What Protaphane contains
The active substance is insulin human made by recombinant biotechnology. Protaphane is an isophane insulin suspension NPH. 1 ml contains 100 IU of insulin human. 1 cartridge contains 3 ml equivalent to 300 IU
The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
What Protaphanelooks like and contents of the pack
The suspension for injection comes as a cloudy, white, aqueous suspension.
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml. Not all packs may be marketed.
Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd, Denmark
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
If the second and third characters are S6, P5, K7, R7 or ZF Novo Nordisk AS, Novo Allé, DK-2880 Bagsværd, Denmark is the manufacturer
If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue dOrléans F-28002 Chartres, France is the manufacturer.
This leaflet was last approved in
WHAT TO DO IN AN EMERGENCY
If you get a hypo
A hypo means your blood sugar level is too low.Thewarning 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.
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).Thewarning 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.
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.