Insulatard is an isophane insulin suspension (NPH). The active substance is insulin human made by recombinant biotechnology. Insulatard also contains the following excipients: Zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections. The suspension for injection comes as a cloudy, white, aqueous suspension.
Insulatard is a long-acting insulin with onset of action about 1½ hrs after injection and the effect will last for approximately 24 hrs. Insulatard is often given in combination with fast-acting insulins.
Treatment of diabetes mellitus.
Follow carefully the advice of the doctor and diabetes nurse on insulin needs. If the doctor has switched the patient from one type or brand of insulin to another, the dose may have to be adjusted by the doctor. It is recommended to measure the blood glucose regularly.
Before use: Check the label to ensure the right type of insulin. Disinfect the rubber membrane with a medicinal swab.
Insulatard is for SC injection. Never inject insulin directly into a vein or muscle. Always vary the sites of injection to avoid lumps (see Side Effects). The best place to inject is the front of the thighs. If convenient, the front abdomen, the buttocks or the front the upper arms may be used.
Vial: Insulatard vials are for use with insulin syringes with the corresponding unit scale.
To inject Insulatard on its own: Just before injecting this insulin, roll the vial between the hands until the liquid is uniformly white and cloudy. Draw air into the syringe, in the same amount as the dose of insulin needed. Inject the air into the vial: push the needle through the rubber stopper and press the plunger. Turn the vial and syringe upside down. Draw the right dose of insulin into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check for the right dose. Inject straight away.
To mix Insulatard with fast-acting insulin: Roll the vial of Insulatard between the hands until the liquid is uniformly white and cloudy. Draw as much air into the syringe as the dose of Insulatard needed. Inject the air into the Insulatard vial, then pull out the needle. Draw as much air into the syringe as the dose of fast-acting insulin needed. Inject the air into the fast-acting insulin vial. Then turn the vial and syringe upside down. Draw the right dose of fast-acting insulin into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check the dose. Now push the needle into the vial of Insulatard. Then turn the vial and syringe upside down. Draw the right dose of Insulatard into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe, and check the dose. Inject the mixture straight away. Always mix fast-acting and long-acting insulin in this order.
Injecting the insulin: Inject the insulin SC. Keep the needle under the skin for at least 6 seconds to make sure the full dose has been delivered.
Penfill: Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles. If treated with Insulatard Penfill and another insulin Penfill cartridge, use 2 insulin delivery systems, 1 for each type of insulin.
Mixing is easier when the insulin has reached room temperature. Before the Penfill cartridge is put into the insulin delivery system, move it slowly up and down and back so that the glass ball moves from 1 end of the cartridge to the other at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy. Complete the other stages of injection without delay. Check that there are at least 12 units of insulin left in the cartridge to allow even mixing. If there are <12 units left, use a new one.
How to Inject: Inject the insulin SC. Use injection technique described in the delivery system manual. Keep the needle under the skin for at least 6 sec to make sure the full dose has been delivered. Remove the needle after each injection, otherwise the liquid may leak out when the temperature changes.
NovoLet: NovoLet is a simple, compact pre-filled pen with dial doses from 2-78 units in increments of 2 units. NovoLet is designed to be used with NovoFine needles. As a precautionary measure, always carry a spare insulin delivery device in case if NovoLet is lost or damaged.
1. Getting started: Check the label to make sure that the NovoLet contains the correct type of insulin. Take off the pen cap. Mixing is easier when the insulin has reached room temperature.
Before every injection: Check that there are at least 12 units of insulin left in the cartridge to allow even mixing. If there are <12 units left, use a new NovoLet. Move the pen slowly up and down so that the glass ball moves from 1 end of the cartridge to the other at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated, until the liquid appears uniformly white and cloudy.
After mixing complete all the following stages of injection without delay: Disinfect the rubber membrane with a medicinal swab; remove the protective tab from a NovoFine needle; screw the needle straight and tightly onto NovoLet; pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap.
2. Priming to expel air: Small amounts of air may collect in the needle and cartridge during normal use. To avoid injection of air and ensure proper dosing: Hold NovoLet with the needle pointing upwards. Tap the cartridge gently with the finger a few times. Any air bubbles will collect at the top of the cartridge. Keeping the needle upwards, turn the cartridge for one click. Still with the needle upwards, press the push-button fully down. A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times. If a drop of insulin still does not appear, the device is defective and must not be used.
3. Setting the dose: Put the cap back on the pen, with 0 next to the dosage indicator. Check that the push-button is fully down. If not, turn the cap until the push-button is fully depressed. Hold NovoLet horizontally. Turn the cap to set the right dose. Cap clicking can be felt, and the push-button will rise up. Do not put hand over the push-button when setting the dose. If the push-button cannot rise freely, some of the insulin will be pushed out of the needle. The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units. For every click felt when turning the cap, 2 units more is set. The push-button also rises as the cap is turned. The scale under the push-button shows 20, 40 and 60 units. For every full turn of the cap, 20 units is set.
Dosage examples: To set 8 units: Turn the cap until 8 is opposite the dosage indicator; 4 clicks.
To select 26 units: Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again. Now, 20 units have been set. Keep turning the cap until 6 is opposite the dosage indicator. The 20-line will show on the push-button scale. Add the 6 from the dosage indicator to the 20 on the push-button scale and 26 units have been set.
To check a dose set: Note the figure on the cap next to the dosage indicator. Note the highest figure seen on the push-button scale. Add the two together to show the set dose. If the wrong dose was set, simply turn the cap forwards or backwards until the right number of units is set.
The maximum dose is 78 units. Do not try to set a dose >78 units. Otherwise, insulin will leak out of the needle and the dose will be incorrect. If by mistake, a dose over 78 units was set, follow these steps: Turn the cap back as far as possible. Turn it till the push-button is fully down and resistance is felt. Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator. Now set the dose again. Remember that 78 units is the maximum dose. After the dose is set, remove the cap to inject the insulin.
4. Injecting the insulin: Insert the needle into the skin. Deliver the dose by pressing the push-button fully down. Be careful only to push the push-button when injecting. Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin. The needle must remain under the skin for at least 6 seconds. This will ensure that the full dose has been delivered.
Subsequent injections: Always check that the push-button is completely down. If not, turn the cap until the push-button is fully depressed, then proceed as described in “Getting Started”. When the push-button is pressed, a clicking sound may be heard. Do not use this to set or check the dose; it may not be accurate. A dose higher than the number of units left in the cartridge cannot be set. Use the insulin level indicator to estimate how much is left but it cannot be used to set or select the dose.
5. Removing the needle: Replace the big outer needle cap and unscrew the needle. Dispose of it carefully. Use a new needle for each injection. Remove the needle after each injection, otherwise the liquid may leak out when the temperature changes and the strength of the insulin may change. Close the NovoLet fully with 0 next to the dosage indicator. Dispose of used NovoLet carefully without the needle attached.
6. Maintenance: NovoLet is designed to work accurately and safely. It must be handled with care. Clean the exterior of NovoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it. This may damage the mechanism.
In Emergency: Hypoglycaemia: Causes of hypoglycaemia includes taking too much insulin, eat too little or miss a meal or exercise more than usual.
The warning signs of a hypoglycaemia may come on suddenly and can include: Cold sweat; cool pale skin; headache; rapid heart beat; nausea or vomiting; excessive hunger; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty in concentrating.
If any of these signs is experienced, eat glucose tablets or a high sugar snack, then rest.
Do not take any insulin if hypoglycaemia is felt coming on.
Carry glucose tablets, sweets, biscuits or fruit juice, just in case.
Relatives, friends and close colleagues of the patient must be informed that if the patient becomes unconscious, they must turn the patient on their side and seek medical advice immediately. Any food or drink must not be given as it could choke.
If severe hypoglycaemia is not treated, it can cause temporary or permanent brain damage and even death.
Consult the doctor if the patient has a hypoglycaemia that makes them unconscious or has frequent episodes of hypoglycaemias. The amount or timing of insulin, food or exercise may need to be adjusted.
Using Glucagon: The patient may recovery more quickly from unconsciousness with an injection of the hormone glucagon. If glucagon is given, the patient will need glucose or a sugary snack as soon as consciousness is regained. If there is no response to glucagon treatment, the patient will have to be treated in a hospital. Seek medical advice after an injection of glucagon to find the reason for hypoglycaemia to avoid getting more.
Hyperglycaemia: Causes of hyperglycaemia includes having forgotten to take insulin, repeatedly taking less insulin than needed, an infection or a fever, eating more than usual or less exercise than usual.
The warning signs appear gradually which include: increased urination; thirst; loss of appetite; nausea or vomiting; drowsiness or tiredness; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
If any of these signs is experienced, test the blood glucose level; test the urine for ketones if possible; then seek medical advice immediately. These may be signs of a very serious condition called diabetic ketoacidosis. If left untreated, it could lead to diabetic coma and death.
Hypersensitivity to human insulin or any of the excipients of Insulatard. Hypoglycaemia.
Dose adjustment may be required in patients with impairment of the kidney, liver and the adrenal, pituitary or thyroid glands.
Watch for signs of hypoglycaemia if drinking alcohol and never drink alcohol on an empty stomach.
Dose adjustment may be required if exercising more than usual or if the patient wants to change their usual diet.
Carry on taking insulin even if ill.
Travelling abroad over time zones may affect the insulin needs and the timing of injections.
Effects on the Ability to Drive or Operate Machinery: The ability to concentrate or react will be less during hypoglycaemia. Never drive or use machinery if a hypoglycaemia is felt coming on. Discuss with the doctor whether the patient can drive or use machines at all, if there are frequent episodes of hypoglycaemia or if the patient finds it hard to recognize hypoglycaemia.
Use in pregnancy & lactation: Consult the doctor if pregnant, planning pregnancy or breastfeeding.
Consult the doctor if pregnant, planning pregnancy or breastfeeding.
Insulatard may cause hypoglycaemia.
Side effects reported uncommonly (<1 in 100): Frequent injection at the same site may result in lumps developing underneath. In addition, pain and bruising may be experienced at the injection site. This is prevented by choosing different injection sites each time within the same region.
Local allergic reactions (redness, swelling, itching) may occur. These reactions usually disappear after a few weeks of continued insulin use. If they do not disappear, consult the doctor. If signs of allergy spread to other parts of the body or if the patient suddenly feels unwell (sweating; vomiting; difficulties in breathing; rapid heart beat; dizziness; feel like fainting), seek medical advice immediately as it may be due to a very rare serious systemic allergic reaction.
If the patient has diabetic retinopathy and the blood glucose levels improve very fast, the retinopathy may get worse. Consult the doctor about this.
When starting insulin, water retention may cause swelling around the ankles and other joints but this soon disappears.
Side effects reported very rarely (<1 in 10,000): When first starting insulin treatment, visual disturbances may occur but the reaction usually disappears.
Painful neuropathy (burning, tingling or electric pain) may occur if the blood glucose levels improve very fast. It usually disappears otherwise, consult the doctor.
Most common medicines which may affect insulin treatment and the need for insulin may change: Oral antidiabetic products; monoamine oxidase inhibitors (MAOI); β-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; anabolic steroids and glucocorticoids; thyroid hormone therapy; β-sympathomimetics; danazol; octreotide; lanreotide; oral contraceptives and sulphonamides. Consult the doctor or pharmacist if any other medicines are taken recently, even those not prescribed.
Do not used Insulatard in insulin infusion pumps; if it has not been stored correctly or if it has been frozen; if the insulin does not appear uniformly white and cloudy when mixed.
Vial: Do not use if the protective cap is loose or missing.
Penfill: Always check the cartridge, including the rubber plunger. Do not use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Penfill/NovoLet: Do not refill Penfill/NovoLet. Do not use if the cartridge or the device containing the cartridge or NovoLet is dropped, damaged or crushed as there is a risk of leakage of insulin.
Vial/Penfill/NovoLet that are not being used are to be stored in a refrigerator (2-8°C) and not in or near the cooling compartment. Do not freeze.
Vial/Penfill/NovoLet that are being used or about to be used are not to be kept in a refrigerator. Patient can carry and keep vials at room temperature (below 25°C) for 6 weeks or up to 4 weeks at temperatures below 30°C; while Penfill/NovoLet can be kept at room temperature (not above 30°C) for up to 6 weeks.
Always keep the vial and cartridge in the outer carton and the pen cap on the NovoLet when not in use in order to protect it from light.
Insulatard must be protected from excessive heat and sunlight.
A10AC01 - insulin (human) ; Belongs to the class of intermediate-acting insulins and analogues. Used in the treatment of diabetes.
Inj (vial) 100 IU/mL x 10 mL x 1's. Penfill 100 IU/mL (cartridge) x 3 mL x 5's.