100 IU / ml injection, suspension in the cartridge
(human insulin)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Humulin NPH is and what it is used for
2. What you need to know before using Humulin NPH
3. How to use Humulin NPH
4. Possible side effects
5. How to store Humulin NPH
6. Contents of the packaging and other information

1. What Humulin NPH is and what it is used for

Humulin NPH contains the active substance human insulin, which is used to treat diabetes. You get diabetes if your pancreas does not produce enough insulin, which controls the level of glucose in the blood (blood sugar). Humulin NPH is used to control the level of glucose in the blood for a long time. The duration of action has been extended by adding protamine sulfate to suspension one.

Your doctor may prescribe both Humulin NPH and fast-acting insulin at the same time. Each type of insulin has its user information. Do not change your insulin unless your doctor tells you to. Be very careful if you change your insulin. The different types of insulin have different colors and symbols on the package and ampoule one so that you can easily distinguish them.

2. What you need to know before using Humulin NPH

Do not use Humulin NPH

NPH in the cartridge you will only be injected under the skin with a reusable pen. Talk to your doctor if you need to inject your insulin with another method.

  • if you think that a so-called insulin sensation ( hypoglycaemia , low blood sugar) begins . Later in this user information, there are instructions on how to deal with a mild insulin sensation (see A in section 4).
  • if you are allergic to human insulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Humulin NPH.

  • If your blood sugar is under good control of your current insulin , you may not be able to detect the warning signs when your blood sugar gets too low. The warning signals are listed later in this information. You should carefully keep track of when you should eat, how often you should exercise and how much you should exercise. You should also carefully check your blood sugar level by testing your blood sugar frequently.
  • Some people who have had insulin sensations (low blood sugar) after switching from animal insulin to human insulin have reported that the early warning symptoms were less clear or different. If you often have insulin sensations or have difficulty recognizing them, talk to your doctor.
  • If you answer YES to any of the following questions, talk to your diabetes nurse, doctor or pharmacist
    • Have you recently become ill?
    • Do you have kidney or liver problems?
    • Do you train more than usual?
  • Insulin requirements may also change with alcohol intake.
  • You should also talk to your diabetes nurse, doctor or pharmacist if you plan to travel abroad. The time difference between countries may mean that you have to take your injections and eat at other times than when you are at home.
  • Some patients who have had type 2 diabetes mellitus and heart disease for many years or earlier stroke , 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 ).

Skin changes at the injection site:

To prevent skin changes, e.g. nodules under the skin, you should constantly change the injection site. It may be that insulin et not work as well if you inject in an area of nodules (see “How to use NPH”). Contact your doctor before changing the injection site if you are currently injecting in an area with lumps. 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.

Other medicines and Humulin NPH

Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.

Your insulin requirements may change if you take any of the following medicines:

  • cortisone
  • drugs for thyroid disease
  • tablets for the treatment of diabetes
  • acetylsalicylic acid
  • growth hormone er
  • octreotide, lanreotide
  • beta 2 stimulators (eg ritodrin, salbutamol or terbutaline )
  • beta blockers
  • thiazides or certain antidepressants ( monoamine oxidase inhibitors )
  • danazol
  • certain angiotensin converting (ACE) enzyme inhibitors (eg captopril , enalapril ) or angiotensin II receptor blockers.

Pregnancy, breastfeeding and fertility

Insulin requirements usually decrease during the first 3 months of pregnancy and then increase during the remaining 6 months. If you are breastfeeding, adjusting your insulin dose and/or diet may be necessary.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Your ability to concentrate and react may be impaired in hypoglycemia (low blood sugar). Keep this in mind in all situations where you may expose yourself or others to risks (eg while driving or using machines). Contact your diabetes nurse or doctor regarding the suitability of driving if:

  • you often suffer from hypoglycemia
  • your warning signs of hypoglycaemia are weakened or completely absent

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Humulin NPH contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is almost “sodium-free”.

3. How to use Humulin NPH

3 ml cartridge should only be used in a 3 ml pen. It should not be used in 1.5 ml pencils.

Always check the packaging and the cartridge label so that the name and type of insulin match when you get it from the pharmacy. Make sure you get the Humulin prescribed by your doctor.

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. To prevent the risk of transmitting diseases, the cartridge should only be used by you, even if the needle on the dosing aid is replaced.

Dosage instructions

  • You should normally inject Humulin NPH as a basal insulin. Your doctor has decided which insulin to use, how much, when and how often you should take the insulin . These instructions are personal and just for you. Follow them closely and visit your diabetes clinic regularly.
  • If you change the type of insulin (eg from animal insulin to human insulin) you may need to take more or less than before. This may appear at the first injection one or it may be a gradual change over several weeks or months.
  • NPH in the cartridge you will only be injected under the skin with a reusable pen. Talk to your doctor if you need to inject your insulin with another method.

Preparation of Humulin NPH

  • Cylinders containing Humulin NPH should be rolled back and forth between palms 10 times and inverted (180 °) 10 times immediately before use so that the insulin suspension mixes well and becomes evenly cloudy or milky. If the contents do not get the correct appearance, repeat the procedure until an even mixture is obtained. The cartridge contains a small glass bead to facilitate mixing . Do not shake vigorously, as foam may form which may affect the dosing accuracy. The cartridges should be checked frequently and should not be used if they contain lumps or if solid white particles get stuck on the bottom or walls ofampoule one and gives a frosty appearance. Check before each injection .

Preparation of the pen

  • Wash your hands. Disinfect the rubber membrane of the cartridge one.
  • NPH cartridge may only be used in appropriate Lilly insulin pen to ensure you are getting the right dose .
  • Follow the instructions that come with the pen. Place the cartridge a pen.
  • Set dose one to 1 or 2 units. Then hold the pen so that the needle points upwards and tap lightly on the side so that any air bubbles float up. Hold the pen so that the needle points upwards, press the injection button on the pen. Continue pressing until a drop of Humulin NPH appears at the far end of the needle tip. There may still be small air bubbles left in the pen. These are harmless, but if the air bubbles are too large, they can affect the insulin dose.

Injection of Humulin NPH

  • Before injection , wash the injection site as instructed. Inject under the skin as you have been shown. Do not inject directly into a blood vessel. Wait 5 seconds after finishing the injection before pulling out the needle, then you are sure that you have received the full dose one. Do not massage the injection site. Make sure that you have at least a 1 cm margin to the previous injection site and that you change the injection site that you have been assigned.

After injection

  • Once you have finished injecting one, unscrew the needle from the pen using the outer needle guard. In this way, insulin remains sterile and leakage is prevented. It also prevents air from entering the pen and clogging the needle. Never share needles or pens with anyone else . Put the protective cap on the pen.

Additional injection er

  • Let the cartridge one in the pen. Before each injection , turn 1 to 2 units and press the injection button until a drop of Humulin NPH appears on the needle. You can see how much insulin is left by looking at the scale on the cartridge . Between each line there are about 20 units of insulin . Replace the cartridge if there is not enough insulin left for a full dose

Mix any other insulin in the NPH cartridge. When the cartridge is empty, it should not be used again.

If you use more Humulin NPH than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you use more Humulin NPH than you need, your blood sugar may be low. Check your blood sugar (see A in section 4).

If you forget to use Humulin NPH

If you use less Humulin NPH than you need, your blood sugar level may rise. Check your blood sugar. Do not take a double dose to make up for a forgotten dose.

If you stop using Humulin NPH

If you use less Humulin NPH than you need, your blood sugar may become too high. Do not change your insulin intake unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Human insulin may cause hypoglycaemia (low blood sugar). For more information on hypoglycaemia, see the section below “Common problems with diabetes”.

Any side effects are

General allergy is very rare (affects less than 1 user in 10,000). The symptoms are:

drop in blood pressure rash all over the body
breathing difficulties hissing breathing
palpitation sweating

If you think you may have this type of insulin allergy, talk to your doctor straight away.

Local allergy is common (affects less than 1 user in 10). Some people get redness, swelling, or itching at the injection site. This usually stops after a few days or a few weeks. If you get any of these symptoms, talk to your doctor.

Skin changes at the injection site

If you inject insulin too often in the same place, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.

Edema (swollen arms, ankles; fluid retention ) has been reported, especially when starting insulin therapy or when changing treatment to improve the control of your blood sugar.

Common problems with diabetes

A. Hypoglycemia

Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. This can be caused by:

  • that you are taking too much Humulin NPH or other insulin
  • that you skip or postpone meals or change your diet
  • that you exercise or work too hard just before or after a meal
  • that you have an infection or are ill (especially with diarrhea or vomiting)
  • that your insulin needs have changed, or
  • that you have problems with your kidneys or liver that have gotten worse.

Alcohol and certain medications can affect blood sugar levels.

The first symptoms of low blood sugar usually appear quickly and involve

fatigue palpitation
nervousness and tremors nausea
headache cold sweats

If you are not sure about recognizing the warning symptoms, avoid situations, such as driving a car, where you may expose yourself or others to risks due to hypoglycemia.

Do not inject Humulin NPH if you think that a so-called insulin sensation (low blood sugar, hypoglycaemia ) is starting.

If your blood sugar is low, take glucose tablets, sugar, or a sweet drink. Then take fruit, biscuits, or a sandwich according to your doctor’s instructions and rest for a while. Often, a weak insulin sensation or a slight overdose of insulin disappears with this treatment. If you get worse, have shortness of breath, and turn pale, contact your doctor immediately. Quite severe hypoglycaemia can be treated with a glucagon injection. Eat glucose or sugar after the glucagon injection. If you are not improved by glucagon, you should be treated in a hospital. Ask your doctor to tell you about glucagon.

B. Hyperglycaemia and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can occur if:

  • you have not taken your Humulin NPH or other insulin
  • you have taken less insulin than your doctor told you to
  • you have eaten more than your diet allows, or
  • you have a fever, infection or are emotionally stressed.

Hyperglycaemia can lead to diabetic ketoacidosis . The first symptoms creep in for several hours or days. They are:

somnolence no appetite
flushing fruit smell from the breath
thirst nausea or vomiting

Serious symptoms are heavy breathing and rapid heartbeat. Seek medical attention immediately.

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, it can have serious consequences and lead to headaches, nausea, vomiting, dehydration, unconsciousness, coma, and even death.

Three simple steps to avoid hypoglycemia or hyperglycemia are:

  • Always have a spare syringe and spare bottle of Humulin NPH.
  • Always carry something with you that shows that you are diabetic.
  • Always have sugar with you.

C. In case of illness

If you are sick, especially if you feel nauseous or vomit, your insulin needs may change. Even if you do not eat normally, you still need insulin. Test urine or blood, follow the instructions for your illness, and talk to your diabetes nurse or doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Humulin NPH

Keep this medicine out of the sight and reach of children.

Humulin NPH should be stored in a refrigerator (2 ° C – 8 ° C) before use. Do not freeze. The pen and cartridge currently in use should be stored at room temperature (not above 30 ° C) and used within 28 days. The cartridge or pen currently in use should not be stored in the refrigerator. Do not expose them to excessive heat or sunlight

Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.

Do not use this medicine if the cartridge contains lumps or solid, white particles that stick to the bottom or walls of the cartridge and give a frosty appearance. Check this before each injection.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human insulin. Human insulin is manufactured in the laboratory using “recombinant DNA technology”. It is identical in structure to the hormone produced in the pancreas. This makes it different from animal insulin. Humulin NPH is a suspension with added protamine sulphate.
  • The other ingredients are protamine sulphate, metacresol, phenol, glycerol , dibasic sodium phosphate 7H 2 O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added during manufacture to adjust the pH .

What the medicine looks like and contents of the pack

Humulin NPH 100 IU / ml suspension for injection is a white, sterile suspension containing 100 units of insulin per milliliter (100 IU / ml). Each cartridge contains 300 units (3 milliliters).

The cartridges are in packs of 5 cartridges.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Humulin NPH 100 IU / ml suspension for injection in the cartridge is manufactured by:

Lilly France SAS, Rue du Colonel Lilly, 67640 Fegersheim, France

Eli Lilly Italia SpA, Via A. Gramsci 731-733, 50019 Sesto Florence, Italy

Marketing Authorization Holder / Information provided by:

This medicinal product is authorized under the European Economic Area under the names:

Huminsulin Lilly Basal 100 (Austria)

Humuline NPH (Belgium, Luxembourg, Netherlands)

Humulin N (Bulgaria, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia), Slovenia)

Humulin N (NPH) Cartridge (Czech Republic, Slovakia)

Huminsulin Basal (NPH) for Pen 3 ml (Germany)

Humulin NPH (Cyprus, Greece, Norway, Portugal, Slovenia, Sweden)

Humulin I (Ireland, Italy, Malta, UK)

UMULINE NPH (France)

Muhammad Nadeem

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