Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sucrose, maltodextrin, hypromellose phthalate HP-55, carbopol 974P, titanium dioxide, fruit punch flavor, potassium sorbate, povidone K90, castor oil, silicon dioxide, citric acid, xanthan gum.

Klacid Paediatric Suspension contains 550 mg/ml Sucrose and 3.2 mg/ml Castor Oil.

6.2.   Incompatibilities
None known.

6.3.      Shelf life

Bottles: The recommended shelf life is 24 months.
Once reconstituted, Klacid Paediatric Suspension should be used within 14 days. store the reconstituted suspension at room temperature, not to exceed 30°C. do not keep prepared suspension in a refrigerator.

6.4.      Special precautions for storage

Store below 30oC.
6.5.      Nature and contents of container

Granules for reconstitution in a HDPE bottle. Pack sizes of 30ml, 50ml, 60ml and 100ml.

6.6.      Instructions for use and handling
100 ml bottle: 52ml of water should be added to the granules in the bottle and shaken to yield 100ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

60 ml bottle: 31ml of water should be added to the granules in the bottle and shaken to yield 60ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

50 ml bottle: 26ml of water should be added to the granules in the bottle and shaken to yield 50ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

30 ml bottle: 16ml of water should be added to the granules in the bottle and shaken to yield 30ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

7.     Manufacturer:

AbbVie S.r.l., Campoverde di Aprilia(LT), Italy