Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Lactose monohydrate
Citric acid anhydrous (to adjust the pH)
Sodium hydroxide (to adjust the pH)

6.2     Incompatibilities
This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted concentrate in vial:
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Diluted infusion solution:
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Mycamine contains no preservatives. From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.

6.4     Special precautions for storage

Unopened vials: store below 25 OC.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.


6.5        Nature and contents of container

10 ml Type I glass vial with an isobutylene-isoprene (Fluoro resin film laminated) rubber stopper and a flip-off cap. The vial is wrapped with an UV-protective film.

Pack size: packs of 1 vial.

6.6        Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.

Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below. Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:

1.   The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
2.   Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall. Although the concentrate will foam, every effort should be made to minimise the amount of foam generated. A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
3.   The vial should be rotated gently. DO NOT SHAKE. The powder will dissolve completely.
The concentrate should be used immediately. The vial is for single use only. Therefore, unused reconstituted concentrate must be discarded immediately.
4.   All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken. The diluted infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
5.   The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming. The solution must not be used if it is cloudy or has precipitated.
6.   The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.

Preparation of the solution for infusion

Dose        Mycamine vial     Volume of sodium          Volume                 Standard infusion (mg)        to be used        chloride (0.9%) or        (concentration)        (added up to (mg/vial)         glucose (5%) to be        of reconstituted       100 ml) added per vial            powder                 Final concentration
50          1 x 50            5 ml                      approx. 5 ml           0.5 mg/ml (10 mg/ml)
100         1 x 100           5 ml                      approx. 5 ml           1.0 mg/ml (20 mg/ml)
150         1 x 100 + 1 x     5 ml                      approx. 10 ml          1.5 mg/ml 50
200         2 x 100           5 ml                      approx. 10 ml          2.0 mg/ml

After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.


7.         Name of manufacturer
Astellas Ireland Co., Ltd. Killoglin, Co. Kerry, Ireland
8.    Name of registration holder

Astellas Pharma International B.V. Israel.