Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Rocurim contains the following excipients:
Acetic acid 30% (for pH adjustment)
Sodium chloride
Acetic acid 99% (for pH adjustment)
Sodium acetate trihydrate
Sodium hydroxide (for pH adjustment)
Water for injections
6.2 Incompatibilities
Physical incompatibility has been documented for Rocurim when added to solutions containing the following drugs: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.
Rocurim must not be mixed with other medicinal products except those mentioned in section 6.6.

If Rocurim is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed (e.g., with 0.9% NaCl) between administration of Rocurim and drugs for which incompatibility with Rocurim has been demonstrated or for which compatibility with Rocurim has not been established.

6.3 Shelf life
The expiry date of the product is indicated in the packaging materials.
After dilution with infusion fluids, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator 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
Storage in the refrigerator
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the ampoule/vial in the outer carton in order to protect from light.
Storage out of the refrigerator
Rocurim may also be stored outside of the refrigerator at a temperature of up to 25°C for a maximum 12 weeks, after which it should be discarded. For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container
For vials: Clear, colorless glass type I, closed with bromobutyl rubber stopper and polypropylene flip-off cap, packed in carton box.
Each carton contains 10 vials of 5 ml solution.
For ampoules: Clear, colorless glass type I, packed in carton box.
Each carton contains 10 ampoules of 5 ml solution.

6.6 Special precautions for disposal and other handling
Compatibility studies with the following infusion fluids have been performed: In nominal concentrations of up to 5 mg/ml Rocurim has been shown to be compatible with: sodium chloride 0.9%, glucose 5%, sodium chloride 0.9% with glucose 5%, water for injections and Lactated Ringers.