qanastek/EMEA-V3 huggingface dataset:
The terminal half-life is between 5 and 7 hours depending on dose.
Il- half life terminali huwa bejn 5 sa 7 sigħat jiddependi mid- doża.
Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
9 Il- proporzjonalità tad- doża fil- konċentrazzjonijiet tas- serum (il- konċentrazzjoni massima, il- firxa ta ’ l - assorbiment) hija osservata wara l- għoti taħt il- ġilda fil- medda tad- doża terapewtika.
The pharmacokinetic properties of insulin detemir were investigated in children (6– 12 years) and adolescents (13– 17 years) and compared to adults with type 1 diabetes.
Popolazzjonijiet Speċjali Il- karatteristiċi farmakokinetiċi ta ’ insulin detemir ġew investigati fit- tfal (6– 12- il sena) u fl - adoloxxenti (13– 17- il sena) u mqabbla ma ’ adulti b’ dijabete ta ’ tip 1.
There was no clinically relevant difference in pharmacokinetic properties.
Ma kienx hemm differenzi klinikament rilevanti fil- karatteristiċi farmakokinetiċi.
There was no clinically relevant difference in pharmacokinetics of insulin detemir between elderly and young subjects or between subjects with renal or hepatic impairment and healthy subjects.
Ma kien hemm l- ebda differenza klinikament rilevanti fil- farmakokinetiċi ta ’ insulin detemir bejn l - anzjani u individwi li għadhom żgħar jew bejn persuni b’ mard tal- kliewi jew tal- fwied u individwi f’ saħħithom.
No clinically relevant differences in the pharmacokinetics of insulin detemir are expected between healthy subjects and subjects with renal or hepatic impairment, based on the studies performed.
L- ebda differenza klinikament rilevanti fil- farmakokinetiċi ta ’ insulin detemir ma hija mistennija bejn individwi f’ saħħithom u individwi b’ mard tal- kliewi u tal- fwied, dan ibbażat fuq l - istudji li saru.
As the pharmacokinetics of insulin detemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations.
Minħabba li l- farmakokinetiċi ta ’ insulin detemir ma ġewx studjati b’ mod estensiv f’ dawn il- popolazzjonijiet, huwa rrikkmandat li l- glukosju fil- plażma jiġi mmonitorjat mill- qrib f’ dawn il- popolazzjonijiet.
9 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin..
Receptor affinity data and in-vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
L- informazzjoni dwar l- affinità tar- riċettur u testijiet tal- mitoġeiċità in- vitro ma rrilevaw l- ebda evidenza ta ’ żjieda fil- potenzjal mitoġeniku meta mqabbla ma ’ l- insulina umana.
Glycerol Phenol Metacresol Zinc acetate Disodium phosphate dihydrate Sodium chloride Hydrochloric acid 2N (pH adjustment) Sodium hydroxide 2N (pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc acetate Disodium phosphate dihydrate Sodium chloride Hydrochloric acid 2N (aġġustament tal- pH) Hydrochloric acid 2N (aġġustament tal- pH) Ilma għall- injezzjonijiet
Substances added to Levemir may cause degradation of insulin detemir, e. g. if the medicinal product contains thiols or sulphites.
Sustanzi miżjuda ma ’ Levemir jistgħu jikkawżaw id- degradazzjoni ta ’ insulin detemir, eż. jekk il - prodott mediċinali fih thiols jew sulphites.
Levemir should not be added to infusion fluids.
Levemir m’ għandux jiżdied ma ’ fluwidi għall- infużjoni.
6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċnali
30 months.
30 xahar
After first opening the product must be stored for a maximum of 6 weeks, not above 30°C.
Wara li jinfetaħ għall- ewwel darba, il- prodott għandu jinħażen għal massimu ta ’ 6 ġimgħat, f’ temperatura ta ’ mhux iżjed minn 30°C.
Store in a refrigerator (2°C - 8°C) not near a freezing compartment.
Aħżen fi friġġ (2°C – 8°C) mhux qrib xi kompartiment tal- friża.
Keep the cartridge in the outer carton in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tipproteġih mid- dawl.
During use:
10 Waqt l- użu:
Levemir should be protected from excessive heat and sunlight.
Levemir għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
3 ml solution in a cartridge (type 1 glass), with a plunger (bromobutyl) and a stopper (bromobutyl/ polyisoprene) in a carton.
Soluzzjoni ta ’ 3 ml fi skartoċċ (ħġieġ ta ’ tip 1), bi planġer (bromobutyl) u tapp (bromobutyl/ polyisoprene) f’ kartuna.
Pack size of 1, 5 and 10 cartridges.
Daqs tal- pakkett ta ’ 1, 5 u 10 skrataċ.
Levemir Penfill is designed to be used with Novo Nordisk delivery systems and NovoFine needles.
Levemir Penfill huwa maħsub biex jintuża mas- sistemi ta ’ Nordisk li jerħu l- mediċina u labar tat- tip NovoFine.
Detailed instruction accompanying the delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkompnajaw is- sistema li terħi l- mediċina għandhom jiġu segwiti.
Levemir is for use by one person only.
Levemir hu għal użu minn persuna waħda biss.
The cartridge must not be refilled.
L- iskartoċċ m’ għandux jimtela mill- ġdid.
10 Levemir should not be used if it does not appear clear and colourless.
Levemir m’ għandux jintuża jekk ma jidhirx ċar u bla kulur.
Levemir which has been frozen must not be used.
Levemir li ġie ffriżat m’ għandux jintuża.
The patient should be advised to discard the needle after each injection.
Il- pazjent għandu jingħata parir biex jarmi l- labar użati wara kull injezzjoni.
01 June 2004
1 ta ’ Ġunju 2004
Levemir 100 U/ ml solution for injection in a pre-filled pen.
Levemir 100 U/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
1 ml contains 100 U of insulin detemir (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 ml fih 100 U ta ’ insulin detemir (prodotta mit- teknoloġija rikombinanti tad- DNA fis- Saccharomyces cerevisiae).
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 pinna mimlija għal- lest fiha 3 ml ekwivalenti għal 300 U.
Levemir is a long-acting insulin analogue used as a basal insulin..
Levemir huwa analog ta ’ l- insulina li jaħdem fit- tul, użat bħala insulina bażi.
Dosage: In combination with oral antidiabetic agents it is recommended to initiate Levemir treatment with once daily administration at a dose of 10 U or 0.1-0.2 U/ kg.
Flimkien ma ’ aġenti antidijabetiċi orali, huwa rrikkmandat li l- kura b’ Levemir tibda permezz ta ’ amministrazzjoni darba kuljum f’ doża ta’ 10 U jew 0. 1- 0. 2 U/ kg.
For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
12 Għal pazjenti li jeħtieġu dożaġġ darbtejn kuljum biex jikkontrollaw aħjar il- glukosju fid- demm, id - doża ta ’ filgħaxija tista ’ tingħata filgħaxija jew f’ ħin l- irqad.
12 Transfer from other insulins:
It- trasferiment minn insulini oħrajn:
As with all insulins, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Bħall- insulini l- oħrajn kollha, huwa rrikkmandat li jsir monitoraġġ mill- qrib tal- glukosju waqt it - trasferiment u fl- ewwel ġimgħat wara t- trasferiment.
Levemir FlexPen is accompanied by a package leaflet with detailed instruction for use to be followed.
Levemir FlexPen huwa akkompanjat b’ fuljett ta ’ tagħrif li fih struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.8 and 4.9).
Ipogliċemija tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa ta ’ l - insulina (ara sezzjoni 4. 8 u 4. 9).
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.
13 Pazjenti, li l- kontroll tal- glukosju fid- demm tagħhom jitjieb bil- kbir, eż. permezz ta ’ terapija bl - insulina intensifikata, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tagħhom ta ’ ipogliċemija, u għandhom jingħataw parir kif xieraq.
13 Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
If Levemir is mixed with other insulin preparations the profile of action of one or both individual components will change.
Jekk Levemir jitħallat ma ’ preparazzjonijiet ta ’ l- insulina oħrajn, il- profil ta ’ l- azzjoni ta ’ komponent wieħed jew taż- żewġ komponenti individwali jinbidel.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Aġenti tat- tip beta- blocking jistgħu jaħbu s- sintomi ta ’ ipogliċemija u jittardjaw il- fejqan milipogliċemija.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
14 L- alkoħol jista ’ jħarrax u jtawwal l- effetti ipogliċemiċi ta ’ l- insulina.
Pregnancy:
It- tqala:
There is no clinical experience with insulin detemir during pregnancy.
M’ hemmx esperjenza klinika bi insulin detemir waqt it- tqala.
14 In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
B’ mod ġenerali, kontroll intensifikat tal- glukosju fid- demm u l- monitoraġġ ta ’ nisa tqal bid- dijabete huma rrikkmandati matul it- tqala u meta dawn in- nisa jkunu qegħdin jippjanaw li jinqabdu tqal.
There is no clinical experience with insulin detemir during lactation.
M’ hemmx esperjenza klinika b’ insulin detemir waqt it- treddigħ.
The overall percentage of treated patients expected to experience adverse drug reactions is estimated to be 12%.
Il- perċentwal totali ta ’ pazjenti ttrattati li kien mistenni li jkollhom reazzjonijiet avversi għall- mediċina huwa stmat li hu 12%.
Common (> 1/ 100, < 1/ 10)
15 Komuni (> 1/ 100, < 1/ 10) Mard ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Dawn jistgħu jinkludu għaraq kiesaħ, ġilda friska u ċara, għeja kbira, nervożiżmu jew rogħda, ansjetà, għeja jew dgħjufija mhux tas- soltu, konfużjoni, diffikultà biex tikkonċentra, ngħas, ġuħ eċċessiv, tibdil fil - vista, uġigħ ta ’ ras, dardir u palpitazzjoni.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or
Ipogliċemija serja tista ’ twassal għal telfien mis - sensi u/ jew għal konvulżjonijiet u tista ’ tirriżulta fi ħsara temporanja jew permanenti tal- funzjoni tal- moħħ jew anke f’ mewt.
Uncommon (> 1/ 1,000, < 1/ 100) Immune system disorders
Mhux Komuni (> 1/ 1000, < 1/ 100)
Uncommon (> 1/ 1,000, < 1/ 100)
Mhux Komuni (> 1/ 1, 000, < 1/ 100)
Refraction disorders:
Mard tar- rifrazzjoni:
Refraction anomalies may occur upon initiation of insulin therapy.
Anomaliji tar- rifrazzjoni jistgħu jseħħu meta tibda t- terapija bl- insulina.
Diabetic retinopathy:
Retinopatija dijabetika:
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Kontroll gliċemiku mtejjeb fit- tul inaqqas ir -
16 Nervous system disorders
16 riskju tal- progressjoni tar- retinopatija dijabetika.
• 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 by glucose given intravenously by a medical professional.
• Episodji ipoglikemiċi serji, meta l- pazjent ikun intilef minn sensih, jistgħu jiġu ttrattati bil - glucagon (0. 5 sa 1 mg) mogħti ġol- muskoli jew taħt il- ġilda minn persuna mħarrġa, jew bil - glukosju li jingħata ġol- vina minn professjonist mediku.
The time action profile of insulin detemir is statistically significantly less variable and therefore more predictable than for NPH insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Il- profil ta ’ l- azzjoni mal- ħin ta ’ insulin detemir huwa statistikament ferm inqas varjabbli u għalhekk jista ’ jitbassar iktar milli għall- insulina NPH kif jidher mill- Ko- effiċjenti tal- Varjazzjoni (CV) fl- istess suġġett għall- effett farmakodinamiku totali u massimu f ’ (Tabella 1).
*Area under the curve ** Glucose Infusion Rate p-value < 0.001 for all comparisons with insulin detemir
* Erja taħt il- kurva ** Rata ta ’ Infużjoni tal- Glukosju valur p < 0. 001 għall- paraguni kollha b’ insulin detemir
The prolonged action of insulin detemir is mediated by the strong self-association of insulin detemir molecules at the injection site and albumin binding via the fatty acid side-chain.
L- azzjoni fit- tul ta ’ insulin detemir hija mtaffija bl- assoċjazzjoni qawwija tal- molekuli ta ’ insulin detemir nfushom fis- sit ta ’ l- injezzjoni u mit- tgħaqqid ta ’ l- albumina permezz tas- side- chain ta ’ l- aċidi grassi.
Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Insulin detemir jinxtered iktar bil- mod lit- tessuti periferali fil- mira meta mqabbel ma ’ l- insulina
These combined mechanisms of protraction provide a more reproducible absorption and action profile of insulin detemir compared to NPH insulin.
Dawn il- mekkaniżmi ta ’ titwil flimkien jipprovdu assorbiment u profil ta’ azzjoni ta ’ insulin detemir iktar riproduċibbli, meta mqabbla ma ’ l- insulina NPH.
17 The blood glucose lowering effect of insulin detemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
L- effett ta ’ insulin detemir, jiġifieri li jbaxxi l- livell ta ’ glukosju fid- demm, iseħħ minħabba t- teħid faċilitat tal- glukosju wara t- tgħaqqid ta ’ l- insulina mar- riċetturi taċ- ċelluli tal- muskoli u tax- xaħam u minħabba l- inibizzjoni tal- produzzjoni tal- glukosju mill- fwied li ssir fl- istess ħin.
Pharmacodynamic Parameters for Levemir and NPH Glucose infusion rate (mg/ kg/ min)
Parametri Farmakodinamici għal Levemir u NPH
For doses in the interval of 0.2 - 0.4 U/ kg, Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Għal dożi fl- intervall ta ’ 0. 2 – 0. 4 U/ kg, Levemir jeżerċita iktar minn 50% ta ’ l- effett massimu tiegħu minn 3- 4 sigħat u sa madwar 14- il siegħa wara l- għoti tad- doża.
Dose proportionality in pharmacodynamic response (maximum effect, duration of action, total effect) is observed after subcutaneous administration.
Il- proporzjonalità tad- doża fir- rispons farmakodinamiku (l- effett massimu, it- tul ta ’ l- azzjoni, l- effett totali) huwa osservat wara l- għoti taħt il- ġilda
In trials with the use of OAD-insulin combination therapy Levemir treatment resulted lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
Fi studji fejn intuzat it- terapija kombinata ta ’ mediċini antidijabetiċi orali u insulina, bil- kura ta ’ Levemir kien hemm 61- 65% ta ’ riskju inqas ta ’ ipogliċemija ta ’ matul il- lejl minuri meta mqabbla ma ’ insulina NPH.
In long-term treatment trials in patients with type 1 diabetes, fasting plasma glucose was improved with Levemir compared with NPH insulin when given as basal/ bolus therapy including in children and adolescents aged 6 to 17 years.
18 Fi provi ta ’ trattament fit- tul f’ pazjenti bid- dijabete ta ’ tip 1, il- glukosju fil- plażma fl- istat sajjem f’ pazjenti b’ dijabete ta ’ tip 1 kien imtejjeb b’ Levemir meta mqabbel ma ’ l- insulina NPH meta mogħti bħala reġimen tat- tip basal/ bolus inkluż lil tfal u adolexxenti ta ’ bejn 6 u 17- il sena.
Glycaemic control (HbA1c) with Levemir is comparable to NPH insulin, with a lower risk of nocturnal hypoglycaemia and no associated weight gain.
Kontroll gliċemiku (HbA1c) b’ Levemir hu komparabbli ma ’ l- insulina NPH, b’ riskju inqas ta ’ ipogliċemija ta ’ matul il- lejl u l- ebda żjieda assoċjata fil- piż.
Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed 18 by capillary blood glucose less than 2.8 mmol/ L or 3.1 mmol/ L if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Analiżi ta ’ ipogliċemija ta ’ matul il- lejl f’ pazjenti b’ dijabete ta ’ tip 1 uriet riskju ferm iktar baxx ta ’ ipogliċemija ta ’ matul il- lejl minuri (u kapaċi li jikkura lilu nnifsu u kkonfermat mill- glukosju fid- demm kapillari ta ’ inqas minn 2. 8 mmol/ L jew 3. 1 mmol/ L jekk espress bħala glukosju fil- plażma) milli bl- insulina NPH, filwaqt li l- ebda differenza ma ġiet innotata f’ dijabete ta ’ tip 2.
Furthermore, the overall risk of nocturnal hypoglycaemia in children and adolescents aged 6 to 17 years with type 1 diabetes was significantly lower with Levemir compared to NPH insulin.
Barra minn hekk, ir- riskju totali ta ’ ipogliċemija matul il- lejl fit- tfal u fl - adolexxenti ta ’ bejn 6 u 17- il sena b’ dijabete tat- tip 1 kienet ferm iktar baxxa b’ Levemir meta mqabbla ma ’ insulina NPH.
There are no clinically relevant differences between genders in pharmacokinetic properties of insulin detemir.
M’ hemm l- ebda differenza klinikament rilevanti bejn is- sessi fil- karatteristiċi farmakokinetiċi ta ’ insulin detemir.
Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
Il- proporzjonalità tad- doża fil- konċentrazzjonijiet tas- serum (il- konċentrazzjoni massima, il- firxa ta ’ l - assorbiment) hija osservata wara l- għoti taħt il- ġilda fil- medda tad- doża terapewtika.
Special Populations:
Popolazzjonijiet Speċjali
The pharmacokinetic properties of insulin detemir were investigated in children (6– 12 years) and adolescents (13– 17 years) and compared to adults with type 1 diabetes.
19 Il- karatteristiċi farmakokinetiċi ta ’ insulin detemir ġew investigati fit- tfal (6– 12- il sena) u fl - adoloxxenti (13– 17- il sena) u mqabbla ma ’ adulti b’ dijabete ta ’ tip 1.
19 Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin..
Keep the pen cap on when Levemir FlexPen is not in use in order to protect from light.
Żomm it- tapp tal- pinna magħluq meta Levemir FlexPen ma jkunx qed jintuża sabiex tilqa ’ mid- dawl.
During use:
Waqt l- użu:
6.5 Nature and contents of container
20 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml solution in a cartridge (type 1 glass) with a plunger (bromobutyl) and a stopper (bromobutyl/ polyisoprene) contained in a pre-filled pen (multidose disposable pen) (polypropylene).
Soluzzjoni ta ’ 3 ml fi skartoċċ (ħġieġ ta ’ tip 1), bi planġer (bromobutyl) u tapp (bromobutyl/ polyisoprene) f’ pinna mimlija għal- lest (pinna b’ ħafna dożi li tintrema wara li tintuża) (polypropylene).
Pack size of 1, 5 and 10 pre-filled pens.
Daqs tal- pakkett ta ’ 1, 5 u 10 pinen mimlijin għal- lest.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjoniet speċjali li ghandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Levemir should not be used if it does not appear clear and colourless.
Levemir m’ għandux jintuża jekk ma jidhirx ċar u bla kulur.
20 The patient should be advised to discard the needle after each injection.
Il- pazjent għandu jingħata parir biex jarmi l- labar użati wara kull injezzjoni.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL- AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
1 ml contains 100 U of insulin detemir (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 ml fih 100 U ta ’ insulin detemir (prodotta mit- teknoloġija rikombinanti ta ’ DNA fis- Saccharomyces cerevisiae).
InnoLet
InnoLet Soluzzjoni ċara, bla kulur u newtrali.
Levemir is a long-acting insulin analogue used as a basal insulin.
Levemir huwa analog ta ’ l- insulina li jaħdem fit- tul, użat bħala insulina bażi.
22 For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
22 Għal pazjenti li jeħtieġu dożaġġ darbtejn kuljum biex jikkontrollaw aħjar il- glukosju fid- demm, id - doża ta ’ filgħaxija tista ’ tingħata filgħaxija jew f’ ħin l- irqad.
Concomitant antidiabetic treatment may need to be adjusted (dose and/ or timing of oral antidiabetic agents or concurrent short/ rapid-acting insulins).
It- trattament tad- dijabete li jingħata fl- istess ħin jista ’ jkun jeħtieġ aġġustament (id- doża u/ jew l- ħin ta ’ l- għoti ta ’ agenti antidijabetiċi orali jew ta ’ insulini li jintuzaw fl- istess ħin li jaħdmu għal tul ta ’ żmien qasir/ ta ’ malajr).
Levemir is administered subcutaneously by injection in the thigh, abdominal wall, or the upper arm.
Levemir jingħata taħt il- ġilda b’ injezzjoni fil- koxxa, fiż- żaqq, jew fin- naħa ta ’ fuq ta ’ driegħ.
Levemir InnoLet is accompanied by a package leaflet with detailed instruction for use to be followed.
Levemir InnoLet huwa akkompanjat b’ fuljett ta ’ tagħrif li fih struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti.
4.4 Special warnings and precautions for use
4. 4 Avviżi u prekawzjonijiet speċjali għall- użu
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Li taqbeż ikla jew li tagħmel eżerċizzju fiżiku qawwi mhux ippjanat jista ’ jwassal għalipogliċemija.
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.
23 Pazjenti, li l- kontroll tal- glukosju fid- demm tagħhom jitjieb bil- kbir, eż. permezz ta ’ terapija bl - insulina intensifikata, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tagħhom ta ’ ipogliċemija, u għandhom jingħataw parir kif xieraq.
23 Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Mard li jseħħ fl- istess żmien, speċjalment infezzjonijiet u kondizzjonijiet ta ’ deni, normalment iżidu l - ħtieġa ta ’ l- insulina tal- pazjent.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
24 L- alkoħol jista ’ jħarrax u jtawwal l- effetti ipogliċemiċi ta ’ l- insulina.
There is no clinical experience with insulin detemir during pregnancy.
M’ hemmx esperjenza klinika b’ insulin detemir waqt it- tqala.
24 Animal reproduction studies have not revealed any differences between insulin detemir and human insulin regarding embryotoxicity and teratogenicity.
Studji dwar ir- riproduzzjoni fl- annimali ma żvelaw l- ebda differenza bejn insulin detemir u l- insulina umana fir- rigward ta ’ l- embrijotossiċità u t- teratoġeniċità.
From clinical investigations it is known that major hypoglycaemia, defined as requirement for third party interventions, occurs in approximately 6% of the patients treated with Levemir.
Minn investigazzjonijiet kliniċi huwa magħruf li ipogliċemija maġġuri, definita bħala l- ħtieġa ta ’ intervent minn terza persuna, isseħħ f’ madwar 6% tal - pazjenti ttrattati b’ Levemir.
Common (> 1/ 100, < 1/ 10)
25 Komuni (> 1/ 100, < 1/ 10) Mard ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Severe
Dawn jistgħu jinkludu għaraq kiesaħ, ġilda friska u ċara, għeja kbira, nervożiżmu jew rogħda, ansjetà, għeja jew dgħjufija mhux tas- soltu, konfużjoni, diffikultà biex tikkonċentra, ngħas, ġuħ eċċessiv, tibdil fil - vista, uġigħ ta ’ ras, dardir u palpitazzjoni.
Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions:
Reazzjonijiet allerġiċi, reazzjonijiet potenzjalment allerġiċi, urtikarja, raxx u nfafet:
Other signs of generalised hypersensitivity may be itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Sinjali oħra ta ’ sensittività eċċessiva ġeneralizzata jistgħu jkunu ħakk tal- ġilda, għaraq, taqlib gastrointestinali, edema anġjonewrotika, diffikultajiet fit- teħid tan- nifs, palpitazzjoni u tnaqqis fil- pressjoni ta ’ demm.
Diabetic retinopathy:
Dawn is- sintomi huma normalment ta ’ natura temporanja.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Retinopatija dijabetika:
26 Nervous system disorders
26 Kontroll gliċemiku mtejjeb fit- tul inaqqas ir - riskju tal- progressjoni tar- retinopatija dijabetika.
Fast improvement in blood glucose control may be associated with the condition “ acute painful neuropathy”, which is usually reversible.
Newropatija periferali: ta ’ Titjib malajr fil- kontroll tal- glukosju fid - demm jista ’ jkun assoċjat mal- kondizzjoni “ newropatija akuta bl- uġigħ ”, li normalment hija riversibbli.
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, madankollu, l- ipogliċemija tista ’ tiżviluppa fuq medda ta ’ stadji sekwenzjali jekk jingħataw dożi qawwija wisq meta mqabbla mal - ħtieġa tal- pazjent. • Episodji ipoglikemiċi ħfief jistgħu jiġu ttrattati bl- għoti mill- ħalq ta ’ prodotti tal- glukosju jew prodotti li fihom iz- zokkor.
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Għalhekk huwa rrikkmandat li l- pazjent dijabetiku dejjem iżomm fuqu prodotti li jkun fihom iz- zokkor.
27 The blood glucose lowering effect of insulin detemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
L- effett ta ’ insulin detemir jbaxxi l- livell ta ’ glukosju fid- demm, jiġifieri li jbaxxi l- livell ta ’ glukosju fid- demm, iseħħ minħabba l - użu faċilitat tal- glukosju wara t- tgħaqqid ta ’ l- insulina mar- riċetturi taċ- ċelluli tal- muskoli u tax- xaħam u minħabba l- inibizzjoni tal- produzzjoni tal- glukosju mill- fwied li ssir fl- istess ħin.
The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
L- azzjoni tieħu sa 24 siegħa u dan jiddependi mid- doża li tista ’ tingħata darba jew darbtejn kuljum.
For doses in the interval of 0.2 - 0.4 U/ kg, Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Għal dożi fl- intervall ta ’ 0. 2 – 0. 4 U/ kg, Levemir jeżerċita iktar minn 50% ta ’ l- effett massimu tiegħu minn 3- 4 sigħat u sa madwar 14- il siegħa wara l- għoti ta ’ doża.
Dose proportionality in pharmacodynamic response (maximum effect, duration of action, total effect) is observed after subcutaneous administration.
Il- proporzjonalità ta ’ doża fir- rispons farmakodinamiku (l- effett massimu, it- tul ta ’ l- azzjoni, l- effett totali) huwa osservat wara l- għoti taħt il- ġilda.
In long-term treatment trials in patients with type 1 diabetes, fasting plasma glucose was improved with Levemir compared with NPH insulin when given as basal/ bolus therapy including in children and adolescents aged 6 to 17 years.
28 Fi provi ta ’ trattament fit- tul f’ pazjenti bid- dijabete ta’ tip 1, il- glukosju fil- plażma fl- istat sajjem f’ pazjenti b’ dijabete ta ’ tip 1 kien imtejjeb b’ Levemir meta mqabbel ma ’ l- insulina NPH meta mogħti bħala reġimen tat- tip basal/ bolus inkluż lil tfal u adolexxenti ta ’ bejn 6 u 17- il sena.
28 In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar.
Fi provi kliniċi bl- użu tat- terapija ta ’ l- insulina basal bolus, ir- rati totali ta ’ ipogliċemija ma ’ Levemir u l- insulina NPH kienu simili.
Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/ L or 3.1 mmol/ L if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Analiżi ta ’ ipogliċemija ta ’ matul il- lejl f’ pazjenti b’ dijabete ta ’ tip 1 uriet riskju ferm iktar baxx ta ’ ipogliċemija ta ’ matul il- lejl minuri (u kapaċi li jikkura lilu nnifsu u kkonfermat mill- glukosju - fid- demm kapillari ta ’ inqas minn 2. 8 mmol/ L jew 3. 1 mmol/ L jekk espress bħala glukosju fil- plażma) milli bl- insulina NPH, filwaqt li l- ebda differenza ma ġiet innotata f’ dijabete ta ’ tip 2.
Within-patient variation in absorption is lower for Levemir than for other basal insulin preparations.
Il- varjazzjoni fl- assorbiment fil- pazjenti stess hija iktar baxxa għal Levemir milli għal preparazzjonijiet oħrajn ta ’ t’ insulina bażi.
Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
Il- proporzjonalità ta ’ doża fil- konċentrazzjonijiet tas- serum (il- konċentrazzjoni massima, il- firxa ta ’ l - assorbiment) hija osservata wara l- għoti taħt il- ġilda fil- medda ta ’ doża terapewtika.
The pharmacokinetic properties of insulin detemir were investigated in children (6– 12 years) and adolescents (13– 17 years) and compared to adults with type 1 diabetes.
29 Il- karatteristiċi farmakokinetiċi ta ’ insulin detemir ġew investigati fit- tfal (6– 12- il sena) u fl - adoloxxenti (13– 17- il sena) u mqabbla ma ’ adulti b’ dijabete ta ’ tip 1.
As the pharmacokinetics of insulin detemir has not been studied extensively in these populations, it is
Minħabba li l- farmakokinetiċi ta ’ insulin detemir ma ġewx studjati b’ mod estensiv f’ dawn il- popolazzjonijiet, huwa rrikkmandat li l- glukosju fil- plażma jiġi mmonitorjat mill- qrib f’ dawn il- popolazzjonijiet.
29 advised to monitor plasma glucose closely in these populations.
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin. ta ’.
Receptor affinity data and in-vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
L- informazzjoni dwar l- affinità tar - riċettur u testijiet tal- mitoġeiċità in- vitro ma rrilevaw l- ebda evidenza ta ’ żjieda fil- potenzjal mitoġeniku meta mqabbla ma ’ l- insulina umana.
Store in a refrigerator (2°C - 8°C) not near a freezing compartment.
Aħżen fi friġġ f’ temperatura ta ’ 2oC – 8oC mhux qrib xi kompartiment tal- friża.
Keep the pen cap on when Levemir InnoLet is not in use in order to protect from light.
Żomm it- tapp tal- pinna magħluq meta Levemir InnoLet ma jkunx qed jintuża sabiex tipproteġih mid - dawl.
Levemir should be protected from excessive heat and sunlight.
30 Levemir għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
3 ml solution in a cartridge (type 1 glass) with a plunger (bromobutyl) and a stopper (bromobutyl/ polyisoprene) contained in a pre-filled pen (multidose disposable pen) (polypropylene).
Soluzzjoni ta ’ 3 ml fi skartoċċ (ħġieġ ta ’ Tip I), bi planġer (bromobutyl) u tapp (bromobutyl/ polyisoprene) f’ pinna mimlija għal- lest (pinna b’ ħafna dożi li tintrema wara li tintuża) (polypropylene).
30 Levemir should not be used if it does not appear clear and colourless.
Levemir m’ għandux jintuża jekk ma jidhirx ċar u bla kulur.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
32 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
32 A MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Levemir Penfill and FlexPen
Levemir Penfill u FlexPen
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING ANDTHE IMMEDIATE PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Levemir 100 U/ ml solution for injection in a cartridge Insulin detemir
Levemir 100 U/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulin detemir
1 ml contains 100 U (14.2 mg) of insulin detemir, rDNA,
1 ml fih 100 U (14. 2 mg) ta ’ insulin detemir, rDNA,
glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections
glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, u ilma għall- injezzjonijiet
Subcutaneous use Levemir Penfill cartridges for use with Novo Nordisk insulin devices Levemir Penfill is for use by one person only Read the package leaflet before use
Skrataċ ta ’ Levemir Penfill għal użu ma ’ strumenti ta ’ l- insulina ta ’ Novo Nordisk Levemir Penfill hu għal użu minn persuna waħda biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
SPECIAL STORAGE CONDITIONS
36 Tiffriżax Żomm l- iskartoċċ fil- kartuna ta ’ barra Waqt l- użu:
Do not refrigerate or store above 30°C
Tagħmlux fil- friġġ u taħżinx f’ temperatura ta ’ ‘ l fuq minn 30°C
MARKETING AUTHORISATION NUMBER(S)
NUMRU (/ I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Penfill
Soluzzjoni għall- injezzjoni fi skartoċċ.
SPECIAL STORAGE CONDITIONS
38 Tiffriżax Żomm il- kontenitur fil- kartuna ta ’ barra Waqt l- użu:
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPECIAL STORAGE CONDITIONS
40 Tiffriżax Żomm il- kontenitur fil- kartuna ta ’ barra Waqt l- użu:
Do not refrigerate or store above 30°C
Tagħmlux fil- friġġ u taħżinx f’ temperatura ta ’ ’ l fuq minn 30°C
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL
TIKKETTA
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM IL- PRODOTT MEDIĊINALI
Levemir 100 U/ ml solution for injection in a cartridge Insulin detemir SC use
Levemir 100 U/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulin detemir Għal użu taħt il- ġilda
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Levemir 100 U/ ml solution for injection in a pre-filled pen Insulin detemir
Insulin detemir
FlexPen
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Levemir FlexPen is for use by one person only Read the package leaflet before use
Magħmul biex jintuża ma ’ labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta ’ mhux iżjed minn 8 mm Il- labar m’ humiex inklużi Levemir FlexPen hu għal użu minn persuna waħda biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN 43 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
5 x 3 ml
FlexPen 5 x 3 ml
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mmNeedles are not included Levemir FlexPen is for use by one person only Read the package leaflet before use
Magħmul biex jintuża ma ’ labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta ’ mhux iżjed minn 8 mm Il- labar m’ humiex inklużi Levemir FlexPen hu għal użu minn persuna waħda biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN 45 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
10 x 3 ml
FlexPen 10 x 3 ml
SPECIAL STORAGE CONDITIONS
47 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
Levemir 100 U/ ml solution for injection in a pre-filled pen Insulin detemir SC use
Levemir 100 U/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulin detemir Għal użu taħt il- ġilda
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
InnoLet
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
1 x 3 ml
InnoLet 1 x 3 ml
Subcutaneous use Levemir InnoLet is especially designed to be used with NovoFine S needles.
Levemir InnoLet hu magħmul b’ mod speċjali biex jintuża mal- labar S NovoFine.
NovoFine needles are not included.
Il- labar NovoFine m’ humiex inklużi.
Levemir InnoLet is for use by one person only Read the package leaflet before use
Levemir InnoLet hu għal użu minn persuna waħda biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
EXP/ During use: use within 6 weeks
Waqt l- użu: uża fi żmien 6 ġimgħat
SPECIAL STORAGE CONDITIONS
50 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Subcutaneous use Levemir InnoLet is especially designed to be used with NovoFine S needles.
Levemir InnoLet hu magħmula b’ mod speċjali biex jintuża mal- labar S NovoFine.
SPECIAL STORAGE CONDITIONS
52 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPECIAL STORAGE CONDITIONS
54 Aħżen fi friġġ (2°C - 8°C) Tiffriżax Żomm l- għatu tal- pinna magħluq biex tipproteġih mid- dawl Waqt l- użu:
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Levemir 100 U/ ml solution for injection in a pre-filled pen Insulin detemir Sc use
Levemir 100 U/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
57 PACKAGE LEAFLET:
57 FULJETT TA ’ TAGĦRIF:
Levemir 100 U/ ml solution for injection in a cartridge Penfill insulin detemir
Levemir 100 U/ ml soluzzjoni għall- injezzjoni fi skartoċċ Penfill insulin detemir
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. – Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lin- ners jew lill- ispiżjar tiegħek. – Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lin- ners jew lill- ispiżjar tiegħek.
WHAT LEVEMIR IS AND WHAT IT IS USED FOR
X’ INHU LEVEMIR U GĦALXIEX JINTUŻA
Levemir is a human insulin analogue to treat diabetes.
Levemir huwa analog ta ’ l- insulina umana għat- trattament tad- dijabete.
It comes in a 3 ml cartridge, called Penfill, which fits into an insulin delivery system.
Jiġi fi skartoċċ ta ’ 3 ml, li jissejjaħ Penfill, li jidħol fis- sistema li terħi l- insulina.
Levemir is a long-acting human insulin analogue lowering your blood glucose.
Levemir huwa analog ta ’ l- insulina umana li jaħdem fit- tul li jbaxxi l- livell ta ’ glukosju fid- demm tiegħek.
The effect will last for up to 24 hours depending on dose.
L- effett idum sa 24 siegħa, jiddependi mid- doża.
It may be used in combination with oral antidiabetic agents or with meal-related short- or rapid acting insulins.
Jista ’ jintuża flimkien ma ’ mediċini antidijabetiċi orali jew ma ’ insulini li jaħdmu f’ ħin qasir jew ta ’ malajr u li għandhom x’ jaqsmu ma ’ l - ikliet.
BEFORE YOU USE LEVEMIR
QABEL MA TUŻA LEVEMIR
Do not use Levemir
Tużax Levemir
► If you are allergic (hypersensitive) to insulin detemir, metacresol or any of the other ingredients (see 7 Further information).
Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal insulin detemir, metacresol jew ► sustanzi oħra ta ’ insulin detemir (ara 7 Aktar tagħrif).
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
Jekk tħoss li ġejja ipo (ipo hija taqsira ta ’ reazzjoni ipogliċemika u hija sintomu ta ’ livell baxx ► ta ’ zokkor fid- demm).
See 4 What to do in an emergency for more about hypos.
Ara 4 X’ għandek tagħmel f’ każ ta ’ emerġenza, għal aktar informazzjoni dwar ipos.
Take special care with Levemir
Oqgħod attent ħafna b’ Levemir
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs
Jekk għandek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - ► tirojde Jekk qed tixrob l- alkoħol: oqgħod attent/ a għal sinjali ta ’ ipo ► Jekk qed tagħmel iktar eżerċizzju mis- soltu jew jekk trid tibdel id- dieta normali tiegħek ► Jekk inti marid: kompli ħu l- insulina tiegħek ► Jekk ser issiefer: li tivvjaġġa fuq medda ta ’ żoni tal- ħin jista ’ jaffettwa l- ħtiġijiet ta ’ l- insulina ► tiegħek
Pregnancy and breast-feeding ► If you are pregnant, planning a pregnancy or breast-feeding please contact your doctor for advice.
Tqala u Treddigħ Jekk inti tqila, qed tippjana li toħroġ tqila jew qed tredda ’ jekk jogħġbok kellem lit- tabib ► tiegħek għall- parir.
Driving and using machines ► If you drive or use tools or machines: watch out for signs of a hypo.
Sewqan u tħaddim ta ’ magni Jekk issuq jew tuża għodda jew makkinarju: oqgħod attent għal sinjali ta ’ ipo.
Your ability to concentrate or to react will be less during a hypo.
Il- ħila tiegħek ► li tikkonċentra jew tirreaġġixxi ser tkun inqas waqt ipo.
Never drive or use machinery if you feel a hypo coming on.
Qatt issuq jew tuża makkinarju jekk tħoss li ġejja ipo.
Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Iddiskuti mat- tabib tiegħek jekk fuq kollox, inti għandekx issuq jew tuża makkinarju, jekk ikollok ħafna ipos jew jekk tħossha diffiċli li tagħraf l- ipos.
There is no clinical experience with Levemir in children below the age of 6 years.
M’ hemm l- ebda esperjenza klinika b’ Levemir fi tfal taħt l- età ta ’ 6 snin.
58 Using other medicines
58 L- użu ta ’ mediċini oħrajn
Many medicines affect the way glucose works in your body and this may influence your insulin dose.
Ħafna mediċini jaffettwaw il- mod kif il- glukosju jaħdem fil- ġisem tiegħek u dan jista ’ jinfluwenza d - doża ta ’ l- insulina tiegħek.
Listed below are the most common medicines, which may affect your insulin treatment.
Elenkati hawn taħt hawn l- iktar mediċini komuni, li jistgħu jaffettwaw il - kura ta ’ l- insulina tiegħek.
Talk to your doctor or pharmacist if you take or change any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Your need for insulin may change if you also take: oral antidiabetic medicinal products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel jekk inti tieħu wkoll: prodotti mediċinali kontra d - dijabete li jittieħdu mill- ħalq, inibituri ta ’ monoamine oxidase (MAOI), beta- blockers, inibituri ta ’ l - ACE, aċidu aċetilsaliċiliku; thiazides; glucocorticoids; terapija ta ’ ormoni tat- tirojde; beta - sympathomimetics; ormon tat- tkabbir danazol; octreotide u lanreotide.
HOW TO USE LEVEMIR
KIF GĦANDEK TUŻA LEVEMIR
Talk about your insulin needs with your doctor and diabetes nurse.
Tkellem dwar il- ħtiġijiet ta ’ l- insulina tiegħek mat- tabib tiegħek u man- ners.
This leaflet is a general guide.
Dan il- fuljett huwa gwida ġenerali.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jekk it- tabib tiegħek biddillek l- insulina minn tip jew marka ta ’ insulina għal oħra, id- doża tiegħek tista ’ tkun aġġustata mit- tabib tiegħek.
Before using Levemir
Qabel tuża Levemir
► Check the label to make sure it is the right type of insulin ► Always check the cartridge, including the rubber plunger (stopper).
Iċċekkja t- tikketta biex tiżgura li l- insulina hija dik ix- xierqa ► Dejjem iċċekkja l- iskartoċċ, inkluż il- planġer tal- gomma (tapp).
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Tużahx jekk tara xi ħsara jew ► jekk tara spazju bejn il- planġer tal- gomma u l- faxxa l- bajda tat- tikketta.
See your delivery system manual for further instructions ► Disinfect the rubber membrane with a medicinal swab ► Always use a new needle for each injection to prevent contamination.
Iddiżinfetta l- membrana tal- gomma bi swab mediċinali. ► Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni. ►
Levemir must not be used
Levemir m’ għandux jintuża
► In insulin infusion pumps ► If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin ► If it hasn ’ t been stored correctly or if it has been frozen (see 6 How to store Levemir) ► If the insulin does not appear water clear and colourless.
F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk l- iskartoċċ jew l- apparat li fih l- iskartoċċ jitwaqqa ’, jiġrilu l- ħsara jew jitgħaffeġ, hemm ir - ► riskju ta ’ telf ta ’ likwidu ta ’ l- insulina Jekk ma nħażinx b’ mod korrett jew jekk ġie ffriżat (ara 6 Kif taħżen Levemir) ► Jekk l- insulina ma tidhirx ċara bħall- ilma u bla kulur. ►
Do not refill the cartridge.
Terġax timla l- iskartoċċ.
Levemir Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
L- iskrataċ ta ’ Levemir Penfill huma maħsuba biex jintużaw mas- sistemi ta ’ Novo Nordisk li jerħu l - insulina u mal- labar tat- tip NovoFine.