NovoMix 30 FlexPen 100 units/mL suspension for injection – biphasic insulin aspart 30/70 for diabetes

NovoMix 30 FlexPen is a modern insulin (insulin analogue) with combined fast and intermediate action. It contains insulin aspart – 30% soluble insulin aspart (fast action) and 70% insulin aspart crystallised with protamine (intermediate action), at a strength of 100 units/mL.

It starts lowering blood sugar 10–20 minutes after injection, has its maximum effect 1–4 hours after injection and lasts up to 24 hours. In Serbia only NovoMix 30 in the FlexPen pre-filled pen is authorised; NovoMix 50 has no marketing authorisation in Serbia, so this text refers only to NovoMix 30 FlexPen.

What is NovoMix 30 FlexPen used for and how is it used correctly?

Basic information about the medicine

What is NovoMix 30 FlexPen used for?

According to the patient leaflet, NovoMix 30 FlexPen is intended:

• to lower high blood sugar in adults, adolescents and children aged 10 years and above with diabetes mellitus;
• in type 2 diabetes it can be used alone or together with diabetes tablets and/or injectable diabetes medicines (e.g. GLP-1 receptor agonists).

How is NovoMix 30 FlexPen used and dosed?

Dosing is individual and decided by your doctor. According to the leaflet and SmPC:

• It is usually given immediately before a meal, and a meal or snack should be eaten within 10 minutes; when necessary it can be given soon after a meal.
• Type 2 diabetes: the recommended starting dose is 6 units at breakfast and 6 units at dinner, or 12 units once daily at dinner; when a once-daily dose reaches 30 units, splitting it into two equal doses (breakfast and dinner) is recommended. The doctor adjusts the dose weekly according to pre-meal blood sugar.
• Type 1 diabetes: the individual requirement is usually 0.5–1.0 units/kg body weight per day and may be fully or partly covered by this medicine.
• When diabetes tablets or GLP-1 receptor agonists are added to NovoMix 30, your doctor may reduce the insulin dose.
• It is injected under the skin into the front of the abdomen, buttocks, front of the thigh or upper arm; always rotate injection sites. Never into a vein or muscle.
• Mixing: before using a new pen for the first time, let the insulin reach room temperature; roll the pen between your palms 10 times (horizontally), then turn it up and down 10 times until the liquid is uniformly white and cloudy. Before each following injection turn the pen at least 10 times. Then perform a flow check (2 units) and after injecting keep the needle under the skin for at least 6 seconds.

Special patient groups

• Children and adolescents: may be used from 10 years when premixed insulin is an advantage; experience in children aged 6–9 years is limited and there are no data for children under 6.
• People over 65: may be used with more frequent blood sugar checks and individual dose adjustment.
• Kidney or liver impairment: insulin requirements may be reduced – more frequent blood sugar checks and dose adjustment with your doctor are needed.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to insulin aspart or any of the excipients;
• if you feel a hypo starting;
• in insulin infusion pumps;
• if the FlexPen has been dropped, damaged or crushed, if it has not been stored correctly or has been frozen;
• if after mixing the suspension is not uniformly white, cloudy and watery, or if lumps or solid white particles stick to the bottom or wall of the cartridge.

Precautions and warnings

• problems with the kidneys, liver, pituitary, adrenal or thyroid glands change insulin needs;
• more exercise, changes in diet, illness or travelling across time zones affect blood sugar – if you are ill, do not stop insulin but ask your doctor;
• rotate injection sites to prevent thickened, shrunken or lumpy skin (lipodystrophy, cutaneous amyloidosis) where insulin works less well;
• a rapid improvement in blood sugar may temporarily worsen diabetic retinopathy or cause transient painful neuropathy; temporary vision problems and swelling around the joints may occur at the start;
• check the label and colour of the pen before each injection so you do not mix up insulin types.

Interactions with other medicines, food and drink

• blood sugar may be lowered by: other diabetes medicines, MAO inhibitors, beta blockers, ACE inhibitors, salicylates, anabolic steroids, sulfonamides;
• blood sugar may be raised by: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics (adrenaline, salbutamol, terbutaline), growth hormone, danazol;
• octreotide and lanreotide may raise or lower blood sugar; beta blockers may mask the signs of a hypo;
• pioglitazone with insulin: heart failure has been reported in patients with long-standing type 2 diabetes and heart disease or previous stroke – contact your doctor if you notice shortness of breath, rapid weight gain or swelling;
• alcohol may raise or lower blood sugar – careful monitoring is needed.

Pregnancy and breastfeeding

• Pregnancy: clinical experience with insulin aspart in pregnancy is limited; talk to your doctor before use. Insulin requirements may change during pregnancy and after delivery, and avoiding hypoglycaemia is also important for the baby.
• Breastfeeding: there are no restrictions on treatment with NovoMix 30 FlexPen during breastfeeding.

Driving and using machines

• Low or high blood sugar can affect concentration and reaction time. If you have frequent hypos or find it hard to recognise them, ask your doctor whether you may drive or use machines.

Possible side effects

• Very common (more than 1 in 10): hypoglycaemia – cold sweat, pale skin, headache, palpitations, nausea, excessive hunger, vision changes, drowsiness, weakness, trembling, nervousness, confusion, difficulty concentrating.
• Uncommon (up to 1 in 100): local allergic reactions at the injection site (pain, redness, hives, swelling, itching, bruising); temporary vision problems; swelling around the joints; worsening of diabetic retinopathy with rapid improvement of blood sugar; lipoatrophy or lipohypertrophy at the injection site.
• Rare (up to 1 in 1000): acute painful neuropathy, usually transient.
• Very rare (up to 1 in 10,000): serious systemic allergic reaction, potentially life-threatening.
• Frequency not known: lumps under the skin due to amyloid build-up (cutaneous amyloidosis).

Overdose, missed dose and stopping treatment

• Too much insulin: hypoglycaemia occurs – take glucose tablets or a sugary snack, measure your blood sugar and rest; always carry glucose or a sugary snack.
• If you lose consciousness, a person who knows how may give glucagon; after waking take glucose or a sugary snack, and if there is no response to glucagon hospital treatment is needed. Do not give an unconscious person food or drink – turn them on their side and call emergency help.
• Missed dose: blood sugar may become too high (hyperglycaemia) – follow your doctor's advice.
• Stopping treatment without your doctor may lead to severe hyperglycaemia and ketoacidosis.

Related information

For additional care and support with diabetes and foot care, see also the category Creams for diabetics – products in this category do not replace the medicine prescribed to you.

Composition, pack and manufacturer

• Active substance: insulin aspart – 100 units per 1 mL (soluble insulin aspart/protamine-crystallised insulin aspart 30/70); one 3 mL pen contains 300 units.
• Excipients: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide, water for injections; less than 1 mmol (23 mg) sodium per dose.
• Pack: 5 pre-filled pens of 3 mL; the cartridge contains a glass ball to aid mixing; needles not included (the pen is designed for NovoFine or NovoTwist needles up to 8 mm).
• Marketing authorisation holder: Novo Nordisk Pharma DOO Beograd; manufacturers: Novo Nordisk A/S, Bagsvaerd, Denmark and Novo Nordisk Production SAS, Chartres, France. Authorisation 515-01-03838-22-001 of 09.08.2023.

Storage

• Keep out of the sight and reach of children; do not use after the expiry date.
• Before opening: in a refrigerator at 2–8 °C, away from the cooling element; do not freeze.
• In use or carried as a spare: do not refrigerate; can be carried and stored for up to 4 weeks at up to 30 °C.
• Keep the cap on the pen to protect from light; remove the needle after each injection; return unused medicine to a pharmacy.

Frequently asked questions

What does the 30 in NovoMix 30 mean?

The pen contains a mixture of 30% fast-acting insulin aspart and 70% intermediate-acting (protamine-crystallised) insulin aspart. That is why it starts working in 10–20 minutes and lasts up to 24 hours.

Why do I have to mix the pen before injecting?

The insulin is a suspension that settles. Before first use the pen is rolled between the palms 10 times and turned up and down 10 times, and before each following injection it is turned at least 10 times, until the liquid is uniformly white and cloudy – this gives you an accurate dose.

Is NovoMix 50 available in Serbia?

According to the available ALIMS lists, only NovoMix 30 FlexPen is authorised in Serbia. Other mixture ratios and the choice of insulin are decided by your doctor.

Can I use NovoMix 30 in an insulin pump?

No. According to the leaflet, NovoMix 30 FlexPen must not be used in insulin infusion pumps and is given only by subcutaneous injection.

Sources

• ALIMS – Patient information leaflet NovoMix 30 FlexPen (PIL)
• ALIMS – Summary of product characteristics NovoMix 30 FlexPen (SmPC)

Sources checked on: 25 October 2026.