Levemir 300 IU PEN
Levemir is used to treat diabetes mellitus in adults, adolescents and children aged b years
Levemir 300 IU PEN
What Levemir is and what it is used
Levemir is a modern insulin (insulin analogue) with a long-acting effect. Modern insulins are improved versions of human insulin.
Levemir is used to treat diabetes mellitus in adults, adolescents and children aged b years. Diabetes is a disease in which the body does not produce enough insulin to control your blood sugar. Levemir can be used in combination with oral antidiabetic drugs or diet-related short-or rapid-acting insulin medication.
Levemir is a long and steady blood sugar reducing effect starting within a few hours (3-4). Levemir provides 24-hour coverage of basal insulin after injection.
Before using the
Do not use Levemir
If you are allergic (hypersensitive) to insulin detemir or any of the other ingredients in Levemir (see Section 6 Further information).
If you suspect hypoglycaemia (low blood sugar) (see section 3 How to use Levemir).
In insulin infusion pumps.
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
If not stored correctly or been frozen (see 5. How to store Levemir).
If insulin does not appear water clear and colorless.
Before you use Levemir
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 Levemir Penfill should not be shared with others.
Take special care with Levemir
If you have problems with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
For more than usual or when you want to change your usual diet, as this can affect blood sugar levels.
If you are sick / on, continue 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.
If you have low levels of albumin should carefully monitor their blood sugar. Discuss this with your doctor.
Taking other medicines
Some medicines affect the way glucose works in your body and can affect your insulin dose. Below are listed the medicines most often can affect your insulin treatment. 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)
- Sulphonamides (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 used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes mellitus and heart disease or stroke, treated with pioglitazone and insulin 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).
Levemir 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 a pregnancy or breast-feeding please contact your doctor for advice. You need to change your insulin dosage during pregnancy and after birth. Careful control of your diabetes, and 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. Ask your doctor whether you can drive:
If you often get hypoglycemia
If hard to recognize hypoglycaemia
Important information about some of the first ingredients in Levemir
Levemir contains less than 1 mmol sodium (23 mg) per dose, ie Levemir is essentially sodium.
How to use Levemir
Talk to your doctor and nurse about your insulin dose. Make sure you use Levemir Penfill, as your doctor and nurse have told you to follow their advice carefully. If your doctor changes the type or brand of insulin to another, you may need to change your dose. Do not change your insulin unless your doctor tells you to.
Use in children
Levemir can be used in children and adolescents aged 6 years and over.
No experience using Levemir in children below the age of 6 years. So use Levemir in children below this age, especially if your doctor has told you.
Use in special populations
If you have reduced kidney or liver function, or if you are over 65, have a regular check your blood sugar and to discuss changes in your insulin dose with your doctor.
Frequency of use
Levemirse When used in combination with oral antidiabetic medicine, Levemir should be administered once daily. When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily, depending on the patient's needs. The dose of Levemir should be adjusted individually. It can be injected at any time of the day, but at the same time each day. In patients who optimize the control of blood glucose require two injections, the evening dose can be administered in the evening or at bedtime.
Route of administration
Levemir is for injection 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 the thighs, the front of your waist (abdomen), or upper arm. You should always measure your blood glucose regularly.
- Inject the insulin under the skin. Use the injection method, which is recommended by your doctor or nurse and is described in the instructions for use of the injection device you.
- 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 Levemir without a needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Do not refill the cartridge.
Levemir Penfill cartridges are designed for use with insulin delivery devices
Novo Nordisk (Novo Nordisk) and NovoFine or NovoTwist. Make sure you are not using fake needles. Ask your pharmacist.
If you are treated with Levemir Penfill and another insulin cartridge Penfill, you should use two insulin delivery systems, one for each type of insulin.
If you use more than the amount of Levemir
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.
- In more than usual.
The warning signs of hypoglycemia may occur suddenly and can include: cold sweat, cool pale skin, headache, rapid heart beat, feeling of nausea, excessive hunger, temporary vision disturbances, drowsiness, unusual tiredness and weakness, nervousness or tremor; feeling 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 to pass out (become unconscious) due to hypoglycemia.
Tell people that if you pass, 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 coming soon your mind is you need to give 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 Levemir
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 or vomiting, lethargy or fatigue; flushed dry skin, dry mouth, and breath smell fruity (acetone). If you experience any of these signs: test your blood sugar, check your urine for ketones if you can, then seek medical attention immediately. These may be signs of a very serious condition called diabetic ketoacidosis. If left untreated, it can lead to diabetic coma and eventually death.
If you stop using Levemir
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of fatty acids in the blood because the body is breaking down fat instead of sugar). Do not stop taking your insulin without talking to your doctor who 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, Levemir can cause side effects, although not everybody gets them. Side 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 from the available data can not be estimated
Very common side effects
Low blood sugar (hypoglycemia). Find tips in "If you use more than the amount of Levemir in section 3. How to use Levemir.
Common side effects
Reactions at the injection site (pain, redness, hives, inflammation, bruising, swelling and itching). They usually disappear after a few weeks of taking your insulin. If they do not disappear, consult your doctor. If you have serious or continuing reactions, you may need to stop using Levemir and use another insulin.
Allergic reactions, potentially allergic reactions, see below
Uncommon side effects
Signs of allergy (allergic reactions, potentially allergic). May occur urticaria and rash. Allergic reactions and potentially allergic reactions are uncommon reactions when Levemir is used in combination with insulin (basal-bolus regimen). However, according to three clinical trials for use in combination with oral antidiabetic agents, are common. Seek medical help immediately: if the above signs of allergy or if you suddenly feel unwell and you start sweating, start to vomit, have trouble breathing, have a fast heart beat, you feel dizzy.
Vision problems. When you first start your insulin treatment, it may disturb your vision, but they are 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.
Rare side effects
Abnormal sensation (peripheral neuropathy). The rapid improvement in the control of glucose in the blood can cause an abnormal sensation (numbness, weakness or pain) in legs or arms. Usually these symptoms disappear.
Very rare side effects
Severe allergic reaction to Levemir or one of its ingredients (called a generalized allergic reaction). See also warning in 2. Before using Levemir.
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 Levemir
Keep out of reach of children.
Do not use Levemir 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.
Levemir Penfill, which used to be stored in the refrigerator at 2 ° C - 8 ° C, away from the cooling elment. Do not freeze.
Levemir Penfill, used or carried as a spare, it should be stored in the refrigerator. You can carry it with you and keep it at room temperature (below 30 ° C) up to 6 weeks.
Always keep the cartridge in the outer carton when not in use to protect it from light.
Levemir must 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.
The active substance is insulin detemir. Each ml contains 100 U of insulin detemir. Each cartridge contains 300 U of insulin detemir in 3 ml solution for injection. 1 unit (U) of insulin detemir corresponds to 1 international unit (IU) of human insulin.
The other ingredients are: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Levemir looks like and contents of pack
Levemir is a clear, colorless, aqueous solution