Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol, hydrochloric acid 1M and water for injections.

6.2 Incompatibilities
In the absence of compatibility studies, 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.
Once the vial or ampoule has been opened, the product must be used immediately.
6.4 Special precautions for storage
Store at 2°C - 8°C, in the original package in order to protect from light.
Atosiban Altan 5 ml vial after dilution: Chemical and physical stability has been demonstrated for 24 hours at 25℃.
From a microbiological point of view, the 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 2-8℃, unless dilution has taken place in controlled and validated aseptic conditions.
6.5 Nature and contents of container
One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban base.
One ampoule of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban base.
Transparent type I glass vial/ampoule.
The vial is sealed with bromobutyl rubber stopper and flip off aluminium cap.


6.6 Instructions for use and handling
The vials/ampoules should be inspected visually for particulate matter and discoloration prior to administration.

Preparation of the initial intravenous injection:
Withdraw 0.9 ml of a 0.9 ml ampoule of Atosiban Altan, solution for injection, and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit. The Atosiban Altan ampoule, solution for injection, should be used immediately.
In the absence of incompatibility studies, this medicinal product should not be mixed with other medicinal products (see section ”Incompatibilities”).

Preparation of intravenous infusion solution:
For intravenous infusion, following the bolus dose, Atosiban Altan 5 ml vial, concentrate for solution for infusion, should be diluted in one of the following solutions:
• sodium chloride 9mg/ml (0.9%) solution for injection
• Ringer’s lactate solution
• 5% w/v glucose solution 
Withdraw 10 ml solution from a 100 ml infusion bag and discard. Replace it by 10 ml Atosiban Altan 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.

The reconstituted product is a clear, colourless solution without particles.

The loading infusion is given by infusing 24 ml/hour (18 mg/hour) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit. After three hours the infusion rate is reduced to 8 ml/hour.

Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.

If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation. To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/minute. An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.

If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used. This permits the continued independent control of the rate of infusion.