Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Esmeron contains the following excipients:
Sodium chloride
Sodium acetate (for pH adjustment)

Acetic acid (for pH adjustment)
Water for injection
No preservative has been added.

6.2 Incompatibilities
Physical incompatibility has been documented for Esmeron 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.

Esmeron must not be mixed with other medicinal products except those mentioned in section 6.6.

If Esmeron 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 Esmeron and drugs for which incompatibility with Esmeron has been demonstrated or for which compatibility with Esmeron has not been established.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials (see also section 6.4 “Special precautions for storage”). Since Esmeron does not contain a preservative, the solution should be used immediately after opening the vial.
From 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 method rules out microbiological contamination. The chemical and physical in-use stability of the diluted product (see section 6.6) has been demonstrated for 72 hours at 30°C 

6.4 Special precautions for storage
Storage in the Refrigerator
Store in the refrigerator at 2°C-8°C.

Storage out of the refrigerator
The product can be stored outside the refrigerator at a temperature of up to 30°C for a maximum of 12 weeks. The product may not be placed back, once kept outside the refrigerator. 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
Esmeron 50 mg in 5 ml (10 mg/ml)
Packaging of 12 or 10 vials each containing 50 mg rocuronium bromide.

Not all pack sizes may be marketed.

Type 1 Ph.Eur., glass vial with a rubber closure and flip off cap. The rubber stopper of the vial does not contain latex.

In correspondence please quote lot number.

6.6 Special precautions for disposal and other handling
Compatibility studies with the following infusion fluids have been performed: In nominal concentrations of 0.5 mg/ml and 2.0 mg/ml Esmeron has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injections, Lactated Ringers and Haemaccel. Administration should be begun immediately after mixing, and should be completed within 24 hours. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.