Humulin R 100 IU/mL solution in cartridge – fast-acting human insulin for diabetes

Humulin R contains human insulin, produced by recombinant DNA technology and with the same structure as the insulin made by the pancreas. It is a fast-acting human insulin in the form of a clear solution.

In Serbia it is authorised as Humulin® R, 100 IU/mL, solution for injection in cartridge (Eli Lilly), in a pack of 5 cartridges of 3 mL. Your doctor may also prescribe a long-acting insulin to be used with it.

What is Humulin R used for and how is it used correctly?

Key facts about the medicine

What is Humulin R used for?

Humulin R is used to treat diabetes mellitus, when the pancreas does not make enough insulin to control blood sugar. It is a fast-acting insulin used for glucose control, and doctors often combine it with a long-acting insulin.

How is it used and dosed?

The dose, timing and frequency are decided only by your doctor, according to your needs – follow these instructions strictly and attend regular check-ups at your diabetes clinic.

• Appearance: Humulin R is a solution and does not need mixing, but use it only if it looks like water – clear, colourless and free of particles.
• The 3 mL cartridge is used only in a Lilly 3 mL pen (not in a 1.5 mL pen). Before each injection dial 1–2 units and, holding the needle upwards, prime until a drop of insulin appears at the needle tip.
• Insulin is injected under the skin (upper arm, thigh, buttock or abdomen); keep the needle in the skin for 5 seconds and do not rub the site.
• Rotate injection sites – each new one at least 1 cm from the last – to prevent lumps under the skin (lipodystrophy, cutaneous amyloidosis) and poor insulin action.
• Remove the needle after the injection; never add another insulin to the cartridge and do not reuse an empty cartridge.
• When switching from another insulin (e.g. of animal origin) the dose may be higher or lower and may change over several weeks or months.

Special patient groups

• Children: according to the labelling text the medicine is intended for children and adults; the dose is set by the doctor.
• Kidney or liver disease: tell your doctor – insulin needs may change, and worsening kidney or liver function increases the risk of hypoglycaemia.
• Illness, extra exercise, alcohol, travel across time zones: can change the dose and injection schedule you need – ask your doctor.

Contraindications – when the medicine must not be used

Do not use Humulin R:

• if you think hypoglycaemia (low blood sugar) is starting;
• if you are allergic to human insulin or to any of the excipients (except when used as part of a desensitisation programme, according to the SmPC).

Warnings and precautions

• With well-controlled blood sugar, long-standing diabetes, neuropathy or beta-blockers, the early warning signs of a hypo may be weaker or different – frequent blood sugar testing is therefore important.
• Too little insulin or stopping treatment can lead to hyperglycaemia and diabetic ketoacidosis, which can be life-threatening.
• Heart failure has occurred in patients with long-standing type 2 diabetes and heart disease or previous stroke who used pioglitazone with insulin – contact your doctor if you notice unusual shortness of breath, rapid weight gain or swelling.
• Injecting into thickened or lumpy skin may weaken the effect of insulin; ask your doctor before changing injection areas.
• The medicine is essentially sodium-free (less than 1 mmol per dose).

Interactions with other medicines and alcohol

Your insulin needs may change if you take:

• steroid hormones (corticosteroids), thyroid hormone replacement, growth hormone, danazol;
• oral medicines for diabetes, acetylsalicylic acid (aspirin), MAO inhibitors (some antidepressants);
• beta2-sympathomimetics (e.g. salbutamol, terbutaline, ritodrine), beta-blockers, thiazide diuretics;
• some ACE inhibitors (e.g. captopril, enalapril) or angiotensin II receptor blockers;
• octreotide or lanreotide (may either increase or decrease insulin needs).

Alcohol affects blood sugar and may change the insulin dose you need.

Pregnancy and breast-feeding

Insulin needs usually fall during the first three months of pregnancy and rise during the remaining six. A pregnant woman using insulin must be well controlled throughout pregnancy. While breast-feeding, your insulin dose or diet may need adjusting. If you are pregnant, planning a pregnancy or breast-feeding, ask your doctor for advice.

Driving and using machines

During hypoglycaemia your ability to concentrate and react may be reduced. Talk to your doctor about driving if you have frequent hypos or if the warning signs are weak or absent.

Possible side effects

The most common side effect of insulin is hypoglycaemia (low blood sugar). The first signs usually come on quickly: tiredness, nervousness or shakiness, headache, fast heartbeat, nausea, cold sweat.

• common (up to 1 in 10): local allergy – redness, swelling or itching at the injection site, usually settling within a few days to a few weeks;
• uncommon (up to 1 in 100): lipodystrophy or lipohypertrophy – thinning or thickening of fatty tissue at the injection site;
• very rare (up to 1 in 10,000): generalised allergy – fall in blood pressure, rash all over the body, difficulty breathing, wheezing, fast heartbeat, sweating;
• frequency not known: cutaneous amyloidosis (lumps under the skin); oedema (swelling of the hands or ankles), especially at the start of treatment or when treatment is changed.

Overdose, missed dose and stopping treatment

• Too much insulin: your blood sugar may fall – check it. For a mild hypo take glucose tablets, sugar or a sweet drink, then fruit, biscuits or a sandwich, and rest. A more severe hypo is treated with glucagon (followed by glucose or sugar); if there is no response to glucagon, hospital treatment is needed.
• Missed or smaller dose: your blood sugar may rise – check it. Do not use a double dose.
• Stopping treatment: may lead to very high blood sugar; do not change or stop insulin without your doctor’s advice.
• Illness: you still need insulin even when you are not eating normally – check your blood sugar, follow your “sick day” rules and tell your doctor.

Related information

For home blood sugar self-monitoring, see also the category Blood glucose meters – products in this category do not replace the medicine prescribed to you.

Composition, pack and manufacturer

• Active substance: human insulin (rDNA) – 100 IU/mL; one 3 mL cartridge contains 300 IU.
• Excipients: m-cresol; glycerol; water for injections; sodium hydroxide or hydrochloric acid to adjust acidity.
• Appearance: clear, colourless solution.
• Pack: carton of 5 cartridges of 3 mL.
• Marketing authorisation holder: Predstavništvo Eli Lilly (Suisse) SA, Belgrade (Novi Beograd), Vladimira Popovića 38–40. Manufacturers: Lilly France, Fegersheim (France) and Eli Lilly Italia S.p.A., Sesto Fiorentino (Italy).

Storage

• Before first use: in a refrigerator at 2–8 °C; do not freeze.
• After first use: below 30 °C for up to 28 days; do not keep the pen with the cartridge in use in the fridge and do not expose it to heat or direct sunlight.
• Keep out of the sight and reach of children. The shelf life of the unopened medicine is printed on the pack.
• Return unused medicine to a pharmacy that collects unwanted medicines.

Frequently asked questions

Does Humulin R need to be mixed before use?

No. Humulin R is a solution and does not need mixing, but it may only be used if it is clear, colourless and free of particles, like water.

Can Humulin R be given into a vein?

The cartridges are intended for injection under the skin with a pen. According to the labelling, only in exceptional situations may a doctor give insulin intravenously – never do this yourself.

Where should I keep the cartridge in use?

Below 30 °C for up to 28 days, out of the fridge and protected from heat and direct sunlight. Unopened cartridges are kept in the fridge at 2–8 °C.

What should I do if I missed a dose?

Check your blood sugar. Do not use a double dose to make up for the missed one. If you are unsure how to continue, ask your doctor or diabetes nurse.

Sources

• ALIMS – Labelling text for Humulin® R 100 IU/mL (document in the SmPC section, Serbian)
• ALIMS – Package leaflet, Humulin® R 100 IU/mL solution for injection in cartridge (PIL, Serbian)

Sources checked on: 25 October 2026.