qanastek/EMEA-V3 huggingface dataset:
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin.
Provi kliniċi f' pazjenti bid- dijabete tat- tip 1 u tat- tip 2 urew tnaqqis fiz- zokkor baxx fid- demm ta 'wara l- ikel bl- insulina lispro mqabbla ma' insulina umana li tinħall.
13 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Bħal bil- preparazzjonijiet kollha ta 'l- insulina, il- ħin ta' l- azzjoni ta 'l- insulina lispro jista' jvarja f' individwi differenti jew f' ħinijiet differenti fl- istess individwu u jiddependi fuq id- doża, is- sit ta 'l - injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
The typical activity profile following subcutaneous injection is illustrated below.
Il- profil tipiku ta 'l- attività wara injezzjoni taħt il- ġilda huwa muri hawn taħt.
Time (Hours)
Ħin (sigħat) Time (Hours)
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.
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower glycosylated haemoglobin levels compared to soluble insulin.
Fi studju double- blind u crossover,
In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
15 it- tnaqqis fil- livelli tal- emoglobina glycosylated wara 12- il ġimgħa, id- dożaġġ kien 0. 37 punti fil- mija bl- insulina lispro, imqabbel ma '0. 03 punti fil- mija għall- insulina li tinħall (p=0. 004).
14 The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.
Il- farmakokinetiċi ta 'l- insulina lispro jirriflettu sustanza li hija assorbita rapidament, u jikseb l- ogħla livelli fid- demm minn 30 sa 70 minuta wara l- injezzjoni taħt il- ġilda.
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Meta tiġi kkunsidrata r- relevanza klinika ta 'dawn il- kinetiċi, huwa aktar xieraq li jiġu eżaminati l- kurvi dwar l- użu tal- glukożju (kif diskuss f' 5. 1).
6.2 Incompatibilities
16 6. 2 Inkompatibilitajiet
After insertion of the cartridge in a pen, the solution should be used in 28 days when stored below 30°C.
Wara l- ewwel użu tal- kunjett, is- soluzzjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt +30°C.
Do not freeze.
Tagħmlux fil- friża..
Do not expose to excessive heat or direct sunlight.
Tesponix għall- sħana eċċessiva jew f' dawl dirett tax - xemx.
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 skrataċ 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- iskrataċ.
15 5 x 3 ml Humalog cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog cartridges for a 3 ml pen
2 x (5 x 3 ml) skrataċ ta ’ Humalog għal pinna ta ’ 3 ml.
Instructions for use and handling Humalog 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- iskrataċ ta ’ Humalog għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
The following is a general description.
Din li ġejja hija deskrizzjoni ġenerali.
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- iskartoċċ, twaħħal il- labra u tagħti l- injezzjoni ta ’ l- insulina.
Clean the skin as instructed.
Naddaf il- ġilda kif indikat.
Remove outer needle cap.
Neħħi l- għatu ta ’ barra tal- labra.
Stabilise the skin by spreading it or pinching up a large area.
Stabbilizza l- ġilda billi tifrixa jew billi toqros parti kbira 'l fuq.
Insert the needle as instructed.
Daħħal il- labra u njetta kif indikat.
Press the knob.
Agħfas il- buttuna.
Do not rub the area.
Torokx is- sit.
Using the outer needle cap, unscrew the needle and dispose of it safely.
Ħoll il- labra bill tagħmel użu ta ’ l- għatu ta ’ barra tal- labra u armiha bil- galbu.
Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Is- siti ta 'l- injezzjoni għandhom jinbidlu sabiex l- istess sit ma jintużax aktar minn bejn wieħed u ieħor darba fix- xahar.
Eli Lilly Nederland B V., Grootslag 1-5, 3991 RA Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA Houten, L- Olanda.
EU/ 1/ 96/ 007/ 004 EU/ 1/ 96/ 007/ 023
EU/ 1/ 96/ 007/ 004 5 x 3 ml skrataċ ta ’ Humalog għal pinna ta ’ 3 ml.
5 x 3 ml Humalog cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog cartridges for a 3 ml pen
EU/ 1/ 96/ 007/ 023 2 x (5 x 3ml) skrataċ ta ’ Humalog għal pinna ta ’ 3 ml.
Humalog Mix25 100 U/ ml suspension for injection in vial
Humalog Mix25 100 U/ ml, soluzzjoni għall- injezzjoni f’ kunjett
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Humalog Mix25 tikkonsisti fi 25% soluzzjoni ta ’ insulina lispro u 75% suspensjoni ta ’ insulina lispro protamine.
Suspension for injection.
Soluzzjoni għall- injezzjoni.
Humalog Mix25 is a white, sterile suspension.
Humalog Mix25 huwa suspensjoni bajda u sterili.
Humalog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Humalog Mix25 huwa indikat għall- kura ta 'pazjenti li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall- manteniment omeostatiku ta' livelli normali tal- glukożju.
Humalog Mix25 may be given shortly before meals.
Humalog Mix25 jista 'jingħata ftit qabel l- ikliet.
When necessary, Humalog Mix25 can be given soon after meals.
Meta neċessarju Humalog Mix25 jista 'jingħata eżatt wara l- ikliet.
Humalog Mix25 should only be given by subcutaneous injection.
Humalog Mix25 għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstances should Humalog Mix25 be given intravenously.
Humalog Mix25 m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
When administered subcutaneously care should be taken when injecting Humalog Mix25 to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Humalog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix25.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ Humalog huwa osservat wara l- għoti taħt il- ġilda ta ’ Humalog Mix25.
This allows Humalog Mix25 to be given very close to mealtime.
Dan jippermetti li Humalog Mix25 jingħata viċin ħafna tal- ħin ta 'l- ikel.
The duration of action of the insulin lispro protamine suspension (BASAL) component of Humalog 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 ’ Humalog Mix25 huwa simili għall- insulina bażi (NPH).
The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual.
Iż- żmien ta 'kemm iddum l- azzjoni ta' kwalunkwe insulina tista ’ tvarja f’ individwi differenti jew f’ ħinijiet differenti fl- istess individwu.
As with all insulin preparations, the duration of action of Humalog Mix25 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall- preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Humalog Mix25 jiddependi fuq id - doża, is- sit ta 'l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
4.3 Contraindications
19 4. 3 Kontra- indikazzjonijiet
18 Hypoglycaemia.
Ipogliċemija
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Reazzjonijiet mhux ikkoreġġuti ta 'ipoglikimja jew ta' zokkor baxx jew għoli fid- demm jistgħu jikkawżaw telf mis- sensi, koma, jew mewt.
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.
Humalog għandu jintuża fit- tfal biss f' preferenza għall- insulina li tinħall meta l- azzjoni mgħaġġla t' insulina tista 'tkun benefiċċjali.
Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as ritodrine, salbutamol, terbutaline).
Il- ħtiġijiet ta 'l- insulina jistgħu jiżdiedu bi prodotti mediċinali li għandhom attività li tgħolli z- zokkor fid- demm, bħal ma huma l- kontraċettivi orali, il- kortikosterojdi, jew terapija bl- ormoni tat- tirojde, danazol, stimulanti beta2 (bħal ma huma ritodrine, salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulphate antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
20 acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II, l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
Mixing Humalog Mix25 with other insulins has not been studied.
It- taħlit ta ’ Humalog Mix25 ma ’ insulini oħra għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Humalog Mix25.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix25.
19 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e. g. a patient`s level of diet and exercise.
M’ hemmx frekwenza speċifika ta ’ zokkor baxx fid- demm, billi z- zokkor baxx fid- demm huwa riżultat kemm tad- doża ta ’ l- insulina kif ukoll ta ’ fatturi oħra eż. il - livell ta ’ dieta u eżerċizzju ta ’ pazjent.
Systemic allergy, which is rare (1/ 10,000 to < 1/ 1,000) but potentially more serious, is a generalised allergy to insulin.
L- allerġija sistemika, li hi rari (1/ 10, 000 sa < 1/ 1, 000) iżda li tista 'tkun aktar serja, hija allerġija ġeneralizzata għall- insulina.
Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
L- insulini m' għandhomx definizzjoni ta 'doża eċċessiva speċifika għax il- konċentrazzjonijiet tal - glukożju fis- serum huma riżultat ta' l- interazzjonijiet komplessi bejn il- livelli ta 'l- insulina, id -
20 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
Pharmaco-therapeutic group:
Grupp farmakoterapewtiku:
ATC Code:
Kodiċi ATC:
A10A D04.
A10A B04.
The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Humalog Mix25.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ l- insulina lispro huwa osservat wara l- għoti taħt il- ġilda ta ’ Humalog Mix25.
Humalog BASAL has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Humalog 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 Humalog Mix25 compared to human insulin mixture 30/ 70.
Provi kliniċi f' pazjenti bid- dijabete tat- tip 1 u tat- tip 2 urew tnaqqis fl- ipergliċemija ta 'wara l- ikel b’ Humalog Mix25 mqabbla ma' taħlita 30/ 70 ta ’ insulina umana.
In one clinical study there was a small (0.38 mmol/ l) increase in blood glucose levels at night (3a. m.).
Fi studju klinikiu wieħed kien hemm żieda żgħira (0. 38 mmol/ l) fil- livelli ta ’ glucose fid- demm bil- lejl (3a. m.).
In the figure below the pharmacodynamics of Humalog Mix25 and BASAL are illustrated.
Fid- dijagramma ta ’ hawn taħt hemm murija l- farmakodinamiċi ta ’ Humalog Mix25 u BASAL.
Hypoglycemic Activity
22 Attività Ipogliċemika
Time, hours
Ħin, sigħat
21 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.
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 Humalog 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’ Humalog Mix25 (użat darbtejn kuljum ma ’ metformin) u insulin glargine (użat darba kuljum ma ’ metformin) f’ sekwenza b’ mod arbitrarju.
Detailed information can be found in the following table.
Tagħrif dettaljat jista ’ jinsab fit- tabella li ġejja.
Insulin-Naive Patients n = 78
Pazjenti li qatt ma ħadu insulina n = 78
Not Insulin-Naive Patients n = 97
Pazjenti li diġà ħadu insulina n = 97
Mean total daily insulin dose at endpoint 1
Doża totali medja ta ’ kuljum ta ’ insulina fl- aħħar stadju tal- proċess 1
0.63 U/ kg
0. 63 U/ kg
0.42 U/ kg
0. 42 U/ kg
Haemoglobin A1c – Reduction
Tnaqqis ta ’ emoglobina A1c
1.30%
1. 30%
1.00%
1. 00%
Reduction of the mean of combined morning / evening two-hour postprandial 1 blood glucose
(medja fil- linja bażi = 8. 7%) (medja fil- linja bażi = 8. 5%) Tnaqqis fil- medja ta ’ glucose fid- demm sagħtejn wara l- ikla ta ’ filgħodu / 1 filgħaxija flimkien
3.46 mM
3. 46 mM
2.48 mM
2. 48 mM
Reduction of the mean fasting blood 1 glucose
Tnaqqis fil- medja ta ’ glucose fid- demm 1 wara s- sawm
0.55 mM
0. 55 mM
0.65 mM
0. 65 mM
Incidence of hypoglycaemia at endpoint Bodyweight gain2
Inċidenza ta ’ ipogliċemija fl- aħħar stadju tal- proċess
1 from baseline to end of Humalog Mix25 treatment 2 in patients randomised to Humalog Mix25 during the first crossover period
Żieda fil- piż tal- ġisem2 1 mil- linja bażi sa tmiem il- kura b’ Humalog Mix25 2
22 Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [0. 80 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
6.2 Incompatibilities
24 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fl- assenza ta ’ studji dwar kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
Two years.
Sentejn.
After first use of the vial, the suspension should be used within 28 days, when stored below 30°C.
Wara l- ewwel użu tal- kunjett, is- suspensjoni għandha tintuża fi żmien 28 ġurnata, meta tinħażen f' temperatura taħt 30°C.
The suspension is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals.
Is- suspensjoni tiġi f’ kunjetti 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 have been used to treat the vial stoppers.
Setgħu ntużaw emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati it- tappijiet tal- kunjett.
1 x 10 ml Humalog Mix25 vial.
1 x 10 ml kunjett ta ’ Humalog Mix25.
Instructions for use and handling The vial is to be used in conjunction with an appropriate syringe (100 U markings).
Istruzzjonijiet għall- użu u mmaniġġar Il- kunjett għandu tintuża flimkien ma 'siringa adattata (gradwazzjonijiet ta' 100 U).
Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend the insulin until it appears uniformly cloudy or milky.
Kunjetti li fihom Humalog Mix25 għandhom ikunu mdawra fil- pali ta 'l- idejn qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
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 vials 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 vial, giving it a frosted appearance.
Il- kunjetti 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.
Draw air into the syringe equal to the prescribed Humalog Mix25 dose.
Iġbed l- istess ammont ta ’ arja ġos- siringa daqs id- doża ta ’ Humalog Mix25 li għandek tieħu skond kif qallek it- tabib.
Wipe the top of the vial with an alcohol swab.
Imsaħħ it- tapp tal- kunjett b’ tajjara mxarrba bl- alkoħol.
Put the needle through rubber top of the Humalog Mix25 vial and inject the air into the vial.
Daħħal l- labra fil- gomma tat- tapp tal- kunjett ta 'Humalog Mix25 u njetta l- arja ġol- kunjett.
Turn the vial and syringe upside down.
4 Dawwar il- kunjett u s- siringa rashom ’ l isfel.
Making sure the tip of the needle is in the Humalog Mix25, withdraw the correct dose into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Humalog Mix25, 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 Humalog Mix25 in it.
Qabel ma tneħħi l- labra mill- kunjett, eżamina s- siringa għal xi bżieżaq ta 'l- arja li jnaqqsu l - ammont ta' Humalog Mix25 fiha.
Insert the needle and inject as instructed.
Daħħal il- labra u njetta kif indikat.
Dispose of the syringe and needle safely.
Armi l- labra u s- siringa bil- galbu.
MARKETING AUTHORISATION NUMBER
NUMRU TA 'L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
30th April 1996 Date of last renewal:
30 ta ’ April 1996 Data ta ’ l- aħħar tiġdid:
30th April 2006
30 ta ’ April 2006
Humalog Mix25 100 U/ ml suspension for injection in cartridge
Humalog Mix25 100 U/ ml, suspensjoni għall- injezzjoni fi skartoċċ
Humalog Mix 25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Humalog Mix25 tikkonsisti fi 25% insulina lispro u 75% suspensjoni ta ’ insulina lispro protamine.
Humalog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Humalog 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.
The duration of action of the insulin lispro protamine suspension (BASAL) component of Humalog 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 ’ Humalog Mix25 huwa simili għall- insulina bażi (NPH).
25 Hypoglycaemia.
27 Ipogliċemija
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Il- ħtiġijiet għall- insulina jistgħu jonqsu fil- preżenza ta 'sustanzi b' attività li tbaxxi z- zokkor fid- demm, bħal ma huma l- mediċini orali li jbaxxu z- zokkor fid- demm, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II, l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
The physician should be consulted when using other medications in addition to Humalog Mix25.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog.
4.6 Pregnancy and lactation
28 4. 6 Tqala u Treddigħ
26 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
29 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
27 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
Hypoglycaemic activity Humalog Mix25 Humalog Basal
30 Attività Ipogliċemika
28 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.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ Studju qabel l- użu kliniku dwar is- sigurtà tal- mediċina
29 6.1 List of excipients
6. 1 Lista ta 'sustanzi mhux attivi
Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [0. 80 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
6.2 Incompatibilities
32 6. 2 Inkompatibilitajiet
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- iskartoċċ 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 skrataċ 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- iskartoċċ, u/ jew l- iskartoċċ tal- ħġieġ.
Not all packs may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
5 x 3 ml Humalog Mix25 cartridges for a 3 ml pen.
5 X 3 ml skrataċ ta ’ Humalog Mix25 għal pinna ta ’ 3 ml.
2 x (5 x 3 ml) Humalog Mix25 cartridges for a 3 ml pen.
2 X (5 X 3 ml) skrataċ ta ’ Humalog Mix25 għal pinna ta ’ 3 ml.
Instructions for use and handling Humalog 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- iskrataċ ta ’ Humalog Mix25 għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
Cartridges containing Humalog 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.
Skrataċ li fihom Humalog 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.
If not, repeat the above procedure until contents are mixed.
Jekk le, irrepeti din il- proċedura sakemm il - kontenut jitħallat.
Cartridges contain a small glass bead to assist mixing.
L- iskrataċ 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- iskrataċ 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.
30 Humalog Mix25 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- iskrataċ ta ’ Humalog Mix25 mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- iskartoċċ.
Cartridges are not designed to be refilled.
L - iskrataċ 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- iskartoċċ, twaħħal il- labra u tagħti l- injezzjoni ta ’ l- insulina.
b) Injecting a dose
33 b) Injezzjoni ta 'doża
Insert the needle as instructed.
Daħħal il- labra kif indikat.
MARKETING AUTHORIZATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 96/ 007/ 008 EU/ 1/ 96/ 007/ 024
EU/ 1/ 96/ 007/ 008 5 X 3 ml skrataċ ta ’ Humalog Mix25 għal pinna ta ’ 3 ml.
5 x 3 ml Humalog Mix25 cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog Mix25 cartridges for a 3 ml pen
EU/ 1/ 96/ 007/ 024 2 X (5 X 3ml) skrataċ ta ’ Humalog Mix25 għal pinna ta ’ 3 ml.
30th April 1996 Date of last renewal:
30 ta ’ April 1996 Date ta ’ l- aħħar tiġdid:
Humalog Mix50 100 U/ ml suspension for injection in vial
Humalog Mix50 100 U/ ml, suspensjoni għall- injezzjoni f’ kunjett
Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension
Humalog Mix50 tikkonsisti fi 50% insulina lispro u 50% suspensjoni ta ’ insulina lispro protamine.
Humalog Mix50 is a white sterile suspension.
Humalog Mix50 huwa suspensjoni bajda u sterili.
Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Humalog 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.
Humalog Mix50 may be given shortly before meals.
Humalog Mix50 jista 'jingħata ftit qabel l- ikliet.
When necessary, Humalog Mix50 can be given soon after meals.
Meta neċessarju Humalog Mix50 jista 'jingħata eżatt wara l- ikliet.
Humalog Mix50 should only be given by subcutaneous injection.
Humalog Mix50 għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstances should Humalog Mix50 be given intravenously.
Humalog Mix50 m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
When administered subcutaneously, care should be taken when injecting Humalog Mix50 to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Humalog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix50.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ Humalog huwa osservat wara l- għoti taħt il- ġilda ta ’ Humalog Mix50.
This allows Humalog Mix50 to be given very close to mealtime.
Dan jippermetti li Humalog Mix50 jingħata viċin ħafna tal- ħin ta 'l- ikel.
The duration of action of the insulin lispro protamine suspension (BASAL) component of Humalog 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 ’ Humalog Mix50 huwa simili għall- insulina bażi (NPH).
As with all insulin preparations, the duration of action of Humalog Mix50 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall- preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Humalog Mix50 jiddependi fuq id - doża, is- sit ta 'l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
32 Hypoglycaemia.
Ipogliċemija
4.4 Special warnings and precautions for use
35 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
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.
L- għoti ta ’ l- insulina lispro lit- tfal taħt it- 12- il sena għandha tiġi kkunsidrata biss f’ każ li tistenna benefiċċju meta mqabbel ma ’ l- insulina regolari.
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulphate antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide, or alcohol.
Il- ħtiġijiet għall- insulina jistgħu jonqsu fil- preżenza ta 'sustanzi b' attività li tbaxxi z- zokkor fid- demm, bħal ma huma l- mediċini orali li jbaxxu z- zokkor fid- demm, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
Mixing Humalog Mix50 with other insulins has not been studied.
It- taħlit ta ’ Humalog Mix25 ma ’ insulini oħra għadu ma ġiex studjat.
The physician should be consulted when using other medications in addition to Humalog Mix50.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix25.
4.6 Pregnancy and lactation
36 4. 6 Tqala u Treddigħ
33 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet, or both.
Pazjenti dijabetiċi li qed ireddgħu jistgħu jkollhom bżonn aġġustamenti fid- doża ta 'l- insulina, fid - dieta, jew fit- tnejn li huma.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
37 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
Patients who fail to respond to glucagon must be given glucose solution intravenously.
Pazjenti li ma jirrispondux għall- glucagon għandhom jingħataw Suspensjoni tal- glukożju ġol- vina.
34 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
Humalog Mix50 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Humalog Mix50 huwa suspensjoni mħallta lesta li tikkonsisti f’ insulina lispro (analogu ta ’ l- insulina umana li jaġixxi malajr).
The primary activity of insulin lispro is the regulation of glucose metabolism.
L- attività primarja ta 'l- insulina lispro hija li tirregola l- metaboliżmu ta ’ glucose.
The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of Humalog Mix50.
Il- bidu mgħagġel u l- quċċata kmieni ta ’ l- attività ta ’ l- insulina lispro huwa osservat wara l- għoti taħt il- ġilda ta ’ Humalog Mix50.
In the figure below the pharmacodynamics of Humalog Mix50 and BASAL are illustrated.
Fid - dijagramma ta ’ hawn taħt hemm murija l- farmakodinamiċi ta ’ Humalog Mix50 u BASAL.
Hypoglycaemic activity
Attività ipogliċemika
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.
38 Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
35 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 insulin lispro protamine suspension are consistent with those of an intermediate acting insulin such as NPH.
Il- farmakokinetiċi tas - suspensjoni ta ’ insulina lispro huma konsistenti ma ’ dawk ta ’ insulina li taħdem għal ħin intermedju bħal ma ’ hu NPH.
The pharmacokinetics of Humalog Mix50 are representative of the individual pharmacokinetic properties of the two components.
Il- farmakokinetiċi ta ’ Humalog Mix25 jirreflettu l- propjetajiet farmakokinetiċi taż - żewġ komponenti.
Protamine sulphate m-cresol [2.20 mg/ ml] Phenol [1.00 mg/ ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0-7.8.
Protamine sulphate m- cresol [1. 76 mg/ ml] Phenol [0. 80 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
Mixing Humalog Mix50 with other insulins has not been studied.
It- taħlit ta ’ Humalog Mix50 ma ’ insulini oħra għadu ma ġiex studjat.
36 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
1 x 10 ml Humalog Mix50 vial.
1 x 10 ml kunjett ta ’ Humalog Mix50.
Instructions for use and handling The vial is to be used in conjunction with an appropriate syringe (100 U markings).
Istruzzjonijiet għall- użu u mmaniġġar Il- kunjett għandu jintuża flimkien ma 'siringa adattata (gradwazzjonijiet ta' 100 U).
Vials containing Humalog Mix50 should be rotated in the palms of the hands before use to resuspend the insulin until it appears uniformly cloudy or milky.
Kunjetti li fihom Humalog Mix50 għandhom ikunu mdawra fil- pali ta 'l- idejn qabel ma jintużaw sabiex tirrisospendi l- insulina sakemm tidher imċajpra jew qiesa ħalib uniformement.
The vials 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 vial, giving it a frosted appearance.
Il- kunjetti għandhom ikunu eżaminati ta 'spiss u m' għandhomx jintużaw jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb tal- kunjett, u jidher qiesu ġelu.
Draw air into the syringe equal to the prescribed Humalog Mix50 dose.
Iġbed l- istess ammont ta ’ arja ġos- siringa daqs id- doża ta ’ Humalog Mix50 li għandek tieħu skond kif qallek it- tabib.
Put the needle through rubber top of the Humalog Mix50 vial and inject the air into the vial.
Daħħal l- labra fil- gomma tat- tapp tal- kunjett ta 'Humalog Mix50 u njetta l- arja ġol- kunjett.
Making sure the tip of the needle is in the Humalog Mix50, withdraw the correct dose into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Humalog Mix50, 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 Humalog Mix50 in it.
Qabel ma tneħħi l- labra mill- kunjett, eżamina s- siringa għal xi bżieżaq ta 'l- arja li jnaqqsu l - ammont ta' Humalog Mix50 fiha.
Insert the needle and inject as instructed.
Daħħal il- labra u injetta skond kif qalulek.
MARKETING AUTHORISATION NUMBER
NUMRI TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Humalog Mix50 100 U/ ml suspension for injection in cartridge
Humalog Mix50 100 U/ ml, suspensjoni għall- injezzjoni fi skartoċċ
Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension.
Humalog Mix50 tikkonsisti fi 50% insulina lispro u 50% suspensjoni ta ’ insulina lispro protamine.
Humalog Mix50 is a white, sterile suspension.
Humalog Mix50 huwa suspensjoni bajda u sterili.
When administered subcutaneously care should be taken when injecting Humalog Mix50 to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Humalog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
39 Hypoglycaemia.
42 Ipoglicemija
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants, (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Il- ħtiġijiet għall- insulina jistgħu jonqsu fil- preżenza ta 'sustanzi b' attività li tbaxxi z- zokkor fid- demm, bħal ma huma l- mediċini orali li jbaxxu z- zokkor fid- demm, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
The physician should be consulted when using other medications in addition to Humalog Mix50.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog Mix50.
4.6 Pregnancy and lactation
43 4. 6 Tqala u Treddigħ
40 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Huwa essenzjali li jinżamm kontroll tajjeb tal- pazjenti kkurati bl- insulina (dawk li jiddependu fuq l - insulina jew id- dijabete ta 'waqt it- tqala) matul it- tqala.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
44 Il- korrezzjoni ta 'zokkor baxx fid- demm moderatament severa tista' tinkiseb b' għoti tal- glucagon intramuskolari jew taħt il- ġilda, segwita minn karboidrat orali meta l- pazjent jirkupra biżżejjed.
41 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
It- teħid sostenut ta 'karboidrati u l- osservazzjoni jistgħu jkunu neċessarji minħabba li zokkor baxx fid - demm jista' jerġa jseħħ wara li l- pazjent ikun jidher li rkupra klinikament.
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.
45 Id- dijagramma t' hawn fuq tirrifletti l- ammont relattiv ta ’ glucose maż- żmien meħtieġ biex iżżomm il - konċentrazzjonijiet kollha ta ’ glucose fid- demm ta 'l- individwu viċin il- livelli ta' sawm u huwa indikatur ta 'l- effett ta' dawn l- insulini fuq il- metaboliżmu ta ’ glucose maż- żmien.
42 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.
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
Differenzi glukodinamiċi bejn l- insulina lispro u l- insulina umana li tinħall, kif imkejla waqt proċedura fejn il- livell ta ’ glucose fid- demm inżamm kostanti, dawn inżammu fuq firxa wiesa ta 'funzjoni tal- kliewi.
Protamine sulphate m-cresol [2.20 mg/ ml] Phenol [1.00 mg/ ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0-7.8.
Protamine sulphate m- cresol [2. 20 mg/ ml] Phenol [1. 00 mg/ ml] Glycerol Dibasic sodium phosphate. 7H2O Zinc oxide Ilma għall- injezzjonijiet Hydrochloric acid u sodium hydroxide jistgħu jintużaw biex jaġġustaw il- pH għal 7. 0 - 7. 8.
6.2 Incompatibilities
46 6. 2 Inkompatibilitajiet
43 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- iskartoċċ fil- pinna, is- suspensjoni għandha tintuża fi żmien 28 ġurnata meta tinħażen f' temperatura taħt 30°C.
5 x 3 ml Humalog Mix50 cartridges for a 3 ml pen.
5 x 3 ml skrataċ ta ’ Humalog Mix50 għal pinna ta ’ 3 ml.
2 x (5 x 3 ml) Humalog Mix50 cartridges for a 3 ml pen.
2 x (5 x 3 ml) skrataċ ta ’ Humalog Mix50 għal pinna ta ’ 3 ml.
Instructions for use and handling Humalog Mix50 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- iskrataċ ta ’ Humalog Mix50 għandhom jintużaw b’ pinna mmarkata CE kif rakkomandat fit- tagħrif provdut mill- manifattur ta ’ l- istrument.
Cartridges containing Humalog Mix50 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.
Skrataċ li fihom Humalog Mix50 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.
Humalog Mix50 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- iskrataċ ta ’ Humalog Mix50 mhumiex iddisinjati biex tkun tista ’ tħallat insulini oħra fl- iskartoċċ.
EU/ 1/ 96/ 007/ 006 EU/ 1/ 96/ 007/ 025
EU/ 1/ 96/ 007/ 006 5 x 3 ml skrataċ ta ’ Humalog Mix50 għal pinna ta ’ 3 ml.
5 x 3 ml Humalog Mix50 cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog Mix50 cartridges for a 3 ml pen
EU/ 1/ 96/ 007/ 025 2 x (5 X 3ml) skrataċ ta ’ Humalog Mix50 għal pinna ta ’ 3 ml.
Humalog BASAL 100 U/ ml suspension for injection in cartridge
Humalog BASAL 100 U/ ml, suspensjoni għall- injezzjoni fi skartoċċ
Humalog BASAL consists of insulin lispro protamine suspension.
Humalog BASAL tikkonsisti f’ suspensjoni ta ’ insulina lispro protamine.
Humalog BASAL is a white, sterile suspension.
Humalog BASAL huwa suspensjoni bajda u sterili.
Humalog BASAL is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Humalog BASAL huwa indikat għall- kura ta 'pazjenti li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall- manteniment omeostatiku ta' livelli normali ta ’ glucose.
Humalog BASAL can be mixed with or given in conjunction with Humalog.
Humalog BASAL jista 'jitħallat ma ’ jew jingħata ma ’ Humalog.
Humalog BASAL should only be given by subcutaneous injection.
Humalog BASAL għandu jingħata biss b' injezzjoni taħt il- ġilda.
Under no circumstance should Humalog BASAL be given intravenously.
Humalog BASAL m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
When administered subcutaneously care should be taken when injecting Humalog BASAL to ensure that a blood vessel has not been entered.
Meta jingħata taħt il- ġilda għandha tittieħed kawtela meta Humalog ikun injettat biex tkun żgur li ma dħaltx f' vina jew arterja.
As with all insulin preparations, the duration of action of Humalog BASAL is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Bħall- preparazzjonijiet kollha ta ’ l- insulina, kemm idum jaħdem Humalog BASAL jiddependi fuq id- doża, is- sit ta 'l- injezzjoni, il - provvista tad- demm, it- temperatura u fuq l- attività fiżika.
46 4.4 Special warnings and precautions for use
49 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Under no circumstances should Humalog BASAL be given intravenously.
Humalog BASAL m’ għandux jingħata ġol- vina taħt l- ebda ċirkostanzi.
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Il- ħtiġijiet għall- insulina jistgħu jonqsu fil- preżenza ta 'sustanzi b' attività li tbaxxi z- zokkor fid- demm, bħal ma huma l- mediċini orali li jbaxxu z- zokkor fid- demm, salicylates (per eżempju, acetyl salicylic acid), antibijotiċi sulpha, ċerti antidipressanti, (impedituri ta ’ monoamine oxidase), ċerti impedituri t' enżimi li jibdlu l- anġjotensina (captopril, enalapril), sustanzi li jibblokkjaw ir- riċetturi anġjotensin II l- imblokkaturi tat- tip beta, octreotide jew l- alkoħol.
Mixing Humalog BASAL with insulins other than Humalog has not been studied.
It- taħlit ta ’ Humalog Mix50 ma ’ insulini oħra għadu ma ġiex studjat.