When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. Name of the Medicinal Product
Active substance: Glucagon, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae cells by recombinant DNA technology).
3 Pharmaceutical Form
Powder and solvent for solution for injection in pre-filled syringe.
4.1 Indications
Diagnostic indications
Inhibition of motility: a. As a motility inhibitor in examinations of the gastrointestinal tract, e.g. double contrast radiography and endoscopy. b. As a motility inhibitor in computerised tomography (CT), nuclear magnetic resonance scanning (NMR) and digital subtraction angiography (DSA). Motility inhibition in examinations of the gastrointestinal tract
b. As a motility inhibitor in computerised tomography (CT), nuclear magnetic resonance scanning (NMR) and digital subtraction angiography (DSA).
Motility inhibition in examinations of the gastrointestinal tract
4.2 Posology and method of administration
Severe hypoglycaemiTherapeutic indication (Severe hypoglycaemia)a Dosage for adult patients Administer 1 mg by subcutaneous or intramuscular injection. Post treatment: as described below. mg.
Dosage for adult patients
Administer 1 mg by subcutaneous or intramuscular injection. Post treatment: as described below. mg.
by subcutaneous or intramuscular injection. Post treatment: as described below. a Administration by medical personnel b. Administration to the patient by a relative Inject GlucaGen as indicated below. Administer by subcutaneous or intramuscular injection. The patient will normally respond within 10 minutes. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.
Inject GlucaGen as indicated below.
Administer by subcutaneous or intramuscular injection. The patient will normally respond within 10 minutes. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.
b. In CT-scanning, NMR and DSA intravenous doses of up to 1mg are used.
4.4 Special warnings and special precautions for use
4.6 Pregnancy and lactation
The estimated number of treatment episodes is 26.246.9 millions over a 163-year period. 4.9 Overdose
In case of suspected overdosing (i.e. above therapeutic dosages) dosages substantially above the approved range, the serum potassium may decrease and should be monitored and corrected if needed. 6.1 List of excipients
Sterile Water for injections 6.4 Special precautions for storage GlucaGen HypoKit The user can, within the shelf life period, be stored GlycaGen HypoKit at room temperature (up to 25oC) for 18 months within the shelf life period. 6.6 Special precautions for disposal and other handling Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation 17 December 1991 Date of last renewal 15 October 2006 10. DATE OF THIS September 2009
6.4 Special precautions for storage
GlucaGen HypoKit The user can, within the shelf life period, be stored GlycaGen HypoKit at room temperature (up to 25oC) for 18 months within the shelf life period.
6.6 Special precautions for disposal and other handling Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation 17 December 1991 Date of last renewal 15 October 2006 10. DATE OF THIS September 2009
Section 1. Name of the medicinal product
The second presentation of GlucaGen is now included: GlucaGen 1 mg Powder and solvent for injection.
Section 2. Qualitative and Quantitative composition
The non-proprietary name has been changed from 'Glucagon, biosynthetic (rys)' to 'Glucagon rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae)'.
Section 3. Pharmaceutical form
A description of the product before and after reconstitution has been added.
Section 4.1. Indications
In the therapeutic indication 'diabetic patients receiving insulin' has been changed to 'insulin treated persons with diabetes'.
Under diagnostic indications the division into examinations with radiography/endoscopy and CT/NMR/DSA has been deleted. The indication is not general 'Motility inhibitor in examinations of the gastrointestinal tract', with no mention of type of procedure.
Section 4.2. Posology and method of administration
An important change here is that intravenous injection is no longer recommended for the therapeutic indication, treatment of severe hypoglycaemia. The section dealing with dosage and administration for severe hypoglycaemia is no longer divided into administration by medical personnel or by relatives since it is now equally applicable to both. The dosage for children has not been changed, but the wording has been clarified as the previous wording was ambiguous.
For the diagnostic indication it is now stated that administration should only be by medical personnel. A new statement has been added that oral carbohydrate should be given at the end of the diagnostic procedure if compatible with the diagnostic procedure applied. To be consistent with the more general diagnostic indication (Section 4.1) mention of dosages specific procedures (CT/NMR/DSA) has been deleted.
Section 4.3 Contraindications
Hypersensitivity to 'any of the excipients' has been changed to specifically mention lactose. This is the only excipient in GlucaGen which has the potential for causing hypersensitivity reactions.
Section 4.4 Special warnings and precautions for use
The warnings have been divided into those relevant for the therapeutic indication and those relevant for the diagnostic indication.
A new paragraph has been included under the diagnostic indication. This concerns patients experiencing discomfort especially if they have been fasting, and the need for oral carbohydrate at the end of the procedure. The possibility of patients needing intravenous glucose under certain circumstances is also mentioned.
A new warning that GlucaGen should not be given via intravenous infusion has been included.
Section 4.7 Effect on ability to drive and use machines
This has been amended to state that no studies have been performed and to include a warning concerning the possibility of hypoglycaemia following use of GlucaGen in diagnostic procedures.
Section 4.8 Undesirable effects
This section has been amended so that adverse events are separated into those occurring with the therapeutic indication and those occurring with the diagnostic indication.
Section 6.5 Nature and contents of container
This section now includes details of the second type of container for the diluent (glass vial).
This section now includes details of the second type of container for the diluent (glass vial); this is not available in the UK and a comment has been added as such.
Section 6.6. Special precautions for disposal
Instructions of ruse of the presentation containing tow vials is included (not relevant for UK)
The principal changes are as follows:
1. Name of the medicinal product
The name of the product has been harmonised throughout the EU. In Ireland this has meant a minor name change from 'GlucaGen 1 mg HypoKit' to 'GlucaGen HypoKit 1 mg'.
2. Qualitative and quantitative composition
Reference included to glucagon being produced in Saccharomyces cerivisiae cells by recombinant DNA technology.
3. Pharmaceutical form
A description of the glucagon powder and the solvent has been included.
4.2. Posology and method of administration
The general statement that reconstituted GlucaGen is given by subcutaneous, intramuscular or intravenous injection which was given at the beginning of this section has been deleted. Instead the recommended routes of administration are given as appropriate for each indication. It should be noted that intravenous administration is no longer recommended for treatment of severe hypoglycaemia, even when administered by medical personnel.
For treatment of severe hypoglycaemia the recommended dosage for children has been reworded and separated from the dosage for adults as the previous wording was considered ambiguous.
For the diagnostic indications two additional statements have been included:
'GlucaGen must be administered by medical personnel'
and
'After end of the diagnostic procedure oral carbohydrate can be given, if this is compatible with the diagnostic procedure applied.'
4.3. Contraindications
Hypersensitivity to lactose has been included.
4.4. Special warnings and special precautions for use
The statement concerning the need for caution if glucagon is used in patients with insulinoma has been expanded to state that caution is required with regard to relapse of hypoglycaemia.
A new paragraph has been added concerning possible effects of use of glucagon in diagnostic procedures and precautions to take after the procedure:
'Persons who have been given glucagon in connection with diagnostic procedures amy 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 carbohydrate can be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. In case of severe hypoglycaemia, intravenously given glucose may be required.'
A warning that 'GlucaGen should not be given by intravenous infusion' has been included.
4.7 Effect on ability to drive and use machines
A new statement has been included:
'No studies on the effects on the ability to drive and use machines have been performed. After diagnostic procedures hypoglycaemia has been reported infrequently. Therefore driving a car should be avoided until the patient has had a meal with carbohydrate.'
4.8 Undesirable effects
The whole section has been revised according to new requirements for describing adverse reactions; this includes tabulation of adverse reactions to include frequency, and separation of adverse reactions which may occur in connection with treatment of hypoglycaemia from adverse reactions which may occur in connection with diagnostic use.
Hypertension is a new adverse reaction listing. It is noted that cardiovascular adverse events have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
A note that nausea and vomiting sometimes seen on injection of glucagon may also be seen 2-3 hours after injection.
6. Pharmaceutical particulars
There have been a number of editorial changes to sections 6.1, 6.3, 6.4, 6.5 and 6.6. No additional information has been included other than statements in section 6.6 describing the appearance of the reconstituted solution and that unused product should be disposed of in accordance with local requirements.
10. Date of revision of the text