Propofol: Product Information (Page 3 of 3)

HUMAN USER SAFETY

Not for human use. Keep out of reach of children.

Propofol injectable emulsion injection should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting. Rare cases of self-administration of propofol have been reported, including dose-related fatalities.

Preventive care should be taken to avoid self-administration; for example, use of a guarded needle until the moment of injection is recommended. Symptoms of self-administration may include cardiovascular and/or respiratory depression. Anaphylaxis to propofol may occur during its first use, especially in patients with a history of drug allergy.7 In the event of accidental self-administration, seek medical attention immediately.

Contact of this product with skin, eyes, and clothes should be avoided. If contact occurs, skin and eyes should be liberally flushed with water for 15 minutes. If irritation develops and continues, consult a physician.

Initial arousal following propofol anesthesia can be extremely rapid. Caution should be used at this time in manipulations involving the mouth, such as removing an endotracheal tube.

ADVERSE REACTIONS

The primary side effect of propofol injectable emulsion injection is respiratory depression and apnea. Apnea was observed in 20% of the dog cases in the clinical trial. Apnea was observed in 1.4% of the cat cases in the clinical trial. All apnea cases responded satisfactorily to oxygen supplementation and/or controlled ventilation.

Apnea lasting less than 1 minute in healthy dogs or cats may cause no harm. Animals breathing atmospheric air that become apneic may show signs of cerebral damage after 2 minutes. Animals breathing 100% oxygen that become apneic may not show signs of cerebral damage for 5 to 8 minutes.

Ventricular arrhythmias may occur secondary to hypoxia induced by apnea.

The primary side effect of propofol injectable emulsion injection in cats is paddling during recovery. Paddling was observed in 11% of the cat cases in the clinical trial.

Other transient side effects in dogs or cats are observed infrequently or rarely:

Respiratory: panting, reverse sneezing, cyanosis
Musculoskeletal: paddling during recovery, tremors, tenseness, movements, fasciculations
Cardiovascular: bradycardia, hypotension, cyanosis, tachycardia, premature ventricular contractions
Central Nervous System: excitation, opisthotonus, seizure
Injection Site: pain during injection
Gastrointestinal: emesis/retching
Other: rubbing at face or nose during recovery, vocalization during recovery, chewing or licking the injection site during recovery

CLINICAL PHARMACOLOGY

After a single dose, propofol blood level profiles are characterized by a rapid distribution phase and a rapid elimination phase. The liver is the main site of metabolism with the major portion of metabolites being excreted in urine. No change in pharmacokinetics occurs after multiple daily dosing in dogs. Concomitant medication may affect the pharmacokinetics of either propofol or other medications.

In dogs, propofol injectable emulsion injection has been used in association with acepromazine, atropine, glycopyrrolate, halothane, isoflurane, medetomidine, oxymorphone, and xylazine. No pharmacological incompatibility has been encountered.

In cats, propofol injectable emulsion injection has been used in association with acepromazine, atropine, glycopyrrolate, butorphanol, oxymorphone, xylazine, and halothane. No pharmacological incompatibility has been encountered.

To report suspected adverse drug events, call 1-855-724-3461.

To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance go to covetrus.com.

For additional information about adverse drug experience reporting for animal drugs, Contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinarySafetyHealth.

STORAGE

Store between 4 — 25°C (40-77°F). Do not freeze.

Shake well before use. Discard opened vial with care. Within 6 hours after opening, any withdrawn unused product should be discarded safely.

HOW SUPPLIED

Propofol injectable emulsion injection is supplied in cartons of five-20 mL vials containing 10 mg propofol per mL.

REFERENCES

1. Thurman JC, Tranquilli WJ, Benson GJ, eds. Preanesthetics and anesthetic adjuncts. In: Lumb and Jones’ Veterinary Anesthesiolog y. 3rd ed; 1996: chap8.

2. Robertson SA, Johnson S, Beemsterboer J. Cardiopulmonary, anesthetic and postanesthetic effects of intravenous infusions of propofol in greyhounds and non-greyhounds. Am J Vet Res 53:1027- 1032: 1992.

3. Zoran DL, Riedesel DH, Dyer DC. Pharmacokinetics of propofol in mixed-breed dogs and greyhounds. Am J Vet Res 54:755-760: 1993.

4. Kamibayashi T, Hayashi Y, Sumikawa K, Yamatodani A, Kawabata K, Yoshiya I. Enhancement by propofol of epinephrine-induced arrhythmias in dogs. Anesthesiology 75:1035-1040 1991.

5. Bush BM. Interpretation of laboratory results for small animal clinicians. Blackwell Science: 1996.

6. Andress JL, Day TK, Day DG. The effects of consecutive day propofol anesthesia on feline red blood cells. Veterinary Surgery 24:277-282:1995.

7. Laxenaire MC, Mata-Bermejo E, Moneret-Vautrin DA, Gueant JL. Life-threatening anaphylactoid reactions to propofol (DIPRIVAN®). Anesthesiology 77:275-280: 1992.

8. Plumb D. Veterinary Drug Handbook 2nd ed. pp. 455-458: 1995.

9. Branson, KR, Gross ME, Booth NH, Adams RH, ed. Veterinary Pharmacology and Therapeutics 7th ed., pp. 299-300: 1995.

Net Contents: 5 x 20 mL

Made in Italy
Distributed by:
Covetrus North America
Dublin, OH 43017
covetrus.com

AH-Propofol-02Rev: 1019

PRINCIPAL DISPLAY PANEL — Carton Label

Principal Display Panel -- Carton Label
(click image for full-size original)

Carton Label

Front and Back Panel

covetrus

NDC 11695-2801-1

Propofol injectable
emulsion
Anesthetic Injection

Each mL contains 10 mg propofol
Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian
Approved by FDA under NADA # 141-070
FOR USE IN ANIMALS ONLY

5 x 20 mL

Reorder #059333

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

AH-059333-C-02
REV:1019

Made in Italy

Left Side Panel

Emulsion for intravenous use in dogs and cats.

Read package insert for complete product information.

Use strict aseptic technique. Contains no preservative.
Begin use promptly after removing entire vial contents.
Discard appropriately within 6 hours after opening. Do not
use if contamination is suspected.

Each mL contains propofol (10 mg), soybean oil (100 mg),
glycerol (22.5 mg), egg yolk phospholipid (12 mg) and sodium
metabisulfite (0.25 mg), with sodium hydroxide to adjust pH.
The propofol emulsion is isotonic and has a pH of 4.5-6.6.

Store between 4°C-25°C (40°F-77°F). Do not freeze.
Shake well before use.

Right Side Panel

For intravenous use in dogs and cats.

Uses: Propofol injectable emulsion is an injectable anesthetic
for use in dogs and cats as follows:

1. As a single injection to provide general anesthesia for
short procedures.

2. For induction and maintenance of general anesthesia
using incremental doses to effect.

3. For induction of general anesthesia where maintenance
is provided by inhalant anesthetics.

Read package insert for complete product information.

Contains no antimicrobial preservative.

Shake well before use. Remaining contents of a vial should be discarded safely within 6 hours after opening.

Store between 4°C-25°C (40°F-77°F). Do not freeze.

PROPOFOL propofol injection, emulsion
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:11695-2801
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOFOL (PROPOFOL) PROPOFOL 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
GLYCERIN
EGG PHOSPHOLIPIDS
SODIUM METABISULFITE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11695-2801-1 5 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (11695-2801-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141070 02/01/2021
Labeler — Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant — Ivaoes, LLC (080126338)

Revised: 02/2021 Butler Animal Health Supply, LLC dba Covetrus North America

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