Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS
6.1 List of excipients

MEGAXIN Tablets:
The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose 15 cP, macrogol 4000, titanium dioxide, and ferric oxide red.

MEGAXIN IV:
The inactive ingredients are Water for Injection, sodium chloride, and may include sodium hydroxide solution 2N and/or hydrochloric acid 1N for pH adjustment.
MEGAXIN IV contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.


6.2 Incompatibilities
IV: The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions
Sodium bicarbonate 4.2% and 8.4% solutions
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Tablets: Not applicable.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage

MEGAXIN Tablets: Store below 25°C; store in the original package in order to protect from moisture.

MEGAXIN IV: Do not store below 15ºC.

6.5 Nature and contents of container
MEGAXIN Tablets are available in PP/Aluminium foil blisters in cartons of 5, 7, 10 film-coated tablets.
Not all pack sizes may be marketed.

MEGAXIN IV in sodium chloride injection is available as infusion bottles 250 ml of colourless glass (type 2) sealed with chlorbutyl grey mat with foil-clad PTFE siliconized type 1 or Bromobutyl gray siliconized type 1 or Bromobutyl gray mat siliconized type 1 infusion stoppers and containing 400 mg of moxifloxacin in 0.8% saline.
NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.

Parenteral drug products should be inspected visually for particulate matter prior to administration.
Samples containing visible particulates should not be used.
Because the containers are for single-use only, any unused portion should be discarded.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

IV: This product is for single use only. Any unused solution should be discarded.
The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion:
Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer’s solution, Compound Sodium Lactate Solution (Hartmann’s Solution, Ringer- Lactate Solution).
Moxifloxacin solution for infusion should not be co-infused with other drugs.
Do not use if there are any visible particulate matter or if the solution is cloudy.
At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended not to store the infusion solution below 15°C.


Tablets: No special requirements.