CeeNU

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Lomustine 40mg

Beszerezhető a:

Link Pharmaceuticals Ltd

INN (nemzetközi neve):

Lomustine 40 mg

Adagolás:

40 mg

Gyógyszerészeti forma:

Capsule

Összetétel:

Active: Lomustine 40mg Excipient: Gelatin Indigo carmine Iron oxide yellow Magnesium stearate Mannitol Opacode black S-1-27794 Titanium dioxide  

db csomag:

Bottle, HDPE with PP child resistant closure, 20 capsules

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Dr Reddy's Laboratories Limited

Terápiás javallatok:

CeeNU is indicated as palliative therapy to be employed in addition to other modalities, or in established combination therapy with other approved chemotherapeutic agents in the following: 1. Brain Tumours - both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.

Termék összefoglaló:

Package - Contents - Shelf Life: Bottle, HDPE with PP child resistant closure - 20 capsules - 36 months from date of manufacture stored at or below 25°C protect from light

Engedély dátuma:

1980-07-17

Termékjellemzők

CeeNU V6.0
1
DATA SHEET
1
PRODUCT NAME
CeeNU
®
10 mg capsules.
CeeNU
®
40 mg capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEENU 10 MG CAPSULES
Each capsule contains 10 mg of lomustine.
Excipients with known effect:
Each capsule contains 213.87 mg of mannitol.
CEENU 40 MG CAPSULES
Each capsule contains 40 mg of lomustine.
Excipients with known effect:
Each capsule contains 278.40 mg of mannitol.
Mannitol 213.87 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, 10mg (white, marked CPL 3030/10mg)
Capsules, 40mg (white/dark green, marked CPL 3031/40mg)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CeeNU is indicated as palliative therapy to be employed in addition to
other modalities, or in
established combination therapy with other approved chemotherapeutic
agents in the following:
1.
Brain Tumours - both primary and metastatic, in patients who have
already received
appropriate surgical and/or radiotherapeutic procedures.
2.
Hodgkin's Disease - as a secondary therapy.
3.
Advanced Lung Carcinoma - for small cell carcinoma CeeNU is effective
in combination
with other appropriate neoplastic agents, particularly
cyclophosphamide. Patients who have
demonstrated delayed hypersensitivity competence in pretreatment
testing are usually more
responsive to therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of CeeNU in adults and children is 130 mg/m
2
as a single dose by mouth
every 6 weeks. (see Directions to Pharmacists below).
CeeNU V6.0
2
In individuals with compromised bone marrow function, the dose should
be reduced to 100 mg/m
2
every 6 weeks.
A repeat course of CeeNU should not be given until circulating blood
elements have returned to
acceptable levels (platelets > 100,000/mm
3
; leukocytes > 4,000/mm
3
). Blood counts should be
monitored weekly, and repeat courses should not be given before 6
weeks because the haematologic
toxicity is delayed and cumulative.
Doses subsequent to the initial dose should be adjusted according to
the haematologic response