Alkeran Caution For Usage

Incompatibilities: Tab: None known.
Inj: ALKERAN Injection is not compatible with infusion solutions containing dextrose, and it is recommended that ONLY Sodium Chloride Intravenous Infusion 0.9% w/v is used.
Special Precautions for Disposal and Other Handling: Tab: Safe handling of melphalan tablets: The handling of melphalan should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and/or regulations.
Provided the outer coating of the tablet is intact, there is no risk in handling melphalan tablets.
Melphalan tablets should not be divided.
Inj: Alkeran injection should be prepared for administration either by or under the direct supervision of a pharmacist who is familiar with its properties and safe handling requirements.
Alkeran injection should be prepared for use in the aseptic unit of a pharmacy equipped with a suitable vertical laminar flow cabinet. Where such a facility is not available, a specially designated side room of a ward or clinic may be used.
Personnel preparing or handling Alkeran injection should wear the following protective clothing: Disposable gloves of surgical latex or polyvinylchloride of a suitable quality (rubber gloves are not adequate); surgical face mask of suitable quality; protective goggles or glasses which should be washed thoroughly with water after use; disposable apron.
In an aseptic facility, other suitable clothing will be required.
Any spillage should be dealt with immediately (by personnel wearing suitable protective clothing), by mopping with damp, disposable paper towels which are placed in a high-risk waste disposal bag after use and disposed of in compliance with relevant local legislation. Contaminated surfaces should be washed with copious quantities of water.
Should Alkeran injection solution come into contact with the skin, wash immediately, and thoroughly with soap and plenty of cold water. In such instances, it may be prudent to seek medical advice.
In case of contact with eyes, immediate irrigation with sodium chloride eye wash should be carried out and medical attention sought without delay. If sodium chloride solution is not available, large volumes of water may be used.
Disposal: Tab: Melphalan tablets should be destroyed in accordance with relevant local regulatory requirements concerning the disposal of cytotoxic drugs.
Inj: ALKERAN Injection solution should be disposed of in compliance with relevant local legislation. In the absence of such guidelines, the solution should be disposed of in a manner appropriate for toxic chemicals, for example, high-temperature incineration or deep burial.
Disposal of sharp objects, such as needles, syringes, administration sets and ampoules should be in rigid containers labelled with a suitable hazard warning seal. Personnel involved in disposal should be aware of the precautions to be observed, and the material should be destroyed by incineration if appropriate. All disposal must be in accordance with local regulatory requirements.
Instructions for Use/Handling: Safe Handling of ALKERAN Injection: ALKERAN Injection should be prepared for administration either by or under the direct supervision of a pharmacist who is familiar with its properties and safe handling requirements.
ALKERAN Injection should be prepared for use in the aseptic unit of a pharmacy equipped with a suitable vertical laminar flow cabinet. Where such a facility is not available, a specially designated side room of a ward or clinic may be used.
Personnel preparing or handling ALKERAN Injection should wear the following protective clothing: Disposable gloves of surgical latex or polyvinylchloride of a suitable quality (rubber gloves are not adequate); Surgical facemask of suitable quality; Protective goggles or glasses which should be washed thoroughly with water after use; Disposable apron.
In an aseptic facility, other suitable clothing will be required.
Any spillage should be dealt with immediately (by personnel wearing suitable protective clothing), by mopping with damp, disposable paper towels which are placed in a high-risk waste disposal bag after use and disposed of in compliance with relevant local legislation. Contaminated surfaces should be washed with copious quantities of water.
Should ALKERAN Injection solution come into contact with the skin, wash immediately and thoroughly with soap and plenty of cold water. In such instances it may be prudent to seek medical advice.
In case of contact with eyes, IMMEDIATE irrigation with sodium chloride eye wash should be carried out and medical attention sought without delay. If sodium chloride solution is not available, large volumes of water may be used.
Preparation of ALKERAN Injection Solution: (See also Safe Handling of ALKERAN as previously mentioned).
ALKERAN Injection should be prepared, AT ROOM TEMPERATURE, by reconstituting the freeze-dried powder with the Solvent-Diluent provided. 10 ml of this vehicle should be added, as a single quantity, and the vial immediately shaken vigorously until solution is complete. The resulting solution contains the equivalent of 5 mg/ml anhydrous melphalan and has a pH of approximately 6.5.
ALKERAN Injection solution has limited stability and should be prepared immediately before use. Any unused solution should be discarded (see Disposal as previously mentioned).
The reconstituted solution should not be refrigerated as this will cause precipitation.
When further diluted in an infusion solution, ALKERAN Injection has reduced stability and the rate of degradation increases rapidly with rise in temperature. If administration occurs at a room temperature of approximately 25°C, the total time from preparation of the Injection solution to the completion of infusion should not exceed 1.5 hours.
Should any visible turbidity or crystallization appear in the reconstituted or diluted solutions the preparation must be discarded.