OGLUO Solution for injection Ref.[50398] Active ingredients: Glucagon

Posology

Adults and adolescents (≥6 years)

The recommended dose is 1 mg, administrated by subcutaneous injection.

Paediatric population (≥2 to <6 years)

• The recommended dose for paediatric patients who weigh less than 25 kg is 0.5 mg administered by subcutaneous injection.
• The recommended dose for paediatric patients who weigh 25 kg or greater is 1 mg administered by subcutaneous injection.

Time to respond and additional doses

The patient will normally respond within 15 minutes. When the patient has responded to the treatment, give an oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia. If the patient does not respond within 15 minutes, an additional dose of Ogluo from a new device may be administered while waiting for emergency assistance. It is recommended that patients are prescribed two Ogluo devices.

Special populations

Elderly (≥65 years old)

Ogluo can be used in elderly patients. No dose adjustment is required. Efficacy and safety data are very limited in patients aged 65 years and absent in patients aged 75 and above.

Renal impairment

Ogluo can be used in patients with renal impairment. No dose adjustment is required.

Hepatic impairment

Ogluo can be used in patients with hepatic impairment. No dose adjustment is required.

Paediatric population (<2 years)

The safety and efficacy of Ogluo in children aged less than 2 years have not been established. No data are available.

Method of administration

Ogluo pre-filled pen and pre-filled syringe are for subcutaneous injection only.

Patients and their caregivers should be instructed on the signs and symptoms of severe hypoglycaemia. As severe hypoglycaemia requires the help of others to recover, the patient should be instructed to inform those around them about Ogluo and its package leaflet. Ogluo should be administered as soon as possible when severe hypoglycaemia is recognised.

The patient or caregiver should be instructed to read the package leaflet at the time they receive a prescription for Ogluo. The following instructions should be emphasised:

• The foil pouch should not be opened until glucagon needs to be administered.
• The medicinal product should be administered according to the printed instructions on the foil pouch label, carton, or the package leaflet.
• The solution should be visually inspected prior to administration. The solution should appear clear and colourless to pale yellow and be free of particles. If the solution is discoloured or contains particulate matter, the medicinal product should not be used.
• Any clothing covering the injection site should be removed. The injection should be administered in the lower abdomen, outer thigh, or outer upper arm.
• Emergency assistance should be called immediately after administering the dose, even if the patient is not unconsious.
• Each device contains a single dose of glucagon and cannot be reused.

If overdose occurs, the patient may experience nausea, vomiting, inhibition of gastro-intestinal tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, use of non-selective α-adrenergic blockade has been shown to be effective in lowering blood pressure for the short time that control would be needed (see section 4.4).

Ogluo 0.5 mg solution for injection in pre-filled pen.
Ogluo 0.5 mg solution for injection in pre-filled syringe.

2 years.

Ogluo 1 mg solution for injection in pre-filled pen.
Ogluo 1 mg solution for injection in pre-filled syringe.

27 months.

Do not store above 25°C.

Do not refrigerate or freeze. Do not store below 15°C.

Store in original sealed foil pouch until time of use in order to protect from light and moisture.

Ogluo 0.5 mg solution for injection in pre-filled pen:

A pre-filled, single-dose pen containing a 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle,bromo butyl rubber flexible needle shield, and a red cap.

Each pre-filled pen contain 0.1 mL of solution for injection and is individually packaged in a predominantly red-coloured foil pouch, in a red on white carton displaying a pre-filled pen image.

Pack sizes of one and two single-dose pre-filled pens.

Ogluo 1 mg solution for injection in pre-filled pen:

A pre-filled, single-dose pen containing a 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle,bromo butyl rubber flexible needle shield, and a red cap.

Each pre-filled pen contains 0.2 mL of solution for injection and is individually packaged in a predominantly blue-coloured foil pouch, in a blue on white carton displaying a pre-filled pen image.

Pack sizes of one and two single-dose pre-filled pens.

Ogluo 0.5 mg solution for injection in pre-filled syringe:

A pre-filled 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle, and bromo butyl rubber rigid needle shield. Each syringe contains 0.1 mL of solution for injection and is individually packaged in a predominantly red-coloured foil pouch, in a red on white carton displaying a pre-filled syringe image.

Pack sizes of one and two single-dose pre-filled syringes.

Ogluo 1 mg solution for injection in pre-filled syringe:

A pre-filled 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless steel needle, and bromo butyl rubber rigid needle shield. Each syringe contains 0.2 mL of solution for injection and is individually packaged in a predominantly blue-coloured foil pouch, in a blue on white carton displaying a pre-filled syringe image.

Pack sizes of one and two single-dose pre-filled syringes.

Not all pack sizes may be marketed.

This is a ready to use medicinal product and for single-use only.

The single-dose device contains only one dose.

The instructions for using the medicinal product in the package leaflet must be followed carefully.

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