Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sodium metabisulfite
Water for injections
Hydrochloric acid
Sodium Hydroxide
6.2     Incompatibilities
Do not dilute MIOZAC with 5% sodium bicarbonate solutions or with other solutions strongly alkaline. MIOZAC should not be used with other substances containing sodium metabisulfite and ethanol.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
For shelf life after dilution see clause 6.6.

6.4      Special precautions for storage
Store at a temperature below 25 °C and protected from light.
6.5     Nature and contents of container
The product is packaged in type I colorless and transparent glass vials, closed with rubber stopper and sealed with aluminum cap with flip-off made of plastic.

6.6   Special precautions for disposal and other handling
Dobutamine concentrate solution must be further diluted to at least 50 ml prior to administration in an i.v.
container with one of the intravenous solutions listed below:
• 5% Dextrose
• 5% Dextrose + 0.45% Sodium chloride
• 5% Dextrose + 0.9% Sodium chloride
• 10% Dextrose
• Isolyte M + 5% Dextrose
• Ringer Lactate
• 5% Dextrose + Ringer Lactate
• 20% Osmitrol in water
• 0.9% Sodium Chloride
• Sodium Lactate
• Normosol M in D5W

Solutions containing MIOZAC, may turn pink, which may increase in intensity over time.
This colour change is due to a slight oxidation of the drug but, over the recommended time of administration, there is no significant loss of potency.

The diluted solution must be used within 24 hours, stored at a temperature below 25°C, but from a microbiological point of view, the product should be used immediately after dilution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.