Novo Nordisk Insulin Pen 30 User Manual

blood pressure or oedema), thyroid hormones  
(used for the treatment of malfunction of the  
thyroid gland), sympathomimetics (used for the  
treatment of asthma), danazol (used for the  
treatment of some female hormonal disorders),  
octreotide (used in special endocrine conditions)  
and sulphonamides (antibiotic).  
Please inform your doctor or pharmacist if you are  
taking or have recently taken any other medicine,  
even those not prescribed.  
confusion, difficulty in concentration, drowsiness,  
excessive hunger, temporary vision changes,  
headache, nausea and palpitation.  
you should consult your doctor immediately as  
these reactions may be due to systemic allergic  
reactions which are rare but may be serious.  
Your skin may thicken or pit if the injection site is  
not rotated.  
When you first start your insulin treatment you  
may suffer from visual disturbances or swelling of  
the extremities.  
If you suffer from diarrhoea, vomiting or eat less  
than usual you may also need less insulin than  
usual.  
What to do in case of hypoglycaemia?  
If you experience any of the symptoms mentioned  
above, you should immediately take sugar or a  
sugar containing product. So always carry sugar  
lumps, sweets, biscuits or fruit juice with you.  
Tell your relatives, friends and close colleagues that  
you have diabetes and how they can help you if  
you get a severe hypoglycaemic reaction. They  
must know that they should not give you anything  
to eat or drink if you are unconscious as you could  
choke.  
If you are unconscious, you should be turned on  
your side and your relatives, friends or colleagues  
should get medical help immediately. You may  
recover from unconsciousness more quickly if you  
are given an injection of the hormone glucagon by  
a person who has been instructed in how to use it.  
If glucagon is injected, you should also be given  
sugar, a product containing sugar or glucose by  
mouth as soon as you are conscious again. If you  
do not respond to glucagon treatment, you will  
have to be treated in a hospital.  
100 U/ml  
NovoMix® 30 FlexPen®  
What precautions have to be taken  
before going abroad?  
The time difference between countries may mean  
that you have to take your insulin and meals at  
different times than usual. You should therefore  
consult your doctor if you are planning to go  
abroad.  
Suspension for injection in a pre-filled pen  
If you notice any side effects not mentioned in this  
leaflet, please inform your doctor or pharmacist.  
The active substance in NovoMix® 30 FlexPen® is  
insulin aspart produced biosynthetically (i.e. by use  
of recombinant DNA technology). NovoMix 30  
contains 30% insulin aspart in a soluble fraction  
and 70% insulin aspart crystallised with protamine.  
NovoMix 30 FlexPen also contains the following  
other ingredients: Mannitol, Phenol, Metacresol,  
Zinc (as chloride), Sodium chloride, Disodium  
phosphate dihydrate, Protamine sulphate, Sodium  
hydroxide, Hydrochloric acid and Water for  
injections.  
How to use NovoMix® 30 FlexPen®  
To avoid the risk of passing on diseases  
NovoMix 30 FlexPen is for use by one person only.  
Do not use NovoMix 30 FlexPen if it does not  
appear uniformly white and cloudy after shaking.  
NovoMix 30 FlexPen should not be used if clumps  
of material are present or if solid white particles  
stick to the bottom or wall of the cartridges, giving  
a frosted appearance.  
Remove air from the pen before each injection until  
a drop of insulin appears at the tip of the needle.  
Do not use NovoMix 30 FlexPen if you need to  
make more than 6 airshots before the first  
injection.  
When you are using NovoMix 30 FlexPen, you  
should remove and dispose of the needle after  
each injection.  
If you do not remove it, temperature changes may  
cause liquid to leak out of the needle and the  
concentration may change.  
Storing NovoMix® 30 FlexPen®  
Store NovoMix 30 FlexPen which you are not  
using at 2ºC - 8ºC in a refrigerator (not too near  
the freezer compartment). Do not freeze.  
NovoMix 30 FlexPen that you are using must not  
be kept in a refrigerator. NovoMix 30 FlexPen can  
be used or carried with you as a spare for up to  
4 weeks (not above 30°C), after which it must be  
discarded.  
Taking NovoMix® 30 FlexPen® with  
food and drink  
Alcohol (including beer and wine) may lead to  
hypoglycaemia (too low blood sugar). Therefore,  
be careful when you drink alcohol and never drink  
alcohol on an empty stomach.  
In order to protect from light keep the cap on  
when NovoMix 30 FlexPen is not in use.  
Keep out of the reach and sight of children.  
Do not use after the expiry date stated on the label  
and carton.  
Do not use NovoMix 30 FlexPen if it does not  
appear uniformly white and cloudy after shaking.  
Pregnancy  
Produced by  
Novo Nordisk A/S  
DK-2880 Bagsvaerd, Denmark  
If you are pregnant or planning pregnancy you  
should see your doctor immediately to discuss your  
need for and type of insulin in order to control your  
diabetes and thereby avoid hyperglycaemia  
(too high blood sugar) and hypoglycaemia (too low  
blood sugar) as these conditions could harm your  
baby. There is limited clinical experience with  
insulin aspart in pregnancy.  
What NovoMix® 30 FlexPen® is and what  
it is used for  
See your doctor if you have had repeated  
hypoglycaemic reactions or one reaction that led to  
unconsciousness, as your insulin dose may need to  
be changed.  
If severe hypoglycaemia is not treated, it can cause  
temporary or permanent brain damage, and death.  
NovoMix 30 FlexPen is a white suspension for  
subcutaneous injection in 3 ml pre-filled pens.  
NovoMix 30 FlexPen is an antidiabetic agent, which  
lowers your blood sugar after injection. When  
injected under your skin (subcutaneously), the  
onset of action will occur within 10-20 minutes of  
injection, the maximum effect between 1-4 hours,  
and the effect will last for up to 24 hours.  
Breast-feeding  
Take care not to drop or knock the pen.  
Do not use the residual scale to measure your dose  
of insulin.  
Breast-feeding while you are taking insulin does  
not put your baby at risk. Your insulin dosage and  
diet may, however, need to be adjusted.  
If you use less NovoMix® 30 FlexPen®  
than you should  
If you are ill with fever or if you eat much more  
than usual and repeatedly take less insulin than  
you need, your blood sugar may become unusually  
high (i.e. result in hyperglycaemia).  
The symptoms of unusually high blood sugar  
levels will appear gradually. They include:  
increased urination, thirst, loss of appetite, nausea,  
vomiting, drowsiness (fatigue), flushed dry skin, dry  
mouth, acetone breath.  
Do not refill NovoMix 30 FlexPen.  
Do not use NovoMix 30 FlexPen in insulin pumps.  
If you switch from another insulin to biphasic  
insulin aspart, your dosage may have to be  
adjusted by your doctor.  
Driving and using machines  
Therapeutic indications  
Your ability to concentrate or react may be reduced  
if you have hypoglycaemia. Please keep this  
possible problem in mind in all situations where  
you might put yourself and others at risk  
(e.g. driving a car or operating machinery). You  
should contact your doctor about the advisability  
of driving if you have:  
NovoMix 30 FlexPen is used for the treatment of  
patients with diabetes mellitus (a disease where  
your pancreas does not produce enough insulin to  
control your blood sugar level). Extra insulin is  
therefore needed.  
How to handle this insulin  
FlexPen pre-filled insulin pens should only be used  
in combination with products that are compatible  
therewith and allow the pre-filled pens to function  
safely and effectively.  
Before you use NovoMix® 30 FlexPen®  
NovoMix 30 FlexPen should be given immediately  
before a meal.  
When necessary, NovoMix 30 FlexPen may be given  
soon after a meal.  
If you have reduced kidney or liver function, your  
doctor may lower your insulin dosage.  
There is no clinical experience in children and  
adolescents under the age of 18 years.  
Frequent episodes of hypoglycaemia  
Reduced or absent warning signs of  
hypoglycaemia.  
What to do in case of hyperglycaemia?  
How to take this insulin  
If you recognise any of the symptoms mentioned  
above, you should test your blood sugar level and  
your urine for ketones as soon as possible as the  
symptoms may indicate that you have a condition  
called ketoacidosis. This condition is critical and if  
untreated may result in diabetic coma and death.  
You should therefore seek medical advice  
Before injection make sure that you have got the  
type and strength of insulin prescribed.  
NovoMix 30 FlexPen is for injection under the skin  
(subcutaneously). NovoMix 30 FlexPen should  
never be injected into a vein.  
Using other medicines  
Your insulin need may change if you take other  
medicines. You should therefore consult your  
doctor if you are currently taking any of the listed  
medicines or medicines which you are not sure of:  
Oral hypoglycaemic agents (used for the treatment  
of non insulin-dependent (Type 2) diabetes  
mellitus), monoamine oxidase (MAO) inhibitors  
(used for the treatment of depression), non-  
selective beta-blocking agents (used for the  
treatment of certain heart conditions and high  
blood pressure), angiotensin converting enzyme  
(ACE) inhibitors (used for the treatment of certain  
heart conditions, high blood pressure or elevated  
protein/albumin in the urine), salicylates (e.g.  
acetylsalicylic acid, a substance present in many  
medicinal products used to relieve pain and lower  
fever), anabolic steroids and glucocorticoids (used  
to treat inflammatory conditions, except topical  
administration), oral contraceptives (used for birth  
control), thiazides (used for the treatment of high  
The insulin may be injected in the abdomen, thigh,  
upper arm or buttock. It is recommended that you  
eat a meal or snack containing carbohydrate within  
10 minutes of the injection and measure your  
blood sugar level regularly. When necessary  
NovoMix 30 FlexPen may be given soon after a  
meal.  
You should not take NovoMix® 30 FlexPen® if:  
immediately and possibly take some extra insulin.  
Your blood sugar is too low (hypoglycaemia).  
Follow the guidance for hypoglycaemia  
You are allergic to insulin aspart or any  
of the other ingredients contained in  
NovoMix 30 FlexPen.  
Possible side effects  
Like all medicines, NovoMix 30 FlexPen can have  
side effects.  
NovoMix 30 FlexPen may cause hypoglycaemia of  
which the symptoms have been mentioned above.  
Redness, swelling and itching at the site of  
injection (also called local allergic reactions) may  
be experienced by some people. Usually these  
symptoms disappear within a few weeks during  
continued use.  
If the symptoms do not disappear, spread to other  
parts of your body or if you suddenly feel sick  
(i.e. if you sweat, vomit, have difficulties in  
Take special care with NovoMix® 30 FlexPen®  
Never stop taking insulin if you are ill. Your need  
for insulin may, however, be changed.  
If you have an infection, fever or an operation you  
may need to have more insulin than usual.  
If you use more NovoMix® 30 FlexPen®  
than you should  
If you take too much insulin, miss a meal or  
exercise more than usual, your blood sugar may  
become too low (i.e. hypoglycaemia).  
NovoMix®, FlexPen®, NovoFine® and Í  
are trademarks owned by  
Novo Nordisk A/S, Denmark  
The first symptoms of hypoglycaemia can come  
on suddenly. They may include: cold sweats, cool  
pale skin, fatigue, nervousness or tremor, anxious  
© December 2001  
Novo Nordisk A/S  
2880 Bagsvaerd, Denmark  
 
breathing, have rapid heart beat, feel dizzy),  
8-9673-90-001-1  
feeling, unusual tiredness and weakness,  

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