Velosulin (insulin human) – Summary of product characteristics - A10AB01

1. NAME OF THE MEDICINAL PRODUCT

Velosulin 100 IU/ml solution for injection or infusion in a vial.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).

One IU (International Unit) corresponds to 0.035 mg of anhydrous humanauthorisedinsulin.

3. PHARMACEUTICAL FORM

This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps.

Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin

products. For incompatibilities see section 6.2.

DosageMedicinal

Dosage is individual and determined by the physician in accordance with the needs of the patient. Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% as boluses divided between the three main meals.

In general, when patients are transferred from injection to infusion therapy, it may be advisable to reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals.

Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.

In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is therefore recommended.

An injection or infusion should be followed within 30 minutes by a meal or snack containing carbohydrates.

Dosage adjustment

Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.

Renal or hepatic impairment may reduce insulin requirement.

Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.

For subcutaneous or intravenous use.

Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4 ).authorised Administration

Insulin infusion (CSII):

Continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps is usually administered in the abdominal wall. Velosulin should never be mixed with any other insulin products when used in a pump.

Patients started on CSII must receive comprehensive instructionlongerin the use of the pump, and the necessary actions in case of illness, hypoglycaemia, hyperglycaemia or pump failure.

The patient should read and follow the instructions that accompany the infusion pump and use the correct reservoir and catheter for the pump (see section 6.6).

The infusion set should be changed every 48 hours using aseptic technique when inserting the infusion set.

When filling a new syringe, no large air bubbles should be left in either the syringe or the catheter. The patient should follow the instructions from the physician about the basal infusion rate and the

To get the benefit of insulinproductinfusion, and to detect possible malfunction of the pump, the patient should measure his blood glucose level regularly.

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, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered. A pump

available in case of emergency or pump interruption or failure, in order that insulin can be administered by subcutaneous injection.

malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If the patient suspectsMedicinalan interruption to insulin flow the patient should notify the health care professional. Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily

Insulin injection:

Administration of Velosulin is also possible by subcutaneous or intravenous injection. Intravenous administration should only be carried out by health care professionals.

Velosulin is administered subcutaneously in the abdominal wall. The thigh, the gluteal region or the deltoid region may also be used.

Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.

Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.

The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.

Patients using CSII may be more prone to infection at the site of infusion. Infections can be minimised by careful attention to personal hygiene of the hands and infusion site and by frequent changes of catheter (maximum usage 2 days).

Velosulin contains metacresol, which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

A number of medicinal products are known to interact with glucose metabolism. The physician must therefore take possible interactions into account and should always ask his patients about any

medicinal products they take.

Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.

The following substances may reduce insulin requirement: authorised

The following substances may increase insulin requirement:

Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.

Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.

Octreotide/lanreotide may both decrease and increase insulin requirement.

Alcohol may intensify and prolong the hypoglycaemic effect of insulin.

longer

4.6Pregnancy and lactation

There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.

Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero. Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when

contemplating pregnancy.

After delivery, insulin requirements return rapidly to pre-pregnancy values.

InsulinMedicinalrequirements usually fall in the first trimester and subsequently increase during the second and third trimesters.

Insulin treatment of the nursing mother presents no risk to the baby. However, the Velosulin dosage may need to be adjusted.

4.7 Effects on ability to drive and use machines

The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).

6.4 Special precautions for storage

Before use: store in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

During use: do not refrigerate. Do not store above 25°C.

After first use as infusion: the insulin solution may be stored in the pump reservoir at up to 37°C (close to the body).

the reservoir of the infusion pump with Velosulin.

When combination with long-acting insulin is necessary it is only possible to mix Velosulin with isophane or premixed insulin products. Velosulin should not be mixed with insulin zinc suspensions since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way.

InsulinMedicinalpreparations which have been frozen must not be used.

Insulin solutions should not be used if they do not appear water clear and colourless.

Insulin infusion (CSII):

Use only syringes made of polyethylene, polypropylene or glass.

Use only catheters where the material in contact with the insulin is made of polyethylene or polypropylene.

Use only teflon-coated or stainless steel needles.

Any unused product or waste material should be disposed of in accordance with local requirements.

7.MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark