Pharmaceutical particulars : מידע רוקחי

6.      Pharmaceutical particulars
6.1     List of excipients
Mannitol, Hydrochloric acid solution and Sodium Hydroxide solution (for pH adjustment) and Water for injections.

6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf life for 37.5 mg/5 ml and 75 mg/10 ml:
- Once the vial has been opened, the product must be diluted (see Section 6.6).
6.4     Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
For storage conditions after first opening of the medicinal product (see Section 6.3).

6.5     Nature and contents of container
One colourless glass vial (5 ml or 10 ml), closed with a suitable rubber stopper and a 13 mm aluminium crimp cap with a plastic flip-off.
Lithographed cardboard box containing 1 vial and internal package leaflet.

6.6    Special precautions for disposal and other handling
The vials should be inspected visually for particulate matter and discoloration prior to administration.


Preparation of the initial intravenous infusion solution:
For intravenous infusion, following the bolus dose, Atosiban EVER Pharma 37.5 mg/5ml or Atosiban EVER Pharma 75 mg/10 ml, 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 EVER Pharma 75 mg/10 ml concentrate for solution for infusion or two 5 ml vials of 37.5 mg/5 ml 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 (i.e. 18 mg/h) 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 I00 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/min. An intravenous micro-drip chamber can provide a convenient range of infusion rates within the recommended dose levels for Atosiban EVER Pharma.

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.

All infusion solutions remain stable at all storage conditions (refrigerated without light, room temperature with or without light) for 48 hours. The samples exposed to typical laboratory light conditions do not show any difference to samples stored in the dark.
Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature with and without light protection and refrigerated conditions.
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 be no longer than  24 hours at 2 to 8ºC, unless dilution has taken place in control and aseptic conditions.

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