Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Citric acid monohydrate (E330)
Sodium chloride
Water for injections
Sodium hydroxide (E524) (for pH-adjustment)

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25°C.

From a microbiological point of view, the medicinal 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 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

This medicinal product does not require any special storage conditions.
For storage conditions of the diluted medicinal product, see section 6.3.

6.5   Nature and contents of container

Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.
Pack size of 1 vial includes either 10 ml or 25 ml of concentrate.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Read all steps before administration.
An infusion pump is the preferred delivery device. However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.

Preparation of BRINAVESS for infusion

Step 1:
BRINAVESS vials should be visually inspected for particulate matter and discolouration before administration. Any vials exhibiting particulate matter or discolouration should not be used.
Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow. Variations of colour within this range do not affect potency.

Step 2: Dilution of concentrate
To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted.
Create a solution with a concentration of 4 mg/ml following the dilution guidelines below: Patients ≤ 100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent.
Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.

Recommended diluents are Sodium Chloride 9 mg/ml (0.9%) solution for Injection, Lactated Ringers solution for Injection, or 5% glucose solution for injection.

Step 3: Inspection of the solution
The diluted sterile solution should be clear, colourless to pale yellow. The solution should be visually re-inspected for particulate matter and discolouration before administering.

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