Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
The dosage should be determined by the physician, according to the requirement of the patient.
Liprolog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
Liprolog may be given shortly before meals. When necessary Liprolog can be given soon after meals.
Liprolog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Liprolog injection (or, in the case of administration by continuous subcutaneous infusion, a Liprolog bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. As with all insulin preparations, the duration of action of Liprolog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Liprolog can be used in conjunction with a longer-acting insulin or oral sulphonylurea agents, on the advice of a physician.
Liprolog KwikPen is available in two strengths. The Liprolog 100 units/ml KwikPen (and Liprolog 200 units/ml KwikPen, see separate SmPC) delivers 1–60 units in steps of 1 unit in a single injection. The Liprolog 100 units/ml Junior KwikPen delivers 0.5–30 units in steps of 0.5 units in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step.
Insulin requirements may be reduced in the presence of renal impairment.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Liprolog can be used in adolescents and children (see section 5.1).
Liprolog preparations should be given by subcutaneous injection. The KwikPen and Junior KwikPen are only suitable for subcutaneous injections. Liprolog in cartridges is only suitable for subcutaneous injections from a Lilly reusable insulin pen, BerliPen areo 3 or compatible pump systems for continuous subcutaneous insulin infusion (CSII).
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month, in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).
When administered subcutaneously care should be taken when injecting Liprolog to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use the proper injection techniques.
For subcutaneous injection of Liprolog using a continuous infusion pump, you may fill the pump reservoir from a Liprolog 100 units/ml vial. Some pumps are compatible with cartridges that can be inserted intact into the pump.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the pump manufacturer’s instructions should be studied to ascertain the suitability for the particular pump. Use the correct reservoir and catheter for the pump. When filling the pump reservoir avoid damaging it by using the correct needle length on the filling system. The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, consider the need to reduce or stop an insulin infusion. A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the pump product literature. When used with an insulin infusion pump, Liprolog should not be mixed with any other insulin.
If necessary, Liprolog may also be administered intravenously, for example: for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods. Liprolog 100 units/ml is available in vials if administration of intravenous injection is necessary.
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring of the blood glucose levels is required.
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.
Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Before use: 3 years.
After first use /after cartridge insertion: 28 days.
Do not freeze. Do not expose to excessive heat or direct sunlight.
Store in a refrigerator (2°C-8°C).
Vial: Store in a refrigerator (2°C-8°C) or below 30°C.
Cartridge: Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
KwikPen and Junior KwikPen: Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.
Vial:
The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.
10 ml Vial: Packs of 1 or 2 or a multipack of 5 (5 packs of 1). Not all packs may be marketed
Cartridge:
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/or the glass cartridges.
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed
KwikPen:
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable pen injector. Needles are not included.
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed
Junior KwikPen:
Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.
3 ml Junior KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed
To prevent the possible transmission of disease, each cartridge or pen must be used by one patient only, even if the needle on the delivery device is changed. Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.
The Liprolog solution should be clear and colourless. Liprolog should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Do not mix insulin in vials with insulin in cartridges. See section 6.2.
Vial:
The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
i) Liprolog
1. Wash your hands.
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
3. If the therapeutic regimen requires the injection of basal insulin and Liprolog at the same time, the two can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that follow in Section (ii) and 6.2.
4. Draw air into the syringe equal to the prescribed Liprolog dose. Wipe the top of the vial with a swab. Put the needle through the rubber top of the Liprolog vial and inject the air into the vial.
5. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
6. Making sure the tip of the needle is in the Liprolog, withdraw the correct dose into the syringe.
7. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
8. Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.
ii) Mixing Liprolog with longer-acting Human Insulins (see section 6.2)
1. Liprolog should be mixed with longer-acting human insulins only on the advice of a doctor.
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle into the longer-acting insulin vial and inject the air. Withdraw the needle.
3. Now inject air into the Liprolog vial in the same manner, but do not withdraw the needle.
4. Turn the vial and syringe upside down.
5. Making sure the tip of the needle is in the Liprolog, withdraw the correct dose of Liprolog into the syringe.
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
7. Remove the needle from the vial of Liprolog and insert it into the vial of the longer-acting insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longeracting insulin.
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything.
Cartridge:
Liprolog cartridges are to be used with a Lilly reusable insulin pen or a BerliPen areo 3 and should not be used with any other reusable pen, as the dose accuracy has not been established with other pens.
The instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
KwikPen and Junior KwikPen:
Before using the pre-filled pen the user manual included in the package leaflet must be read carefully. The pre-filled pen has to be used as recommended in the user manual.
Pens should not be used if any part looks broken or damaged.
If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting the dose, the following is a general description.
1. Wash your hands
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as instructed.
5. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
6. Dispose of the syringe and needle safely. For an injection device use the outer needle cap, unscrew the needle and dispose of it safely.
7. Use of the injection sites should be rotated so that the same is not used more than approximately once a month.
Any unused product or waste material should be disposed of in accordance with local requirements.
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