NovoRapid 100 IU 3 ml. 5 pen
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulins are improved versions of human insulin. NovoRapid is used for the treatment of diabetes mellitus in adults, children and adolescents aged 2 to 17 years. NovoRapid will start to lower your blood sugar 10-20 minutes after injection, has a maximum effect between 1 and 3 hours and the effect lasts for 3-5 hours. Because of its short duration of action, NovoRapid should be administered in combination with intermediate or long-acting insulin preparations.
2. Before you use NovoRapid
Do not use NovoRapid
If you are allergic (hypersensitive) to insulin aspart or any of the other ingredients Do not use NovoRapid (see section 6. Further information).
If you suspect hypoglycaemia (low blood sugar) (see section 4. Possible side effects).
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 Do not use NovoRapid)
If insulin does not appear water clear and colorless.
Before using NovoRapid
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 it if any damage is seen or if there is a gap between the rubber plunger and the white label band. Return it to your dealer. Look at the instructions for use of the injection device for further instructions
Disinfect the rubber membrane with a medicinal swab with disinfectant
Always use a new needle for each injection to prevent contamination.
Take special care with NovoRapid
If you have problems with your kidneys or liver, or with your adrenal, pituitary or thyroid glands
In more than usual or if you want to change your usual diet, as this may affect 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 of the injection. Consult your doctor if you are planning a similar trip.
NovoRapid can be used in demos instead of soluble human insulin when a rapid onset of action might be beneficial. For example, when it is difficult to dose compared to the feeding of the child. There is no clinical experience with NovoRapid in children under the age of 2 years. Therefore, use NovoRapid in children below this age, if your doctor have specifically told you. As with all insulin products, in patients in the elderly and in patients with renal or hepatic impairment should be intensified glucose monitoring and insulin aspart dosage should be adjusted individually.
Using other medicines
Some medicines affect the way glucose works in your body and they may influence your insulin dose. The most common drugs, 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 are using any medicine that affects your blood sugar levels, as described below.
If you take any of the below medicines, your blood sugar may fall (hypoglycaemia):
• Other medicines to treat diabetes
• Monoamine oxidase (MAO) inhibitors (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used in the treatment of certain heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).
If you take any of the below medicines, your blood sugar may increase (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 influence on the metabolic processes of the body)
• Danazol (medicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly) may increase or decrease the level of blood sugar.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognize hypoglycaemia.
Application of NovoRapid with food and drink
If you drink alcohol, your need for insulin may change as your blood sugar may rise or fall. Careful monitoring.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant, planning a pregnancy or breast-feeding please contact your doctor for advice. NovoRapid can be used during pregnancy. You may need to change your insulin dosage during pregnancy or after birth. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
Driving and using machines
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 may put yourself and others at risk. Discuss with your doctor whether you can drive a car:
If a lot of hypos
If it hard to recognize hipoglzhemiyata
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs after an injection, you may experience it earlier than soluble human insulin.
3. How to use NovoRapid
Consult with your doctor and nurse about your insulin dose. Make sure to use NovoRapid Penfill, that your doctor and nurse have told you and follow their advice carefully. This leaflet is a general guide.
If your doctor has changed the type or brand of insulin you use, you may need to adjust your dose. Do not change your insulin unless your doctor tells you to do so.
Within 10 minutes of the injection Eat a meal or snack containing carbohydrates to avoid hypoglycaemia. When necessary, NovoRapid may be given soon after the meal, instead of before the meal.
Method of administration
NovoRapid is injected under the skin (subcutaneously) or for continuous infusion in a pump system. NovoRapid can be administered directly into a vein (intravenously) by health care professionals under close medical supervision. Never inject your insulin directly into a vein or muscle (intramuscular).
Always vary the injection site within a given area, to avoid lumps (see 4 Possible side effects). The best places for injection are: the front of your waist (abdomen); armpits or front of your thighs. You should regularly monitor your blood sugar.
• Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and described in your manual for the delivery device
• Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected
• After each injection be sure to remove and discard the needle and store NovoRapid without
needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Do not refill the cartridge. NovoRapid Penfill cartridges are designed for use with the insulin delivery devices Novoo Nordisk (Novo Nordisk) and NovoFine needles or NovoTwist.
If you are treated with NovoRapid Penfill and another insulin cartridge Penfil, you should use two insulin delivery systems, one for each type of insulin.
Using an infusion pump system
NovoRapid should never be mixed with any other insulin when used in a pump. Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a pump. Before using NovoRapidpompena system must receive detailed instructions and information about what to take in case of illness, too high or too low blood sugar or failure of the pump system.
• Before inserting the needle, use soap and water your hands and the injection site to avoid any infection at the site of infusion
• When you fill a new reservoir, make sure that no large air bubbles in either the syringe or the catheter
• Changing of the infusion set (catheter and needle) must be done according to the
instructions in the product information supplied with the infusion set.
To get the benefit of insulin insruziya and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar regularly.
What should you do in case of pump system failure
Always carry a spare insulin injection under the skin in case of pump system failure.
If you take more insulin than you need
If you take too much insulin your blood sugar gets too low (this is called hypoglycaemia). This may also occur:
• If you eat too little or miss a meal
• When more than usual.
The warning signs of hypoglycemia may occur suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; hunger; temporary changes in vision; drowsiness; unusual tiredness and 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), then rest. In any case, always carry glucose tablets, sweets, biscuits or fruit juice. When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilized continue insulin treatment. Tell people of your people that you have diabetes and what may be the consequences, including the risk of passing out due to hypoglycemia. Tell people to you 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 consciousness can be accelerated by injection of the hormone glucagon by a trained person. If you are given glucagon soon as you are conscious you need to be given glucose or a sugary snack. If not respond to glucagon, 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 avoid getting more.
• 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 hypoglycemia, consult your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
If you forget to inject insulas
If you forget to take your insulin, your blood sugar may get too high (this is called hyperglycaemia). This may also occur:
• 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. They include: increased urination; thirst; loss of appetite; gad or vomiting; feeling drowsy or tired; flushed with> skin; dry mouth and breath smell a fruity (acetone). If you experience any of these signs: test your blood sugar, test your urine for ketones ow you, then seek immediate medical poms These may be signs of a very serious condition called diabetic ketoacidosis. If not treated, it my lead to diabetic coma and eventually death.
If you stop taking your insulin
This can lead to severe hyperglycaemia (very Vissa blood sugar) and ketoacidosis (build-up of fatty acid in the blood because the body is breaking down fat vmests sugar). Do not stop taking your insulin without speaking to a doctor, who will advise you what to do.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, NovoRapid can cause side effects, although not everybody gets them. Adverse effects may occur with certain frequencies, which are 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 patients in 1000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 in 10,000 patients
• Not known: frequency can not be estimated from the available data.
Uncommon side effects
Signs of allergy. Reactions may occur (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
Seek medical advice immediately:
If signs of allergy spread to other parts of your body, or
If you suddenly feel unwell and you start sweating; feel that you feel sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Visual disturbances. When you first start your 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 of the joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. Diabetic retinopathy. If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Talk to your doctor about this.
Common side effects
Low blood sugar (hypoglycemia).
Rare side effects
Painful neuropathy. If your blood glucose levels improve very fast, you can get connected with nerve pain - this is called acute painful neuropathy and is usually transient.
Very rare side effects
Serious allergic reaction to NovoRapid or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before using NovoRapid
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet; side effects, please tell your doctor, nurse or pharmacist medicine.
5. How to store NovoRapid
Keep out of the reach and sight of children.
Do not use NovoRapid after the expiry date stated on the label and carton of the cartridge after "EXP". The date of the expiry date refers to the last day of that month.
NovoRapid Penfill, which is not being used should be stored in a refrigerator at 2 ° C - 8 ° C, away from the cooling element. Do not freeze.
NovoRapid Penfill, which is currently in use or carried as a spare should be kept in the refrigerator. 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.
NovoRapid must be protected from excessive heat and light.
Medicines should not be disposed of via household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What NovoRapid contains
- The active substance is insulin aspart. Each ml contains 100 U of insulin aspart. Each cartridge contains 300 U insulin aspart in 3 ml of solution for injection
- The other ingredients are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What NovoRapid looks like and contents of the pack
NovoRapid is a clear, colorless, aqueous solution. Not all pack sizes may be marketed.