RASAGILINE B&B rasagiline (as mesilate) 1 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rasagiline mesilate, Quantity: 1.56 mg (Equivalent: rasagiline, Qty 1 mg)

Available from:

GM Pharma International Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: purified talc; maize starch; citric acid monohydrate; microcrystalline cellulose; stearic acid; colloidal anhydrous silica; pregelatinised maize starch

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rasagiline is indicated for the symptomatic treatment of idiopathic Parkinson?s disease (PD) as monotherapy and as adjunct therapy to dopamine agonists or to levodopa.

Product summary:

Visual Identification: White to off-white, circular, flat faced, beveled edge, uncoated tablets, "1" debossed on one face with the other face plain.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-13

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - RASAGILINE B&B (RASAGILINE)
1. NAME OF THE MEDICINE
Rasagiline mesilate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate)
Rasagiline mesilate is a white to off-white powder, freely soluble in
water or ethanol and
sparingly soluble in isopropanol
Dissociation Constant: pKa (R
2
NH
2
+
/R
2
NH) = 7.4
Partition Coefficient (Log P): Octanol/Water
pH
1.2
5.0
7.0
7.4
Log P
-1.10
0.09
1.56
1.84
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
White to off-white, circular, flat faced, beveled edge, uncoated
tablets, “1” debossed on one face
with the other face plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline is indicated for the symptomatic treatment of idiopathic
Parkinson’s disease (PD) as
monotherapy and as adjunct therapy to dopamine agonists or to
levodopa.
4.2 DOSE AND METHOD OF ADMINISTRATION
Rasagiline should be administered orally, at a dose of 1 mg once daily
in both monotherapy and
adjunct therapy. It may be taken with or without food. Clinical trials
have demonstrated no
efficacy advantage for higher doses of rasagiline.
Change of levodopa dose in adjunct therapy: When rasagiline is used in
combination with
levodopa, a reduction of the levodopa dosage may be considered based
upon individual response.
ELDERLY PATIENTS (>65 YEARS)
No change in dosage is required for elderly patients.
Rasagiline was shown to be well-tolerated in elderly PD patients in
both monotherapy and
adjunct therapy.
CHILDREN AND ADOLESCENTS (<18 YEARS)
Not recommended as the safety and efficacy have not been established
in this population.
PATIENTS WITH HEPATIC IMPAIRMENT
Rasagiline
should
not
be
used
in
patients
with
hepatic
insufficiency
(SEE
SECTION
4.3
CONTRAINDICATIONS).
PATIENTS WITH RENAL IMPAIRMENT
No change in dosage is required for moderate renal impairment.
4.3 CONTRAINDICATIONS:
Rasagiline is contraindicated for use in patients who have
demonstrated hypersensitivity to
rasagiline or