DBL™ Bortezomib

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Bortezomib 2.5mg (as a mannitol boronic ester)

Sẵn có từ:

Pfizer New Zealand Limited

Liều dùng:

2.5 mg

Dạng dược phẩm:

Powder for injection

Thành phần:

Active: Bortezomib 2.5mg (as a mannitol boronic ester) Excipient: Mannitol

Loại thuốc theo toa:

Prescription

Chỉ dẫn điều trị:

Bortezomib in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. Bortezomib as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. Bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Vial, glass, Clear type I with rubber stopper and aluminium seal in cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C 8 hours reconstituted stored at or below 25°C

Ngày ủy quyền:

2018-01-08

Đặc tính sản phẩm

Version: pfdbortv10323
Supersedes: pfdbortv11221
Page 1 of 40
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
DBL™ Bortezomib 1 mg, 2.5 mg, 3.0 mg, 3.5 mg powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains:
•
1mg of bortezomib as a sterile lyophilised powder
•
2.5 mg of bortezomib as a sterile lyophilised powder
•
3.0 mg of bortezomib as a sterile lyophilised powder
•
3.5 mg of bortezomib as a sterile lyophilised powder
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for Injection.
DBL Bortezomib Powder for Injection is supplied as white, to off white
lyophilised powder.
The solubility of bortezomib, as the monomeric boronic acid, in water
is: 3.3 – 3.8 mg/mL in
a pH range of 2 – 6.5.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Bortezomib powder for injection in combination with melphalan and
prednisone, is
indicated for the treatment of patients with previously untreated
multiple myeloma, who are
not suitable for high dose chemotherapy.
DBL Bortezomib powder for injection, as part of combination therapy,
is indicated for
induction therapy prior to high dose chemotherapy with autologous stem
cell rescue for patients
under 65 years of age with previously untreated multiple myeloma
DBL Bortezomib powder for injection is also indicated for the
treatment of multiple myeloma
patients who have received at least one prior therapy, and who have
progressive disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
DBL
BORTEZOMIB
POWDER
FOR
INJECTION
IS
FOR
INTRAVENOUS
OR
SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN
DEATH.
DBL Bortezomib Powder for Injection may be administered:
•
Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus
injection or
Version: pfdbortv10323
Supersedes: pfdbortv11221
Page 2 of 40
•
Subcutaneously (at a concentration of 2.5 mg/mL).
Because each route of administration has a different reconstituted
concentration, caution should
be used when calculating the