NovoMix PEN 30 100 IU ml. 3 ml. 5
NovoMix 30 is used to treat diabetes mellitus in adults, adolescents and children aged over 10 years.
NovoMix PEN 30 100 IU / ml. 3 ml. 5
What NovoMix 30 and what it is used
NovoMix 30 is a modern insulin ( insulin analogue) and with fast action and with intermediate effect in the ratio 30/70 . Modern insulins are improved versions of human insulin.
NovoMix 30 is used to treat diabetes mellitus in adults , adolescents and children aged over 10 years. Diabetes mellitus is a disease in which the body does not produce enough insulin to control your blood sugar.
NovoMix 30 will start to lower your blood sugar 10-20 minutes after injection, the maximum effect between 1 and 4 hours and the effect lasts up to 24 hours. It may be used in combination with certain oral antidiabetic agents .
2 . Before izpolzvateNovoMix 30
Do not use NovoMix 30
If you are allergic (hypersensitive ) to insulin aspart or any of the other ingredients of NovoMix 30 (see section 6 Additional Information;
If you suspect hypoglycaemia ( low blood sugar) (see section 3 . How to use NovoMix 30) ;
In insulin infusion pumps;
If the cartridge or the device containing the cartridge is dropped , damaged or crushed ;
If stored correctly or been frozen (see 5 . How to store NovoMix 30) ;
If the resuspended insulin does not appear uniformly white and cloudy ;
If after resuspension clumps or hard, white particles adhering to the bottom or the wall of the cartridge .
Before using NovoMix 30
Check the label to make sure it is the right type of insulin .
Always check the cartridge , including the rubber plunger (stopper ) . Do not use it if any damage is seen or if there is a gap between the rubber plunger and the white label band . Return it to your dealer. See the instructions for use of the injection device for further instructions .
Always use a new needle for each injection to prevent contamination
Needles and NovoMix 30 Penfill must not be transferred to others .
Take special care with NovoMix 30
If you have problems with your kidneys or liver, or with your adrenal, pituitary or thyroid glands
In more than usual or if you want to change your usual diet , as this may affect your blood sugar levels
If you're sick / : carry on taking your insulin and consult your doctor
When traveling abroad: traveling over time zones may affect your insulin needs and the timing of injection. Consult your doctor if you are planning a similar trip.
Using other medicines
Tell your doctor , nurse or pharmacist if you are taking or have recently taken any other medicines , including medicines obtained without a prescription. Some medicines affect the way glucose works in your body and may affect your insulin dose . The most common drugs , which may affect your insulin treatment are listed below .
Your blood sugar level may fall (hypoglycaemia) if you take:
Other drugs for the treatment of diabetes ;
Monoamine oxidase ( MAO ) inhibitors ( used to treat depression) ;
Beta- blockers (used to treat high blood pressure ) ;
Angiotensin converting enzyme ( ACE) inhibitors ( used in the treatment of certain heart disease or high blood pressure ) ;
Salicylates (used to relieve pain and lower fever) ;
Anabolic steroids ( such as testosterone ) ;
Sulphonamides (used to treat infections) .
Your blood sugar level may rise (hyperglycaemia ) if you take:
Oral contraceptives (birth control pills ) ;
Thiazides (used to treat high blood pressure or excessive fluid retention ) ;
Glucocorticoids (such as "cortisone " , used in the treatment of inflammation ) ;
Thyroid hormones (used for the treatment of disorders of the thyroid gland ) ;
Sympathomimetics (such as epinephrine ( adrenaline ) or salbutamol, terbutaline used to treat asthma ) ;
Growth hormone ( medicine for stimulation of bone growth and body and pronounced influence on metabolic processes in the body) ;
Danazol (medicine acting on ovulation).
Octreotide and lanreotide (used for the treatment of acromegaly , a rare hormonal disorder that usually occurs in middle- age , induced by the overproduction of growth hormone by the pituitary gland ) can increase or decrease the level of blood sugar .
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognize a hypoglycaemia.
Pioglitazone ( oral antidiabetic medicine ): Some patients with long-standing type 2 diabetes , especially those with heart disease or previous stroke who were treated with pioglitazone and insulin may develop heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (edema) .
If you have taken any of the drugs listed here , contact your doctor , nurse or pharmacist.
Drinking alcohol and taking NovoMix 30
If you consume alcohol, your need for insulin may change as your blood sugar level may rise or fall. Careful observation.
Pregnancy and lactation
If you are pregnant , planning a pregnancy or breast-feeding please contact your doctor for advice. There is limited clinical experience with insulin aspart in pregnancy. You may need to change your insulin dosage during pregnancy and after birth. Careful control of your diabetes , particularly prevention of hypoglycaemia , is important for the health of your baby.
No restrictions on treatment with NovoMix 30 during lactation .
Ask your doctor or pharmacist before taking any medicine while you are pregnant or breastfeeding.
Driving and using machines
Please ask your doctor whether you should drive or operate machinery :
If you have frequent hypoglycemia ;
If hard to recognize hypoglycaemia .
If your blood sugar is low or high your concentration and ability to react might be affected and therefore also your ability to drive or operate machinery. Note that you can put yourself and others at risk.
Important information about some of the ingredients of NovoMix 30
NovoMix 30 contains less than 1 mmol sodium (23 mg ) per dose, i.e. NovoMix 30 contains virtually no sodium.
3 . How to use NovoMix 30
How much and when to apply your insulin
Always use your insulin as prescribed by your doctor and follow his advice carefully.
Usually NovoMix 30 applies immediately before a meal . Within 10 minutes of the injection Eat a meal or snack to avoid the occurrence of low blood sugar. When necessary, NovoMix 30 can be given soon after a meal. See route and site of injection , the following information .
When NovoMix 30 in combination with diabetes pills , the dosage should be adjusted .
Do not change your insulin unless your doctor tells you to do so. If your doctor changes the type or brand of insulin to another , you may need to change your dose .
Use in children
NovoMix 30 can be used in children and adolescents aged over 10 years old when he prefers premixed insulin . There are limited clinical data in children 6 to 9 years old. Use NovoMix 30 in children under 10 years of age, if your doctor specifically told you to.
No clinical studies with NovoMix 30 in children under 6 years.
Use in special populations
If you have reduced kidney or liver function , or if you are older than 65 years should more regularly check your blood sugar and discuss changes in your insulin dose with your doctor.
How and where to inject
NovoMix 30 is injected under the skin ( subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle ( intramuscular) .
At each injection alter the injection site within the area of skin that you use for injection. This can reduce the risk of forming lumps or pitting of the skin ( see section 4 . Possible side effects). The best places for injection are: the front of your waist (abdomen); seat , the front of your thighs or upper arms. Your insulin will work more quickly if you inject around the waist. You should regularly monitor your blood sugar.
Do not refill the cartridge.
NovoMix 30 Penfill cartridges are designed for use with insulin delivery systems NovoNordisk ( Novo Nordisk ) and needles NovoFine or NovoTwist.
If you use NovoMix 30 Penfill and another insulin cartridge Penfill, you should use two insulin delivery systems, one for each type of insulin.
Always carry a spare Penfill as a precaution, in case your Penfill cartridge is lost or damaged.
Resuspension of NovoMix 30
Always make sure the cartridge is left enough insulin (at least 12 units ) to ensure uniform resuspension . If not enough insulin left , use a new one . See the manual of your pen for further instructions.
Every time you use a new NovoMix 30 Penfill ( before inserting the cartridge into the insulin delivery device)
Let the insulin reach room temperature before using it. This facilitates resuspension.
Roll the cartridge between your palms 10 times - it is important to keep the cartridge horizontal (see picture A).
Shake 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 .
Repeat the rolling and shaking ( see pictures A and B ) until the liquid appears uniformly white and cloudy. Do not use the pen if the resuspended insulin does not appear uniformly white and cloudy .
Complete the other stages of injection without delay .
Upon subsequent injections
Move the delivery system with the cartridge inside it up and down between a and b (see picture B ) at least 10 times until the liquid appears uniformly white and cloudy. Do not use the pen if the resuspended insulin does not appear uniformly white and cloudy .
Complete the other stages of injection without delay .
How to inject NovoMix 30
Inject the insulin under the skin . Use the injection technique that you have been advised by your doctor or nurse and as described in the manual of your pen.
Keep the needle under the skin for at least 6 seconds. Keep the button pressed while removing the needle from the skin . This will ensure proper injection and limit the possible influx of blood in the needle or insulin cartridge.
After each injection be sure that you remove and discard the needle and store NovoMix 30 without the needle attached. Otherwise , the liquid may leak out , which can result in inaccurate dosing .
If you use more insulin than
If you take too much insulin , your blood sugar gets too low , this is called hypoglycaemia. See Other effects of diabetes in section 4.
If you forget to take your insulin
If you forget to take your insulin , your blood sugar may get too high , this is called hyperglycemia . See Other effects of diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without talking with a doctor who will tell you what needs to be done. This can lead to very high blood sugar ( severe hyperglycaemia ) and ketoacidosis. See Other effects of diabetes in section 4.
If you have any questions about using this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines , NovoMix 30 can cause side effects, although not everybody gets them.
Very common side effects - affects more than 1 in 10 people :
Low blood sugar (hypoglycaemia ): See details in Other effects from diabetes in section 4.
Uncommon : affects less than 1 in 100 people :
Signs of allergy : may arise local allergic reactions (pain, erythema , urticaria, inflammation , swelling and itching) at the injection site . They usually disappear after a few weeks of taking your insulin . If they do not disappear , consult your doctor.
Seek immediate medical attention :
If signs of allergy spread to other parts of your body, or
If you suddenly feel unwell and you start sweating; begin to vomit , have trouble breathing , have a fast heart beat , you feel dizzy .
If you notice any of these effects, seek medical advice .
Visual disturbances : When you first start your insulin treatment , it may disturb your vision, but the offense is usually temporary .
Changes at the injection site (lipodystrophy ): The fatty tissue under the skin at the injection site may shrink ( lipoatrophy) or thicken ( lipohypertrophy ) . By changing the location at each injection may reduce the risk of such skin changes. If you notice your skin pitting or thickening at the injection site , tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site .
Swelling of joints : When you start taking insulin , water retention may cause swelling around your ankles and other joints. Normally this soon disappears .
Diabetic retinopathy ( diabetes-related eye disease , which can lead to vision loss ): If you have diabetic retinopathy and your blood sugar to normal very fast, the retinopathy may get worse . Talk to your doctor about this .
Rare side effects - affects less than 1 in 1000 people :
Painful neuropathy (pain due to nerve damage) : If your blood sugar to normal very quickly , you may get nerve related pain , this is called acute painful neuropathy and is usually transient.
Very rare side effects - affects less than 1 in 10,000 people :
A serious allergic reaction to NovoMix 30 or any of its ingredients ( called a systemic allergic reaction). See also warning in 2 . Before using NovoMix 30 .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor, nurse or pharmacist.
Other effects of diabetes
Low blood sugar ( hypoglycemia)
Low blood sugar can have if :
Too much insulin ;
Eat too little or miss a meal ;
Doing more physical activity than usual ;
Drinking alcohol ( See Drinking and taking Levemir in section 2) .
Warning signs of low blood sugar:
The warning signs may occur suddenly and can include: cold sweat , cool pale skin , headache , rapid heart beat , nausea, feeling of hunger , temporary vision changes , drowsiness , unusual tiredness and weakness , nervousness or shakiness , feeling anxiety , confusion , difficulty in concentrating .
What to do if you have low blood sugar:
If you have low blood sugar, eat glucose tablets or another snack high in sugar (sweets, biscuits, fruit juice) . Measure your blood sugar if possible and rest . For each case , always carry glucose tablets, sweets, biscuits or fruit juice.
When symptoms of low blood sugar have disappeared or when blood sugar levels are stabilized continue insulin treatment as usual.
Tell those around you that you have diabetes and what may be the consequences, including the risk of passing out ( become unconscious ) , resulting in low blood sugar. Tell them that if you pass , they must turn you on your side and immediately seek medical attention . You should not give anything to eat or drink due to risk of suffocation.
You may come to mind more quickly after injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon soon as you awake , you will need glucose or a sugary snack . If treatment with glucagon is not your strength , should be treated in hospital.
If prolonged severe low blood sugar is not treated , it can cause brain damage (temporary or permanent) and even death.
If you have low blood sugar so that you lose consciousness if you had to inject glucagon , or if you have had many cases of low blood sugar , consult a doctor. You may need to adjust the amount of insulin or hours of injection, food or exercise .
High blood sugar ( hyperglycemia )
High blood sugar can have if :
Not injected enough insulin ;
Forget to use your insulin or stop using insulin;
Repeated use less insulin than necessary ;
Have an infection and / or fever ;
Eat more than usual ;
Doing less exercise than usual.
Warning signs of high blood sugar :
The warning signs appear gradually. They include: frequent urination , thirst , loss of appetite , nausea or vomiting , feeling of drowsiness or fatigue , flushed dry skin , dry mouth and breath smell fruity (acetone) .
What to do if you have high blood sugar :
If you have any of these signs: test your blood sugar, test your urine for ketones if you can, then seek medical assistance immediately .
These may be signs of a very serious condition called diabetic ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar) . If left untreated , it can lead to diabetic coma and eventually death .
5 . How to store NovoMix 30
Keep out of reach of children.
Do not use NovoMix 30 after the expiry date stated on the label and carton cartridge after " EXP " . Date of expiry date refers to the last day of that month.
Before opening : NovoMix 30 Penfill, which is not used should be stored in a refrigerator at 2 ° C to 8 ° C, away from the cooler. Do not freeze .
Before using NovoMix 30 Penfill, remove it from the refrigerator. It is recommended to resuspend the insulin as instructed for first time use NovoMix 30 Penfill. See Resuspension of NovoMix 30 in section 3.
During use or when carried as a spare : NovoMix 30 Penfill, which is used or carried as a spare should not be refrigerated. You can carry it with you or store it at room temperature (below 30 ° C) to 4 weeks.
Always keep the cartridge in the outer carton when not in use to protect it from light . NovoMix 30 must be protected from excessive heat and light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Additional information
What does NovoMix 30
The active substance is insulin aspart . NovoMix 30 is a mixture composed of 30 % soluble insulin aspart and 70% insulin aspart crystallized with protamine . 1 ml contains 100 U of insulin aspart. Each cartridge contains 300 U of insulin aspart in 3 ml suspension for injection .
Other ingredients are: glycerol, phenol , m-cresol , zinc chloride , disodium phosphate dihydrate, sodium chloride , protamine sulfate , hydrochloric acid , sodium hydroxide and water for injection.
NovoMix 30 looks like and contents of pack
NovoMix 30 is a white suspension. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the fluid must appear uniformly white and cloudy.
Do not use insulin if it appears uniformly white and cloudy after resuspension.
Packs of 5 and 10 cartridges of 3 ml. He all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder : Novo Nordisk A / S, Denmark.