ZEGALOGUE Solution for injection Ref.[115117] Active ingredients: Dasiglucagon

Posology

Adults, adolescents and children aged 6 years and over

The recommended dose is 0.6 mg administered by a subcutaneous injection.

If there has been no response after 15 minutes, an additional dose of Zegalogue from a new pre-filled syringe may be administered.

Special populations

Elderly

Zegalogue 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

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

Hepatic impairment

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

Paediatric population (<6 years)

The safety and efficacy of Zegalogue in children aged less than 6 years have not yet been established. No data are available.

Method of administration

Subcutaneous use.

Zegalogue is to be injected in the lower abdomen, buttocks, thigh, or outer upper arm.

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 Zegalogue and its package leaflet. Zegalogue should be administered as soon as possible when severe hypoglycaemia is recognised.

Patients and caregivers should be instructed on how to correctly use Zegalogue and to read the package leaflet. The following instructions should be emphasised:

Instructions for use, pre-filled syringe:

1. When administering Zegalogue pre-filled syringe, insert the needle into the skin and press the plunger fully down until the syringe is empty.

2. After the injection is given, if the person is unconscious, turn the person on their side to prevent choking.

3. After giving the dose, the caregiver should call for medical help right away.

4. If there has been no response after 15 minutes, an additional dose of Zegalogue from a new pre-filled syringe may be administered while waiting for emergency assistance.

5. When the patient has responded to treatment, give oral carbohydrate to restore liver glycogen and prevent relapse of hypoglycaemia.

Each pre-filled syringe contains a single dose of dasiglucagon and cannot be reused.

For further information before administration see section 6.6.

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.

3 years when stored in a refrigerator (2°C – 8°C).

During the shelf life, the medicinal product may be kept at a temperature under 25°C for a single period no longer than 1 year, and not exceeding the original expiry date (EXP). Once the product has been stored outside the refrigerator, the product must not be returned to the refrigerator. Upon removing the medicinal product from the refrigerator, the new expiry date must be written on the protective case label and the medicinal product should be used or discarded by the new expiry date. The original expiry date should be crossed out.

For special precautions for storage, see section 6.4.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Store in the original protective case in order to protect from light.

For additional storage conditions at a temperature under 25°C, see section 6.3.

Zegalogue 0.6 mg solution for injection in pre-filled syringe:

Glass (type I) pre-filled syringe with staked stainless steel needle, rigid needle shield/grey needle cover, rubber plunger (bromobutyl) and red plunger rod (polypropylene). Each pre-filled syringe contains 0.6 mL of solution for injection and is individually packaged in a protective case.

Pack sizes of 1 or 2 single-dose pre-filled syringes.

Not all pack sizes or presentations may be marketed.

Instructions for use

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

The single-dose pre-filled syringe contains only one dose.

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

If the solution is discoloured or contains particulate matter, the product should not be used.

Disposal

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