Water For Injections
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 Special Precautions for Use
Not applicable.
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
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.
Nature and Content of Container
Syringe made of glass type 1, Ph. Eur., and closed with a bromobutyl plunger.
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.
POM
10.