Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Sodium acetate trihydrate Acetic acid glacial
(for pH adjustment)
Water for injection
No preservative has been added.

6.2 Incompatibilities

Physical incompatibility has been documented for rocuronium bromide 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.

Rocuronium bromide Kalceks must not be mixed with other medicinal products except those mentioned in section 6.6.
If Rocuronium bromide Kalceks 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 Rocuronium bromide Kalceks and drugs for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with Rocuronium bromide Kalceks has not been established.

6.3 Shelf life

Unopened vial:
The expiry date of the product is indicated on the packaging materials (see also section 6.4 “Special precautions for storage”). Since Rocuronium bromide Kalceks does not contain a preservative, the solution should be used immediately after opening the vial.

Diluted solution:

The chemical and physical in-use stability of the diluted product (see section 6.6) has been demonstrated for 72 hours at 30°C.
From a microbiological point of view, the diluted product should be used immediately after dilution. 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 to 8°C unless the dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Storage in the Refrigerator
Store in the refrigerator (2 -8°C). Do not freeze.

Storage out of the refrigerator

The product may also be stored outside the refrigerator at a temperature of up to 25°C for a maximum of 12 weeks, after which it should be discarded. The product should not be placed back into the refrigerator once it has been kept outside. After first removal from the refrigerator, the 12 week shelf life applies and must not exceed the expiry date given on the pack.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container
5 ml of solution is filled in a colourless (type I) glass vial closed with a bromobutyl rubber stopper and flip-off aluminium cap.
Package size: 10 vials.

6.6 Special precautions for disposal and other handling

For single use.

Compatibility studies with the following infusion fluids have been performed: In nominal concentrations of 0.5 mg/ml and 2.0 mg/ml Rocuronium bromide Kalceks has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injections and Lactated Ringers solution.

Administration should be begun immediately after dilution, and should be completed within 24 hours. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.