Granocyte 13

Productkenmerken

                                pfdgrani10319
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
GRANOCYTE
®
13 lenograstim 105 µg (13.4 million IU) powder for injection
GRANOCYTE
®
34 lenograstim 263 µg (33.6 million IU) powder for injection
Lenograstim (rch) is expressed in a mammalian host cell system,
Chinese hamster ovary (CHO) cells.
Lenograstim has a molecular weight of about 20,000 Daltons and
consists of 174 amino acids and
approximately 4% carbohydrate.
The amino acid sequence analysis of lenograstim reveals that it is
identical to native G-CSF.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
GRANOCYTE
®
13: Each 5mL vial contains lenograstim (rch) 105 µg (13.4 million IU)
GRANOCYTE
®
34: Each 5mL vial contains lenograstim (rch) 263 µg (33.6 million IU)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for injection.
White cake (lyophilised powder) in a glass vial with a rubber stopper
and a flip off cap.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

GRANOCYTE is indicated as a treatment to reduce the duration of
neutropenia and the severity
of infections in patients
with
non-myeloid malignancy
who have undergone autologous or
allogeneic bone marrow transplantation, or treatment with established
cytotoxic chemotherapy
and
in addition to reduce the incidence
of infection associated
with
established cytotoxic
chemotherapy.

GRANOCYTE is also indicated to mobilise peripheral blood progenitor
cells (PBPCs) with
GRANOCYTE
alone,
or
after
myelosuppressive
chemotherapy,
in
order
to
accelerate
haematopoietic recovery by infusion of such cells, after
myelosuppressive or myeloablative
therapy. GRANOCYTE is also indicated to accelerate the engraftment of
these cells after their
reinfusion.

GRANOCYTE
is
also
indicated
for
the
treatment
of
severe
chronic
neutropenia
including
congenital agranulocytosis (Kostmann's syndrome).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
GRANOCYTE 34 263 µg (33.6 million IU) per vial is used in patients
with body surface area up to 1.8 m².
GRANOCYTE 13 105 µg (13.4 million I
                                
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