qanastek/EMEA-V3 huggingface dataset:
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu)
Package size 14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets 14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets
14 - il pillola 28 pillola 56 pillola 112- il pillola 168 pillola 196 pillola 50x1 pillola 14 - il pillola 28 pillola 56 pillola 112 - il pillola 168 pillola 196 pillola 50x1 pillola
Velmetia 50 mg/ 850 mg film-coated tablets
Velmetia 50 mg/ 850 mg pilloli miksijin b’ rita
Capsule-shaped, pink film-coated tablet with “ 515 ” debossed on one side.
Pillola roża miksija b’ rita, forma ta ’ kapsula b ’ “ 515 ” imnaqqxa fuq naħa waħda.
Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Velmetia huwa indikat bħala żieda mad- dieta u ma ’ l- eżerċizzju biex itejjeb il- kontroll gliċemiku għal pazjenti mhux ikkontrollati adegwatament, fuq id- doża massima ttollerata ta ’ metformin waħdu jew għal dawk li diġà qegħdin jiġu kkurati b’ kumbinazzjoni ta ’ sitagliptin u metformin.
Velmetia is also indicated in combination with a sulphonylurea (i. e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Velmetia huwa indikat ukoll f’ kumbinazzjoni ma ’ sulphonylurea (jiġifieri, terapija ta ’ kumbinazzjoni tripla) bħala żieda mad- dieta u l- eżerċizzju f’ pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ metformin u sulphonylurea.
The dose of antihyperglycaemic therapy with Velmetia should be individualised on the basis of the patient ’ s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Id- doża ta ’ terapija kontra l- ipergliċemija b’ Velmetia għandha tkun individwalizzata fuq il- bażi tal - kors kurrenti, l- effettività, u t- tolerabbilità tal- pazjent waqt li ma tinqabiżx id- doża massima ta ’ kuljum irrakkomandata ta ’ 100 mg sitagliptin.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Velmetia should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ monoterapija b’ metformin Għal pazjenti mhux ikkontrollati adegwatament fuq metformin waħdu, id- doża tal- bidu tas- soltu ta ’ Velmetia għandha tkun ta ’ 50 mg sitagliptin darbtejn kuljum (doża totali ta ’ kuljum 100 mg) kif ukoll id- doża ta ’ metformin li tkun diġà bdiet tittieħed.
For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Velmetia should be initiated at the dose of sitagliptin and metformin already being taken.
Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin, Velmetia għandu jinbeda fid- doża ta ’ sitagliptin u metformin li tkun diġà bdiet tittieħed.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Velmetia should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq terapija ta ’ kombinazzjoni doppja bid- doża massima ttollerata ta ’ metformin u sulphonylurea Id- doża ta ’ Velmetia għandha tipprovdi sitagliptin 50 mg darbtejn kuljum (doża totali ta ’ kuljum 100 mg) u doża ta ’ metformin simili għad- doża li diġà qegħda tittieħed.
When Velmetia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Meta Velmetia jintuża f’ kombinazzjoni ma ’ sulphonylurea, tista ’ tkun meħtieġa doża aktar baxxa ta ’ sulphonylurea biex tnaqqas ir- riskju ta ’ ipogliċemija (ara sezzjoni 4. 4).
2 For the different doses on metformin, Velmetia is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1000 mg metformin hydrochloride.
2 Għal dożi differenti ta ’ metformin, Velmetia jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
Velmetia should be given twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin.
Velmetia għandu jingħata darbtejn kuljum ma ’ l- ikel biex itaffi l- effetti gastrointestinali mhux mixtieqa assoċjati ma ’ metformin.
Patients with renal insufficiency Velmetia should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/ min) (see sections 4.3 and 4.4).
Pazjenti b’ indeboliment tal- kliewi Velmetia m’ għandux jintuża f’ pazjenti b’ indeboliment tal- kliewi moderat jew serju (eliminazzjoni ta ’ kreatinin < 60 ml/ min) (ara sezzjonijiet 4. 3 u 4. 4).
Patients with hepatic insufficiency Velmetia should not be used in patients with hepatic impairment (see sections 4.3 and 5.2).
Pazjenti b’ indeboliment tal- fwied Velmetia m’ għandux jintuża f’ pazjenti b’ indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
Elderly As metformin and sitagliptin are excreted by the kidney, Velmetia should be used with caution as age increases.
L- anzjani Minħabba li metformin u sitagliptin huma eliminati mill- kliewi, Velmetia għandu jintuża b’ kawtela fuq pazjenti li huma akbar fl- età.
Paediatric population Velmetia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy in this population.
Populazzjoni pedjatrika Velmetia mhuwiex irrakkomandat fi tfal taħt l- età ta ’ 18- il sena minħabba nuqqas ta ’ dejta fuq is - sigurtà u l- effikaċja tiegħu f’ din il- popolazzjoni.
Velmetia is contraindicated in patients with:
Velmetia huwa kontraindikat f’ pazjenti b ’:
General Velmetia should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Ġenerali Velmetia m’ għandux jintuża f’ pazjenti b’ dijabete tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Hypoglycaemia Patients receiving Velmetia in combination with a sulphonylurea may be at risk for hypoglycaemia.
Ipogliċemija Pazjenti li qegħdin jirċievu Velmetia flimkien ma ’ sulphonylurea jistgħu jkunu f’ riskju għal ipogliċemija.
The use of Velmetia in combination with insulin has not been adequately studied.
L- użu ta ’ Velmetia f’ kumbinazzjoni ma ’ insulina ma ġiex studjat adegwatament.
If a hypersensitivity reaction is suspected, discontinue Velmetia, assess for other potential causes of the event, and institute alternative treatment for diabetes (see section 4.8).
Jekk tkun issuspettata reazzjoni ta ’ sensittività eċċessiva, waqqaf Velmetia, ivvaluta kawżi potenzjali oħrajn għar- reazzjoni, u ibda kura alternattiva għad- dijabete (ara sezzjoni 4. 8).
Surgery As Velmetia contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Kirurġija Minħabba li Velmetia fih metformin hydrochloride, il- kura għandha titwaqqaf 48 siegħa qabel kirurġija elettiva b’ loppju ġenerali, anestesija spinali jew epidurali.
Velmetia should not usually be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
Velmetia ġeneralment m’ għandux jerġa ’ jinbeda aktar kmieni minn 48 siegħa wara u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali.
Therefore, Velmetia should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Għaldaqstant, Velmetia għandu jitwaqqaf qabel, jew fiż- żmien tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali (ara sezzjoni 4. 5).
4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Velmetia who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
4 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Velmetia li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
If acidosis of either form occurs, Velmetia must be stopped immediately and other appropriate corrective measures initiated.
Jekk isseħħ aċidożi ta ’ forma waħda jew l- oħra, Velmetia għandu jitwaqqaf minnufih u jinbdew miżuri korrettivi adattati
Pharmacokinetic drug interaction studies with Velmetia have not been performed; however, such studies have been conducted with the individual active substances of Velmetia, sitagliptin and metformin.
Ma sarux studji farmakokinetiċi ta ’ interazzjoni ta ’ mediċini b’ Velmetia; madankollu, studji bħal dawn saru individwalment bis- sustanzi attivi ta ’ Velmetia, sitagliptin u metformin.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Velmetia (see section 4.4).
B’ intossikazzjoni akuta ta ’ alkoħol (partikolarment fil- każ ta ’ sawm, malnutriment jew indeboliment epatiku) hemm żieda ta ’ riskju ta ’ aċidożi lattika minħabba s- sustanza attiva metformin bħala parti minn Velmetia (ara sezzjoni 4. 4).
Therefore, Velmetia should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Għaldaqstant, Velmetia għandu jitwaqqaf qabel, jew fil- ħin tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali (ara sezzjoni 4. 4).
Velmetia should not be used during pregnancy.
Velmetia m’ għandux jintuża waqt it- tqala.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Velmetia should be discontinued and switched to insulin treatment as soon as possible.
Jekk pazjenta tixtieq li toħroġ tqila jew jekk isseħħ tqala, il - kura b’ Velmetia għandha titwaqqaf u l- pazjenta għandha tinqaleb għal kura bl- insulina mill- aktar fis possibbli.
No studies in lactating animals have been conducted with the combined active substances of Velmetia.
Ma sar l- ebda studju b’ sustanzi attivi kkumbinati ta ’ Velmetia f’ annimali li qegħdin ireddgħu.
Velmetia must therefore not be used in women who are breast-feeding (see section 4.3).
Velmetia għalhekk m’ għandux jintuża f’ nisa li qegħdin ireddgħu (ara sezzjoni 4. 3).
No studies on the effects on the ability to drive and use machines have been performed with Velmetia.
Ma sar l- ebda studju b’ Velmetia fuq l- effetti fuq il- ħila biex issuq u li tħaddem magni.
In addition, patients should be alerted to the risk of hypoglycaemia when Velmetia is used in combination with other sulfonylurea agents.
Barra minn hekk, il- pazjenti għandhom ikunu mwissija dwar ir- riskju ta ’ ipogliċemija meta Velmetia jintuża f’ kumbinazzjoni ma ’ mediċini tat- tip sulfonylurea oħrajn.
There have been no therapeutic clinical trials conducted with Velmetia tablets however bioequivalence of Velmetia with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Ma saru l- ebda provi terapewtiċi kliniċi b’ pilloli Velmetia, madankollu ntweriet il- bijoekwivalenza ta ’ Velmetia ma ’ sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5. 2).
During post-marketing experience of Velmetia or sitagliptin, one of the active substances of Velmetia, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Waqt ġbir ta dejta ta ’ wara t- tqegħid fis- suq ta ’ Velmetia jew sitagliptin, wieħed mis- sustanzi attivi ta ’ Velmetia, ġew irrapportati l- effetti sekondarji oħra li ġejjin (frekwenza mhux magħrufa): reazzjonijiet ta ’ sensittività eċċessiva li jinkludu anafilassi, anġjoedima, raxx, urtikarja, u kondizzjonijiet esfoljativi tal- ġilda inkluż is- sindromu ta ’ Stevens- Johnson (ara sezzjoni 4. 4).
No data are available with regard to overdose of Velmetia.
Ma hemm l- ebda tagħrif disponibbli dwar teħid eċċessiv ta ’ Velmetia.
Velmetia combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Velmetia jikkumbina żewġ mediċini kontra l- ipergliċemija b’ mekkaniżmi ta ’ azzjoni kumplimentari biex jitjieb il- kontroll gliċemiku f’ pazjenti b’ dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP- 4), u metformin hydrochloride, li hu membru tal- klassi biguanide.
Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulphonylureas or meglitinides, biguanides, peroxisome proliferator-activated receptor gamma (PPAR γ) agonists, alpha- glucosidase inhibitors, and amylin analogues.
Sitagliptin huwa differenti fl- istruttura kimika u azzjoni farmakoloġika minn analogi GLP- 1, insulin, sulphonylureas jew meglitinides, biguanides, agonisti peroxisome proliferator- activated receptor gamma (PPARγ), impedituri alpha- glucosidase, u analogi amylin.
in HbA1c (%) at Week 24 †
Bidla medja f’ HbA1c ikkoreġuta bi plaċebo (%) f ’ Ġimgħa 24 †
at Week 24 †
HbA1c fil- linja bażi (%) f’ Ġimgħa 24 †
-0.7 ‡
(- 0. 8, - 0. 5) - 0. 9 ‡
-0.9 ‡ (-1.1, -0.7)
(- 1. 1, - 0. 7) - 1. 6 ‡
-1.6 ‡ (-1.8, -1.3)
(- 1. 8, - 1. 3) - 2. 1 ‡
-2.1 ‡ (-2.3, -1.8)
(- 2. 3, - 1. 8)
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
- bi tnaqqis fil- produzzjoni ta ’ zokkor fil- fwied billi jimpedixxi glukoneoġenesi u glajkoġenoliżi
Velmetia A bioequivalence study in healthy subjects demonstrated that the Velmetia (sitagliptin/ metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Velmetia Studju ta ’ bijoekwivalenza f’ suġġetti b’ saħħithom wera li pilloli ta ’ kumbinazzjoni Velmetia (sitagliptin/ metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta ’ sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
The following statements reflect the pharmacokinetic properties of the individual active substances of Velmetia.
L- istqarrijiet li ġejjin jirriflettu l- kwalitajiet tas- sustanzi attivi individwali ta ’ Velmetia.
No animal studies have been conducted with Velmetia.
Ma sar l- ebda studju fl- annimali b’ Velmetia.
Velmetia 50 mg/ 1000 mg film-coated tablets
Velmetia 50 mg/ 1000 mg pilloli miksijin b’ rita
Capsule-shaped, red film-coated tablet with “ 577 ” debossed on one side.
Pillola ħamra miksija b’ rita, forma ta ’ kapsula b ’ “ 577 ” imnaqqxa fuq naħa waħda.
17 For the different doses on metformin, Velmetia is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
18 Għal dożi differenti ta ’ metformin, Velmetia jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
19 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Velmetia who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
20 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Velmetia li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
24 Velmetia combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Velmetia jikkumbina żewġ mediċini kontra l- ipergliċemija b’ mekkaniżmi ta ’ azzjoni kumplimentari biex jitjieb il- kontroll gliċemiku f’ pazjenti b’ dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP- 4), u metformin hydrochloride, li hu membru tal- klassi biguanide.
Outer carton for Velmetia 50 mg/ 850 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Velmetia 50 mg/ 850 mg
Velmetia 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Velmetia 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 112- il pillola miksija b’ rita 168 pillola miksija b’ rita 196 pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
36 Do not store above 30°C.
Taħżinx f’ temperatura ogħla minn 30°C.
EU/ 1/ 08/ 456/ 001 14 film-coated tablets EU/ 1/ 08/ 456/ 002 28 film-coated tablets EU/ 1/ 08/ 456/ 003 56 film-coated tablets EU/ 1/ 08/ 456/ 004 112 film-coated tablets EU/ 1/ 08/ 456/ 005 168 film-coated tablets EU/ 1/ 08/ 456/ 006 196 film-coated tablets EU/ 1/ 08/ 456/ 007 50 x 1 film-coated tablets EU/ 1/ 08/ 456/ 015 196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 456/ 001 14- il pillola miksija b’ rita EU/ 1/ 08/ 456/ 002 28 pillola miksija b’ rita EU/ 1/ 08/ 456/ 003 56 pillola miksija b’ rita EU/ 1/ 08/ 456/ 004 112- il pillola miksija b’ rita EU/ 1/ 08/ 456/ 005 168 pillola miksija b’ rita EU/ 1/ 08/ 456/ 006 196 pillola miksija b’ rita EU/ 1/ 08/ 456/ 007 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 456/ 015 196 (2 pakketti ta ’ 98) pillola miksija b’ rita
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without blue box - 50 mg/ 850 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Velmetia - 50 mg/ 850 mg pillola miksija b’ rita
Velmetia 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Velmetia 50 mg/ 850 mg pillola miksija b’ rita sitagliptin/ metformin hydrochloride
Blister for Velmetia 50 mg/ 850 mg film-coated tablets
Folji għal pilloli miksijin b’ rita Velmetia 50 mg/ 850 mg
Velmetia 50 mg/ 850 mg tablets sitagliptin/ metformin HCl
Pilloli Velmetia 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
Outer carton for Velmetia 50 mg/ 1,000 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Velmetia 50 mg/ 1000 mg
Velmetia 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Velmetia 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 112- il pillola miksija b’ rita 168 pillola miksija b’ rita 196 pillola miksija b’ rita Pakkett multiplu li fih 196 (2 pakketti ta ’ 98) pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
EU/ 1/ 08/ 456/ 008 14 film-coated tablets EU/ 1/ 08/ 456/ 009 28 film-coated tablets EU/ 1/ 08/ 456/ 010 56 film-coated tablets EU/ 1/ 08/ 456/ 011 112 film-coated tablets EU/ 1/ 08/ 456/ 012 168 film-coated tablets EU/ 1/ 08/ 456/ 013 196 film-coated tablets EU/ 1/ 08/ 456/ 014 50 x 1 film-coated tablets EU/ 1/ 08/ 456/ 016196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 455/ 008 14- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 009 28 pillola miksija b’ rita EU/ 1/ 08/ 455/ 010 56 pillola miksija b’ rita EU/ 1/ 08/ 455/ 011 112- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 012 168 pillola miksija b’ rita EU/ 1/ 08/ 455/ 013 196 pillola miksija b’ rita EU/ 1/ 08/ 455/ 014 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 455/ 016 196 (2 pakketti ta ’ 98) pillola miksija b’ rita
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without bleu box - 50 mg/ 1,000 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Velmetia - 50 mg/ 1, 000 mg pilloli miksijin b’ rita
Velmetia 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Velmetia 50 mg/ 1, 000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
Blister for Velmetia 50 mg/ 1,000 mg film-coated tablets
Folja għal pilloli miksijin b’ rita Velmetia 50 mg/ 1000 mg
Velmetia 50 mg/ 1,000 mg tablets sitagliptin/ metformin HCl
Pilloli Velmetia 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
Velmetia 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Velmetia 50 mg/ 850 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
What Velmetia is and what it is used for 2.
X’ inhu Velmetia u għalxiex jintuża 2.
Before you take Velmetia 3.
Qabel ma tieħu Velmetia 3.
How to take Velmetia 4.
Kif għandek tieħu Velmetia 4.
How to store Velmetia 6.
Kif taħżen Velmetia 6.
WHAT VELMETIA IS AND WHAT IT IS USED FOR
X’ INHU VELMETIA U GĦALXIEX JINTUŻA
The name of your tablet is Velmetia.
L- isem tal- pillola tiegħek hija Velmetia.
Velmetia helps to improve the levels of insulin after a meal and lowers the amount of sugar made by your body.
Velmetia jgħin biex itejjeb il- livelli ta ’ insulina wara ikla u jbaxxi l - ammont ta ’ zokkor magħmul minn ġismek.
Velmetia can be used alone or with another medicine for diabetes called a sulphonylurea.
Velmetia jista ’ jintuża waħdu jew flimkien ma ’ mediċina oħra għad- dijabete msejħa sulphonylurea.
BEFORE YOU TAKE VELMETIA
QABEL MA TIEĦU VELMETIA
Do not take Velmetia:
Tiħux Velmetia:
Velmetia (listed in section 6)
sustanzi oħra ta ’ Velmetia (elenkati f’ sezzjoni 6)
taking Velmetia at the time of the X-ray and for a few days after
Trid tieqaf tieħu Velmetia fil- ħin tar- raġġi- X u għal ftit jiem wara
Do not take Velmetia if any of the above apply to you.
Tiħux Velmetia jekk xi problema minn dawn tapplikaw għalik.
If you are not sure, talk to your doctor or pharmacist before taking Velmetia.
Jekk m’ intix ċert, kellem lit- tabib jew l- ispiżjar tiegħek qabel tieħu Velmetia.
Take special care with Velmetia Check with your doctor or pharmacist before taking your medicine:
Oqgħod attent ħafna b’ Velmetia Iċċekkja mat- tabib jew l- ispiżjar tiegħek qabel tieħu l- mediċina tiegħek:
Metformin hydrochloride, one of the ingredients in Velmetia, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death.
Metformin hydrochloride, wieħed mis- sustanzi f’ Velmetia, jista ’ jikkaġuna effett sekondarju rari iżda serju msejjaħ aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fid- demm) li tista ’ tkun ta ’ periklu.
If you experience some of the symptoms of lactic acidosis stop taking Velmetia and consult a doctor immediately
Jekk tesperjenza xi wħud mis- sintomi ta ’ aċidożi lattika ieqaf milli tieħu Velmetia u fittex parir ta ’ tabib minnufih
- During treatment with Velmetia, your doctor will check your kidney function at least once a
- Waqt kura b’ Velmetia, it- tabib tiegħek sejjer jiċċekkja l- funzjoni tal- kliewi tiegħek ta ’ l- anqas
year and more frequently if you are elderly or if your kidney function is borderline or at risk of worsening
darba f’ sena jew aktar spiss jekk inti anzjan jew il- funzjoni tal- kliewi tiegħek mhix sodisfaċenti jew f’ riskju li tmur għall- agħar
- if you have or have had an allergic reaction to sitagliptin, metformin, or Velmetia
- Jekk għandek jew kellek reazzjoni alleġika għal sitagliptin, metformin, jew Velmetia
- if you are taking a sulphonylurea, a diabetes medicine, together with Velmetia, as you may
- Jekk barra Velmetia qiegħed tieħu wkoll sulphonylurea, mediċina ta ’ kontra d- dijabete, flimkien
experience low blood sugar levels (hypoglycaemia).
ma ’ Velmetia, għaliex jista ’ jkollok livelli ta ’ zokkor fid- demm baxxi (ipogliċemija).
need to stop taking Velmetia for a couple of days before and after the procedure
jeħtieġ li tieqaf tieħu Velmetia għal xi jiem qabel u wara l- proċedura
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Velmetia.
Jekk m’ intix ċert jekk waħda minn dawn ta ’ hawn fuq japplikaw għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tieħu Velmetia.
Taking Velmetia with food and drink Take Velmetia with meals to lower your chance of an upset stomach.
Meta tieħu Velmetia ma ’ l- ikel u max- xorb Ħu Velmetia ma ’ l- ikel biex tnaqqas iċ- ċans ta ’ taqliba ta ’ l- istonku
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should talk to their doctor before taking Velmetia.
Tqala u Treddigħ Nisa li huma tqal jew li qed jippjanaw li joħorġu tqal għandhom ikellmu lit- tabib tagħhom qabel ma jieħdu Velmetia.
You should not use Velmetia during pregnancy.
M’ għandekx tieħu Velmetia waqt it- tqala.
It is not known if Velmetia passes into human breast milk.
Mhuwiex magħruf jekk sitagliptin jgħaddix għal ġol- ħalib tas- sider tal - bniedem.
You must not use Velmetia if you are breast-feeding or plan to breast-feed.
M’ għandekx tieħu Velmetia jekk qegħda tredda ’ jew qegħda tippjana li tredda ’.
Driving and using machines No studies on the effects of Velmetia on the ability to drive or to use machines have been performed.
50 Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Velmetia fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Taking Velmetia in combination with medicines called sulphonylureas can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
It- teħid ta ’ Velmetia f’ kumbinazzjoni ma ’ mediċini msejħin sulphonylureas jista ’ jikkaġuna ipogliċemija, li tista ’ taffettwa l- ħila tiegħek li ssuq u tuża magni jew taħdem f’ post li mhux sod biżżejjed.
HOW TO TAKE VELMETIA
KIF GĦANDEK TIEĦU VELMETIA
Always take Velmetia exactly as your doctor has told you.
Dejjem ħu Velmetia eżattament kif qallek it- tabib tiegħek.
• Velmetia should be taken:
• Velmetia għandu jittieħed:
• Continue to take Velmetia as long as your doctor prescribes it so you can continue to help control your blood sugar.
• Kompli ħu Velmetia sakemm jibqa ’ jiktibulek fuq ir- riċetta t- tabib tiegħek sabiex inti tibqa ’ tgħin tikkontrolla z- zokkor fid- demm.
You should continue your diet during treatment with Velmetia and take care that your carbohydrate intake is equally distributed over the day.
Għandek tkompli d- dieta waqt kura b’ Velmetia u tagħmel mezz li tqassam il- karboidrati ugwalment matul il- jum.
Velmetia alone is unlikely to cause abnormally low blood sugar (hypoglycaemia).
Velmetia waħdu mhuwiex mistenni li jikkawża livelli ta ’ zokkor fid- demm baxxi ħafna (ipogliċemija).
When Velmetia is used with a sulphonylurea medicine, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea.
Meta Velmetia jintuża ma ’ mediċina tat- tip sulphonylurea, jista ’ jseħħ livell baxx ta ’ zokkor fid- demm u t- tabib tiegħek jista ’ jnaqqas id- doża ta ’ sulphonylurea li tkun qed tieħu.
If you take more Velmetia than you should If you take more than the prescribed dosage of Velmetia, contact your doctor immediately.
Jekk tieħu Velmetia aktar milli suppost Jekk tieħu aktar Velmetia mid- dożaġġ miktub fir- riċetta, ikkuntattja lit- tabib tiegħek minnufih.
If you forget to take Velmetia If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu Velmetia Jekk tinsa tieħu doża, ħudha mill- aktar fis malli tiftakar.
Do not take a double dose of Velmetia.
Tiħux doża doppja ta ’ Velmetia.
Like all medicines, Velmetia may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Velmetia jista ’ jkollu effetti sekondarji, għalkemm mhux kulħadd ikollu.
Very rarely patients taking metformin (one of the active substances of Velmetia) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood).
Rari ħafna, pazjenti li jkunu qegħdin jieħdu metformin (wieħed mis- sustanzi attivi ta ’ Velmetia) ikollhom kundizzjoni serja msejħa aċidożi lattika (wisq aċidu lattiku fid- demm).
Stop taking Velmetia and see a doctor straight away if you notice any of the following symptoms: • feeling sick (nausea) or being sick (vomiting), abdominal pain, muscular cramps, unexplained weight loss, rapid breathing, and feeling cold or uncomfortable.
Waqqaf Velmetia u ara tabib minnufih jekk tara xi sintomi minn dawn li ġejjin: • ikollok dardir jew tirremetti, jew ikollok uġigħ ta ’ żaqq, bugħawwieġ, telf ta ’ piż mhux mistenni, nifs mgħaġġel u tħoss tkexkix ta ’ bard jew skumdità.
Some patients have experienced the following side effects while taking Velmetia with a sulphonylurea:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu Velmetia ma ’ sulphonylurea:
During post-marketing experience with Velmetia or sitagliptin, one of the medicines in Velmetia, the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Waqt sorveljanza ta ’ wara t- tqegħid fis- suq b’ Velmetia jew sitagliptin, waħda mill- mediċini f’ Velmetia, ġew irrapportati wkoll l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa): reazzjonijiet allerġiċi, inklużi raxx, urtikarja, u nefħa tal- wiċċ, xofftejn, ilsien, u ġerżuma li jistgħu jikkaġunaw diffikultà biex tieħu n- nifs jew biex tibla ’.
If you have an allergic reaction, stop taking Velmetia and call your doctor right away.
Jekk ikollok reazzjoni allerġika, waqqaf Velmetia u sejjaħ lit- tabib tiegħek minnufih.
HOW TO STORE VELMETIA
KIF TAĦŻEN VELMETIA
Do not use Velmetia after the expiry date which is stated on the blister and the carton.
Tużax Velmetia wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
What Velmetia contains
X’ fih Velmetia
What Velmetia looks like and contents of the pack
Id- dehra ta ’ Velmetia u l- kontenut tal- pakkett:
Velmetia 50 mg/1000 mg film-coated tablets sitagliptin/metformin hydrochloride
Velmetia 50 mg/ 1000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
taking Velmetia at the time of the X -ray and for a few days after
tieqaf tieħu Velmetia fil- ħin tar- raġġi- X u għal ftit jiem wara
Driving and using machines No studies on the effects of Velmetia on the ability to drive or to use machines have been performed.
57 Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Velmetia fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Very rarely patients taking metformin (one of the active substances of Velmetia) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood).
Din hija iktar komuni
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@merck.com Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070 Bc-kontakt@berlin-chemie.de
60 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 Velmetia@ msd. dk
It explains how
t za Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropew (EPAR).
is the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
riz Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
or If you need more information about your medical condition or your treatment, read the Package
to Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
aw Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
er What is Velosulin?
x du X’ inhu Velosulin?
Velosulin is a solution for injection or infusion (drip).
Velosulin hu soluzzjoni għall- injezzjoni jew infużjoni (dripp).
It contains the active substance insulin human ng (rDNA). lo
Fih is- sustanza attiva insulina umana ħa (rDNA). ’ g
What is Velosulin used for?
Għalxiex jintuża Velosulin?
Velosulin is used to treat patients with diabetes. no
Velosulin jintuża għat- trattament ta ’ pazjenti bid- dijabete. m
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib. li
How is Velosulin used? ct
Kif jintuża Velosulin? li
Velosulin is intended for continuous subcutaneous infusion (under the skin) using an insulin infusion du
Velosulin hu magħmul biex jintuża f’ infużjoni kontinwa taħt il- ġilda permezz ta ’ pompa għall - a
pump.
infużjoni ta ’ l- insulina.
Velosulin may also be injected into a vein or given subcutaneously by injection.
Velosulin jista ’ wkoll jiġi injettat f’ vina jew jingħata taħt il- ġilda permezz ta ’ infużjoni.
Velosulin is a fast-acting insulin and may be used with longer-acting insulin products.
Velosulin hu insulina li taħdem malajr u jista ’ jintuża flimkien ma ’ prodotti ta ’ l- insulina li in
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. ro
Il- livell ta ’ glukożju (zokkor) fid- demm tal- pazjent għandu jiġi ttestjat regolarment biex tinstab l - iżgħar doża effettiva. ed
Velosulin should be given before meals.
Velosulin għandu jingħata qabel l- ikel.
See the Package Leaflet for exact timings. lp
Ara l- Fuljett ta ’ Tagħrif għall- ħinijiet eżatti. tm
How does Velosulin work? a
Kif jaħdem Velosulin?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Id- dijabete hi marda li fiha l- ġisem ma jipproduċix biżżejjed insulina biex jikkontrolla l- livell ta ’ glukożju fid- demm.
The active in
Velosulin hu insulina ta ’ sostituzzjoni identika għall- insulina magħmula mill - ot
substance in Velosulin, insulin human (rDNA), is produced by a method known as ‘ recombinant DNA ic
Is- sustanza attiva f’ Velosulin, l- insulina umana (rDNA), hi prodotta b’ metodu magħruf bħala od
technology ’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
‘ teknoloġija rekombinanti tad- DNA ’: l- insulina tiġi magħmula minn ħmira li tkun irċeviet ġene (DNA), li tagħmilha kapaċi tipproduċi l- insulina.
The replacement insulin acts in same way as naturally produced insulin and helps ed
L- insulina ta ’ sostituzzjoni taħdem l- istess bħall - Pr
glucose to enter cells from the blood.
insulina prodotta b’ mod naturali u tgħin lill- glukożju jidħol mid- demm għal ġoċ- ċelloli.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Bil- kontroll tal- livell tal- glukożju fid- demm, is- sintomi u l- kumplikazzjonijiet tad- dijabete jitnaqqsu.
The solution of insulin in Velosulin is specially prepared to M
Is- soluzzjoni ta ’ insulina f’ Velosulin hi mħejjija b’ mod speċjali li jagħmilha stabbli għat- tul ta ’ l- amministrazzjoni f’ pompa ta ’ l- insulina.
How has Velosulin been studied?
Kif ġie studjat Velosulin?
The studies used to support Velosulin are those that have been used to support Actrapid, another insulin approved in the European Union (EU).
L- istudji użati biex jappoġġjaw Velosulin huma dawk li ntużaw biex jappoġġaw Actrapid, insulina oħra approvata fl- Unjoni Ewropea (UE).
The studies measured the level of fasting blood sugar or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell taz- zokkor fid- demm bil- pazjent sajjem, jew ta ’ sustanza fid- demm magħrufa bħala emoglobina glikoċilata (HbA1c), li tagħti
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Velosulin shown during the studies?
Velosulin ġie studjat ukoll meta użat f’ pompa ta ’ l- insulina.
Velosulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with the other human insulin.
Velosulin wassal għal tnaqqis fil- livell ta ’ HbA1c, li juri li l- livelli ta ’ glukożju kienu ġew ikkontrollati għal livell simili għal dak li deher fl- insulina umana l- oħra.
Velosulin was effective for both type 1 and type 2 diabetes.
Velosulin kien effettiv kemm għad- dijabete ta ’ l- ewwel tip kif ukoll għal dik tat- tieni tip.
What is the risk associated with Velosulin?
X’ inhu r- riskju assoċjat ma ’ Velosulin?
As with all insulins, Velosulin may cause hypoglycaemia (low blood glucose).
Bħall- insulini kollha, Velosulin jista ’ jikkawża ipogliċemija (livell baxx ta ’ zokkor).
For the full list of all side effects reported with Velosulin, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rappurtati ma ’ Velosulin, ara l- Fuljett ta ’ Tagħrif.
Velosulin should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Velosulin m’ għandux jintuża minn persuni allerġiċi għall- insulina umana (rDNA) jew għal
Velosulin doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Il- lista sħiħa
The full list is available in the Package Leaflet.
riz tinstab fil- Fuljett ta ’ Tagħrif.
ed Why has Velosulin been approved?
to Għaliex ġie approvat Velosulin?
The Committee for Medicinal products for Human Use (CHMP) decided that Velosulin’ s benefits are
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’
is greater than its risks for the treatment of diabetes.
aw Velosulin fit- trattament tad- dijabete jisbqu r- riskji tiegħu.
The Committee recommended that Velosulin be
Il- Kumitat irrakkomanda li Velosulin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
th Other information about Velosulin:
x Tagħrif ieħor dwar Velosulin:
au The European Commission granted a marketing authorisation valid throughout the EU for Velosulin to Novo Nordisk A/ S on 7 October 2002.
du Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Velosulin valida fl- Unjoni Ewropea kollha lil Novo Nordisk A/ S fis- 7 ta ’ Ottubru 2002.
The marketing authorisation was renewed on 7 October 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 7 ta ’ Ottubru 2007. ħa L- EPAR sħiħ għal Velosulin huwa disponibbli minn hawnhekk. ’ g m
This summary was last updated in 10-2007. no ct du ro a lp in ic ed M
Dan is- sommarju ġie aġġornat l- aħħar f’ 10- 2007. li li a in iċ ed tm ot od Pr
EU number
t za Numru ta ’ l- EU
Invented name Strength
Isem inventat
Pharmaceutical form
Qawwa
Route of administration
Għamla farmaċewtika Soluzzjoni għall- injezzjoni
Packaging
Mnejn jingħata Użu għal taħt il- ġilda
Package size
Kontenut konċentrazzjoni)
ed (concentration)
Daqs tal- pakkett
is EU/ 1/ 02/ 232/ 001 Velosulin
riz EU/ 1/ 02/ 232/ 001
Solution for injection or infusion
jew għal ġol- vini Użu għal taħt il- ġilda
Subcutaneous and intravenous Vial (glass) use
kunjett (ħġieġ)
or EU/ 1/ 02/ 232/ 002 Velosulin
to EU/ 1/ 02/ 232/ 002
Solution for injection or infusion
jew għall- infużjoni
10 ml (3.5 mg/ ml)
kunjetti
5 x (1 x 10 ml) vials
jew għall- infużjoni
au use
jew għal ġol- vini
er ng lo o tn uc od pr al in ic ed M
x du ħa ’ g m li li a in iċ ed tm ot od Pr
1 1.
t za riz to aw x du ANNESS I ħa SOMMARJU TAL- KARATTERISTI I TAL- PRODOTT ’ g m li li a in iċ ed tm ot od Pr 1.
Velosulin 100 IU/ ml solution for injection or infusion in a vial.
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni jew infu joni f’ kunjett
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Insulina umana, rDNA (mag mula permezz tat- teknolo ija tad- DNA rikombinanti f’ Saccharomyces cerevisiae).
1 ml contains 100 IU of insulin human.
Millilitru fih 100 UI ta ’ insulina umana
1 vial contains 10 ml equivalent to 1000 IU.
t Kunjett fih 10 ml, ekwivalenti g al 1000 UI
ed One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
za UI (Unità Internazzjonali) wa da tikkorrispondi g al 0. 035 mg ta ’ insulina umana anidra.
is For a full list of excipients, see section 6.1.
riz G al- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
or 3.
to aw 3.
th au Solution for injection or infusion in a vial.
Soluzzjoni g all- injezzjoni jew infu joni f’ kunjett.
er ng 4.
x du Soluzzjoni akweja, ara u ming ajr kulur. ħa 4.
CLINICAL PARTICULARS lo
TAG RIF KLINIKU ’ g
4.1 Therapeutic indications no
4. 1 Indikazzjonijiet terapewti i m
Treatment of diabetes mellitus.
Kura ta ’ dijabete mellitus. li li
4.2 Posology and method of administration ct du
4. 2 Po olo ija u metodu ta ’ kif g andu jing ata a in
This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps. ro
Din l- insulina li tin all b’ buffer tal- phosphate hi intenzjonata g al infu joni kontinwa ta t il - ilda (continuous subcutaneous insulin infusion - CSII) f’ pompi tal- infu joni esterni ta ’ l- insulina. iċ ed
Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin lp
Velosulin hu insulina li ta dem malajr u jista ’ jintu a flimkien ma ’ erti prodotti ta ’ l- insulina li ja dmu fit- tul.
For incompatibilities see section 6.2. a
G al informazzjoni dwar l- inkompatibilitajiet ara sezzjoni 6. 2. tm
Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% ic
Do a Id- do a hu individwali u ji i stabbilit mit- tabib skond il - ti ijiet tal- pazjent. ot
as boluses divided between the three main meals. ed
Normalment, 40- 60% tad- do a totali ta ’ kuljum ting ata b ala rata ba ali kontinwa u l- bqija 40- 60% b ala boluses imqassmin fuq it- tlett ikliet prin ipali. od
In general, when patients are transferred from injection to infusion therapy, it may be advisable to M
eneralment, meta l- pazjenti jkunu ttrasferiti minn terapija bl- injezzjoni g al wa da bl- infuzjoni, Pr
reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals.
jista ’ jkun rakkomandat li tnaqqas id- do a billi l- pazjent tinbdielu l- kura b’ 90% tad- do a totali ta ’ qabel ta ’ kuljum, b’ 40% b ala r- rata ba ali u 50% b ala boluses imqassmin fuq it- tlett ikliet prin ipali.
Dosage is individual and determined in accordance with the needs of the patient.
Id- do a hu individwali u ji i stabbilit skond il - ti ijiet tal- pazjent.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Il - tie a individwali ta ’ l - insulina normalment hi ta ’ bejn 0. 3 u 1. 0 IU/ kg/ kuljum.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Il - tie a ta ’ l- insulina ta ’ kuljum tista ’ tkun og la f’ pazjenti b’ re istenza g all- insulina (e. waqt il- pubertà jew min abba l - xuna ejda), u aktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endo enika.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
2 F’ pazjenti bid- dijabete mellitus, l- a jar kontroll possibbli tal- gli emija jittardja l- bidu ta ’ kumplikazzjonijiet dijabeti i li jse u tard fil- marda.
2 An injection or infusion should be followed within 30 minutes by a meal or snack containing carbohydrates.
L- injezzjoni jew infu joni g andha tkun segwita minn ikla afifa li jkun fiha il- karboidrati, fi mien 30 minuta.
Renal or hepatic impairment may reduce insulin requirement.
t L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a ta ’ l- insulina.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
za L- a ustament fid- do a jista ’ jkun ne essarju wkoll jekk il- pazjenti jibdlu l- attività fi ika jew id -
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra
ed Administration
to (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
is For subcutaneous or intravenous use.
aw Kif Jing ata Jing ata ta t il - ilda jew ol- vini.
or Insulin infusion (CSII):
x Infu joni ta ’ l- insulina (CSII):
Velosulin should never be mixed with any other insulin products
du L- infu joni kontinwa ta ’ l- insulina ta t il - ilda (CSII) permezz ta ’ pompi esterni ta ’ l- infu joni, normalment ting ata fil- wi ta ’ l- addome.
au when used in a pump.
Velosulin m’ g andu qatt jit allat ma ’ kwalunkwe prodotti ħa o rajn ta ’ l- insulina meta jintu a f’ pompa. ’ g
Patients started on CSII must receive comprehensive instruction in the use of the pump, and the
Il- pazjenti li jinbdew fuq il- kura bis- CSII g andhom jing ataw struzzjonijiet komprensivi dwar l- u u tal- pompa, u dwar x’ g andhom jag mlu f’ ka ta ’ mard, ipogli emija, ipergli emija jew sara fil - m
er necessary actions in case of illness, hypoglycaemia, hyperglycaemia or pump failure.
Il- pazjent g andu jaqra u jsegwi l- istruzzjonijiet li ji u mal- pompa ta ’ l- infu joni u ju a t- tank u l - li