100 units/ml suspension for injection in a cartridge
What NovoMix 30 is and what it is used for
NovoMix 30 is modern insulin (insulin analog) with both fast-acting and medium-acting effects in the ratio of 30/70. Modern insulin preparations are improved versions of human insulin.
NovoMix 30 is used to lower high blood sugar in adults, adolescents, and children aged 10 years or older with diabetes ( diabetes mellitus ). Diabetes is a disease in which your body does not produce enough insulin to keep your blood sugar levels under control.
NovoMix 30 starts lowering your blood sugar 10-20 minutes after injection one. The maximum effect is reached after 1-4 hours after injection one and lasts up to 24 hours.
For the treatment of type 2 diabetes, NovoMix 30 can be used in combination with tablets for diabetes and/or with diabetes drugs for injection.
What you need to know before using NovoMix 30
Do not use NovoMix 30
- if you are allergic to insulin aspart or any of the other ingredients of this medicine (listed in section 6, Contents of the pack and other information).
- If you feel you are experiencing insulin sensation (symptoms of low blood sugar), see a) Summary of serious and very common side effects in section 4.
- in insulin pumps.
- if cartridge one or the injection device containing cartridge one has been dropped, damaged or shocked.
- if the insulin has not been stored properly or if it has been frozen, see section 5, How to store NovoMix 30.
- if the reconstituted insulin is not evenly white, cloudy and watery.
- if, after mixing, there are lumps or if solid, white particles adhere to the bottom or wall of the cartridge .
If any of these apply to you, do not use NovoMix 30. Talk to your doctor, nurse, or pharmacist.
Before using NovoMix 30
- Check on the label that it is the right kind of insulin .
- Always check the cartridge one, including the rubber plunger on the bottom of the cartridge one. Do not use it if it has any visible damage or if the rubber plunger has been pulled above the white line on the label at the bottom of the cartridge . This may be due to insulin leakage. If you suspect that the cartridge is damaged, return it to the pharmacist. See the operating instructions for the pen.
- Always use a new needle for each injection to prevent contamination.
- Injection needles and NovoMix 30 Penfill must not be shared with anyone else.
- NovoMix 30 Penfill should only be injected under the skin with a reusable pen. Talk to your doctor if you need to inject your insulin using another method.
Warnings and cautions
Certain conditions and activities may affect your need for insulin. Consult a doctor:
- If you have problems with your kidneys, liver, adrenal glands, pituitary gland or thyroid gland.
- If you exercise more than usual or want to change your diet, as this can affect your blood sugar level.
- If you become ill, continue to take your insulin and consult your doctor.
- If you are traveling abroad, travel over different time zones can affect your need for insulin and when to take it.
Skin changes at the injection site
To help prevent changes in the adipose tissue under the skin, e.g. skin thickening, skin shrinkage, or lumps under the skin, you should always change the injection site. Insulin may not work as well if you inject in an area with nodules or in a thickened or shrunken area (see “How to use NovoMix 30”). Contact your doctor if you notice skin changes at the injection site and before changing the injection site if you are currently injecting in an affected area. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Children and young people
- NovoMix 30 can be used for adolescents and children 10 years and older.
- There is limited experience with NovoMix 30 in children aged 6–9 years.
- No data are available for NovoMix 30 in children under 6 years of age.
Other medicines and NovoMix 30
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines affect your blood sugar level and this may mean that your insulin dose needs to be changed. Below is a list of the most common medicines that may affect your insulin treatment.
Your blood sugar level may drop (hypoglycemia) if you take:
- Other medicines to treat diabetes
- MAO inhibitors (for the treatment of depression)
- Beta-blockers (for the treatment of high blood pressure )
- ACE inhibitors (for the treatment of certain heart diseases or high blood pressure )
- Salicylates (analgesics and antipyretics)
- Anabolic steroids (eg testosterone )
- Sulfonamides (for the treatment of infections ).
Your blood sugar level may rise (hyperglycemia) if you take:
- Oral contraceptives ( birth control pills )
- Thiazides (for the treatment of high blood pressure or severe fluid retention)
- Glucocorticoids (eg cortisone for the treatment of inflammation )
- Thyroid hormones (for the treatment of thyroid diseases)
- Sympathomimetics (eg adrenaline , salbutamol or terbutaline for the treatment of asthma )
- Growth hormone (for stimulation of skeletal and body growth with a pronounced effect on the body’s metabolism)
- Danazol (an agent that affects ovulation).
Octreotide and lanreotide (for the treatment of acromegaly, an unusual hormonal disorder with pituitary overproduction one of the growth hormone usually in middle-aged adults) can either raise or lower your blood sugar level.
Beta-blockers (for the treatment of high blood pressure ) may weaken or eliminate the first warning signs of low blood sugar.
Pioglitazone (tablets for the treatment of type 2 diabetes )
Some patients who have had type 2 diabetes and heart disease for many years or previous strokes developed heart failure during treatment with pioglitazone and insulin. Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling ( edema ).
If you have taken any of these medicines, talk to your doctor, nurse, or pharmacist.
NovoMix 30 and alcohol
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful blood glucose monitoring is recommended.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Experience with insulin aspart during pregnancy is limited. The insulin dose may need to be changed during pregnancy and after delivery. Careful monitoring of your diabetes and especially counteracting low blood sugar is important for your baby’s health.
- There are no restrictions on treatment with NovoMix 30 during breast-feeding.
Ask your doctor, nurse, or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Driving and using machines
Ask your doctor if you can drive or use machines:
- if you often get low blood sugar levels
- if you find it difficult to recognize signs of low blood sugar (insulin detection).
If your blood sugar is low or high, it can affect your ability to concentrate and react and therefore also your ability to drive or use machines. Remember 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, ie NovoMix 30 is essential ‘sodium-free’.
How to use NovoMix 30
Dose and when you take your insulin
Always use your insulin and adjust your dose exactly as your doctor advised. If you are not sure, talk to your doctor, nurse, or pharmacist.
NovoMix 30 is normally used immediately before a meal. Eat a meal or snack within 10 minutes of injecting one to avoid low blood sugar. When necessary, NovoMix 30 can also be injected shortly after a meal. See How and where to inject below for information.
Only change your insulin as advised by your doctor. If your doctor has switched you from one type of insulin or brand to another, your doctor may need to adjust your dose.
Your doctor may need to adjust your dose when NovoMix 30 is used in combination with tablets for diabetes and/or diabetes medicines for injection.
Use for children and adolescents
NovoMix 30 can be used on adolescents and children aged 10 years or older when a mixture of insulin is preferred. There are limited clinical data in children aged 6–9 years. No data are available for NovoMix 30 in children under 6 years of age.
Use for special patient groups
If you have impaired kidney or liver function or if you are over 65, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How and where to inject
NovoMix 30 is for subcutaneous injection. You should never inject insulin directly into a blood vessel ( intravenously ) or a muscle ( intramuscularly ). NovoMix 30 Penfill should only be injected under the skin with a reusable pen. Talk to your doctor if you need to inject your insulin using another method.
At each injection, change the injection site within the same specific skin area. This may reduce the risk of developing lumps or pits in the skin (see section 4, Possible side effects ). The best area to inject one is the front of the waist (abdomen); the buttocks; the front of the thighs or upper arm. Insulin works faster if you inject it around the waist. Always check your blood sugar regularly.
- Do not refill cartridge one .
- NovoMix 30 Penfill cartridges are designed to be used with insulin injection devices from Novo Nordisk and NovoFine or NovoTwist injection needles.
- If you are taking NovoMix 30 Penfill and another insulin in a Penfill cartridge , use two different injection aids, one for each type of insulin.
- Always carry an extra Penfill cartridge with you in case of loss or damage.
Mixing NovoMix 30
Always check that there is enough insulin left (at least 12 units) in cartridge one. This gives an even mixture. If there is not enough insulin left, use a new cartridge. See also the instructions for use for the pen.
Each time you use a new NovoMix 30 Penfill ( before inserting a cartridge into the injection aid).
- Allow insulin to reach room temperature before using. This makes it easier to remix.
- Roll the cartridge one between the palms 10 times – it is important that the cartridge is held horizontally (horizontally) (see picture A ).
- Then turn the cartridge one upside down between positions a and b (see picture B ) 10 times so that the glass ball moves from one end of the cartridge one to the other.
- Repeat this rolling and turning procedure (see pictures A and B ) until the injection liquid is evenly white, cloudy and watery. Do not use cartridge if the reconstituted insulin is not evenly white, cloudy and watery.
- Complete other injection steps without delay.
Before each subsequent injection
- Turn the injection device with a cartridge one up and down between positions a and b (see picture B ) at least 10 times with a cartridge one i, until the solution for injection is evenly white, cloudy and watery. Do not use cartridge if the reconstituted insulin is not evenly white, cloudy and watery.
- Complete other injection steps without delay.
How to inject NovoMix 30
- Inject insulin under your skin. Use the injection technique shown to you by your doctor or nurse and described in the instructions for use of the pen.
- Hold the injection needle under the skin for at least 6 seconds. Hold down the push-button completely until the injection needle has been pulled out of the skin. This ensures proper administration and limits the possibility of blood entering the injection needle or insulin container.
- After each injection , it is important to remove and discard the injection needle and store NovoMix 30 without the needle attached. Liquid may otherwise leak and cause incorrect dosing .
If you take more insulin than you should
If you take too much insulin, your blood sugar may become too low (hypoglycemia). See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar may become too high (hyperglycemia). See c) Diabetes Disorders in Section 4.
If you stop taking your insulin
Do not stop taking insulin without talking to your doctor, who will tell you what to do. This can lead to very high blood sugar (severe hyperglycemia) and ketoacidosis. See c) Diabetes Disorders in Section 4.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
How to store NovoMix 30
Keep this medicine out of the sight and reach of children.
Do not use this medicine before the expiry date which is stated on the label and carton of the cartridges after “EXP”. The expiration date is the last day of the specified month.
To protect insulin from light, always keep the cartridge in the outer carton when not in use. NovoMix 30 must be protected from strong heat and light.
Unopened packaging: NovoMix 30 Penfill that is not being used should be stored in a refrigerator at 2 ° C-8 ° C, not near the cooling element. Do not freeze.
Before using the NovoMix 30 Penfill, remove it from the refrigerator. You should mix the insulin according to the instructions each time you use a new NovoMix 30 Penfill. See section 3, How to use NovoMix 30.
During use or as a spare: NovoMix 30 Penfill that is currently being used or taken as a spare should not be stored in the refrigerator. You can take it with you and store it at room temperature (maximum 30 ° C) for up to 4 weeks.
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.
Contents of the pack and other information
Content declaration
- The active substance is insulin aspart. NovoMix 30 is a mixture containing 30% soluble insulin aspart and 70% insulin aspart crystallized with protamine. 1 ml contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection .
- The other ingredients are glycerol , phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulphate, hydrochloric acid , sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
NovoMix 30 is in the form of a suspension for injection. The cartridge contains a glass ball to facilitate mixing. After mixing, the liquid should be evenly white, cloudy, and watery. Do not use insulin unless it is uniformly white, cloudy, and watery after mixing.
Pack sizes: 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
The suspension is cloudy, white, and watery.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the tab on the carton and the label:
- If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo Nordisk A / S, Novo Allé, DK-2880 Bagsværd, Denmark
- If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.