Insulatard Penfill 100 IU/mL suspension for injection in cartridge – human NPH insulin for diabetes

Insulatard Penfill is a human insulin with a gradual onset and long duration of action – a suspension of isophane (NPH) human insulin, 100 international units per millilitre. It starts to lower blood sugar about 1½ hours after injection, and the effect lasts about 24 hours.

The medicine is used to treat diabetes mellitus and is usually given in combination with fast-acting insulin. The 3 mL cartridge is used with a reusable Novo Nordisk pen. The marketing authorisation holder is Novo Nordisk Pharma d.o.o. Belgrade.

What is Insulatard Penfill used for and how is it injected correctly?

Key facts about the medicine

What is Insulatard Penfill used for?

The medicine is used to treat diabetes mellitus. It lowers high blood sugar in people whose bodies do not produce enough insulin, helping to prevent complications of diabetes. It can be used alone or combined with fast-acting insulin; in intensified insulin therapy it serves as basal insulin (evening and/or morning injection) together with fast-acting insulin given with meals.

How is it used and dosed?

• Dosing is individual and determined by the doctor – one or more injections a day. The individual insulin requirement is usually 0.3–1.0 IU per kilogram of body weight per day.
• The insulin is injected under the skin – into the front of the abdomen, buttocks, front of the thighs or upper arm. It acts faster when injected into the abdomen. Change the injection site with every injection within the same area.
• Mix the cartridge before every use: let the insulin reach room temperature, then move the cartridge up and down at least 20 times at first use and at least 10 times before each injection, until the suspension is uniformly cloudy and white. At least 12 units should remain in the cartridge for proper mixing.
• Use a new needle (NovoFine® or NovoTwist®) for every injection. Keep the needle under the skin for at least 6 seconds with the button fully pressed, then remove and discard the needle after the injection.
• The cartridge must not be refilled; always carry a spare cartridge. If you use another insulin in a Penfill cartridge, use a separate pen for each type of insulin.
• Measure your blood sugar regularly. Dose adjustment may be needed when physical activity or diet changes, or during illness.

Special patient groups

• Children and adolescents: the medicine can be used.
• Over 65 years: the medicine can be used, with more frequent blood sugar checks and individual dose adjustment.
• Kidney or liver impairment: insulin requirements may be lower – more frequent blood sugar checks and dose adjustment are needed.
• Switching from another insulin: the dose and timing may need adjustment, with close blood sugar monitoring over the following weeks.

Contraindications – when the medicine must not be used

• allergy to human insulin or any of the excipients;
• suspected hypoglycaemia (low blood sugar);
• use in insulin infusion pumps;
• a cartridge or pen that has been dropped, damaged or crushed;
• medicine that has not been stored correctly or has been frozen;
• resuspended insulin that is not uniformly cloudy and white.

Warnings and precautions

Consult your doctor:

• if you have problems with your kidneys, liver, pituitary, adrenal or thyroid gland;
• if you exercise more than usual or change your diet;
• if you are ill – continue taking your insulin and contact your doctor;
• if you travel across time zones – your insulin requirement and injection times may change.

Skin changes: injecting always in the same place can cause thickened, wrinkled skin or lumps under the skin (lipodystrophy, cutaneous amyloidosis), and insulin works less well at such sites. Tell your doctor before changing the injection site, as closer blood sugar monitoring and dose adjustment may be needed.

Before use, check the label and the condition of the cartridge (do not use if the rubber plunger is above the white band). Needles and cartridges must not be shared with others.

Interactions with other medicines, food and drink

Many medicines affect blood sugar and may require a change in insulin dose:

• may lower blood sugar: other diabetes medicines, MAO inhibitors, beta-blockers, ACE inhibitors, salicylates, anabolic steroids and sulfonamides;
• may raise blood sugar: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics (e.g. adrenaline, salbutamol, terbutaline), growth hormone and danazol;
• octreotide and lanreotide may either raise or lower blood sugar;
• beta-blockers may mask the first warning signs of hypoglycaemia;
• with pioglitazone, heart failure developed in some patients with long-standing type 2 diabetes and heart disease – tell your doctor if you notice unusual shortness of breath, rapid weight gain or swelling.

Alcohol can either raise or lower blood sugar – careful monitoring is recommended.

Pregnancy and breast-feeding

• Pregnancy: Insulatard Penfill can be used during pregnancy. Insulin requirements may change during pregnancy and after delivery; strict diabetes control and prevention of hypoglycaemia are also important for the baby’s health.
• Breast-feeding: there are no restrictions on use during breast-feeding.

Driving and using machines

Low or high blood sugar can affect concentration and reaction time, and therefore driving or using machines. Ask your doctor whether you may drive if you often have hypoglycaemia or find it hard to recognise its signs.

Possible side effects

Like all medicines, Insulatard Penfill can cause side effects. According to the leaflet:

• Very common (more than 1 in 10): hypoglycaemia – cold sweat, cool pale skin, headache, fast heartbeat, nausea, extreme hunger, temporary vision changes, drowsiness, unusual tiredness and weakness, nervousness or tremor, anxiety, confusion, difficulty concentrating.
• Uncommon (up to 1 in 100): local allergic reactions at the injection site (pain, redness, rash, inflammation, bruising, swelling, itching) that usually disappear within a few weeks; worsening of diabetic retinopathy with rapid improvement in blood sugar control; swelling around joints at the start of treatment; lipoatrophy or lipohypertrophy at the injection site.
• Very rare (up to 1 in 10,000): serious (systemic) allergic reaction; temporary vision problems at the start of treatment; acute painful neuropathy with rapid improvement in blood sugar control.
• Not known: cutaneous amyloidosis (lumps under the skin).

Overdose, missed dose and stopping treatment

• Overdose: too much insulin causes hypoglycaemia. At the first signs, take glucose tablets or a sugary snack (sweets, biscuits, fruit juice), measure your blood sugar if you can and rest. Severe hypoglycaemia can lead to unconsciousness – then glucagon can be given by someone who knows how, and after regaining consciousness you should take glucose or a sugary snack.
• Missed dose: blood sugar may become too high (hyperglycaemia) – measure your blood sugar and follow your doctor’s instructions.
• Stopping treatment: do not stop insulin without talking to your doctor – serious hyperglycaemia and ketoacidosis may occur.

Related information

For additional care and support with blood sugar self-monitoring, see also the category Blood glucose meters – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: human insulin (isophane, NPH); 1 mL contains 100 IU, one cartridge 300 IU in 3 mL suspension.
• Excipients: zinc chloride; glycerol; metacresol; phenol; disodium phosphate dihydrate; sodium hydroxide; hydrochloric acid; protamine sulfate; water for injections.
• Pack: 3 mL glass cartridge with a glass ball for mixing; carton with 5 cartridges.
• Marketing authorisation holder: Novo Nordisk Pharma d.o.o., Milutina Milankovića 9b, Belgrade. Manufacturers: Novo Nordisk Production SAS, Chartres, France; Novo Nordisk A/S, Bagsvaerd, Denmark.
• Marketing authorisation: 515-01-01170-23-001 of 27.12.2023.

Storage

• Before opening: store in a refrigerator (2 °C to 8 °C), away from the cooling element. Do not freeze.
• In use or carried as a spare: do not refrigerate; can be kept at room temperature (below 30 °C) for up to 6 weeks.
• Keep the cartridge in the outer carton to protect from light.
• Keep out of the sight and reach of children; discard the needle after each injection.

Frequently asked questions

How quickly does Insulatard work and for how long?

Insulatard starts to lower blood sugar about 1½ hours after injection, and the effect lasts about 24 hours. It is therefore usually combined with fast-acting insulin given with meals.

Why must the cartridge be mixed before injection?

Insulatard is a suspension whose particles settle. Move the cartridge up and down until the suspension is uniformly cloudy and white – at least 20 times at first use and at least 10 times before each injection. If it does not become uniformly white, do not use it.

How long can an opened cartridge be used?

A cartridge in use or carried as a spare can be kept at room temperature up to 30 °C for a maximum of 6 weeks and should not be returned to the refrigerator.

What should I do if I notice signs of low blood sugar?

Immediately take glucose tablets or a sugary snack, measure your blood sugar if you can and rest. When the symptoms subside, continue your usual treatment. If hypoglycaemia keeps recurring, talk to your doctor about your dose.

Sources

• ALIMS – Summary of Product Characteristics, Insulatard® Penfill® 100 IU/mL suspension for injection in cartridge (SmPC, Serbian)
• ALIMS – Patient leaflet, Insulatard® Penfill® 100 IU/mL suspension for injection in cartridge (PIL, Serbian)

Sources checked on: 25 October 2026.