What NovoMix 30 contains
The active substance is insulin aspart. NovoMix 30 is a mixture consisting of 30 soluble insulin aspart and 70 insulin aspart crystallised with protamine. 1 ml contains 100 U of insulin aspart. Each pre-filled pen contains 300 U of insulin aspart in 3 ml suspension for injection The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulphate, hydrochloric acid, sodium hydroxide and water for injections.
What NovoMix 30 looks like and contents of the pack
NovoMix 30 comes as a white suspension in a pre-filled pen.The cartridge contains a glass ball to facilitate resuspension. After resuspension the liquid shall appear uniformly white and cloudy.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml. Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Autorisation Holder
Novo Nordisk A/S
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 W5, 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 your FlexPen.
This leaflet was last approved in
NOVOMIX 30 suspension for injection in a pre-filled pen. FlexPen. INSTRUCTIONS FOR USE
Please read the following instructions carefully before using your NovoMix 30 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 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 FlexPen is lost or damaged.
The colour of the pen in the illustrations differs from your FlexPen.
NovoMix 30 FlexPen Pen cap Cartridge Residual scale Doseselector 12 units PointerPush- button Glass ball Needle example Big outer needle cap NeedleInner needle cap Protective ta
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 NovoMix 30 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.
Roll the pen between your palms ten times ? it is important that the pen is kept horizontal.
Then move the pen up and down ten times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy.
For every following injection move the pen up and down between the two positions 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
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 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.
- Needles and NovoMix 30 FlexPen must not be shared.