 100 mg/kg, sa 250 mg/kg jekk meħtieġ.
English: Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Maltese: Tista' tkun indikata restrizzjoni ta' proteini u teħid żejjed ta' arginine f'każ ta' tolleranza baxxa ta'
English: Dispersible tablet.
Maltese: Pillola li tinfirex.
English: Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Maltese: Studji oħra li saru fuq il-firien taħt kundizzjonijiet sperimentali differenti wasslu għal żjieda fiddisponibilità tal-ammonja (nuqqas ta' ikel, dieta mingħajr proteini jew b'ħafna proteini).
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05.
Maltese: Aċidi aminiċi u derivati; Kodiċi ATC:
English: Date of first authorisation: 23 June 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 Ġunju 2017
English: The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10 kg, you should take 1 g per day, or 5 tablets of 200 mg).
Maltese: id-doża inizjali ta' kuljum hi ġeneralment ta' 100 mg kull kilogramma ta' piż tal-ġisem, sa massimu ta' 250 mg kull kilogramma ta' piż tal-ġisem (pereżempju jekk inti tiżen 10 kg, għandek tieħu 1 g kuljum jew 5 pilloli ta' 200 mg).
English: Absorption After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Maltese: Wara doża orali waħdanija ta' 100 mg/kg piż korporali, madwar 30% ta' carglumic acid hi stmata li tista' tiġi assorbita.
English: • diarrhoea,
Maltese: • dijarea, • deni,
English: At that dose-level, in 12 volunteers given carglumic acid tablets, plasma concentration peaked at 2.6 μg/mL (median; range 1.8-4.8) after 3 hours (median; range 2-4).
Maltese: F'dik il-livell ta' doża, fi 12-il voluntiera mogħtija l-pilloli ta' carglumic acid, il-konċentrazzjoni ta' plażma laħqet l-ogħla livell f'2.6 µg/ml (medjan; firxa 1.8-4.8) wara tliet sigħat (medjan; firxa 2-4).
English: • fever,
Maltese: Madankollu,
English: Eurocept International BV (Lucane Pharma)
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eurocept International BV (Lucane Pharma)
English: Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7-122 mg/kg/day).
Maltese: Il-livelli ta' carglumic acid fil-plażma kienu mkejjla f'pazjenti fil-kategoriji ta' kull età, minn trabi għadhom kif jitwieldu sa adoloxxenti, li ngħataw trattament b'dożi ta' kuljum li jvarjaw (7122 mg/kg/kuljum).
English: Pack size of 12 or 60 dispersible tablets.
Maltese: Daqs tal-pakkett ta' 12 jew 60 pillola li jinfirxu.
English: Not known rash
Maltese: Mhux magħruf raxx
English: - In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
Maltese: - Fuq pazjent b'iperammonemija moderata, agħti doża ta' prova ta' 100 sa 200 mg/kg/kuljum għal tliet ijiem b'għoti kostanti ta' proteini u kejjel b'mod ripetut il-konċentrazzjoni ta' ammonja filplażma (siegħa qabel u siegħa wara ikla); biddel d-doża b'mod li żżomm il-livelli normali ta'
English: EU/1/17/1202/001 EU/1/17/1202/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1202/002
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON X 60 TABLETS
Maltese: KARTUNA TA' BARRA X 60 PILLOLI
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Maltese: Reazzjonijiet avversi rapportati huma elenkati hawn isfel, skont is-sistema tal-klassifika tal-organi u skont il-frekwenza.
English: For carglumic acid no clinical data on exposed pregnancies are available.
Maltese: Tqala Għal carglumic acid l-ebda data klinika fuq tqalat esposti mhu disponibbli.
English: Lucane Pharma Tél: + 33 153 868 750
Maltese: Tél: + 33 153 868 750
English: Ucedane dispersible tablets are rod-shaped, white, and biconvex with three score lines on both sides and engraving “L/L/L/L” on one side.
Maltese: Il-pilloli huma forma ta' qasba, bojod, bikonvessi bi tliet linji ta' qsim fuq iż-żewġ naħat u b' inċiżjoni “L/L/L/L” fuq naħa waħda.
English: The tablets must be dispersed in a minimum of 5 to 10 mL of water and taken immediately.
Maltese: Il-pilloli għandhom jinfirxu f'minimu ta' 5 sa 10 ml ilma u għandhom jittieħdu minnufih.
English: Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
Maltese: It-treddigħ waqt l-użu ta' carglumic acid huwa kontra-indikat (ara sezzjonijiet 4.6 u 5.3). 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Monitoraġġ terapewtiku
English: In the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Maltese: Fuq medda twila ta' żmien, id-doża ta' kuljum normalment tvarja minn 10 mg sa 100 mg kull kilogramma ta' piż tal-ġisem.
English: This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for Nacetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
Maltese: Dan jista' jkun spjegat permezz tal-osservazzjonijiet li ġejjin: i) Ir-rita mitokondrijali hi aktar permeabbli għal carglumic acid milli għal N-acetylglutamate. ii) Carglumic acid hu aktar reżistenti minn N-acetylglutamate għall-idroliżi minn aminoacylase preżenti fis-cytosol.
English: In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
Maltese: Effikaċja klinika u sigurtà F'pazjenti b'nuqqas ta' N-acetylglutamate synthase, instab li carglumic acid jżid in-normalizzazzjoni ta' malajr tal-livelli ta' ammonja fil-plażma, ġeneralment fi żmien 24 siegħa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON X 12 TABLETS
Maltese: KARTUNA TA' BARRA X 12 PILLOLI
English: Uncommon pyrexia
Maltese: Reazzjoni Avversa
English: The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half-life up to 28 hours).
Maltese: Il-kurva tal-eliminazzjoni minn ġol-plażma ta' carglumic acid hi bifażika b'fażi rapida fl-ewwel 12-il siegħa wara l-amministrazzjoni segwita minn fażi kajmana (ħalf-life terminali sa 28 siegħa).
English: Pregnancy and breast-feeding
Maltese: Immaniġġjar nutrizzjonali
English: FrostPharma AB Tlf: +45 808 20 101 info@frostpharma.com
Maltese: Tlf: +45 808 20 101
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn 100):
English: Ucedane 200 mg dispersible tablets
Maltese: Ucedane 200 mg pilloli li jinfirxu
English: Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased.
Maltese: Instab li carglumic acid jnaqqas il-livelli ta' ammonja fid-demm u jżid il-livelli tal-urea fid-demm u fl-awrina, filwaqt li l-kontenut ta'attivaturi ta' carbamoyl phosphate synthetase fil-kliewi żdied b'mod sinifikanti.
English: It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Maltese: Hu suġġerit li skont l-attività, il-flora batterika fl-imsaren tista' tikkontribwixxi għal bidu tal-proċess ta' degradazzjoni, li b'hekk twassal għal metaboliżmu varjabbli tal-molekula.
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn 10):
English: Based on clinical experience, the treatment may be started as early as the first day of life.
Maltese: Skont l-esperjenza klinika, it-trattament jista' jinbeda minn kmieni sa mill-ewwel jum ta' ħajja.
English: The tablets are presented in Aluminium/aluminium blister packed in cartons.
Maltese: Il-pilloli huma ppreżentati f'folja ta' Aluminju/Aluminju ppakkjata f'kartuniet.
English: Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with
Maltese: Carglumic acid jitnixxa fil-ħalib ta' firien li jreddhħu u għalkemm il-parametri ta' żvilupp ma kinux affettwati, kien hemm xi effetti fuq il-piż korporali / żieda fil-piż korporali ta' ġriewi mredgħa min-nisa trattati b'2000 mg/kg/kuljum, doża li kkawżat maternotossiċità.
English: Other medicines and Ucedane
Maltese: IL-PRODOTT MEDIĊINALI
English: Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for Nacetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Maltese: Minkejja l-affinità aktar baxxa ta' carbamoyl phosphate synthetase għal carglumic acid milli għal N-acetylglutamate, in vivo instab li carglumic acid jistimula carbamoyl phosphate synthetase u li hu ħafna aktar effettiv minn
English: Safety pharmacology studies have shown that carglumic acid administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
Maltese: 1000 mg/kg ma kellha l-ebda effett statistikament sinifikanti fuq respirazzjoni, fuq is-sistema nervuża ċentrali u fuq is-sistema kardjovaskulari.
English: The tablets must be dispersed in a minimum of 5-10 mL of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube.
Maltese: Il-pilloli għandhom jinfirxu f'minimu ta' 5-10 ml ta' ilma u jittieħdu immedjatament jew mogħtija b'għafsa ta' malajr permezz ta' siringa minn tubu nażogastriku.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Ucedane
English: EXP
Maltese: LOTT
English: Not known side effects (frequency cannot be estimated from the available data) rash
Maltese: Effetti sekondarji mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli):
English: Blister (ALU/ALU) packed in cartons.
Maltese: acetylglutamate synthase.
English: Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/mL.
Maltese: Irrispettivament mid-doża ta' kuljum, kien hemm tnaqqis bil-mod f'15il siegħa għal-livelli ta' madwar 100 ng/ml.
English: FrostPharma AB Tlf: +47 815 03 175 info@frostpharma.com
Maltese: Tlf: +47 815 03 175
English: 17 April 2015
Maltese: 17 ta' April 2015
English: Implementation of the agreement by the Member States (submission of the Type IB variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (sottomissjoni tal-varjazzjoni tat-Tip IB midDetentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq):
English: March 2015 CMDh
Maltese: CMDh
English: 19 June 2015
Maltese: 19 ta' Ġunju 2015
English: EMA/622534/2010 EMEA/V/C/002251
Maltese: EMEA/V/C/002251
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti mill-EPAR ukoll).
English: The virus exists in several forms (serotypes) throughout the world; the types used in ZULVAC 1+8 Ovis are serotypes 1 and 8.
Maltese: Il-vajrus jeżisti f'diversi forom (serotipi) fid-dinja kollha; it-tipi użati f'ZULVAC 1+8 Ovis huma s-serotip 1 u 8.
English: ZULVAC 1+8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Maltese: ZULVAC 1+8 Ovis huwa vaċċin li fih il-vajrusis inattivati (maqtula) tas-serotipi 1 u 8 tal-lingwablu bħala s-sustanza attiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ZULVAC 1+8 Ovis on 14 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal ZULVAC 1+8 Ovis fl-14 ta' Marzu 2011.
English: It is available as a suspension for injection.
Maltese: Jiġi f'sospensjoni għall-injezzjoni.
English: Sheep may show a temporary increase in rectal temperature, not more than 1.2 °C in the 24 hours following vaccination.
Maltese: Fl-24 siegħa ta' wara t-tilqima, in-nagħaġ jista' jkollhom żieda temporanja fit-temperatura rettali ta' mhux aktar minn 1.2 ºC.
English: The CVMP concluded that the benefits of ZULVAC 1+8 Ovis outweigh the risks for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8 in sheep from 1.5 months of age.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' ZULVAC 1+8 Ovis huma akbar mir-riskji għall-prevenzjoni talviremija kkawżata mill-vajrus tal-lingwablu tas-serotipi 1 u 8 fin-nagħaġ minn xahar u nofs 'l fuq.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 1+8 Ovis to convert to a normal status.
Maltese: Fl-2013 is-CVMP qies li d-dejta mressqa kienet adegwata biex l-awtorizzazzjoni ta' ZULVAC 1+8 Ovis tinbidel għal stajtus normali.
English: This summary was last updated in May 2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Mejju 2013.
English: ZULVAC 1+8 Ovis is a vaccine.
Maltese: ZULVAC 1+8 Ovis huwa vaċċin.
English: ZULVAC 1+8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: ZULVAC 1+8 Ovis jintuża fuq in-nagħaġ biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: There may be a local reaction at the injection site, such as swelling (lasting no more than one week) or ‘nodules' (hardening under the skin) possibly lasting more than six or seven weeks.
Maltese: Tista' tiżviluppa reazzjoni lokali fil-post tal-injezzjoni, bħal nefħa (li ma ddumx aktar minn ġimgħa) jew ‘għoqiedi' (twebbis taħt il-ġilda) li possibbilment idum aktar minn sitt jew seba' ġimgħat.
English: What is ZULVAC 1+8 Ovis?
Maltese: X'inhu ZULVAC 1+8 Ovis?
English: The efficacy of the vaccine was studied in four main laboratory trials in sheep of young age where animals were challenged with both BTV-1 and BTV-8 serotypes using ZULVAC 1-8 Ovis vaccines containing low antigen quantities.
Maltese: L-effikaċja tal-vaċċin ġiet studjata f'erba' provi ewlenin f'laboratorju fuq in-nagħaġ żgħar fejn lannimali ngħataw kemm is-serotip BTV-1 kif ukoll dak BTV-8 bl-użu tal-vaċċini ZULVAC 1+8 Ovis li kien fihom kwantitajiet baxxi ta' antiġene.
English: What is the risk associated with ZULVAC 1+8 Ovis?
Maltese: X'hinu r-riskju assoċjat ma' ZULVAC 1+8 Ovis?
English: Inactivated adjuvanted vaccine against bluetongue disease virus, serotypes 1 and 8
Maltese: Vaċċin aġġuvant inattivat kontra s-serotipi 1 u 8 tal-vajrus tal-marda tallingwablu
English: Other information about ZULVAC 1+8 Ovis:
Maltese: Tagħrif ieħor dwar ZULVAC 1+8 Ovis:
English: Why has ZULVAC 1+8 Ovis been approved?
Maltese: Għaliex ġie approvat ZULVAC 1+8 Ovis?
English: HIV-infection).
Maltese: HIV).
English: Stevens-Johnson syndrome; Lyell syndrome;
Maltese: Sindrome ta' Stevens-Johnson;
English: {mm/yyyy}
Maltese: {XX/SSSS}
English: Within the following table, adverse reactionsare ranked under the MedDRA frequency classification:
Maltese: Fit-tabella reazzjonijiet avversi huma kklassifikati taħt il-klassifikazzjoni tal-frekwenza ta' MEDRA:
English: What PANTOZOL Control contains - The active substance is pantoprazole.
Maltese: X'fih PANTOZOL Control - Is-sustanza attiva hi pantoprazole.
English: Liver enzymes increased (transaminases, γ-GT)
Maltese: Żieda fl-enzimi tal-fwied (transaminases, γ-GT)
English: PANTOZOL Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Maltese: PANTOZOL Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.
English: Common Uncommon Rare
Maltese: Rari ħafna
English: Fundic gland polyps (benign)
Maltese: Polipi tal-glando la fundika (beninni)
English: PANTOZOL Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: PANTOZOL Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: However, you may take PANTOZOL Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Maltese: Madankollu, tista' tieħu PANTOZOL Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Ammonia solution, concentrated
Maltese: Red iron oxide (E172) Black iron oxide (E172)
English: Investigations revealed no evidence of impaired fertility or teratogenic effects.
Maltese: ---L-investigazzjonijiet ma żvelaw l-ebda evidenza ta' indeboliment fil-fertilità jew effetti teratoġeniċi.
English: Constipation; Dry mouth;
Maltese: Ferita epatoċellulari; Suffejra;
English: Agranulocytosis Thrombocytopenia; Leukopenia,
Maltese: Tromboċitopenja; Lewkopenja, Panċitopenija
English: PANTOZOL Control 20 mg gastro-resistant tablets
Maltese: PANTOZOL Control 20 mg pilloli gastro-reżistenti
English: To avoid this interference, PANTOZOL Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Maltese: Biex din l-interferenza tiġi evitata, il-kura bi PANTOZOL Control għandha titwaqqaf għal mill-inqas 5 ijiem qabel il-kejl ta' CgA (ara sezzjoni 5.1).
English: Other medicines and PANTOZOL Control
Maltese: Mediċini oħra u PANTOZOL Control
English: What PANTOZOL Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Maltese: Kif jidher PANTOZOL Control u l-kontenut tal-pakkett Il-pilloli gastro-reżistenti huma pilloli sofor, ovali, bikonvessi, miksija b'rita u stampati bi “P20” fuq naħa waħda.
English: PANTOZOL Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Maltese: PANTOZOL Control jista' jnaqqas l-assorbiment ta' sustanzi attivi li l-bijodisponibiltà tagħhom tiddependi fuq il-pH gastrika (eż. ketoconazole).
English: Talk to your doctor before taking PANTOZOL Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to PANTOZOL
Maltese: Kellem lit-tabib tiegħek qabel tieħu PANTOZOL Control - jekk kont ikkurat/a għal qrusa fl-istonku jew indiġestjoni kontinwament għal 4 ġimgħat jew iktar - jekk għandek iktar minn 55 sena u qed tieħu kura ta' kuljum għall-indiġestjoni mingħajr riċetta tat-tabib - jekk għandek iktar minn 55 sena u għandek sintomi tar-rifluss ġodda jew sintomi li nbidlu dan l-aħħar - jekk kellek operazzjoni minħabba ulċera gastrika jew tal-istonku - jekk għandek problemi tal-fwied jew suffejra (sfura tal-ġilda jew fl-għajnejn) - jekk regolarment tara lit-tabib tiegħek għal problemi jew kundizzjonijiet serji - jekk ser ikollok endoskopija jew test tan-nifs imsejjaħ C-urea test - jekk qatt kellek reazzjoni fil-ġilda wara kura b'mediċina simili għal PANTOZOL Control li tnaqqas l-aċtu fl-istonku - inti wasalt biex ikollok test tad-demm speċifiku (Kromogranin A) - jekk qed tieħu impedituri ta' protease ta' HIV bħal atazanavir; nelfinavir (għat-trattament ta'
English: OTHER
Maltese: Ara
English: Subacute cutaneous lupus erythematosus (see section
Maltese: Lupus erythematosus talġilda subakut (ara sezzjoni 4.4).
English: - Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema.
Maltese: - Reazzjonijiet allerġiċi serji (rari: jistgħu jaffettwaw sa persuna 1f'1,000): Reazzjonijiet ta' sensittività eċċessiva, dawk hekk imsejħa reazzjonijiet anafilattiċi, xokk anafilattiku u anġjoedema.
English: PANTOZOL Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Maltese: PANTOZOL Control fih is-sustanza attiva pantoprazole, li timblokka l-'pompa' li tipproduċi l-aċidu fl-istonku.
English: Diarrhoea;
Maltese: Artralġja;
English: You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTOZOL Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Maltese: jkollok bżonn ta' testijiet tad-demm addizzjonali. - methotrexate (użat għat-trattament ta' artrite rewmatojdi, psorjasi, u kanċer) - jekk qed tieħu methotrexate t-tabib tiegħek għandu mnejn iwaqqaf it-trattament tiegħek bi PANTOZOL Control peress li pantoprazole jista' jgħolli l-livelli ta' methotrexate fid-demm.
English: Stop taking PANTOZOL Control when you are completely symptom-free.
Maltese: Għandek tieqaf tieħu PANTOZOL Control meta ma jkollokx aktar sintomi.
English: See ‘Other medicines and PANTOZOL Control'.
Maltese: Ara “Mediċini oħra u PANTOZOL Control).
English: - Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test; fracture in the hip, wrist or spine.
Maltese: - Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100): uġigħ ta' ras; sturdament; dijarea; dardir, rimettar; nefħa u gass fl-istonku; stitikezza; ħalq xott; uġigħ ta' żaqq u skonfort; raxx tal-ġilda jew urtikarja; ħakk; tħossok dgħajjef, għajjien jew ġeneralment ma tħossokx tajjeb; problemi biex torqod; żieda fl-enzimi tal-fwied f'test tad-demm, ksur fil-ġenbejn, il-polz jew l-ispina dorsali.
English: Do not take PANTOZOL Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Maltese: Tiħux PANTOZOL Control: - jekk inti allerġiku għal pantoprazole jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6). - jekk qed tieħu impedituri tal-protease ta' HIV bħal atazanavir; nelfavir (għal kura ta' infezzjoni bl-HIV).
English: Package leaflet: Information for the patient PANTOZOL Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: Informazzjoni għal min qed jagħmel użu minnu PANTOZOL Control 20 mg pilloli gastro-reżistenti Pantoprazole