About Novomix Penfill Cartridges
WHAT NOVOMIX 30 AND WHAT IT IS USED
NovoMix 30 is a modern insulin (insulin analogue) and fast action, and with intermediate effect in the ratio 30/70. Modern insulins are improved versions of human insulin.
NovoMix 30 is used to treat diabetes mellitus in adults, adolescents and children aged 10 years and over. Diabetes is a disease in which the body does not produce enough insulin to control your blood sugar.
NovoMix 30 will start to lower your blood sugar 10-20 minutes after injection, the maximum effect between the first and fourth hours and the effect lasts up to 24 hours. It can be used in combination with certain oral antidiabetic drugs.
Before use NovoMix 30
DO NOT USE NOVOMIX 30
If you are allergic (hypersensitive) to insulin aspart or any of the other ingredients of NovoMix 30 (see Section 6 Further information)
If you suspect hypoglycaemia (low blood sugar) (see section 3. How to use NovoMix 30)
In insulin infusion pumps
If the cartridge or the device containing the cartridge is dropped, damaged or crushed
If stored correctly or been frozen (see 5. How to store NovoMix 30)
If resuspend the insulin does not appear uniformly white and cloudy.
If there are lumps or sticking hard, white particles on the bottom or the sides of the cartridge, giving it a frosted appearance.
BEFORE USING NOVOMIX 30
Check the label to make sure it is the right type of insulin.
Always check the cartridge, including the rubber plunger (stopper). Do not use if damaged or if there is a gap between the rubber plunger and the white label band. Return it to your dealer. See the instructions for use of the injection device for further instructions.
Always use a new needle for each injection to prevent contamination
Needles and NovoMix 30 Penfill should not be transferred to others.
Take special care with NovoMix 30
If you have problems with your kidneys or liver, or with your adrenal, pituitary or thyroid glands
For more than usual or if you want to change your usual diet, as this may affect your blood sugar levels
If you’re sick /: carry on taking your insulin and consult your doctor
When traveling abroad: traveling over time zones may affect your insulin needs and the timing. Check with your doctor if you are planning a similar trip.
TAKING OTHER MEDICINES
Some medicines affect the way glucose works in your body and can affect your insulin dose. The most common medicines which may affect your insulin treatment are listed below. Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you use any drug that affects blood sugar levels, as described below.
If you are taking any of the following medications, your blood sugar may fall (hypoglycaemia):
OTHER MEDICINES FOR DIABETES
Monoamine oxidase (MAO) inhibitors (used to treat depression)
Beta-blockers (used to treat high blood pressure)
Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
Salicylates (used to relieve pain and lower fever)
Anabolic steroids (such as testosterone)
Sulfonamides (used to treat infections).
If you are taking any of the following medications, your blood sugar level may rise (hyperglycaemia):
Oral contraceptives (birth control pills)
Thiazides (used to treat high blood pressure or excessive fluid retention)
Glucocorticoids (such as “cortisone” used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics (such as epinephrine (adrenaline) or salbutamol, terbutaline used to treat asthma)
Growth hormone (medicine for stimulation of bone growth and body and pronounced effect on metabolic processes in the body)
Danazol (medicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually develops in middle age, caused by overproduction of growth hormone by the pituitary gland) may increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognize a hypoglycaemia.
Pioglitazone (oral antidiabetic medicine): Some patients with longstanding type 2 diabetes, especially those with heart disease or previous stroke who were treated with pioglitazone and insulin may develop heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (edema).
NovoMix 30 with food and drink
If you consume alcohol, your need for insulin may change as your blood sugar may be increased or decreased. Careful monitoring.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant, planning to become pregnant or breast-feeding, contact your doctor for advice. There is limited clinical experience with insulin aspart in pregnancy. You need to change your insulin dosage during pregnancy and after birth. Careful control of your diabetes and especially prevention of hypoglycaemia, is important for the health of your baby.
Driving and operating machinery
If your blood sugar is low or high your concentration and ability to react might be affected and therefore also your ability to drive or operate machinery. Note that you can put yourself and others at risk. Discuss with your doctor whether you can drive:
If you often get hypoglycemia
If hard to recognize hypoglycaemia.
Important information about some of the ingredients of NovoMix 30
NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, ie NovoMix 30 essentially sodium.
HOW TO USE NOVOMIX 30 DOSE
Talk to your doctor and nurse about your insulin dose. Make sure you use this NovoMix 30 Penfill, that your doctor and nurse have told you to follow their advice carefully. When NovoMix 30 in combination with oral antidiabetic medication dosage should be adjusted. If your doctor has changed the type or brand of insulin to another, you may need to adjust your dose. Do not change your insulin unless your doctor tells you to.
Within 10 minutes of injection Eat a meal or snack containing carbohydrates to avoid hypoglycaemia. Usually NovoMix 30 applies immediately before eating. When necessary, NovoMix 30 can be given soon after a meal.
USE IN CHILDREN
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin favors. There are limited clinical data in children 6 to 9 years old. There have been no clinical studies with NovoMix 30 in children under 6 years.
Use NovoMix 30 for children under 10 years of age, especially if your doctor has told you.
Use in special populations
As with all insulin preparations in elderly patients and patients with renal or hepatic impairment necessitates increased monitoring of glucose and insulin aspart dose should be adjusted individually.
Route of administration
NovoMix 30 is injected under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscular). Always vary the sites you inject within the same region, to avoid lumps (see 4. Possible side effects). The best places for injection are: the front of your waist (abdomen); seat, the front of your thighs or upper arms. The insulin will work more quickly if you inject around the waist. We regularly measure your blood sugar.
Do not refill the cartridge.
NovoMix 30 Penfill are designed for use with insulin delivery devices
NovoNordisk (Novo Nordisk) and NovoFine or NovoTwist. Make sure you are not using fake needles.
ASK YOUR PHARMACIST.
If you use NovoMix 30 Penfill and another insulin cartridge Penfill, you should use two insulin
delivery systems, one for each type of insulin.
Always carry a spare Penfill as a precaution, in case your Penfill cartridge is lost or damaged.
Resuspension of NovoMix 30
Before you put the cartridge into the insulin delivery system:
The first use NovoMix 30 Penfill roll the cartridge between your palms 10 times – it is important to keep the cartridge horizontally (see picture A). Shake the cartridge up and down between positions a and b (see picture B) 10 times, so that the glass ball moves from one end of the cartridge to the other. Repeat the rolling and shaking (see pictures A and B) until the liquid appears uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature. Complete the other stages of injection without delay
For every following injection move the delivery system with the cartridge inside it up and down between a and 6 (see picture B) at least 10 times until the liquid appears uniformly white and cloudy. Complete the other stages of injection without delay.
Make sure you have 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 one.
How to inject NovoMix 30
Inject the insulin under the skin. Use the injection technique that you have been advised by your doctor or nurse and is described in the manual delivery system
Keep the needle under the skin for at least 6 seconds. Keep the button pressed all the way while removing the needle. This will ensure proper injection and limit the possible influx of blood in the needle or insulin cartridge
After each injection be sure to remove and discard the needle and store MoUoM! ® x 30 without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
If you use more than the amount of NovoMix 30
If you take too much insulin, your blood sugar is too low (called hypoglycemia). This may also happen:
If you eat too little or miss a meal
For more than usual.
The warning signs of hypoglycemia may occur suddenly and can include: cold sweat, cool pale skin, headache, rapid heart beat, nausea, hunger, temporary vision disturbances, drowsiness, unusual tiredness or weakness; nervousness or tremor, anxiety , confusion, difficulty in concentrating.
If you feel a hypo coming on: take a high sugar snack and then measure your blood sugar. If your blood sugar is too low: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice) and rest.
In any case, always carry glucose tablets, sweets, biscuits or fruit juice.
When symptoms of hypoglycaemia have disappeared or when blood glucose level is stabilized continue insulin treatment.
Tell people you have diabetes and what may be the consequences, including the risk of passing out due to hypoglycemia. Tell people that if you pass out (become
unconscious), they must turn you on your side and get medical help. You should not give anything to eat or drink. It could choke you.
Coming your mind can be accelerated by injection of the hormone glucagon by a trained person. If you are given glucagon immediately after regaining consciousness, you will need glucose or a sugary snack. If you do not respond to glucagon treatment, you will have to go into hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to prevent further occurrence.
If prolonged severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
If you have hypoglycemia, leading to unconsciousness, or recurrent episodes of hypoglycemia, talk to your doctor. You may need to adjust the amount or timing of insulin, food or exercise.
If you forget to use NovoMix 30
If you forget to take your insulin, your blood sugar may get too high (this is called hyperglycaemia).
This may also happen:
If you repeatedly take less insulin than you need
If you get an infection or fever
If you eat more than usual
In less than usual.
The warning signs appear gradually. These include frequent urination, thirst, loss of appetite, nausea and vomiting, lethargy or fatigue; Mrs. flushed dry, dry mouth, and breath smell fruity (acetone).
If you experience any of these signs: test your avnata your sugar test your urine for ketones if you can, then seek medical attention immediately, ca may be signs of a very serious condition, said diabetic ketoacidosis. If left untreated, it can be produced to diabetic coma and eventually death.
If you stop NovoMix 30
This could lead to severe hyperglycaemia (very high avna sugar) and ketoacidosis (build up of acid in the blood, as her body is breaking down fat instead of sugar). Not irayte your insulin without talking to your doctor yto will advise you what to do.
If you have any questions about using this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, NovoMix 30 can produce desired effects, although not everybody gets them.
Side effects may occur with certain frequencies, a flock is defined as follows:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 in 10,000 patients
Not known from the available data can not be estimated.
Very common side effects
Low blood sugar (hypoglycemia).
UNCOMMON SIDE EFFECTS
Signs of allergy. Reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site (local allergic reactions). They usually disappear after a few weeks of taking your insulin. If they do not disappear, consult your doctor. Seek immediate medical attention:
If signs of allergy spread to other parts of your body, or
If you suddenly feel unwell and you start sweating, start to vomit, have trouble breathing, have a fast heart beat, you feel dizzy.
When you first start your insulin treatment, it may disturb your vision, but the offense is usually temporary.
Changes at the injection site (lipodystrophy). In inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a place.
Swelling. When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears.
Diabetic retinopathy (diabetes-related eye disease, which can lead to vision loss). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Talk to your doctor about this.
Rare side effects
Painful neuropathy (pain due to nerve damage). If your blood glucose levels improve very fast, you may get nerve related pain
This is called acute painful neuropathy and is usually transient.
Very rare side effects
A serious allergic reaction to NovoMix 30 or any of its ingredients (called a systemic allergic reaction). See also warning in 2. Before using NovoMix 30
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
HOW TO STORE NOVOMIX 30
Keep out of reach of children. Do not use NovoMix 30 after the expiry date stated on the label and carton cartridge after “EXP.” Date of expiry date refers to the last day of that month.
NovoMix 30 Penfill, which used to be stored in the refrigerator at 2 ° C – 8 ° C, away from the cooler. Do not freeze.
NovoMix 30 Penfill, used or carried as a spare should not be refrigerated. After removing, NovoMix 30 Penfill from the refrigerator it is recommended to mix the insulin as instructed for first time use. See 3.
HOW TO USE NOVOMIX 30.
You can carry it with you and keep it at room temperature (below 30 ° C) to 4 weeks.
Always keep the cartridge in the outer carton when not in use to protect it from light. NovoMix 30 should be protected from excessive heat and light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
ADDITIONAL INFORMATION WHAT NOVOMIX 30
The active substance is insulin aspart. NovoMix 30 is a mixture composed of 30% soluble insulin aspart and 70% insulin aspart crystallized with protamine. 1 ml contains 100 U of insulin aspart. Each cartridge 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 sulfate, hydrochloric acid, sodium hydroxide and water for injections.
NovoMix 30 looks like and contents of pack
NovoMix 30 is a white suspension. The cartridge contains a glass ball to facilitate resuspension. After resuspension, the fluid must appear uniformly white and cloudy.