Glyset R PenSet(Protamine crystallised Insulin Aspart)

Therapeutic Group: Anti Diabetic

Presentation

Glyset R PenSet 100 IU: Each ml solution contains 100 IU (equivalent to 3.50 mg) Insulin Aspart

(rDNA) BP.

Description

Glyset R (Insulin Aspart rDNA) is a sterile, clear solution of Insulin Aspart human insulin analogue for

subcutaneous injection/infusion or intravenous injection. Glyset R is a blood glucose lowering agent

with an earlier onset of action. Glyset R produces a more rapid onset of action compared to soluble

human insulin. Insulin Aspart is homologous with regular human insulin with the exception of a single

substitution of the amino acid Proline by aspartic acid in position B28, and is produced by recombinant

DNA technology.

Indications

Glyset R is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

Instructions to be given to the patient

Before injecting this Insulin:

1. According to the instruction given with ConviPen, insert the Glyset cartridge into the pen correctly &

equip the needle

2. In case of Glyset Mix, gently turn the pen upside down for 8-10 times until the insulin in the cartridge

becomes uniformly mixed suspension

3. Remove the needle cap, discharge air bubbles in the catridge

4. Adjust the dosage button to get correct dose & inject to the specific site

5. In order to avoid cross contamination, do not let the needle touch anything during the process of

preparation.

For detail description, please see the Patient Instruction Leaflet provided with ConviPen.

Dosage & Administration

Glyset R has a faster onset and a shorter duration of action than soluble human insulin. Due to the
faster onset of action, Glyset R should generally be given immediately before a meal. When necessary
Glyset R may be given soon after a meal.
Dosage of Glyset R is individual and determined on the basis of the physician's advice in accordance
with the needs of the patient. It should normally be used in combination with long-acting insulin given
at least once a day.
The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day in adults and children over
2 years of age. In a meal-related treatment 50-70% of this requirement may be provided by Glyset R
and the remainder by long-acting insulin. Adjustment of dosage may also be necessary if patients
undertake increased physical activity or change their usual diet. Exercise taken immediately after a
meal may increase the risk of hypoglycaemia.
Subcutaneous Injection
Glyset R should be administered by subcutaneous injection in the abdominal region, buttocks, thigh,
or upper arm. Because Glyset R has a more rapid onset and a shorter duration of activity than human
regular insulin, it should be injected immediately (within 5-10 minutes) before a meal
Continuous Subcutaneous Insulin Infusion (CSII) by External Pump
Glyset R can also be infused subcutaneously by an external insulin pump. The initial programming of
the external insulin infusion pump should be based on the total daily insulin dose of the previous
regimen. Approximately 50% of the total dose is usually given as meal-related boluses of Glyset R and
the remainder is given as a basal infusion. When used with an infusion pump Glyset R should not be
mixed with any other insulin.
Intravenous Use
Glyset R can be administered intravenously under medical supervision for glycemic control with close
monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. For
intravenous use, Glyset R should be used at concentrations from 0.05 IU/mL to 1.0 IU/mL insulin
aspart in infusion systems using polypropylene infusion bags. Glyset R has been shown to be stable in
infusion fluids such as 0.9% sodium chloride.

Side Effects

Side effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction,
lipodystrophy, pruritus and rash.

Precautions

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with
insulin. Insulin regimens should be modified cautiously and only under medical supervision

Use in Pregnancy & Lactation

Pregnancy: Pregnancy category B.
Lactation: There are no restrictions on treatment with Glyset R during lactation. Insulin treatment of the
nursing mother should not affect the baby. However, dosage may need to be adjusted.