Velosulin
insulin human (rDNA)
Insulin human (rDNA)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, diabetes 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Medicinal product no longer authorised
� If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects
� If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos.
� 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.
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.
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.
Eat a meal or snack containing carbohydrates within 30 minutes of administration. It is recommended that you measure your blood glucose regularly.
� Check the label to make sure it is the right type of insulin
� Disinfect the rubber membrane with a medicinal swab.
� 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
Medicinal product no longer authorised
� If it hasn’t been stored correctly or been frozen (see 6 How to store Velosulin)
� If it does not appear water clear and colourless. Use in infusion pump
Follow the instructions and recommendations from your doctor regarding the use of Velosulin in a pump.
Velosulin should never be mixed with any other insulin when used in a pump. Read and follow carefully the instructions that accompany your insulin pump. Always have ordinary syringes available in case of pump interruption or failure.
Velosulin is for injection under the skin (subcutaneously). Always vary the sites you inject, to avoid lumps (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.
Velosulin vials are for use with insulin syringes with the corresponding unit scale.
Velosulin may also be administered intravenously in special situations by medical professionals.
Draw air into the syringe, in the same amount as the dose of insulin you need
Inject the air into the vial: push the needle through the rubber stopper and press the plunger
Turn the vial and syringe upside down
Draw the right dose of 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 you have the right dose
Inject the insulin straight away 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 that the full dose has been delivered.
Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
A hypo means your blood sugar level is too low.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Medicinal product no longer authorised
� 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.
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.
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.
Your blood sugar may get too high (this is called hyperglycaemia).
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.
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.
Like all medicines, Velosulin can cause side effects, although not everybody gets them. Velosulin may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.
Medicinal product no longer authorised
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; feel like fainting.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
Keep out of the reach and sight of children.
Do not use Velosulin after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
Do not freeze.
Keep the vials in the original package.
Always keep the vial in the outer carton when you’re not using it in order to protect it from light. Velosulin must be protected from excessive heat and sunlight.
Velosulin 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.
Medicinal product no longer authorised
The solution for injection or infusion comes as a clear, colourless, aqueous solution.
It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials. Not all packs may be marketed.
Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd, Denmark