AMYL NITRITE INHALANT USP 0.3 ml/ampoule

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AMYL NITRITE

Available from:

MEDSUPPLY INTERNATIONAL PTE. LTD.

ATC code:

V03AB22

Dosage:

0.3 ml/ampoule

Pharmaceutical form:

SOLUTION

Composition:

AMYL NITRITE 0.3 ml/ampoule

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Pharmacy Only

Manufactured by:

JAMES ALEXANDER CORPN

Authorization status:

ACTIVE

Authorization date:

1989-04-22

Patient Information leaflet

AMYL NITRITE INHALANT USP
845 ROUTE 94 BLAIRSTOWN, NJ 07825 ∙ [phone] ∙ FAX (908)
362-5019 ∙ WWW.JAMES-ALEXANDER.COM ∙ EMAIL:
[e-mail]
PRODUCT INFORMATION SHEET
INDICATIONS
AMYL NITRITE INHALANT USP IS AN ORGANIC NITRITE USED FOR THE RELIEF
AND PROPHYLACTIC
MANAGEMENT OF ANGINA PECTORIS. THE DRUG IS DELIVERED VIA INHALATION.
PHARMACOLOGY
THE PRINCIPAL PHARMACOLOGICAL ACTION OF AMYL NITRITE IS RELAXATION OF
VASCULAR SMOOTH MUSCLE,
RESULTING IN GENERALIZED VASODILATION. ALTHOUGH AMYL NITRITE REFLEXLY
INCREASES HEART RATE AND
MYOCARDIAL CONTRACTILITY WHICH INCREASES MYOCARDIAL OXYGEN
CONSUMPTION, THE REDUCTION IN
VENTRICULAR WALL TENSION RESULTS IN A NET DECREASE IN MYOCARDIAL
OXYGEN CONSUMPTION. BY DECREASING
MYOCARDIAL OXYGEN CONSUMPTION, AMYL NITRITE ALTERS THE IMBALANCE OF
MYOCARDIAL OXYGEN SUPPLY
WHICH CAUSES ANGINA PECTORIS.
PRODUCT STABILITY
JAC'S AMYL NITRITE INHALANT USP CARRIES A THREE (3) YEAR EXPIRATION
DATE.
PRODUCT STORAGE CONDITIONS
KEEP PROTECTED FROM LIGHT AT 2-8 DEGREES C (36-46 DEGREES F). AMYL
NITRITE IS EXTREMELY
FLAMMABLE. KEEP FROM HEAT AND OPEN FLAME.
DIRECTIONS FOR USE
_FOR INHALATION ONLY_. THE INHALANT SHOULD BE HELD AWAY FROM THE FACE
WHILE ACTIVATING THE
PACKAGE. TO BREAK THE INNER VIAL, CRUSH ONCE BETWEEN THE THUMB AND
FOREFINGER AT THE DOT LOCATED
AT THE CENTER OF THE INHALANT. CAREFULLY PASS THE INHALANT BACK AND
FORTH CLOSE TO THE NOSE OF THE
AFFECTED PERSON SEVERAL TIMES. DISCARD INHALANT AFTER USE. RELIEF
USUALLY OCCURS IN ONE TO THREE
MINUTES.
PRECAUTIONS
AMYL NITRITE INHALANT IS A PRESCRIPTION DRUG. USE ONLY IN ACCORDANCE
WITH A PHYSICIAN'S
INSTRUCTIONS. FDA REGULATIONS SPECIFICALLY PROHIBIT LABELING THE
PRODUCT FOR USES OTHER THAN THE
TREATMENT OF ANGINA PECTORIS (SEE 21CFR 250.102)
JAC PRODUCT CONFIGURATION AND PACKAGING
JAC OFFERS AMYL NITRITE INHALANT USP AS A UNIT DOSE INHALANT
CONTAINING 0.3 MLS (0.01 OUNCE).
JAC PRODUCT CODE 22101- NDC# 46414-2222-1- TWELVE INHALANTS PACKAGED
IN A BOX. PACKAGED 264
BOXES PER SHIPPER.
_PAGE 1 OF 2 _
AMYL NITRI

Safety Data Sheet

AMYL NITRITE INHALANT USP
Safety Data Sheet
according to the federal final rule of hazard communication revised on
2012 (HazCom 2012)
Date of issue: 06/03/2014
Version: 1.0
06/06/2014
EN (English)
Page 1
SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE
COMPANY/UNDERTAKING
1.1.
PRODUCT IDENTIFIER
Product form
:
Mixture
Trade name
:
Amyl Nitrite Inhalant USP
1.2.
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
Use of the substance/mixture
:
Prescription drug used for treatment of angina pectoris
Use of the substance/mixture
:
For professional use only
1.3.
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
James Alexander Corporation
845 Route 94 Blairstown
NJ 07825
Tel: [phone]
Note: The CHEMTREC emergency number is to be used only in the event of
chemical emergencies involving a spill, leak, fire, exposure, or
accident
involving chemicals. All non-emergency questions should be directed to
JAC at [phone].
1.4.
EMERGENCY TELEPHONE NUMBER
Emergency number
:
Chemtrec [phone]
SECTION 2: HAZARDS IDENTIFICATION
2.1.
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
GHS-US CLASSIFICATION
Flam. Liq. 2
H225
Acute Tox. 4 (Oral)
H302
Acute Tox. 4 (Inhalation:dust,mist)
H332
2.2.
LABEL ELEMENTS
GHS-US LABELLING
Hazard pictograms (GHS-US)
:
GHS02
GHS07
Signal word (GHS-US)
:
Danger
Hazard statements (GHS-US)
:
H225 - Highly flammable liquid and vapour
H302+H332 - Harmful if swallowed or if inhaled
Precautionary statements (GHS-US)
:
P210 - Keep away from heat, hot surfaces, open flames, sparks. - No
smoking
P233 - Keep container tightly closed
P240 - Ground/bond container and receiving equipment
P241 - Use explosion-proof electrical, lighting, ventilating equipment
P242 - Use only non-sparking tools
P243 - Take precautionary measures against static discharge
P261 - Avoid breathing dust, fume, gas, mist, spray, vapours
P264 - Wash hands thoroughly after handling
P270 - Do not eat, drink or smoke when using this product
P271 - Use only outdoors or in a well-ventilated area
P