Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of excipients
None.


6.2.   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

6.3.   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4.   Special precautions for storage

Unopened vial: Do not store above 30°.
Once opened the product should be used immediately after reconstitution.
When aseptically prepared the solution may be kept for not more than 24 hours if stored under refrigeration at a temperature between 2ºC and 8ºC.
For reconstitution instructions see enclosed appendix {SPC- 6.6 (step 1 and step 2)}.

6.5.   Nature and contents of container

Type I glass tubing vial with grey siliconised cholrobutyl lyophillisation stopper.

6.6.   Special precautions for use and disposal

Continuous intravenous infusion with an erythromycin concentration of 1 mg/ml (0.1% solution) is recommended. The infusion should be completed within 8 hours of preparation to ensure potency.

If required, solution strengths up to 5 mg/ml (0.5% solution) may be used, but should not be exceeded. Higher concentrations may result in pain along the vein. Bolus injection is not recommended.

For single use only, discard any unused contents.

The product must be reconstituted (step 1) and then further diluted (step 2) prior to administration.



Preparation of 1 g dose for Intermittent Infusion:

STEP 1                                       STEP 2


Add 20 ml Water for Injections    Add 20 ml of Step 1 solution to 200-250 ml Ph. Eur. to the 1 g vial.         of 0.9% Sodium Chloride Intravenous No other solvent apart from       Infusion BP. The resulting diluted solution Water for Injections Ph.Eur       contains 5 mg/ml – 4 mg/ml of should be used to prepare this    erythromycin.
initial solution.
When administering the product by intermittent infusion do not use solution strengths greater than 5 mg/ml and do not use rapid infusion rates – failure to observe these precautions may result in pain along the vein. For detailed instructions on administration, see section 4.2.

For Continuous Infusion of 1 gram dose:

Add 20 ml of Step 1 solution to 500-1000 ml of 0.9% Sodium Chloride
Intravenous Infusion BP. The resulting diluted solution contains 2 mg/ml – 1 mg/ml of erythromycin.

As rapid infusion is more likely to be associated with arrhythmias or hypotension, it is recommended that erythromycin IV is given over a minimum of 60 minutes. A longer period of infusion should be used in patients with risk factors or previous evidence of arrhythmias.

When fully prepared Erythrocin Lactobionate IV 1g powder for concentrate for solution should be virtually free of particulate matter prior to administration.