qanastek/EMEA-V3 huggingface dataset:
ris (blurred vision, difficulty in focusing, double vision),, flushes, transient loss of consciousness (fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ECG), hypotension (low blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test).
aw (ħass ħażin), arritmja, bradikardja, jew palpitazzjonijiet (tibdil fir- rata tal- qalb jew fl- ECG), pressjoni baxxa, eżinofilja (żieda ta ’ tip ta ’ ċerti ċelluli bojod fid- demm, tinduna biha permezz ta ’ test tad- demm).
tho Very rare side effects(less than 1 out of 10,000 patients) which may occur with Levviax are:
x Effetti sekondarji u rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent) li jistgħu jiġru b' Levviax huma:
Disturbance of smell, muscle cramps.
du Disturbi fix- xamm, bugħawwieġ.
au Additional side effects which may occur with Levviax are: abnormality of electrocardiogram (ECG) called prolongation of QT interval and inflamed pancreas (pancreatitis).
Effetti sekondarji oħra li jistgħu jiġru b’ Levviax huma: ħa Abnormalità fl- elettrokardjogramma (ECG) li tissejjaħ intervall tal- QT imtawwal u infjammazzjoni tal- frixa (pankreatite).
During post-marketing experience, liver failure has been reported (frequency unknown).
Mill- esperjenza meħuda wara li l- prodott tpoġġa fuq is- suq, l- indeboliment tal- fwied kien rapportat ’ g (frekwenza mhix magħrufa). im
r ge If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on, tell your doctor. lon If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk waħda minn dawn l- effetti mhux mixtieqa qiegħda tagħtik fastidju, hija severa, jew ma tmurx waħidha meta tkompli tieħu l- kura, għid lit- tabib tiegħek. li l
HOW TO STORE LEVVIAX no
KIF TAĦŻEN LEVVIAX iċi
Keep out of the reach and sight of children. t
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. ed
Medicines should not be disposed of via wastewater or household waste.
Tużax Levviax wara d- data ta ’ skadenza li tidher fuq il- kaxxa. tm
FURTHER INFORMATION lP
AKTAR TAGĦRIF
What Levviax contains
X’ fih Levviax ot
na
od
magnesium stearate in the tablet core as well as talc, macrogol 8000, hypromellose 6 cp, titanium dioxide E171, yellow iron oxide E172, red iron oxide E172 in the film-coating. i dic
Pr
What Levviax looks like and contents of the pack Me
Id- dehra tal Levviax u d- daqs tal- pakkett
Levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “ H3647” on one side and “ 400” on the other.
Il- pilloli ta ’ Levviax400 mg huma ta ’ kulur oranġjo ċar, oblongi, imbuzzati miż- żewġ naħat, miksija b’ rita, b ’ “ H3647 ” imnaqqax fuq naħa waħda u “ 400 ” fuq in- naħa l- oħra.
Levviax tablets are presented in blister packs.
26 Il- pilloli ta ’ Levviax jiġu ġo folji.
25 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
20 Avenue Raymond Aron F-92160 ANTONY
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ta ’ Levviax huwa:
ed France
t za Il- manifattur ta ’ Levviax huwa:
tho For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
to aw Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja ir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
au Belgique/ België/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
x sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
r ge България sanofi-aventis Bulgaria EOOD Тел: +359 (0)2 970 53 00
du Magyarország България sanofi- aventis Bulgaria EOOD Тел: +359 (0) 2 970 53 00 Česká republika sanofi- aventis, s. r. o.
lon
’ g
Magyarország sanofi-aventis zrt., Magyarország Tel: +36 1 505 0050
ħa sanofi- aventis zrt., Magyarország Tel: +36 1 505 0050 Malta sanofi- aventis Malta Ltd.
no
im
Danmark sanofi-aventis Denmark A/ S Tlf: +45 45 16 70 00
Nederland Danmark li l
Tel: +31 (0)182 557 755
sanofi- aventis Netherlands B. V. sanofi- aventis Denmark A/ S Tel: +31 (0) 182 557 755 Tlf: +45 45 16 70 00 na
Norge Aventis Pharma AS Tlf: +47 67 10 71 00
Norge Deutschland Aventis Pharma AS Sanofi- Aventis Deutschland GmbH Tlf: +47 67 10 71 00 Tel: +49 (0) 180 2 222010 iċi
Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88 lP
Österreich Eesti ed
sanofi-aventis GmbH Tel: +43 1 80 185 – 0
sanofi- aventis GmbH sanofi- aventis Estonia OÜ Tel: +43 1 80 185 – 0 Tel: +372 627 34 88 tm
Τηλ.: +30 210 900 16 00
Ελλάδα sanofi- aventis AEBE Τηλ.: +30 210 900 16 00 ot
España i
España od
sanofi-aventis, S. A. U. dic
sanofi- aventis, S. A. U.
Tel: +34 93 485 94 00
Tel: +34 93 485 94 00 Pr
Slovenija sanofi-aventis d. o. o.
27 Slovenija Ireland sanofi- aventis d. o. o. sanofi- aventis Ltd.
Italia sanofi-aventis S. p. A.
t za Italia sanofi- aventis S. p. A.
Κύπρος
riz Sverige Κύπρος
Τηλ.: +357 22 871600
to sanofi- aventis AB sanofi- aventis Cyprus Ltd.
sanofi-aventis AB Tel: +46 (0)8 634 50 00
Tel: +46 (0) 8 634 50 00 Τηλ.: +357 22 871600
tho Latvija sanofi-aventis Latvia SIA Tel.: +371 7 33 24 51
aw United Kingdom Latvija sanofi- aventis sanofi- aventis Latvia SIA Tel: +44 (0) 1483 505 515 Tel.: +371 7 33 24 51
United Kingdom sanofi-aventis Tel: +44 (0) 1483 505 515
x Lietuva
au Lietuva UAB sanofi-aventis Lietuva Tel: +370 5 2755224
du UAB sanofi- aventis Lietuva Tel: +370 5 2755224 Dan il- fuljett kien approvat l- aħħar f ’
d ic
’ g
i
ħa
na
im li l na iċi ed tm ot od Pr
What is Liprolog?
X’ inhu Liprolog?
Liprolog is a range of solutions and suspensions for injection.
Liprolog jiġi f’ varjetà ta ’ soluzzjonijiet u sospensjonijiet ta ’ l- insulina għall- injezzjoni.
Liprolog is supplied in vials, cartridges or in prefilled pens (Liprolog Pen and Liprolog KwikPen).
Liprolog jiġi fornut f’ kunjetti, stoċċijiet jew pinen mimlija diġa ’ (Liprolog Pen u Liprolog KwikPen).
Liprolog contains the active substance insulin lispro.
Liprolog fih is- sustanza attiva insulina lispro.
The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer- acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix): • Liprolog: insulin lispro solution; • Liprolog Basal: insulin lispro protamine suspension; • Liprolog Mix25:
Il- varjetà Liprolog fiha soluzzjonijiet ta ’ insulina li taġixxi fil- pront (Liprolog), sospensjonijiet ta ’ insulina li taġixxi aktar fit- tul (Liprolog Basal) u kumbinazzjonijiet tat - tnejn f’ porzjonijiet varji (Liprolog Mix): • Liprolog: soluzzjoni insulina lispro; • Liprolog Basal: sospensjoni insulina lispro protamina; • Liprolog Mix25:
25% insulin lispro solution and 75% insulin lispro protamine suspension; • Liprolog Mix50:
35% soluzzjoni insulina lispro u 75% sospensjoni insulina lispro protamina; • Liprolog Mix25:
50% insulin lispro solution and 50% insulin lispro protamine suspension.
50% soluzzjoni insulina lispro u 50% sospensjoni insulina lispro protamina.
What is Liprolog used for?
Għal x’ hiex jintuża Liprolog?
Liprolog is used to treat adults and children who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Liprolog huwa wżat għat- trattament ta ’ adulti u tfal li għandhom id- dijabete u jeħtieġu l- insulina sabiex il- livell tal- glukożju (zokkor) f’ demmhom jiġi kontrollat, inklużi pazjenti li d- dijabete tagħhom għadha kif ġiet dijanostikata.
The medicine is only available with a prescription.
Il- mediċina hija disponibbli biss b’ riċetta tat- tabib.
How is Liprolog used?
Kif jintuża Liprolog?
Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Liprolog, Liprolog Basal u Liprolog Mix jistgħu jingħataw b’ injezzjoni taħt il- ġilda tal- parti ta ’ fuq tad- driegħ, koxxa, warrani jew fil- parti addominali (iż- żaqq).
Liprolog may also be given by continuous infusion using an insulin pump or into a vein.
Liprolog jista ’ jingħata wkoll permezz ta ’ infużjoni kontinwa bl- użu ta ’ pompa ta ’ l- insulina jew fil- vina.
Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Liprolog u Liprolog Mix jingħataw normalment ftit qabel ikla, iżda jistgħu jiġu mogħtija eżatt wara l - ikel jekk meħtieġ.
Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of antidiabetic medicines that are taken by mouth).
Liprolog jista ’ jintuża flimkien ma ’ insulina li taġixxa aktar fit- tul jew flimkien ma sulfonilureji (sulphonylureas) (grupp ta ’ mediċini antidijabetiċi li jittieħdu oralment).
Liprolog Basal can be used alone or in combination with medicines taken by mouth.
Liprolog Basal jista ’ jintuża waħdu jew f’ kombinazzjoni ma ’ mediċini meħuda oralment.
If intensive insulin therapy is needed, Liprolog Basal can be given in the morning or evening, together with a fast- acting insulin at mealtimes.
Jekk tkun meħtieġa terapija intensiva bl- insulina, Liprolog Basal jista ’ jingħata filgħodu jew filgħaxija, flimkien ma ’ insulina li taġixxi fil- pront waqt ħin l- ikel.
How does Liprolog work?
Kif jaħdem Liprolog?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Id- dijabete hija marda li biha l- ġisem ma jipproduċix biżżejjed insulina biex jikkontrolla l- livell tal - glukożju fid- demm jew meta l- ġisem ma jkunx kapaċi juża l- insulina b' mod effikaċi.
Liprolog is a replacement insulin, which very similar to the insulin made by the pancreas.
Liprolog huwa insulina ta 'sostituzzjoni li hija simili ħafna għall- insulina magħmula mill- frixa (pankreas).
The active substance in Liprolog, insulin lispro, is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin lispro.
Is- sustanza attiva f’ Liprolog, insulina lispro tiġi prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: hija magħmula minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi li jipproduċi l- insulina lispro.
Insulin lispro is very slightly different from human insulin.
L- insulina lispro hija ftit biss differenti mill- insulina umana.
The change means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Il- bidla tfisser li l- insulina lispro hija assorbita aktar malajr mill- ġisem minn insulina regolari umana u tista ’ għalhekk taġixxi aktar malajr.
Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘ protamine suspension’ form, which is absorbed much more slowly so that it works for longer.
L- insulina lispro hija disponibbli bħala Liprolog f’ forma ta ’ solubbli, li taġixxi pjuttost immedjatament wara l- injezzjoni, u bħala Liprolog Basal f’ forma ta ’ ‘ sospensjoni protamina ’, li hija assorbita aktar bil- mod sabiex taħdem aktar fit- tul.
Liprolog Mix is a mixture of these two formulations.
Liprolog Mix hija taħlita ta ’ dawn iż- żewġ formulazzjonijiet.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ sostituzzjoni taġixxi bl- istess mod bħall- insulina prodotta naturalment u tgħin lill - glukożju jidħol fiċ- ċelloli mid- demm.
How has Liprolog been studied?
Kif ġie studjat Liprolog?
Liprolog was originally studied in eight clinical trials including 2,951 patients with type 1 or type 2 diabetes.
Liprolog kien oriġinarjament studjat f' tmien provi kliniċi li kienu jinkludu 2, 951 pazjent bit- dijabete tat- tip 1 jew 2.
The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when they were added to long-acting insulins given once or twice a day.
L- effikaċja ta ’ Liprolog tqabblet ma ’ dik ta ’ Humulin R (rikombinant tad- DNA solubbli ta ’ l- insulina umana), meta dawn ġew miżjuda ma ’ insulini li jaġixxu aktar fit- tul u mogħtija darba jew darbtejn kuljum.
The studies measured the level of a substance in the blood called ‘ glycosylated haemoglobin’ (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘ fasting’ blood glucose levels (measured at least eight hours after eating).
L- istudji kejlu l- livelli ta ’ sustanza fid- demm magħrufa bħala ‘ emoglobina glikosilata ’ (glycosylated haemoglobin) (HbA1c), li tagħti indikazzjoni ta ’ kemm il- glukożju fid - demm ikun ikkontrollat tajjeb (imkejjel mill- anqas tmien sigħat wara l- ikel).
Studies were also done looking at the use of Liprolog in 542 children and adolescents (aged between two and 19 years), and the use of Liprolog in combination with sulphonylureas (antidiabetic medicines taken by mouth).
Saru wkoll studji li raw l - użu ta ’ Liprolog f’ 542 tifel u adolexxenti (ta ’ etajiet bejn sentejn u 19 – il sena), u l- użu ta ’ Liprolog f’ kombinazzjoni ma ’ sulfonilureji ((mediċini antidijabetiċi meħuda oralment).
What benefit has Liprolog shown during the studies?
Liema benefiċċju wera Liprolog waqt l- istudji li ġew mwettqa?
Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Liprolog u Humulin R kellhom effett simili fuq il- kontroll tad- dijabete kif imkejla mill- HbA1c u l - livelli tal- glukożju.
What is the risk associated with Liprolog?
X’ inhu r- riskju assoċjat ma ’ Liprolog?
Liprolog may cause hypoglycaemia (low blood glucose).
Liprolog jista ’ jikkawwża ipogliċemija (glukożju baxx fid- demm).
For the full description of all side effects reported with Liprolog, see the Package Leaflet.
Għal deskrizzjoni sħiħa ta ’ l- effetti sekondarji rappurtati ma ’ Liprolog, ara l- Fuljett ta ’ Tagħrif.
Liprolog should not be used in people who may be hypersensitive (allergic) to insulin lispro or any of the other ingredients.
Liprolog m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal insulina lispro jew għal kwalunkwe wieħed mill- ingredjenti l- oħra.
Liprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Dożi ta 'Liprolog jistgħu wkoll jeħtieġu li jiġu aġġustati meta jingħataw ma' xi mediċini oħrajn li jista 'jkollhom effett fuq il- livelli ta' glukożju fid- demm.
Liprolog Mix and Liprolog Basal should never be given into a vein.
Liprolog Mix u Liprolog Basal ma għandhom qatt jingħataw fil- vina.
Why has Liprolog been approved?
Għaliex ġie approvat Liprolog?
The Committee for Medicinal Products for Human Use (CHMP) decided that Liprolog’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Liprolog għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete mellitu.
The Committee recommended that Liprolog be given marketing authorisation.
Il- Kumitat irrakkomanda li Liprolog jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Liprolog:
Tagħrif ieħor dwar Liprolog:
The European Commission granted marketing authorisations valid throughout the European Union for Liprolog to Eli Lilly Nederland B V. on 1 August 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Liprolog lil Eli Lilly Nederland B. V. fl- 1 ta 'Awwissu 2001.
The marketing authorisation was renewed on 1 August 2006.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 1 ta 'Awwissu 2006.
The full EPAR for Liprolog is available here.
L- EPAR sħiħ għal Liprolog jista ’ jiġi kkonsultat hawn.
EU Number EU/ 1/ 01/ 195/ 001
Numru ta ’ l- EU EU/ 1/ 01/ 195/ 001
Invented name Liprolog
Isem inventat Liprolog
Strength 100 U/ ml
Qawwa 100 U/ ml
Pharmaceutical Form Solution for injection
Għamla farmaċewtika Soluzzjoni għall- injezzjoni
Route of Administration Subcutaneous or intravenous use
Mnejn jingħata Użu għal taħt il- ġilda jew għal ġol- vini
Packaging vial (glass)
Il- pakkett kunjett (ħġieġ)
Content 10 ml (3.5 mg/ ml)
Kontenut 10 ml (3. 5 mg/ ml)
Package size 1 vial
Daqs tal- pakkett kunjett
Subcutaneous or intravenous use
Użu għal taħt il- ġilda jew għal ġol- vini
3 ml (3.5 mg/ ml)
3 ml (3. 5 mg/ ml) 5 skrataċ
Liprolog Pen
Liprolog Pinna
3 ml (3.5 mg/ ml)
3 ml (3. 5 mg/ ml) 5 pinen mimlijin għal - lest
Liprolog Mix25 Pen
Liprolog Mix25 Pinna
Liprolog Mix50 Pen
Liprolog Mix50 Pinna
10 ml (3.5 mg/ ml)
10 ml (3. 5 mg/ ml) 2 kunjetti
10 ml (3.5 mg/ ml)
10 ml (3. 5 mg/ ml) 5 x (1 x 10 ml) kunjetti
2 x (5 x 3 ml) cartridges
3 ml (3. 5 mg/ ml) 2 x (5 x 3 ml) skrataċ
2 x (5 x 3 ml) pre-filled pens
3 ml (3. 5 mg/ ml) 2 x (5 x 3 ml) pinen mimlijin għal- lest
EU/ 1/ 01/ 195/ 019
1/ 2 EU/ 1/ 01/ 195/ 019
2 x (5 x 3 ml) pre-filled pens
2 x (5 x 3 ml) pinen mimlijin għal- lest
5 pre-filled pens
5 pinen mimlijin għal - lest
5 x cartridges
5 x skrataċ
2 x (5 x 3 ml) cartridges
2 x (5 x 3 ml) skrataċ
Liprolog Basal Pen
Liprolog Basal Pinna
Liprolog 100 U/ ml, solution for injection in vial
Liprolog 100 U/ ml, soluzzjoni għall- injezzjoni f’ kunjett
Liprolog is a sterile, clear, colourless, aqueous solution.
Liprolog huwa soluzzjoni akweja sterili, ċara u bla kulur.
Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
Liprolog huwa ukoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
Liprolog may be given shortly before meals.
Liprolog jista 'jingħata ftit qabel l- ikliet.
When necessary Liprolog can be given soon after meals.
Meta neċessarju Liprolog jista 'jingħata eżatt wara l- ikliet.
Liprolog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Il - preparazzjonijiet ta 'Liprolog għandhom jingħataw b' injezzjoni taħt il- ġilda jew b' pompa ta' l- infużjoni kontinwa taħt il- ġilda (ara sezzjoni 4. 2) u jista ', għalkemm mhux rakkomandat, jingħata ukoll b' injezzjoni ġol- muskoli.
If necessary, Liprolog may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Jekk hemm bżonn, Liprolog jista 'ukoll jingħata ġol- vina, per eżempju; għall - kontroll tal- livelli tal- glukożju fid- demm waqt ketoaċidożi, mard akut jew waqt perijodi ta' waqt operazzjoni jew wara.
When administered subcutaneously care should be taken when injecting Liprolog to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
Liprolog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Liprolog jaġixxi malajr u għandu żmien t' attività aktar qasira (2 sa 5 sigħat) meta jingħata taħt il- ġilda meta mqabbel ma 'insulina regolari.
This rapid onset of activity allows a Liprolog injection (or, in the case of administration by continuous subcutaneous infusion, a Liprolog bolus) to be given very close to mealtime.
Il- bidu mgħagġel ta ’ l- attività tħalli l- injezzjoni ta 'Liprolog (jew, fil- każ t' għoti b' infużjoni taħt il- ġilda kontinwa, bolus ta' Liprolog) biex tingħata viċin ħafna tal- ħin ta 'l- ikel.
As with all insulin preparations, the duration of action of Liprolog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħal b' kull preparazzjonijiet ta 'l - insulina, iż- żmien ta' kemm iddum l- azzjoni ta 'Liprolog jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
2 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
2 Liprolog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
Use of Liprolog in an insulin infusion pump:
Użu ta 'Liprolog ġo pompa ta' l- infużjoni ta 'l- insulina
When used with an insulin infusion pump, Liprolog should not be mixed with any other insulin.
Meta użat b' pompa ta ’ l- infużjoni ta 'l- insulina, Liprolog m' għandux jitħallat ma' xi insulina oħra.
The shorter-acting Liprolog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin.
Liprolog li jdum jaħdem għal ħin iqsar għandu jinġibed l- ewwel fis- siringa, biex tevita kontaminazzjoni tal- kunjett mill- insulina li ddum taħdem għal ħin itwal.
3 Insulin requirements may be reduced in the presence of renal impairment.
Il- ħtiġijiet ta 'l- insulina jistgħu jonqsu meta jkun hemm indeboliment tal- kliewi.
Liprolog should only be used in children in preference to soluble insulin when a fast action of insulin might be beneficial.
Liprolog għandu jintuża fit- tfal biss f' preferenza għall- insulina li tinħall meta l- azzjoni mgħaġġla t' insulina tista 'tkun benefiċċjali.
The physician should be consulted when using other medications in addition to Liprolog.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
4 Il- ħila tal- pazjent biex jikkonċentra u jirreaġixxi tista 'tkun affettwata bħala riżultat taz- zokkor baxx fid- demm.
Pharmacotherapeutic group:
5 Grupp farmakoterapewtiku:
5 Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
L- insulina lispro għandha l- bidu ta ’ l- azzjoni mgħaġġla (bejn wieħed u ieħor 15- il- minuta), għalhekk tista 'tingħata aktar viċin t' ikla (bejn żero sa 15- il minuta mill- ikla) meta mqabbla ma' insulina regolari (30 sa 45 minuta qabel).
Humulin R Hypoglycaemic Activity
Humulin R Hypoglycaemic Attività ta ’ Activity baxx fid - zokkor demm
5
Time (Hours) Ħin (sigħat)
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone.
6 F' pazjenti bid- dijabete tat- tip 2 fuq dożaġġ massimu tas- sustanzi sulphonyl urea, studji urew li ż- żieda ta 'l- insulina lispro sinifikament naqqset HbA1c imqabbel mas- sulphonyl urea waħida.
6 Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
L- insulina lispro uriet li hija ekwipotenti għal insulina umana fuq bażi molari imma l- effett tagħha huwa aktar rapidu u iqsar.
Liprolog preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
7 Il- preparazzjonijiet ta 'Liprolog m' għandhomx jitħalltu m' insulini magħmula minn manifatturi oħra jew ma 'preparazzjonijiet t' insulina ta' l- annimali.
7 The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals.
Is- soluzzjoni tiġi fi fjali tal- ħġieġ taż- żnied tat- tip I, siġillati b' tappijiet ta ’ butyl jew halobutyl u miżmuma f' posthom permezz ta 'siġill ta' l- aluminju.
1 x 10 ml Liprolog vial.
1 x 10 ml kunjett ta ’ Liprolog.
2 x 10 ml Liprolog vials.
2 x 10 ml kunjetti ta ’ Liprolog.
5 x (1 x 10 ml) Liprolog vials.
5 x (1 x 10 ml) kunjetti ta ’ Liprolog.
Inspect the Liprolog solution.
Eżamina s- soluzzjoni ta 'Liprolog.
Do not use Liprolog if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Tużax Liprolog jekk jidher imċajpar, magħqud, jew ftit ikkulurit jew jekk jidhru partiċelli solidi.
If the therapeutic regimen requires the injection of basal insulin and Liprolog at the same time, the two can be mixed in the syringe.
Jekk l- iskeda ta ’ dożaġġ teħtieġ l- injezzjoni ta 'insulina bażilari u Liprolog fl- istess ħin, it- tnejn jistgħu jitħalltu fis- siringa.
Draw air into the syringe equal to the prescribed Liprolog dose.
Iġbed l- istess ammont ta ’ arja ġos- siringa daqs id- doża ta ’ Liprolog li ordnalek it- tabib.
Put the needle through the rubber top of the Liprolog vial and inject the air into the vial.
Daħħal il- labra fil- gomma tat- tapp tal - kunjett ta 'Liprolog u injetta l- arja ġol- kunjett.
Making sure the tip of the needle is in the Liprolog, withdraw the correct dose into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Liprolog, iġbed id- doża l- korretta ġos- siringa.
Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it.
Qabel ma tneħħi l- labra mill- kunjett, eżamina s- siringa għal xi bżieżaq ta 'l- arja li jnaqqsu l - ammont ta' Liprolog fiha.
ii) Mixing Liprolog with longer-acting Human Insulins (see section 6.2)
ii) Taħlit ta ’ Liprolog ma 'Insulina Umana li ddum taħdem għal ħin itwal (ara sezzjoni 6. 2)
Liprolog should be mixed with longer-acting human insulins only on the advice of a doctor.
Liprolog għandu jitħallat ma 'insulini li jdumu jaħdmu għal ħin itwal fuq il- parir tat- tabib biss.
Now inject air into the Liprolog vial in the same manner, but do not withdraw the needle.
Issa injetta l- arja fil- kunjett ta 'Liprolog bl- istess mod, imma tneħħix il- labra.
Making sure the tip of the needle is in the Liprolog, withdraw the correct dose of Liprolog into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Liprolog, iġbed id- doża korretta ta 'Liprolog ġos- siringa.
Remove the needle from the vial of Liprolog and insert it into the vial of the longer-acting insulin.
Neħħi l- labra mill- kunjett ta 'Liprolog u daħħalha fil- kunjett ta' l- insulina li ddum taħdem għal ħin itwal.
c) Mixing insulins
9 c) Taħlit ta 'insulini
Do not mix insulin in vials with insulin in cartridges.
Tħallatx l- insulina fil- kunjetti ma 'l- insulina fl- istoċċijiet.
1 x 10 ml Liprolog vial 2 x 10 ml Liprolog vials 5 x (1 x 10 ml) Liprolog vials
1 x 10 ml Liprolog kunjetti 2 x 10 ml Liprolog kunjetti 5 x (1 x 10 ml) Liprolog kunjetti
1st August 2001 Date of last renewal:
1 ta ’ Awwissu 2001 Data ta ’ l- aħħar tiġdid:
1st August 2006
1 ta ’ Awwissu 2006
Liprolog 100 U/ ml, solution for injection in cartridge
Liprolog 100 U/ ml, soluzzjoni għall- injezzjoni fi stoċċ
The faster onset of action compared to soluble human insulin is maintained regardless of injection site As with all insulin preparations, the duration of action of Liprolog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħal b' kull preparazzjonijiet ta 'l -
11 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
11 insulina, iż- żmien ta 'kemm iddum l- azzjoni ta' Liprolog jiddependi fuq id- doża, is- sit ta 'l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
When used with an insulin infusion pump, Liprolog should not be mixed with any other insulin.
Meta użat b' pompa tal- infużjoni ta 'l- insulina, Liprolog m' għandux jitħallat ma' xi insulina oħra.
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
12 Ftit pazjenti li kellhom reazzjonijiet ta ’ zokkor baxx fid- demm wara t- trasferiment minn insulina li tiġi mill- annimali għal insulina umana rrappurtaw li s- sintomi ta 'twissija tal- bidu taz- zokkor baxx fid - demm kienu jidhru anqas jew kienu differenti minn dawk esperjenzati bl- insulina li kienu jużaw qabel.
12 Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Il- ħtiġijiet ta 'l - insulina jistgħu jitnaqqsu f' pazjenti b’ indeboliment tal- fwied minħabba l- kapaċità mnaqqsa għal glukoneoġeneżi u metaboliżmu mnaqqas ta' l- insulina; madankollu, f' pazjenti b’ indeboliment kroniku tal- fwied, żjieda fir- reżistenza għall- insulina tista 'twassal għall- ħtiġijiet miżjuda ta' l- insulina.
13 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
5.1 Pharmacodynamic properties
14 5. 1 Tagħrif farmakodinamiku
14 Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
L- insulina lispro għandha l- bidu ta ’ l- azzjoni mgħaġġla (bejn wieħed u ieħor 15- il- minuta), għalhekk tista 'tingħata aktar viċin t' ikla (bejn żero sa 15- il minuta mill- ikla) meta mqabbla ma' insulina regolari (30 sa 45 minuta qabel).
Humulin R Hypoglycaemic Activity
Humulin R Hypoglycaemic Attività ta ’ Activity zokkor baxx fid - demm
Time (Hours)
Time (Hours) Ħin (sigħat)
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower glycosylated haemoglobin levels compared to soluble insulin.
15 Meta użat bil- pompi ta 'l- infużjoni taħt il- ġilda, il- kura bl- insulina lispro wriet li tirriżulta f' livell ta' l - emoglobina glycosylated inqas imqabbel ma 'l- insulina li tinħall.
15 The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Ir- rispons glukodinamiku għall- insulina lispro m' huwiex affettwat b’ indeboliment fil- funzjoni tal - kliewi jew tal- fwied.
Liprolog preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
Il- preparazzjonijiet ta 'Liprolog m' għandhomx jitħalltu m' insulini magħmula minn manifatturi oħra jew ma 'preparazzjonijiet t' insulina ta' l- annimali.
16 Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C – 8°C).
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals.
Is- soluzzjoni tiġi fi stoċċijiet tal- ħġieġ taż- żnied tat- tip I, siġillati b' tappijiet ta ’ butyl jew halobutyl u miżmuma f' posthom permezz ta 'siġill ta' l- aluminju.
Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/ or the glass cartridges.
Tista ’ tintuża emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati it- tappijiet ta’ l- istoċċijiet.
5 x 3 ml Liprolog cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog cartridges for a 3 ml pen
2 x (5 x 3 ml) stoċċijiet ta ’ Liprolog għal pinna ta ’ 3 ml.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar
Instructions for use and handling Liprolog cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Istruzzjonijiet għall- użu u mmaniġġar L- istoċċijiet ta ’ Liprolog għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
The manufacturer’ s instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
Għandek timxi skond l- istruzzjonijiet tal- manifattur ma ’ kull pinna biex timla l- istoċċ, twaħħal il- labra u tagħti l- injezzjoni ta ’ l- insulina.
5 x 3 ml Liprolog cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog cartridges for a 3 ml pen
2 x (5 x 3ml) stoċċijiet ta ’ Liprolog għal pinna ta ’ 3 ml.
1st August 2001 Date of last renewal:
1 ta’ Awwissu 2001 Data ta ’ l- aħħar tiġdid:
1st August 2006
1 ta ’ Awwissu 2206
Liprolog Mix25 100 U/ ml suspension for injection in cartridge
Liprolog Mix25 100 U/ ml, suspensjoni għall- injezzjoni fi stoċċ
Liprolog Mix 25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Liprolog Mix25 tikkonsisti fi 25% insulina lispro u 75% suspensjoni ta ’ insulina lispro protamine.
Liprolog Mix25 is a white, sterile suspension.
Liprolog Mix25 huwa suspensjoni bajda u sterili.
Liprolog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Liprolog Mix25 huwa indikat għall- kura ta 'pazjenti li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall- manteniment omeostatiku ta' livelli normali ta ’ glucose.
Liprolog Mix25 may be given shortly before meals.
Liprolog Mix25 jista 'jingħata ftit qabel l- ikliet.
When necessary, Liprolog Mix25 can be given soon after meals.
Meta neċessarju Liprolog Mix25 jista 'jingħata eżatt wara l- ikliet.
Liprolog Mix25 should only be given by subcutaneous injection.
Liprolog Mix25 għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstances should Liprolog Mix25 be given intravenously.
Liprolog Mix25 m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
When administered subcutaneously care should be taken when injecting Liprolog Mix25 to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
The rapid onset and early peak of activity of Liprolog itself is observed following the subcutaneous administration of Liprolog Mix25.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ Liprolog huwa osservat wara l- għoti taħt il- ġilda ta ’ Liprolog Mix25.
This allows Liprolog Mix25 to be given very close to mealtime.
Dan jippermetti li Liprolog Mix25 jingħata viċin ħafna tal- ħin ta 'l- ikel.
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix25 is similar to that of a basal insulin NPH.
Iż- żmien kemm idum jaħdem il- komponent protamine tas- suspensjoni ta ’ insulina lispro (Basal) ta ’ Liprolog Mix25 huwa simili għall- insulina bażi (NPH).
As with all insulin preparations, the duration of action of Liprolog Mix25 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall - preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Liprolog Mix25 jiddependi fuq id- doża, is - sit ta 'l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
19 Hypersensitivity to insulin lispro or to any of the excipients.
19 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
Administration of insulin lispro to children below 12 years of age should be considered only in case of an expected benefit when compared to regular insulin.
Liprolog għandu jintuża fit- tfal biss f' preferenza għall- insulina li tinħall meta l- azzjoni mgħaġġla t' insulina tista 'tkun benefiċċjali.
The physician should be consulted when using other medications in addition to Liprolog Mix25.
20 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog.
20 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Data fuq numru kbir ta 'każijiet tat- tqala esposti ma tindikax xi effetti avversi ta' l- insulina lispro fuq it- tqala jew fuq is- saħħa tal- fetu/ it- tarbija tat- twelid.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
21 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
21 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Jekk il- pazjent huwa f' koma, il- glucagon għandu jkun mogħti fil- muskolu jew taħt il- ġilda.
Liprolog Mix25 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Liprolog Mix25 huwa suspensjoni mħallta lesta li tikkonsisti f’ insulina lispro (analogu ta ’ l- insulina umana li jaġixxi malajr) u suspenzjoni ta ’ insulina lispro protamine (analogu ta ’ insulina umana li jdum jaħdem għal ħin intermedju)
The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Liprolog Mix25.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ l- insulina lispro huwa osservat wara l- għoti taħt il- ġilda ta ’ Liprolog Mix25.
Liprolog Basal has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Liprolog Basal għandu profil ta ’ l- attività simili ħafna għal dak ta ’ insulina bażi (NPH) fuq perjodu ta ’ bejn wieħed u ieħor 15- il siegħa.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with Liprolog Mix25 compared to human insulin mixture 30/ 70.
Provi kliniċi f' pazjenti bid- dijabete tat- tip 1 u tat- tip 2 urew tnaqqis fiz- zokkor baxx fid- demm ta 'wara l- ikel b’ Liprolog Mix50 mqabbla ma' taħlita 30/ 70 ta ’ insulina umana.
In the figure below the pharmacodynamics of Liprolog Mix25 and Liprolog Basal are illustrated.
Fid- dijagramma ta ’ hawn taħt hemm murija l- farmakodinamiċi ta ’ Liprolog Mix25 u Liprolog Basal.
Hypoglycaemic activity Liprolog Mix25 Liprolog Basal
22 Liprolog Mix25 Liprolog Basall
4
Attività Ipogliċemika
22 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv tal- glukożju maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha tal- glukożju fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu tal- glukożju maż- żmien.
In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Liprolog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.
F’ żewġ studji crossover tat- tip open label li damu 8 xhur, pazjenti bid- dijabete tat- tip 2 li jew kienu qegħdin jużaw l- insulina għall- ewwel darba jew kienu diġà jużaw waħda jew żewġ injezzjonijiet ta ’ insulina, ingħataw 4 xhur kura b’ Liprolog Mix25 (użat darbtejn kuljum ma ’ metformin) u insulin glargine (użat darba kuljum ma ’ metformin) f’ sekwenza b’ mod arbitrarju.
0.63 U/ kg
0. 63 IU/ kg
0.42 U/ kg
0. 42 IU/ kg
Incidence of hypoglycaemia at endpoint Bodyweight gain2 1 from baseline to end of Liprolog Mix25 treatment 2
Inċidenza ta ’ ipogliċemija fl- aħħar stadju tal- proċess
in patients randomised to Liprolog Mix25 during
Żieda fil- piż tal- ġisem2 1 mil- linja bażi sa tmiem il- kura b’ Liprolog Mix25 2
the first crossover period
f’ pazjenti li nqalbu b’ mod arbitrarju fuq Liprolog Mix25 fl- ewwel perijodu ta ’ crossover
Mixing Liprolog Mix25 with other insulins has not been studied.
It- taħlit ta ’ Liprolog Mix25 ma ’ insulini oħra għadu ma ġiex studjat.
After insertion of the cartridge in a pen, the suspension should be used in 28 days when stored below 30°C.
Wara li ddaħħal l- istoċċ fil- pinna, is- suspensjoni għandha tintuża fi żmien 28 ġurnata meta tinħażen f' temperatura taħt 30°C.
The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals.
Is- suspensjoni tiġi fi stoċċijiet tal- ħġieġ taż- żnied tat- tip I, siġillati b' diski tas- siġill u rjus tal- planġer ta ’ butyl jew halobutyl u miżmuma f' posthom permezz ta 'siġill ta' l- aluminju.
Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/ or the glass cartridge.
Setgħu ntużaw emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati l- planġer ta ’ l- istoċċ, u/ jew l- istoċċ tal- ħġieġ.
5 x 3 ml Liprolog Mix25 cartridges for a 3 ml pen.
5 x 3 ml stoċċijiet ta ’ Liprolog Mix25 għal pinna ta ’ 3 ml.
2 x (5 x 3 ml) Liprolog Mix25 cartridges for a 3 ml pen.
2 x( 5 x 3 ml) stoċċijiet ta ’ Liprolog Mix25 għal pinna ta ’ 3 ml.
Instructions for use and handling Liprolog Mix25 cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Istruzzjonijiet għall- użu u mmaniġġar L- istoċċijiet ta ’ Liprolog Mix25 għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
Cartridges containing Liprolog Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
Stoċċijiet li fihom Liprolog Mix25 għandhom ikunu mdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet immedjatamnet qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
Cartridges contain a
Jekk le, irrepeti din il- proċedura sakemm il - kontenut jitħallat.
24 small glass bead to assist mixing.
L- istoċċijiet fihom żibġa żgħira tal- ħġieġ biex tassisti fit- taħlit.
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Tħawwadiex bis - saħħa għax hekk tista 'toħloq ragħwa li tista tfixkel il- miżura eżatta tad- doża.
The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.
L- istoċċijiet għandhom ikunu eżaminati ta 'spiss u m' għandhomx jintużaw jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew il- ġenb tal- kunjett, u jidher qiesu ġelu.
Liprolog Mix25 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- istoċċijiet ta ’ Liprolog Mix25 mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- istoċċ.
Cartridges are not designed to be refilled.
L - istoċċijiet mhumiex iddisinjati biex jerġgħu jintmlew.
The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
Għandek timxi skond l- istruzzjonijiet tal- manifattur ma ’ kull pinna biex timla l- istoċċ, twaħħal il- labra u tagħti l- injezzjoni ta ’ l- insulina.
5 x 3 ml Liprolog Mix25 cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog Mix25 cartridges for a 3 ml pen
2 x (5 x 3ml) stoċċijiet ta ’ Liprolog Mix25 għal pinna ta ’ 3 ml.
1st August 2001 Date of last renewal:
1 ta ’ Awwissu 2001 Date ta ’ l- aħħar tiġdid:
1st August 2006
1 ta’ Awwissu 2006
Liprolog Mix50 100 U/ ml suspension for injection in cartridge
Liprolog Mix50 100 U/ ml, suspensjoni għall- injezzjoni fi stoċċ
Liprolog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension.
Liprolog Mix50 tikkonsisti fi 50% insulina lispro u 50% suspensjoni ta ’ insulina lispro protamine.
Liprolog Mix50 is a white, sterile suspension.
Liprolog Mix50 huwa suspensjoni bajda u sterili.
Liprolog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Liprolog Mix50 huwa indikat għall- kura ta 'pazjenti li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall- manteniment omeostatiku ta' livelli normali ta ’ glucose.
Liprolog Mix50 may be given shortly before meals.
Liprolog Mix50 jista 'jingħata ftit qabel l- ikliet.
When necessary, Liprolog Mix50 can be given soon after meals.
Meta neċessarju Liprolog Mix50 jista 'jingħata eżatt wara l- ikliet.
Liprolog Mix50 should only be given by subcutaneous injection.
Liprolog Mix50 għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstances should Liprolog Mix50 be given intravenously.
Liprolog Mix50 m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
When administered subcutaneously care should be taken when injecting Liprolog Mix50 to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Liprolog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
The rapid onset and early peak of activity of Liprolog itself is observed following the subcutaneous administration of Liprolog Mix50.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ Liprolog huwa osservat wara l- għoti taħt il- ġilda ta ’ Liprolog Mix50.
This allows Liprolog Mix50 to be given very close to mealtime.
Dan jippermetti li Liprolog Mix50 jingħata viċin ħafna tal- ħin ta 'l- ikel.
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix50 is similar to that of a basal insulin (NPH).
Iż- żmien kemm idum jaħdem il- komponent protamine tas- suspensjoni ta ’ insulina lispro (Basal) ta ’ Liprolog Mix50 huwa simili għall- insulina bażi (NPH).
As with all insulin preparations, the duration of action of Liprolog Mix50 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall - preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Liprolog Mix50 jiddependi fuq id- doża, is - sit ta 'l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Hypersensitivity to insulin lispro or to any of the excipients.
27 Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
26 Hypoglycaemia.
Ipoglicemija
Mixing Liprolog Mix50 with other insulins has not been studied.
It- taħlit ta ’ Liprolog Mix50 ma ’ insulini oħra għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Liprolog Mix50.
28 Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Liprolog Mix50.
27 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Data fuq numru kbir ta 'każijiet tat- tqala esposti ma tindikax xi effetti avversi ta' l- insulina lispro fuq it- tqala jew fuq is- saħħa tal- fetu/ it- tarbija tat- twelid.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
29 Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
28 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Jekk il- pazjent huwa f' koma, il- glucagon għandu jkun mogħti fil- muskolu jew taħt il- ġilda.
The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Liprolog Mix50.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ l- insulina lispro huwa osservat wara l- għoti taħt il- ġilda ta ’ Liprolog Mix50.
In the figure below the pharmacodynamics of Liprolog Mix50 and Liprolog Basal are illustrated.
Fid- dijagramma ta ’ hawn taħt hemm murija l- farmakodinamiċi ta ’ Liprolog Mix50 u Liprolog Basal.
Liprolog Liprolog Basall
30 Liprolog Mix50 Liprolog Basall
Hypoglycaemic activity
Attività Ipogliċemika
29 The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Ir- rispons glukodinamiku għall- insulina lispro m' huwiex affettwat b’ indeboliment fil- funzjoni tal - kliewi jew tal- fwied.
The pharmacokinetics of Liprolog Mix50 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Liprolog Mix25 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.
31 lispro mar- riċetturi ta 'l- insulina, hija ekwivalenti ma' l- insulina umana.
30 After insertion of the cartridge in a pen, the suspension should be used in 28 days when stored below 30°C.
Wara li ddaħħal l- istoċċ fil- pinna, is- suspensjoni għandha tintuża fi żmien 28 ġurnata meta tinħażen f' temperatura taħt 30°C.
5 x 3 ml Liprolog Mix50 cartridges for a 3 ml pen.
5 x 3 ml stoċċijiet ta ’ Liprolog Mix50 għal pinna ta ’ 3 ml.
2 x (5 x 3 ml) Liprolog Mix50 cartridges for a 3 ml pen.
2 x (5 x 3 ml) stoċċijiet ta ’ Liprolog Mix50 għal pinna ta ’ 3 ml.