Pharmaceutical particulars : מידע רוקחי

6.PHARMACEUTICAL PARTICULARS

6.1 LIST OF EXCIPIENTS
Each ampoule also contains sodium chloride 7.43 mg/ml and water for injection.
Morphine Injections 20 mg/ml contains no preservatives.
Morphine Injections 20mg/ml is a clear and colorless to pale yellow preservative-free solution supplied as a sterile solution in sealed clear glass ampoules.

Not for single dose epidural, intrathecal or IV administration, but rather only as continuous infusion.

Neuraxial administration: Morphine Injections 20 mg/ml are for epidural and intrathecal infusion using a continuous microinfusion device, and only after filtering through a microfilter (5 microns or smaller). If dilution is required use 0.9% Sodium Chloride injection.
Continuous IV administration: Morphine Injections 20 mg/ml are for continuous IV infusion only after dilution in either Dextrose 5% injection or Sodium Chloride 0.9% injection to a final concentration of 0.1 mg/ml to 5 mg/ml, as determined by the patient's needs, prior administration.

6.2 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25˚C, protected from light. Keep stored in carton until time of use.
Morphine Injections 20 mg/ml contains no preservatives or antioxidants.

Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the injection is darker than pale yellow or if it contains a precipitate.

6.3 INCOMPATIBILITIES

Morphine sulphate has been reported to be physically or chemically incompatible with solutions containing aminophylline, amobarbital sodium, chlorothiazide sodium, heparin sodium, meperidine hydrochloride, methicillin sodium, nitrofurantoin sodium, pentobarbital sodium, phenobarbital sodium, phenytoin sodium, sodium bicarbonate, sodium iodide, thiopental sodium, sulfadiazine and sulfisoxazole.

Each 5 ml ampoule of Morphine Injections 20mg/ml contains 100 mg morphine sulphate and therefore it is recommended that special measures be taken to control this product within the hospital or clinic.
Consideration should be given to the limited indications for this product, the risk of overdosage and risk of its diversion and abuse.

Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.

6.4 SHELF LIFE
The expiry date of the product is indicated on the packaging materials.
Each ampoule of Morphine Injections 20 mg/ml is intended for single use only. Discard any unused portion.

6.5 NATURE AND CONTENT OF CONTAINER
Clear colourless to yellowish solution in translucent 5 ml ampoules.

7. REGISTRATION HOLDER
Rafa Laboratories Ltd., P.O. Box 405, Jerusalem 9100301, Israel.