Summary of medicine characteristics - DILUENT FOR GLUCAGEN 1 MG (WATER FOR INJECTIONS 1ML)
1. NAME OF THE MEDICINAL PRODUCT
Diluent for GlucaGen lmg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient : Water for injections 1.1ml.
3. PHARMACEUTICAL FORM
Sterile liquid, for reconstitution for GlucaGen 1mg.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Not applicable.
4.2 Posology and Method of Administration
Not applicable.
4.3 Contra-Indications
Not applicable.
4.4 Special warnings and precautions for use
Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion.
Therapeutic indication
To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment.
Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.
Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.
Diagnostic indication
Persons who have been given glucagon in connection with diagnostic procedures may experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia, and blood pressure changes have been reported in these situations. After the end of a diagnostic procedure, oral carbohydrates should be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. If fasting is needed post-examination or in case of severe hypoglycaemia, glucose given intravenously may be required.
Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma. Caution should also be observed in patients with glucagonoma.
Caution should be observed when GlucaGen is used as an adjunct in endoscopic or radiographic procedures in diabetic patients or in elderly patients with known cardiac disease.
Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction. Glucagon is contraindicated in patients with phaeochromocytoma (see section 4.3).
Excipients
GlucaGen contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
4.5 Interaction with other Medicinal Products and other Forms of Interaction
Not applicable.
4.6 Pregnancy and Lactation
Not applicable.
4.7 Effect on Ability to Drive and Use Machines
Not applicable.
4.8 Undesirable Effects
Not applicable.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Not applicable.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Pre-clinical Safety Data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Not applicable.
6.2 Incompatibilities
Not applicable.
6.3 Shelf-Life
Prior to reconstitution, the shelf-life is 36 months when stored at 2 to 8°C.
The reconstituted solution should be prepared immediately prior to use and any portion of the solution remaining after use should be discarded.
6.4 Special Precautions for Storage
Store in a refrigerator (2 to 8°C).
Packs carried for use may be kept at ambient temperature (max 25°C) for up to 18 months, provided the expiry date is not exceeded.
6.5 Nature and Content of Container
Syringe made of glass type 1, Ph. Eur., and closed with a bromobutyl plunger.
6.6 Instructions for Use, Handling and Disposal
GlucaGen lmg is reconstituted with diluent before use. Each carton contains a patient information leaflet with instructions for reconstitution.
7. MARKETING AUTHORISATION HOLDER
Novo Nordisk A/S
Novo Alle
DK-2880 Bagsvaerd
Denmark
8. MARKETING AUTHORISATION NUMBER(S)
PL 04668/0028