Actrapid

Main information

  • Trade name:
  • Actrapid 100 IU/mL Solution for injection
  • Dosage:
  • 100 IU/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, 10 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Novo Nordisk A/S

Documents

Localization

  • Available in:
  • Actrapid 100 IU/mL Solution for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Treatment of diabetes mellitus. Furthermore indicated for the initial stabilisation of diabetes, during treatment of diabetic ketoacidosis and the hyperosmolar non ketotic syndrome, and during stress situations such as severe infections and major surgery in diabetic patients.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 3501
  • Authorization date:
  • 09-06-1983
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Actrapid Vial PIL 3

Page 1 of 5

New Zealand Consumer Medicine Information

Actrapid

®

100 IU/ml solution for injection in vial

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin

Keep this leaflet. You may need to read it again.

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

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor, nurse or your pharmacist.

1. WHAT ACTRAPID

®

IS AND WHAT IT IS USED FOR

Actrapid

®

is human insulin used to treat diabetes. Diabetes mellitus is a disease where your body

does not produce enough insulin to control the level of your blood sugar. Actrapid

is a fast-acting

insulin. This means that it will start to lower your blood sugar about ½ hour after you take it, and the

effect will last for approximately 8 hours. Actrapid

is often given in combination with longer-acting

insulin products.

2. BEFORE YOU USE ACTRAPID

®

Do not use Actrapid

®

In insulin infusion pumps.

If you are allergic (hypersensitive) to human insulin or any of the other ingredients in

Actrapid

(see 7. FURTHER INFORMATION).

If you suspect hypoglycaemia (low blood sugar) is starting (see 4. WHAT TO DO IN AN

EMERGENCY).

If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap.

If it is not in perfect condition when you get the vial, return the vial to your supplier.

If it has not been stored correctly or been frozen (see 6. HOW TO STORE ACTRAPID

If the insulin does not appear clear and colourless.

Before using Actrapid

®

Check the label to make sure it is the right type of insulin.

Remove the protective cap.

Take special care with Actrapid

®

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you drink alcohol, watch for signs of a hypo and never drink alcohol on an empty stomach.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad: travelling over time zones may affect your insulin needs and the

timing of your injections. Consult your doctor if you are planning such travelling.

Actrapid Vial PIL 3

Page 2 of 5

Using other medicines

Some medicines affect the way glucose works in your body and this may influence your insulin dose.

Listed below are the most common medicines which may affect your insulin treatment. Tell your

doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription. In particular, you should tell your doctor if you are using

any medicine mentioned below that may affect your blood sugar level.

Your need for insulin may change if you also take: other medicines for treatment of diabetes;

monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic

steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy;

sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Thiazolidinediones (class of oral antidiabetic medicines used for the treatment of type 2 diabetes

mellitus)

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are

treated with thiazolidinediones in combination with insulin may develop heart failure. Inform your

doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or

rapid increase in weight or localised swelling (oedema).

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding, please contact your doctor for advice.

Driving and using machines

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.

3. HOW TO USE ACTRAPID

®

Talk about your insulin needs with your doctor and nurse.

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.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood sugar regularly.

How to use this insulin

Actrapid

®

is for injection under the skin (subcutaneously). Always vary the sites you inject within

the same region, to reduce the risk of developing lumps or skin pitting (see 5. POSSIBLE SIDE

EFFECTS). The best places to give yourself an injection are: the front of your waist (abdomen); your

buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it

around the waist.

Actrapid

may also be administered intravenously in special situations by your healthcare

professionals.

How to inject Actrapid

®

on its own or to mix with long-acting insulin

Actrapid Vial PIL 3

Page 3 of 5

Make sure you have the correct syringe with the corresponding unit scale for insulin

injections.

Draw air into the syringe, in the same amount as the dose of insulin you need.

Follow the instructions given by your healthcare professional.

Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.

Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been

delivered.

4. 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.

Do not 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 and test your urine for ketones if you can.

Then seek medical advice straight away.

Actrapid Vial PIL 3

Page 4 of 5

These may be signs of a very serious condition called diabetic ketoacidosis. If you do not treat it, this

could lead to diabetic coma and eventually

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

5. POSSIBLE SIDE EFFECTS

Like all medicines, Actrapid

can cause side effects, although not everybody gets them.

Side effects reported very commonly (in more than 1 patient in 10)

Low blood sugar (hypoglycaemia). See the advice in 4. WHAT TO DO IN AN EMERGENCY.

Side effects reported uncommonly (in less than 1 patient in 100)

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Changes at the injection site (lipodystrophy). The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic

reactions). These 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 difficulty

in breathing; have a rapid heart beat; feel dizzy.

Painful neuropathy (pain due to nerve damage). If your blood sugar level improves very fast, you

may get nerve related pain, this is called acute painful neuropathy and is usually transient.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears.

Side effects reported very rarely (in less than 1 patient in 10,000)

Diabetic retinopathy (eye disease related to diabetes which can lead to loss of vision). If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask

your doctor about this.

Actrapid Vial PIL 3

Page 5 of 5

Serious allergic reaction to Actrapid

or one of its ingredients (called a systemic allergic reaction).

See also the warning in 4. WHAT TO DO IN AN EMERGENCY.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell

your doctor, nurse or pharmacist.

6. HOW TO STORE ACTRAPID

®

Keep out of the reach and sight of children.

Do not use Actrapid

after the expiry date which is stated on the label and the carton after ‘EXP.’ The

expiry date refers to the last day of that month.

Actrapid vial that is not being used is to be stored in the refrigerator at 2°C - 8°C, away from the

cooling element. Do not freeze.

Actrapid vial that is being used or carried as a spare is not to be kept in a refrigerator.

You can carry it with you and keep it at room temperatures (below 25ºC) for up to 6 weeks.

Always keep the vial in the outer carton when you are not using it in order to protect it from light.

Actrapid

must be protected from excessive heat and light.

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.

7. FURTHER INFORMATION

What Actrapid

®

contains

- 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 1,000 IU.

- The other ingredients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid

and water for injections.

What Actrapid

®

looks like and contents of the pack

The solution for injection comes as a clear, colourless, aqueous solution.

It is supplied in packs of 1 vial of 10 ml.

Actrapid

is a trademark owned by Novo Nordisk A/S, Denmark

© 2012

Marketed by

Novo Nordisk Pharmaceuticals Ltd.

Auckland

This leaflet was last approved in June 2012.

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