Terrell: Package Insert and Label Information (Page 2 of 2)

HOW SUPPLIED


Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles.

100 ML — NDC 66794-011-10

250 ML — NDC 66794-011-25

SAFETY AND HANDLING

Occupational Caution
There is no specific work exposure limit established for Isoflurane. However, the National Institute for Occupational Safety and Health Administration (NIOSH) recommends that no worker should be exposed at ceiling concentrations greater than 2ppm of any halogenated anesthetic agent over a sampling period not to exceed one hour.

The predicted effects of acute overexposure by inhalation of Isoflurane include headache, dizziness or (in extreme cases) unconsciousness. There are no documented adverse effects of chronic exposure to halogenated anesthetic vapors (Waste Anesthetic Gases or WAGs) in the workplace. Although results of some
epidemiological studies suggest a link between exposure to halogenated anesthetics and increased health problems (particularly spontaneous abortion), the relationship is not conclusive. Since exposure to WAGs is one possible factor in the findings for these
studies, operating room personnel, and pregnant women in particular, should minimize exposure. Precautions include adequate general ventilation in the operating room, the use of a well-designed and well-maintained scavenging system, work practices to
minimize leaks and spills while the anesthetic agent is in use, and routine equipment maintenance to minimize leaks.

STORAGE

Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature].

Preserve in tight containers.Isoflurane, contains no additivesand has been demonstrated to be stable at room temperature for periods in excess of five years.

REFERENCES

1. J.C. Sill, et al , Anesthesiology 66:273-279, 1987

2. R.F. Hickey, et al , Anesthesiology 68:21-30, 1988

3. C.W. Buffington, et a l , Anesthesiology 66:280-292, 1987

4. S. Reiz, et al , 59:91-97, 1983

5. S. Slogoff and A.S. Keats, Anesthesiology 70:179-188, 1989

6. K.J. Tuman, et al , Anesthesiology 70:189-198, 1989

7. D.T. Mangano, Editorial Views, Anesthesiology 70:175-178, 1989

Bottle Label — 100 ml

100-ml-label
(click image for full-size original)

Bottle Label — 250 ml

250-ml-label
(click image for full-size original)

TERRELL isoflurane liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66794-011
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOFLURANE (ISOFLURANE) ISOFLURANE 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66794-011-10 100 mL in 1 BOTTLE, GLASS None
2 NDC:66794-011-25 250 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074416 02/28/2010
Labeler — Piramal Critical Care Inc (805600439)
Registrant — Piramal Critical Care Inc (805600439)
Establishment
Name Address ID/FEI Operations
Piramal Critical Care Inc 805600439 manufacture (66794-011)

Revised: 09/2019 Piramal Critical Care Inc

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