Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Solution for infusion:
Glucose monohydrate
Sodium citrate dihydrate
Citric acid anhydrous
Hydrochloric acid
Sodium hydroxide
Water for injections
600mg tablet:
Microcrystalline cellulose
Corn starch
Sodium starch glycollate
Hydroxypropyl cellulose
Magnesium stearate
Opadry white YS-1-18202-A
Carnauba wax

6.2    Incompatibilities
Solution for infusion:
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 sulfamethoxazole / trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.

600mg tablets:    Not applicable.

6.3 Shelf life
Solution for infusion:
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.
600mg tablets:
The expiry date of the product is indicated on the packaging materials.

6.4    Special precautions for storage

Solution for infusion:
Store below 25°C.
Store in the original package (overwrap and carton) until ready to use.
For storage conditions after first opening of the medicinal product, see section 6.3.
600mg tablets:
Store below 25°C, protect from light.
6.5    Nature and contents of container
Solution for infusion: Single use, ready-to-use, multilayered polyolefine film infusion bags sealed inside a foil laminate. overwrap. The bag holds either 100 ml, 200 ml or 300 ml solution.

600mg tablets: Polyvinyl chloride {PVC)/foil blisters of either 10,30 or 100 tablets, packaged in a box.

Not all package sizes may be marketed.

6.6     Special precautions for disposal and other handling
Solution for infusion:
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).

600 mg tablets:
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.