Active Ingredients: Insulin Aspart 100 U/mL.
Excipients/Inactive Ingredients: Glycerol, Phenol, Metacresol, Zinc chloride, Disodium phosphate dihydrate, Sodium chloride, Hydrochloric acid, Sodium hydroxide and Water for injections.
Pharmacology: Kirsty is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.
Kirsty will start to lower blood sugar 10-20 minutes after injecting it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours. Due to this short action Kirsty should normally be taken in combination with intermediate-acting or long-acting insulin preparations.
Kirsty is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.
How to use Kirsty: How much to use: Talk about the insulin dose with a doctor and nurse. Make sure to use a colour-coded Kirsty as told by the doctor and nurse and follow their advice carefully.
If the doctor has switched from one type or brand of insulin to another, the dose may have to be adjusted by the doctor. Do not change insulin unless told by the doctor.
When to use it: Kirsty is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, Kirsty can be given soon after a meal.
How to use it: Kirsty is for injection under the skin (subcutaneously) or for continuous infusion in a pump system. Administration in a pump system will require a comprehensive instruction by a healthcare professional. Kirsty may also be given directly into a vein (intravenously) by physicians or other healthcare staff if applicable. Never inject the insulin directly into a muscle (intramuscularly).
Always vary the sites injected within the same region to reduce the risk of developing lumps or skin pitting. The best places to give an injection are: the front of the waist (abdomen); the upper arm or the front of the thighs. The insulin will work more quickly if injected into the waist (abdomen). Blood sugar should be measured regularly.
How long to use it: Continue taking Kirsty for as long as the doctor recommends. Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia and diabetic ketoacidosis.
If too much Kirsty have been injected: If the patient takes too much insulin the blood sugar gets too low (hypoglycaemia).
Hypoglycaemia may also happen: If the patient eats too little or miss a meal.
If the patient exercises more than usual.
The warning signs of a hypoglycaemia may come suddenly and can include: cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
If the patient feels a hypoglycaemic episode coming on, the patient should take a high sugar snack and then measure blood sugar.
If blood sugar is too low, eat glucose tablets or another high sugar snack (sweets, biscuits, fruit juice), then rest.
When the symptoms of hypoglycaemia have disappeared or when the patient's blood sugar level is stabilised, continue insulin treatment.
The patient may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If the patient is given glucagon, the patient will need glucose or a sugary snack as soon as the patient is conscious. If the patient do not respond to glucagon treatment, the patient will have to be treated in a hospital. Contact a doctor or an emergency ward after an injection of glucagon; the patient needs to find the reason for the hypoglycaemia to avoid getting more.
Kirsty has a rapid effect. Therefore, if hypoglycaemia occurs, the patient may experience it earlier after an injection when compared to soluble human insulin.
When not to use the insulin: If the patient is allergic to insulin aspart, or any of the other ingredients in this medicine.
If the patient suspects hypoglycaemia (low blood sugar) is starting.
If the patient forgets to use Kirsty: If the patient forgets to take the insulin, blood sugar may get too high (hyperglycaemia).
This may also happen: If the patient repeatedly take less insulin than needed.
If the patient gets an infection or a fever.
If the patient eats more than usual.
If the patient exercise less than usual.
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath. These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If the patient does not treat it, this could lead to diabetic coma and eventually death. If the patient gets any of the signs mentioned previously, test the patient's blood sugar level, test the urine for ketones if possible, then seek medical advice immediately.
If the patient stop using: Do not stop taking insulin without speaking with a doctor, who will tell what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Side Effects.
If the patient have any further questions on the use of this product, ask a doctor or pharmacist.
While the patient is using Kirsty: Things the patient must do: Eat a meal or snack containing carbohydrates within 10 minutes of the injection to avoid hypoglycaemia.
Things the patient must not do: Do not take any insulin if the patient feel a hypo coming on.
Always carry glucose tablets, sweets, biscuits or fruit juice, just in case.
Inform relevant people that the patient have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to hypo.
Inform relevant people that if the patient pass out, the patient must be turned on the side and get medical help straight away. The patient must not be given any food or drink. It could choke the patient.
If prolonged severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
If the patient have a hypo that makes the patient pass out, or a lot of hypos, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Things the patient must be careful of: Some conditions and activities can affect the patient's need for insulin. Consult a doctor: If the patient is having trouble with kidneys or liver, or with adrenal, pituitary or thyroid glands.
If the patient exercises more than usual or if the patient wants to change the usual diet.
If the patient is ill, carry on taking the insulin and consult a doctor.
If the patient is going abroad: travelling over time zones may affect the patient's insulin needs and the timing of injections. Consult a doctor if the patient is planning such travelling.
If the patient drinks alcohol, the need for insulin may change as blood sugar level may either rise or fall. Careful monitoring is recommended.
Driving and using machines: Ask a doctor whether the patient can drive a car or operate a machine: If the patient have frequent hypoglycaemia.
If the patient finds it hard to recognise hypoglycaemia.
If the blood sugar is low or high, the patient's concentration and ability to react might be affected and therefore also the ability to drive or operate a machine. Bear in mind that this could endanger the patient or others.
Kirsty has a rapid onset of effect therefore if hypoglycaemia occurs, the patient may experience it earlier after an injection when compared to soluble human insulin.
Kirsty contains less than 1 mmol sodium (23 mg) per dose, i.e. Kirsty is essentially 'sodium-free'.
Use in special patient groups: If the patient has reduced kidney or liver function, or if the patient is above 65 years of age, the patient needs to check the blood sugar more regularly and discuss changes in insulin dose with a doctor.
Use in Children: Kirsty can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.
Pregnancy and breast-feeding: Ask a doctor or pharmacist for advice before taking any medicine.
If the patient is pregnant, planning a pregnancy or breast-feeding, contact a doctor for advice. Kirsty can be used during pregnancy and breast-feeding. The insulin dosage may need to be changed during pregnancy and after delivery. Careful control of diabetes, particularly prevention of hypoglycaemia, is important for the health of the baby.
Like all medicines, Kirsty 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 user in 10; Uncommon: affects 1 to 10 users in 1,000; Rare: affects 1 to 10 users in 10,000; Very rare: affects less than 1 user in 10,000.
Very common side effects: Low blood sugar (hypoglycaemia).
Uncommon side effects: Vision problems: When the patient first start the insulin treatment, it may disturb the vision, but the disturbance is usually temporary.
Changes at the injection site (lipodystrophy and cutaneous amyloidosis): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis: how often this occurs is not known). Changing the site with each injection reduces the risk of developing such skin changes. If the patient notices skin pitting or thickening at the injection site, tell a doctor or nurse. These reactions can become more severe, or they may change the absorption of the insulin if injected in such a site.
Signs of allergy: Reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking insulin. If they do not disappear, see a doctor.
Seek medical advice immediately: If signs of allergy spread to other parts of the body, or; If the patient suddenly feel unwell, and starts sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If the patient has diabetic retinopathy and blood sugar level improves very fast, the retinopathy may get worse. Ask a doctor about this.
Swollen joints: When the patient starts taking insulin, water retention may cause swelling around the ankles and other joints. Normally this soon disappears.
Rare side effects: Painful neuropathy (pain due to nerve damage): If blood sugar level improves very fast, the patient may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Very rare side effects: Serious allergic reaction to Kirsty or one of its ingredients (called a systemic allergic reaction).
If any of the side effects get serious, or if the patient notices any side effects not listed in this monograph, tell a doctor, nurse or pharmacist.
The patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by calling Tel: 03-78835490, or visiting the website npra.gov.my [Consumers - Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)].
Taking other medicines: Some medicines affect the way glucose works in the body and this may influence the insulin dose. The most common medicines which may affect the insulin treatment are listed as follows. Tell a doctor, nurse or pharmacist if the patient took or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell a doctor if the patient used any medicine listed as follows that may affect blood sugar level.
If the patient took any of the following medicines, blood sugar level may fall (hypoglycaemia): Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
If the patient took any of the following medicines, blood sugar level may rise (hyperglycaemia): Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Octreotide and lanreotide may either increase or decrease blood sugar level.
Beta-blockers may weaken or suppress entirely the first warning symptoms which help to recognise a hypoglycaemia.
Thiazolidinediones (class of oral antidiabetic medicines used for treatment of type 2 diabetes mellitus): Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure. Inform a doctor as soon as possible if the patient experiences signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
When not to use the insulin: If the protective cap is loose or missing. Each pen has a protective, tamper-proof. If the pen is not in perfect condition, return the pen to the supplier.
If the insulin has not been stored correctly or been frozen.
If the insulin does not appear clear and colourless.
Disposal: Any unused product or waste material should be disposed of in accordance with local requirements. Kirsty formulations should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required.
Instructions for Use: Insulin Aspart Injection (rDNA Origin) 3 mL Prefilled Pen (100 U/mL).
Kirsty prefilled disposable pen injector contains 300 units of insulin Aspart (rDNA Origin). Read all the instructions carefully before using Kirsty (hereafter "pen"). If the patient is unable to read or follow all of the instructions completely on their own, seek the help of someone who has been trained to use the pen.
Follow the instructions every time the patient will use the pen. If the patient will not follow these instructions each time using the pen, the patient may either get too much or too little insulin. This may affect the blood glucose level.
Before Using the Pen for the First Time: Check that the carton is sealed with an intact hologram. After opening the carton check that the pen looks new and undamaged.
Storage: Before first use, store the cartons containing the pen in the refrigerator at 2°C-8°C (36°F - 46°F). DO NOT freeze.
Once the pen is taken out of the refrigerator, allow it to reach room temperature (around 25°C) naturally before first use. Cold insulin is painful to inject.
Always store the pen with the cap on, to avoid any contamination.
After first use, store the pen at room temperature up to 30°C (86°F).
Use the pen within 28 days from first use. Dispose of the pen after 28 days.
DO NOT refrigerate the pen after first use.
Store at room temperature between uses.
NEVER leave the needle attached to the pen during storage.
This could lead to contamination or needle blockage.
Each Time Using the Pen: 1. Wash hands with soap and water before handling the pen.
2. Check the pen's label to ensure that the patient is taking the correct type of insulin. The pen has a orange label and a orange injection button.
3. Check the expiration date given on the pen's label.
4. Check the appearance of the drug in the cartridge. This is important especially if the patient is taking more than one type of insulin.
5. DO NOT use the pen if the drug in the cartridge appears cloudy, colored or has visible particles.
6. ALWAYS use a new Sterile disposable Hypodermic needle for each injection.
7. Select the injection location as recommended by Healthcare Professional (HCP).
8. ALWAYS put the pen cap back on the pen after use, and store the pen at room temperature in a cool, dry place.
Required Supplies: Make sure to have the following items: Pen, Sterile disposable hypodermic needle*, 2 Alcohol Wipes*.
* Not provided with the pen.
Needles Compatible with this Pen: BD UltraFine 31G, 5mm; BD UltraFine 32G, 4mm; Novofine 32G, 6mm; Terumo Nanopass 34G, 4mm.
Step-By-Step Instructions: Preparing the Pen: A. 1. Inspect the pen: Check the orange-coloured label present on the pen for: Correct insulin type; Expiration date.
Check the Insulin through the cartridge holder for: Clear and colourless appearance of the solution; Absence of cracks, breakage, or solution leakage.
B. 1. Hold the pen body with one hand.
2. With the other hand, pull off the pen cap.
3. Keep the pen cap aside for later use (in Step Q).
C. 1. Remove an alcohol wipe from its package.
2. Wipe the rubber seal at the front end of the cartridge with the alcohol wipe.
Note: Use of an alcohol wipe reduces chances of infection.
Attaching a New Needle: D. 1. Take a new sterile disposable hypodermic needle.
2. Hold the outer needle cap with one hand.
3. With the other hand, pull off the protective tab from the outer needle cap.
Caution: DO NOT use the needle if the protective tab is damaged or missing. The needle may not be sterile.
E. 1. Hold the pen body facing upwards with one hand.
2. With the other hand, attach the outer needle cap straight on to the cartridge holder.
Caution: DO NOT try to attach the outer needle cap in a tilted manner. This can bend or damage the needle.
3. Screw the outer needle cap in the clockwise direction, till it feels securely fixed on the pen.
F. 1. With a gentle pull, remove the outer needle cap.
2. Keep the outer needle cap. It is required to safely remove the needle later (in Step P).
G. 1. Carefully pull off and throw away the inner needle cap.
Caution: DO NOT re-use the inner needle cap to cover the needle. May accidentally injure yourself. Only use the outer needle cap to cover the needle (in Step P).
Priming the Pen Needle with 2 Units: H. 1. Turn the white-coloured dose knob to set 2 units. "2" must be visible in the dose window, and align with the pointer on the pen body.
The patient will hear a "CLICK" for each unit dialled.
Note: If the patient turns past 2 units, then simply turn back the dose knob in the opposite direction to correct the dose.
I. 1. Hold the pen body facing upwards with one hand.
2. Tap the cartridge holder gently with finger. This helps any large air bubbles present to rise to the top of the cartridge.
Note: Small bubbles may still be visible, and will not pose any problem.
J. 1. Hold the pen body facing upwards with one hand.
2. With thumb, press the injection button in until it stops moving and the dose window shows "0".
3. Keep the injection button pressed down.
4. Priming is complete when the patient observe drops of insulin at the tip of the needle.
Note: If no drops can be seen at the needle tip, repeat Steps H to J for a maximum of 4 times.
After 4 attempts, if insulin drops are still not visible at the needle-tip, it is likely that the needle is clogged.
Proceed directly to Step P to remove the needle. Then, return to Step D to attach the new needle and repeat priming (Step H).
Important: Always prime the pen needle before each injection to check insulin flow and avoid incomplete dose.
Setting the Dose: K. 1. Check that the dose window shows "0".
2. Look at the cartridge holder scale to estimate the insulin units left in the cartridge. If enough medication is not available in the cartridge, use a new pen to inject the required dose.
3. Turn the dose knob to set the required dose. The number in the dose window must align with the pointer on the pen body.
Note: Ensure to hear "CLICK" when setting the desired dose.
The pen does not allow to dial a dose beyond the units available within the cartridge.
Do not force the dose knob to turn beyond 80 units. 80 units is the maximum dose that can be injected in a single injection.
Caution: DO NOT push the injection button when turning the dose knob (during dose setting).
Select and Clean Injection Site: L. 1. Select the injection location as recommended by Healthcare Professional.
Note: Preferred injection locations on the body are both arms, hips, thighs, and lower abdomen. It is advised to rotate the injection site for each injection.
M. 1. Clean the skin with an alcohol wipe, at the spot where the patient wants to inject.
Injecting the Dose: N. 1. Insert the needle in a single continuous motion, as instructed by a Healthcare Professional.
Caution: DO NOT inject with the needle at an angle.
O. 1. Place thumb or finger on the injection button.
2. Press the injection button all the way in. The white dose-knob will turn and will hear "Clicks" when press down.
3. WAIT. Hold the injection button pressed in for an additional 6 seconds after the dose window shows "0". This pause ensures that all of the medication is delivered.
Caution: DO NOT press the injection button sideways or block the white dose-knob with fingers. This will prevent from injecting the medication.
If the patient doesn't keep the injection button pressed for 6 seconds after "0" is displayed in the dose window, it could result in an inaccurate dose and the patient may see drops of insulin at the injection site or at the needle tip.
Needle Removal and Disposal: P. 1. Take the outer needle cap that has been saved in Step F.
2. Hold the outer needle cap from its base and carefully cover the needle without touching it.
3. Squeeze the base of the outer needle cap while unscrewing the needle in a counter clockwise (left) direction. Keep twisting until the needle can be separated from the pen.
4. Discard the needle safely, as instructed by a Healthcare Professional or as per local regulations in the country.
Note: It may take several twists to release the needle.
Q. 1. Replace the pen cap and store the pen at room temperature (under 86°F or 30°C) for next use. NEVER store with a used needle attached.
Care and Disposal: Always carry a spare insulin prefilled pen injector as recommended by a Healthcare Professional, as a precautionary measure, in case the pen is lost or damaged.
Always use a new sterile disposable hypodermic needle for each injection.
Keep the pen away from moisture, dust, direct sunlight and places where the temperature may get too high or too low.
Discard an empty pen without the needle attached, as instructed by a Healthcare Professional.
Clean the outside of the pen by wiping it with a damp cloth.
DO NOT soak or wash the pen as this may damage it. Do not use alcohol, hydrogen peroxide, bleach or any other solvent to clean the pen. Also, do not apply lubricants such as oil, as this could damage the pen.
DO NOT share the pen with others. This pen is intended and recommended for use by one person only.
DO NOT attempt to repair the pen by yourself. Remove the needle as described in Step P, make a note of the problem, and return the pen to the manufacturer. Use a new pen instead.
The pen is designed to work accurately and safely. It must be handled with care. Avoid dropping the pen, as this can cause cartridge breakage or can damage the pen.
Store in a refrigerator at temperature between 2°C to 8°C. Do not freeze.
During use or when carry as a spare: The solution can be kept at room temperature not above 30°C for up to 28 days once the pen has been put to use. Do not refrigerate. Do not freeze. Keep the pen cap on the pen in order to protect from light.
Do not expose to excessive heat or direct sunlight. Do not use it after this time period. It is recommended that the date of the first use be noted on the label. Do not use Kirsty if particles are noticed in it. Only use Kirsty if the solution is clear and colourless. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
A10AB05 - insulin aspart ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Kirsty soln for inj (pre-filled pen) 100 U/mL
3 mL x 1's;3 mL x 3 × 1's;3 mL x 5 × 1's
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 100 U_mLb84140bb-1a1e-4fcd-8064-b02100c76827.GIF)
