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 and Manufacturer
Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd, Denmark
Now turn over for information on how to use yourInnoLet.
This leaflet was last approved in
Information on how to use Protaphane InnoLet
Please read the following instructions carefully before using your Protaphane InnoLet.
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. Be sure you are not using any counterfeit needles. Ask your pharmacist.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Push-button Dose selector dial Residualscale Dose scale Insulin cartridge Compartment for needles Glass ballRubber membrane Disposable needle exampleNeedlePen cap Protective tabInner needle cap Big outerneedle cap
Preparing for injectionCheck the label to make sure
that your Protaphane InnoLet contains the correct type of insulin. Take off the pen cap (as shown by the arrow).
Resuspending is easier when the insulin has reached room temperature.
Suspending the insulin
Before every injection:
- Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new Protaphane InnoLet
- Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated, until the liquid appears uniformly white and cloudy
- After resuspending, complete all of the following stages of injection without delay.
Attaching the needle
- Disinfect the rubber membrane with a medicinal swab
- Always use a new needle for each injection to prevent contamination
- Remove the protective tab from a new disposableneedle
- Screw the needle straight and tightly onto Protaphane InnoLet (picture 1B)
- Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.
Priming to expel air
Small amounts of air may collect in the needle and cartridge during normal use.
To avoid injection of air and ensure proper dosing:
- Dial 2 units by turning the dose selector clockwise
- Hold Protaphane InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few timesto make any air bubbles collect at the top of the cartridge (picture 1C)
- Keeping the needle upwards, press the push-button and the dose selector returns to zero
- A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
If a drop of insulin still does not appear, the device is defective and must not be used.
Setting the dose
- Always check that the push-button is fully depressed and the dose selector is set at zero
- Dial the number of units required by turning the dose selector clockwise (picture 2). Do not use the residual scale to measure your dose of insulin
- You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way.
You cannot set a dose larger than the number of units left in the cartridge.
Injecting the insulin
- Insert the needle into your skin. Use the injection technique advised by your doctor
- Deliver the dose by pressing the push-button fully down (picture 3).You will hear clicks as the dose selector returns to zero
- After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered
- Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button
- Remove the needle after each injection.
Removing the needle
- Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.
Use a new needle for each injection.
Remove the needle after each injection and store InnoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration. Dispose of your used Protaphane InnoLet carefully without the needle attached.
Your Protaphane InnoLet is designed to work accurately and safely. It must be handled with care. Do not refill Protaphane InnoLet.
You can clean your Protaphane InnoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism.
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.