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 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 yourNovoLet.
This leaflet was last approved in
Information on how to use Protaphane NovoLet
Please read the following instructions carefully before using your Protaphane NovoLet.
Protaphane NovoLet is a simple, compact pre-filled pen. You can dial doses from 2 to 78 units in increments of 2 units. Protaphane NovoLet is designed to be used with NovoFine needles. As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
NovoLetNovoFine needle Big outer needle cap Protective tab Pen cap Inner needle cap Cap scale Needle Rubber membrane Insulin level indicator Insulin cartridge Glass ball Dosage indicator Colour coding Push button scale Push button
Getting startedCheck the label to make sure
that your Protaphane NovoLet contains the correct type of insulin. Take off the pen cap.
Resuspending is easier when the insulin has reached room temperature.
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 NovoLet
- Move the pen up and down between positions a and b and back(picture A) so that the glass ball moves from one end of the cartridge to the other, 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
- 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 NovoFine needle
- Screw the needle straight and tightly onto Protaphane NovoLet (picture B)
- Pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap.
A Ba b
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:
- Hold Protaphane NovoLet with the needle pointing upwards
- Tap the cartridge gently with your finger a few times. Any air bubbles will collect at the top of the cartridge
- Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture C)
- Still with the needle upwards, press the push-button fully down (picture D)
- 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
- Put the cap back on the pen, with 0 next to the dosage indicator(picture E)
- Check that the push-button is fully down. If it isn?t, turn the cap until the push-button is fully depressed
- Hold your Protaphane NovoLet horizontally. Now you?re ready to set the dose you need
- Turn the cap in the direction of the arrow (picture F) to set the right dose. You?ll feel the cap clicking, and the push-button will rise up
- Don?t put your hand over the push-button when you set the dose . If the push-button cannot rise freely, some of your insulin will be pushed out of the needle
- The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units. For every click you feel when you turn the cap, you set 2 units more. The push-button also rises as you turn the cap
- The scale under the push-buttonshows 20, 40 and 60 units. Every time you fully turn the cap, you set 20 units.
Dosage examplesTo set 8 units:
Turn the cap until 8 is opposite the dosage indicator; four clicks
To select 26 units:
Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again. You?ve now set 20 units. Keep turning the cap until 6 is opposite the dosage indicator. On the push-button scale you?ll see a 20-line.
Add the 6 from the dosage indicator to the 20 on the push-button scale. There, you?ve set 26 units (picture G).
To check a dose you set
- Note the figure on the cap next to the dosage indicator
- Note the highest figure you can see on the push-button scale
- Add the two together to show the dose you set
- If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
The maximum dose is 78 units
- Don?t try to set a dose higher than 78 units. Otherwise, insulin will leak out of the needle and the dose will be incorrect
- If you have, by mistake, tried to set a dose over 78 units, follow these steps: Turn the cap back as far as you can. Turn it till the push-button is fully down and you can feel resistance. Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator. Now set the dose again. Remember that 78 units is the maximum dose
- After the dose is set, remove the cap to inject the insulin. Go straight on to Injecting the insulin.
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. Be careful only to push the push-button when injecting
- Keep the push-button fully depressed after the injectionuntil the needle has been withdrawn from the skin. The needle must remain under the skin for at least 6 seconds. This will ensure that the full dose has been delivered.
- Always check that the push-button is completely down. If not, turn the cap until the push-button is fully depressed, then proceed as described in Getting started
- You may hear a clicking sound when you press the push-button. Don?t use this to set or check your dose; it may not be accurate
- You can?t set a dose higher than the number of units left in the cartridge
- You can use the insulin level indicator to estimate how much is left, but you can?t use it to set or select your dose.
Removing the needle
- Replace the big outer needle cap and unscrew the needle.Dispose of it carefully.
Use a new needle for each injection.
Remove the needle after each injection and store NovoLet without a 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. Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Dispose of your used Protaphane NovoLet carefully without the needle attached.
Your Protaphane NovoLet is designed to work accurately and safely. It must be handled with care. Do not refill Protaphane NovoLet.
You can clean the exterior of your Protaphane NovoLet 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.