Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for injections
6.2 Incompatibilities

When mixed with other medicinal products, potential incompatibilities should be considered.
A physiological solution is used as the main solvent and a vehicle of parenterally administered medicinal products. Detection of the added medicinal product incompatibility with the Sodium Chloride 0.9 % Imuna solution falls within the physician’s responsibility. A physician should inspect potential change in the solution colour and/or the potential presence of a clot, insoluble complexes, or formation of crystals. A physician should also read the manual on the use of the added medicinal product.
Prior to the addition of a medicinal product, it should be verified whether the medicinal product is soluble and stabile in water within the pH range.
Once a compatible medicinal product is added to the Sodium Chloride 0.9 % Imuna solution, the solution must be used immediately.
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.

6.4 Special precautions for storage
Store below 25°C. Do not freeze.
Keep in the outer package in order to protect from light.
Take the infusion bag out of the outer bag immediately before use. The infusion bag maintains the medicinal product sterility.


6.5 Nature and contents of container
A polyolefin and polypropylene bag with an infusion port and an injection port, with volumes of 100 ml, 250 ml, 500 ml, and 1,000 ml.

The bags are available in the following sizes:

1 x 100 ml, 1 x 250 ml, 1 x 500 ml, 1 x 1,000 ml (individually) 50 x 100 ml, 30 x 250 ml, 20 x 500 ml, 10 x 1,000 ml (in a cardboard box) 
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
For single use only. Any unused solution should be discarded.
Partially used bags should not be repeatedly attached.
Use only if the solution is clear, free of any visible particles, and if the packaging is intact. Apply immediately once attached to the infusion set.
Do not attach plastic bags in series. Such use may lead to an air embolism caused by drawing the remaining air in from the main bag before the fluid administration from the auxiliary bag is terminated. If the residual air is not fully removed from the bag prior to the administration, squeezing the intravenous solution in a flexible plastic packaging to accelerate the flow rate may cause an air embolism.
The solution must be administered aseptically, using a sterile device. To prevent the air from penetrating the system, the device must be filled up with the solution.
Other medicinal products may be added before or after the infusion administration via a venous line.
If another medicinal product is added to the solution, check the isotonicity prior to the parenteral administration. All added medicinal products must be thoroughly and carefully mixed in an aseptic manner. Solutions containing also other added medicinal products must be used immediately and must not be stored for later use.
For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Do not reattach partially used bags.
Take the infusion bag out of the outer bag immediately before use. The infusion bag maintains the medicinal product sterility.

BAG MANIPULATION INSTRUCTIONS MANUAL



1. INSPECTION PRIOR TO APPLICATION a) Check the bag for any leakage of fluid. If you observe any bag integrity disruption, discard the bag containing the solution, as its sterility may be impaired.
b) Check visually whether the solution meets the characteristics listed in the Summary of Product Characteristics. If not, the solution should be discarded. Prepare and apply the solution while using sterile materials.

2. PREPARATION FOR THE APPLICATION a) Hang the bag on a stand or put it on a horizontal surface (Figure 2a).
b) Break off a blue plastic cover from the delivery port (infusion port) (Figure 2b).
c) A rubber cap of the port is sterile, so the disinfection is not required. Attach a thick perforation needle of the infusion set to the infusion port (Figure 2c).
d) Proceed as described in the manual attached to the infusion set (set filling and solution application).
3. ADDING A MEDICINE TO THE SOLUTION a) Break off a transparent cover on the injection port. A rubber plug is sterile, so the disinfection is not required (Figure 3a).
b) Puncture the injection port and add the medicine. A recommended needle size: 19 G (1.10 mm) to 22 G (0.70 mm) (Figure 3b).
c) Thoroughly mix the bag content (Figure 3c).



Warning: Respect the instructions for the disposal of bags in the healthcare segment (content of the added medicine).

The bag may be filled up with the following maximum amounts of other medicines: