| FILGEN |
|
Composition |
FILGEN contains filgrastim, [INN: recombinant-methionyl
human granulocyte-colony stimulating factor, r-met-HuG-CSF,
from E. coli bacteria.
Each
1.0 mL single use vial contains 300 mcg of filgrastim.
|
Indications

|
FILGEN is indicated for the reduction in the duration of neutropenia
and the incidence of febrile neutropenia in patients treated
with established cytotoxic chemotherapy for malignancy (with
the exception of chronic myeloid leukaemia and myelodysplastic
syndromes) and for the reduction in the duration of neutropenia
in patients undergoing myeloablative therapy followed by bone
marrow transplantation considered to be at increased risk of
prolonged severe neutropenia.
FILGEN
is also indicated for the mobilisation of peripheral blood
progenitor cells (PBPC).
In
patients, children or adults, with severe congenital, cyclic,
or idiopathic neutropenia with an ANC of 0.5 x 109/L, and
a history of severe or recurrent infections, long term administration
of FILGEN is indicated to increase neutrophil counts and to
reduce the incidence and duration of infection-related events.
FILGEN
is indicated for the treatment of persistent neutropenia (ANC
less than or equal to 1.0 x 109/L) in patients with advanced
HIV infection, in order to reduce the risk of bacterial infections
when other options to manage neutropenia are inappropriate.
|
| Dosage
and administration |
The
recommended dose of FILGEN is 0.5 MU (5 µg)/kg/day. The
first dose of FILGEN should not be administered less than 24
hours following cytotoxic chemotherapy. |
| How
supplied |
Each
1.0 ml single use vial contains 300 µg (30 million units)
of filgrastim. |
| Storage
condition |
Store
between 2 to 8 degree C. |
| Shelf
life |
Shelf life of the medicinal product: 2 years. |
| |
 |
| INF |
|
Composition
|
Each vial of INF powder for solution for injection contains
3 and 5 million IU of recombinant interferon alfa-2b. |
Indications

|
Chronic
Hepatitis B: Treatment of adult patients with
chronic hepatitis B associated with evidence of hepatitis B
viral replication (presence of HBV-DNA and HBeAg), elevated
ALT and histologically proven active liver inflammation and/or
fibrosis.
Chronic
Hepatitis C: Treatment of adult patients with
histologically proven chronic hepatitis C who have serum markers
for virus C replication, e.g., those who have elevated transaminases
without liver decompensation and who are positive for serum
HCV-RNA or anti-HCV.
The
efficacy of interferon alfa-2b in the treatment of hepatitis
C is enhanced when combined with ribavirin.
Hairy
Cell Leukaemia: Treatment of patients with hairy
cell leukaemia.
Chronic
Myelogenous Leukaemia: Monotherapy: Treatment
of adult patients with Philadelphia chromosome or bcr/abl
translocation positive chronic myelogenous leukaemia.
Clinical
experience indicates that a haematologic and cytogenetic major/
minor response is obtainable in the majority of patients treated.
A major cytogenetic response is defined by < 34 % Ph+ leukaemic
cells in the bone marrow, whereas a minor response is 34 %,
but < 90 % Ph+ cells in the marrow.
Combination
therapy: The combination of interferon alfa-2b and cytarabine
(Ara-C) administered during the first 12 months of treatment
has been demonstrated to significantly increase the rate of
major cytogenetic responses and to significantly prolong the
overall survival at three years when compared to interferon
alfa-2b monotherapy.
Multiple
Myeloma: As maintenance therapy in patients who have
achieved objective remission (more than 50 % reduction in
myeloma protein) following initial induction chemotherapy.
Current
clinical experience indicates that maintenance therapy with
interferon alfa-2b prolongs the plateau phase; however, effects
on overall survival have not been conclusively demonstrated.
Follicular
Lymphoma: Treatment of high tumour burden follicular
lymphoma as adjunct to appropriate combination induction chemotherapy
such as a CHOP-like regimen. High tumour burden is defined
as having at least one of the following: bulky tumour mass
> 7 cm), involvement of three or more nodal sites (each>
3 cm), systemic symptoms (weight loss> 10 %, fever>
38°C for more than 8 days, or nocturnal sweats), splenomegaly
beyond the umbilicus, major organ obstruction or compression
syndrome, orbital or epidural involvement, serous effusion,
or leukaemia.
Carcinoid
Tumour: Treatment of carcinoid tumours with lymph node
or liver metastases and with "carcinoid syndrome".
Malignant
Melanoma: As adjuvant therapy in patients who are free
of disease after surgery but are at high risk of systemic
recurrence, e.g., patients with primary or recurrent (clinical
or pathological) lymph node involvement.
|
| Dosage
and administration |
Chronic
Hepatitis B: The recommended dosage is in the
range 5 to 10 million IU administered subcutaneously three times
per week (every other day) for a period of 4 to 6 months.
Chronic
Hepatitis C: INF is administered subcutaneously
at a dose of 3 million IU three times a week (every other
day), whether administered as monotherapy or in combination
with ribavirin (Xolox).
Hairy
Cell Leukaemia: The recommended dosage is 2
million IU/m2 administered subcutaneously three times a week
(every other day) for both splenectomised and non-splenectomised
patients.
Chronic
Myelogenous Leukaemia: The recommended dosage
of INF is 4 to 5 million IU/m2 administered daily subcutaneously.
Some patients have been shown to benefit from INF 5 million
IU/m2 administered daily subcutaneously in association with
cytarabine (AraC) 20 mg/m2 administered daily subcutaneously
for 10 days per month (up to a maximum daily dose of 40 mg).
Multiple
Myeloma: Maintenance therapy: In patients who
are in the plateau phase (more than 50 % reduction of myeloma
protein) following initial induction chemotherapy, INF may
be administered as monotherapy, subcutaneously, at a dose
of 3 million IU/m2 three times a week (every other day).
Follicular
Lymphoma: Adjunctively with chemotherapy, INF
may be administered subcutaneously, at a dose of 5 million
IU three times a week (every other day) for a duration of
18 months. CHOP-like regimens are advised, but clinical experience
is available only with CHVP (combination of cyclophosphamide,
doxorubicin, teniposide and prednisolone).
Carcinoid
Tumour: The usual dose is 5 million IU (3 to
9 million IU) administered subcutaneously three times a week
(every other day). Patients with advanced disease may require
a daily dose of 5 million IU.
Malignant
Melanoma: As induction therapy, INF is administered
intravenously at a dose of 20 million IU/m2 daily for five
days a week for a four-week period; the calculated INF dose
is added to 0.9 % sodium chloride solution and administered
as a 20 minute infusion.
|
| How
supplied |
Packages
containing 1 vial, lyophilized with 3 or 5 MIU of interferon
alfa 2b and 1 vial of diluent containing 1 ml Water for Injection.
Includes sterile apyrogen syringe and sterile apyrogen needle
for sub-cataneous administration. |
| Storage
conditions |
Store
in the refrigerator at 2 to 8?C.
Use immediately after reconstitution. |
| Shelf
life |
3
years
After reconstitution: Chemical and physical
in-use stability has been demonstrated for 24 hours at 25ºC.
|
| |
 |
| PANATAXEL |
|
| Composition |
Paclitaxel 30 mg /
5mL injection |
Indications

|
PANATAXEL is indicated as first-line and subsequent therapy
for the treatment
of advanced carcinoma of the ovary. As first-line therapy,
TAXOL is indicated
in combination with cisplatin.
PANATAXEL is indicated for the adjuvant treatment of node-positive
breast
cancer, administered sequentially to standard doxorubicin-containing
combination chemotherapy.
PANATAXEL is indicated for the treatment of breast cancer
after failure of
combination chemotherapy for metastatic disease or relapse
within 6 months of adjuvant chemotherapy. Prior therapy
should have included an anthracycline unless clinically
contraindicated.
PANATAXEL, in combination with cisplatin, is indicated for
the first-line treatment of non-small cell lung cancer in
patients who are not candidates for
potentially curative surgery and/or radiation therapy.
PANATAXEL is indicated for the second-line treatment of
AIDS-related Kaposi’s sarcoma.
|
| Dosage
and administration |
Metastatic
carcinoma of the ovary
Adults: 135 mg/m2 given IV over 3 hr q 3 weeks after failure
of first-line or subsequent chemotherapy.
Advanced ovarian cancer
Paclitaxel, 135 mg/m2, followed by cisplatin, 75 mg/m2 over
24 hr, once q 3 weeks.
Metastatic breast cancer
Adults: 175 mg/m2 given IV over 3 hr q 3 weeks after failure
of chemotherapy for metastatic disease or relapse after 6
months of adjuvant chemotherapy.
Non samll cell lung cancer
the recommended regimen, given every 3 weeks, is TAXOL administered
intravenously over 24 hours at a dose of 135 mg/m2 followed
by cisplatin, 75 mg/m2.
AIDS-related Kaposi's sarcoma
135 mg/m2 given IV over 3 hr q 3 weeks or 100 mg/m2 given
IV over 3 hr q 2 weeks. |
| How
supplied |
One vial containing
paclitaxel 30 mg / 5 mL concentrate for injection |
| Storage
condition |
Store at 2-8 degree
celcius
Protect from light
(freezing does not affect this product) |
| |
 |
| DONATAXEL |
|
| Description |
DONATAXEL (docetaxel)
for Injection Concentrate is an antineoplastic agent belonging
to the taxane family. |
| Composition |
Each vial contains
docetaxel 20 mg |
| Indications |
Breast
Cancer
DONATAXEL is indicated for the treatment of patients with
locally advanced or metastatic breast cancer after failure
of prior chemotherapy.
Non-Small Cell Lung Cancer
DONATAXEL as a single agent is indicated for the treatment
of patients with locally advanced or metastatic non-small
cell lung cancer after failure of prior platinum-based chemotherapy.
Non-small cell lung cancer
DONATAXEL in combination with cisplatin is indicated for the
treatment of patients with unresectable, locally advanced
or metastatic non-small cell lung cancer who have not previously
received chemotherapy for this condition.
|
| Dosage
and administration |
Breast
Cancer: The recommended dose of DONATAXEL is 60-100 mg/m2
administered intravenously over 1 hour every 3 weeks.
Non-Small Cell Lung Cancer
The recommended dose is 75 mg/m2 administered intravenously
over 1 hour every 3 weeks.
Premedication Regimen
All patients should be premedicated with oral corticosteroids
such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3
days starting 1 day prior to DONATAXEL administration in order
to reduce the incidence and severity of fluid retention as
well as the severity of hypersensitivity reactions.
|
| How
supplied |
DONATAXEL
for Injection Concentrate is supplied in a single-dose vial
as a sterile, pyrogen-free, non-aqueous, viscous solution
with an accompanying sterile, non-pyrogenic, diluent (13%
ethanol in Water for Injection) vial. The following strengths
are available:
DONATAXEL 20 mg (docetaxel) 20 mg Concentrate
for Infusion: 20 mg docetaxel in 0.5 mL polysorbate 80 and
diluent for DONATAXEL 20 mg. 13% (w/w) ethanol in Water for
Injection. Both items are in a blister pack in one carton. |
| Storage
condition |
Docetaxel can be stored
at temperatures between 2°C and 25°C (36°F and 77°F). |