RASALINE 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:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: stearic acid; purified talc; mannitol; colloidal anhydrous silica; maize starch; pregelatinised maize starch

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RASALINE 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, round, flat, bevelled tablets, debossed with GIL + 1 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-30

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – RASALINE™ (RASAGILINE)
1
NAME OF THE MEDICINE
Rasagiline 1 mg tablets
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, round, flat, bevelled tablets, debossed with
“GIL” and “1” underneath on one
side and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RASALINE 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
D
OSE 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.
Rasaline PI V1.0
Based on CCSI_752_03_03_17
Page 1
PATIENTS WITH HEPATIC IMPAIRMENT
Rasagiline should not be used in patients with hepatic insufficiency
(SEE SECTION 4.3).
PATIENTS WITH RENAL IMPAIRMENT
No change in dosage is required for moderate renal impairment.
4.3
C
ONTRAINDICATIONS
Rasagiline is contraindicated for use in patients who have
demonstra