Adrenalin

drugsafety@parpharm.com

Revision date : 2015-05-01

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-317-6/57-15-8

Name of the chemical

Chlorobutanol

Concentration

≤0.5%

EC/CAS

200-098-7/51-43-4

Name of the chemical

Epinephrine (INN)

Concentration

≤0.1%

General Information

Version

1.1.0

Revision date

2015-05-01

Product name

Adrenalin

Product Synonyms

Epinephrine chloride solution; For epinephrine: 4-[1-hydroxy-2-(methylamino)ethyl]1,2 benzenediol

Chemical name

Mixture - contains benzenediol derivative

1.2.1 Relevant identified uses

Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product of the substance or packaged in final form for patient use; indicated for the emergency treatment of mixture and uses severe acute allergic reactions, asthma, and chronic pulmonary disease

Emergency telephone

+1 (800) 424-9300, +1 (703) 527-3887

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Company Information

company name

drugsafety@parpharm.com

e-mail address of the competent person responsible for the Safety Data Sheet

drugsafety@parpharm.com

GHS Information

Signal word

None required

Section 2

SECTION 2: Hazards identification

GHS Classification Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk Epinephrine Solution Regulation (EC) 1272/ 2008 [GHS] Not classified Directive 67/548/EEC Not classified or 1999/45/EC

2.2 Label elements

CLP/GHS hazard None required

Signal word

None required CLP/GHS hazard None required US Hazard overview Note None required This mixture does not meet criteria for classification according to directive 1999/

Hazard statements

CLP/GHS None required

Precautionary statements

EU symbol/indication of danger None required Risk (R) Phrase(s) None required None required

2.3 Other hazards

Epinephrine (i.e., adrenaline) is an endogenous neurotransmitter hormone and its primary effects are vasoconstriction, cardiac stimulation, and smooth muscle relaxation. The most common adverse effects reported with therapeutic use include transient/moderate anxiety, feelings of over stimulation, restlessness, headache, tremor, weakness, shakiness, dizziness, sweating, increased heart rate, palpitations, paleness, nausea, vomiting, and difficulty breathing. Other symptoms, such as high blood pressure, cardiac arrhythmias, and cerebral bleeding, have occurred. As epinephrine can cross the placenta, it may adversely affect the fetus (e.g., reduce fetal oxygen levels due to constriction of blood vessels).

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to substance or mixture

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