Insulin Glargine (rDNA) USP
Composition : Mytus 100 IU vial : Each ml solution contains Insulin Glargine (rDNA) USP 100 IU.
Mytus
100 IU PenSet : Each
ml solution contains Insulin Glargine (rDNA) USP 100 IU.
Indications
: Mytus is
indicated to improve glycemic control in adults and children with type 1
diabetes mellitus and in adults with type 2 diabetes mellitus.
Dosage
and administration : Mytus exhibits a
relatively constant glucose-lowering profile over 24 hours that permits once-daily
dosing. Potency of insulin glargine is approximately the same as human insulin.
Mytus is recommended for once daily subcutaneous administration & may be
administered at any time during the day. However, once started should be
administered at the same time every day. The dose of Mytus must be
individualized based on clinical response. Blood glucose monitoring is
essential in all patients with diabetes. In patients with type 1 diabetes,
Mytus must be used in regimens with
short-acting insulin. Mytus is not
recommended for intravenous administration. Intravenous administration of the
usual subcutaneous dose could result in severe hypoglycemia. Injection sites
should be rotated within the same region (abdomen, thigh, or deltoid) from one
injection to the next. or, as directed by the registered physician.
Use
in pregnancy and lactation : Pregnancy : Pregnancy category C. Insulin glargine should be
used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation
: lt is unknown
whether insulin glargine is excreted in human milk. Because many drugs,
including human insulin, are excreted in human milk, caution should be
exercised when Insulin glargine is administered to a nursing woman. Lactating women
may require adjustments in insulin dose & diet.
Storage : Store at 2ºC to 8ºC in a
refrigerator. Do not freeze. Protect from light.
Packing : Mytus 100 IU vial : Each box contains 3 ml glass
vial.
Mytus 100 IU PenSet : Each Box contains 3 ml glass cartridge.