qanastek/EMEA-V3 huggingface dataset:
NovoMix 30 is for use by one person only.
NovoMix 30 hu g al u u minn persuna wa da biss.
Before using NovoMix 30
Qabel ma tu a NovoMix 30
Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper).
I ekkja t- tikketta biex ti gura li hi t- tip korrett ta ’ insulina Dejjem i ekkja l- iskarto, inklu il- plan er tal- gomma (tapp).
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Tu ahx jekk tara li g andu xi sara jew jekk ikun hemm xi spazju bejn il- plan er tal- gomma u l- istrixxa bajda tat- tikketta. udu lura ming and min xtrajtu.
Take it back to your supplier.
Ara l- manwal tas- sistema ta ’ l- g oti ta ’ l- insulina g al iktar struzzjonijiet.
See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination.
Iddi infetta l- membrana tal- gomma b’ tajjara mxarrba b’ di infettant Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni
NovoMix 30 should not be used
NovoMix 30 m’ g andux jintu a
In insulin infusion pumps If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 30) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- iskarto jew it- tag mir li jkun fih l- iskarto jitwaqqa ’, ji rilu l - sara jew jitg affe, hemm ir- riskju li jkun hemm xi ru ta ’ l- insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 30) Jekk l- insulina meta tit allat ma tkunx bajda u qisa alib b’ mod uniformi Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jtieh dehra qisu nkesa bil - elu.
How to use this insulin
76 Kif g andek tu a din l- insulina
NovoMix 30 is for injection under the skin (subcutaneously).
NovoMix 30 g andu jing ata b ala injezzjoni minn ta t il - ilda.
Never inject your insulin directly into a vein or muscle.
Qatt m’ g andek tinjetta l - insulina tieg ek direttament o vina jew o muskolu.
The best places to give
Dejjem ibdel i - ona tal - isem fejn tinjetta, biex tevita l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
74 yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
L- a jar postijiet fejn tinjetta lilek innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (l- addome); il- warrani; in- na a ta ’ quddiem tal- koxox u n- na a ta ’ fuq dirg ajk.
Your insulin will work more quickly if you inject around the waist.
L- insulina tieg ek ta dem iktar malajr jekk tinjetta madwar il- qadd.
NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 30 Penfill hu mag mul biex jintu a mas- sistemi ta ’ l- g oti ta ’ l- insulina ta ’ Novo Nordisk u mal- labar NovoFine.
If you are treated with NovoMix 30 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ NovoMix 30 Penfill u bi skarto Penfill ta ’ insulina o ra, g andek tu a sistema wa da ta ’ - l- g oti ta ’ l- insulina g al kull tip ta ’ insulina.
Do not refill NovoMix 30 Penfill cartridges.
Timliex mill - did l- iskarto i NovoMix 30 Penfill.
As a precautionary measure, always carry a spare Penfill cartridge in case your Penfill cartridge is lost or damaged.
B ala mi ura ta ’ prekawzjoni, dejjem orr mieg ek skarto Penfill ejjed fil- ka li l- iskarto Penfill jintilef jew ji rilu l - sara.
Resuspension of the insulin
Suspensjoni mill - did ta ’ l- insulina
Before you put the cartridge into the insulin delivery system:
Qabel ma tpo i l- iskarto fis- sistema li biha ting ata l- insulina:
The first time you use NovoMix 30 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
L- ewwel darba li tu a NovoMix 30 Penfill irrombla l- iskarto bejn idejk g al 10 darbiet – huwa importanti li l- iskarto jin amm b’ mod orizzontali (ara stampa A). aqlaq l- iskarto ’ il fuq u ’ l isfel bejn il- po izzjonijiet a u b (ara stampa B) 10 darbiet, biex b’ hekk il- bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto.
Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
Irrepeti l- pro eduri ta ’ l- irrumblar u ta - aqliq (ara stampi A u B) sakemm b’ mod uniformi l- likwidu jidher proprju abjad u qisu alib.
Repeat the rolling and moving procedures (see pictures A and B until the liquid does appears uniformly white and cloudy.
Is - suspensjoni mill - did tkun e fef meta l- insulina tkun la qet it- temperatura tal- kamra.
Resuspension is easier when the insulin has reached room temperature.
Wettaq l - istadji l- o rajn ta ’ l- injezzjoni ming ajr telf ta ’ mien
Complete the other stages of injection without delay For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy.
G al kull injezzjoni li ti i wara, aqlaq is- sistema ta’ l- g oti ta ’ l- insulina bl- iskarto
Complete the other stages of injection without delay.
’ l fuq u ’ l isfel bejn a u b (ara stampa B) g allinqas 10 darbiet sakemm il- likwidu jidher abjad u qisu alib b’ mod uniformi Wettaq l- istadji l- o rajn ta ’ l- injezzjoni ming ajr telf ta ’ mien
Pict ure A
Stampa A
Picture B a
Stampa B
Check there are at least 12 units of insulin left in the cartridge to allow even resuspension.
I ekkja li jkun fadal mill- inqas 12- il unità ta ’ insulina fl- iskarto biex is- suspensjoni mill - did tkun tista ’ ssir b’ mod uniformi.
If there are less than 12 units left, use a new one.
Jekk ikun baqa ’ inqas minn 12- il unità, u a wie ed did.
Inject the insulin under the skin.
Injetta l- insulina ta t il - ilda.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
Wara kull injezzjoni a erta ru ek li tne i u tarmi l- labra u a zen NovoMix ming ajr ma l - labra tkun imwa la.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, jista ’ jkun hemm xi telf tal- likwidu li tista ’ tkun il- kaw a ta ’
If you get a hypo (hypoglycaemia)
Jekk ikollok ipo (ipogli emija)
A hypo means your blood sugar level is too low.
Ipo tfisser li l- livell taz- zokkor fid- demm tieg ek hu baxx wisq.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistg u jigu g al g arrieda u jistg u jinkludu g araq kiesa; ilda kies a u pallida; u ig ta ’ ras; ta bit mg a el tal- qalb; t ossok imqalla ’; t oss u kbir; tibdil temporanju fil- vista; edla; g eja u debbulizza mhux tas- soltu; nervo ità jew rog da; t ossok ansju / a; t ossok konfu / a; diffikultà biex tikkon entra.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wie ed minn dawn is- sinjali: kul xi pastilji tal- glucose jew xi a a afifa li jkun fiha afna zokkor (elu, gallettini, meraq tal- frott), imbag ad strie.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case it is needed.
Ti ux l- insulina jekk t oss li ejja ipo. orr mieg ek pastilji tal- glucose, elu, gallettini jew meraq tal- frott, fil- ka li jkollok b onnhom.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and get medical help straight away.
G id lill- qraba, bieb u kollegi tieg ek li jekk ikollok ass a in (tintilef minn sensik), huma g andhom: idawruk fuq enbek u j ibu g ajnuna medika immedjatament.
They must not give you any food or drink, as it could choke you.
M’ g andhomx jag tuk ikel jew xorb, g ax dan jista ’ j ag lek tifga.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Jekk ikollok ipo li ieg lek tintilef minn sensik, jew ikollok afna ipos, kellem lit- tabib tieg ek.
The amount or timing of insulin, food or exercise may need to be adjusted.
L- ammont jew il - in ta’ meta tie u l- insulina, l- ikel jew l- e er izzju fi iku jista ’ jkun li jkollhom b onn li ji u a ustati.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Jekk tintilef minn sensik, tista ’ tirkupra aktar malajr b’ injezzjoni ta ’ l- ormon glucagon mg oti minn xi add li jaf kif ju ah.
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Jekk ting ata glucagon, ikollok tie u glucose jew tiekol xi a a afifa li jkun fiha z- zokkor malli ti i f’ tieg ek.
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Jekk ma tirrispondix g all- kura b’ glucagon, ser ikollok b onn ta ’ kura fi sptar.
Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
Wara injezzjoni ta ’ glucagon ikkuntattja lit- tabib tieg ek jew it- taqsima ta ’ l- emer enza fl - isptar: ikollok b onn issib ir- ra uni g aliex kellek ipo biex tevita li jkollok iktar minnhom.
Causes of a hypo
Il- kaw i ta ’ ipo
You get a hypo if your blood sugar gets too low.
Ikollok ipo jekk il- livell taz- zokkor fid- demm tieg ek jitbaxxa • Jekk tie u wisq insulina • Jekk tiekol ftit wisq jew taqbe xi ikla • Jekk tag mel iktar e er izzju mis- soltu.
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
Dan jista ’ ji ri:
Your blood sugar may get too high (this is called hyperglycaemia).
Il- livell taz- zokkor fid- demm tieg ek jista ’ jitla ’ ejjed (din tissejja ipergli emija).
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Dawn jinkludu: tag mel l- awrina iktar ta ’ spiss; t ossok bil- g atx; titlef l- aptit; t ossok imqalla ’ (dardir jew rimettar); t ossok im eddel/ im edla jew g ajjien/ a; mura fil- wi, ilda xotta; alq xott u nifs li jkollu ri a ta ’ frott (acetone)).
If you get any of these signs, test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.
Jekk ikollok xi wie ed minn dawn is- sinjali, i ekkja l- livell taz- zokkor fid- demm tieg ek; jekk tista ’ ekkja l- awrina tieg ek g al ketoni; imbag ad fittex parir mediku immedjatament.
These may be signs of a very serious condition called diabetic ketoacidosis.
Dawn jistg u jkunu sinjali ta ’ kundizzjoni serja afna li tissejja ketoa idosi dijabetika.
Causes of hyperglycaemia
78 Il- kaw i ta ’ ipergli emija
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
• Tkun insejt tie u l- insulina tieg ek • Li ripetutament tie u inqas insulina milli g andek b onn • Ikollok infezzjoni jew deni • Tiekol iktar mis- soltu • Tag mel e er izzju fi iku inqas mis- soltu.
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
B al kull medi ina o ra, NovoMix 30 jista ’ jkollu effetti sekondarji g alkemm ma jidhrux fuq kul add.
The most common side effect is low blood sugar (hypoglycaemia).
L- iktar effett sekondarju komuni hu livell baxx ta ’ zokkor fid- demm (ipogli emija).
Side effects reported uncommonly
Effetti sekondarji rrappurtati b’ mod mhux komuni
(less than 1 in 100)
(inqas minn 1 minn kull 100):
When you first start your insulin treatment, it may disturb your vision, but the condition usually disappears.
Fil- bidu tal- kura bl- insulina, jista ’ jkollok xi problemi fil- vista tieg ek, i da din il - kundizzjoni normalment tmur wa idha.
Changes of the injection site (Lipodystrophy).
Tibdil fis- sit ta ’ l- injezzjoni (Lipodistrofija).
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Jekk tinjetta lilek innifsek ta ’ spiss wisq fl- istess sit, it - tessut tax- xa am ta t il - ilda f’ dan is- sit jista ’ jinxtorob (lipoatrofija) jew je xien (lipoipertrofija).
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota ofor fil - ilda tieg ek jew li l - ilda qed te xien fis- sit ta ’ l- injezzjoni, g id lit- tabib tieg ek jew lill - infermier/ a, g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk l- injezzjoni ssir f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions).
Jistg u jse u reazzjonijiet (mura, nef a, akk) fis- post ta ’ l- injezzjoni (reazzjonijiet aller i i lokali).
These usually disappear after a few weeks of taking your insulin.
Dawn normalment imorru wa idhom wara ftit img at minn meta tibda tie u l- insulina.
If they do not disappear, see your doctor.
Jekk jibqg u hemm, kellem lit- tabib tieg ek.
Seek medical advice immediately: • If signs of allergy spread to other parts of your body, or • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Fittex parir mediku immedjatament: • Jekk is- sinjali ta ’ l- aller ija jinfirxu g al partijiet o ra ta ’ ismek, jew • Jekk f’ daqqa wa da t ossok ma tifla x u: tibda teg req; tibda t ossok imdardar/ imdardra (tirremetti); ikollok diffikultà biex tie u n- nifs; ikollok ta bit mg a el tal- qalb; t ossok stordut/ a.
You may have a very rare serious allergic reaction to NovoMix 30 or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni aller ika serja u rari afna g al NovoMix 30 jew g al xi wie ed mill - ingredjenti tieg u (imsej a reazzjoni aller ika sistemika).
See also the warning in 2 Before you use NovoMix 30.
Ara wkoll it- twissija f’ 2 Qabel ma tu a NovoMix 30.
Diabetic retinopathy.
Retinopatija dijabetika.
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Jekk g andek retinopatija dijabetika u l- livelli tal- glucose fid- demm tieg ek jitjiebu malajr afna, ir- retinopatija tista ’ tmur g all- ag ar.
When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Meta tibda tie u l- insulina, i - amma ta ’ l- ilma tista ’ tikkaw alek nef a madwar l - g ekiesi u ogi o ra.
Normally, this soon disappears.
Normalment din malajr tmur.
Side effects reported rarely
Effetti sekondarji rrappurtati b’ mod rari
(less than 1 in 1,000)
(inqas minn 1 minn kull 1, 000)
Painful neuropathy.
Newropatija bl- u ig.
If your blood glucose levels improve very fast, you may get nerve related pain – this is called acute painful neuropathy and is usually transient.
Jekk il- livelli tal- glucose fid- demm tieg ek jitjiebu malajr afna, dan jista ’ jkun il- kaw a ta ’ u ig li jkun ej min- nervituri – din tissejja newropatija akuta bl- u ig u normalment din tkun temporanja.
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 pharmacist.
Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex
HOW TO STORE NOVOMIX 30
EN NOVOMIX 30
Do not use NovoMix 30 after the expiry date which is stated on the label and carton.
Tu ax NovoMix 30 wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi g all- a ar urnata ta ’ dak ix- xahar.
NovoMix 30 Penfill that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or too near the freezer section or cooling element.
NovoMix 30 Penfill li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 30 Penfill that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 30 Penfill li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to mix the insulin as instructed 77 for the first time use.
Wara li tne i NovoMix 30 Penfill mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
See 3 How to use NovoMix 30.
Ara 3 Kif g andek tu a NovoMix 30.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 4 weeks, but any remainder must then be discarded.
Tista ’ orru mieg ek u ommu fit - temperatura ambjentali tal- kamra (mhux iktar minn 30°C) sa 4 img at, wara dan i - mien kull fdal tal- prodott g andu jintrema.
Always keep the cartridge in the outer carton when you’ re not using it in order to protect it from light.
Dejjem omm l- iskarto fil- kartuna ta ’ barra meta ma tkunx qed tu ah sabiex tilqa ’ mid- dawl.
NovoMix 30 Penfill must be protected from excessive heat and sunlight.
NovoMix 30 Penfill g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
NovoMix 30 should not be disposed of via wastewater or household waste.
NovoMix 30 m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispi jar dwar kif g andek tarmi medi ini li m’ g andekx b onn.
These measures will help to protect the environment.
Dawn il- mi uri jg inu g al protezzjoni ta ’ l- ambjent.
What NovoMix 30 contains
X’ fih NovoMix 30
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (30% insulin aspart in a soluble fraction and 70% insulin aspart crystallised with protamine) – The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
Is- sustanzi l- o ra huma glycerol, phenol, metacresol, zinc (b ala chloride), sodium chloride, – disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid u ilma g all- injezzjonijiet.
What NovoMix 30 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 5 or 10 cartridges of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 30 u l- kontenut tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta ’ 5 jew 10 skarto i ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
1 ml contains 100 U (3.5 mg) of insulin aspart.
1 ml fih 100 U (3. 5 mg) ta ’ insulin aspart.
Marketing Authorisation Holder Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
78 PACKAGE LEAFLET:
80 FULJETT TA ’ TAG RIF:
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
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 l- insulina tieg ek. – 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, 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’ dan il- fuljett, jekk jog bok g id lit- tabib lill- infermier/ a jew lill - ispi jar tieg ek.
WHAT NOVOMIX 50 IS AND WHAT IT IS USED FOR
X’ INHU NOVOMIX 50 U G ALXIEX JINTU A
NovoMix 50 is an insulin analogue to treat diabetes.
NovoMix 50 huwa analogu ta ’ l- insulina g all- kura tad- dijabete.
NovoMix 50 is a mixture of rapid-acting insulin analogue (50%) and long-acting insulin analogue (50%).
NovoMix 50 hu ta lita ta ’ analogu ta ’ l- insulina li ja ixxi b’ mod malajr (50%) u analogu ta ’ l- insulina li ja ixxi fit- tul (50%).
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 14-24 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 14- 24 sieg a.
BEFORE YOU USE NOVOMIX 50
QABEL MA TU A NOVOMIX 50
Do not use NovoMix 50
Tu ax NovoMix 50
Take special care with NovoMix 50
Oqg od attent afna b’ NovoMix 50
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 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, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids 79 (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
81 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.
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: oqg od attent/ a g as- sinjali ta ’ 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).
Meta ssuq karozza jew t addem xi makkinarju).
There is no clinical experience in children and adolescents under the age of 18 years.
M’ hemmx esperjenza klinika fi tfal u f’ adoloxxenti ta ’ ta t it- 18- il sena.
HOW TO USE NOVOMIX 50
KIF G ANDEK TU A NOVOMIX 50
When NovoMix 50 is used in combination with metformin the dosage should be adjusted.
Meta NovoMix 50 jintu a flimkien ma ’ metformin, id- do a g andu jkun a ustat.
NovoMix 50 may also be given soon after the meal.
NovoMix 50 jista ’ jing ata wkoll dritt wara xi ikla.
NovoMix 50 is for use by one person only.
NovoMix 50 hu g al u u minn persuna wa da biss.
Before using NovoMix 50
Qabel ma tu a NovoMix 50
NovoMix 50 should not be used
NovoMix 50 m’ g andux jintu a
In insulin infusion pumps If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 50) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- iskarto jew it- tag mir li jkun fih l- iskarto jitwaqqa ’, ji rilu l - sara jew jitg affe, hemm ir- riskju li jkun hemm xi ru ta ’ l- insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 50) Jekk l- insulina meta tit allat ma tkunx bajda u qisa alib b’ mod uniformi Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jag tih dehra qisu nkesa bil - elu
NovoMix 50 is for injection under the skin (subcutaneously).
NovoMix 50 g andu jing ata b ala injezzjoni minn ta t il - ilda.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
82 Dejjem ibdel i - ona tal - isem fejn tinjetta, biex tevita l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
L- a jar postijiet fejn tinjetta lilek innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (l- addome); il- warrani; in- na a ta ’ quddiem tal- koxox u n- na a ta ’ fuq dirg ajk.
80 NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 50 Penfill hu mag mul biex jintu a mas- sistemi ta ’ l- g oti ta ’ l- insulina ta ’ Novo Nordisk u mal- labar NovoFine.
If you are treated with NovoMix 50 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ NovoMix 50 Penfill u bi skarto Penfill ta ’ insulina o ra, g andek tu a sistema wa da ta ’ - l- g oti ta ’ l- insulina g al kull tip ta ’ insulina.
Do not refill NovoMix 50 Penfill cartridges.
Timliex mill - did l- iskarto i NovoMix 50 Penfill.
The first time you use NovoMix 50 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
L- ewwel darba li tu a NovoMix 50 Penfill irrombla l- iskarto bejn idejk g al 10 darbiet – huwa importanti li l- iskarto jin amm b’ mod orizzontali (ara stampa A). aqlaq l- iskarto ’ il fuq u ’ l isfel bejn il- po izzjonijiet a u b (ara stampa B) 10 darbiet, biex b’ hekk il- bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto.
Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
Irrepeti l- pro eduri ta ’ l- irrumblar u - aqliq (ara stampi A u B) sakemm b’ mod uniformi l- likwidu jidher proprju abjad u qisu alib.
Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white and cloudy.
Is - suspensjoni mill - did tkun e fef meta l- insulina tkun la qet it- temperatura tal- kamra.
Complete the other stages of injection without delay For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy.
Jekk il- pro edura ta - aqliq wa idha ma tkunx bi ejjed
If the moving procedure alone is not enough to give a uniformly white and cloudy liquid, repeat the rolling and moving procedures described above until the liquid does appear uniformly white and cloudy.
- aqliq kif deskritt iktar ’ l fuq sakemm b’ mod uniformi l- likwidu jidher proprju abjad u qisu
Complete the other stages of injection without delay.
Wettaq l- istadji l- o rajn ta ’ l- injezzjoni ming ajr telf ta ’ mien
Check there are at least 12 units of insulin left in the cartridge to allow even resuspension.
I ekkja li jkun fadal mill- inqas 12- il unità ta ’ insulina fl- iskarto biex is- suspensjoni mill - did tkun jista ’ ssir b’ mod uniformi.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
U a teknika ta ’ injezzjoni li jkun tak parir dwarha t- tabib jew l - infermier/ a tieg ek u li hi deskritta fil- manwal tieg ek tas- sistema ta ’ l- g oti ta ’ l- insulina.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il- likwidu jista ’ jnixxi ’ l barra li tista ’ tkun il- kaw a ta ’ te id ta ’ do a baljata.
Causes of hyperglycaemia
84 Il- kaw i ta ’ ipergli emija
The most common side effect is low blood sugar (hypoglycaemia).
B al kull medi ina o ra, NovoMix 50 jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add L- iktar effett sekondarju komuni hu livell baxx ta ’ zokkor fid- demm (ipogli emija).
See the advice in 4 What to do in an emergency.
Ara l - pariri f’ 4 X’ g andek tag mel f’ emer enza.
Changes of the injection site (Lipodystrophy).
Tibdil fis- sit fejn ting ata l- injezzjoni (Lipodistrofija).
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Jekk tinjetta lilek innifsek wisq ta ’ spiss fl - istess sit, it- tessut tax- xa am ta t il - ilda f’ dan is- sit jista ’ jinxtorob (lipoatrofija) jew je xien (lipoipertrofija).
Changing the site with each injection may help to prevent such skin changes.
Li tibdel is- sit ma ’ kull injezzjoni jista ’ jg in biex ji i evitat dan it- tibdil fil - ilda.
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota ofor fil - ilda tieg ek jew li l - ilda qed te xien fis- sit ta ’ l- injezzjoni, g id lit- tabib tieg ek jew lill- infermier/ a, g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk tinjetta f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
You may have a very rare serious allergic reaction to NovoMix 50 or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni aller ika serja u rari afna g al NovoMix 50 jew g al xi wie ed mill - ingredjenti tieg u (imsej a reazzjoni aller ika sistemika).
See also the warning in 2 Before you use NovoMix 50.
Ara wkoll it- twissija f’ 2 Qabel ma tu a NovoMix 50.
Normally, this soon disappears.
Normalment dan imur malajr.
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 pharmacist.
Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek.
HOW TO STORE NOVOMIX 50
EN NOVOMIX 50
Do not use NovoMix 50 after the expiry date which is stated on the label and carton.
Tu ax NovoMix 50 wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
NovoMix 50 Penfill that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 50 Penfill li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 50 Penfill that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 50 Penfill li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to mix the insulin as instructed 83 for the first time use.
Wara li tne i NovoMix 50 Penfill mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
See 3 How to use NovoMix 50.
Ara 3 Kif g andek tu a NovoMix 50.
You can carry it with you and keep it at room temperature (not above 30ºC) for up to 4 weeks, but any remainder must then be discarded.
Tista ’ orru mieg ek u ommu fit - temperatura ambjentali tal- kamra (mhux iktar minn 30°C) sa 4 img at, wara dan i - mien kull fdal tal- prodott g andu jintrema.
NovoMix 50 Penfill must be protected from excessive heat and sunlight.
NovoMix 50 Penfill g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
NovoMix 50 should not be disposed of via wastewater or household waste.
NovoMix 50 m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
What NovoMix 50 contains
X’ fih NovoMix 50
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (50% insulin aspart in a soluble fraction and 50% insulin aspart crystallised with protamine) – The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
Is- sustanzi l- o ra huma glycerol, phenol, metacresol, zinc (b ala chloride), sodium chloride, – disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid u ilma g all- injezzjonijiet.
What NovoMix 50 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 cartridges of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 50 u l- kontenuti tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta’ 1, 5 jew 10 skarto i ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq u l- Manifattur
Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id -- Danimarka
84 PACKAGE LEAFLET:
86 FULJETT TA ’ TAG RIF:
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
WHAT NOVOMIX 70 IS AND WHAT IT IS USED FOR
X’ INHU NOVOMIX 70 U G ALXIEX JINTU A
NovoMix 70 is an insulin analogue to treat diabetes.
NovoMix 70 huwa analogu ta ’ l- insulina g all- kura tad- dijabete.
NovoMix 70 is a mixture of rapid-acting insulin analogue (70%) and long-acting insulin analogue (30%).
NovoMix 70 hu ta lita ta ’ analogu ta ’ l- insulina li ja ixxi b’ mod malajr (70%) u analogu ta ’ l- insulina li ja ixxi fit- tul (30%).
BEFORE YOU USE NOVOMIX 70
QABEL MA TU A NOVOMIX 70
Do not use NovoMix 70
Tu ax NovoMix 70
Take special care with NovoMix 70
Oqg od attent afna b’ NovoMix 70
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids 85 (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
87 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.
HOW TO USE NOVOMIX 70
KIF G ANDEK TU A NOVOMIX 70
When NovoMix 70 is used in combination with metformin the dosage should be adjusted.
Meta NovoMix 70 jintu a flimkien ma ’ metformin, id- do a g andu jkun a ustat.
NovoMix 70 may also be given soon after the meal.
NovoMix 70 jista ’ jing ata wkoll dritt wara xi ikla.
NovoMix 70 is for use by one person only.
NovoMix 70 hu g al u u minn persuna wa da biss.
Before using NovoMix 70
Qabel ma tu a NovoMix 70
See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination.
Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni
NovoMix 70 should not be used
NovoMix 70 m’ g andux jintu a
In insulin infusion pumps If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 70) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- iskarto jew it- tag mir li jkun fih l- iskarto jitwaqqa ’, ji rilu l - sara jew jitg affe, hemm ir- riskju li jkun hemm xi ru ta ’ l- insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en NovoMix 50) Jekk l- insulina ma tkunx bajda u qisa alib b’ mod uniformi meta tit allat Jekk ikun hemm xi apep ta ’ materjal jew jekk je el xi frak abjad mal- qieg jew mal - enb ta ’ l- iskarto li jag tih dehra qisu nkesa bil - elu
NovoMix 70 is for injection under the skin (subcutaneously).
NovoMix 70 g andu jing ata b ala injezzjoni minn ta t il - ilda.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
88 Dejjem ibdel i - ona tal - isem fejn tinjetta, biex tevita l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
86 NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 70 Penfill hu mag mul biex jintu a mas- sistemi ta ’ l- g oti ta ’ l- insulina ta ’ Novo Nordisk u mal- labar NovoFine.
If you are treated with NovoMix 70 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ NovoMix 70 Penfill u bi skarto Penfill ta ’ insulina o ra, g andek tu a sistema wa da ta ’ - l- g oti ta ’ l- insulina g al kull tip ta ’ insulina.
Do not refill NovoMix 70 Penfill cartridges.
Timliex mill - did l- iskarto i NovoMix 70 Penfill.
The first time you use NovoMix 70 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
L- ewwel darba li tu a NovoMix 70 Penfill irrombla l- iskarto bejn idejk g al 10 darbiet – huwa importanti li l- iskarto jin amm b’ mod orizzontali (ara stampa A). aqlaq l- iskarto ’ il fuq u ’ l isfel bejn il- po izzjonijiet a u b (ara stampa B) 10 darbiet, biex b’ hekk il- bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
U a teknika ta ’ injezzjoni li jkun tak parir dwarha t- tabib jew l - infermier/ a u li hi deskritta fil- manwal tieg ek tas- sistema ta ’ l- g oti ta ’ l- insulina.
Causes of hyperglycaemia
90 Il- kaw i ta ’ ipergli emija
Like all medicines, NovoMix 70 can cause side effects, although not everybody gets them.
B al kull medi ina o ra, NovoMix 70 jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota ofor fil - ilda tieg ek jew li l - ilda qed te xien fis- sit ta ’ l- injezzjoni, g id lit- tabib tieg ek jew lill- infermier/ a g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk tinjetta f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
You may have a very rare serious allergic reaction to NovoMix 70 or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni aller ika serja u rari afna g al NovoMix 70 jew g al xi wie ed mill - ingredjenti tieg u (imsej a reazzjoni aller ika sistemika).
See also the warning in 2 Before you use NovoMix 70.
Ara wkoll it- twissija f’ 2 Qabel ma tu a NovoMix 70.
HOW TO STORE NOVOMIX 70
EN NOVOMIX 70
Do not use NovoMix 70 after the expiry date which is stated on the label and carton.
Tu ax NovoMix 70 wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
NovoMix 70 Penfill that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 70 Penfill li ma jkunx qed jintu a g andu jin a en fil- fri (2°C – 8°C), mhux fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
NovoMix 70 Penfill that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 70 Penfill li jkun qed jintu a jew li ser jintu a, m’ g andux jin amm fil- fri.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to mix the insulin as instructed 89 for the first time use.
Wara li tne i NovoMix 70 Penfill mill- fri, hu rakkomandat li t allat l- insulina kif hemm fl- istruzzjonijiet g all- ewwel u u.
See 3 How to use NovoMix 70.
Ara 3 Kif g andek tu a NovoMix 70.
NovoMix 70 Penfill must be protected from excessive heat and sunlight.
NovoMix 70 Penfill g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
NovoMix 70 should not be disposed of via wastewater or household waste.
NovoMix 70 m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
What NovoMix 70 contains
X’ fih NovoMix 70
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (70% insulin aspart in a soluble fraction and 30% insulin aspart crystallised with protamine) – The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
Is- sustanzi l- o ra huma glycerol, phenol, metacresol, zinc (b ala chloride), sodium chloride, – disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid u ilma g all- injezzjonijiet.
What NovoMix 70 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 cartridges of 3 ml (not all packs may be marketed).
Id- dehra ta ’ NovoMix 70 u l- kontenuti tal- pakkett Is- suspensjoni g all- injezzjoni ti i b ala suspensjoni bajda f’ pakketti ta’ 1, 5 jew 10 skarto i ta ’ 3 ml (mhux il- pakketti kollha jistg u jkunu g al skop kummer jali).
Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
90 PACKAGE LEAFLET:
92 FULJETT TA ’ TAG RIF:
NovoMix 30 FlexPen 100 U/ ml suspension for injection in a pre-filled pen Insulin aspart
Insulin aspart
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
Jista ’ jkollok b onn ter a ’ taqrah. – Jekk ikollok aktar mistoqsijiet, 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, 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’ dan il- fuljett, jekk jog bok g id lit- tabib lill- infermier/ a jew lill - ispi jar tieg ek.
1.
Din in- na a tal- fuljett 1.
What NovoMix 30 is and what it is used for 2.
X’ inhu NovoMix 30 u g alxiex jintu a 2.
Before you use NovoMix 30 3.
Qabel ma tu a NovoMix 30 3.
How to use NovoMix 30 4.
Kif g andek tu a NovoMix 30 4.
What to do in an emergency 5.
X’ g andek tag mel f’ emer enza 5.
How to Store NovoMix 30 7 Further information
Aktar tag rif
It comes in a 3 ml pre-filled pen, called FlexPen - see overleaf for detailed instructions.
Ji i f’ pinna mimlija g al- lest ta ’ 3 ml li tissejja FlexPen.
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
Ara l- pa na ta ’ wara g al struzzjonijiet dettaljati.
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.
NovoMix 30 hu ta lita ta ’ analogu ta ’ l- insulina li ta dem malajr (30%) u analogu ta ’ l- insulina li ta dem fit- tul. (70%) Dan ifisser li jibda jbaxxi z- zokkor fid- demm tieg ek minn 10- 20 minuta wara li tie du, g andu effett massimu bejn 1 u 4 sig at, u l- effett idum sa 24 sieg a.
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 l- insulina jew g al xi wie ed mill- ingredjenti l- o rajn (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 hi taqsira ta ’ reazzjoni ipogli emika u hi abra ta ’ sintomi ta ’ livell baxx ta ’ zokkor fid- demm).
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: 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 91 usual If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Il - tie a tieg ek g all- insulina tista ’ tinbidel Jekk g andek infezzjoni, deni, jew kellek xi operazzjoni, jista ’ jkollok b onn iktar insulina mis- soltu.
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, 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.