Summary of Product Characteristics (SmPC) - Diluent for Glucagen 1 mg (water for Injections 1 ml)
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
Traceability
In order to improve the traceability of biological medicial products, the name and the batch number of the adminitered product should be clearly recorded.
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.
GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate. Monitor patients with cardiac disease during use of GlucaGen as a diagnostic aid and treat if indicated.
GlucaGen may cause short term hyperglycaemia in patients with diabetes mellitus when used as a diagnostic aid. Monitor patients with diabetes for changes in blood glucose levels during use and treat if indicated.
Caution should be observed in pateints with glucagonoma when usede a diagnotic aid.
Therapeutic and diagnotic indications
Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma.
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 1mmol sodium (23 mg) per maximum dose (2 ml), 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
Summary of the safety profile
Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (less than 1 case per 10,000 patients). When used in the diagnostic indication,
hypoglycaemia/hypoglycaemic coma have been reported, especially in patients who have fasted. Cardiovascular adverse events, such as tachycardia and blood pressure changes have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
Tabulated summary of adverse reactions
Frequencies of undesirable effects considered related to treatment with GlucaGen during clinical trials and/or post-marketing surveillance are presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as ‘very rare’. During marketed use reporting of adverse drug reactions is very rare (< 1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light.
Therapeutic indication
| System Organ Class | Subject incidence | Adverse drug reaction |
| Immune system disorders | Very rare < 1/10,000 ≥ | Hypersensitivity reactions including anaphylactic reaction/shock |
| Gastrointestinal disorders | Common 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 | Nausea Vomiting Abdominal pain |
| General disorders and administration site conditions | Not known (cannot be estimated from the available data) | Injection site reactions |
Paediatric population
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.
Other special populations
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
Diagnostic indication
| System Organ Class | Subject incidence | Adverse drug reaction |
| Immune system disorders | Very rare < 1/10,000 ≥ | Hypersensitivity reactions including anaphylactic reaction/shock |
| Metabolism and nutrition disorders | Uncommon 1/1,000 to < 1/100 Very rare < 1/10,000 | Hypoglycaemia*1 Hypoglycaemic coma |
| Cardiac disorders | Very rare < 1/10,000 | Tachycardia*2 |
| Vascular disorders | Very rare < 1/10,000 Very rare < 1/10,000 ≥ | Hypotension*2 Hypertension*2 |
| Gastrointestinal disorders | Common 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 | Nausea Vomiting Abdominal pain |
| General disorders and administration site conditions | Not known (cannot be estimated from the available data) | Injection site reactions |
*1 After a diagnostic procedure this could be more pronounced in patients that have fasted (see section 4.4). *2 Cardiovascular adverse events have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
Paediatric population
There are no data available on the diagnostic use of GlucaGen in children.
Other special populations
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
30 September 1991 / 15 October 2001
10 DATE OF REVISION OF THE TEXT
11/01/2023