daptomycin: package leaflet

stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 7 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

stand for 10 minutes.

reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

needle that is 21 gauge or smaller in diameter.

insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
7.
Replace needle with a new needle for the intravenous injection.
8.
Expel air, large bubbles, and any excess solution in order to obtain the required dose.
9.
The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25 °C and up to 48 hours if stored under refrigeration (2 °C – 8 °C).
However, from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2 °C – 8 °C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.
Cubicin vials are for single-use only. Any unused portion remaining in the vial should be discarded.

stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

stand for 10 minutes.

reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

needle that is 21 gauge or smaller in diameter.

insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
7.
Replace needle with a new needle for the intravenous injection.
8.
Expel air, large bubbles, and any excess solution in order to obtain the required dose.
9.
The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25 °C and up to 48 hours if stored under refrigeration (2 °C – 8 °C).
However, from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2 °C – 8 °C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.
Cubicin vials are for single-use only. Any unused portion remaining in the vial should be discarded.