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Mixtard 30 Penfill (human insulin 30/70, cartridge 100 IU/mL) – not marketed in Serbia: information and registered alternatives
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- Stock: Zabrana online prodaje
- Brand: NOVO NORDISK
- Model: BR-161214614
This medicine is currently not marketed in Serbia
- Mixtard 30 Penfill (cartridge) currently has no valid marketing authorisation in Serbia (ALIMS) and cannot be obtained from pharmacies in Serbia, including ApotekaOnline.
- Authorisation 515-01-01545-18-001 of 24 October 2018 (holder Novo Nordisk Pharma d.o.o. Belgrade) ceased to be valid by decision 515-01-00138-23-001 of 19 September 2023, at the request of the authorisation holder. No new authorisation for the cartridge has been issued.
- Mixtard 30 FlexPen (pre-filled pen from the same manufacturer) is still authorised in Serbia, as is Humulin M3 in cartridges (Eli Lilly). Switching to another insulin or another device must be decided by your doctor only.
- This page is for information only and is not an offer to sell the medicine.
Mixtard 30 Penfill was an insulin cartridge (Penfill) for a reusable insulin pen. It contains human insulin as a mixture of 30% soluble (fast-acting) and 70% isophane (NPH, intermediate-acting) insulin, at a strength of 100 international units (IU) per mL. One 3 mL cartridge contained 300 IU.
According to the last Summary of Product Characteristics approved in Serbia, Mixtard 30 Penfill was intended for the treatment of diabetes mellitus. It was a prescription-only medicine. All information on this page comes from the official ALIMS documents listed in the sources.
What was Mixtard 30 Penfill, what was it used for and what is registered in Serbia today?
Key facts about the medicine
| Name of the medicine | Mixtard® 30 Penfill®, 100 IU/mL, suspension for injection in a cartridge |
|---|---|
| Active substance | human insulin – 30% soluble and 70% isophane (NPH) insulin |
| Strength | 100 IU/mL (300 IU in a 3 mL cartridge) |
| Pharmaceutical form | suspension for injection in a cartridge, for subcutaneous use |
| Therapeutic group | intermediate-acting insulins combined with fast-acting insulins (A10AD01) |
| Pack | 5 cartridges of 3 mL |
| Former authorisation holder | Novo Nordisk Pharma d.o.o. Belgrade; manufacturers Novo Nordisk A/S (Denmark) and Novo Nordisk Production SAS (France) |
| Status in Serbia | no valid authorisation since 19 September 2023 (previously: prescription-only medicine) |
What was Mixtard 30 Penfill used for?
The only approved indication was the treatment of diabetes mellitus. The mixture of fast-acting and intermediate-acting insulin in one cartridge covered both the insulin needed after meals and the basic (basal) need between meals.
The type of insulin, the dose and the injection schedule were always set by the doctor according to blood glucose values, diet and physical activity.
How was it used?
The medicine was injected under the skin using a suitable insulin pen into which the cartridge is inserted. Before use, the suspension was mixed until it became uniformly milky white, and the injection site was rotated within the same area to reduce the risk of changes in the fatty tissue under the skin (lipodystrophy).
This describes the official leaflet and is not an individual recommendation. If you used Mixtard 30 Penfill, do not change the type of insulin or the dose on your own – agree the switch with your doctor.
Important safety information from the official documents
- The medicine had to be avoided in case of hypersensitivity to human insulin or any of the excipients, and it was not to be injected during hypoglycaemia (low blood sugar).
- Hypoglycaemia was the most common side effect – it may be caused by a missed meal, unplanned physical activity or too high an insulin dose.
- An inadequate dose or stopping treatment, especially in type 1 diabetes, can lead to hyperglycaemia and diabetic ketoacidosis.
- Infections and fever usually increase the need for insulin; diseases of the kidneys, liver, adrenal gland, pituitary or thyroid may require a change of dose.
- Many medicines affect blood sugar: oral antidiabetics, beta blockers, ACE inhibitors and salicylates may reduce the need for insulin, while oral contraceptives, thiazides, glucocorticoids and thyroid hormones may increase it. Beta blockers may mask the symptoms of hypoglycaemia, and alcohol may increase or decrease the effect of insulin.
- Pregnancy and breast-feeding: there are no restrictions on insulin treatment, but blood glucose must be checked more often and the dose adjusted.
- Hypoglycaemia may reduce the ability to concentrate and to drive.
What is available in Serbia?
According to ALIMS documents, the same manufacturer still holds an authorisation for Mixtard 30 FlexPen (pre-filled pen with the same insulin), and in cartridge form Humulin M3 is registered – biphasic human insulin (30% soluble and 70% isophane insulin), 100 IU/mL, 5 cartridges of 3 mL (Eli Lilly).
| Option | What it is | Note |
|---|---|---|
| Mixtard 30 FlexPen | the same human insulin 30/70 in a pre-filled pen (Novo Nordisk) | different device – training for the pen is needed |
| Humulin M3 cartridge | biphasic human insulin 30/70, 100 IU/mL (Eli Lilly) | same type of insulin, different manufacturer and different pen |
| Other types of insulin | fast-acting, basal insulins or insulin analogues | the choice depends on the type of diabetes and on the doctor’s assessment |
Any switch to another insulin, another manufacturer or another pen is carried out under medical supervision, with more frequent blood glucose checks during the first days and weeks.
When to seek medical help immediately?
- signs of severe hypoglycaemia: sweating, trembling, confusion, drowsiness, slurred speech, loss of consciousness or seizures
- intense thirst, frequent urination, nausea, vomiting, rapid breathing and a smell of acetone on the breath (possible ketoacidosis)
- swelling of the face, lips or tongue, difficulty breathing or a rash all over the body after an injection
- sudden visual disturbance or chest pain
Pharmacist's advice
If you previously used Mixtard 30 Penfill, the most important thing is not to switch to another insulin on your own. Bring your blood glucose diary to your doctor and agree on the exact name of the insulin, the device (cartridge or pre-filled pen) and how to use it.
A cartridge from one manufacturer does not necessarily fit another manufacturer’s pen – with a new insulin, also check the matching pen and needles. Always carry a quick source of sugar in case of hypoglycaemia.
Availability and price
Mixtard 30 Penfill is currently not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because the medicine has no valid authorisation.
Insulins are dispensed on prescription only. For the availability of registered insulins, please contact your doctor and pharmacy. This page is for information only.
Further information
For additional care and support with diabetes and blood glucose self-monitoring, see also the Blood glucose meters category – products in this category do not replace the medicine you have been prescribed.
Composition, pack and manufacturer
- Active substance: human insulin (produced by recombinant DNA technology in Saccharomyces cerevisiae), 100 IU/mL, 30% soluble and 70% isophane insulin.
- The medicine contained less than 1 mmol sodium (23 mg) per dose.
- Pack: 5 glass cartridges of 3 mL each, with a glass ball to help mix the suspension.
- Manufacturers: Novo Nordisk A/S (Denmark) and Novo Nordisk Production SAS, Chartres (France).
Storage
- According to the leaflet: before opening, store in a refrigerator (2–8 °C), do not freeze.
- Cartridge in use or carried as a spare: below 30 °C, not in the refrigerator; keep in the outer carton to protect from light.
- Do not use insulin after the expiry date; keep out of the reach of children.
Frequently asked questions
Can Mixtard 30 Penfill be bought in Serbia?
No. The authorisation for Mixtard 30 Penfill ceased on 19 September 2023 and the medicine cannot be obtained from pharmacies in Serbia. The same insulin in a pre-filled pen (Mixtard 30 FlexPen) is still authorised.
What can replace Mixtard 30 Penfill?
In cartridge form, Humulin M3 (biphasic human insulin 30/70, Eli Lilly) is registered in Serbia, and the same manufacturer offers Mixtard 30 FlexPen. Which option is right for you, and the dose, is decided only by your doctor.
Can a Mixtard cartridge be used in a pen from another manufacturer?
A cartridge is used only in the pen it is intended for according to the leaflet. When switching to an insulin from another manufacturer, the matching pen and needles must also be checked.
What is hypoglycaemia and why does it matter with insulin?
Hypoglycaemia is a drop in blood sugar below normal values. According to the official documents it was the most common side effect of this insulin; it occurs after a missed meal, exertion or too high a dose and requires a quick response.
Sources
- ALIMS – Summary of Product Characteristics, Mixtard® 30 Penfill®, 100 i.j./mL, suspenzija za injekciju u ulošku (dozvola 515-01-01545-18-001) (Serbian)
- ALIMS – Patient information leaflet, Mixtard® 30 Penfill® (Serbian)
- ALIMS – Summary of Product Characteristics, Humulin® M3, 100 i.j./mL, suspenzija za injekciju u ulošku (Serbian)
- ALIMS – Patient information leaflet, Humulin® M3 (Serbian)
- ALIMS – Decisions on termination of marketing authorisations 01.07–31.12.2023 (Serbian)
- ALIMS – National Register of Medicines 2021 (Serbian)
Sources checked on: 25 October 2026.
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Additional information
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Shipping cost
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