Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Hydrochloric acid and/or sodium hydroxide (to adjust pH)
Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
For single use only.
After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately: Store at 2-8°C and use within 24 hours unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Store below 30ºC.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
6.5 Nature and contents of container

2 ml of solution in type I transparent glass vial closed with bromobutyl rubber stoppers with aluminium crimp-cap and plastic flip-off seal.
Pack size: 10 vials of 2 mL.

6.6 Special precautions for disposal and other handling
SUGAMAX can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9 %), glucose 50 mg/mL (5 %), sodium chloride 4.5 mg/mL (0.45 %) and glucose 25 mg/mL (2.5 %), Ringer’s lactate solution, Ringers solution, glucose 50 mg/mL (5 %) in sodium chloride 9 mg/mL (0.9 %).

The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride) between administration of SUGAMAX and other drugs.

For paediatric patients, SUGAMAX can be diluted using sodium chloride 9 mg/ml (0.9 %) to a concentration of 10 mg/mL (see section 6.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.