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Generic name: Insulatard
Brand names:
Manufacturer: Novo Nordisk

Insulatard 100 IU/ml Suspension for injection in a vial Insulin human, rDNA.

Insulatard is an isophane insulin suspension (NPH).

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 100 IU of insulin human.

1 vial contains 10 ml equivalent to 1000 IU.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

The suspension for injection comes as a cloudy, white, aqueous suspension in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1x10 ml) vials (not all packs may be marketed).

What Insulatard is and what it is used for
Insulatard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Insulatard is a long-acting insulin. This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulins.

Before you use Insulatard

Do not use Insulatard
If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See What to do in an emergency for more about hypos
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see list above). Look out for the signs of allergy in Possible side effects.

Take special care with Insulatard
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands
If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach
If you are exercising more than usual or if you want to change your usual diet
If you are ill: carry on taking your insulin
If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice
If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Using other medicines
Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); betablockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.

How to use Insulatard
Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

It is recommended that you measure your blood glucose regularly.

Before using Insulatard
Check the label to make sure it is the right type of insulin
Disinfect the rubber membrane with a medicinal swab.

Do not use Insulatard
In insulin infusion pumps.
If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier
If it hasn’t been stored correctly or been frozen (see Storing Insulatard)
If it’s not uniformly white and cloudy when it’s mixed.

How to use this insulin
Insulatard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see Possible side effects). The best place to give yourself an injection is the front of your thighs. If convenient, the front of your waist (abdomen), your buttocks or the front of your upper arms may be used.

Insulatard vials are for use with insulin syringes with the corresponding unit scale.

To inject Insulatard on its own
1. Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly white and cloudy
2. Draw air into the syringe, in the same amount as the dose of insulin you need
3. Inject the air into the vial: push the needle through the rubber stopper and press the plunger
4. Turn the vial and syringe upside down
5. Draw the right dose of insulin into the syringe
6. Pull the needle out of the vial
7. Make sure there is no air left in the syringe: point the needle upwards and push the air out
8. Check you have the right dose
9. Inject straight away.

To mix Insulatard with fast-acting insulin
1. Roll the vial of Insulatard between your hands. Do this until the liquid is uniformly white and cloudy
2. Draw as much air into the syringe as the dose of Insulatard you need. Inject the air into the Insulatard vial, then pull out the needle
3. Draw as much air into the syringe as the dose of fast-acting insulin you need. Inject the air into the fast-acting insulin vial. Then turn the vial and syringe upside down
4. Draw the right dose of fast-acting insulin into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check the dose
5. Now push the needle into the vial of Insulatard. Then turn the vial and syringe upside down
6. Draw the right dose of Insulatard into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe, and check the dose
7. Inject the mixture straight away.

Always mix fast-acting and long-acting insulin in this order.

Inject the insulin
Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse Keep the needle under your skin for at least 6 seconds to make sure the full dose has been delivered.

What to do in an emergency

If you get a hypo
A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

  • If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
  • If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo
You get a hypo if your blood sugar gets too low. This might happen:
If you take too much insulin
If you eat too little or miss a meal
If you exercise more than usual.
If your blood sugar gets too high
Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia
Having forgotten to take your insulin
Repeatedly taking less insulin than you need
An infection or a fever
Eating more than usual
Less exercise than usual.

Possible side effects
Like all medicines, Insulatard can have side effects. Insulatard may cause hypoglycaemia (low blood sugar).

Side effects reported uncommonly
(less than 1 in 100)
Changes at the injection site. If you inject yourself too often at the same site, lumps may develop underneath. In addition, you may experience pain and bruising at the injection site. Prevent this by choosing different injection sites each time within the same region.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These reactions usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:
If signs of allergy spread to other parts of the body, or
If you suddenly feel unwell and you: start sweating; start being sick (vomiting); have difficulties in breathing; have a rapid heart beat; feel dizzy; feel like fainting.
You may have a very rare serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction). See also warning in Before you use Insulatard.
Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.
Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Side effects reported very rarely
(less than 1 in 10,000)
Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.
Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.
If you notice any side effects also those not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing Insulatard
Keep out of the reach and sight of children.
Insulatard vials that are not being used are to be stored in a refrigerator (2°C - 8°C) in the original package. Do not freeze.
Insulatard vials that are being used or about to be used are not to be kept in a refrigerator. You can carry them with you and keep them at room temperature (not above 25°C) for up to 6 weeks.
Always keep the vial in the outer carton when you’re not using it in order to protect it from light.
Insulatard must be protected from excessive heat and sunlight.
Do not use Insulatard after the expiry date stated on the label and carton.

News Update

September 7th, 2016:

October 26, 2015:
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