Tasmar

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Tolcapone 200mg;  

Dostopno od:

Roche Products (NZ) Ltd

INN (mednarodno ime):

Tolcapone 200 mg

Odmerek:

200 mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Tolcapone 200mg  

Enote v paketu:

Blister pack,

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

DSM Nutritional Products Ltd

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, -   - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, -   - 36 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

1996-07-22

Lastnosti izdelka

NEW ZEALAND DATA SHEET
TASMAR®
TASMAR
Page 1 of 14
1 PRODUCT NAME
TASMAR 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg tolcapone.
Excipients with known effect
Lactose monohydrate
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
TASMAR 100 mg is a pale to light yellow, hexagonal, biconvex
film-coated tablet with "TASMAR 100"
engraved on one side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
TASMAR is indicated for use in combination with levodopa/benserazide
and levodopa/carbidopa in
Parkinson's disease, including both fluctuating and non-fluctuating
patients.
4.2
Dose and method of administration
Children
TASMAR is not recommended for use in children below the age of 18 due
to insufficient data on
safety or efficacy. There is no relevant indication for use in
children and adolescents.
Elderly patients
No dose adjustment of TASMAR is recommended for elderly patients.
Patients with impaired renal function
No dose adjustment of TASMAR is recommended for patients with mild to
moderate renal
impairment (creatinine clearance of 30 mL/min or greater).
Patients with severe renal impairment (creatinine clearance < 30
mL/min) should be treated with
caution. No information on the tolerability of tolcapone in these
populations is available (see section
5.2).
Patients with hepatic impairment
TASMAR is contraindicated for patients with liver disease or increased
liver enzymes (see section
4.3).
Method of administration
The administration of TASMAR is restricted to prescription and
supervision by physicians
experienced in the management of advanced Parkinson's disease.
NEW ZEALAND DATA SHEET
TASMAR®
TASMAR
Page 2 of 14
TASMAR is administered orally three times daily. The first dose of the
day of TASMAR should
be taken together with the first dose of the day of a levodopa
preparation, and the
subsequent doses should be given approximately 6 and 12 hours later.
TASMAR may be taken with or without food (see section 5.2).