Insuget 100IU/mL Suspension for injection (IM / SC)

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Biphasic Isophane Human Insulin (Rdna) , Isophane Suspension , Soluble Insulin

Available from:

Getz Pharma Phils., Inc.

INN (International Name):

Biphasic Isophane Human Insulin (Rdna) , Isophane Suspension , Soluble Insulin

Dosage:

100IU/mL

Pharmaceutical form:

Suspension for injection (IM / SC)

Units in package:

Glass vial x 10mL (Box of 1's

Manufactured by:

Getz Pharma (Private) Limited

Therapeutic area:

Anti-Diabetic

Therapeutic indications:

For the treatment of Diabetes Mellitus type I; Diabetes Mellitus type II either alone or in combination with oral anti-diabetic agents; emergency management of Diabetic ketoacidosis; adult patients with diabetes mellitus for the control of hyperglycemia should be used in regimens that include a longer-acting insulin.

Authorization date:

2020-01-06

Summary of Product characteristics

Injection sites should be rotated within an anatomic region in order
to avoid lipodystrophy. An injection should be followed within 30
minutes by a meal or a snack containing carbohydrates.
ADMINISTRATION
1.
Pinch the skin between two fingers, push the needle into the
skinfold and inject the insulin under the skin.
2.
Keep the needle under the skin for at least 6 seconds to make
sure all the insulin has been injected.
3.
If blood appears after the needle has been withdrawn, press the
injection site lightly with a finger.
_Do not reuse needles. Dispose of the needle in a responsible manner._
_Needles must not be shared._
ADVERSE EFFECTS
Hypoglycemia is the most frequently occurring undesirable effect of
insulin therapy that a patient with diabetes may suffer. Symptoms of
hypoglycemia usually occur suddenly. They may include cold sweat,
cool pale skin, nervousness or tremor, anxious feeling, unusual
tiredness or weakness, confusion, difficulty in concentration,
headache,
nausea and palpitation. Severe hypogl
ycemia may lead to
unconsciousness and may result in temporary or permanent impairment
of brain function or even death. Weight gain is common when taking
insulin.
Edema and refraction anomalies may occur upon ‘initiation’ of
insulin
therapy. Local hypersensitivity reactions (redness, swelling and
itching
at the injection site) are those transitory reactions, which may occur
during the treatment with insulin and normally disappear during
continued treatment.
Lipodystrophy may occur at the injection site as a consequence of
failure to rotate injection site within an area.
Generalised hypersensitivity reactions may occur occasionally and
can cause generalised skin rash, itching, sweating, gastrointestinal
upset, angioneurotic edema, difficulties in breathing, palpitation and
reduction in blood pressure. These are potentially life threatening.
CONTRAINDICATIONS
Insulin is contraindicated in:
−
Patients with hypersensit
ivity to any components of this medication.
−
Patients with hypoglycemia.
−
Patients in