qanastek/EMEA-V3 huggingface dataset:
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other.
Skarto tal - ie (Tip 1) mag luq b’ pistun tal- gomma ming ajr latti i (bromobutyl) f’ tarf wie ed, u g eluq tal- gomma ming ajr latti i (bromobutyl/ polyisoprene) in- na a l- o ra.
The cartridge contains a glass ball to facilitate resuspension.
L- iskarto fih bo a tal - ie biex tg in biex ter a ’ ti i mag mula s- suspensjoni.
Cartons of 1, 5 or 10 cartridges.
Kaxxi tal- kartun ta ’ 1, 5 jew 10 skarto i.
NovoMix 50 Penfill is for use by one person only.
NovoMix 50 Penfill hu g al u u minn persuna wa da biss.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
17 Il - tie a li ter a ’ tifforma suspensjoni mill - did ta ’ NovoMix 50 immedjatament qabel l- u u g andha ti i enfasizzata lill- pazjent.
NovoMix 50 which has been frozen must not be used.
Il- likwidu li jkun mag mul f’ suspensjoni mill - did g andu jidher abjad u qisu alib b’ mod uniformi NovoMix 50 li kien iffri at m’ g andux jintu a.
1 August 2000 Date of last renewal:
1 ta’ Awwissu, 2000 Data ta ’ l- a ar ti did:
1 August 2005
1 ta’ Awwissu, 2005
NovoMix 70 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 70 Penfill 100 U/ ml, suspensjoni g all- injezzjoni fi skarto.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 70/ 30
Insulin aspart * li jin all / insulin aspart * ikkristallizzat bi protamine ……... 100 U/ ml fi proporzjon ta ’ 70/ 30
NovoMix 70 is a white suspension.
NovoMix 70 hu suspensjoni bajda.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 70 to be given immediately before a meal.
Il- fatt li insulin aspart jibda ja dem malajr u jil aq il- massimu ta ’ l- attività tieg u kmieni jippermetti li NovoMix 70 jing ata immedjatament qabel ikla.
When necessary, NovoMix 70 can be given soon after start of a meal.
Meta jkun me tie, NovoMix 70 jista ’ jing ata dritt wara li tkun bdejt tiekol.
Dosage of NovoMix 70 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Id- do a ta ’ NovoMix 70 hu individwali u hu stabbilit fuq il- ba i tal- parir tat- tabib skond il - ti ijiet tal- pazjent.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 70.
F’ pazjenti adulti, il - tie a individwali ta ’ l- insulina normalment hi ta ’ bejn 0. 5 u 1. 0 Unitajiet/ kg/ kuljum u dan jista ’ ji i pprovdut b’ mod s i jew b’ mod parzjali b’ NovoMix 70.
In patients with type 2 diabetes, NovoMix 70 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
F’ pazjenti b’ dijabete ta ’ tip 2, NovoMix 70 jista ’ jing ata f’ monoterapija jew flimkien ma ’ metformin, meta l- glucose fid - demm ikun ikkontrollat b’ mod inadegwat b’ metformin wa du.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
It- trasferiment g al NovoMix 70 minn preparazzjonijiet o rajn ta ’ l- insulina jista ’ jkollu b onn ta ’ a ustament fid- do a u fil - in ta ’ l- g oti.
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
F’ pazjenti bid- dijabete mellitus, kontroll metaboliku mill- a jar effettivament jittardja l- bidu u jnaqqas
Optimised metabolic control, including glucose monitoring, is therefore recommended.
L- a jar kontroll metaboliku possibbli, li jinkludi l- monitora ta ’ glucose, hu g alhekk irrakkomandat.
18 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
B all- insulini l- o rajn kollha, f’ pazjenti anzjani u f’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi, il- monitora tal- glucose g andu jkun intensifikat, u d- do a a ustat fuq ba i individwali.
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
Ma sar l- ebda studju b’ NovoMix 70 fit- tfal u fl- adoloxxenti ta ’ ta t it- 18- il sena.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 70 jing ata minn ta t il - ilda fil- koxxa jew fil - ajt addominali.
The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
L- effett ta ’ siti differenti ta ’ l- injezzjoni fuq l- assorbiment ta ’ NovoMix 70 ma kienx investigat.
NovoMix 70 should never be administered intravenously.
NovoMix 70 m’ g andu qatt jing ata minn ol- vini.
NovoMix 70 should be administered in immediate relation to a meal.
NovoMix 70 g andu jing ata b’ rabta immedjata ma ’ l- ikel.
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
Jista ’ jkun li pazjenti li jkunu qed jie du NovoMix 70 ikollhom b onn ta ’ bidla fid- do a minn dak u at ma ’ l- insulina normali tag hom ta ’ qabel.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Li fl- istess ona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jg in biex inaqqas jew jimpedixxi dawn ir -
Reactions usually resolve in a few days to a few weeks.
20 reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
On rare occasions, injection site reactions may require discontinuation of NovoMix 70.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni jista ’ jkun hemm il- b onn li NovoMix 70 jitwaqqaf
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
There is limited clinical experience with NovoMix 70 in pregnancy.
M’ hemmx tag rif kliniku bi ejjed dwar l- u u ta ’ NovoMix 70 waqt it- tqala.
There are no restrictions on treatment with NovoMix 70 during lactation.
M’ hemm l- ebda restrizzjonijiet fuq il- kura b’ NovoMix 70 matul it- treddig.
However, the NovoMix 70 dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm b onn li d - do a ta ’ NovoMix 70 ikun a ustat.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
Kif ji ri ma ’ prodotti o rajn ta ’ insulina, eneralment l- effett mhux mixtieq li jse bl- aktar mod komuni hija l -
It may occur if the insulin dose is too high in relation to the insulin requirement.
Din tista ’ sse jekk id- do a ta ’ l- insulina tkun g olja wisq meta mqabbla mal - tie a ta ’ l- insulina.
In clinical trials and during marketed use the frequency varies with patient population and dose
Waqt studji klini i u matul l- u u tal- medi ina meta l- prodott tqieg ed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond l- iskeda tad- do a, u g alhekk l- ebda frekwenza spe ifika ma tista ’ ti i ppre entata.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Minn studji klini i, il- frekwenzi tar- reazzjonijiet avversi tal- medi ina, li permezz ta’ evalwazzjoni s i a huma kkunsidrati li huma konnessi ma ’ insulin aspart, huma mni lin hawn ta t.
4.9 Overdose
22 4. 9 Do a e essiva
21 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
G alhekk hu rakkomandat li l- pazjent dijabetiku dejjem i omm fuqu prodotti li jkun fihom iz- zokkor. • Episodji ipogli emi i serji, meta l- pazjent ikun intilef minn sensih, jistg u jkunu kkurati bi glucagon (0. 5 sa 1 mg) mog ti ol- muskoli jew ta t il - ilda minn persuna m arr a, jew bi glucose li jing ata minn ol- vini minn persuna medika professjonali.
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 70 hu suspensjoni bifa ika ta ’ insulin aspart (analogu ta ’ l- insulina umana li ja dem malajr) u insulin aspart ikkristallizzat bi protamine (analogu ta ’ l- insulina umana li ja dem b’ mod intermedju).
NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
NovoMix 70 hu insulina bifa ika li fiha 70% insulin aspart li jin all.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Il- fa i kristallina (30%) tikkonsisti f’ insulin aspart ikkristallizzat bi protamine, li g andu profil ta ’ attività li jixbah lil dak ta ’ l- insulina NPH umana.
When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Meta NovoMix 70 ikun injettat minn ta t il - ilda, jibda ja dem fi mien 10 sa 20 minuta mill - injezzjoni.
Glucose Infusion Rate
23 Rata ta ’ l- infu joni ta ’ Glucose
Hours NovoMix 70
Sig at NovoMix 70
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
Il- Profil ta ’ l- Attività g al NovoMix 70 f’ Pazjenti Kawkasi b’ Sa ithom
22 5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 70, as compared with soluble human insulin.
F’ insulina aspart, is- sostituzzjoni ta ’ l- a idu amminiku proline b’ aspartic acid f’ po izzjoni B28 tnaqqas it- tendenza li jiffurmaw e ameri fil- porzjon li jin all ta ’ NovoMix 70, meta mqabbel ma ’ l - insulina umana li tin all.
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
L- insulin aspart fil- fa i li jin all ta ’ NovoMix 70, jinkludi 70% ta ’ l- insulina totali; dan ji i assorbit iktar malajr mill- istrat sottokutanju meta mqabbel mal- komponent ta ’ l- insulina bifa ika li tin all.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
It- 30% li jibqa ’ jkun f’ sura kristallina b ala insulin aspart ikkristallizzat bi protamine; dan g andu profil ta ’ assorbiment imtawwal li jixbah lil dak ta ’ l- insulina NPH umana.
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
F’ voluntiera b’ sa ithom, il- medja tal- kon entrazzjoni massima fis- serum ta ’ 645 ± 185 pmol/ l intla qet madwar 60 minuta wara li ng atat do a ta t il - ilda ta ’ 0. 30 U/ kg ta ’ pi tal - isem.
In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
F’ pazjenti bid- dijabete ta ’ tip 2, il- kon entrazzjoni massima ntla qet madwar 75 minuta wara li ng atat id- do a.
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
F’ pazjenti bid- dijabet tat- tip1 il- medja tal- kon entrazzjoni massima fis- serum ta ’ 721± 184 pmol/ l intla qet madwar 60 minuta wara li ng atat do a minn ta t il - ilda ta ’ 0. 30 U/ kg ta ’ pi tal - isem.
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
Il- farmakokinetika ta ’ NovoMix 70 ma ietx investigata fl- anzjani, fit- tfal jew f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi jew tal- fwied.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc (b ala chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide( g all- a ustament fil- pH) Hydrochloric acid (g all- a ustament fil- pH) Ilma g all- injezzjonijiet
23 6.4 Special precautions for storage
6. 4 Prekawzjonijiet spe jali g all - a na
NovoMix 70 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Skarto i NovoMix 70 Penfill waqt l- u u jew li jin arru g al li jista jinqala ’: jistg u jin ammu fit - temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 70 Penfill mill- fri, hu rakkomandat li t alli NovoMix 70 Penfill jil aq it - temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina, kif hemm fl - istruzzjonijiet g all- ewwel u u.
NovoMix 70 Penfill is for use by one person only.
NovoMix 70 Penfill hu g al u u minn persuna wa da
The necessity of resuspending the NovoMix 70 suspension immediately before use is to be stressed to the patient.
Il - tie a li ter a ’ tifforma suspensjoni mill - did ta ’ NovoMix 70 immedjatament qabel l- u u g andha ti i enfasizzata lill- pazjent.
NovoMix 70 which has been frozen must not be used.
Il- likwidu li jkun mag mul f’ suspensjoni mill - did g andu jidher abjad u qisu alib b’ mod uniformi NovoMix 70 li kien iffri at m’ g andux jintu a.
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 30 FlexPen 100 U/ ml, suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*………… 100 U/ ml in the ratio of 30/ 70
Insulin aspart * li jin all / insulin aspart * ikkristallizzat bi protamine …….. 100 U/ ml f’ proporzjon ta ’ 30/ 70
1 pre-filled pen contains 3 ml equivalent to 300 U.
Pinna mimlija g al- lest fiha 3 ml ekwivalenti g al 300 U.
26 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
Meta tu a NovoMix 30 darba kuljum, eneralment hu rakkomandat li malli til aq 30 unità tmur g al do a ta ’ darbtejn kuljum billi taqsam id- do a f ’ ew do i ndaqs wa da waqt il- kolazzjon u l- o ra waqt il- pranzu.
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.
28 Dawk il- pazjenti, li l- kontroll taz- zokkor fid- demm tag hom jitjieb bil- kbir, e. permezz ta ’ terapija intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tag hom ta ’ l - ipogli emija, u g andhom jing ataw parir dwar dan il- fatt.
27 Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
Kontroll iktar strett tal- livelli ta ’ glucose jista ’ j id il- potenzjal g al episodji ipogli emi i u g alhekk te tie attenzjoni spe jali matul l- intensifikazzjoni tad- do a kif spjegat fil- qosor f’ sezzjoni 4. 2.
The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
G alhekk, il- fatt li jibda ja dem malajr g andu jkun ikkunsidrat f’ pazjenti li fl- istess in ikollhom mard ie or jew ikunu qed jir ievu kura bi prodotti medi inali o rajn u jkun mistenni li jista ’ jkun hemm xi dewmien fl- assorbiment ta ’ l- ikel
The following substances may increase the patient’ s insulin requirements:
29 Dawn is- sustanzi li ejjin jistg u j idu l - ti ijiet tal- pazjent g all- insulina:
28 4.6 Pregnancy and lactation
4. 6 Tqala u Treddig
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L -
29 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Disturbi fis- sistema nervu a Rari - Newropatija periferali Titjib mg a el fil- kontroll ta ’ glucose fid- demm jista ’ jkun asso jat ma ’ kundizzjoni msej a newropatija akuta bl- u ig, li s- soltu tkun riversibbli.
30 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
L- effett ta ’ l- insulina li jbaxxi l- glucose fid- demm ise meta l- molekuli jing aqdu mar- ri etturi ta ’ l - insulina fuq i - elluli tal- muskoli u tax- xa am u b’ hekk jiffa ilitaw id- d ul ta ’ glucose u fl- istess in jinibixxu l- produzzjoni ta ’ glucose mill- fwied.
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
Profil ta ’ l- attività ta ’ NovoMix 30 (___) u l- insulina bifa ika umana 30 (---) f’ pazjenti b’ sa ithom.
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
Fi studju wie ed, 341 pazjent bid- dijabete ta ’ tip 2 kienu mag ula b’ mod ka wali g al kura jew b’ NovoMix 30 wa du jew b’ NovoMix 30 flimkien ma ’ metformin, jew b’ metformin flimkien ma ’ sulfonylurea.
The primary efficacy variable - HbA1c after 16 weeks of treatment - did not differ between patients with NovoMix 30 combined with metformin and patients with metformin plus sulfonylurea.
32 differenti bejn pazjenti b’ NovoMix 30 flimkien ma ’ metformin u pazjenti b’ metformin flimkien ma ’ sulfonylurea.
With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/ L (from 14.0 mmol/ L at baseline to 7.1 mmol/ L).
B’ NovoMix 30, 66% u 42% tal - pazjenti la qu livelli HbA1c ta t 7% u 6. 5%, rispettivament, u l- medja ta ’ FPG tnaqqset b’ madwar 7 mmol/ L (minn linja ba i ta ’ 14. 0 mmol/ L g al 7. 1 mmol/ L).
31 In patients with type 2 diabetes a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
F’ pazjenti bid- dijabete tat- tip 2, meta- anali i wriet tnaqqis fin- numru totali ta ’ riskju ta ’ episodji ipogli emi i ta ’ matul il- lejl u ta ’ ipogli emija ma uri b’ NovoMix 30 meta mqabbla ma ’ insulina umana bifa ika 30.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
33 Il- farmakokinetika ta ’ NovoMix 30 ma ietx investigata fl- anzjani, fit- tfal jew f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi jew tal- fwied.
Non-clinical data with insulin aspart 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 b’ insulin aspart, mag mula fuq studji konvenzjonali ta ’ sigurtà farmakolo ika, effett tossiku minn do i ripetuti, effett tossiku fuq il - eni, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu spe jali g all- bnedmin >
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glycerol Phenol Metacresol Zinc (b ala chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (g all- a ustament fil- pH) Hydrochloric acid (g all- a ustament fil- pH) Ilma g all- injezzjonijiet
NovoMix 30 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 30 FlexPen waqt l- u u jew li jin arr g al li jista ’ jinqala ’: jistg u jin ammu fit- temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
Do not refrigerate.
Tag mlux fil - fri.
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
Ta inx f’ temperatura ’ l fuq minn 30°C. omm l - fuq il- pinna meta NovoMix 30 FlexPen ma jkunx qed jintu a sabiex tilqa ’ mid- dawl.
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to allow NovoMix 30 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 30 FlexPen mill- fri, hu rakkomandat li t alli NovoMix 30 FlexPen jil aq it- temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina, kif hemm fl - istruzzjonijiet g all- ewwel u u.
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other in a multidose disposable pre-filled pen with a pen injector (plastic).
tal - ie (Tip 1) mag luq b’ pistun tal- gomma ming ajr latti e (bromobutyl) f’ tarf wie ed, u
The cartridge contains a glass ball to facilitate resuspension.
g eluq tal- gomma ming ajr latti e (bromobutyl/ polyisoprene) fit- tarf l- ie or, o pinna mimlija g al - lest li tintrema wara l- u u u li tag ti do i multipli flimkien ma ’ injettatur ta ’ pinen (tal- plastik). L - iskarto fih bo a tal - ie biex tg in biex ter a ’ ti i mag mula s- suspensjoni.
Each pre-filled pen contains 3 ml suspension.
Kull pinna mimlija g al- lest fiha 3 ml ta ’ suspensjoni.
Cartons of 5 or 10 pre-filled pens.
Kaxxi tal- kartun ta ’ 5 jew 10 pinen mimlijin g al- lest.
NovoFine S needles are designed to be used with the pre-filled pen.
Il- labar NovoFine S huma mag mula biex jintu aw mal- pinna mimlija g al- lest.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
L- istruzzjonijiet dettaljati li jakkumpanjaw NovoMix 30 FlexPen g andhom ikunu segwiti.
NovoMix 30 FlexPen is for use by one person only.
NovoMix 30 FlexPen hu g al u u minn persuna wa da biss.
NovoMix 30 FlexPen must not be refilled.
NovoMix 30 FlexPen m’ g andux jimtela mill - did.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Il - tie a li ter a ’ tifforma suspensjoni mill - did ta ’ NovoMix 30 immedjatament qabel l- u u g andha ti i enfasizzata lill- pazjent.
EU/ 1/ 00/ 142/ 009 EU/ 1/ 00/ 142/ 010
EU/ 1/ 00/ 142/ 009 EU/ 1/ 00/ 142/ 010.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 FlexPen 100 U/ ml, suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest.
35 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
B all- insulini l- o rajn kollha, f’ pazjenti anzjani u f’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi, il- monitora tal- glucose g andu jkun intensifikat, u d- do a a ustat fuq ba i individwali.
Reactions usually resolve in a few days to a few weeks.
37 reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
On rare occasions, injection site reactions may require discontinuation of NovoMix 50.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni jista ’ jkun hemm il- b onn li NovoMix 50 jitwaqqaf
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
4.9 Overdose
39 4. 9 Do a e essiva
38 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
G alhekk hu rakkomandat li l- pazjent dijabetiku dejjem i omm fuqu prodotti li jkun fihom iz- zokkor. • Episodji ipogli emi i serji, meta l- pazjent ikun intilef minn sensih, jistg u jkunu kkurati bi glucagon (0. 5 sa 1 mg) mog ti ol- muskoli jew ta t il - ilda minn persuna m arr a, jew bi glucose li jing ata minn ol- vini minn persuna medika professjonali.
Glucose Infusion Rate
40 Rata ta ’ l- infu joni ta ’ Glucose
39 5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
40 NovoMix 50 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 FlexPen waqt l- u u jew li jin arr g al li jista jinqala ’: jistg u jin ammu fit- temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
Ta inx f’ temperatura ’ l fuq minn 30°C. omm l- g atu fuq il- pinna meta NovoMix 50FlexPen ma jkunx qed jintu a sabiex tilqa ’ mid- dawl.
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 50 FlexPen mill- fri, hu rakkomandat li t alli NovoMix 50 FlexPen jil aq it- temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina, kif hemm fl - istruzzjonijiet g all- ewwel u u.
The cartridge contains a glass ball to facilitate resuspension.
Skarto tal - ie (Tip 1) mag luq b’ pistun tal- gomma ming ajr latti e (bromobutyl) f’ tarf wie ed, u g eluq tal- gomma ming ajr latti e (bromobutyl/ polyisoprene) fit- tarf l- ie or, o pinna mimlija g al - lest li tintrema wara l- u u u li tag ti do i multipli flimkien ma ’ injettatur ta ’ pinen (tal- plastik). L - iskarto fih bo a tal - ie biex tg in biex ter a ’ ti i mag mula s- suspensjoni.
Cartons of 1, 5 or 10 pre-filled pens.
Kaxxi tal- kartun ta ’ 1, 5 jew 10 pinen mimlijin g al- lest.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
L- istruzzjonijiet dettaljati li jakkumpanjaw NovoMis 50 FlexPen g andhom ikunu segwiti.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen hu g al u u minn persuna wa da biss.
NovoMix 50 FlexPen must not be refilled.
NovoMix 50 FlexPen m’ g andux jimtela
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
Il - tie a li ter a ’ tifforma suspensjoni mill - did ta ’ NovoMix 50 immedjatament qabel l- u u g andha ti i enfasizzata lill- pazjent.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 FlexPen 100 U/ ml, suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest.
42 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
B all- insulini l- o rajn kollha, f’ pazjenti anzjani u f’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi, il- monitora tal- glucose g andu jkun intensifikat, u d- do a a ustat fuq ba i individwali.
Reactions usually resolve in a few days to a few weeks.
45 reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
4.9 Overdose
47 4. 9 Do a e essiva
45 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
G alhekk hu rakkomandat li l- pazjent dijabetiku dejjem i omm fuqu prodotti li jkun fihom iz- zokkor. • Episodji ipogli emi i serji, meta l- pazjent ikun intilef minn sensih, jistg u jkunu kkurati bi glucagon (0. 5 sa 1 mg) mog ti ol- muskoli jew ta t il - ilda minn persuna m arr a, jew bi glucose li jing ata minn ol- vini minn persuna medika professjonali.
Glucose Infusion Rate
48 Rata ta ’ l- infu joni ta ’ Glucose
46 5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
47 6.4 Special precautions for storage
6. 4 Prekawzjonijiet spe jali g all - a na
NovoMix 70 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 FlexPen waqt l- u u jew li jin arr g al li jista jinqala ’: jistg u jin ammu fit- temperatura ta ’ l- ambjent (ta t 30°C) sa 4 img at, i da kwalunkwe fdal imbag ad irid jintrema.
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
Ta inx f’ temperatura ’ l fuq minn 30°C. omm l- g atu fuq il- pinna meta NovoMix 70 FlexPen ma jkunx qed jintu a sabiex tilqa ’ mid- dawl.
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to allow NovoMix 70 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tne i NovoMix 70 FlexPen mill- fri, hu rakkomandat li t alli NovoMix 50 FlexPen jil aq it- temperatura tal- kamra qabel ma ter a ’ tag mel suspensjoni mill - did ta ’ l- insulina, kif hemm fl - istruzzjonijiet g all- ewwel u u.
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
L- istruzzjonijiet dettaljati li jakkumpanjaw NovoNix 70 FlexPen g andhom ikunu segwiti.
NovoMix 70 FlexPen is for use by one person only.
L- iskarto
NovoMix 70 FlexPen must not be refilled.
m’ g andux jimtela mill - did.
49 ANNEX II
51 ANNESS II
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI G AT - TQEG ID FIS- SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLO IKA (I) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
NovoMix 30 Penfill and NovoMix 30 FlexPen:
NovoMix 30 Penfill u NovoMix 30 FlexPen:
NovoMix 50 Penfill and NovoMix 50 FlexPen:
NovoMix 50 Penfill u NovoMix 50 FlexPen:
NovoMix 70 Penfill and NovoMix 70 FlexPen:
NovoMix 70 Penfill u NovoMix 70 FlexPen:
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tag rif tal- prodott medi inali g andu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill - ru tal- lott kon ernat.
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- U U • IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ
Medicinal product subject to medical prescription.
Prodott medi inali jing ata bir- ri etta tat- tabib.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- U U MING AJR PERIKLU U EFFETTIV TAL- PRODOTT MEDI INALI
51 ANNEX III
53 ANNESS III
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
55 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 U/ ml Suspensjoni g all- injezzjoni fi skarto Insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
1 ml suspensjoni fiha 100 U (3. 5 mg) ta ’ insulin aspart (rDNA) (30% insulin aspart li jin all u 70% insulin aspart ikkristallizzat bi protamine),
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glycerol, phenol, metacresol, zinc (b ala chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, ilma g all- injezzjonijiet
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
U u g al ta t il - ilda Skarto i NovoMix 30 Penfill huma g all- u u ma ’ strumenti ta ’ l- insulina Novo Nordisk Aqra l- fuljett ta ’ tag rif qabel l- u u.
OTHER SPECIAL WARNINGS, IF NECESSARY
TWISSIJIET SPE JALI O RA, JEKK ME TIE A
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Skarto i NovoMix 30 Penfill huma g al u u minn persuna wa da biss
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPE JALI TA ’ KIF JIN A EN
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cartridges in the outer carton in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
A en fi fri (2°C – 8°C) Tag mlux fil- fri a omm l- iskarto i fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl ° Waqt l- u u: tag milx fil- fri jew ta en f’ temperatura ’ l fuq minn 30°C U a fi mien 4 img at
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
57 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 Penfill 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
Resuspend according to instructions
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
58 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 U/ ml Suspensjoni g all- injezzjoni fi skarto Insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 50% and insulin aspart crystallised with protamine 50%),
1 ml suspensjoni fiha 100 U (3. 5 mg) ta ’ insulin aspart (rDNA) (50% insulin aspart li jin all u 50% insulin aspart ikkristallizzat bi protamine),
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
U u g al ta t il - ilda Skarto i NovoMix 50 Penfill huma g all- u u ma ’ strumenti ta ’ l- insulina Novo Nordisk Aqra l- fuljett ta ’ tag rif qabel l- u u.
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Skarto i NovoMix 50 Penfill huma g al u u minn persuna wa da biss
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
60 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 Penfill 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 U/ ml Suspensjoni g all- injezzjoni fi skarto Insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
1 ml suspensjoni fiha 100 U (3. 5 mg) ta ’ insulin aspart (rDNA) (70% insulin aspart li jin all u 30% insulin aspart ikkristallizzat bi protamine),
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
U u g al ta t il - ilda Skarto i NovoMix 70 Penfill huma g all- u u ma ’ strumenti ta ’ l- insulina Novo Nordisk Aqra l- fuljett ta ’ tag rif qabel l- u u.
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Skarto i NovoMix 70 Penfill huma g al u u minn persuna wa da biss
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 Penfill 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 30 FlexPen 100 U/ ml Suspensjoni g all- injezzjoni fi skarto 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
U u g al ta t il - ilda Mag mul biex jintu a ma ’ labar NovoFine jew NovoTwist li jintu aw darba biss u li g andhom tul ta ’ mhux i jed minn 8 mm Il- labar m’ humiex inklu i Aqra l- fuljett ta ’ tag rif qabel l- u u.
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet NovoMix 30 FlexPen huma g al u u minn persuna wa da biss
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cap on the pen in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
A en fi fri (2°C – 8°C) Tag mlux fil- fri a omm l- g atu fuq il- pinna sabiex tipprote iha mid- dawl ° Waqt l- u u: tag milx fil- fri jew ta en f’ temperatura ’ l fuq minn 30°C U a fi mien 4 img at
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 FlexPen 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
Insulin aspart
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet NovoMix 50 FlexPen hu g al u u minn persuna wa da biss
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 FlexPen 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
Insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
1 ml suspensjoni fiha 100 U (3. 5 mg) ta ’ insulin aspart (rDNA) (70% insulin aspart li jin all u 30% insulin aspart ikkristallizzat bi protamine)
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
Er a ’ ifforma suspensjoni skond l- istruzzjonijiet NovoMix 70 FlexPen hu g al u u minn persuna wa da biss.
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 FlexPen 100 U/ ml Suspensjoni g all- injezzjoni Insulin aspart G al u u ta t il - ilda
72 PACKAGE LEAFLET:
74 FULJETT TA ’ TAG RIF:
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 U/ ml suspensjoni g all- injezzjoni fi skarto 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 tu a din il- medi ina – omm dan il- fuljett.
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 b onn ter a ’ taqrah – Jekk ikollok aktar mistoqsijiet, jekk jog bok staqsi lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek. – Din il- medi ina iet mog tija 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 ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi b al tieg ek. – Jekk xi wie ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f 'il- fuljett, jekk jog bok, g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek. dan
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
X’ INHU NOVOMIX 30 U G ALXIEX JINTU A
NovoMix 30 is an insulin analogue to treat diabetes.
NovoMix 30 huwa analogu ta ’ l- insulina g all- kura tad- dijabete.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Ji i fi skarto ta ’ 3 ml, imsejja Penfill, li jaqbel ma ’ apparat li jintu a g all- g oti ta ’ l- insulina.
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
NovoMix 30 hu ta lita ta ’ analogu ta ’ l- insulina li ja ixxi b’ mod malajr (30%) u analogu ta ’ l- insulina li ja ixxi fit- tul (70%).
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 24 hours.
Dan ifisser li jibda jbaxxi z- zokkor fid- demm tieg ek minn 10- 20 minuta wara li tie du, l- effett massimu tieg u jkun bejn 1 u 4 sig at, u l- effett idum sa 24 sieg a.
It may be used in combination with certain oral antidiabetic drugs.
Jista ’ jintu a flimkien ma ’ erti medi ini kontra d- dijabete li jittie du mill - alq.
BEFORE YOU USE NOVOMIX 30
QABEL MA TU A NOVOMIX 30
Do not use NovoMix 30
Tu ax NovoMix 30
If you are allergic (hypersensitive) to this insulin product or any of the other ingredients (see 7 Further information).
Jekk int aller iku/ a ((tbati minn sensittività e essiva) g al din it- tip ta ’ insulina jew g al xi wie ed mill- ingredjenti l- o ra (ara 7 Aktar tag rif).
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 t oss li ejja ipo (ipo hija taqsira ta ’ reazzjoni ipogli emika u hija abra 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’ g andek tag mel f’ emer enza, g al iktar informazzjoni dwar l- ipos.
Take special care with NovoMix 30
Oqg od attent afna b’ NovoMix 30
If you have trouble with your kidneys or liver, your doctor may decide to alter your insulin dose If you are drinking alcohol (also beer, wine): watch for signs of a hypo and never drink alcohol on an empty stomach 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.
Jekk tixrob l- alko ol (anki birra u nbid): oqg od attent/ a g al sinjal ta ’ xi ipo u qatt m’ g andek tixrob l- alko ol fuq stonku vojt Jekk tag mel e er izzju fi iku iktar mis- soltu jew jekk trid tibdel id- dieta normali tieg ek Jekk inti marid/ a: kompli u l- insulina tieg ek.
Your need for insulin may change If you have an infection, fever or have had an operation you may need more insulin than usual If you suffer from diarrhoea, vomiting or eat less than usual you may need less insulin than usual If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk ser issiefer: li tivvja a bejn oni tal - in differenti, jista ’ jaffettwa l - ti ijiet tieg ek ta ’ l - insulina u l - in meta tie u l- injezzjonijiet.
Consult your doctor if you are planning such travelling.
Tkellem mat- tabib jekk qed tippjana xi vja b al dan
Using other medicines
Meta tu a medi ini o ra
Many medicines affect the way your glucose works in your body and this may influence your insulin dose.
Il- mod kif ja dem glucose fil - isem tieg ek ji i affetwat minn afna medi ini u dan jista ’ jinfluwenza d- do a tieg ek ta ’ insulina.
Listed below are the most common medicines which may affect your insulin treatment.
Hawn ta t hawn elenkati l- iktar medi ini komuni li jistg u jaffettwaw il - kura tieg ek bl- insulina.
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg ed tie u jew
Your need for insulin may change if you also take:
75 adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, 73 angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
Il - tie a tieg ek g all- insulina tista ’ tinbidel jekk inti tie u wkoll: prodotti medi inali kontra d- dijabete li jittie du mill - alq, inibituri ta ’ monoamine oxidase (MAO), beta- blokkanti, inibituri ta ’ l- enzima li tikkonverti l- an jotensin (ACE), sali ilati, sterojdi anaboli i u glukokortikojdi (minbarra dawk li jing ataw b’ mod topiku), kontra ettivi orali, tija idi, ormoni tat - tirojde, simpatomimeti i danazol, octreotide u sulfonamidi.
Pregnancy and breast-feeding If you are planning a pregnancy or if you are pregnant or breast-feeding: please contact your doctor for advice.
Tqala u Treddig Jekk inti qed tippjana tqala jew inti tqila jew qed tredda 'jekk jog bok ikkuntattja lit- tabib: tieg ek g al parir.
There is limited clinical experience with insulin aspart in pregnancy.
L- esperjenza klinika ta ’ insulin aspart fit- tqala hija limitata.
Driving and using machines If you drive or use tools or machines: watch out for signs of a hypo.
Sewqan u t addim ta ’ magni Jekk issuq jew tu a g odda jew magni: og qod attent g as- sinjali ta ’ ipo.
Your ability to concentrate or to react may be reduced during a hypo.
Il- kapa ità tieg ek li tikkon entra jew li tirrea ixxi jistg u jonqsu waqt ipo.
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e. g. driving a car or operating machinery).
Jekk jog bok omm din il- possibbiltà f’ mo ok fis- sitwazzjonijiet kollha fejn tista ’ tqieg ed lilek innifsek jew lil addie or fil- periklu (e. is- sewqan ta ’ karrozza jew it- t addim ta ’ magni).
Never drive or use machinery if you feel a hypo coming on.
Qatt m’ g andek issuq jew t addem magni jekk t oss li ejja xi 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 tieg ek jekk g andekx issuq jew t addem magni jekk ikollok episodji frekwenti ta ’ ipos jew jekk issibha diffi li biex tag raf l- ipos.
For children 6-9 years limited clinical data exists.
G al tfal bejn 6- 9 snin l- informazzjoni klinika hija limitata.
HOW TO USE NOVOMIX 30
KIF G ANDEK TU A NOVOMIX 30
Talk about your insulin needs with your doctor and diabetes nurse.
Tkellem dwar il - ti ijiet tieg ek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tieg ek.
Follow their advice carefully.
Segwi l- parir tag hom b’ attenzjoni.
When NovoMix 30 is used in combination with oral antidiabetic drugs the dosage should be adjusted.
Meta NovoMix 30 jintu a flimkien ma ’ medi ini orali antidijabeti i, id- do a g andu jkun a ustat.
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 tieg ek biddillek l- insulina minn tip jew marka ta ’ insulina g al o ra, jista ’ jkun li d- do a tieg ek ti i a ustata mill- istess tabib.
Eat a meal or snack containing carbohydrates within 10 minutes of the injection.
Kul ikla jew xi a a afifa li jkun fiha l- karboidrati fi mien 10 minuti mill- injezzjoni.
NovoMix 30 may also be given soon after the meal.
NovoMix 30 jista ’ jing ata wkoll dritt wara xi ikla.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li ti ekkja l- livell tal- glucose fid- demm tieg ek regolarment.