GENRX ALENDRONATE alendronate sodium trihydrate (equivalent to 70 mg alendronic acid) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

alendronate sodium trihydrate, Quantity: 91.35 mg (Equivalent: alendronic acid, Qty 70 mg)

Available from:

GM Pharma International Pty Ltd

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; mannitol; microcrystalline cellulose

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults, or by the presence of osteoporotic fracture.

Product summary:

Visual Identification: White, oval biconvex tablet engraved "APO" on one side and "ALE 70" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-08-28