Hydrea

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Hydroxycarbamide 500mg;  

Tilgjengelig fra:

Link Pharmaceuticals Ltd

INN (International Name):

Hydroxycarbamide 500 mg

Dosering :

500 mg

Legemiddelform:

Capsule

Sammensetning:

Active: Hydroxycarbamide 500mg   Excipient: Citric acid Dibasic sodium phosphate dodecahydrate Erythrosine Gelatin   Indigo carmine Iron oxide yellow Lactose monohydrate Magnesium stearate Opacode black S-1-277002 Titanium dioxide  

Enheter i pakken:

Bottle, glass, 100 capsules

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Prime European Therapeuticals SpA - Euticals SpA

Indikasjoner:

Significant tumour response to Hydrea (hydroxyurea) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent metastatic or inoperable carcinoma of the ovary. Hydrea 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: Bottle, glass, - 100 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with Child resistant cap - 100 capsules - 18 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1969-12-31

Preparatomtale

Hydrea v13.0
1
DATA SHEET
1
PRODUCT NAME
Hydrea
®
500 mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg of hydroxycarbamide (hydroxyurea).
Excipients with known effect:
Contains Lactose Monohydrate 42.2 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule: 500 mg; opaque green and pink marked CHP 500 in black ink,
size 0 capsule shell.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Significant
tumour
response
to
Hydrea
(
hydroxycarbamide
)
has
been
demonstrated
in
chronic
myelocytic leukaemia (pre-treatment phase and palliative care) and
recurrent metastatic or inoperable
carcinoma of the ovary. Hydrea 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
Because of the rarity of 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 TUMOURS:
_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
_single_
dose every
_third_
day.
Administration of Hydrea (hydroxycarbamide) should be begun at least
seven days before initiation of
irradiation and continued during radiotherapy as well as indefinitely
afterwards provided that the patient
may