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With the advent of the new year, we have launched the Oncology Division, with a range of highly sophisticated products in collaboration with the Bago Group of Argentina -- the leading pharmaceutical group in Latin America.

 

PRODUCTS  

 

  • FILGEN (Filgrastim)
  • INF (Interferon alfa 2b)
  • PANATAXEL (Paclitaxel)
  • DONATAXEL (Docetaxel)
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).
 
           
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