NovoMix 30 Caution For Usage

Special Precautions for Disposal and other Handling: Needles and NovoMix 30 FlexPen must not be shared. The cartridge must not be refilled. NovoMix 30 must not be used if the resuspended liquid does not appear uniformly white and cloudy.
The necessity of resuspending the NovoMix 30 FlexPen suspension immediately before use is to be stressed to the patient.
NovoMix 30 which has been frozen must not be used.
The patient should be advised to discard the needle after each injection.
Instructions for Use For the Patient: Do not use NovoMix 30: If the patient is allergic (hypersensitive) to insulin aspart or any of the other ingredients in NovoMix 30 (see Excipients/Inactive Ingredients under Description).
If the patient's hypoglycaemia (low blood sugar) is starting (see Precautions).
In insulin infusion pumps.
If FlexPen is dropped, damaged or crushed.
If it has not been stored correctly or if it has been frozen.
If the resuspended insulin does not appear uniformly white and cloudy.
If, after re-suspension clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.
Before using NovoMix 30: Check the label to make sure it is the right type of insulin.
Always use a new needle for each injection to prevent contamination.
Needles and NovoMix 30 FlexPen must not be shared.
NovoMix 30 is for injection under the skin (subcutaneously). Never inject the insulin directly into a vein (intravenously) or muscle (intramuscularly).
With each injection, change the injection site within the particular area of skin that the patient use. This reduces the risk of developing lumps or skin pitting. The best places to give the patient an injection are: The front of your waist (abdomen); the buttocks; the front of the thighs or upper arms. The insulin will work more quickly if the patient inject around the waist. The patient should always measure the blood sugar regularly.
How to Handle NovoMix 30 FlexPen: Read and follow the included NovoMix 30 FlexPen instructions for use carefully.
NovoMix 30 suspension for injection in a pre-filled pen. FlexPen Instructions for Use for the Patient: Please read the following instructions carefully before using NovoMix30 FlexPen.
The FlexPen is a unique dial-a-dose insulin pen. The patient 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. As a precautionary measure, always carry a spare insulin delivery device in case the FlexPen is lost or damaged.
Maintenance: The FlexPen is designed to work accurately and safely. It must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage.
The patient can clean the exterior of the FlexPen by wiping it with a medicinal swab. Do not soak, wash or lubricate it as it may damage the pen.
Do not refill the FlexPen.
Preparing the NovoMix 30 FlexPen: Check the label to make sure that the FlexPen contains the correct type of insulin. Before the first injection with a new FlexPen, the patient must resuspend the insulin: A. Let the insulin reach room temperature before the patient use it. This makes it easier to resuspend. Pull off the pen cap.
B. Roll the pen between the palms 10 times-it is important that the pen is kept horizontal.
C. Then move the pen up and down 10 times between the two positions, so the glass ball moves from one end of the cartridge to the other.
Repeat rolling and moving the pen until the liquid does appear uniformly white and cloudy.
For every following injection move the pen up and down between the two positions at least 10 times until the liquid does appear uniformly white and cloudy.
After the patient 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: D. Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto the FlexPen.
E. Pull off the big outer needle cap and keep it for later.
F. 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 the patient 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: G. Turn the dose selector to select 2 units.
H. Hold the FlexPen with the needle pointing upwards and tap the cartridge gently with finger a few times to make any air bubbles collect at the top of the cartridge.
I. 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 6 times.
If a drop of insulin still does not appear, the pen is defective, and the patient must use a new one.
Selecting the Dose: Check that the dose selector is set at 0.
J. Turn the dose selector to select the number of units the patient needs 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.
The patient cannot select a dose larger than the number of units left in the cartridge.
Do not use the residual scale to measure the dose of insulin.
Making the Injection: Insert the needle into the skin. Use the injection technique shown by the physician or nurse.
K. 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.
L. Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. This will make sure the patient get the full dose.
Withdraw the needle from the skin, then release the pressure on the push-button.
M. Lead the needle into the big outer needle cap without touching it. 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 the 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.