Cermin Dunia Kedokteran

Produk Baru

Paxus

Quantitative Composition (per ml)

Each ml Paxus

injection contains 6 mg of paclitaxel, 527 mg of

purified Cremophor

(polyoxyl 35 castor oil) and 49.7% (v/v) of

dehydrated alcohol.

Indications

Paxus

indicated as first-line and subsequent therapy for the

treatment of advanced carcinoma of the ovary. As first-line therapy

Paxus

is indicated in combination with cisplatin.

Paxus

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.

Contraindications

Paclitaxel is contraindicated in patients who have a history of

severe hypersensitivity reactions to paclitaxel or other drugs

formulated in polyoxyl 35 castor oil.

Paclitaxel should not be used in patients with baseline

neutrophil count of less than 1,500 cells/mm

or in patients with

AIDS related Kaposi's sarcoma with baseline neutrophil counts

of < 1000 cells/mm

Storage

Store the vials in original cartons between 21-30

°C. Retain in the

original package to protect from light.

Packag

1 Box @ 1 vial (5 ml)

Registration

Reg. No. DKL0303300143A1

Dosage and Administration

1) Premedication

Following sequence of premedication shall be done to prepare patient

for infusion with Paxus

injection.

12 hours before treatment.............. Dexamethasone 20 mg P.O.

6 hours before treatment................Dexamethasone 20 mg P.O.

30-60 minutes before treatment........Diphenhydramine 50 mg I.V.

Cimetidine 300 mg or

Ranitidine 50 mg I.V.

PAXUS

Inj

2) Preparation

Prior to infusion to patients, Paxus

injection shall be diluted in any of

following injection solutions to get a final concentration of 0.3-1.2 mg

of paclitaxel/ml.

0.9% Sodium Chloride Injection

5% Dextrose Injection

5% Dextrose/0.9% Sodium Chloride Injection

5% Dextrose in Ringer Injection solution

3) Dose schedule

Intravenous (i.v.) infusion at a dose of 175 mg/m

over a 3 hour

period. The treatment may be repeated every 3 weeks.

4) Repeat dosage

Subsequent treatment shall not be given to patients until neutrophil

count is at least 1,500 cells/mm

and platelet count is at least 100,000

cells/mm

. For patients who experienced severe neutropenia

(neutrophil < 500 cells/mm

) for a week or longer or moderate to

severe peripheral neuropathy during Paxus

injection treatment,

dosage shall be reduced by 20% for subsequent courses of Paxus

therapy.

5) Stability of diluted solutions

Physically and chemically stable for up to 27 hours at ambient

temperature (15-30

°C).

6) Infusion set

Undiluted concentrate shall not come in contact with plasticized

PVC equipments during preparation. To minimize patients'

exposure to the plasticizer DHEP, which may be leached from

PVC infusion bags or sets, diluted Paxus

solutions shall

preferably be stored in bottles (glass, propylene) or plastic bags

(polypropylene, polyolefin) and administered with polyethylene-

lined administration sets.

- Paxus

shall be administered through an in-line filter with a

microporous membrane not greater than 0.22 microns. Use of

filter devices such as IVEX-2 filters which incorporate short inlet

and outlet PVC-coated tubing has not resulted in significant

leaching of DHEP.

Marketing Office:

PT. KALBE FARMA Tbk

Gedung Enseval, Jl. Letjend. Suprapto, Jakarta 10510

PO Box 3105 JAK, Jakarta Indonesia

Tlp.: (021) 428 73888-89, Fax. : (021) 428 73680

Website : http://www.kalbe.co.id/paxus

Hotline service (bebas pulsa): 0-800-123-0-123, Senin Jumat (07.00-15.30)

Cermin Dunia Kedokteran No. 141, 2003 55