FrancophonIA/ELRC3.0 huggingface dataset:
English: In the intention-to-treat population, among patients who were using insulin and/or a sulphonylurea at baseline, the incidence of severe hypoglycaemia was 2.7% in sitagliptin-treated patients and 2.5% in placebo-treated patients; among patients who were not using insulin and/or a sulphonylurea at baseline, the incidence of severe hypoglycaemia was 1.0% in sitagliptin-treated patients and 0.7% in placebo-treated patients.
Maltese: Fil-popolazzjoni bl-intenzjoni li tiġi ttrattata, fost pazjenti li kienu qed jużaw l-insulina u/jew xi wieħed mis-sulphonylureas fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet 2.7 % f'pazjenti ttrattati b'sitagliptin u 2.5 % f'pazjenti ttrattati bi plaċebo; fost pazjenti li ma kinux qed jużaw insulina u/jew xi wieħed mis-sulphonylureas fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet 1.0 % f'pazjenti ttrattati b'sitagliptin u 0.7 % f'pazjenti ttrattati bi plaċebo.
English: * See Section 4.4.
Maltese: 2 Reazzjoni avversa b'sitagliptin. * Ara Sezzjoni 4.4. †
English: • Steglujan 5 mg/100 mg film-coated tablets (tablets) are beige, 12.0 x 7.4 mm, almond-shaped,
Maltese: • Il-pilloli miksija b'rita (pilloli) Steglujan 5 mg/100 mg huma pilloli miksija b'rita, kannella flisfar, forma ta' lewża, 12.0 x 7.4 mm, imnaqqxa b'“554” fuq naħa waħda u bla marki fuq innaħa l-oħra.
English: Mean plasma AUC of sitagliptin was 8.52 M•hr and Cmax was 950 nM.
Maltese: Ilmedja tal-AUC ta' sitagliptin fil-plażma kienet ta' 8.52 µM•siegħa u s-Cmax kienet 950 nM. Ilbijodisponibiltà assoluta ta' sitagliptin hija madwar 87%.
English: The incidence of adjudication-confirmed pancreatitis events was 0.3% in sitagliptin-treated patients and 0.2% in placebo-treated patients.
Maltese: L-inċidenza ta' avvenimenti ta' pankreatite kkonfermati permezz ta' aġġudikazzjoni kienet 0.3 % f'pazjenti ttrattati b'sitagliptin u 0.2 % f'pazjenti ttrattati bi plaċebo.
English: Change from baseline (LS mean Difference from placebo (LS mean
Maltese: Differenza mill-plaċebo (medja tal-LS†, CI ta'
English: Bullous pemphigoid
Maltese: Qalba tal-pillola
English: All myocardial infarction (fatal and nonfatal)
Maltese: Il-puplesiji kollha (fatali u mhux fatali)
English: • A serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Maltese: • Reazzjoni allerġika serja (frekwenza mhux magħrufa), li tinkludi raxx, ħorriqija, infafet filġilda/ġilda titqaxxar u nefħa fil-wiċċ, fix-xofftejn, fl-ilsien, u fil-griżmejn li tista' tikkawża diffikultà biex tieħu n-nifs jew biex tibla'.
English: • if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
Maltese: • jekk inti qed tieħu digoxin (mediċina li tintuża biex titratta taħbit irregolari tal-qalb u problemi oħra tal-qalb).
English: In patients with type 2 diabetes treated with ertugliflozin in combination with sitagliptin, the improvement in HbA1c was similar across subgroups defined by age, sex, and race, and duration of type 2 diabetes mellitus.
Maltese: F'pazjenti b'dijabete tat-tip 2 trattati b'ertugliflozin flimkien ma' sitagliptin, it-titjib fl-HbA1c kien simili fis-sottogruppi kollha definiti mill-età, mis-sess u mir-razza, u mit-tul ta' żmien b'dijabete mellitus tat-tip 2.
English: Pool of placebo-controlled trials
Maltese: Ertugliflozin Ġabra ta' provi kkontrollati bil-plaċebo
English: Urinary glucose excretion and urinary volume
Maltese: Tneħħija tal-glucose mal-awrina u volum tal-awrina
English: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Maltese: Sitagliptin jintreħa f'ammonti konsiderevoli fil-ħalib ta' firien li qed ireddgħu (proporzjon ta' ħalib/plażma: 4:1).
English: Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Maltese: Esperjenzi avversi addizjonali rrappurtati mingħajr ma tqies jekk il-kawża tagħhom kinitx il-mediċina, li seħħew b'mod aktar frekwenti f'pazjenti ttrattati b'sitagliptin (li ma laħqux illivell ta' 5 %, iżda li seħħew b'inċidenza ta' > 0.5 % ogħla b'sitagliptin minn dik fil-grupp ta' kontroll) kienu jinkludu osteoartrite u uġigħ fid-dirgħajn u fir-riġlejn.
English: Sitagliptin, but not metformin, increased active GIP concentrations.
Maltese: Sitagliptin, iżda mhux metformin, żied il-konċentrazzjonijiet ta' GIP attiv.
English: Secondary cardiovascular endpoints included the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; first occurrence of the individual components of the primary composite; all-cause mortality; and hospital admissions for congestive heart failure.
Maltese: Skopijiet finali kardjovaskulari sekondarji kienu jinkludu l-ewwel okkorrenza ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, jew puplesija mhux fatali; l-ewwel okkorrenza talkomponenti individwali tal-kompost primarju; mortalità minn kull kawża; u rikoverar l-isptar minħabba insuffiċjenza konġestiva tal-qalb.
English: o Each Steglujan 15 mg/100 mg film-coated tablet contains 15 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
Maltese: o Kull pillola miksija b'rita ta' Steglujan 15-il mg/100 mg fiha 15-il mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 100 mg sitagliptin (bħala sitagliptin phosphate monohydrate).
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Maltese: Ġew identifikati sitt metaboliti fil-livell ta' traċċa u mhux mistennija li jikkontribwixxu għall-attività ta' sitagliptin li jinibixxi DPP-4 fil-plażma.
English: By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Maltese: Konċentrazzjonijiet inqas ta' glucagon, flimkien ma' livelli ogħla ta' insulina, iwasslu għal tnaqqis fil-produzzjoni ta' glucose mill-fwied, li jwassal għal tnaqqis fil-livelli ta' glucose fid-demm.
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 l. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
Maltese: Il-porzjon ta' sitagliptin li hu marbut b'mod reversibbli mal-proteini tal-plażma huwa baxx (38%).
English: C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
Maltese: Wara doża ta' sitagliptin[14C] mill-ħalq, madwar 16 % tar-radjuattività tneħħiet bħala metaboliti ta' sitagliptin.
English: Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
Maltese: Kull pillola fiha 15-il mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 100 mg sitagliptin (bħala sitagliptin phosphate monohydrate).
English: • interstitial lung disease
Maltese: • mard tal-interstizju tal-pulmun
English: Ertugliflozin in combination with sitagliptin
Maltese: Outcomes with sitagliptin])
English: Sitagliptin is also a substrate of P-gp, which may also be involved in mediating the renal elimination of sitagliptin.
Maltese: Sitagliptin huwa wkoll sustrat ta' P-gp, li jista' jkun involut ukoll fl-eliminazzjoni ta' sitagliptin millkliewi.
English: Table 5: Rates of composite cardiovascular outcomes and key secondary outcomes
Maltese: Rati tar-riżultati kardjovaskulari komposti u r-riżultati sekondarji l-aktar importanti
English: Effects of other medicinal products on sitagliptin
Maltese: Effetti ta' ertugliflozin fuq il-farmakokinetika ta' prodotti mediċinali oħra
English: In vitro assessment of sitagliptin
Maltese: Valutazzjoni in vitro ta' sitagliptin
English: • itching
Maltese: • gass
English: Ertugliflozin as add-on combination therapy with metformin and sitagliptin A total of 463 patients, with type 2 diabetes inadequately controlled on metformin (≥ 1,500 mg/day) and sitagliptin 100 mg once daily participated in a randomised, double-blind, multi-centre, 26-week, placebo-controlled study to evaluate the efficacy and safety of ertugliflozin.
Maltese: Total ta' 463 pazjent b'dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'metformin (≥ 1,500 mg/jum) u sitagliptin 100 mg darba kuljum ipparteċipaw fi studju ta' 26 ġimgħa, arbitrarju b'ħafna ċentri, ikkontrollat bi plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin.
English: The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
Maltese: L-inċidenza totali ta' avvenimenti avversi serji f'pazjenti li kienu qed jirċievu sitagliptin kienet simili ta' dik f'pazjenti li kienu qed jirċievu plaċebo.
English: , BUN
Maltese: pazjent*
English: The renal clearance was approximately 350 ml/min.
Maltese: 60 ml/min.
English: Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Maltese: Steglujan huwa indikat fl-adulti li għandhom 18-il sena u aktar b'dijabete mellitus tat-tip 2 bħala żieda mad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku:
English: Hypoglycaemia with concomitant use with insulin and insulin secretagogues Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue, which are known to cause hypoglycaemia (see section 4.8).
Maltese: Barra dan, il-pazjenti għandhom jiġu mwissija dwar ir-riskju ta' ipogliċemija meta Steglujan jintuża flimkien mal-insulina jew ma' sustanza li tikkawża t-tnixxija talinsulina u dwar ir-riskju ogħla ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum, bħal ma huwa sturdament meta wieħed iqum bilwieqfa (ara sezzjonijiet 4.2, 4.4, u 4.8).
English: Baseline (mean) Change from baseline (LS mean Difference from Sitagliptin Ertugliflozin 5 mg Ertugliflozin 15 mg (LS mean
Maltese: Dawn il-pazjenti, li ma kienu qed jirċievu l-ebda trattament antiipergliċemiku fl-isfond, intagħżlu b'mod arbitrarju biex jirċievu ertugliflozin 5 mg jew ertugliflozin 15-il mg flimkien ma' sitagliptin (100 mg) jew plaċebo darba kuljum (ara Tabella 4).
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signalling pathways involving cyclic AMP.
Maltese: Meta lkonċentrazzjonijiet ta' glucose fid-demm ikunu normali jew għoljin, GLP-1 u GIP iżidu s-sintesi u rrilaxx tal-insulina miċ-ċelluli beta tal-frixa permezz ta' sensiela ta' reazzjonijiet li jagħtu sinjali ġewwa ċ-ċelluli li jinvolvu AMP ċiklika.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD24.
Maltese: Mediċini li jintużaw fid-dijabete, kombinazzjonijiet ta' mediċini li jittieħdu mill-ħalq li jbaxxu l-glucose fid-demm, Kodiċi ATC:
English: The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily.
Maltese: Id-doża tal-bidu rakkomandata hija 5 mg ertugliflozin/100 mg sitagliptin darba kuljum.
English: In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving Steglujan.
Maltese: F'każ ta' kondizzjonijiet li jistgħu jwasslu għal telf ta' fluwidi (eż., mard gastrointestinali), huwa rakkomandat monitoraġġ b'attenzjoni tal-istat tal-volum (eż., eżami fiżiku, kejl tal-pressjoni, testijiet tal-laboratorju inkluż l-ematokrit) u tal-elettroliti għall-pazjenti li jkunu qed jirċievu Steglujan.
English: Each tablet contains 5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg of sitagliptin (as sitagliptin phosphate monohydrate).
Maltese: Kull pillola fiha 5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 100 mg sitagliptin (bħala sitagliptin phosphate monohydrate).
English: Steglujan 5 mg/100 mg film-coated tablets Steglujan 15 mg/100 mg film-coated tablets ertugliflozin/sitagliptin
Maltese: Steglujan 5 mg/100 mg pilloli miksija b'rita Steglujan 15-il mg/100 mg pilloli miksija b'rita ertugliflozin/sitagliptin
English: Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
Maltese: Ġew osservati anormalitajiet fis-snien inċiżuri fil-firien b'livelli ta'esponiment 67 darba ikbar mil-livell ta' esponiment kliniku; illivell li fih ma jkunx hemm effett għal din is-sejba kien 58 darba aktar abbażi tal-istudju ta' 14-il ġimgħa fil-far.
English: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered.
Maltese: Waqt provi kliniċi kkontrollati f'individwi f'saħħithom, ingħataw dożi waħdiet sa 800 mg sitagliptin.
English: Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Maltese: Sitagliptin jitneħħa primarjament mhux mibdul fl-awrina, u l-metaboliżmu huwa sensiela ta' reazzjonijiet minuri.
English: Pharmacokinetic drug interaction studies with Steglujan have not been performed; however, such studies have been conducted with ertugliflozin and sitagliptin, the individual active substances of Steglujan.
Maltese: Ma sarux studji farmakokinetiċi dwar interazzjonijiet tal-mediċina b'Steglujan; madankollu, dawn listudji saru b'ertugliflozin u sitagliptin, is-sustanzi attivi individwali ta' Steglujan.
English: Each tablet contains 15 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg of sitagliptin (as sitagliptin phosphate monohydrate).
Maltese: Kull pillola fiha 15-il mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 100 mg ta' sitagliptin (bħala sitagliptin phosphate monohydrate).
English: Before initiating ertugliflozin/sitagliptin, consider factors in the patient history that may increase the risk for amputation.
Maltese: Qabel ma tibda ertugliflozin/sitagliptin, qis fatturi fl-istorja tal-pazjent li jistgħu jżidu r-riskju ta' amputazzjoni.
English: Impairment in renal function
Maltese: Infezzjonijiet fl-apprat tal-awrina
English: All stroke (fatal and nonfatal)
Maltese: L-infarti mijokardijaċi kollha (fatali u mhux fatali)
English: Steglujan should be discontinued when eGFR is persistently less than 45 ml/min/1.73 m 2 or CrCl is persistently less than 45 ml/min.
Maltese: Steglujan għandu jitwaqqaf meta l-eGFR tkun b'mod persistenti inqas minn 45 ml/min/1.73 m2 jew ilCrCl tkun b'mod persistenti inqas minn 45 ml/min.
English: No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża abbażi tas-sess, tar-razza jew tal-indiċi tal-massa talġisem (BMI, body mass index).
English: Adverse reaction with ertugliflozin.
Maltese: Mhux applikabbli.
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: Steglujan combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor.
Maltese: Ma saru l-ebda studji dwar interazzjonijiet bejn mediċina u oħra b'Steglujan u prodotti mediċinali oħra; madankollu, studji bħal dawn saru bis-sustanzi attivi individwali.
English: *,a,2
Maltese: Urtikarjaa,*,2
English: Hypoglycaemia*
Maltese: Għatx§
English: Approximately 79% of sitagliptin is excreted unchanged in the urine.
Maltese: Madwar 79% ta' sitagliptin jitneħħa mhux mibdul fl-awrina.
English: o Each Steglujan 5 mg/100 mg film-coated tablet contains 5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
Maltese: o Kull pillola miksija b'rita ta' Steglujan 5 mg/100 mg fiha 5 mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 100 mg sitagliptin (bħala sitagliptin phosphate monohydrate).
English: Patients 65 years and older treated with ertugliflozin, had a higher incidence of adverse reactions related to volume depletion compared to younger patients.
Maltese: Pazjenti li għandhom 65 sena u aktar li ġew ittrattati b'ertugliflozin, kellhom inċidenza ogħla ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum meta mqabbla ma' pazjenti iżgħar.
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors.
Maltese: Interferenza mal-analiżi ta' 1,5-anhydroglucitol (1,5-AG)
English: Further information on Kriptazen can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/Kriptazen.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/Kriptazen.
English: Kriptazen (halofuginone) EMA/878973/2018
Maltese: EMA/878973/2018
English: Other information about Kriptazen
Maltese: Informazzjoni oħra dwar Kriptazen
English: Kriptazen received a marketing authorisation valid throughout the EU on 8 February 2019.
Maltese: Kriptazen ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-8 ta' Frar 2019.
English: Kriptazen contains the active substance halofuginone and is a ‘generic medicine'.
Maltese: Kriptazen fih is-sustanza attiva alofuġinon u huwa “mediċina ġenerika”.
English: What are the benefits and risks of Kriptazen?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Kriptazen?
English: For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of the diarrhoea.
Maltese: Għall-prevenzjoni tad-dijarea, ilkura għandha tinbeda fi żmien 24 sa 48 siegħa mit-twelid; għat-tnaqqis tad-dijarea, il-kura għandha tinbeda fi żmien 24 siegħa mill-bidu tad-dijarea.
English: The active substance in Kriptazen, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Maltese: Is-sustanza attiva fi Kriptazen, il-lattat ta' alofuġinon, tipprevjeni t-tkabbir tal-Cryptosporidium parvum.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system, producing an infection called cryptosporidiosis that results in diarrhoea.
Maltese: Dan huwa parassit li jagħmel parti mill-familja "protozoa" li tinvadi s-sistema diġestiva, li tipproduċi infezzjoni msejħa kriptosporidjożi li tirriżulta f'dijarea.
English: How has Kriptazen been studied?
Maltese: Kif ġie studjat Kriptazen?
English: Why is Kriptazen authorised in the EU?
Maltese: Għalfejn Kriptazen huwa awtorizzat fl-UE?
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Halocur, and do not need to be repeated for Kriptazen.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat bil-mediċina ta' referenza, Halocur, u ma għandhomx għalfejn jiġu ripetuti għal Kriptazen.
English: This means that Kriptazen contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Halocur.
Maltese: Dan ifisser li Kriptazen fih listess sustanza attiva u jaħdem bl-istess mod ta' “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Europea (UE) msejħa Halocur.
English: Because Kriptazen is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Kriptazen huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Kriptazen can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Maltese: Kriptazen jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala soluzzjoni orali (likwidu li għandu jingħata mill-ħalq).
English: Kriptazen is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Maltese: Kriptazen huwa mediċina li tintuża biex tikkura għoġġiela tat-twelid biex tipprevjeni jew tnaqqas iddijarea kkawżata minn organiżmu msejjaħ Cryptosporidium parvum.
English: How does Kriptazen work?
Maltese: Kif jintuża Kriptazen?
English: No additional studies were needed as Kriptazen is a water based oral solution containing the same active substance and other ingredients as the reference medicine.
Maltese: Ma kien meħtieġ l-ebda studju addizzjonali peress li Kriptazen huwa soluzzjoni orali bbażata fuq l-ilma li fiha l-istess sustanza attiva u ingredjenti oħra bħall-mediċina ta' referenza.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Kriptazen, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Kriptazen, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti talkura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: every medicine, the company provided studies on the quality and manufacture of Kriptazen.
Maltese: Bħal kull mediċina oħra, ilkumpanija pprovdiet studji dwar il-kwalità u l-manifattura ta' Kriptazen.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Kriptazen has been shown to be comparable to Halocur.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Kriptazen intwera li huwa komparabbli ma' Halocur.
English: The precautions are the same as for the reference medicine since Kriptazen is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Kriptazen huwa mediċina ġenerika.
English: How is Kriptazen used?
Maltese: Kif jaħdem Kriptazen?
English: Outcome of a procedure under Article 78 of Directive 2001/82/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 78 tad-Direttiva 2001/82/KE
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 March 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Marzu 2016 EMA/672999/2015
English: 1 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Romania, Spain, Sweden, Slovenia, Slovakia and the United Kingdom
Maltese: 1 l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Polonja, ilPortugall, ir-Rumanija, Spanja, l-Iżvezja, is-Slovenja, is-Slovakkja u r-Renju Unit
English: Closamectin Pour-On Solution and associated names contain closantel and ivermectin and are authorised in several European Union (EU) Member States1 via decentralised and national procedures.
Maltese: Closamectin Pour-On Solution u ismijiet assoċjati fihom closantel u ivermectin u huma awtorizzati f'diversi Stati Membri tal-Unjoni Ewropea (UE)1 permezz ta' proċeduri deċentralizzati u nazzjonali.