FrancophonIA/ELRC3.0 huggingface dataset:
English: No mutagenic response was elicited by cidofovir at dose levels up to 5 mg/plate, in the presence and absence of metabolic activation by rat liver S-9 fraction, in microbial assays involving Salmonella typhimurium for base pair substitutions or frameshift mutations (Ames) and Escherichia coli for reverse mutations.
Maltese: F'analiżi mikrobiċi li kienu jinvolvu Salmonella typhimurium għal sostituzzjonijiet base pair jew mutazzjonijiet frameshift (Ames) u Escherichia coli għall-mutazzjonijiet reverse, ma rriżultawx reazzjonijiet mutaġeniċi meta cidovovir intuża f'konċentrazzjonijiet li waslu sa 5 mg/plattina, kemm bl-attivazzjoni metabolika permezz tal-frazzjoni S-9 tal-fwied tal-far kif ukoll mingħajrha.
English: You should receive a total of one litre of 0.9% (normal) saline solution intravenously (as a drip into a vein) before each Vistide dose.
Maltese: Inti għandek tingħata total ta' litru ta' soluzzjoni ta' salina (normali) 0.9 % fil-vina (bħala dripp ġo vina) qabel kull doża ta' Vistide.
English: (See sub-sections “How to take probenecid with Vistide” and “How IV fluids are given before Vistide” below.)
Maltese: (Ara sub-sezzjonijiet “Kif għandek tieħu probenecid ma' Vistide” u “Kif jingħataw fluwidi IV qabel Vistide” hawn taħt.)
English: Vistide must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid).
Maltese: Vistide għandu jingħata ma' probenecid mill-ħalq u salina li tingħata mill-ġolvina kif deskritt hawn taħt (ara sezzjoni 4.4 għal rakkomandazzjonijiet xierqa, u ara sezzjoni 6.6 għal informazzjoni fuq kif takkwista probenecid).
English: Women of childbearing potential/Contraception in males and females:
Maltese: Nisa li jistgħu joħorġu tqal/Kontraċezzjoni fl-irġiel u n-nisa:
English: Patients who can tolerate the additional fluid load may receive up to a total of 2 litres of 0.9% saline intravenously with each dose of cidofovir.
Maltese: Dawk il-pazjenti li jistgħu jittolleraw tagħbija żejda ta' fluwidu jistgħu jingħataw sa total ta' 2 litri ta' salina 0.9 % ġol-vina ma' kull doża ta' cidofovir.
English: Patients treated at 3.0 mg/kg, 5.0 mg/kg or 10 mg/kg without concomitant probenecid developed evidence of proximal tubular cell injury, including glycosuria, and decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Maltese: 0 mg/kg, mingħajr probenecid fl-istess ħin, kellhom sinjali ta' ħsara fiċ-ċelluli tal-proximal tubules, li kienu jinkludu l-preżenza taz-zokkor fl-awrina, u tnaqqis fil-livelli ta' phosphate, ta' uric acid u ta' bicarbonate fis-serum, u żieda fil-livell ta' krejatinina fis-serum.
English: With a syringe, transfer under aseptic conditions the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly.
Maltese: B'siringa taħt kundizzjonijiet asettiċi, itrasferixxi d-doża adattata ta' Vistide minn ġol-kunjett għal ġo borża ta' l-infużjoni b'100 ml ta' taħlita tas-salina 0.9 % (normali), u mbagħad ħallat sew.
English: Hearing impaired
Maltese: Tqala u treddigħ
English: Dyspnea
Maltese: Dispneja
English: Interactions of cidofovir/probenecid and anti-HIV drugs or drugs used to treat common chronic viral infections in this population, such as HCV- and HBV-related hepatitis, have not been investigated in clinical trials.
Maltese: Interazzjonijiet ta' cidofovir/probenecid u ta' mediċini għal kontra l-HIV jew mediċini li jintużaw għall-kura ta' infezzjonijiet kroniċi virali komuni f'din il-popolazzjoni, bħal epatite relatata ma' HCV u HBV, għadhom ma ġewx studjati permezz ta' studji kliniċi.
English: Obtaining probenecid
Maltese: Kif takkwista probenecid
English: This medicine contains 2.5 mmol (or 57 mg) sodium per vial which should be taken into consideration if you are on a controlled sodium diet.
Maltese: Din il-mediċina fiha 2.5 mmol (jew 57 mg) sodju f'kull kunjett u dan għandu jitqies jekk inti qed tikkontrolla l-ammont ta' sodium li tieħu fid-dieta.
English: The doctor or nurse will transfer the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Maltese: It-tabib jew infermiera ser jittrasferixxu d-doża adattata ta' Vistide mill-kunjett għal borża talinfużjoni li jkun fiha 100 ml ta' soluzzjoni ta' salina (normali) 0.9%.
English: 8 hours after end of Vistide infusion
Maltese: 8 sigħat wara tmiem tal-infużjoni b'Vistide
English: No cross-resistance between foscarnet and cidofovir was seen with foscarnet-selected mutants.
Maltese: Ma kienx hemm cross resistance bejn foscarnet u cidofovir f'mutanti magħżula b'foscarnet.
English: CMV retinitis is an eye infection caused by a virus named cytomegalovirus (CMV).
Maltese: Ir-retinite kkawżata mis-CMV hija infezzjoni fl-għajn ikkawżata minn virus msejjaħ cytomegalovirus (CMV).
English: Allergic reactions, with skin inflammation, itching, hives and, rarely, severe allergic reactions, and serious skin reaction have occurred.
Maltese: Reazzjonijiet allerġiċi ġraw, b'infjammazjoni tal-ġilda, ħakk, tixwik u tingiż, u rarament, reazzjonijiet allerġiċi severi u reazzjonijiet serji fil-ġilda.
English: Probenecid tablets are given to lower the risk of kidney damage.
Maltese: Il-pilloli probenecid jingħataw biex jitnaqqas ir-riskju ta' ħsara fil-kliewi.
English: Beginning two weeks after completion of induction treatment, the recommended maintenance dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once every two weeks.
Maltese: Dan jinbeda' ġimgħatejn wara li jitlesta t-trattament tal-bidu, u d-doża ta' Vistide li hija rrakkomandata biex tmantni biha f'pazjenti b'funzjoni tal-kliewi normali hija ta' 5 mg għal kull kg talpiż tal-ġisem mogħtija darba kull ġimagħtejn.
English: • low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/fatigue and fever.
Maltese: • għadd baxx ta' ċelluli bojod fid-demm, uġiegħ ta' ras, dardir, rimettar, proteina fl-awrina, żieda fil-livell tal-krejatinina fis-serum (li huwa kejl tal-funzjoni tal-kliewi), tfartis, raxx,
English: Nausea, vomiting
Maltese: Disturbi tas-smigħ
English: Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to administration of cidofovir (see section 4.8).
Maltese: It-tossiċità fuq il-kliewi marbuta mad-doża hija l-aktar ħaġa li tillimita d-doża ta' cidofovir li tista' tingħata (ara sezzjoni 4.8).
English: You are not to be given Vistide.
Maltese: M'għandekx tingħata Vistide.
English: All clinical trials relevant to clinical efficacy evaluation were performed using probenecid concomitantly with cidofovir.
Maltese: Ġew irrapportati żewġ każijiet ta' doża eċċessiva b'cidofovir.
English: Therefore, when co-prescribing cidofovir/probenecid with other agents, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) and the respective prescribing information of the other co-administered products for full information regarding drug interactions and other features of that product.
Maltese: Għalhekk, meta tagħti cidofovir/probenecid ma'aġenti oħra, huwa importanti li it-tobba jikkonsultaw l-iktar SmPC riċenti tal-probenicid (jew fonti ta' referenza adattata, bħal Formularju Nazzjonali) u informazzjoni rispettiva tal-prodotti l-oħra li jingħataw miegħu għal informazzjoni kompluta dwar fatturi oħra tal-prodott u interazzjonijiet ma' mediċini oħra.
English: Treatment with Vistide must not be initiated in patients with creatinine clearance ≤ 55 ml/min, or ≥ 2+ proteinuria (≥ 100 mg/dl), as the optimum induction and maintenance doses for patients with moderate to severe renal impairment are not known.
Maltese: It-trattament b'Vistide m'għandux jinbeda f'pazjenti li jkollhom clearance tal-krejatinina ta' ≤ 55 ml/min, jew ≥ 2 + ta' proteini fl-awrina (≥ 100 mg/dl), billi l-aħjar dożi biex tibda t-trattament u biex tmantnih m'humiex magħrufin fil-każ ta' pazjenti li għandhom indeboliment moderat għal sever tal-kliewi.
English: België/Belgique/Belgien Gilead Sciences Belgium BVBA Tél/Tel: + 32 (0) 24 01 35 79
Maltese: België/Belgique/Belgien Gilead Sciences Belgium BVBA
English: The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency.
Maltese: It-tabella ta' hawn taħt turi l-lista tar-reazzjonijiet avversi identifikati minn studji kliniċi jew sorveljanza ta' wara t-tqegħid fis-suq elenkati bis-sistema tal-klassifika ta' l-organi u l-frekwenza.
English: It is unknown whether cidofovir/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk cidofovir/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: In addition to probenecid, patients must receive a total of one litre of 0.9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir.
Maltese: Flimkien ma' probenecid, il-pazjenti għandhom jingħataw ukoll total ta' litru ta' taħlita ta' salina (normali) 0.9 % ġol-vina eżatt qabel kull infużjoni ta' cidofovir.
English: Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by ≥ 44 µmol/l (≥ 0.5 mg/dl), or if persistent proteinuria ≥ 2+ develops.
Maltese: It-terapija b'cidofovir għandha titwaqqaf u tajjeb ukoll li wieħed jiġi idratat minn ġol-vina kemm ildarba l-livell ta' krejatinina fis-serum jiżdied b' ≥ 44 µmol/l (> 0.5 mg/dl), jew inkella jekk wieħed titfaċċalu l-proteina fl-awrina f'ammonti ta' ≥ 2 +, u tippersisti f'dan il-livell.
English: Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation (S-9 fraction).
Maltese: Cidofovir ikkaġuna aberrazzjonijiet tal-kromosomi f'limfoċiti ġewwa s-sistema ċirkolatorja talbniedem, in vitro, mingħajr ma kellu bżonn ikollu attivazzjonni metabolika (bil-frazzjoni S-9).
English: In vitro protein binding of cidofovir to plasma or serum protein was 10% or less over the cidofovir concentration range 0.25 to 25 µg/ml.
Maltese: Fuq medda ta' konċentrazzjonijet ta' cidofovir li tvarja minn 0.25-25 µg/ml kien jidher li l-irbit ta' cidofovir ma' proteini fil-plażma jew fis-serum kien ta' 10 % jew inqas.
English: The appropriate dose of Vistide should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Maltese: Id-doża adattata ta' Vistide għandha tiġi ttrasferita mill-kunjett għal ġo borża tal-infużjoni li jkun fiha 100 ml ta' soluzzjoni ta' salina (normali) 0.9%.
English: Probenecid may also cause other side effects including loss of appetite, sore gums, flushing, hair loss, dizziness, reduced red blood cell count and increased frequency of passing water (urinating).
Maltese: Probenecid jista' wkoll jikkawża effetti sekondarji oħra li jinkludu tnaqqis fl-aptit, uġiegħ fil-ħanek, fwawar, tfartis, sturdament, tnaqqis fl-għadd taċ-ċelluli ħomor tad-demm u żieda fil-frekwenza ta' lawrina.
English: Very common side effects possibly related to probenecid (These can affect more than 1 user in 10)
Maltese: Effetti sekondarji komuni ħafna possibbilment relatati ma' probenecid (Dawn jistgħu jaffettwaw iktar minn utent 1 minn kull 10)
English: • If you cannot take the medicine probenecid because of a serious allergy to probenecid or other sulfa-containing medicines (e.g. sulfamethoxazole).
Maltese: • Jekk ma tistax tieħu l-mediċina probenecid minħabba f'allerġija serja għal probenecid jew għal xi mediċini oħra li jkun fihom s-sulfa- (eż., sulfamethoxazole).
English: To reduce the risk of kidney damage, you will receive intravenous fluids (normal saline) before each dose of Vistide and probenecid tablets before and after each dose of Vistide (see section 3 below for more information).
Maltese: Biex jitnaqqas ir-riskju ta' ħsara fil-kliewi, inti ser tingħata fluwidi fil-vina (salina normali) qabel kull doża ta' Vistide u pilloli ta' probenecid qabel u wara kull doża ta' Vistide (ara sezzjoni 3 hawn taħt għal aktar informazzjoni).
English: Two grams of probenecid should be administered 3 hours prior to the cidofovir dose and one gram administered at 2 and again at 8 hours after completion of the 1 hour cidofovir infusion (for a total of 4 grams).
Maltese: Żewġ grammi ta' probenecid għandhom jingħataw 3 sigħat qabel id-doża ta' cidofovir u gramma waħda terġa' tingħata sagħtejn u mbagħad 8 sigħat (għal total ta' 4 grammi) wara li titlesta l-infużjoni ta' cidofovir li tkun ingħatat fuq medda ta' siegħa.
English: The finding of any glycosuria, proteinuria/aminoaciduria, hypouricemia, hypophosphatemia and/or hypokalemia, should prompt for the consideration of cidofovir-related Fanconi syndrome.
Maltese: Għandha tkun ikkunsidrata s-sindromu ta' Fanconi relatata ma' cidofovir, meta jinstab fl-awrina xi zokkor, proteini/amino aċidi, livelli baxxi ta' aċidu uriku, livelli baxxi ta' fosfati u/jew ipokalemija.
English: Common side effects (These can affect 1 to 10 users in 100)
Maltese: Effetti sekondarji li huma komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 utenti minn kull 100)
English: What Vistide looks like and contents of the pack
Maltese: Id-dehra ta' Vistide u l-kontenuti tal-pakkett
English: Vistide is contraindicated in patients with renal insufficiency (see section 4.2).
Maltese: Vistide m'għandux jintuża f'pazjenti li għandhom insuffiċjenza tal-kliewi (ara sezzjoni 4.2).
English: Hepatic insufficiency:
Maltese: Kategorija farmakoterapewtika:
English: 6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter.
Maltese: Jekk aċċidentalment ġejt mogħti iktar Vistide minn dik li tkun ordnata lilek, avża lit-tabib tiegħek minnufih.
English: Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir (see section 4.4).
Maltese: L-irġiel għandhom jingħataw parir biex jużaw metodi ta' kontraċezzjoni barriera waqt u sa 3 xhur wara t-trattament b'cidofovir (ara sezzjoni 4.4).
English: If administered, the second litre of saline should be given either at the start of the Vistide infusion or immediately afterwards, and infused over a 1 to 3 hour period.
Maltese: Jekk dan it-tieni litru ta' salina jingħata, għandu jingħata jew mal-bidu ta' l-infużjoni ta' Vistide, jew immedjatament wara u għandu jiġi nfuż fuq 1-3 sigħat.
English: Asthenia, fever Chills
Maltese: Sindromi ta' Fanconi akkwiżita
English: 2 hours after end of Vistide infusion
Maltese: Meta tuża mediċini oħra
English: Reports of renal failure (plus events possibly caused by renal failure, e.g. blood creatinine increased, proteinuria, glycosuria) received during post-marketing surveillance include some which were fatal.
Maltese: Rapporti ta' falliment tal-kliewi (ma' ġrajjiet possibilment kkawżati minn dan il-falliment, eż. żieda fil-livell tal-krejatinina fid-demm, ħruġ ta' proteini fl-awrina, zokkor fl-awrina) kienu rrappurtati waqt is-sorvelljanza ta' wara l-ħruġ tal-prodott fis-suq u jinkludu wkoll uħud li kienu fatali.
English: Following in vitro selection of ganciclovir-resistant HCMV isolates, cross-resistance between ganciclovir and cidofovir was seen with ganciclovir-selected mutations in the HCMV DNA polymerase gene but not with mutations in the UL97 gene.
Maltese: Mutanti magħżulin b'cidofovir kellhom tibdil ġenetiku fil-ġene tal-polymerase tad-DNA u kien hemm cross resistance għal ganciclovir, iżda kienu suxxettibbli għal foscarnet.
English: No tumours were observed in cynomolgus monkeys administered cidofovir intravenously once weekly for 52 weeks at doses up to 2.5 mg/kg/week.
Maltese: Ma ġewx osservati tumuri f'xadini tal-ġenus cynomolgus li ngħataw cidofovir fil-vina darba f'ġimgħa għal 52 ġimgħa f'dożi li kienu jaslu sa 2.5 mg/kg/ġimgħa.
English: A significantly increased foetal incidence of external, soft tissue and skeletal anomalies occurred in rabbits at 1.0 mg/kg/day, which was also maternally toxic.
Maltese: Kien hemm żieda sinifikanti flinċidenza ta' anomaliji esterni, tat-tessuti rotob tal-ġisem u anki skeletriċi, fil-fetu tal-fenek f'dożi ta' 1.0 mg/kg/kuljum, u saret ħsara anki lill-omm.
English: NAME OF THE MEDICINAL PRODUCT Vistide 75 mg/ml concentrate for solution for infusion
Maltese: Vistide 75 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: If you are taking zidovudine, you should discuss with your doctor whether to temporarily stop taking zidovudine or decrease the dose of zidovudine by 50% on days when Vistide and probenecid are given.
Maltese: Jekk tkun qed tieħu zidovudine, għandek tiddiskuti mat-tabib tiegħek jekk ikunx aħjar li tieqaf tieħu zidovudine għal ftit jew inkella tnaqqas id-doża ta' zidovudine b'50% f'dawk il-ġranet li fihom jingħataw Vistide u probenecid.
English: Compatibility of Vistide with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
Maltese: Il-kompatibilità mas-soluzzjoni tat-tip Ringer, u mas-soluzzjoni tat-tip Lactated Ringer jew ma' sustanzi fluwidi u batterjostatiċi għall-infużjonijiet, ma ġietx valutata.
English: Vistide must be administered by a healthcare professional (doctor or nurse) in a hospital setting.
Maltese: Vistide għandu jingħata minn professjonista fil-qasam mediku (tabib jew infermiera) fi sptar.
English: Luxembourg/Luxemburg Gilead Sciences Belgium BVBA Tél/Tel: + 32 (0) 24 01 35 79
Maltese: Tél/Tel: + 32 (0) 24 01 35 79
English: Patients receiving cidofovir should be advised to have regular follow-up ophthalmologic examinations for possible occurrence of uveitis/iritis and ocular hypotony.
Maltese: Pazjenti li jirċievu cidofovir għandhom jiġu avżati sabiex isirulhom eżamijiet oftalmoloġiċi regolari ta' follow-up għall-possibbiltà ta' l-okkorrenza ta' uveitis/iritis u tnaqqis fil-pressjoni ta' ġol-għajn.
English: (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Pack size
Maltese: Myclausedn
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Route of Administration
Maltese: Għamla farmaċewtika
English: Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Subacute cutaneous lupus erythematosus (EPITT no 18119)
Maltese: Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Lupus erythematosus tal-ġilda subakut (EPITT nru 18119)
English: Donepezil - Rhabdomyolysis (EPITT no 18261)
Maltese: Donepezil - Rabdomijoliżi (EPITT nru 18261)
English: Section 4: Possible side effects
Maltese: Sezzjoni 4: Effetti sekondarji possibbli
English: Adopted at the 6-9 July 2015 PRAC
Maltese: Adottat fil-PRAC tas-6-9 ta' Lulju 2015
English: Subacute cutaneous lupus erythematosus (SCLE)
Maltese: Lupus erythematosus tal-ġilda subakut (SCLE)
English: Section 4: Possible side effects • Frequency 'not known': rash, possibly with pain in the joints
Maltese: Sezzjoni 4: Effetti sekondarji possibbli • Frekwenza 'mhux magħrufa': raxx, possibbilment b'uġigħ fil-ġogi
English: Proton pump inhibitors are associated with very infrequent cases of SCLE.
Maltese: Inibituri tal-pompa tal-protoni huma assoċjati ma' każijiet infrekwenti ħafna ta' SCLE.
English: Frequency 'not known': Subacute cutaneous lupus erythematosus (see section 4.4).
Maltese: Lupus erythematosus tal-ġilda subakut (ara sezzjoni 4.4).
English: Talk to your doctor before taking {Drug name}:
Maltese: Kellem lit-tabib tiegħek qabel tieħu {Isem tal-mediċina}:
English: You may need urgent medical treatment.
Maltese: Jista' jkollok bżonn kura medika urġenti.
English: Musculoskeletal, connective tissue and bone disorders Frequency ‘very rare': Rhabdomyolysis* (To be inserted in the table footnote): * Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase.
Maltese: Disturbi muskoloskeletali, tat-tessuti konnettivi u tal-għadam Frekwenza ‘rari ħafna': Rabdomijoliżi* (Li għandha tiddaħħal fin-nota f'qiegħ il-paġna tat-tabella):
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/450962/2015
Maltese: Kliem ġdid tal-informazzjoni dwar il-prodott - Siltiet mir-rakkomandazzjonijiet tal-PRAC dwar is-sinjali EMA/PRAC/522629/2015
English: • if you have ever had a skin reaction after treatment with a medicine similar to {Drug name} that reduces stomach acid.
Maltese: • jekk qatt kellek reazzjoni fil-ġilda wara kura b'mediċina simili għal {Isem tal-mediċina} li tnaqqas l-aċtu fl-istonku.
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Maltese: SCLE wara kura preċedenti b'inibitur tal-pompa tal-protoni jista' jżid ir-riskju ta' SCLE b'inibituri tal-protoni oħrajn.
English: The full EPAR for Pantozol Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Pantozol Control, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantozol Control, pantoprazole, hija inibitur tal-pompa tal-proton.
English: Pantozol Control is a medicine that contains the active substance pantoprazole.
Maltese: Pantozol Control huwa mediċina li fiha s-sustanza attiva pantoprazole.
English: This is a summary of the European public assessment report (EPAR) for Pantozol Control.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pantozol Control.
English: Pantozol Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantozol.
Maltese: Pantozol Control huwa simili għal ‘mediċina ta' referenza' msejħa Pantozol li hija diġà awtorizzata flUnjoni Ewropea (UE).
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantozol Control on 12 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Pantozol Control fit-12 ta' Ġunju 2009.
English: Other information about Pantozol Control
Maltese: Informazzjoni oħra dwar Pantozol Control
English: The reference medicine, Pantozol, is only available with a prescription.
Maltese: Il-mediċina ta' referenza, Pantozol, hija disponibbli biss permezz ta' riċetta tat-tabib.
English: Pantozol Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Maltese: Pantozol Control jintuża għall-kura għal żmien qasir tas-sintomi ta' rifluss tal-aċidu fl-adulti.
English: The CHMP therefore decided that Pantozol Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pantozol Control huma akbar mirriskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Pantozol Control been approved?
Maltese: Għaliex ġie approvat Pantozol Control?
English: What is Pantozol Control?
Maltese: X'inhu Pantozol Control?
English: Pantozol Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Maltese: Pantozol Control m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal pantoprazole, soja jew għal xi sustanza oħra tiegħu.
English: How does Pantozol Control work?
Maltese: Kif jintuża Pantozol Control?
English: What is the risk associated with Pantozol Control?
Maltese: Għal xiex jintuża Pantozol Control?
English: 1 Meador K, et al. Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
Maltese: Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
English: CMDh agreement
Maltese: Ftehim mas-CHMDh
English: Clinical Investigation of Medicinal Products in the Pediatric Population E11.
Maltese: Investigazzjoni Klinika tal-Prodotti Mediċinali fil-Popolazzjoni Pedjatrika E11.