Cyclophosphamide 2g powder for solution for injection vials

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Cyclophosphamide monohydrate

Dostupno od:

Sandoz Ltd

ATC koda:

L01AA01

INN (International ime):

Cyclophosphamide monohydrate

Doziranje:

2gram

Farmaceutski oblik:

Powder for solution for injection

Administracija rute:

Intravenous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 08010100; GTIN: 5050650128031

Svojstava lijeka

OBJECT 1
CYCLOPHOSPHAMIDE 2000 MG POWDER FOR SOLUTION
FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 26-Jun-2017 | Sandoz
Limited
1. Name of the medicinal product
Cyclophosphamide 2000 mg Powder for Solution for Injection or Infusion
2. Qualitative and quantitative composition
Each vial of Cyclophosphamide 2000 mg Powder for Solution for
Injection or Infusion contains 2138.0
mg cyclophosphamide monohydrate equivalent to 2000 mg cyclophosphamide
Strength after reconstitution: 20 mg cyclophosphamide (anhydrous)/ml
solution (for reconstitution
volumes, see 6.6.)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection/infusion
White crystalline powder
4. Clinical particulars
4.1 Therapeutic indications
Cyclophosphamide may be used alone or in combination with other
chemotherapeutic agents, depending
on the indication. Cyclophosphamide is indicated in the treatment of:
• Chronic Lymphocytic Leukemia (CLL)
• Acute Lymphocytic Leukemia (ALL)
• As conditioning for a bone marrow transplantation, in the
treatment of Acute Lymphoblastic Leukemia,
Chronic Myelogenous Leukemia and Acute Myelogenous Leukemia, in
combination with whole body
irradiation or busulfan
• Hodgkin's lymphoma, Non-Hodgkin's lymphoma and Multiple Myeloma.
• Metastatic ovarian, and breast, carcinoma
• Adjuvant treatment of breast carcinoma
• Ewing's sarcoma
• Small cell lung cancer
• Advanced or metastatic neuroblastoma
• Life-threatening autoimmune diseases: severe progressive forms of
lupus nephritis and Wegener's
granulomatosis
4.2 Posology and method of administration
Cyclophosphamide should only be used by clinicians experienced in the
use of cancer chemotherapy.
Cyclophosphamide should only be administered where there are
facilities for regular monitoring of
clinical, biochemical and haematological parameters before, during,
and after administration and under
the direction of a specialist oncology service.
_POSOLOGY_
Dosage must be individualised. Doses and