Fonkopac 300mg/50ml injection

Ferron Par Pharmaceuticals

Ingredients in every 50 ml

Paclitaxel 300 mg

Each package contains

1 vial of 50 ml

Other details

Dosage form:Injection
Flavour: None

W.H.O. classification

ATC Level 1: L - Antineoplastic and immunomodulating agents
ATC Level 2: L01 - Antineoplastic Agents
ATC Level 3: L01C - Plant Alkaloids and Other Natural Products; Antineoplastic Drugs

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution.

Available in

Indonesia

Dosage information

18 YEARS OLD AND ABOVE
Ovarian cancer:
First-line treatment:
Intravenous administration of 175 mg/m² of body surface area (BSA) over 3 hours, followed by 75 mg/m² of cisplatin, or 135 mg/m² of paclitaxel as an infusion over 24 hours, followed by 75 mg/m² of cisplatin. A therapy-free interval of three weeks is recommended between therapy courses.
Second-line treatment:
The recommended dosage of paclitaxel is 175 mg/m² of body surface area, administered as a 3 hours infusion, with a 3-week interval between courses.

Breast cancer
The recommended dose of paclitaxel is 175 mg/m² of body surface area, administered over 3 hours, with a 3-week interval between courses.

Non-small cell lung cancer
The recommended dose of paclitaxel is 175 mg/m2 BSA administered over 3 hours followed by 80 mg/m² of cisplatin, with a 3-week interval between courses

Dose adjustment during treatment:
Subsequent dosing of paclitaxel depends on individual patient tolerance levels. Treatment courses with paclitaxel may be repeated only if blood counts with at least 1,500/mm³ of neutrophils and at least 100,000/mm³ of platelets have been achieved. In patients who exhibit severe neutropenia (neutrophils < 500/mm³ over a one-week period or longer) or severe peripheral neuropathies during paclitaxel therapy, dosage should be reduced by 20% in subsequent courses. PREMEDICATION All patients must be given premedication consisting of corticosteroids, antihistamines and H2-receptor antagonists prior to paclitaxel therapy. Premedication Dose Administration prior to paclitaxel Dexamethasone 20 mg orally approx. 12 and 6 hours Diphenhydramine 50 mg IV 30-60 minutes Cimetidine or 300 mg IV 30-60 minutes ranitidine 50 mg IV 30-60 minutes Paclitaxel should be administered using a microporous filter with a pore size of ≤0.22 µm (in line filter). For strictly intravenous infusion after dilution. Ovarian cancer First-line treatment: Although other dosage regimens are currently being evaluated, a combination therapy with paclitaxel and cisplatin is recommended for first-line treatment of ovarian cancer. Depending on the duration of infusion, two dosages regimens are recommended for paclitaxel treatment : Intravenous administration of 175 mg/m² of body surface area (BSA) over 3 hours, followed by 75 mg/m² of cisplatin, or 135 mg/m² of paclitaxel as an infusion over 24 hours, followed by 75 mg/m² of cisplatin. A therapy-free interval of three weeks is recommended between therapy courses. Second-line treatment: The recommended dosage of paclitaxel is 175 mg/m² of body surface area, administered as a 3-hour infusion, with a 3-week interval between courses. Breast cancer The recommended dose of paclitaxel is 175 mg/m² of body surface area, administered over 3 hours, with a 3-week interval between courses. Non-small cell lung cancer The recommended dose of paclitaxel is 175 mg/m² of body surface area administered over 3 hours followed by 80 mg/m² of cisplatin, with a 3-week interval between courses Dose adjustment during treatment Subsequent dosing of paclitaxel depends on individual patient tolerance levels. Treatment courses with paclitaxel may be repeated only if blood counts with at least 1,500/mm³ of neutrophils and at least 100,000/mm³ of platelets have been achieved. In patients who exhibit severe neutropenia (neutrophils < 500/mm³ over a one-week period or longer) or severe peripheral neuropathies during paclitaxel therapy, dosage should be reduced by 20% in subsequent courses.

Indication

Ovarian cancer
– As first line chemotherapy for the treatment of ovarian cancer in patients with advanced ovarian cancer or residual tumors ( > 1 cm) after preceding laparotomy, in combination with cisplatin.
– For second line chemotherapy of metastatic ovarian cancer in patients who have failed conventional therapeutic treatment with platinum containing agents.

Breast cancer
Paclitaxel given as a single agent is indicated for the treatment of metastatic breast cancer in patients where standardized anthracycline therapy has either failed or is not suitable.

Advanced non-small cell lung cancer
Combination paclitaxel with cisplatin is indicated for the treatment of non-small cell lung cancer in patients for whom a potentially curative surgical treatment and/or radiation therapy is not suitable.

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