| 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 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 revised SmPC is version 3 with a revision date of July 2008, and should be used with immediate effect.
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