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 pre-filled pen 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 Protaphane looks 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 pre-filled pens 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.
Now turn over for information on how to use yourFlexPen.
This leaflet was last approved in
Please read the following instructions carefully before using your Protaphane FlexPen.
Your FlexPen is a unique dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen is designed and tested to be used with NovoFine and NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
The colour of the pen in the illustrations differs from your FlexPen.
Protaphane FlexPen Pen capCartridge PointerRubber membrane 12 units Glass ball Residualscale Doseselector Push-buttonNeedle example Needle Big outer needle cap Innerneedle cap Protectiveta
Your FlexPen is designed to work accurately and safely. It must be handled with care. If it is dropped or crushed, there is a risk of damage and leakage of insulin.
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash or lubricate it as it may damage the pen.
Do not refill your FlexPen.
Preparing your Protaphane FlexPen
Check the label to make sure that your FlexPen contains the correct type of insulin. Before your first injection with a new FlexPen you must resuspend the insulin:
Let the insulin reach room temperature before you use it.
This makes it easier to resuspend.
Pull off the pen cap.
Move the pen up and down twenty times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other. Repeat until the liquid appears uniformly white and cloudy.
For every following injectionmove the pen up and down between position 1 and 2 at least ten times until the liquid appears uniformly white and cloudy.
After you have resuspended the insulin, complete all the following steps of injection without delay.
- Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there are less than 12 units left, use a new FlexPen.
Attaching a needle
Disinfect the rubber membrane with a medicinal swab.
Remove the protective tab from a new disposable needle.
Screw the needle straight and tightly onto your FlexPen.
Pull off the big outer needle cap and keep it for later.
Pull off the inner needle cap and dispose of it.
- Always use a new needle for each injection to prevent contamination.
- Be careful not to bend or damage the needle before use.
- To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.
Checking the insulin flow
Prior to each injection small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:
Turn the dose selector to select 2 units.
Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than six times.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
Selecting your dose
Check that the dose selector is set at 0.
Turn the dose selector to select the number of units you need to inject.
The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector be careful not to push the push-button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
- Do not use the residual scale to measure your dose of insulin.
Making the injection
Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.
Turning the dose selector will not inject insulin.
Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
The needle must remain under the skin for at least six seconds. This will ensure that the full dose has been injected.
Lead the needle into the big outer needle cap without touching the big outer needle cap. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on.
- Always remove the needle after each injection and store your FlexPen without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
- Caregivers should be most careful when handling used needles to avoid needle sticks.
- Dispose of the used FlexPen carefully without the needle attached.
- Do not share your FlexPen with anyone else.
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.