XGEVA Solution for Injection 120 mgvial

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Denosumab

Հասանելի է:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

ATC կոդը:

M05BX04

Դոզան:

120 mg/vial

Դեղագործական ձեւ:

INJECTION, SOLUTION

Կազմը:

Denosumab 120 mg/vial

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Amgen Manufacturing Limited

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2012-03-02

Տեղեկատվական թերթիկ

1. NAME OF THE MEDICINAL PRODUCT  
XGEVA 120 mg solution for injection  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each vial contains 120 mg of denosumab in 1.7 ml of solution
(70 mg/ml).  

Denosumab is a human monoclonal IgG2 antibody produced in
a mammalian cell line (CHO) by  
recombinant DNA technology.  

Excipients with known effects:  
Each 1.7 ml of solution contains 78 mg sorbitol (E420).  

For a full list of excipients, see section 6.1.  

3. PHARMACEUTICAL FORM  

Solution for injection (injection).  
Clear, colourless to slightly yellow solution and may contain
trace amounts of translucent to white 
proteinaceous particles.  

4. CLINICAL PARTICULARS  

4.1 THERAPEUTIC INDICATIONS  
Prevention of skeletal related events (pathological fracture,
radiation to bone, spinal cord compression or 
surgery to bone) in adults with bone metastases from solid
tumours.  

Treatment of adults and skeletally mature
adolescents with giant cell tumor of bone that is unresectable
or 
where surgical resection is likely to result in severe
morbidity. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION  

Posology  

Skeletal-related events in patients with bone metastases from
solid tumours
.  

The recommended dose of XGEVA is 120 mg administered as a
single subcutaneous injection once every 
4 weeks into the thigh, abdomen or upper arm.  

Giant cell tumour of the bone 
The recommended dose of _XGEVA_ is 120 mg administered as
a subcutaneous injection once every 4 
weeks into the thigh, abdomen or upper arm, with
a loading dose of 120 mg on days 8 and 15 of the first 
month of therapy.  

Supplementation of at least 500 mg calcium and 400 IU vitamin
D is required in all patients, unless 
hypercalcaemia is present (see section 4.4).  

_Patients with renal impairment _�

Ապրանքի հատկությունները

1
1.
NAME OF THE MEDICINAL PRODUCT
XGEVA
®
120 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 120 mg of denosumab in 1.7 ml of solution (70
mg/ml).
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian
cell line (Chinese hamster
ovary cells) by recombinant DNA technology.
Excipients with known effects:
Each 1.7 ml of solution contains 78 mg sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution and may contain trace
amounts of translucent to white
proteinaceous particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of skeletal related events (pathological fracture,
radiation to bone, spinal cord compression or
surgery to bone) in patients with multiple myeloma and in patients
with bone metastases from solid
tumours.
Treatment of adults and skeletally mature adolescents with giant cell
tumour of bone that is unresectable
or where surgical resection is likely to result in severe morbidity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
XGEVA should be administered under the responsibility of a healthcare
professional.
Posology
Supplementation of at least 500 mg calcium and 400 IU vitamin D is
required in all patients, unless
hypercalcaemia is present (see section 4.4).
_Skeletal-related events in patients with multiple myeloma and in
patients with bone metastases from solid _
_tumours _
The recommended dose of XGEVA is 120 mg administered as a single
subcutaneous injection once every
4 weeks into the thigh, abdomen or upper arm.
2
_Giant cell tumour of the bone _
The recommended dose of XGEVA is 120 mg administered as a subcutaneous
injection once every
4 weeks into the thigh, abdomen or upper arm, with additional 120 mg
doses on days 8 and 15 of
treatment of the first month of therapy.
_Renal impairment_
No dose adjustment is required in patients with renal impairment (see
section 4.4 for recommendations
relating to monitoring of