100 IU / ml (international units / ml) for injection , suspension in prefilled pen
human insulin
1. What Insulatard is and what it is used for
Insulatard is human insulin with gradual onset of action and long duration of action.
Insulatard is used to lower high blood sugar in patients with diabetes mellitus ( diabetes ). Diabetes is a disease in which your body does not produce enough insulin to keep your blood sugar levels under control. Treatment with Insulatard helps prevent the complications of your diabetes.
Insulatard starts lowering your blood sugar about 1½ hour after you inject it and the effect lasts for about 24 hours. Insulatard is often given in combination with fast-acting insulin preparations.
2. What you need to know before you use Insulatard
Do not use Insulatard
- If you are allergic to human insulin or any of the other ingredients of this medicine, see section 6.
- If you feel you are experiencing insulin sensation (symptoms of low blood sugar), see Summary of serious and very common side effects in section 4.
- in insulin pumps.
- if FlexPen has been dropped, damaged or shocked.
- if the insulin has not been stored properly or if it has frozen, see section 5.
- if the reconstituted insulin is not evenly white and cloudy.
If any of these apply to you, do not use Insulatard. Talk to a doctor, pharmacist, or nurse.
Before you use Insulatard
- Check the label to make sure it is the correct type of insulin .
- Always use a new injection needle for each injection to prevent contamination.
- Injection needles and Insulatard FlexPen must not be shared with anyone else.
- Insulatard FlexPen should only be administered under the skin. Talk to your doctor if you need to inject your insulin using another method.
Warnings and cautions
Certain conditions and activities may affect your need for insulin. Consult a doctor:
- if you have problems with your kidneys or liver, adrenal glands, pituitary gland or thyroid gland.
- if you exercise more than usual or want to change your diet, as this can affect your blood sugar level.
- if you become ill: continue to take your insulin and consult a doctor.
- if you are going to travel abroad: travel over different time zones can affect your insulin needs and when to take the injections .
Skin changes at the injection site
To help prevent changes in the adipose tissue under the skin, e.g. skin thickening, skin shrinkage, or lumps under the skin, you should always change the injection site. It may be that insulin et not work as well if you inject in an area with nodules or in a thickened or shriveled area (see “How to use Insulatard”). Contact your doctor if you notice skin changes at the injection site and before changing the injection site if you are currently injecting in an affected area. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Other medicines and Insulatard
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken or might take any other medicines.
Some medicines affect your blood sugar level, which may mean that your insulin dose needs to be changed. Below is a list of the most common medicines that may affect your insulin therapy.
Your blood sugar level may drop ( hypoglycaemia ) if you take:
- Other medicines to treat diabetes
- MAO inhibitors (for the treatment of depression)
- Beta-blockers (for the treatment of high blood pressure )
- ACE inhibitors (for the treatment of certain heart diseases or high blood pressure )
- Salicylates (analgesics and antipyretics)
- Anabolic steroids (eg testosterone )
- Sulfonamides (for the treatment of infections ).
Your blood sugar level may rise ( hyperglycaemia ) if you take:
- Oral contraceptives ( birth control pills )
- Thiazides (for the treatment of high blood pressure or severe fluid retention)
- Glucocorticoids (eg cortisone for the treatment of inflammation )
- Thyroid hormone (for the treatment of thyroid diseases)
- Sympathomimetics (eg adrenaline , salbutamol or terbutaline for the treatment of asthma )
- Growth hormone (for stimulation of skeletal and body growth with a pronounced effect on the body’s metabolism)
- Danazol (an agent that affects ovulation).
Octreotide and lanreotide (for the treatment of acromegaly, a rare hormonal disorder with pituitary overproduction one of the growth hormones usually in middle-aged adults) can either raise or lower your blood sugar level.
Beta-blockers (for the treatment of high blood pressure ) may weaken or completely eliminate the first warning signs of low blood sugar.
Pioglitazone (tablets for the treatment of type 2 diabetes )
Some patients who have had type 2 diabetes and heart disease for many years or previous strokes developed heart failure during treatment with pioglitazone and insulin. Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling ( edema ).
If you have taken any of these medicines, talk to your doctor, pharmacist, or nurse.
Insulatard and alcohol
- If you drink alcohol, your need for insulin may change, as your blood sugar level may either rise or fall. Careful blood glucose monitoring is recommended.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Insulatard can be used during pregnancy. The insulin dose may need to be changed during pregnancy and after delivery. Careful monitoring of your diabetes and counteracting low blood sugar is important for your baby’s health.
- There are no restrictions on treatment with Insulatard during breast-feeding.
Ask your doctor, pharmacist, or nurse for advice before taking this medicine during pregnancy or breastfeeding.
Driving and using machines
Ask your doctor if you can drive or use machines:
- if you often get low blood sugar levels.
- if you find it difficult to recognize signs of low blood sugar (insulin detection).
If your blood sugar is low or high, it can affect your ability to concentrate and react and therefore also your ability to drive or use machines. Remember that you can put yourself and others at risk.
Insulatard contains sodium
Insulatard contains less than 1 mmol sodium (23 mg) per dose, ie Insulatard is essentially ‘sodium-free.
3. How to use Insulatard
Dose and when you take your insulin
Always use your insulin and make dose adjustments exactly as your doctor advised. If you are not sure, talk to a doctor, pharmacist, or nurse.
Only change insulin preparations on the advice of a doctor. If your doctor has switched you from one type of insulin or brand to another, your dose may need to be adjusted by your doctor.
Use for children and adolescents
Insulatard can be used in children and adolescents.
Use for special patient groups
If you have impaired kidney or liver function or if you are over 65, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How and where to inject
Insulatard is injected under the skin ( subcutaneously ). You should never inject yourself directly into a vein ( intravenously ) or muscle ( intramuscularly ). Insulatard FlexPen should only be administered under the skin. Talk to your doctor if you need to inject your insulin using another method.
At each injection, change the injection site within the same area of skin you are using. This may reduce the risk of developing lumps or pits in the skin, see section 4. The best area to inject is the front of the waist (abdomen), buttocks, front of the thighs, or upper arms. Insulin works faster if you inject it into your waist. Always check your blood sugar regularly.
How to handle Insulatard FlexPen
Insulatard FlexPen is a prefilled injection pen for one-time use containing human insulin as isophane (NPH).
Carefully read the Instructions for use of Insulatard FlexPen contained in this leaflet. You must use the pen according to the instructions in the Instructions for using Insulatard FlexPen.
Always make sure you use the correct pen before injecting your insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar may become too low ( hypoglycaemia ). See Summary of Serious and Very Common Side Effects in Section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar may become too high ( hyperglycaemia ). See Diabetes Disorders in Section 4.
If you stop taking your insulin
Do not stop insulin treatment without talking to a doctor, who will tell you what needs to be done. It can lead to very high blood sugar (severe hyperglycaemia ) and ketoacidosis. See Diabetes Disorders in Section 4.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Summary of serious and very common side effect s
Low blood sugar ( hypoglycemia ) is a very common side effect. It may occur in more than 1 in 10 users.
Low blood sugar can occur if you:
- injecting too much insulin .
- eat too little or skip a meal.
- exercise more than usual.
- drinking alcohol, see Insulatard and alcohol in section 2.
Signs of low blood sugar: Cold sweats; cool and pale skin; headache; palpitation; nausea; strong hunger; temporary vision changes; drowsiness; unusual fatigue and weakness; anxiety or trembling; feelings of anxiety; confusion; concentration difficulties.
Very low blood sugar can lead to unconsciousness. If left untreated for a very long time, very low blood sugar can cause brain damage (temporary or permanent) and even death. You can regain consciousness faster if you receive an injection of the hormone et glucagon from someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar-containing snack as soon as you regain consciousness. If you do not respond to glucagon therapy, you will need to be treated in hospital.
What to do if you get low blood sugar:
- If you feel that your blood sugar is too low, eat grape sugar tablets or any other snack that contains a lot of sugar (sweets, cakes, fruit juice). If possible, check your blood sugar and rest. Always take glucose tablets or snacks with a lot of sugar in them for safety.
- When the symptoms of low blood sugar have disappeared or when your blood sugar level has stabilized, you should continue with the insulin treatment as usual.
- If you have had low blood sugar and lost consciousness or if you have needed a glucagon injection , or if you have had many insulin sensations, talk to your doctor. The amount of insulin or when you take it, diet or exercise may need to be adjusted.
Tell them that you have diabetes for people who need to know it, what the consequences can be, and also the risk of becoming unconscious due to low blood sugar. Tell them that if you become unconscious, they should put you on the side and get medical attention immediately. They must not give you anything to eat or drink as there is a risk that you will suffocate.
Severe allergic reactions to Insulatard or to any of the other ingredients (so-called systemic allergic reaction ) are very rare but can be life-threatening. It may affect less than 1 in 10,000 users.
Contact a doctor immediately:
- if signs of allergy spread to other parts of the body.
- if you suddenly feel unwell and you: start sweating; begins to vomit; have difficulty breathing; get palpitations; feel dizzy.
If you experience any of these, seek medical attention immediately.
Skin changes at the injection site: If you inject insulin at the same site, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). It may be that insulin et not work as well if you inject in an area with nodules or in a thickened or shriveled area. Change the injection site for each injection to prevent these skin changes.
List of adverse reactions are
Uncommon side effects are
May affect less than 1 in 100 users.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching ) may occur at the injection site. These symptoms usually go away after taking your insulin for a few weeks. If they do not disappear or spread throughout the body, talk to a doctor immediately. See also Severe allergic reactions above.
Diabetic retinopathy (an eye disease associated with diabetes that can lead to vision loss): If you have diabetic retinopathy, it can worsen if your blood sugar levels improve very quickly. Ask your doctor about this.
Swollen joints: When you start taking insulin, your body may bind water, causing you to swell around the ankles and other joints. This usually goes away soon, otherwise, you should talk to a doctor.
Very rare side effect s
May affect less than 1 in 10,000 users.
Vision problems: At the beginning of insulin treatment, visual disturbances may occur, but these are usually temporary.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very quickly, you may get nerve-related pain. This is called acute painful neuropathy and is usually transient.
Problems with diabetes
High blood sugar ( hyperglycaemia )
High blood sugar can occur if you:
- have not injected enough insulin .
- forget to take your insulin or stop taking insulin .
- repeatedly take less insulin than you need.
- gets an infection and / or fever.
- eat more than usual.
- exercise less than usual.
Warning signs for high blood sugar:
The warning signals appear gradually. They manifest as: increased urine output; thirst; loss of appetite; feeling sick (nausea or vomiting); drowsiness or fatigue; redness; dry skin; dry mouth and a breath that smells of fruit (acetone).
What should I do if I get high blood sugar:
- If you get any of the above warning signs: check your blood sugar, do a ketone test on your urine if possible and then contact a doctor immediately.
- The symptoms can be a sign of a very serious condition called diabetic ketoacidosis (accumulation of acid in the blood when the body breaks down fat instead of sugar). If left untreated, it can lead to diabetic coma and eventually death.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Insulatard
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton of FlexPen after EXP. The expiration date is the last day of the specified month.
Unopened packaging: Store in a refrigerator at 2 ° C-8 ° C. Do not place near the heat sink. Do not freeze.
During use or taken as a spare: Do not refrigerate or freeze. You can take it with you and store it at room temperature (maximum 30 ° C) for up to 6 weeks.
To protect your insulin from light, always put the pen cap on your FlexPen when you are not using it.
Discard the injection needle after each injection.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is human insulin . Insulatard is a suspension of isofant (NPH) human insulin . Each ml contains 100 IU human insulin . Each pre- filled pen contains 300 IU human insulin in 3 ml injection , suspension .
- The other ingredients are zinc chloride, glycerol , metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid , protamine sulphate and water for injections.
What the medicine looks like and contents of the pack
Insulatard is in the form of injection, suspension. After mixing, the liquid should be evenly white and cloudy.
Pack sizes: 1, 5, or 10 pre-filled 3 ml pens. Not all pack sizes may be marketed.
Suspension one is cloudy, white, and watery.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A / S, Novo Allé, DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the tab on the carton and on the label:
- If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo Nordisk A / S, Novo Allé, DK-2880 Bagsværd, Denmark.
- If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.