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Fonkopac 300mg/50ml injection

Ferron Par Pharmaceuticals

Ingredients in every 50 ml

Paclitaxel 300 mg

Each package contains

1 vial of 50 ml

Dosage form

injection

Dosage formInjection

Flavour

None

W.H.O. classification

L01C
L01C

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01C

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01C

A.T.C. Level 3

Pharmacological subgroup

L01C - Plant Alkaloids and Other Natural Products; Antineoplastic Drugs

Available in

Indonesia

Warnings

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 and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

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.

Dosage

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

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.

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.