qanastek/EMEA-V3 huggingface dataset:
NovoNorm can also be given with metformin, another medicine for diabetes.
NovoNorm jista ’ wkoll jingħata flimkien ma ’ metformin, mediċina oħra għad- dijabete.
BEFORE YOU TAKE NOVONORM
QABEL MA TUŻA NOVONORM
Do not take NovoNorm:
Tieħux NovoNorm:
• If you are hypersensitive (allergic) to repaglinide or any of the other components of the medicine • If you have type 1 diabetes (insulin-dependent diabetes) • If the acid level in your body is raised (diabetic ketoacidosis) • If you have a severe liver disease • If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
– Jekk għandek sensittività eċċessiva (allerġiku/ a) għal repaglinide jew għal xi komponent ieħor ta ’ din il- mediċina. – Jekk inti għandek id- dijabete ta ’ tip 1 (dijabete dipendenti fuq l- insulina) – Jekk il- livell ta ’ l- aċtu fil- ġisem tiegħek jogħla (ketoaċidożi dijabetika) – Jekk għandek mard serju fil- fwied – Jekk tieħu gemfibrozil (mediċina biex tnaqqas il- livelli għoljin ta ’ xaħam fid- demm)
If any of these apply to you, tell your doctor and do not take NovoNorm.
Jekk xi waħda minn dawn tapplika għalik, għid lit- tabib tiegħek u tieħux NovoNorm.
Take special care with NovoNorm:
Oqgħod attent ħafna b’ NovoNorm:
40 • If you have liver problems.
43 – Jekk għandek problemi tal- fwied.
NovoNorm is not recommended in patients with moderate liver disease.
NovoNorm m’ huwiex rakkomandat f’ pazjenti li għandhom mard moderat fil- fwied.
NovoNorm should not be taken if you have a severe liver disease (see Do not take NovoNorm). • If you have kidney problems.
NovoNorm m’ għandux jittieħed jekk għandek mard sever tal- fwied (ara Tieħux NovoNorm). – Jekk għandek problemi fil- kliewi.
NovoNorm should be taken with caution. • If you are about to have major surgery or you have recently suffered a severe illness or infection.
NovoNorm għandu jittieħed b’ kawtela. – Jekk dalwaqt ser ikollok operazzjoni maġġuri jew jekk dan l- aħħar kellek xi marda jew infezzjoni severa.
NovoNorm is not recommended.
F’ dawn iż- żminijiet jista ’ jintilef il- kontroll dijabetiku. – Jekk għandek inqas minn 18- il sena jew iżjed minn 75 sena, NovoNorm m’ huwiex rakkomandat..
It has not been studied in these age groups.
Ma ġiex studjat f’ dawn il- gruppi ta ’ età.
NovoNorm may not be suitable for you.
Kellem lit- tabib tiegħek, jekk xi waħda minn dawn ta ’ hawn fuq tapplika għalik, NovoNorm jista ’ ma jkunx adattat għalik.
Your doctor will advise you.
It- tabib tiegħek ser jagħtik parir dwar dan.
You may get a hypo (short for a hypoglycaemic reaction and is symptoms of low blood sugar) if your blood sugar gets too low.
Jista’ jkollok ipo (taqsira ta ’ reazzjoni ipogliċemika u hija ġabra ta ’ sintomi ta ’ livell baxx ta’ zokkor fid- demm) jekk il- livell taz- zokkor fid- demm tiegħek jitbaxxa żżejjed.
This may happen: • If you take too much NovoNorm • If you exercise more than usual • If you take other medicines or suffer from liver or kidney problems (see other sections of 2.
Dan jista ’ jiġri: • Jekk tieħu wisq NovoNorm • Jekk tagħmel aktar eżercizzju mis- soltu. • Jekk tieħu mediċini oħra jew tbati minn xi problemi fil- fwied jew fil- kliewi (ara sezzjonijiet oħra ta ’ 2.
Before you take NovoNorm).
Qabel ma tieħu NovoNorm)
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistgħu jiġu għall- għarrieda u jistgħu jinkludu: għaraq kiesaħ; ġilda friska u pallida; uġigħ ta ’ ras; tħabbit mgħaġġel tal- qalb; tħossok imdardar; tħossok ħafna bil- ġuħ; tibdil temporanju fil- vista; ngħas; għeja jew dgħjufija mhux tas- soltu; nervożità jew rogħda; tħossok anzjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
If your blood sugar is low or you feel a hypo coming on: eat glucose tablets or a high sugar snack or drink, then rest.
Jekk il- livell taz- zokkor fid- demm huwa baxx jew jekk tħoss li ġejja ipo: kul pilloli tal- glucose jew ħu ikla ħafifa jew xarba li fiha ħafna zokkor, imbagħad strieħ.
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue NovoNorm treatment.
Meta s- sintomi ta ’ l- ipogliċemija jkunu għebu jew meta l- livelli taz- zokkor fid- demm ikunu stabbli, kompli l- kura b’ NovoNorm.
Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away.
Għid lin- nies li għandek id- dijabete u jekk iħossok ħażin (tintilef minn sensik) minħabba ipo, huma għandhom idawwruk fuq ġenbek u jitolbu għajnuna medika mill- aktar fis.
They must not give you any food or drink.
M’ għandhom jagħtuk l - ebda ikel jew xorb.
It could choke you. • If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death. • If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Dan jista ’ jifgak. • Jekk ipogliċemija serja ma tkunx ittrattata, din tista tikkawża ħsara fil- moħħ (temporanja jew permanenti) u anke l- mewt. • Jekk għandek ipo li jġiegħlek tintilef minn sensik, jew ħafna ipos, kellem lit- tabib tiegħek.
The amount of NovoNorm, food or exercise may need to be adjusted.
Jista ’ jkun hemm bżonn li jiġi aġġustat l- ammont ta ’ NovoNorm, ikel jew eżerċizzju.
If your blood sugar gets too high
Jekk iz- zokkor fid- demm tiegħek jitla ’ żżejjed
Your blood sugar may get too high (hyperglycaemia).
Iz- zokkor fid- demm tiegħek jista ’ jitla ’ żżejjed (ipergliċemija).
This may happen: • If you take too little NovoNorm • If you have an infection or a fever • If you eat more than usual • If you exercise less than usual.
Dan jista ’ jiġri: • Jekk tieħu ftit wisq ta ’ NovoNorm • Jekk għandek infezzjoni jew deni • Jekk tiekol aktar mis- soltu • Jekk tagħmel inqas eżerċizzju mis- soltu
The warning signs appear gradually.
Is- sinjali tat- twissija jidhru gradwalment.
They include: increased urination; feeling thirsty; dry skin and dry mouth.
Dawn jinkludu: żieda fl- awrinazzjoni; tħossok bil- għatx; ġilda xotta u ħalq xott.
Talk to your doctor.
Tkellem mat- tabib tiegħek.
The amount of NovoNorm, food or exercise may need to be adjusted.
Jista ’ jkun hemm bżonn li jiġi aġġustat l- ammont ta ’ NovoNorm, ikel jew eżerċizzju
You can take NovoNorm with metformin, another medicine for diabetes, if your doctor prescribes it.
Tista ’ tieħu NovoNorm ma ’ metformin, mediċina oħra għad- dijabete, jekk jiktiblek riċetta għaliha t - tabib.
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take NovoNorm.
Jekk tieħu gemfibrozil (użat biex inaqqas livelli għoljin ta ’ xaħam fid- demm) m’ għandekx tieħu NovoNorm.
John’ s wort (herbal medicine).
44 Il- mod kif il- ġisem tiegħek jirrispondi għal NovoNorm jista ’ jinbidel jekk tieħu mediċini oħrajn, speċejalment dawn: • Inibituri ta ’ monoamine oxidase (MAOI) (użati għall- kura tad- dipressjoni) • Beta blokkanti (użati għall- kura ta ’ pressjoni tad- demm għoli jew kundizzjonijiet tal- qalb) • Inibituri ACE (użati għall- kura ta ’ kundizzjonijiet tal- qalb) • Salicylates (eż. aspirina) • Octreotide (użat għall- kura tal- kanċer) • Mediċini antiinfjammatorji li m’ humiex sterojdi (NSAIDS) (tip ta ’ mediċina għal kontra l - uġigħ) • Sterojdi (sterojdi anaboliċi u kortikosterojdi - użati għall- anemija jew għall- kura ta ’ l - infjammazzjoni) • Kontraċettivi orali (pilloli użati għall- kontroll tat- tqala) • Thiazides (dijuretiċi jew “ pilloli biex tneħħi l- ilma żejjed ” • Danazol (użat għall- kura ta ’ ċisti fis- sider u l- endometrjożi) • Prodotti tat- tirojde (użati għall- kura ta ’ livelli baxxi ta ’ l- ormoni tat- tirojde) • Simpatomimetiċi (jintużaw biex jikkuraw l- ażma) • Clarithromycin, trimethoprim, rifampicin (mediċini antibijotiċi) • Itraconazole, ketoconazole (mediċini antifungali) • Gemfibrozil (użat għall- kura ta ’ xaħam għoli fid- demm) • Ciclosporin (jintuża biex ibaxxi s- sistema immuni) • Phenytoin, carbamazepine, Phenobarbital (użati għall- kura ta ’ l- epilessija) • St. John’ s wort (mediċina magħmula mill- ħxejjex)
Tell your doctor if you have recently taken or are planning to take any of these medicines, or any medicines obtained without a prescription.
Għid lit- tabib tiegħek jekk dan l- aħħar ħadt jew bi ħsiebek tieħu minn dawn il- mediċini jew xi mediċini oħra miksuba mingħajr riċetta.
Using NovoNorm with food and drink
Meta tuża NovoNorm ma ’ l- ikel u max- xorb
Take NovoNorm before main meals.
Ħu NovoNorm qabel l- ikliet prinċipali.
Alcohol can change the ability of NovoNorm to reduce the blood sugar.
L- alkoħol jista ’ jbiddel il- kapaċità ta ’ NovoNorm li jnaqqas iz - zoqqor fid- demm.
Watch for signs of a hypo.
Oqgħod attent għas- sinjali ta ’ ipo.
You should not take NovoNorm if you are pregnant or you are planning to become pregnant.
M’ għandekx tieħu NovoNorm jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
See your doctor as soon as possible if you become pregnant or are planning to become pregnant during treatment.
Ara t- tabib tiegħek kemm jista ’ jkun malajr jekk toħroġ tqila jew jekk qed tippjana toħroġ tqila waqt il- kura.
You should not take NovoNorm if you are breast-feeding.
M’ għandekx tieħu NovoNorm jekk inti qed tredda ’.
Your ability to drive or operate a machine may be affected if your blood sugar is low or high.
Il- kapaċità tiegħek li ssuq jew tħaddem xi makkinarju jista ’ jiġi affettwat jekk iz- zokkor fid- demm tiegħek huwa baxx jew għoli.
Bear in mind that you could endanger yourself or others.
Żomm f’ moħħok li tista ’ tiperikola lilek innifsek jew lil oħrajn.
Please ask your doctor whether you can drive a car if you: • Have frequent hypos • Have few or no warning signs of hypos.
Jekk jogħġbok għid lit- tabib tiegħek jekk tistax issuq jekk • Ikollok ipos ta ’ spiss • Ikollok ftit jew ebda sinjali ta ’ twissija ta ’ ipos
HOW TO TAKE NOVONORM
KIF GĦANDEK TIEĦU NOVONORM
Your doctor will work out your dose.
It- tabib tiegħek se jara kemm għandha tkun id- doża tiegħek.
• The normal starting dose is 0.5 mg before each main meal.
• Id- doża normali tal- bidu hi ta ’ 0. 5 mg li tittieħed qabel kull ikla prinċipali.
Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal. • The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal.
Ibla ’ l- pilloli ma ’ tazza ilma eżatt qabel jew sa 30 minuta qabel kull ikla prinċipali. • Id- doża tista ’ tkun aġġustata mit- tabib tiegħek sa massimu ta ’ 4 mg li għandha tittieħed eżatt qabel jew sa 30 minuta qabel kull ikla prinċipali.
The maximum recommended daily dose is 16 mg.
Id- doża massima rakkomandata hi ta ’ 16 mg kuljum.
Do not take more NovoNorm than your doctor has recommended.
45 Tiħux NovoNorm aktar milli rrakkomandalek it- tabib tiegħek.
Always take NovoNorm exactly as your doctor has told you.
Dejjem ħu NovoNorm eżatt kif qallek it- tabib tiegħek.
Check with your doctor if you are not sure.
Għandek taċċerta ruħek mat- tabib tiegħek jekk ikollok xi dubju.
If you take more NovoNorm than you should
Jekk tieħu aktar NovoNorm milli suppost
42 If you take too many tablets, your blood sugar may become too low, leading to a hypo.
Jekk tieħu żżejjed pilloli, iz- zokkor fid- demm tiegħek jista ’ jinżel ħafna, u dan iwassal għal ipo.
Please see If you get a hypo on what a hypo is and how to treat it.
Jekk jogħġbok ara Jekk ikollok ipo jew x’ inhi ipo u kif għandek tikkuraha.
If you forget to take NovoNorm
Jekk tinsa tieħu NovoNorm
If you miss a dose, take the next dose as usual - do not double the dose.
Jekk taqbeż doża, ħu d- doża li jmiss bħas- soltu - tiħux doża doppja.
If you stop taking NovoNorm
Jekk tieqaf tieħu NovoNorm
Be aware that the desired effect is not achieved if you stop taking NovoNorm.
Kun af li l- effett mixtieq ma jkunx milħuq jekk tieqaf tieħu NovoNorm.
Your diabetes may get worse.
Id- dijabete tiegħek tista ’ tmur għall- agħar.
If any change of your treatment is necessary contact your doctor first.
Jekk ikun hemm bżonn ta ’ xi tibdil fil- kura, l- ewwel kellem lit- tabib tiegħek.
If you have any further questions on the use of NovoNorm, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ NovoNorm, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, NovoNorm can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, NovoNorm jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Possible side effects
Effetti sekondarji li jista ’ jkollok
Common (may affect up to 1 in 10 patients) • Hypoglycaemia (see If you get a hypo).
Komuni (jistgħu jaffettwaw sa 1 minn kull 10 pazjenti)
The risk of getting a hypo may increase if you take other medicines • Stomach pain • Diarrhoea.
Ir- riskju li jkollok ipo jista ’ jiżdied jekk tieħu mediċini oħra. • Uġigħ fl- istonku • Dijarea
Rare (may affect up to 1 in 1000 patients) • Acute coronary syndrome (but it may not be due to the drug).
Rari (jistgħu jaffettwaw sa 1 minn kull 1000 pazjent) • Sindromu koronarju akut (iżda jista ’ ma jkunux minħabba l- mediċina).
Very rare (may affect up to 1 in 10,000 patients) • Allergy (such as swelling, difficulty in breathing, rapid heart beat, feeling dizzy, sweating which could be signs of anaphylactic reaction).
Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10, 000 pazjent) • Allerġija (bħal nefħa, diffikultà biex tieħu n- nifs, tħabbit mgħaġġel tal- qalb, tħossok sturdut/ a, għaraq li jistgħu jkunu sinjali ta ’ reazzjoni anafilattika).
Contact a doctor immediately • Vomiting • Constipation • Visual disturbances • Severe liver problems, abnormal liver function, increased liver enzymes in your blood.
Ikkuntattja tabib mill- aktar fis. • Rimettar • Stitikezza • Disturbi fil- vista • Problemi serji fil- fwied, funzjoni tal- fwied mhux normali, żieda fl- enzimi tal- fwied fid- demm tiegħek
Frequency unknown • Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions – see If you get a hypo).
Frekwenza mhux magħrufa • Koma ipogliċemika jew tintilef minn sensik (reazzjonijiet ipogliċemiċi gravi ħafna – ara Jekk ikollok ipo).
Contact a doctor immediately • Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin) • Feeling sick (nausea).
Ikkuntattja tabib mill- aktar fis. • Sensittività eċċessiva (bħal raxx, ħakk fil- ġilda, il- ġilda tiħmar, nefħa fil- ġilda) • Tħossok imdardar (tqalligħ).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
HOW TO STORE NOVONORM
KIF TAĦŻEN NOVONORM
Keep out of the reach and sight of children.
46 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Store in a dry place in order to protect from moisture.
Aħżen f’ post xott sabiex tilqa ’ mill- umdità.
Do not use after the expiry date.
Tużax wara d- data ta ’ skadenza.
The expiry date refers to the last date of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
This is stated on the outer carton and the blister foil.
Din tinsab fuq il- kaxxa ta ’ barra u fuq il- fojl tal- folja.
Ask your pharmacist
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
43 how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What NovoNorm contains
X’ fih NovoNorm
The active substance is repaglinide.
Is- sustanza attiva hi repaglinide.
Microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, amberlite (polacrilin potassium), povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets.
Microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, amberlite (polacrilin potassium), povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide isfar (E172) fil- pilloli ta ’ 1 mg biss u iron oxide aħmar (E172) fil- pilloli ta ’ 2 mg biss.
Three strengths of tablets are available.
Il- konċentrazzjonijiet huma:
The strengths are 0.5 mg, 1 mg and 2 mg.
0. 5 mg, 1 mg u 2 mg.
What NovoNorm looks like and contents of the pack
Id- Dehra ta ’ NovoNorm u l- kontenuti tal- pakkett
NovoNorm tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Il- pilloli NovoNorm huma tondi u konvessi u mnaqqxa bil- logo ta ’ Novo Nordisk (Apis bull).
0.5 mg tablets are white, 1 mg tablets are yellow and 2 mg tablets are peach-coloured.
Il- pilloli ta ’ 0. 5 mg huma bojod, il- pilloli ta ’ 1 mg huma sofor, u l- pilloli ta ’ 2 mg fihom il- lewn il- ħawħa.
Four blister pack sizes are available.
Erba ’ daqsijiet ta ’ pakketti ta ’ folja huma disponibbli.
Each pack contains 30, 90, 120 or 270 tablets.
Kull pakkett fih 30, 90, 120 jew 270 pillola.
Marketing authorisation holder and manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka.
100 U/ ml
NovoRapid Penfill 100 U/ ml
Cartridge (glass)
Skartoċċ (ħġieġ)
100 U/ ml
NovoRapid 100 U/ ml NovoLet
Pre-filled pen
Skartoċċ (ħġieġ) ġo pinna mimlija għal- lest
5 pre-filled pens
5 pinen mimlijin għal- lest
10 cartridges
10 skrataċ
10 pre-filled pens
10 pinen mimlijin għal- lest
100 U/ ml
NovoRapid FlexPen 100 U/ ml
3.0 ml
Skartoċċ (ħġieġ) ġo pinna 3. 0 ml mimlija għal- lest
1 pre-filled pen
pinna 1 mimlija għal- lest
100 U/ ml
NovoRapid InnoLet 100 U/ ml
Cartridge (glass) in pre-filled pen
Skartoċċ (ħġieġ) ġo pinna mimlija għal- lest
100 U/ ml
NovoRapid 100 U/ ml
5 x (1 x 10 ml) vials
5 x (1 x 10 ml) kunjetti
NovoRapid 100 U/ ml, solution for injection in a vial.
NovoRapid 100 U/ ml, soluzzjoni għall- injezzjoni f’ kunjett.
∗ produced by recombinant DNA technology in Saccharomyces cerevisiae.
∗ magħmul fis- Saccharomyces cerevisiae permezz tat- teknoloġija tad- DNA rikombinanti..
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
Unità waħda ta ’ insulin aspart tikkorrispondi għal 6 nmol, 0. 035 mg insulin aspart anidrat u mingħajr melħ.
Excipient
Sustanza mhux attiva
Metacresol…………………………… 1,72 mg/ ml
Metacresol …………………………… 1. 72 mg/ ml
Clear, colourless, aqueous, solution.
Soluzzjoni ċara, akweja u mingħajr kulur.
Treatment of patients with diabetes mellitus.
Kura ta ’ pazjenti bid- dijabete mellitus.
NovoRapid has a faster onset and a shorter duration of action than soluble human insulin.
NovoRapid jibda jaħdem aktar malajr u jdum jaħdem inqas minn insulina umana solubbli.
Due to the faster onset of action, NovoRapid should generally be given immediately before a meal.
Minħabba li jaħdem aktar f’ malajr, NovoRapid ġeneralment għandu jingħata immedjatament qabel l- ikel.
When necessary NovoRapid can be given soon after a meal.
Fejn meħtieġ, NovoRapid jista ’ jingħata ftit wara l- ikel.
Dosage of NovoRapid is individual and determined on the basis of the physician’ s advice in accordance with the needs of the patient.
Id- doża ta ’ NovoRapid tvarja minn pazjent għal pazjent u tiġi stabbilita fuq il- bażi tal- parir tat- tabib skond il- ħtiġijiet tal- pazjent.
It should normally be used in combination with intermediate- acting or long-acting insulin given at least once a day.
Normalment għandu jintuża flimkien ma ’ insulina li taġixxi b’ effett intermedju jew insulina li taġixxi fit- tul, mogħti għall- inqas darba kuljum.
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 U/ kg/ day.
Il- ħtieġa individwali ta ’ l- insulina fl- adulti u fit- tfal hija normalment bejn 0. 5 u 1. 0 U/ kg/ jum.
In a meal-related treatment 50– 70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin.
F’ kura li għandha x’ taqsam ma ’ l- ikel, 50– 70% ta ’ l- insulina tista ’ tingħata bħala NovoRapid u l- bqija bħala insulina li taġixxi b’ mod intermedju jew fit- tul.
NovoRapid is administered subcutaneously in the abdominal wall, the thigh, the deltoid region or the gluteal region.
NovoRapid jingħata taħt il- ġilda, fiż- żaqq, fil- koxxa, fiż- żona tad- deltojd jew fiż- żona gluteali.
Injection sites should be rotated within the same region.
Għal kull żona, il- postijiet minn fejn tingħata l- injezzjoni għandhom jinbidlu ta ’ spiss.
When injected subcutaneously into the abdominal wall, the onset of action will occur within 10– 20 minutes of injection.
Meta injettata taħt il - ġilda fiż- żaqq, is- soluzzjoni tibda taħdem fi żmien 10- 20 minuta mill- injezzjoni.
The maximum effect is exerted between 1 and 3 hours after the injection.
L- effett massimu jseħħ bejn 1 u 3 sigħat wara l- injezzjoni.
The duration of action is 3 to 5 hours.
Idum jaħdem bejn 3 u 5 sigħat.
As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Bħall- insulini kollha, kemm idum jaħdem ivarja skond id- doża, il- post ta ’ l- injezzjoni, iċ- ċirkolazzjoni tad- demm, it- temperatura u l- livell ta ’ attività fiżika.
As with all insulins, subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites.
Bħall- insulini kollha, injezzjoni taħt il- ġilda fiż- żaqq tiżgura assorbiment aktar mgħaġġel minn postijiet oħrajn fejn tingħata l- injezzjoni.
However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site.
Iżda indipendentement minn fejn tingħata l- injezzjoni, il- bidu ta ’ l- azzjoni hija dejjem aktar malajr meta mqabbel ma ’ insulina umana solubbli.
2 If necessary, NovoRapid may also be administered intravenously (see section 6.6) which should be carried out by health care professionals.
Dan għandu jsir minn professjonisti fil- kura tas- saħħa.
NovoRapid may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion.
NovoRapid jista ’ jintuża għal Infużjoni ta ’ l- Insulina Kontinwa minn taħt il- Ġilda (CSII) f’ sistemi ta ’ pompi xierqa għall- infużjoni ta ’ l- insulina.
CSII should be administered in the abdominal wall.
CSII għandha tingħata fiż- żaqq.
Infusion sites should be rotated.
Il- postijiet minn fejn tingħata l- infużjoni għandhom jinbidlu ta ’ spiss.
When used with an insulin infusion pump NovoRapid should not be mixed with any other insulin.
Meta użat ma ’ pompa għall- infużjoni ta ’ l- insulina, NovoRapid m’ għandux jitħallat ma ’ xi insulina oħra.
Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see section 6.6).
Pazjenti li jużaw CSII għandhom jingħataw istruzzjonijiet dettaljati dwar l- użu tas- sistema tal- pompa, u għandhom jużaw ir- reċipjent u t- tubi korretti għall- pompa (ara sezzjoni 6. 6.).
The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
Is- sett ta ’ l- infużjoni (tubi u kannula) għandu jinbidel skond l- istruzzjonijiet li hemm fl- informazzjoni dwar il- prodott mogħti mas- sett ta ’ l- infużjoni.
Patients administering NovoRapid by CSII must have alternative insulin available in case of pump system failure.
Pazjenti li jieħdu NovoRapid bis- CSII għandu jkollhom insulina alternattiva disponibbli f’ każ li s - sistema tal- pompa ma taħdimx.
Renal or hepatic impairment may reduce the patient's insulin requirements.
Indeboliment renali jew epatiku jista ’ jnaqqas il- ħtieġa tal- pazjent għall- insulina.
Careful glucose monitoring and dose adjustments of insulin aspart are recommended in these patients.
Huwa rakkomandat li f’ dawn il- pazjenti, ikun hemm monitoraġġ mill- qrib tal- glucose u aġġustamenti fid- doża ta ’ insulin aspart.
No studies have been performed in children under the age of 2 years.
Ma sarux studji fi tfal taħt l- età ta ’ sentejn.
NovoRapid can be used in children in preference to soluble insulin human when a rapid onset of action might be beneficial (see section 5.1. and 5.2).
NovoRapid jista ’ jintuża fit- tfal minflok l- insulina umana solubbli meta l- azzjoni mgħaġġla ta ’ l - insulina tista ’ tkun ta ’ benefiċċju (ara sezzjoni 5. 1 u 5. 2).
For example, in the timing of the injections in relation to meals.
Per eżempju, għal injezzjonijiet li jingħataw viċin il- ħin ta’ l- ikel.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi • Ipogliċemija
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 ’ dożi li m’ humiex adegwati jew it- twaqqif tal- kura, speċjalment f’ dijabetiċi li jiddependu fuq l- insulina, jista ’ jwassal għall- ipergliċemija jew ketoaċidożi dijabetika, kundizzjonijiet li potenzjalment jistgħu jwasslu għal mewt.
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Pazjenti li jkollhom titjib kbir fil- kontroll tal- glucose fid- demm, eż., b’ kura ta ’ insulina intensiva, għandhom jiġu avżati li jistgħu jesperjenzaw tibdil fis- sintomi ta ’ twissija normali tagħhom ta ’ ipogliċemija.
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- farmakodinamika ta ’ analogi ta ’ l- insulina li jaħdmu b’ mod malajr hija li jekk isseħħ l- ipogliċemija, din tista ’ sseħħ aktar kmieni wara l- injezzjoni meta mqabbla ma ’ insulina umana solubbli.
NovoRapid should be administered in immediate relation to a meal.
NovoRapid għandu jingħata viċin il- ħinijiet ta ’ l- ikel.
The rapid onset of action should therefore be considered in patients with concomitant diseases or medication where a delayed absorption of food might be expected.
Għalhekk f’ pazjenti li għandhom mard jew trattamenti farmakoloġiċi konkomitanti li jistgħu jittardjaw l- assorbiment ta ’ l- ikel għandu jiġi kkunsidrat il- mod mgħaġġel li bih jaħdem il- prodott medicinali.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Mard konkomitanti, speċjalment infezzjonijiet, ħafna drabi jżidu l- ħtieġa tal- pazjenti għall- insulina.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Meta pazjenti jiġu ttrasferiti għal tipi differenti ta ’ prodotti ta ’ l- insulina, l- ewwel sintomi ta ’ twissija ta ’ l- ipogliċemija jistgħu jinbidlu jew ikunu inqas qawwija minn dawk li kienu jħossu bl- insulina li kellhom qabel.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
3 It- trasferiment ta ’ pazjent għal tip jew għamla oħra ta ’ insulina għandu jsir taħt superviżjoni medika stretta.
Patients taking NovoRapid may require an
Tibdil fil- qawwa, għamla, tip, speċje (ta ’ l- annimali, umana jew analogu ta ’ l- insulina umana) u/ jew metodu tal- manifattura jista ’ jirriżulta f’ tibdil fid- doża.
3 increased number of daily injections or a change in dosage from that used with their usual insulins.
Il- pazjenti li jieħdu NovoRapid jistgħu jkollhom bżonn numru ogħla ta ’ injezzjonijiet kuljum jew li jkun hemm xi tibdil fid- doża minn dik użata fl- insulini normali tagħhom.
If an adjustment is needed, it may occur with the first dose or during the first several weeks or months.
Jekk ikun meħtieġ aġġustament, dan jista ’ jseħħ ma ’ l- ewwel doża jew waqt l- ewwel ġimgħat jew xhur.
As with any insulin, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Bħal kull terapija oħra bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
Reactions usually resolve in a few days to a few weeks.
Li fl- istess żona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jgħin biex inaqqas jew jimpedixxi dawn ir - reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ġranet jew ġimgħat.
On rare occasions, injection site reactions may require discontinuation of NovoRapid.
F’ okkażjonijiet rari, minħabba r- reazzjonijiet fil- post ta ’ l- injezzjoni jista ’ jkun hemm il- bżonn li NovoRapid jitwaqqaf
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Ikla maqbuża jew eżerċizzju fiżiku iebes jistgħu jwasslu għall- ipogliċemija.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Aġġustament tad- doża jista ’ jkun meħtieġ ukoll jekk il- pazjenti jagħmlu aktar eżerċizzju fiżiku jew jibdlu d- dieta tagħhom tas- soltu.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
L- eżerċizzju li jseħħ minnufih wara ikla jista ’ jżid ir- riskju ta ’ l- ipogliċemija.
NovoRapid contains metacresol, which in rare cases may cause allergic reactions.
NovoRapid fih metacresol, li f’ każijiet rari jista ’ jikkawża reazzjonijiet allerġiċi.
A number of medicinal products are known to interact with the glucose metabolism.
Numru ta ’ prodotti mediċinali huma magħrufa li jinteraġixxu mal- metaboliżmu tal- glucose.
The following substances may reduce the patient's insulin requirements:
Dawn is- sustanzi jistgħu jnaqqsu l- ħtieġa għall- insulina:
Oral hypoglycaemic agents (OHAs), octreotide, monoamine oxidase inhibitors (MAOIs), non-selective beta-adrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Sustanzi ipogliċemiċi orali (OHAs), octreotide, inibituri ta ’ monoamine oxidase (MAOI), sustanzi blokkanti beta- adrenerġiċi mhux selettivi, inibituri ta ’ angiotensin converting enzyme (ACE), saliċilati, alkoħol, sterojdi anaboliċi u sulfonamidi.
The following substances may increase the patient's insulin requirements:
Dawn is- sustanzi jistgħu jżidu l- ħtieġa għall- insulina:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Kontraċettivi orali, tajażidi, glukokortikojdi, ormoni tat- tirojde, simpatomimetiċi u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Imblokkaturi tar- riċetturi Beta jistgħu jaħbu s- sintomi ta ’ l- ipogliċemija.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
L- alkoħol jista ’ jintensifika u jtawwal l- effett ipogliċemiku ta ’ l- insulina.
NovoRapid (insulin aspart) can be used in pregnancy.
NovoRapid (insulin aspart) jista ’ jintuża fit- tqala.
Data from two randomised controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/ newborn when compared to insulin human (see section 5.1).
Informazzjoni minn żewġ studji kliniċi magħmula b’ mod arbitrarju u kkontrollati (rispettivament 157 u 14- il tqala esposti għal insulin aspart) ma taw ebda indikazzjoni ta ’ effett avvers ta ’ insulin aspart fuq it- tqala jew fuq is- saħħa tal- fetu/ tarbija tat - twelid meta mqabbel ma ’ l- insulina umana (ara sezzjoni 5. 1).
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy.
Huwa rakkomandat li jiżdied il- kontroll tal- glucose fid- demm u l- monitoraġġ ta ’ nisa tqal bid- dijabete (dijabete ta 'tip 1, dijabete ta' tip 2 jew dijabete ta ’ waqt it- tqala) matul it- tqala kollha u meta tkun qeda tiġi ppjanata t- tqala.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Il- ħtiġijiet ta ’ l- insulina normalment jonqsu fl- ewwel trimestru u sussegwentement jiżdiedu matul it- tieni u t- tielet trimestru.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Wara l- ħlas, il- ħtieġa għall- insulina terġa ’ lura malajr għal- livelli ta ’ qabel it- tqala.
There are no restrictions on treatment with NovoRapid during lactation.
M’ hemmx restrizzjonijiet għall- kura b’ NovoRapid waqt it- treddigħ.
Insulin treatment of the nursing mother presents no risk to the baby.
Il- kura bl- insulina, ta ’ ommijiet li qed ireddgħu, ma tippreżentax riskju għat- tarbija.
However, the NovoRapid dosage may need to be adjusted.
Iżda d- doża ta ’ NovoRapid tista ’ teħtieġ li tiġi aġġustata.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il- kapaċità tal- pazjent li jikkonċentra u li jirreaġixxi tista ’ tonqos minħabba l- ipogliċemija.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ jikkostitwixxi riskju f’ sitwazzjonijiet fejn dawn il- kapaċitajiet huma ta ’ importanza kbira (eż sewqan ta ’ karozza jew tħaddim ta ’ magni).
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom jiġu avżati biex jieħdu prekawzjonijiet biex jevitaw l- ipogliċemija waqt is - sewqan.
This is particularly important in those who have reduced or absent awareness of the warning signs of
Dan huwa partikolarment importanti f’ dawk li għandhom ftit jew m’ għandhom ebda għarfien tas- sinjali ta ’ twissija ta ’ l- ipogliċemija jew li għandhom episodji frekwenti ta ’ ipogliċemija.
The advisability of driving should be considered in these circumstances.
F’ dawn iċ- ċirkostanzi m’ huwiex irrakkomandat is- sewqan.
Adverse drug reactions observed in patients using NovoRapid are mainly dose-dependent and due to the pharmacologic effect of insulin.
Ir- reazzjonijiet avversi tal- mediċina osservati f’ pazjenti li jużaw NovoRapid huma primarjament dipendenti fuq id- doża u huma minħabba l- effett farmakoloġiku ta ’ l- insulina.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Bħall- prodotti oħrajn ta ’ l- insulina, fil- biċċa l- kbira tal- każi, l- ipogliċemija hija l- effett mhux mixtieq l- aktar komuni.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Tista ’ sseħħ jekk id- doża ta ’ l- insulina hija għolja wisq fir- rigward tal- ħtieġa ta ’ l- insulina.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
L- ipogliċemija severa tista ’ twassal għal telf tas- sensi u/ jew konvulżjonijiet u tista ’ tirriżulta fi ħsara temporanja jew permanenti fil- funzjoni tal- moħħ jew saħansitra f’ mewt.
In clinical trials and during marketed use the frequency varies with patient population and dose regimens therefore no specific frequency can be presented.
Fi studji kliniċi u waqt l- użu fis- suq, il- frekwenza tvarja skond il- popolazzjoni ta ’ pazjenti u l- iskeda tad- doża u għalhekk ma tista ’ tiġi ppreżentata l- ebda frekwenza speċifika.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Matul l- istudji kliniċi. l - ammont totali ta ’ każijiet ta ’ ipogliċemija ma kienx differenti bejn pazjenti kkurati b’ insulin aspart u dawk ikkurati b’ insulina umana.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Il- frekwenzi tar- reazzjonijiet avversi tal- mediċina li ġew evidenzjati minn studji kliniċi u li b’ evalwazzjoni sħiħa jitqiesu li għandhom x’ jaqsmu ma ’ insulin aspart huma mniżżlin hawn taħt.
The frequencies are defined as:
Il - frekwenzi huma definiti bħala:
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Każijiet spontanji iżolati huma ppreżentanti bħala rari ħafna definiti bħala (< 1/ 10, 000), inklużi rapporti iżolati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond il- gravità tagħhom, bl - aktar gravi jitniżżel l- ewwel.
Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx tal- ġilda ġeneralizzat, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultajiet fit- teħid tan- nifs, tħabbit mgħaġġel tal- qalb u tnaqqis fil- pressjoni tad- demm.
Generalised hypersensitivity reactions are potentially life threatening.
Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzata jistgħu jkunu ta ’ periklu għall- ħajja.
Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Disturbi fis- sistema nervuża Rari - Newropatija periferali Titjib ta ’ malajr fil- kontroll tal- glucose fid- demm jista ’ jiġi assoċjat ma ’ kundizzjoni msejħa newropatija akuta bl- uġigħ, li ħafna drabi hija riversibbli.
These symptoms are usually of transitory nature.
Disturbi fl- għajnejn Mhux komuni - Disturbi rifrazzjonali Fil- bidu tal- kura bl- insulina jistgħu jseħħu anomaliji ta ’ rifrazzjoni. Dawn is- sintomi huma normalment ta ’ natura tranżitorja.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Mhux komuni - Retinopatija dijabetika Titjib fil- kontroll gliċemiku fuq perijodu ta ’ żmien twil inaqqas ir- riskju ta ’ progressjoni tar - retinopatija dijabetika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Madankollu, l- intensifikazzjoni tat- terapija bl- insulina b’ titjib f’ salt fil- kontroll gliċemiku jista ’ jiġi assoċjat ma ’ aggravar tar- retinopatija dijabetika.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
5 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni - Lipodistrofija Jista ’ jkollok lipodistrofija fil- post minn fejn tingħata l- injezzjoni minħabba l- fatt li f’ dik iż- żona ma tkunx biddilt b’ mod regolari l- post minn fejn tingħata l- injezzjoni.
These reactions are usually transitory and normally they disappear during continued treatment.
Mhux komuni - Sensittività eċċessiva lokali Reazzjonijiet ta ’ sensittività eċċessiva lokali (ħmura, nefħa u ħakk fil- post ta ’ l- injezzjoni) jistgħu jseħħu waqt il- kura bl- insulina Ħafna drabi dawn ir- reazzjonijiet huma tranżitorji u normalment jisparixxu meta titkompla l- kura.
These symptoms are usually of transitory nature.
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Mhux komuni – Edema Edema tista ’ sseħh fil- bidu tal- kura bl- insulina, Ħafna drabi dawn is- sintomi huma ta ’ natura tranżitorja.
A specific overdose for insulin cannot be defined however hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Doża eċċessiva speċifika għall- insulina ma tistax tiġi definita, iżda l- ipogliċemija tista ’ tiżviluppa fi stadji sekwenzjali jekk jiġu mgħotija dożi għoljin wisq fil- konfront tal- ħtieġa tal- pazjent:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Episodji ħfief ta ’ ipogliċemija jistgħu jkunu kkurati bit- teħid orali tal- glucose jew ta ’ prodotti li fihom iz- zokkor.
It is therefore recommended that the diabetic patient constantly carry sugar containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or glucose given intravenously by a medical professional.
Huwa għalhekk rakkomandat li l- pazjent dijabetiku dejjem iġorr xi prodotti li fihom iz- zokkor • Episodji ta ’ ipogliċemija severa, fejn il- pazjent jintilef minn sensih, jistgħu jiġu kkurati bil - glucagon (0. 5 sa 1 mg) mogħti minn ġol- muskoli jew minn taħt il- ġilda minn persuna mħarrġa, jew bil- glucose mogħti minn ġol- vini minn professjonist mediku.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Il- glucose għandu wkoll jingħata minn ġol- vini jekk fi żmien 10 sa 15- il minuta l- pazjent ma jirrispondix għal glucagon.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jerġa ’ jiġi f’ sensih, huwa rakkomandat li l- pazjent jingħata l- karboidrati b’ mod orali sabiex ma jerġax jirkadi.
Pharmacotherapeutic group: insulins and analogues for injection, fast-acting.
Kategorija farmakoterapewtika: insulini u analogi għall- injezzjoni, li jaġixxu malajr.
ATC code A10AB05.
Kodiċi ATC A10AB05.
The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
L- effett ta ’ l- insulina li tbaxxi l- livell taz- zokkor fid- demm iseħħ meta l- molekuli jingħaqdu mar - riċetturi ta ’ l- insulina fiċ- ċelluli tal- muskoli u tax- xaħam u b’ hekk tiġi faċilitata d- dħul ta ’ glucose f’ dawn iċ- celluli - u fl- istess ħin jiġi inibit il- produzzjoni ta ’ glucose mill- fwied.
NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal.
Fuq bażi ta ’ evalwazzjoni magħmula fl- ewwel erba ’ sigħat wara ikla, NovoRapid, meta mqabbel ma ’ l - insulina umana solubbli, jipprovdi azzjoni aktar mgħaġġla, kif ukoll konċentrazzjoni ta ’ glucose aktar baxxa.
NovoRapid has a shorter duration of action compared to soluble human insulin after subcutaneous injection.
Wara injezzjoni minn taħt il- ġilda, NovoRapid idum jaħdem inqas meta mqabbel ma ’ insulina umana solubbli.
Blood glucose (mmol/ l)
14 Blood glucose (mmol/ l) Glucose fid- demm (mmol/ l)
I.
10
Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose with NovoRapid compared to soluble human insulin (Fig.
Konċentrazzjonijiet tal- glucose fid- demm wara doża waħda qabel l- ikel ta ’ NovoRapid injettat immedjatament qabel ikla (kurva sħiħa) jew insulina umana solubbli mogħtija 30 minuta qabel ikla (kurva mhux sħiħa) f’ pazjenti bid- dijabete mellitus tat- tip 1.
I).
Adulti.
In two long-term open label trials in patients with type 1 diabetes comprising 1070 and 884 patients, respectively, NovoRapid reduced glycosylated haemoglobin by 0.12 [95% C. I.
Studji kliniċi f’ pazjenti bid- dijabete tat- tip 1 urew livell aktar baxx ta ’ glucose fid- demm wara l- ikel b’ NovoRapid meta mqabbel ma ’ insulina umana solubbli (Fig I.) F’ żewġ studji open label fit- tul f’ pazjenti bid- dijabete tat- tip 1 li kienu magħmulin minn 1070 u 884 pazjent rispettivament, NovoRapid naqqas l- emoglobina glikosilata b’ 0. 12 [95% C. I.
0.03; 0.22] percentage points and by 0.15 [95% C. I.
0. 03; 0. 22] punt perċentwali u b’ 0. 15 [95% C. I.
0.05; 0.26] percentage points compared to human insulin; a difference of doubtful clinical significance.
0. 05; 0. 26] punt perċentwali meta mqabbel ma ’ insulina umana; differenza li s- sinifikat kliniku tiegħu huwa dubjuż.
Elderly.
Anzjani.
The relative differences in the pharmacodynamic properties (GIRmax, AUCGIR, 0- 120 min) between insulin aspart and human insulin in elderly were similar to those seen in healthy subjects and in younger subjects with diabetes.
Studju farmakokinetiku/ farmakodinamiku cross- over, double- blind u magħmul b’ mod arbitrarju kkompara insulina aspart ma ’ insulina umana solubbli f’ pazjenti adulti bid- dijabete tat- tip 2 (19- il pazjent b’ etajiet bejn 65- 83 sena, età medja ta ’ 70 sena). Id- differenzi relattivi fil- karatteristiċi farmakodinamiċi (GIRmax, AUCGIR, 0- 120 min) bejn insulina aspart u insulina umana fl- anzjani kienu simili għal dawk li kien hemm f’ suġġetti b’ saħħithom u f’ suġġetti iżgħar bid- dijabete
Children and adolescents.
Tfal u adolexxenti.
A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those four were younger than 4 years old) and a single dose PK/ PD trial was performed in children (6-12 years) and adolescents (13-17 years).
Ġie magħmul studju kliniku li qabbel l- insulina umana solubbli mgħoti qabel l- ikel ma 'l- insulin aspart mgħoti wara l- ikel fi tfal żgħar (20 pazjent li kellhom minn sentejn sa inqas minn 6 snin, li kienu studjati għal 12- il ġimgħa, li fosthom kien hemm erbgħa li kellhom inqas minn 4 snin) u studju farmakokinetiku/ farmakodinamiku b' doża waħda ġie magħmul fit- tfal (6 sa 12- il sena) u fl - adolexxenti (13 sa 17- il sena).
The pharmacodynamic profile of insulin aspart in children was similar to that seen in adults.
Il- profil farmakodinamiku ta 'insulin aspart fit- tfal kien simili għal dak li kien osservat fl- adulti.
Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycaemia with insulin aspart compared with soluble human insulin.
Studji kliniċi f’ pazjenti bid- dijabete tat- tip 1 urew li hemm inqas riskju ta ’ ipogliċemija mal- lejl bl - insulin aspart meta mqabbel ma ’ insulina umana solubbli.
The risk of daytime hypoglycaemia was not significantly increased.
Ir- riskju ta ’ l- ipogliċemija waqt il- jum ma żdiedtx b’ mod sinifikanti.
A clinical trial comparing safety and efficacy of insulin aspart vs. insulin human in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart:
Studju kliniku li qabbel is- sigurtà u l- effikaċja ta 'insulin aspart ma' dawk ta ’ l- insulina umana fil- kura ta 'nisa tqal li kellhom dijabete ta' tip 1 (322 nisa tqal li kienu esposti (insulin aspart:
157; insulin human:
157; insulina umana:
165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/ newborn.
165)) ma wera ebda effett avvers ta 'insulin aspart fuq it- tqala jew fuq is- saħħa tal - fetu/ tarbija tat- twelid.
In addition the data from a clinical trial including 27 women with gestational diabetes randomised to treatment with insulin aspart vs. insulin human (insulin aspart:
7 Barra minn hekk, ir- riżultati minn studju kliniku li kien jinkludi 27 mara li kellhom id- dijabete waqt it - tqala u li b’ mod arbitrarju ngħataw trattament b’ insulin aspart jew b’ insulina umana (insulin aspart:
14; insulin human:
14; insulina umana:
13) showed similar safety profiles between treatments.
13) urew profili ta ’ sigurtà simili bejn it- trattamenti.
Insulin aspart is equipotent to soluble human insulin on a molar basis.
Insulin aspart f’ konċentrazzjoni ugwali (molarità) huwa ekwipotenti għall- insulina umana solubbli.
In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin.
F' NovoRapid, is- sostituzzjoni ta ’ l- amino- aċidu proline b’ aspartic acid fil- pożizzjoni B28 tnaqqas it - tendenza li jiġu ffurmati hexamers kif tabilħaqq jiġri bl- insulina umana solubbli.
NovoRapid is therefore more rapidly absorbed from the subcutaneous layer compared to soluble human insulin.
NovoRapid għalhekk jiġi assorbit aktar malajr mill- istrat ta ’ taħt il- ġilda meta mqabbel ma ’ insulina umana solubbli.