qanastek/EMEA-V3 huggingface dataset:
The time to maximum concentration is, on average, half of that for soluble human insulin.
Il- ħin biex jilħaq il- konċentrazzjoni massima, huwa bħala medja, nofs dak ta ’ l- insulina umana solubbli.
A mean maximum plasma concentration of 492±256 pmol/ l was reached 40 (interquartile range:
Bħala medja, f’ pazjenti bid- dijabete tat- tip l, il- konċentrazzjoni massima fil- plażma ta ’ 492±256 pmol/ l intlaħqet 40 (marġni interkwartili:
30– 40) minutes after a subcutaneous dose of 0.15 U/ kg bodyweight in type 1 diabetic patients.
30– 40) minuta wara doża ta ’ 0. 15 U/ kg piż tal - ġisem mgħotija minn taħt il- ġilda.
The insulin concentrations returned to baseline about 4 to 6 hours after dose.
Il- konċentrazzjonijiet ta ’ l- insulina rritornaw għall- livelli bażilari madwar 4 sa 6 sigħat wara li ngħatat id- doża.
The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/ l) and later tmax (60 (interquartile range:
Ir- rata ta ’ l- assorbiment kienet xi ftit aktar bil- mod fil - pazjenti bid- dijabete tat- tip 2, li rriżulta f’ Cmax aktar baxx (352±240 pmol/ l) u ttardjar fit- tmax (60 (marġni interkwartili:
50– 90) minutes).
50– 90) minuta).
The intra-individual variability in time to maximum concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intra- individual variability in Cmax for NovoRapid is larger.
Il- varjabilità fil- pazjent stess fil- ħin biex jilħaq il - konċentrazzjoni massima hija inqas b’ mod sinifikanti għal NovoRapid milli hi għall- insulina umana solubbli, waqt li l- varjabilità fil- pazjent stess f’ Cmax hija akbar għal NovoRapid.
Children and adolescents.
Tfal u adolexxenti:
The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children (6– 12 years) and adolescents (13– 17 years) with type 1 diabetes.
Il- karatteristiċi farmakokinetiċi u farmakodinamiċi ta ’ NovoRapid ġew investigati fit- tfal (6 snin sa 12- il sena) u adolexxenti (13 sa 17- il sena) bid- dijabete tat- tip 1.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Insulin aspart ġie assorbit malajr fiż- żewġ gruppi ta ’ etajiet, b’ tmax simili għal dak ta ’ l- adulti.
However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid.
Iżda, Cmax kien differenti bejn il- gruppi ta ’ etajiet, li jenfasizza l- importanza ta ’ dożaġġ individwali ta ’ NovoRapid.
A decreased absorption
Id- differenzi relattivi fil- karatteristiċi farmakokinetiċi bejn insulina aspart u insulina umana solubbli fl- anzjani (65 sa 83 sena, età medja 70 sena) bid- dijabete tat- tip 2 kienu simili għal dawk li kien hemm f’ suġġetti b’ saħħithom u f’ suġġetti iżgħar bid- dijabete.
7 rate was observed in elderly subjects, resulting in a later tmax (82 (interquartile range:
Ġie osservat tnaqqis fir- rata ta ’ assorbiment f’ suġġetti anzjani, li rriżulta f’ tmax itwal (82 (marġni interkwartili:
60-120) minutes), whereas Cmax was similar to that observed in younger subjects with type 2 diabetes and slightly lower than in subjects with type 1 diabetes.
60- 120) minuta), filwaqt li s- Cmax kien simili għal dak osservat f’ suġġetti iżgħar bid- dijabete tat- tip 2 u ftit inqas minn dak ta ’ suġġetti bid- dijabete tat- tip 1.
A single dose pharmacokinetic study of insulin aspart was performed in 24 subjects with hepatic function ranging from normal to severely impaired.
Studju farmakokinetiku b’ doża waħda ta ’ insulina aspart ġie magħmul f’ 24 suġġett b’ funzjoni epatika li tvarja minn normali għal indeboliment sever.
In subjects with hepatic impairment absorption rate was decreased and more variable, resulting in delayed tmax from about 50 min in subjects with normal hepatic function to about 85 min in subjects with moderate and severe hepatic impairment.
F’ suġġetti b’ indeboliment epatiku, ir- rata ta ’ assorbiment naqset u kienet aktar varjabbli li wassal biex it- tmax. jittardja minn madwar 50 min. f’ suġġetti b’ funzjoni epatika normali għal madwar 85 min. f’ suġġetti b’ indeboliment epatiku moderat u sever.
AUC, Cmax and CL/ F were similar in subjects with reduced hepatic function compared with subjects with normal hepatic function.
L- AUC, is- Cmax, u s- CL/ F kienu simili f’ suġġetti b’ tnaqqis fil- funzjoni epatika meta mqabbla ma ’ suġġetti b’ funzjoni epatika normali.
A single dose pharmacokinetic study of insulin aspart in 18 subjects with renal function ranging from normal to severely impaired was performed.
Studju farmakokinetiku b’ doża waħda ta ’ insulina aspart ġie magħmul f’ 18- il suġġett b’ funzjoni renali li tvarja minn normali għal indeboliment sever.
No apparent effect of creatinine clearance values on AUC, Cmax, CL/ F and tmax of insulin aspart was found.
Il- valuri tat- tneħħija tal - krejatinina dehru li ma kellhom ebda effett fuq l- AUC, is- Cmax is- CL/ F u t- tmax ta’ insulina aspart.
Subjects with renal failure necessitating dialysis treatment were not investigated.
L - informazzjoni kienet limitata f’ suġġetti b’ indeboliment renali moderat u sever. Ma ġewx investigati suġġetti b’ insuffiċjenza renali li jkollhom bżonn kura bid- dijaliżi.
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 mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema riproduttiva, ma turi l - ebda periklu speċjali għall- bnedmin.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Fit- testijiet in vitro, li jinkludu r- rabta mas- siti tar- riċetturi ta ’ l- insulina u ta ’ IGF- 1 u l- effetti fuq t - tkabbir taċ- ċelloli, l- insulin aspart ġab ruħu b’ mod li jixbaħ ħafna l- insulina umana.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
L- istudji juru wkoll li d- dissoċjazzjoni tar- rabta ta ’ insulin aspart minn mar- riċettur ta ’ l- insulina hija ekwivalenti għal dik ta ’ insulina umana.
Glycerol Phenol Metacresol Zinc chloride Disodium phosphate dihydrate Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc chloride Disodium phosphate dihydrate Sodium chloride Hydrochloric acid (għall- aġġustament tal- pH) Sodium hydroxide (għall- aġġustament tal- pH) Ilma għall- injezzjonijiet
Substances added to the insulin may cause degradation of the insulin, e. g. if the medicinal product contains thiol or sulphites.
Sustanzi miżjuda ma ’ l- insulina jistgħu jikkawżaw d- degradazzjoni ta ’ l- insulina eż. jekk il- prodott mediċinali fih thiol jew sulfiti.
30 months
30 xahar.
The in-use shelf life is 4 weeks.
Iż- żmien kemm idum tajjeb waqt l- użu huwa ta ’ 4 ġimgħat
8 Vials in use or carried as a spare:
Kunjetti li qed jintużaw jew li jinġarru għal li jista ’ jkun:
Glass vial (Type 1) closed with a disc (bromobutyl/ polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of solution.
Kunjett tal- ħġieġ (Tip 1) li fih 10 ml ta ’ soluzzjoni, magħluq b’ diska (gomma tal - bromobutyl/ polyisoprene) u għatu protettiv tal- plastik li jingħalaq b’ sikurezza..
Cartons of 1 or 5 vials and a multipack with 5 x (1 x 10 ml) vials.
Kartun ta ’ 1 jew 5 kunjetti u pakkett multiplu b’ 5 x (1 x 10 ml) kunjetti.
Not all pack sizes may be marketed.
Mhux il- pakketti tad- daqsijiet kollha huma għal skop kummerċjali
NovoRapid vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti ta ’ NovoRapid għandhom jiġu użati mas- siringi ta ’ l- insulina bl- iskala ta ’ unità korrispondenti.
NovoRapid may be used in an infusion pump system (CSII) as described in section 4.2.
NovoRapid jista ’ jintuża f’ sistema ta ’ pompi ta ’ l- infużjoni (CSII) kif deskritt fis- sezzjoni 4. 2.
Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
Tubi li għandhom il- materjal intern magħmul mill- polyethylene jew polyolefin ġew evalwati u nstabu li huma kompatibbli ma ’ l- użu tal- pompi.
For intravenous use, infusion systems with NovoRapid 100 U/ ml at concentrations from 0.05 U/ ml to 1.0 U/ ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/ l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours.
9 chloride, 5% dextrose jew 10% dextrose li jinkludi 40 mmol/ l potassium chloride li qegħdin f’ boroż ta ’ l- infużjoni magħmula mill- polypropylene, huma stabbli f‘ temperatura ambjentali għal 24 siegħa.
Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the infusion bag.
Minkejja li tibqa ’ stabbli maż- żmien, fil- bidu, xi ammont ta ’ insulina se tiġi assorbita fil- materjal tal - borża ta ’ l- infużjoni.
Monitoring of blood glucose is necessary during insulin infusion.
Huwa meħtieġ li l- livell ta ’ glucose fid- demm jiġi sorveljat waqt l- infużjoni ta ’ l - insulina.
NovoRapid should not be used if it does not appear clear and colourless.
NovoRapid m’ għandux jintuża jekk ma jidhirx ċar u mingħajr kulur.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Allé DK- DK- 2880 Bagsværd Id- Danimarka
7 September 1999 Date of last renewal:
7 ta ’ Settembru, 1999 Data ta ’ l- aħħar tiġdid:
7 September 2004
7 ta 'Settembru, 2004
DATE OF REVISION OF THE TEXT
10 DATA TA ’ META ĠIET RIVEDUTA L- KITBA
NovoRapid Penfill 100 U/ ml, solution for injection in a cartridge.
NovoRapid Penfill 100 U/ ml, soluzzjoni għall- injezzjoni ġo skartoċċ.
Clear, colourless, aqueous, solution.
Soluzzjoni ċara akweja u, mingħajr kulur.
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 ghandha x’ taqsam ma ’ l- ikel, 50– 70% ta ’ l- insulina tista ’ tingħata bhala NovoRapid u l- bqija bħala insulina li taġixxi b’ mod intermedju jew fit- tul.
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.
Iżda indipendentement minn fejn
However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site.
11 tingħata l- injezzjoni, il- bidu ta ’ l- azzjoni hija dejjem aktar malajr meta mqabbel ma ’ insulina umana solubbli.
10 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.
Infusion sites should be rotated.
Il- postijiet minn fejn tingħata l- infużjoni għandhom jinbidlu ta ’ spiss..
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.
12 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.
It- trasferiment ta ’ pazjent għal tip jew għamla oħra ta ’ insulina għandu jsir taħt superviżjoni medika stretta.
11 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.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Is- sustanzi beta- blokkanti jistgħu jaħbu s- sintomi ta ’ l- ipogliċemija.
There are no restrictions on treatment with NovoRapid during lactation.
13 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.
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).
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, edema anġjonewrotika, diffikultajiet fit- teħid tan- nifs, tħabbit mgħaġġel tal- qalb u tnaqqis fil- pressjoni tad- demm.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
14 Mhux komuni - Retinopatija dijabetika Titjib fil- kontroll gliċemiku fuq perijodu ta ’ żmien twil inaqqas ir- riskju ta ’ progressjoni 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.
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.
13 4.9 Overdose
4. 9 Doża eċċessiva
The duration of action is 3 to 5 hours.
3
14 Adults. 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.
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:
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:
Insulin aspart is equipotent to soluble human insulin on a molar basis.
16 Insulin aspart f’ konċentrazzjoni ugwali (molarità) huwa ekwipotenti għall- insulina umana solubbli.
The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/ l) and later tmax (60 (interquartile range:
Ir- rata ta ’ l- assorbiment kien xi ftit aktar bil- mod fil - pazjenti bid- dijabete tat- tip 2, li rriżulta f’ Cmax aktar baxx (352±240 pmol/ l) u ttardjar fit- tmax (60 (marġni interkwartili:
However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid
Iżda, Cmax kien differenti bejn il- gruppi ta ’ etajiet, li jenfasizza l- importanza ta ’ dożaġġ individwali ta ’ NovoRapid.
15 rate was observed in elderly subjects, resulting in a later tmax (82 (interquartile range:
Ġie osservat tnaqqis fir- rata ta ’ assorbiment f’ suġġetti anzjani, li rriżulta f’ tmax itwal (82 (marġni interkwartili:
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Fit- testijiet in vitro, li jinkludu r- rabta mas- siti tar- reċetturi ta ’ l- insulina u ta ’ IGF- 1 u l- effetti fuq t - tkabbir taċ- ċelloli, l- insulin aspart ġab ruħu b’ mod li jixbaħ ħafna l- insulina umana.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
L- istudji juru wkoll li d- dissoċjazzjoni tar- rabta ta ’ insulin aspart minn mar- reċettur ta ’ l- insulina hija ekwivalenti għal dik ta ’ insulina umana.
Substances added to the insulin may cause degradation of the insulin, e. g. if the medicinal product contains thiol or sulphites.
Sustanzi miżjuda ma ’ l- insulina jistgħu jikkawżaw d- degradazzjoni ta ’ l- insulina eż jekk il- prodott mediċinali fih thiol jew sulfiti.
16 NovoRapid Penfill in use or carried as a spare:
NovoRapid Penfill li qed jintuża jew li jinġarr għal li jista ’ jkun:
A glass (Type 1) cartridge which contains a piston (bromobutyl rubber) and is closed with a disc (bromobutyl/ polyisoprene rubber) containing 3 ml of solution.
Skartoċċ tal- ħġieġ (Tip 1) li fih piston (gomma tal- bromobutyl) u li huwa magħluq b’ diska (gomma tal- bromobutyl/ polyisoprene) u li fih 3 ml ta ’ soluzzjoni.
Cartons of 5 or 10 cartridges.
Kartun ta ’ 5 jew 10 skrataċ.
NovoRapid Penfill should only be used in combination with products that are compatible with them and allow the Penfill to function safely and effectively.
NovoRapid Penfill għandu jiġi użat biss flimkien ma ’ prodotti li huma kompatibbli miegħu u li jħallu l- Penfill jaħdem mingħajr periklu u b’ mod effettiv.
NovoRapid Penfill is for use by one person only.
NovoRapid Penfill huwa għall- użu ta ’ persuna waħda biss.
The cartridge must not be refilled.
L- iskartoċc ma jistax jerġa ’ jimtela mill - ġdid.
NovoRapid Penfill is designed to be used with the Novo Nordisk insulin delivery system and NovoFine needles.
NovoRapid Penfill ġie maħluq biex jintuża mas- sistema ta ’ amministrazzjoni ta ’ insulina Novo Nordisk u labar NovoFine.
For intravenous use, infusion systems with NovoRapid 100 U/ ml at concentrations from 0.05 U/ ml to 1.0 U/ ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/ l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours.
18 Għall- użu għal ġol- vini, is- sistemi ta ’ infużjoni b’ NovoRapid 100 U/ ml f’ konċentrazzjonijiet minn 0. 05 U/ ml sa 1. 0 U/ ml insulin aspart fis- soluzzjonijiet ta ’ infużjoni magħmula minn 0. 9% sodium chloride, 5% dextrose jew 10% dextrose li jinkludi 40 mmol/ l potassium chloride u li qegħdin f’ boroż ta ’ l- infużjoni magħmula mill- polypropylene, huma stabbli f‘ temperatura ambjentali għal 24 siegħa.
NovoRapid NovoLet 100 U/ ml, solution for injection in a pre-filled pen.
NovoRapid NovoLet 100 U/ ml, soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
As with all insulins the duration of action will vary according to the dose, injection site, blood flow, temperature and the 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.
18 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.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
21 It- trasferiment ta ’ pazjent għal tip jew għamla oħra ta ’ insulina għandu jsir taħt superviżjoni medika stretta.
19 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.
4.7 Effects on ability to drive and use machines
22 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
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.
23 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.
21 4.9 Overdose
4. 9 Doża eċċessiva
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
22 Adults.
I.
Insulin aspart is equipotent to soluble human insulin on a molar basis.
25 Insulin aspart f’ konċentrazzjoni ugwali (molarità) huwa ekwipotenti għall- insulina umana solubbli.
However, Cmax differed between the age groups, stressing the importance of the individual titration of NovoRapid Elderly:
Iżda, Cmax kien differenti bejn il- gruppi ta ’ etajiet, li jenfasizza l- importanza ta ’ dożaġġ individwali ta ’ NovoRapid.
The relative differences in pharmacokinetic properties between insulin aspart and soluble human insulin in elderly subjects (65-83 years, mean age 70 years) with type 2 diabetes were similar to those observed in healthy subjects and in younger subjects with diabetes.
Id- differenzi relattivi fil- karatteristiċi farmakokinetiċi bejn insulina aspart u insulina umana solubbli fl- anzjani (65 sa 83 sena, età medja 70 sena) bid- dijabete tat- tip 2 kienu simili għal dawk li kien hemm f’ suġġetti b’ saħħithom u f’ suġġetti iżgħar bid- dijabete.
60-120)
Ġie osservat tnaqqis fir- rata ta ’ assorbiment f’ suġġetti anzjani, li rriżulta f’ tmax itwal (82 (marġni interkwartili:
23 minutes), whereas Cmax was similar to that observed in younger subjects with type 2 diabetes and slightly lower than in subjects with type 1 diabetes.
60- 120) minuta), filwaqt li s- Cmax kien simili għal dak osservat f’ suġġetti iżgħar bid- dijabete tat- tip 2 u ftit inqas minn dak ta ’ suġġetti bid- dijabete tat- tip 1.
Keep the cap on when NovoRapid Novolet is not in use in order to protect from light.
Tneħħix l- għatu meta m’ intix tuża NovoRapid Novolet sabiex tilqa ’ mid- dawl.
NovoRapid NovoLet in use or carried as a spare:
NovoRapid NovoLet li qed jintuża jew li jinġarr għal li jista ’ jkun:
24 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
A glass (Type 1) cartridge which contains a piston (bromobutyl rubber) and is closed with a disc (bromobutyl/ polyisoprene rubber) containing 3 ml of solution in a multidose disposable pre-filled pen with a pen injector (plastic).
Skartoċċ tal- ħġieġ (Tip 1) li fih piston (gomma tal- bromobutyl) u li huwa magħluq b’ diska (gomma tal- bromobutyl/ polyisoprene) u li fih 3 ml ta ’ soluzzjoni ġo pinna b’ ħafna dożi mimlija għal- lest, li tista ’ tintrema, b’ injettatur (tal- plastik).
Cartons of 5 or 10 pre-filled pens.
Kartun ta ’ 5 jew 10 pinen mimlijin għal- lest.
NovoRapid NovoLet should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
NovoRapid NovoLet għandhom jiġu użati biss flimkien ma ’ prodotti li huma kompatibbli magħhom u li jħallu l- pinen jaħdmu mingħajr periklu u b’ mod effettiv.
NovoRapid NovoLet is for use by one person only.
NovoRapid NovoLet huwa għall- użu ta ’ persuna waħda biss.
NovoRapid NovoLet must not be refilled.
NovoRapid NovoLet ma jistax jerġa ’ jimtela mill- ġdid.
NovoFine needles are designed to be used with NovoRapid NovoLet.
Il- labar NovoFine huma magħmula biex jiġu użati ma ’ NovoRapid NovoLet
For intravenous use, infusion systems with NovoRapid 100 U/ ml at concentrations from 0.05 U/ ml to 1.0 U/ ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/ l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours.
27 Għall- użu għal ġol- vini, is- sistemi ta ’ infużjoni b’ NovoRapid 100 U/ ml f’ konċentrazzjonijiet minn 0. 05 U/ ml sa 1. 0 U/ ml insulin aspart fis- soluzzjonijiet ta ’ infużjoni magħmula minn 0. 9% sodium chloride, 5% dextrose jew 10% dextrose li jinkludi 40 mmol/ l potassium chloride u li qegħdin f’ boroż ta ’ l- infużjoni magħmula mill- polypropylene huma stabbli f‘ temperatura ambjentali għal 24 siegħa.
NovoRapid FlexPen 100 U/ ml, solution for injection in a pre-filled pen.
NovoRapid FlexPen 100 U/ ml, soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insulin aspart∗...........................................
Insulin aspart∗.........................................
26 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.
FlexPen are pre-filled pens designed to be used with NovoFine short cap needles.
FlexPen huma pinen mimlijin għal- lest magħmula biex jintużaw mal- labar NovoFine bl- għatu qasir.
The needle box is marked with an S.
Il- kaxxa tal- labar hija mmarkata b’ S.
FlexPen delivers 1-60 units in increments of 1 unit.
Flexpen tagħti 1 sa 60 unità f’ żidiet ta ’ unità 1.
Detailed instruction accompanying the device must be followed.
L- istruzzjonijiet iddettaljati li jakkumpanjaw dan l- apparat għandhom jiġu segwiti.
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.
30 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.
27 Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent għal tip jew għamla oħra ta ’ insulina għandu jsir taħt superviżjoni medika stretta.
Changes in strength, brand, type, species (animal, human, human insulin analogue) and/ or method of manufacture may result in a change in dosage.
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.
Patients taking NovoRapid may require an 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.
There are no restrictions on treatment with NovoRapid during lactation.
31 M’ hemmx restrizzjonijiet għall- kura b’ NovoRapid waqt it- treddigħ.
28 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 hypoglycaemia or have frequent episodes of hypoglycaemia.
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.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
32 Mhux komuni - Retinopatija dijabetika Titjib fil- kontroll gliċemiku fuq perijodu ta ’ żmien twil inaqqas ir- riskju ta ’ progressjoni tar - retinopatija dijabetika.
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.
Adults.
I.
Insulin aspart is equipotent to soluble human insulin on a molar basis.
34 Insulin aspart f’ konċentrazzjoni ugwali (molarità) huwa ekwipotenti għall- insulina umana solubbli.
31 Elderly:
Anzjani:
A decreased absorption rate was observed in elderly subjects, resulting in a later tmax (82 (interquartile range:
Ġie osservat tnaqqis fir- rata ta ’ assorbiment f’ suġġetti anzjani, li rriżulta f’ tmax itwal (82 (marġni interkwartili:
Keep the cap on when NovoRapid FlexPen is not in use in order to protect from light.
Tneħħix l- għatu meta m’ intix tuża NovoRapid FlexPen sabiex tilqa ’ mid- dawl.
NovoRapid FlexPen in use or carried as a spare:
NovoRapid FlexPen li qed jintuża jew li jinġarr għal li jista ’ jkun:
Cartons of 1, 5 or 10 pre-filled pens.
Kartun ta ’ 1, 5 jew 10 pinen mimlijin għal- lest.
NovoRapid FlexPen should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
NovoRapid FlexPen għandhom jiġu użati biss flimkien ma ’ prodotti li huma kompatibbli magħhom u li jħallu l- pinen jaħdmu mingħajr periklu u b’ mod effettiv.
NovoRapid FlexPen is for use by one person only.
NovoRapid FlexPen huwa għall- użu ta ’ persuna waħda biss.
NovoRapid FlexPen must not be refilled.
NovoRapid FlexPen ma jistax jerġa ’ jimtela mill- ġdid.
NovoFine S needles are designed to be used with NovoRapid FlexPen.
Il- labar NovoFine S huma magħmula biex jiġu użati ma ’ NovoRapid FlexPen
For intravenous use, infusion systems with NovoRapid 100 U/ ml at concentrations from 0.05 U/ ml to 1.0 U/ ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/ l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours.
36 Għall- użu għal ġol- vini, is- sistemi ta ’ infużjoni b’ NovoRapid 100 U/ ml f’ konċentrazzjonijiet minn 0. 05 U/ ml sa 1. 0 U/ ml insulin aspart fis- soluzzjonijiet ta ’ infużjoni magħmula minn 0. 9% sodium chloride, 5% dextrose jew 10% dextrose li jinkludi 40 mmol/ l potassium chloride u li qegħdin f’ boroż ta ’ l- infużjoni magħmula mill- polypropylene huma stabbli f‘ temperatura ambjentali għal 24 siegħa.
NovoRapid InnoLet 100 U/ ml, solution for injection in a pre-filled pen.
NovoRapid InnoLet 100 U/ ml, soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
Clear, colourless, aqueous, solution.
Soluzzjoni ċara akweja u mingħajr kulur.
However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site.
38 tingħata l- injezzjoni, il- bidu ta ’ l- azzjoni hija dejjem aktar malajr meta mqabbel ma ’ insulina umana solubbli.
35 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.
InnoLet are pre-filled pens designed to be used with NovoFine short cap needles.
InnoLet huma pinen mimlijin għal- lest magħmula biex jintużaw mal- labar NovoFine bl- għatu qasir.
The needle box is marked with an S.
Il - kaxxa tal- labar hija mmarkata b’ S.
InnoLet delivers 1-50 units in increments of 1 unit.
InnoLet tagħti 1 sa 50 unità f’ żidiet ta ’ unità 1.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
39 Mard konkomitanti, speċjalment infezzjonijiet, ħafna drabi jżidu l- ħtieġa tal- pazjenti għall- insulina.
36 Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent għal tip jew għamla oħra ta ’ insulina għandu jsir taħt superviżjoni medika stretta.
There are no restrictions on treatment with NovoRapid during lactation.
40 M’ hemmx restrizzjonijiet għall- kura b’ NovoRapid waqt it- treddigħ.
37 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
41 Mhux komuni - Retinopatija dijabetika Titjib fil- kontroll gliċemiku fuq perijodu ta ’ żmien twil inaqqas ir- riskju ta ’ progressjoni tar - retinopatija dijabetika.
These symptoms are usually of transitory nature.
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Mhux komuni – Edima Edima tista ’ sseħh fil- bidu tal- kura bl- insulina, Ħafna drabi dawn is- sintomi huma ta ’ natura tranżitorja.
Pharmacotherapeutic group: insulins and analogues for injection, fast-acting.
Kategorija farmakoterapewtika: insulini u analogi għal- injezzjoni, li jaġixxu malajr.
39 Blood glucose (mmol/ l)
14 Blood glucose (mmol/ l) Glucose fid- demm (mmol/ l)
Time (h) Fig.
12
40 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:
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:
Insulin aspart is equipotent to soluble human insulin on a molar basis.
43 Insulin aspart f’ konċentrazzjoni ugwali (molarità) huwa ekwipotenti għall- insulina umana solubbli.
Keep the cap on when NovoRapid InnoLet is not in use in order to protect from light.
Tneħħix l- għatu meta m’ intix tuża NovoRapid InnoLet sabiex tilqa ’ mid- dawl.
NovoRapid InnoLet in use or carried as a spare:
NovoRapid InnoLet li qed jintuża jew li jinġarr għal li jista ’ jkun:
NovoRapid InnoLet should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
NovoRapid InnoLet għandhom jiġu użati biss flimkien ma ’ prodotti li huma kompatibbli magħhom u li jħallu l- pinen jaħdmu mingħajr periklu u b’ mod effettiv.
NovoRapid InnoLet is for use by one person only.
NovoRapid InnoLet huwa għall- użu ta ’ persuna waħda biss.
NovoRapid InnoLet must not be refilled.
NovoRapid InnoLet ma jistax jerġa ’ jimtela mill- ġdid.
NovoFine S needles are designed to be used with NovoRapid InnoLet.
Il- labar NovoFine S huma magħmula biex jiġu użati ma ’ NovoRapid InnoLet.
For intravenous use, infusion systems with NovoRapid 100 U/ ml at concentrations from 0.05 U/ ml to 1.0 U/ ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose
45 Għall- użu għal ġol- vini, is- sistemi ta ’ infużjoni b’ NovoRapid 100 U/ ml f’ konċentrazzjonijiet minn 0. 05 U/ ml sa 1. 0 U/ ml insulin aspart fis- soluzzjonijiet ta ’ infużjoni magħmula minn 0. 9% sodium chloride, 5% dextrose jew 10% dextrose li jinkludi 40 mmol/ l potassium chloride u li qegħdin f’ boroż ta ’ l- infużjoni magħmula mill- polypropylene huma stabbli f‘ temperatura ambjentali għal 24 siegħa.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
NovoRapid Vial, NovoLet and InnoLet:
NovoRapid Kunjett, NovoLet u InnoLet:
NovoRapid Penfill and FlexPen:
NovoRapid Penfill u FlexPen:
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoRapid 100 U/ ml Solution for injection in a vial Insulin aspart
NovoRapid 100 U/ ml Soluzzjoni għall- injezzjoni f’ kunjett Insulin aspart
1 ml solution contains 100 U (3.5 mg) of insulin aspart (r-DNA),
Millilitru ta ’ soluzzjoni fih 100 U (3. 5 mg) ta ’ insulin aspart (r- DNA).
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall- injezzjonijiet
Subcutaneous or intravenous use Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the vial in the outer carton During use: use within 4 weeks Do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra Waqt l- użu: uża fi żmien 4 ġimgħat Waqt l- użu taħżinx fi friġġ jew f’ temperatura ’ l fuq minn 30°C
NovoRapid vial
NovoRapid kunjett
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
1 ml solution contains 100 U (3.5 mg) of insulin aspart (r-DNA),
1 ml ta ’ soluzzjoni fih 100 U (3. 5 mg) ta ’ insulin aspart (r- DNA).
Subcutaneous or intravenous use Read the package leaflet before use
Użu għal taħt il- ġilda jew għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
1 x 10 ml This is part of a multipack and not for sale of individual vials
1 x 10 ml Dan huwa parti minn pakkett multiplu u l- kunjetti individwali m’ humiex għal bejgħ.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the vial in the outer carton During use: use within 4 weeks Do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C – 8°C) 55 Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra Waqt l- użu: uża fi żmien 4 ġimgħat Taħżinx fi friġġ jew f’ temperatura ’ l fuq minn 30°C
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER WRAPPER LABEL ON MULTIPACKS
IT- TIKKETTA TA ’ BARRA MGEŻWRA FUQ IL- PAKKETTI MULTIPLI
5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
5 x (1 x 10 ml) Dan huwa pakkett multiplu u l- kunjetti individwali m’ humiex għal bejgħ.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the vial in the outer carton During use: use within 4 weeks Do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża 57 Żomm il- kunjett fil- kartuna ta ’ barra Waqt l- użu: uża fi żmien 4 ġimgħat Taħżinx fi friġġ jew f’ temperatura ’ l fuq minn 30°C
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NovoRapid 100 U/ ml Solution for injection Insulin aspart SC, IV use
NovoRapid 100 U/ ml, Soluzzjoni għall- injezzjoni Insulin aspart Użu għal taħt il- ġilda u għal ġol- vini
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoRapid Penfill 100 U/ ml Solution for injection in a cartridge Insulin aspart
NovoRapid Penfill 100 U/ ml Soluzzjoni għall- injezzjoni ġo skartoċċ Insulin aspart
Subcutaneous or intravenous use NovoRapid Penfill is for use with Novo Nordisk insulin devices Read the package leaflet before use
Użu għal taħt il- ġilda jew għal ġol- vini NovoRapid Penfill għandu jintuża ma ’ apparat ta ’ insulina Novo Nordisk Aqra l- fuljett ta ’ tagħrif qabel l- użu
NovoRapid Penfill is for use by one person only
NovoRapid Penfill għandu jiġi użat minn persuna waħda biss
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cartridge in the outer carton During use: use within 4 weeks Do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żomm l- iskartoċċ fil- kartuna ta ’ barra Waqt l- użu: uża fi żmien 4 ġimgħat Waqt l- użu taħżinx fi friġġ jew f’ temperatura ’ l fuq minn 30°C
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Subcutaneous or intravenous use NovoRapid Penfill is for use with Novo Nordisk insulin devices Read the package leaflet before use
Użu għal taħt il- ġilda jew għal ġol- vini NovoRapid Penfill għandu jintuża ma ’ l- apparat ta ’ l- insulina Novo Nordisk Aqra l- fuljett ta ’ tagħrif qabel l- użu
NovoRapid Penfill is for use by one person only
NovoRapid Penfill għandu jintuża minn persuna waħda biss
60 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NovoRapid Penfill 100 U/ ml Solution for injection Insulin aspart SC, IV use
NovoRapid Penfill 100 U/ ml Soluzzjoni għall- injezzjoni Insulin aspart Użu għal taħt il- ġilda u għal ġol- vini
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoRapid NovoLet 100 U/ ml Solution for injection in a pre-filled pen Insulin aspart
NovoRapid NovoLet 100 U/ ml Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest Insulin aspart
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONIUŻU TAS- SUSTANZA( I) ATTIVA
Subcutaneous use NovoRapid NovoLet is designed to be used with NovoFine needles NovoFine needles are not included Read the package leaflet before use
Użu għal taħt il- ġilda NovoRapid NovoLet hu magħmul biex jintuża mal- labar NovoFine Il- labar NovoFine m’ humiex inklużi Aqra l- fuljett ta ’ tagħrif qabel l- użu
NovoRapid NovoLet is for use by one person only
NovoRapid NovoLet għandu jiġi użat minn persuna waħda biss
Store in a refrigerator (2°C – 8°C) Do not freeze Protect from light During use: use within 4 weeks Do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C – 8°C) Tagħmlux fil- friża Żommu ’ l bogħod mid- dawl Waqt l- użu: uża fi żmien 4 ġimgħat Waqt l- użu taħżinx fi friġġ jew f’ temperatura ’ l fuq minn 30°C
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE OUTER PACKAGING
66 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
65 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NovoRapid NovoLet 100 U/ ml Solution for injection Insulin aspart SC use
NovoRapid NovoLet 100 U/ ml Soluzzjoni għall- injezzjoni Insulin aspart Użu għal taħt il- ġilda
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE OUTER PACKAGING
69 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoRapid FlexPen 100 U/ ml Solution for injection in a pre-filled pen Insulin aspart
NovoRapid FlexPen 100 U/ ml Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest Insulin aspart
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Read the package leaflet before use
Użu għal taħt il- ġilda 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 Aqra l- fuljett ta ’ tagħrif qabel l- użu
NovoRapid FlexPen is for use by one person only
NovoRapid FlexPen għandu jiġi użat minn persuna waħda biss
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NovoRapid FlexPen 100 U/ ml Solution for injection Insulin aspart SC use
NovoRapid FlexPen 100 U/ ml Soluzzjoni għall- injezzjoni Insulin aspart Użu għal taħt il- ġilda
NovoRapid InnoLet 100 U/ ml Solution for injection in a pre-filled pen Insulin aspart
NovoRapid InnoLet 100 U/ ml Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest Insulin aspart
Subcutaneous use NovoRapid InnoLet is designed to be used with NovoFine S needles NovoFine S needles are not included Read the package leaflet before use
Użu għal taħt il- ġilda NovoRapid InnoLet hu magħmul biex jintuża mal- labar NovoFine S Il- labar NovoFine S m’ humiex inklużi Aqra l- fuljett ta ’ tagħrif qabel l- użu
NovoRapid InnoLet is for use by one person only
NovoRapid InnoLet għandu jiġi użat minn persuna waħda biss
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
79 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NovoRapid InnoLet 100 U/ ml Solution for injection Insulin aspart SC use
NovoRapid InnoLet 100 U/ ml Soluzzjoni għall- injezzjoni Insulin aspart Użu għal taħt il- ġilda
NovoRapid 100 U/ ml solution for injection in a vial insulin aspart
NovoRapid 100 U/ ml soluzzjoni għall- injezzjoni f' kunjett insulin aspart.
Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina – Żomm dan il- fuljett.
You may need to read it again – If you have any further questions, ask your doctor, diabetes nurse or pharmacist – This medicine has been prescribed for you personally.
Jista ’ jkollok bżonn terġa ’ taqrah – Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, lill- infermier/ a tad- dijabete 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 imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermier/ a tad- dijabete jew lill - ispiżjar tiegħek.
WHAT NOVORAPID IS AND WHAT IT IS USED FOR
X’ INHU NOVORAPID U GĦALXIEX JINTUŻA
NovoRapid is an insulin analogue to treat diabetes.
NovoRapid huwa analogu ta ’ l- insulina għall- kura tad- dijabete.
It comes in a 10 ml vial that you use to fill a syringe.
Jiġi f’ kunjett ta ’ 10 ml li tuża biex timla siringa.
NovoRapid is a rapid-acting insulin for use in adults and children from 2 years of age.
NovoRapid huwa insulina li taġixxi malajr għall- użu fl- adulti u fit- tfal minn sentejn ’ il fuq.
It will start to lower your blood sugar 10– 20 minutes after you take it, a maximum effect occurs between 1 and 3 hours and the effect lasts for 3– 5 hours.
Jibda jbaxxi l- livell taz- zokkor fid- demm tiegħek bejn 10 u 20 minuta wara li tieħdu, l- effett massimu jseħħ bejn siegħa u 3 sigħat u l- effett idum bejn 3 u 5 sigħat.
Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations.
Minħabba din l- azzjoni qasira NovoRapid normalment għandu jittieħed flimkien ma ’ preparazzjonijiet oħrajn ta ’ insulina li jaġixxu b’ effett intermedju jew li jaġixxu fit- tul.
BEFORE YOU USE NOVORAPID
QABEL MA TUŻA NOVORAPID
Do not use NovoRapid
Tużax NovoRapid
► If you are allergic (hypersensitive) to insulin aspart, metacresol or any of the other ingredients (see 7 Further information).
► Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal insulin aspart, metacresol jew sustanzi oħra ta ’ NovoRapid (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).
Oqgħod attent/ a għal xi sinjali ta ’ allerġija li jidhru f’ 5 Effetti sekondarji li jista ’ jkollu ► Jekk tħoss li ġejja xi ipo (ipo hija taqsira għal reazzjoni ipogliċemika u hija ġabra ta ’ sintomi li jindikaw livell baxx ta ’ zokkor fid- demm).
See 4 What to do in an emergency for more about hypos.
Ara 4 X' ghandek tagħmel f' każ ta 'emerġenza għal aktar tagħrif dwar l- ipos.
Take special care with NovoRapid
Oqgħod attent ħafna b’ NovoRapid