Orion Temozolomide

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Temozolomide 140mg

Tilgængelig fra:

Orion Laboratories (NZ) Ltd

INN (International Name):

Temozolomide 140 mg

Dosering:

140 mg

Lægemiddelform:

Capsule

Sammensætning:

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

Recept type:

Prescription

Fremstillet af:

Perrigo API Ltd

Terapeutiske indikationer:

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

Produkt oversigt:

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

Autorisation dato:

2013-04-09

Produktets egenskaber

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.