Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS
6.1      List of excipients

Water for Injections.
Carbon dioxide (for pH adjustment).

6.2      Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


6.3      Shelf life
* Shelf life as packaged for sale:
The expiry date of the product is indicated on the packaging materials.
* Shelf life after mixing:
The product, once removed from its overpouch and mixed, should be used within 24 hours.
6.4       Special precautions for storage
Store between 4°C to 25°C, in the original package.

6.5       Nature and contents of container
The Physioneal 40 solution is hermetically sealed inside a two-chambered bag manufactured from medical grade plasticised PVC.
The upper chamber is fitted with an injection port for drug admixture to the glucose with electrolytes solution. The lower chamber is fitted with a port for connection to a suitable administration set allowing dialysis operations.
The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment.
The bag is sealed inside a transparent overpouch obtained by thermic fusion and made of multilayer copolymers.
Container volumes after reconstitution: 1500 ml (544 ml of solution A and 956 ml of solution B), 2000 ml (725 ml of solution A and 1275 ml of solution B), 2500 ml (906 ml of solution A and 1594 ml of solution B).

The single bag is a two-chamber bag (small chamber "A" and large chamber "B", see section 2) to be used in Automated Peritoneal Dialysis. The twin bag is a two-chamber bag (small chamber "A" and large chamber "B", see section 2) with an integrated disconnect system plus an empty drain bag to be used in Continuous Ambulatory Peritoneal Dialysis.
Not all pack sizes may be marketed.

6.6       Special precautions for disposal and other handling

For details on the conditions of administration see section 4.2.
•     Detailed instruction on the Peritoneal Dialysis exchange procedure is given to patients by means of training, in a specialised training centre, prior to home use.

•     After removal of the overpouch, immediately break the interchamber frangible pin to mix the two solutions. Wait until the upper chamber has completely drained into the lower chamber. Mix gently by pushing with both hands on the lower chamber walls. The intraperitoneal solution must be infused within 24 hours after mixing. See section 4.2.

•     Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 10 IU/L, 20 IU/L and 40 IU/L).

•     Aminoglycosides should not be administered with penicillins in the same bag due to chemical incompatibility.
•     Drugs should be added through the medication port in the top chamber before breaking the interchamber frangible pin. Drug compatibility must be checked before admixture and the pH and salts of the solution must be taken into account. The product should be used immediately after any drug addition.

•     Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
•     In the case of damage, the container should be discarded.

•     The solution is free from bacterial endotoxins.

7.   LICENCE HOLDER AND MANUFACTURER
Licence Holder:
Baxter HealthCare Distribution Ltd., 34 Jerusalem St., Ra'anana, 4350110.

Manufacturer:

Baxter Healthcare S.A. Castlebar, Ireland.