Orion Temozolomide

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Temozolomide 140mg

Disponibil de la:

Orion Laboratories (NZ) Ltd

INN (nume internaţional):

Temozolomide 140 mg

Dozare:

140 mg

Forma farmaceutică:

Capsule

Compoziție:

Active: Temozolomide 140mg Excipient: Colloidal silicon dioxide Gelatin Lactose Sodium starch glycolate Stearic acid Tartaric acid Titanium dioxide

Tip de prescriptie medicala:

Prescription

Produs de:

Perrigo API Ltd

Indicații terapeutice:

Treatment of: - Patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment - Patients with recurrent high grade glioma, such as glioblastoma multiforme or anaplastic astrocytoma

Rezumat produs:

Package - Contents - Shelf Life: Bottle, glass, - 5 capsules - 3 years from date of manufacture stored at or below 25°C protect from moisture

Data de autorizare:

2013-04-09

Caracteristicilor produsului

NEW ZEALAND DATASHEET
1 PRODUCT NAME
Orion Temozolomide capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Temozolomide 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg capsules.
3 PHARMACEUTICAL FORM
Orion Temozolomide 5 mg capsules have a white opaque capsule with two
stripes in green ink
on the cap and with “T 5 mg” in green ink on the body.
Orion Temozolomide 20 mg capsules have a white opaque capsule with two
stripes in orange
ink on the cap and with “T 20 mg” in orange ink on the body.
Orion Temozolomide 100 mg capsules have a white opaque capsule with
two stripes in pink ink
on the cap and with “T 100 mg” in pink ink on the body.
Orion Temozolomide 140 mg capsules have a white opaque capsule with
two stripes in blue ink
on the cap and with “T 140 mg” in blue ink on the body.
Orion Temozolomide 180 mg capsules have a white opaque capsule with
two stripes in red ink
on the cap and with “T 180 mg” in red ink on the body.
Orion Temozolomide 250 mg capsules have a white opaque with capsule
two stripes in black
ink on the cap and with “T 250 mg” in black ink on the body.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Orion Temozolomide capsules are indicated for the treatment of:
• patients with newly diagnosed glioblastoma multiforme
concomitantly with radiotherapy and
then as adjuvant treatment.
• patients with recurrent high grade glioma, such as glioblastoma
multiforme or anaplastic
astrocytoma.
Orion Temozolomide capsules are also indicated as first line treatment
for patients with
advanced metastatic malignant melanoma.
4.2 Dosage and method of administration
Anti-emetic
therapy
may
be
administered
prior
to
or
following
administration
of
Orion
Temozolomide capsules.
Orion Temozolomide capsules should be administered in the fasting
state at least one hour
before a meal. If vomiting occurs after the dose is administered, a
second dose should not be
administered that day. Orion Temozolomide capsules must not be opened
or chewed, but are to
be swallowed whole with a glass of water.