qanastek/EMEA-V3 huggingface dataset:
Each container includes 10ml equivalent to 1000U insulin lispro.
Kull kontenitur jinkludi 10ml ekwivalenti għal 1000U t' insulina lispro.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi, ara sezzjoni 6. 1.
Humalog is a sterile, clear, colourless, aqueous solution.
Humalog huwa soluzzjoni akweja sterili, ċara u bla kulur.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Għall- kura ta 'adulti u tfal li għandhom id- dijabete mellitus li għandhom bżonn l- insulina għall - manteniment omeostatiku ta' livelli normali tal- glukożju.
Humalog is also indicated for the initial stabilisation of diabetes mellitus.
Humalog huwa ukoll indikat għall - istabbilizzazzjoni fil- bidu tad- dijabete mellitus.
The dosage should be determined by the physician, according to the requirement of the patient.
Id- dożaġġ għandu jkun determinat mit- tabib, skond il- ħtieġa tal- pazjent.
Humalog may be given shortly before meals.
Humalog jista 'jingħata ftit qabel l- ikliet.
When necessary Humalog can be given soon after meals.
Meta neċessarju Humalog jista 'jingħata eżatt wara l- ikliet.
Humalog 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 'Humalog 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, Humalog 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, Humalog 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.
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen.
L- għoti taħt il- ġilda għandu jsir fil- parti ta 'fuq tad- driegħ, fil- koxxox, fil- warrani, jew fl- addome.
Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
L - użu tas- siti ta 'l- injezzjoni għandhom jinbidlu sabiex l- istess sit ma jintużax aktar minn madwar darba f' xahar.
When administered subcutaneously care should be taken when injecting Humalog 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.
After injection, the site of injection should not be massaged.
Wara l- injezzjoni, is- sit ta 'l- injezzjoni m' għandux ikun mmassaġġjat.
Patients must be educated to use the proper injection techniques.
Il - pazjenti għandhom ikunu mgħallma biex jużaw il- metodi xierqa ta 'l- injezzjoni.
Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Humalog 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 Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime.
Il- bidu mgħagġel ta ’ l- attività tħalli l- injezzjoni ta 'Humalog (jew, fil- każ t' għoti b' infużjoni taħt il- ġilda kontinwa, bolus ta' Humalog) biex tingħata viċin ħafna tal- ħin ta 'l- ikel.
The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual.
Iż- żmien kemm iddum taħdem kwalunkwe insulina jista 'jvarja ħafna f' individwi differenti, jew f' ħinijiet differenti fl- istess individwu.
The faster onset of action compared to soluble human insulin is maintained regardless of injection site.
Il- bidu aktar mgħaġġel ta 'l- azzjoni mqabblamqabbel ma' insulina umana li tinħall tinżamm minkejja s- sit ta 'l- injezzjoni.
As with all insulin preparations, the duration of action of Humalog 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 'Humalog jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
2 Humalog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
2 Use of Humalog in an insulin infusion pump:
Użu ta 'Humalog ġo pompa ta' l- infużjoni ta 'l- insulina
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
Ċerti pompi ta 'l- infużjoni ta' l- insulina mmarkati b’ CE biss jistgħu jintużaw għall- infużjoni ta 'l - insulina lispro.
Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump.
Qabel ma tinfuża l- insulina lispro, għandek taqra sew l- istruzzjonijiet tal- manifattur biex tkun żgur li dik il- pompa partikolari hijiex dik li għandek tuża jew le.
Read and follow the instructions that accompany the infusion pump.
Aqra u segwi l - istruzzjonijiet li jiġu mal- pompa ta 'l- infużjoni.
Use the correct reservoir and catheter for the pump.
Uża l- kontenitur u l- kateter li huma xierqa għall - pompa.
Change the infusion set every 48 hours.
Biddel is- set ta 'l- infużjoni kull 48 siegħa.
Use aseptic technique when inserting the infusion set.
Uża metodi asettiċi meta ddaħħal is- set ta 'l - infużjoni.
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved.
Jekk ikun hemm episodju ipogliċemiku, l- infużjoni għandha titwaqqaf sakemm jgħaddi l - episodju.
If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion.
Jekk jerġa 'jiġri hekk jew jekk ikun hemm livelli baxxi ħafna ta ’ glucose fid- demm, għid lill - professjonista tal- kura tas- saħħa tiegħek u kkunsidra l- bżonn li tnaqqas jew twaqqaf l- infużjoni ta' l - insulina tiegħek.
A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
Ħsara fil- pompa jew ostaklu fis- set ta 'l- infużjoni jista' jirriżulta f' żieda b’ mod mgħaġġel fil- livelli tal- glucose.
If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your health care professional.
Jekk taħseb li hemm interruzzjoni fil- ħruġ ta 'l- insulina, segwi l - istruzzjonijiet fil- letteratura li ġie mal- prodott u jekk hemm bżonn, għid lill- professionist tal- kura tas - saħħa tiegħek.
When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.
Meta użat b' pompa ta ’ l- infużjoni ta 'l- insulina, Humalog m' għandux jitħallat ma' xi insulina oħra.
Intravenous administration of insulin:
Għoti ta 'insulina minn ġol- vini
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system.
Injezzjoni ta 'l- insulina lispro minn ġol- vini għandha issir skond il- prattika klinika normali għall - injezzjonijiet minn ġol- vini, per eżempju permezz ta ’ bolus minn ġol- vini jew b' sistema ta' l- infużjoni.
Frequent monitoring of the blood glucose levels is required.
Huwa meħtieġ sorveljanza ta 'spiss tal- livelli ta ’ glucose fid- demm.
Infusion systems at concentrations from 0.1U/ ml to 1.0U/ ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours.
Sistemi ta 'l- infużjoni f' konċentrazzjonijiet minn 0. 1 U/ ml sa 1. 0 U/ ml ta' insulina lispro f '0. 9% sodium chloride jew 5% dextrose huma stabbli f' temperatura ambjentali ta' ġewwa għal 48 siegħa.
It is recommended that the system is primed before starting the infusion to the patient.
Huwa rakkomandat li s- sistema tiġi mħejjiha qabel ma tibda l- infużjoni lill- pazjent.
Hypersensitivity to insulin lispro or to any of the excipients.
Sensittività eċċessiva għall- insulina lispro jew għal xi sustanzi mhux attivi.
Hypoglycaemia.
Ipogliċemija
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Il- bidla għal xi tip jew marka oħra ta 'l- insulina f' pazjent għandu jsir taħt superviżjoni medika stretta.
Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal, human, human insulin analogue), and/ or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
Tibdiliet fil- qawwa, marka (manifattur), tip (regolari, NPH, lente, etc), l- ispeċi (annimal, bniedem, analogu ta 'l- insulina tal- bniedem), u/ jew il- metodu tal- manifattura (rikombinanti mid- DNA kontra l - insulina li tiġi mill- annimali) jistgħu jirriżultaw fi bżonn għal tibdil fid- dożaġġ.
For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/ fasting glucose control.
Fil- każ ta ’ insulini li jaġixxu malajr, kull pazjent li qiegħed ukoll fuq insulina bażilari irid isib l- aħjar dożaġġ għaż- żewġ insulini biex il- livell tal- glucose ikun ikkontrollat matul il- gurnata kollha, speċjalment il- kontroll tal - glucose matul il- lejl/ wara s- sawm.
The shorter-acting Humalog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin.
Humalog 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.
Mixing of the insulins ahead of time or just before the injection should be on advice of the physician.
It- taħlit t' insulini qabel iż - żmien jew eżatt qabel l- injezzjoni għandu jsir fuq parir tat- tabib.
However, a consistent routine must be followed.
Madankollu, rutina konsistenti għandha tkun segwita.
Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medications such as beta-blockers.
Il- kundizzjonijiet li jistgħu jagħmlu s- sintomi ta 'twissija tal- bidu taz- zokkor baxx fid- demm differenti jew jidhru anqas jinkludu d- dijabete għal żmien twil, it- terapija intensifikata bl- insulina, mard tan - nervituri fid- dijabete jew medikazzjonijiet bħal imblokkaturi tat- tip beta..
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.
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.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
3 Reazzjonijiet mhux ikkoreġġuti ta 'ipoglikimja jew ta' zokkor baxx jew għoli fid- demm jistgħu jikkawżaw telf mis- sensi, koma, jew mewt.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
L- użu ta 'dożaġġi li mhumiex adegwati jew it- twaqqif tal- kura, speċjalment f' dijabetiċi li jiddependu fuq l- insulina, jistgħu jwasslu għaz- zokkor għoli fid- demm u l- ketoaċidożi dijabetika; kundizzjonijiet li jistgħu jikkaġunaw il- mewt.
Insulin requirements may be reduced in the presence of renal impairment.
Il- ħtiġijiet ta 'l- insulina jistgħu jonqsu meta jkun hemm indeboliment tal- kliewi.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced
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.
Insulin requirements may be increased during illness or emotional disturbances.
Il- ħtiġijiet ta 'l- insulina jistgħu jiżdiedu waqt mard jew disturbi emozzjonali.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Tista 'ukoll tkun neċessarja varjazzjoni fid- doża jekk il- pazjenti jagħmlu aktar attività fiżika jew jekk ibiddlu d- dieta tagħhom tas- soltu.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Eżerċizju magħmul eżatt wara ikla jista 'jżid ir- riskju taz- zokkor baxx fid- demm.
A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.
Konsegwenza tal- farmakodinamiċi ta 'l- analogi t' insulina ti taġixxi malajr hija li jekk ikun hemm zokkor baxx fid- demm, tista' titfaċċa aktar kmieni wara injezzjoni meta mqabbla m 'insulina umana li tinħall.
Humalog should only be used in children in preference to soluble insulin when a fast action of insulin might be beneficial.
Humalog għandu jintuża fit- tfal biss f' preferenza għall- insulina li tinħall meta l- azzjoni mgħaġġla t' insulina tista 'tkun benefiċċjali.
For example, in the timing of the injections in relation to meals.
Per eżempju, it- teħid ta 'l- injezzjoni viċin tal- ħin ta ’ l- iklijiet.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott.
Insulin requirements may be increased by medicinal products 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 medicinal products 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.
Għandu jkun ikkonsultat it- tabib meta jintużaw medikazzjonijiet oħra flimkien ma 'Humalog.
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.
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.
Insulin requirements usually fall during the first trimester and increase during the second and third trimesters.
Il- ħtiġijiet ta 'l- insulina normalment jonqsu waqt l- ewwel tlett xhur u jiżdiedu waqt it- tieni u t- tielet tlett xhur.
Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Pazjenti bid- dijabete għandhom jiġu avżati biex jinfurmaw lit- tabib tagħhom jekk huma tqal jew jekk qed jippjanaw li joħorġu tqal.
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Is - sorveljanza bir- reqqa tal- kontroll tal- glukożju, kif ukoll tas- saħħa ġenerali, huwa essenzjali f' pazjenti tqal li għandhom id- dijabete.
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.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il- ħila tal- pazjent biex jikkonċentra u jirreaġixxi tista 'tkun affettwata bħala riżultat taz- zokkor baxx fid- demm.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista 'jkun riskju f' sitwazzjonijiet fejn dawn l- abbiltajiet huma ta' importanza speċjali (eż is- sewqan ta 'karozza jew it- tħaddim ta' magni).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Il- pazjenti għandhom jiġu avżati biex jieħdu l- prekawzjonijiet biex jevitaw iz- zokkor baxx fid- demm waqt is- sewqan, dan huwa speċjalment importanti f' dawk li għandhom is- sinjali ta 'twissija ta' l - ipoglikimja mnaqqsa jew assenti jew jekk għandhom episodji ta 'zokkor baxx fid- demm frekwenti.
The advisability of driving should be considered in these circumstances.
Il - parir dwar is- sewqan għandu jkun ikkunsidrat f' dawn iċ- ċirkostanzi.
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer.
Iz- zokkor baxx fid- demm huwa l- aktar effett frekwenti mhux mixtieq tat- terapija bl- insulina li jista 'jsoffri minnu pazjent li għandu d- dijabete.
No
Zokkor fid- demm severament baxx tista 'twassal għal telf mis- sensi, u f' każijiet estremi, il- mewt.
4 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.
Ma ġietx irrappurtata ebda frekwenza speċifika għall - ipogliċemija, peress li l- ipogliċemija hija riżultat kemm tad- doża ta ’ l- insulina kif ukoll ta ’ fatturi oħra eż. il- livell ta ’ dieta u eżerċizzju ta ’ pazjent.
Local allergy in patients is common (1/ 100 to < 1/ 10).
L- allerġija lokali f' pazjenti hija komuni (1/ 100 sa < 1/ 10).
Redness, swelling, and itching can occur at the site of insulin injection.
Jista ’ jkun hemm ħmura, nefħa, u ħakk fis - sit ta 'l- injezzjoni ta' l- insulina.
This condition usually resolves in a few days to a few weeks.
Din il- kundizzjoni ssoltu tgħaddi fi ftit ġranet sa ftit ġimgħat.
In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Fi ftit każijiet, din il- kundizzjoni tista 'tkun relatata ma' fatturi li mhux dovuti għall- insulina nnifisha, bħal irritazzjonijiet bis- sustanza li tnaddaf il- ġilda jew metodi mhux tajba ta 'l- injezzjoni.
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.
It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.
Tista 'tikkawża raxx mal- ġisem kollu, qtugħ ta' nifs, tħarħir, tnaqqis fil- pressjoni tad - demm, polz mgħaġġel, jew ħafba għaraq.
Severe cases of generalised allergy may be life-threatening.
Każijiet severi t' allerġija ġeneralizzata jistgħu jkunu ta 'periklu għall- ħajja.
Lipodystrophy at the injection site is uncommon (1/ 1,000 to < 1/ 100).
Il- lipodistrofija fis- sit ta 'l- injezzjoni m’ hijiex komuni (1/ 1, 000 sa < 1/ 100).
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 - disponibbiltà tal- glukożju u proċessi oħra metaboliċi.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Iz- zokkor baxx fid- demm jista 'jiġri bħala riżultat t' attività eċċessiva ta' l- insulina relatata mat- teħid ta 'l- ikel u l- ħela ta' enerġija.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Iz- zokkor baxx fid- demm tista 'tkun assoċjata ma' nuqqas t' attenzjoni, konfużjoni, palpitazzjonijiet, uġigħ ta 'ras, ħafna għaraq u remettar.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
Episodji ħfief ta 'zokkor baxx fid- demm jirrispondu għat- teħid orali ta' glukożju jew xi zokkor ieħor jew prodotti li fihom iz- zokkor.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
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 soluzzjoni tal- glukożju ġol- vina.
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.
However, glucose solution must be given intravenously if glucagon is not available or if the patient fails to respond to glucagon.
Madankollu, it- taħlita liwida tal- glukożju għandha tingħata ġol- vina jekk il- glukagon mhux disponibbli jew jekk il- pazjent ma jirrispondix għall- glucagon.
The patient should be given a meal as soon as consciousness is recovered.
Il- pazjent għandu jingħata ikla eżatt kif jiġi lura f' sensieh.
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.
Fast-acting human insulin analogue.
Analogu ta 'l- insulina umana li ddum taħdem.
The primary activity of insulin lispro is the regulation of glucose metabolism.
L- attività primarja ta 'l- insulina lispro hija li tirregola l- metaboliżmu tal- glukożju.
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
Barra minn hekk, l- insulini għandhom ħafna effetti anaboliċi u anti- kataboliċi fuq diversi tessuti differenti.
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.
Fit- tessut tal- muskolu dan jinkludi ż- żieda fil- glycogen, aċidi grassi, il- formazzjoni tal - glycerol u l- proteini u l- ġbir ta 'ammino aċidi, fil- waqt li jkun hemm tnaqqis fit- tkissir tal- glycogen, il - glukoneoġenesi, il- ketoġenesi, it- tkissir tal- lipidi, il- kataboliżmu tal- proteini u l- produzzjoni ta' ammino aċidi.
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).
Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 5 hours) when compared to regular insulin.
L- insulina lispro taġixxi malajr u għandha attività aktar qasira (2 sa 5 sigħat) meta mqabbla ma 'insulina regolari.
5 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.
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- attivita wara injezzjoni taħt il- ġilda huwa muri hawn taħt.
Insulin Lispro
Insulina Insulin Lispro
Humulin R Hypoglycaemic Activity
Humulin R Attività ta ’ Hypoglycaemic zokkor baxx fid - Activity demm
5
Ħin (sigħat)
6
Time (Hours)
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.
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin.
Provi kliniċi saru fuq tfal (61 pazjent bejn 2 sa 11- il- sena) u tfal u adolexxenti (481 pazjenti minn 9 sa 19- il sena), fejn tqabblu l- insulina lispro ma 'l- insulina umana li tinħall.
The pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.
Il- profil farmakodinamiku ta 'l- insulina lispro fit- tfal huwa simili għal dak li deher fl- adulti.
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower glycosylated haemoglobin levels compared to soluble insulin.
6 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.
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).
Fi studju double- blind u crossover, 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).
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.
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.
The reduction of HbA1c would also be expected with other insulin products e. g. soluble or isophane insulins.
It- tnaqqis ta 'HbA1c ikun ukoll mistenni bi prodotti ta' l- insulina oħra eż. insulini li jinħallu jew isophane.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin.
Provi kliniċi f' pazjenti bid- dijabete tat- tip 1 u tat- tip 2 urew tnaqqis fin- numru t' episodji ta ’ zokkor baxx fid- demm matul il- lejl bl- insulina lispro mqabbel ma 'insulina umana li tinħall.
In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
F' xi studji, it - tnaqqis ta 'zokkor baxx fid- demm ta' matul il- lejl kien assoċjat ma 'żieda fl- episodji ta' zokkor baxx fid- demm matul il- ġurnata.
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 tal- glukożju fid- demm inżamm kostanti, dawn inżammu fuq firxa wiesa ta 'funzjoni tal- kliewi.
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.
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 6 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).
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment.
L- insulina lispro żżomm aktar assorbiment rapidu meta mqabbla ma 'insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- kliewi.
In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function.
F' pazjenti bid- dijabete tat- Tip 2 fuq firxa wisa 'ta' funzjoni tal- kliewi d- differenzi farmakokinetiċi bejn l- insulina lispro u l- insulina umana li tinħall kienu ġeneralment miżmuma, u urew li huma indipendenti mill- funzjoni tal- kliewi.
Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
L- insulina lispro żżomm aktar assorbiment rapidu u eliminazzjoni rapida meta mqabbla ma 'l- insulina umana li tinħall f' pazjenti li għandhom indeboliment tal- fwied.
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro behaved in a manner that closely resembled human insulin.
F' testijiet in vitro, li jinkludu l- irbit mas- siti tar- riċetturi ta 'l- insulina u l- effetti fuq ċelluli li qed jikbru, l- insulina lispro tixbaħ ħafna lill- insulina umana.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.
Studji urew ukoll li l- inħall mill- irbit ta 'l- insulina lispro mar- riċetturi ta' l- insulina, hija ekwivalenti ma 'l- insulina umana.
Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
Studji fuq it- tossiċità akuta ta 'tul ta' żmien ta 'xahar u tnax- il xahar, ma wrewx skoperta sinifikanti ta' tossiċità.
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
L- insulina lispro ma kkaġunatx tnaqqis fil- fertilità, u anqas uriet embrijutossiċità jew teratoġeniċità fi studji fuq l- annimali.
7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide maybe used to adjust pH to 7.0 – 7.8.
m- cresol [3. 15 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
7 6. 2 Inkompatibilitajiet
Humalog preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
Il- preparazzjonijiet ta 'Humalog m' għandhomx jitħalltu m' insulini magħmula minn manifatturi oħra jew ma 'preparazzjonijiet t' insulina ta' l- annimali.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m' għandux jitħallat ma 'prodotti mediċinali oħra minbarra dawk imsemmija f' sezzjoni 4. 2.
6.3 Shelflife
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
After first use of the vial, the solution should be used within 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 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 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.
Dimeticone or silicone emulsion may be used to treat the vial stoppers.
Tista ’ tintuża emulsjoni ta ’ dimethicone jew silicone biex jiġu trattati it- tappijiet tal- kunjett.
Not all packs may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
1 x 10 ml Humalog vial.
1 x 10 ml kunjett ta ’ Humalog.
2 x 10 ml Humalog vials.
2 x 10 ml kunjetti ta ’ Humalog.
7 5 x (1 x 10 ml) Humalog vials.
5 x (1 x 10 ml) kunjetti ta ’ Humalog.
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 (b’ gradwazzjonijiet ta' 100 U).
a) Preparing a dose
a) Preparazzjoni ta 'doża
Inspect the Humalog solution.
Eżamina s- soluzzjoni ta 'Humalog.
It should be clear and colourless.
Għandha tkun ċara u bla kulur.
Do not use Humalog if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Tużax Humalog jekk jidher imċajpar, magħqud, jew ftit ikkulurit jew jekk jidhru partiċelli solidi.
If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
Jekk qed tuża kunjett ġdid, neħħi l- għatu ta 'protezzjoni tal- plastik, imma tneħħix it- tapp.
If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe.
Jekk l- iskeda ta ’ dożaġġ teħtieġ l- injezzjoni ta 'insulina bażilari u Humalog fl- istess ħin, it- tnejn jistgħu jitħalltu fis- siringa.
If mixing insulins, refer to the instructions for mixing that follow in Section (ii) and 6.2.
Jekk qed tħallat l- insulini, ara l- istruzzjonijiet ta ’ taħlit li jinsabu f’ Sezzjoni (ii) u 6. 2.
Draw air into the syringe equal to the prescribed Humalog dose.
Iġbed l- istess ammont ta ’ arja ġos- siringa daqs id- doża ta ’ Humalog li ordnalek it- tabib.
Wipe the top of the vial with an alcohol swab.
Imsaħħ il- parti ta ’ fuq tal- kunjett b’ tajjara mxarrba bl- alkoħol.
Put the needle through the rubber top of the Humalog vial and inject the air into the vial.
Daħħal il- labra fil- gomma tat- tapp tal - kunjett ta 'Humalog u injetta l- arja ġol- kunjett.
Turn the vial and syringe upside down.
Dawwar il- kunjett u s- siringa rashom ’ l isfel.
Hold the vial and syringe firmly in one hand.
Żomm il- kunjett u s- siringa sew f' id waħda.
Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Humalog, 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 in it.
Qabel ma tneħħi l- labra mill- kunjett, eżamina s- siringa għal xi bżieżaq ta 'l- arja li jnaqqsu l - ammont ta' Humalog fiha.
If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top.
Jekk hemm bżieżaq, żomm is- siringa dritta 'l fuq u taptap fuq il- ġenb sakemm il- bżieżaq jitilgħu' l fuq.
Push them out with the plunger and withdraw the correct dose.
Imbottahom 'l barra bil- planġer u iġbed id- doża t- tajba.
Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.
Neħħi l- labra mill- kunjett u poġġi s- siringa mimduda sabiex il- labra ma tmiss m' imkien.
ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2)
ii) Taħlit ta ’ Humalog ma 'Insulina Umana li ddum taħdem għal ħin itwal (ara sezzjoni 6. 2)
Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.
Humalog għandu jitħallat ma 'insulini li jdumu jaħdmu għal ħin itwal fuq il- parir tat- tabib biss.
Draw air into the syringe equal to the amount of longer-acting insulin being taken.
Iġbed l- istess ammont ta ’ arja ġos- siringa daqs id- doża li qed tieħu ta ’ insulina li ddum taħdem għal ħin itwal.
Insert the needle into the longer-acting insulin vial and inject the air.
Daħħal il- labra fil- kunjett ta 'l- insulina li ddum taħdem għal ħin itwal u injetta l - arja.
Withdraw the needle.
Neħħi l- labra.
Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.
Issa injetta l- arja fil- kunjett ta 'Humalog bl- istess mod, imma tneħħix il- labra.
Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into the syringe.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fi Humalog, iġbed id- doża korretta ta 'Humalog ġos- siringa.
Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting insulin.
Neħħi l- labra mill- kunjett ta 'Humalog u daħħalha fil- kunjett ta' l- insulina li ddum taħdem għal ħin itwal.
Hold the vial and syringe firmly in one hand and shake gently.
Żomm il- kunjett u s- siringa sew f' id waħda u ċaqlaq bil- mod.
Making sure the tip of the needle is in the insulin, withdraw the dose of longer-acting insulin.
Fil- waqt li tkun żgur li l- ponta tal- labra qegħda fl- insulina, iġbed id - doża ta 'l- insulina li ddum taħdem għal ħin itwal.
Withdraw the needle and lay the syringe down so that the needle does not touch anything.
Neħħi l- labra mill- kunjett u poġġi s- siringa mimduda sabiex il- labra ma tmiss m' imkien.
b) Injecting a dose
b) Injezzjoni ta 'doża
Choose a site for injection.
Agħżel sit ta 'l- injezzjoni.
Clean the skin as instructed.
Naddaf il- ġilda skond l- istruzzjonijiet li rċevejt.
Stabilise the skin by spreading it or pinching up a large area.
Stabbilizza l- ġilda billi tifrixha jew billi toqros parti kbira 'l fuq.
Insert the needle and inject as instructed.
Daħħal il- labra u injetta skond l- istruzzjonijiet li rċevejt
Pull the needle out and apply gentle pressure over the injection site for several seconds.
Iġbed il- labra 'l barra u għamel pressjoni ħafifa fuq is- sit ta' l- injezzjoni għal diversi sekondi.
Do not rub the area.
Torokx il- parti fejn għamilt l- injezzjoni.
Dispose of the syringe and needle safely.
Armi l- labra u s- siringa b’ mod li ma jkunux ta ’ periklu.
Use of the injection sites should be rotated so that the same 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.
c) Mixing insulins
c) Taħlit ta 'insulini
Do not mix insulin in vials with insulin in cartridges.
Tħallatx l- insulina fil- kunjetti ma 'l- insulina fl- iskrataċ.
See section 6.2.
Ara sezzjoni 6. 2.
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.
1 x 10 ml Humalog vial 2 x 10 ml Humalog vials 5 x (1 x 10 ml) Humalog vials
1 x 10 ml kunjett ta ’ Humalog 2 x 10 ml kunjetti ta ’ Humalog 5 x (1 x 10 ml) kunjetti ta ’ Humalog
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI
30th April 1996 Date of last renewal:
30 t 'April 1996 Data ta ’ l- aħħar tiġdid:
30th April 2006
30 t’ April 2006
Humalog 100 U/ ml, solution for injection in cartridge
Humalog 100 U/ ml, soluzzjoni għall- injezzjoni fi skartoċċ
Each container includes 3ml equivalent to 300U insulin lispro.
Kull kontenitur jinkludi 3ml ekwivalenti għal 300U t' insulina lispro.
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 Humalog 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 'Humalog jiddependi fuq id- doża, is- sit ta' l- injezzjoni, il- provvista tad- demm, it- temperatura u fuq l- attività fiżika.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
11 Humalog jista 'jintuża flimkien ma' insulina umana li ddum taħdem għal ħin itwal jew sustanzi sulphonylurea li jittieħdu mill- ħalq, fuq il- parir ta 'tabib.
10 Use of Humalog in an insulin infusion pump:
Użu ta 'Humalog ġo pompa ta' l- infużjoni ta 'l- insulina
Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump.
Qabel ma tinfuża l- insulina lispro, għandhom jiġu studjati l- istruzzjonijiet tal - manifatturi biex tkun żgur jekk il- pompa hijiex dik li għandek tuża jew le.
Use the correct reservoir and catheter for the pump.
Uża l- kontenitur u l- kateter it- tajbin tal- pompa.
Use aseptic technique when inserting the infusion set.
Uża metodi asettiċi meta ddaħħal is- set ta 'l- infużjoni.
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved.
Jekk ikun hemm episodju ta ’ zokkor baxx fid- demm, l- infużjoni għandha titwaqqaf sakemm jgħaddi l- episodju.
If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion.
Jekk jerġa 'jiġri hekk jew jekk ikun hemm livelli ta ’ glucose fid- demm severament baxxi, għid lill - professjonista tal- kura tas- saħħa tiegħek u kkunsidra l- bżonn li tnaqqas jew twaqqaf l- infużjoni ta' l - insulina tiegħek.
A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
Ħsara tal- pompa jew ostaklu fis- set ta 'l- infużjoni jista' jirriżulta f' żieda mgħaġġla fil - livelli ta ’ glucose.
If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your health care professional.
Jekk taħseb li hemm waqfien fil- ħruġ ta 'l- insulina, segwi l- istruzzjonijiet fil - letteratura dwar il- prodott u jekk xieraq, għid lill- professionist tal- kura tas- saħħa tiegħek.
When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.
Meta użat b' pompa tal- infużjoni ta 'l- insulina, Humalog m' għandux jitħallat ma' xi insulina oħra.
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system.
Injezzjoni ta 'l- insulina lispro minn ġol- vini għandu jsir skond il- prattika klinika normali għall - injezzjonijiet minn ġol- vini, per eżempju bi bolus ġol- vina jew b' sistema ta' l- infużjoni.
Infusion systems at concentrations from 0.1U/ ml to 1.0U/ ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours.
Sistemi ta 'l- infużjoni f' konċentrazzjonijiet minn 0. 1 U/ ml sa 1. 0 U/ ml ta' l- insulina lispro f '0. 9% sodium chloride jew 5% dextrose huma stabbli f' temperatura ambjentali ta' ġewwa għal 48 siegħa.
It is recommended that the system is primed before starting the infusion to the patient.
Huwa rakkomandat li s- sistema tkun ipprajmata qabel ma tibda l- infużjoni lill- pazjent.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
12 Reazzjonijiet mhux ikkoreġġuti ta 'ipoglikimja jew ta' zokkor baxx jew għoli fid- demm jistgħu jikkawżaw telf mis- sensi, koma, jew mewt.
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.
11 Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Tista 'ukoll tkun neċessarja varjazzjoni fid- doża jekk il- pazjenti jagħmlu aktar attività fiżika jew jekk ibiddlu d- dieta tagħhom tas- soltu.
4.7 Effects on ability to drive and use machines
13 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.
Zokkor fid- demm severament baxx tista 'twassal għal telf mis- sensi, u f' każijiet estremi, il- mewt.
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.
Ma ġietx irrappurtata ebda frekwenza speċifika għall - ipogliċemija, peress li l- ipogliċemija hija riżultat kemm tad- doża ta ’ l- insulina kif ukoll ta ’ fatturi oħra eż. il- livell ta ’ dieta u eżerċizzju ta ’ pazjent.
12 Local allergy in patients is common (1/ 100 to < 1/ 10).
L- allerġija lokali f' pazjenti hija komuni (1/ 100 sa < 1/ 10).
Lipodystrophy at the injection site is uncommon (1/ 1,000 to < 1/ 100).
Il- lipodistrofija fis- sit ta 'l- injezzjoni m’ hijiex komuni (1/ 1, 000 sa < 1/ 100)..
Pharmacotherapeutic group: Fast-acting human insulin analogue.
Analogu ta 'l- insulina umana li ddum taħdem.