GRANOCYTE 34 INJ.

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

RHUG-CSF(LENOGRASTIM)

Tilgjengelig fra:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

RHUG-CSF(LENOGRASTIM)

Enheter i pakken:

5Units Units

Produsert av:

SANOFI WINTHROP INDUSTRIE

Informasjon til brukeren

Not applicable.

Preparatomtale

GRANOCYTE
® 34
_Lenograstim _
Powder and solvent for solution for injection or infusion in
pre-filled syringes
NAME OF THE MEDICINAL PRODUCT
GRANOCYTE 34 million IU/mL, powder and solvent for solution for
injection or infusion, in
pre-filled syringes
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenograstim* (rHuG-CSF) 33.6 million International Units (equivalent
to 263 micrograms) per
mL after reconstitution.
* Produced by recombinant DNA technology in Chinese Hamster Ovary
(CHO) cells.
Excipients known to have a recognised action or effect: phenylalanine
For excipients, see section
_List of excipients_
.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection/ infusion, in pre-filled
syringes.
-
white powder
-
solvent: clear, colourless solution
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
▪
Reduction of the duration of neutropenia in patients (with non-myeloid
malignancy)
receiving myelosuppressive therapy followed by bone marrow
transplantation and who
are at increased risk of prolonged, severe neutropenia.
▪
Reduction of the duration of severe neutropenia and related
complications in patients
receiving well-established chemotherapy regimens known to be
associated with a
significant incidence of febrile neutropenia.
▪
Mobilization of Peripheral Blood Progenitor Cells (PBPC)
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be given in collaboration with an experienced
oncology and/or
hematology center.
Granocyte can be administered by subcutaneous injection or by
intravenous infusion.
Particular handling ofthe product or instructions for preparation are
given in Section Special
_precautions for disposal and other handling_
.
The recommended dose of Granocyte 34 is 150 μg (19.2 MIU) per m
2
body surface area per day,
therapeutically equivalent to 5 μg (0.64 MIU) per kg bodyweight per
day:
▪
following bone marrow transplantation (BMT) or peripheral stem cell
transplantation;
▪
following use of well-established cytotoxic chemotherapy protocols;
▪
in PBPC mobilization following chemo