Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Mannitol, hydrochloric acid 1M and water for injection.

6.2. Incompatibilities
Atosiban PharmIdea 6.75 mg/0.9 ml solution for injection:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Atosiban PharmIdea 37.5 mg/5 ml concentrate for solution for infusion: 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 has been opened, the product must be used immediately.
Atosiban PharmIdea 37.5mg/5ml concentrate for solution for infusion after dilution: Chemical and physical in use stability has been demonstrated for 24 hours at 20-25°C. 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 to 8°C unless dilution has taken place in controlled and validated aseptic conditions.

6.4. Special precautions for storage
Store in a refrigerator at 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 the container
Atosiban 6.75mg/0.9ml solution for injection and 37.5mg/5ml concentrate for solution for infusion are packed in 2R and 6R colorless glass (Type I) vials respectively. The vials sealed with rubber stopper and flip-off cap.
Pack size: 1 vial.

6.6. Instructions for use and handling
The vials 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 labelled vial of Atosiban Pharmidea 6.75mg/0.9ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
The Atosiban Pharmidea 6.75mg/0.9ml, solution for injection vial 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 Pharmidea 37.5 mg/5ml, 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 Pharmidea 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.