FrancophonIA/ELRC3.0 huggingface dataset:
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Maltese: Dijuretiċi u mediċini oħra kontra l-pressjoni għolja: mediċini oħra kontra l-pressjoni għolja jistgħu jżidu l-effetti ta' tnaqqis fil-pressjoni ta' irbesartan; madankollu irbesartan ingħata mingħajr periklu ma' mediċini oħra ta' kontra l-pressjoni għolja, bħal beta-blockers, imblokkaturi tal-kanali ta' calcium li jaħdmu fit-tul, u dijuretiċi thiazides.
English: What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Maltese: Id-dehra ta' Sabervel u l-kontenuti tal-pakkett Il-pilloli Sabervel 300 mg huma bojod, konkavi, tondi, pilloli miksija b'rita b'dijametru ta' 11 mm.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Maltese: Ġenerali: f pazjenti li għandhom it-ton vaskulari u l-funzjoni renali tagħhom jiddependu l-aktar millattività tas-sistema renin-angiotesin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenosi 'tal-arterja renali), il-kura b'inibituri ta' enzimi li jikkonvertu angiotensin jew antagonisti tar-riċetturi t' angiotensin-II li jaffettwaw din is-sistema ġew assoċjati ma'
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Sabervel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' renin-angiotensinaldosterone, iperkalimja tista' sseħħ waqt il-kura b'Sabervel, speċjalment fil-preżenza t'indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, bid-defiċjenza ta' Lapp lactase jew bi problemi ta' assorbiment ħażin ta' glucosegalactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Each tablet contains 300 mg irbesartan
Maltese: Kull pillola fiha 300 mg irbesartan
English: Sabervel 150 mg film-coated tablets irbesartan
Maltese: Sabervel 150 mg pilloli miksijin b'rita irbesartan
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Maltese: Minn dawn it-23 tifel u tifla, 21 setgħu jiġu evalwati għal taqbil ta' farmakokinetiċi ma' adulti
English: Sabervel 300 mg film-coated tablets irbesartan
Maltese: Sabervel 300 mg pilloli miksijin b'rita irbesartan
English: Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Maltese: Sabervel 75 mg miksijin b'rita jinstabu f' pakketti f' folji ta' 28, 56, 90 jew 98 pillola miksija b'rita.
English: White, concave, round, film-coated tablet with 9 mm diameter.
Maltese: Bajda, konkavu, tonda, pillola miksija b'rita b'dijametru ta' 9mm.
English: impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Maltese: funzjoni indebolita tal-kliewi li tinkludi każijiet ta' insuffiċjenza tal-kliewi f'pazjenti li jinsabu f'riskju (ara sezzjoni 4.4)
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Maltese: Fil-perjodu ta' 26 ġimgħa ta' din il-prova open-label, l-aktar anomaliji frekwenti tal-laboratorju li ġew osservati kienu żidiet fil-kreatina (6.5%) u valuri għoljin ta' CK fi 2% tat-tfal riċevituri.
English: As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Maltese: Kif osservat f'inibituri ta' enzimi li jikkonvertu angiotensin, irbesartan u l-antagonisti ta' angiotensin l oħrajn huma apparentament inqas effettivi biex iniżżlu l-pressjoni f nies suwed milli f dawk li mhumiex suwed, possibilment minħabba li hemm prevelanza ogħla ta' renin baxx f'popolazzjoni ta' razza sewda bi pressjoni għolja (ara sezzjoni 5.1).
English: Lactose: this medicinal product contains lactose.
Maltese: Lactose: dan il-prodott mediċinali fih il-lactose.
English: Each tablet of Sabervel 150 mg contains 150 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan.
English: hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all-cause mortality were examined.
Maltese: 1,715-il pazjent bi pressjoni għolja u b'dijabete tip 2, proteinuria ≥ 900 mg/jum u krejatinina fis-serum li tvarja minn 1.0 - 3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 sena) ta' irbesartan fuq l avvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Maltese: Mewt kardjovaskulari u puplesija t-tnejn kienu numerikament iktar frekwenti fil grupp ta' aliskiren milli fil-grupp tal-plaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalimja, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo.
English: Hepatobiliary disorders: Uncommon:
Maltese: Disturbi _ fil-qalb: Mhux komuni:
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Maltese: Bħalma jseħħ bl-inibituri ACE, l-użu konkomitanti ta' antagonisti ta' angiotensin II u NSAIDs jista' jirriżulta f' żjieda fir-riskju li teħżien il-funzjoni renali, inkluża l-possibbilità ta' insuffiċjenza renali akuta, u żjieda fil-potassium fis-serum, speċjalment f'pazjenti li diġà kellhom funzjoni renali bagħtuta.
English: Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Maltese: Sabervel 300 mg miksijin b'rita jinstabu f' pakketti f' folji ta' 28, 56, 90 jew 98 pillola miksija b'rita.
English: • Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Maltese: • Mhux komuni: taħbit tal-qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/qrusa fl istonku, disfunzjoni sesswali (problemi fl-attività sesswali), uġigħ fis-sider.
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Maltese: Fi studji mhux kliniċi ta' sigurtà, dożi għoljin ta' irbesartan (≥ 250 mg/kg/jum f firien u ≥ 100mg/kg/jum f makakki) ikkawżaw tnaqqis fil-parametri taċ-ċelluli ħomor tad-demm (eritroċiti, emoglobina, ematokrit).
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: irbesartan mill-ħalq jew ġol-vini, 80-85% tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: Some side effects have been reported since marketing of Irbesartan Side effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Maltese: Effetti mhux mixtieqa, fejn il-frekwenza mhijiex magħrufa huma: tħoss rasek iddur bik, uġigħ ta' ras, disturbi fit-togħma, żarżir fil-widnejn, bugħawwieġ, uġigħ fil-ġogi u fil-muskoli, funzjoni tal-fwied anormali, livelli għoljin ta' potassium fid-demm, funzjoni tal-kliewi indebolita, u infjammazzjoni tal-vini ż-żgħar li taffettwa l-ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
English: Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Maltese: Sabervel 150 mg miksijin b'rita jinstabu f' pakketti f' folji ta' 28, 56, 90 jew 98 pillola miksija b'rita.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Espożizzjoni għal terapija AIIRA matul it-tieni u t-tielet trimestri hija magħrufa li twassal għal tossiċità tal-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligohydramnios, tnaqqis fl-ossifikazzjoni talgħadam tar-ras) u tossiċità neonatali (nuqqas fil-funzjoni tal-kliewi, pressjoni baxxa, iperkalemija) (Ara sezzjoni 5.3).
English: Sabervel is for oral use.
Maltese: Sabervel u kkuntattja lit-tabib tiegħek minnufih.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Maltese: AUC u r-rati ta' tneħħija setgħu jitqabblu ma' dawk osservati f pazjenti adulti li jieħdu 150 mg irbesartan kuljum.
English: Slove nija
Maltese: FEJN MA
English: • salt substitutes containing potassium
Maltese: • supplimenti tal-potassium, • sostituti tal-melħ li fihom il-potassium,
English: • potassium supplements
Maltese: 2. GĦAMLA KWALITATTIVA
English: Nervous system disorders: Common:
Maltese: Disturbi _ fis-sistema nervuża:
English: 80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Maltese: (reference medicinal product).
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Hu indikat ukoll għall-kura għall-mard renali f pazjenti adulti li għandhom pressjoni għolja u dijabete mellitus ta' tip 2 bħala parti mill-kura kontra il-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Maltese: Irbesartan jesibixxi farmakokinetika lineari u proporzjonata tad-doża fuq il-firxa mad-doża ta' 10 sa 600 mg.
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Maltese: Il-frekwenza 'tal-effetti avversi msemmija hawn taħt hija definita bl-użu ta' din il-konvenzjoni: 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).
English: ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Maltese: Mediċini kontra l-pressjoni għolja addizzjonali (li jeskludu inibituri t'ACE, antagonisti tar-riċetturi angiotensin-II u dihydropyridine calcium blockers)
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Maltese: Esperjenza f adulti esposti għal dożi sa 900 mg/jum għal 8 ġimgħat ma uriet ebda tossiċità.
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Maltese: Indeboliment epatiku: f pazjenti b'ċirrożi ħafifa għal moderata, il-parametri farmakokinetiċi ta' irbesartan ma jitbidlux b'mod sinifikanti.
English: Breast-feeding:
Maltese: Qalba tal-pillola:
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Maltese: kien studju maħsub biex jittestja l-benefiċċju li jiżdied aliskiren ma' terapija standard ta' inibitur ta' ACE jew imblokkatur tar-riċetturi ta' angiotensin II f'pazjenti b'dijabete mellitus tip 2 u mard kroniku tal-kliewi, mard kardjovaskulari, jew it-tnejn.
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Maltese: Fuq il-perjodu tal-ġimagħtejn ta' wara fejn ilpazjenti ġew re-randomised jew għal prodott mediċinali attiv jew għal plaċebo, il-pazjenti fuq plaċebo kellhom żidiet ta' 2.4 u 2.0 mmHg fis-SeSBP u SeDBP meta mqabbla ma' bidliet rispettivi ta' +0.1 u0.3 mmHg f dawk fuq id-dożi kollha ta' irbesartan (ara sezzjoni 4.2).
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Maltese: Dejta farmakodinamika / tossikoloġika fil-firien uriet li kien hemm eliminazzjoni ta' irbesartan jew ilmetaboliti tiegħu fil-ħalib tas-sider (għad-dettalji ara 5.3).
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta tiġi ddijanjostikata tqala, trattament b'AIIRAs għandu jitwaqqaf minnufih, u jekk xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Maltese: Il-farmakokinetiċi ta' irbesartan kienu ikkalkulati fi 23 tifel u tifla bi pressjoni għolja wara l-għoti ta' doża waħda jew aktar kuljum ta' irbesartan (2 mg/kg) sa doża massima ta' kuljum ta' 150 mg għal erba'
English: • Common : dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Maltese: • Komuni: sturdament, dardir/rimettar u għeja u testijiet tad-demm jistgħu juru livelli ogħla ta'
English: The demonstration of renal benefit of Sabervel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Il-benefiċċju renali muri b'Sabervel f pazjenti b'dijabete ta' tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma' mediċini oħra ta' kontra l-pressjoni għolja kif meħtieġ, biex jintlaħaq il-livell mixtieq ta' pressjoni (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'mikroalbuminurja u b'funzjoni renali normali, iperkalimja (≥ 5.5mEq/l) ġrat f'29.4% (jiġifieri komuni ħafna) tal-pazjenti fil-grupp li ħadu 300 mg ta' irbesartan u fi 22% talpazjenti fil-grupp tal-plaċebo.
English: Teл.
Maltese: Av.
English: Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Sabervel jintuża f pazjenti b'indeboliment renali, hija irrikmandata osservanza perjodika tal-livelli tal-potassju u tal-krejatinina fis-serum.
English: Important information about some of the ingredients of Sabervel Sabervel contains lactose.
Maltese: M'hemmx biżżejjed informazzjoni speċifika disponibbli fuq il-kura tad-doża eċċessiva b'Sabervel.
English: De uts chland
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: Potassium supplements and potassium-sp aring diuretics: based on experience with the use of other medicinal products that affect the reninangiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Maltese: Supplimenti tal-potassium u dijuretiċi potassium-sparing: ibbażat fuq l-esperjenza bl-użu ta' prodotti mediċinali oħra li jaffettwaw lis-sistema ta' renin-angiotensin, l-użu konkomitanti ta' dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium jew prodotti mediċinali oħra li jżidu il-livelli tal-potassium fis-serum (eż. ħeparina) jistgħu jwasslu għal żidiet talpotassium fis-serum u, għalhekk, mhumiex irrikmandati (ara sezzjoni 4.4).
English: • if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel
Maltese: • jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta'
English: HOW TO TAKE SABERVEL
Maltese: X'fih Sabervel
English: B re as t-feeding
Maltese: L-istudju eżamina l-effetti fit-tul
English: NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets irbesartan
Maltese: INFORMAZZJONI GHAL MIN QED JAGHMEL UŻU MINNU Sabervel 300 mg pilloli miksijin b'rita irbesartan
English: • if you suffer from kidney problems
Maltese: • jekk tbati minn problemi fil-kliewi
English: EMA/434854/2014 EMEA/H/C/000918
Maltese: EMEA/H/C/000918
English: It contains the active substance filgrastim (30 or 48 million units).
Maltese: Fih is-sustanza attiva filgrastim (30 jew 48 miljun unità).
English: The full EPAR for Filgrastim Hexal 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 Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Maltese: Is-sustanza attiva f'Filgrastim Hexal, il-filgrastim, hija simili ħafna għal proteina umana msejħa fattur stimolanti tal-kolonja granuloċiti (G CSF).
English: Filgrastim Hexal is a ‘biosimilar' medicine.
Maltese: Filgrastim Hexal huwa mediċina ‘bijosimili'.
English: The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Is-CHMP iddeċieda li, b'mod konformi mar-rekwiżiti tal-UE, Filgrastim Hexal wera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli ma' dak ta' Neupogen.
English: This is a summary of the European public assessment report (EPAR) for Filgrastim Hexal.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Filgrastim Hexal.
English: The reference medicine for Filgrastim Hexal is Neupogen.
Maltese: Il-mediċina ta' referenza għal Filgrastim Hexal hija Neupogen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal on 06 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Filgrastim Hexal fis-06 ta' Frar 2009.
English: Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen.
Maltese: Erba' studji ħarsu lejn il-livelli ta' newtrofili fid-demm f'total ta' 146 voluntier b'saħħithom li rċevew Filgrastim Hexal jew Neupogen.
English: Other information about Filgrastim Hexal
Maltese: Informazzjoni oħra dwar Filgrastim Hexal
English: Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Maltese: Filgrastim Hexal u Neupogen ġabu żjiediet simili ta' numru ta' newtrofili fid-demm f'voluntiera b'saħħithom matul l-istudji.
English: This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Maltese: Dan ifisser li Filgrastim Hexal huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi l-istess sustanza attiva (magħrufa bħala l-‘mediċina ta' referenza').
English: Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Filgrastim Hexal ġie studjat biex jintwera li huwa komparabbli għall-mediċina ta' referenza, Neupogen.
English: What is the risk associated with Filgrastim Hexal?
Maltese: X'inhu r-riskju assoċjat ma' Filgrastim Hexal?
English: What is Filgrastim Hexal?
Maltese: X'inhu Filgrastim Hexal?
English: Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Maltese: Filgrastim Hexal normalment jingħata f'ċentru ta' kura speċjalizzata, għalkemm il-pazjenti li jirċievuh b'injezzjoni taħt il-ġilda jistgħu jinjettaw rwieħhom ladarba jitħarrġu sabiex jagħmlu dan.
English: A risk management plan has been developed to ensure that Filgrastim Hexal is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Filgrastim Hexal jintuża bl-aktar mod sigur possibbli.
English: Why has Filgrastim Hexal been approved?
Maltese: Għaliex ġie approvat Filgrastim Hexal?
English: The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein.
Maltese: L-istudji ħarsu lejn l-effetti ta' amministrazzjoni ta' darba u repetuta ta' dożi varji tal-mediċini, jew injettati taħt il-ġilda jew infużi fil-vina.