Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Glucose (dextrose) monohydrate
Sodium citrate dihydrate
Citric acid anhydrous
Hydrochloric acid (10%) or Sodium hydroxide (10%)
Water for injections


6.2   Incompatibilities
Additives should not be introduced into this solution. If linezolid is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, if the same intravenous line is to be used for sequential infusion of several drugs, the line should be flushed prior to and following linezolid administration with a compatible infusion solution (see section 6.6).

Linezolid solution for infusion is known to be physically incompatible with the following compounds: amphotericin B, chlorpromazine hydrochloride,
diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium and sulphamethoxazole / trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.

6.3   Shelf life
Before opening: The expiry date of the product is indicated on the packaging materials.

After opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.


6.4   Special precautions for storage
This medicinal product does not require any special temperature storage conditions. It is recommended to store at room temperature.
Page 23 of 24
Store in the original package in order to protect from light.


6.5   Nature and contents of container
Single use, ready-to-use, polypropylene film infusion bags sealed with polycarbonate elastomer connector inside a foil laminate overwrap. Bags contain 300 ml solution and are packaged in a box containing 1, 2, 5, 6, 10, 12, 20 or 25 infusion bags.

Not all package sizes may be marketed.

6.6   Special precautions for disposal and other handling
For single use only. Remove overwrap only when ready to use, then check for minute leaks by squeezing the bag firmly. If the bag leaks, do not use as sterility may be impaired. The solution should be visually inspected prior to use and only clear solutions, without particles should be used. Do not use these bags in series connections. Any unused solution must be discarded. No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Do not reconnect partially used bags.

Linezolid solution for infusion is compatible with the following solutions: 5% glucose intravenous infusion, 0.9% sodium chloride intravenous infusion, Ringer-lactate solution for injection (Hartmann’s solution for injection).