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, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4 Special precautions for storage
Store below 30ºC,
Keep the vial in the original package in order to protect from light. Do not freeze.

For storage conditions of the diluted medicinal product, see section 6.3.

6.5 Nature and contents of container

2 ml or 5ml solution in glass vial with rubber stopper and sealed with aluminium flip-off.
Pack size: 10 vials of 2 ml or 10 vials of 5 ml.
Not all pack-sizes may be marketed

6.6 Special precautions for disposal and other handling
SUGAMEDINcan 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 %), Ringers 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 SUGAMEDINand other drugs.


For paediatric patients SUGAMEDINcan 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.


7. MANUFACTURED BY:
ANFARM HELLAS S.A., GREECE
ACHAIAS STR & TRIZINIAS, 14564 KIFISSIA, ATTIKI, GREECE