SEVOFLURANE
Sevoflurane, USP Volatile Liquid for Inhalation
22700993-851a-48aa-941e-1d2b6b04081f
HUMAN PRESCRIPTION DRUG LABEL
May 31, 2023
Baxter Healthcare Corporation
DUNS: 005083209
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sevoflurane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Sevoflurane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
Container Label
NDC 10019-653-64
Sevoflurane, USP
Inhalation Anesthetic
250 mL
Rx only
Amerinet Choice® logo
Manufactured forBaxter Healthcare Corporation
Deerfield, IL 60015
and Amerinet Choice
2060 Craigshire Road
St. Louis, MO 63146
460-666-02
Contains sevoflurane, USP 250 mL.
For inhalation anesthesia.
**Usual Dosage:**See package insert.
Store at controlled room temperature
15°-30°C (59°-86°F) [see USP].
Do not use if tamper evident seal is
broken or loose.
For Product Inquiry 1 800 ANA DRUG
(1-800-262-3784)
N
3 1001965364 8
Container Label
The label is not currently available for NDC 10019-675-06
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
The concentration of sevoflurane, USP being delivered from a vaporizer should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane, USP. The administration of general anesthesia must be individualized based on the patient’s response.
Replacement of Desiccated CO2 Absorbents
When a clinician suspects that the CO2 absorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane, USP and CO2 absorbents is increased when the CO2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters (see PRECAUTIONS).
Pre-anesthetic Medication
No specific premedication is either indicated or contraindicated with sevoflurane, USP. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist.
Induction
Sevoflurane, USP has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults.
Maintenance
Surgical levels of anesthesia can usually be achieved with concentrations of 0.5 - 3% sevoflurane, USP with or without the concomitant use of nitrous oxide. Sevoflurane, USP can be administered with any type of anesthesia circuit.
Table 9: MAC Values for Adults and Pediatric Patients According to Age
| ||
|
Age of Patient (years) |
Sevoflurane in |
Sevoflurane in 65% |
|
0 - 1 months* |
3.3% | |
|
1 - < 6 months |
3.0% | |
|
6 months - < 3 years |
2.8% |
2.0%† |
|
3 - 12 |
2.5% | |
|
25 |
2.6% |
1.4% |
|
40 |
2.1% |
1.1% |
|
60 |
1.7% |
0.9% |
|
80 |
1.4% |
0.7% |
Directions for Filling Vaporizers
Filling occurs directly from the bottle via an integrated valve or, in case of a bottle without an integrated valve, with the use of an appropriate adaptor designed specifically to fit the sevoflurane, USP vaporizer.