Vincristine Injeksi

SAFETY DATA SHEET
SECTION 1 – SUBSTANCE/PREPARATION AND COMPANY

IDENTIFICATION
®
Material VINCRISTINE KALBE
Synonym(s) VINCRISTINE KALBE 1 MG VIAL 1 ML ® *
VINCRISTINE KALBE 2 MG VIAL 2 ML ® * Reg. No.
DKI 0405400543 A1 * VINCRISTINE SULPHATE,
FORMULATED PRODUCT
Company P.T. Kalbe Farma Tbk.
Jl. M.H. Thamrin Blok A3 No. 1
Delta Silicon Industrial Area
Lippo Cikarang – Bekasi 17550
Tel. +62-21-89907333 – 37
Fax. +62-21-8972874
SECTION 2 – COMPOSITION/INFORMATION ON
INGREDIENTS
No. Ingredients Percentage CAS No.

(w/w)
1. Vincristine Sulphate 0.1% 2068-78-2
2. Non-hazardous Ingredients 99.9% Unassigned
SECTION 3 – HAZARDS INFORMATION
Fire and Explosion This product is expected to be non-combustible.

Health This product contains the component that had
been reported, according to IARC, there is
inadequate data for evidence of carcinogenicity in
humans. Toxic. May decrease fertility.
Caution – Cytotoxic agent.
Environment No information available about the potential of
this product to produce adverse environmental
effects.
Page 1 of 5
SECTION 4 – FIRST AID MEASURES
Ingestion Wash out the mouth with water. Obtain medical

attention.
Inhalation If this product is inhaled, remove victim to fresh
air. If necessary, use artificial respiration to
support vital functions.
Skin Contact Flush exposed area with large amounts of
water. Removed contaminated clothing.
Obtain medical attention if skin reactions
occurs, which maybe immediate or delayed.
Eye Contact Wash immediately with clean and gently
flowing water. Continue for at least 15
minutes. Obtain medical attention.
SECTION 5 – FIRE-FIGHTING MEASURES
Fire and Explosion This product is expected to be non-combustible,

Hazards although the packaging is combustible.
Extinguishing Media Water spray, dry chemical powder, carbon dioxide
or foam extinguishers are recommended.
Special Firefighting Wear self contained breathing apparatus and full
Procedure protective equipment. Firefighters whose
protective equipment becomes contaminated
should thoroughly shower with warm, soapy water
and should receive medical evaluation.
SECTION 6 – ACCIDENTAL RELEASE MEASURES
Personal Precautions Use double pairs of latex disposable gloves which

must be disposed of within an hour, goggles,
impermeable body covering, and approved HEPA-
filtered or supplied-air respirator.
Environmental Mark out contaminated area with signs and
Precautions prevent unauthorized access. For large spill, take
precautions to prevent entry into waterways,
sewers, or surface drainage systems.
Clean up Methods Spread an inert absorbent on the spill and place in
a suitable, properly labeled container for disposal.
Decontaminate area by washing with soap and
water, followed by a final rinse with clean water.
Page 2 of 5
Decontaminate the area of the spill thoroughly by
using detergent and water.
SECTION 7 – HANDLING AND STORAGE
Handling Avoid contact with skin and eyes. Use proper

personal protective equipment. Wash hands
thoroughly after handling this product or
equipment and containers which contain this
product.
Storage Keep container tightly closed.
Follow product information storage instruction to
maintain efficacy (store below 8°C, protect from
light, do not freeze).
SECTION 8 – EXPOSURE CONTROLS/PERSONAL

PROTECTION
Respiratory Protection Under normal use, a respirator is not required. If

aerosols are generated, a half mask respirator
with a HEPA cartridges may be used.
Hand Protection Chemical resistant gloves.
Eye Protection Splash goggles recommended.
Skin Protection Impermeable body covering.
SECTION 9 – PHYSICAL AND CHEMICAL PROPERTIES
Appearance A clear colorless solution.

pH 3.50 – 5.50
SECTION 10 – STABILITY AND REACTIVITY
Stability This product is expected to be stable.

Condition to Avoid None for normal handling of this product.
Page 3 of 5
SECTION 11 – TOXICOLOGICAL INFORMATION
Pharmacological It is an antineoplastic agent intended for the

Effects treatment of cancer.
Target Organ Effects Adverse effects might occur in the following
organ(s): reproductive, blood, bone marrow,
livers.
Routes of Exposure
Oral Toxicity N/A.
Skin Effects May cause skin irritation.
Eye Effects May cause eye irritation.
Sensitization N/A.
Genetic Toxicity Not considered mutagenic in bacterial or
mammalian cells.
Carcinogenicity According to IARC, there is inadequate data for
evidence of carcinogenicity in humans.
Reproductive Effects May cause adverse reproductive effects
(decreased fertility, fetal death, embryotoxicity,
skeletal defects).
Other Adverse Effects Neurotoxicity, cranial nerve palsy, atrophy,
cramps, ataxia, constipation, paralytic ileus,
urinary tract disturbance, orthostatic hypotension,
depression, agitation, insomnia, alopecia,
leucopenia, anaemia, thrombocytopenia, nausea,
vomiting.
SECTION 12 – ECOLOGICAL INFORMATION
No information available about the potential of this product to produce

adverse environmental effects.
SECTION 13 – DISPOSAL CONSIDERATIONS
Disposal Methods Observe all local and national regulations while

disposing of this product.
Page 4 of 5
SECTION 14 – TRANSPORT INFORMATION
The SDS should accompany all shipments for reference in the event of
spillage or accidental release. Only authorized persons trained and
competent in accordance with appropriate national and international
regulatory requirements may prepare dangerous goods for transport.
Transport Information Transportation and shipping of this product is not
restricted. It has no know, significant hazard
requiring special packaging or labeling for air,
maritime, or ground transport purposes.
SECTION 15 – REGULATORY INFORMATION
The information included below is an overview of the major regulatory

requirements. It should not be considered to be an exhaustive summary.
Local regulations should be consulted for additional requirements.
US OSHA Standard (29 CFR Part 1910.1200)

Classifications The active ingredient of this product is classified
as hazardous according to the OSHA Hazard
Communication Standard.
European Information
Risk Phrases
R 28 Very toxic if swallowed.
R 38 Irritating to skin.
R 41 Risk serious damage to eyes.
SECTION 16 – OTHER INFORMATION
Prepared by Quality Assurance Department

Date Approved/Revised 07-Aug-08
SDS Version Number 1
The information and recommendations in this safety data sheet are, to the
best knowledge, accurate as of the date of issue. Nothing here in shall be
deemed to create any warranty, express or implied. It is the responsibility
of the user to determine the applicability of this information and the
suitability of the material or product for any particular purpose.
Page 5 of 5

Vincristine Injeksi

Uploaded by

Copyright:

Available Formats

Vincristine Injeksi

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Vincristine Injeksi

Uploaded by

Copyright:

Available Formats

SAFETY DATA SHEET

SECTION 1 – SUBSTANCE/PREPARATION AND COMPANY

No. Ingredients Percentage CAS No.

SECTION 3 – HAZARDS INFORMATION

Fire and Explosion This product is expected to be non-combustible.

Ingestion Wash out the mouth with water. Obtain medical

SECTION 5 – FIRE-FIGHTING MEASURES

Fire and Explosion This product is expected to be non-combustible,

SECTION 6 – ACCIDENTAL RELEASE MEASURES

Personal Precautions Use double pairs of latex disposable gloves which

SECTION 7 – HANDLING AND STORAGE

Handling Avoid contact with skin and eyes. Use proper

SECTION 8 – EXPOSURE CONTROLS/PERSONAL

Respiratory Protection Under normal use, a respirator is not required. If

SECTION 9 – PHYSICAL AND CHEMICAL PROPERTIES

Appearance A clear colorless solution.

SECTION 10 – STABILITY AND REACTIVITY

Stability This product is expected to be stable.

Pharmacological It is an antineoplastic agent intended for the

SECTION 12 – ECOLOGICAL INFORMATION

No information available about the potential of this product to produce

SECTION 13 – DISPOSAL CONSIDERATIONS

Disposal Methods Observe all local and national regulations while

SECTION 15 – REGULATORY INFORMATION

The information included below is an overview of the major regulatory

US OSHA Standard (29 CFR Part 1910.1200)

SECTION 16 – OTHER INFORMATION

Prepared by Quality Assurance Department

You might also like