Hydroxycarbamide

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Hydroxycarbamide 500mg;  ;  

Tilgjengelig fra:

Devatis Limited

Dosering :

500 mg

Legemiddelform:

Capsule

Sammensetning:

Active: Hydroxycarbamide 500mg     Excipient: Citric acid Dibasic sodium phosphate Erythrosine Gelatin Indigo carmine Lactose monohydrate Magnesium stearate Quinoline yellow Titanium dioxide

Resept typen:

Prescription

Indikasjoner:

Significant tumor response to Hydroxycarbamide (hydroxyurea) has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent metastatic or inoperable carcinoma of the ovary. Hydroxycarbamide used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip, and carcinoma of the cervix.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, PA/Al/PVC - 100 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aclar/Al - 100 capsules - 24 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

2017-09-25

Preparatomtale

HYDROXYCARBAMIDE 500 MG CAPSULES
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly Confidential
Page
1
/
9
Version: NZ-V07/November 2023
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
HYDROXYCARBAMIDE 500 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Hydroxycarbamide
500 mg
EXCIPIENT WITH KNOWN EFFECT:
Lactose
42.2 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules.
Size 0 hard gelatin capsule with an opaque pink body and an opaque
light green cap, containing a white to off-
white homogeneous powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Significant tumor response to hydroxycarbamide has been demonstrated
in melanoma, resistant chronic
myelocytic leukemia, and recurrent metastatic or inoperable carcinoma
of the ovary. Hydroxycarbamide used
concomitantly with irradiation therapy is intended for use in the
local control of primary squamous cell
(epidermoid) carcinomas of the head and neck, excluding the lip, and
carcinoma of the cervix.
4.2 DOSE AND METHOD OF ADMINISTRATION
POSOLOGY/DURATION AND FREQUENCY OF ADMINISTRATION
Because of the rarity of melanoma, resistant chronic myelocytic
leukemia, carcinoma of the ovary, and
carcinomas of the head and neck in children, dosage regimens have not
been established. All dosage should
be based on the patient's actual or ideal weight, whichever is less.
Elderly patients may require a lower dose regimen.
Concurrent use of hydroxycarbamide with other myelosuppressive agents
may require adjustments of dosages.
SOLID TUMORS:
_INTERMITTENT THERAPY:_
80 mg/kg administered orally as a
_single _
dose every
_third _
day.
_CONTINUOUS THERAPY:_
20 to 30 mg/kg administered orally as a
_single _
dose
_daily_
.
The intermittent dosage schedule offers the advantage of reduced
toxicity since patients on this dosage regimen
have rarely required complete discontinuance of therapy because of
toxicity.
_CONCOMITANT THERAPY WITH IRRADIATION: (CARCINOMA OF THE HEAD AND
NECK)_
80 mg/kg administered orally as a