PropoFlo: Product Information (Page 2 of 2)

OVERDOSAGE

Rapid administration or accidental overdosage of propofol may cause cardiopulmonary depression. Respiratory arrest (apnea) may be observed. In cases of respiratory depression, stop drug administration, establish a patent airway, and initiate assisted or controlled ventilation with pure oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other techniques as appropriate for the observed abnormality.

WARNINGS

Rapid single or repeat bolus administration may cause undesirable cardiorespiratory depression including hypotension, apnea and oxygen desaturation.

When using propofol, dogs should be continuously monitored and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

SIDE EFFECTS

The primary side effect of propofol is respiratory depression as evidenced by tachypnea and apnea. Tachypnea and apnea were observed in 43 and 26% of the cases in the clinical trial, respectively. All cases of apnea resumed normal breathing spontaneously, or responded satisfactorily to oxygen supplementation and/or controlled ventilation.

Other transient side effects are observed infrequently or rarely:
Respiratory: labored breathing
Cardiovascular: hypotension, bradycardia, tachycardia, membrane cyanosis, arrhythmias
Musculoskeletal: fasciculations, tenseness, paddling, movements
Central Nervous System: excitation, opisthotonus, seizures, excessive depression
Gastrointestinal: emesis, retching, salivation

PRECAUTIONS

1. Propofol contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling since the vehicle is capable of supporting the rapid growth of microorganisms. Failure to follow aseptic handling procedures may result in microbial contamination causing fever, infection/sepsis, and/or other life-threatening illness. Do not use if contamination is suspected. Once propofol has been opened, vial contents should be drawn into sterile syringes; each syringe should be prepared for single patient use only. Unused product should be discarded within 6 hours.

2. Anesthesia effects: Careful monitoring of the patient is necessary when using propofol as a maintenance anesthetic due to the possibility of rapid arousal. Apnea may occur following maintenance doses of propofol. Following induction, additional propofol may be needed to complete the transition to inhalant maintenance anesthesia due to rapid recovery from propofol. Doses administered during the transition to inhalant anesthesia may result in apnea. Propofol has also been used during inhalant maintenance anesthesia to increase anesthetic depth. Propofol used during inhalant maintenance may result in apnea.

3. Physiological effects: Mild hypotension may occur during propofol anesthesia.

4. Premedicants: Premedicants may increase the anesthesia or sedative effect of propofol and result in more pronounced changes in systolic, diastolic and mean arterial blood pressures.

5. Breeding animals: The use of propofol in pregnant and breeding dogs has not been evaluated. Propofol crosses the placenta and, as with other general anesthetic agents, the administration of propofol may be associated with neonatal depression.

6. Neonates: Propofol has not been evaluated in dogs less than 10 weeks of age.

7. Compromised or debilitated dogs: Doses may need adjustment for geriatric or debilitated patients. The administration of propofol to patients with renal failure and/or hepatic failure has not been evaluated. As with other anesthetic agents, caution should be exercised in dogs with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated dogs. Geriatric dogs may require less propofol for induction of anesthesia (see Dosage and Administration).

8. Sighthounds: Propofol induction and maintenance produced satisfactory anesthesia and recoveries in sighthounds. In the clinical study, a total of 27 sighthounds were induced with propofol, 6 of which were maintained on propofol. Induction doses were similar in sighthounds compared to other animals, however, recoveries were delayed.

9. Cardiac arrhythmias: In one study, propofol increased myocardial sensitivity to the development of epinephrine-induced ventricular arrhythmias in a manner similar to other anesthetics.6 In the clinical study, transient ventricular arrhythmias associated with propofol were observed in 2 of 145 animals induced and maintained on propofol.

10. Concurrent medication: No significant adverse interactions with commonly used drugs have been observed.

11. Perivascular administration: Perivascular administration does not produce local tissue reaction.

CONTRAINDICATIONS

Propofol injection is contraindicated in dogs with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated.

HUMAN USER SAFETY

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

Rare cases of self-administration have been reported, including fatalities. Propofol 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.

Exercise caution to avoid accidental self-injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/ or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression should be treated by artificial ventilation and oxygen.

Hypersensitivity reactions to propofol, including anaphylaxis, may occur in some individuals who are also allergic to muscle relaxants7.

Avoid inhalation and direct contact of this product with skin, eyes, and clothes. In case of contact, eyes and skin should be liberally flushed with water for 15 minutes. Consult a physician if irritation persists.

CONTACT INFORMATION

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

STORAGE

Propofol undergoes oxidative degradation in the presence of oxygen and is therefore packaged under nitrogen to eliminate this degradation path. Store between 4 – 25°C (40-77°F). Do not freeze. Protect from light. Shake well before use.

HOW SUPPLIED

PropoFlo™ is supplied in cartons of five-20 mL (200 mg per vial) vials containing 10 mg propofol per mL.

REFERENCES

1. Detailed information on the pharmacokinetics and metabolism of propofol can be obtained from Zoetis Inc.

2. Smith, J.A., J.S. Gaynor, R.M. Bednarski and W.W. Muir. Adverse effects of administration of propofol with various preanesthetic regimens in dogs. JAVMA. 202:1111-1115 (1993).

3. Plumb, D.C. ed. Veterinary Drug Handbook, Second Edition. Iowa State University Press, Ames, IA (1995).

4. Detailed information on the preanesthetic doses used with propofol in clinical studies is available in the Freedom of Information (FOI) Summary or can be obtained from Zoetis Inc.

5. Muir, W.W., J.A.E. Hubbell, R.T. Skarda, and R.M. Bednarski. Handbook of Veterinary Medicine, Second Edition. Mosby-Year Book, Inc. (1995).

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

7. Laxenaire, M.C., E. Mata-Bermejo, D.A. Moneret-Vautrin and J.L. Gueant. Life-threatening anaphylactoid reactions to propofol (Diprivan®). Anesthesiology 77:275-280 (1992).

Approved by FDA under NADA # 141-098
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007Revised: June 2022

339 708

PRINCIPAL DISPLAY PANEL — 20 mL Label

20 mL Label
(click image for full-size original)

PROPOFLO propofol injection, emulsion
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5206
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 100 mg in 1 mL
GLYCERIN 22.5 mg in 1 mL
EGG PHOSPHOLIPIDS 12 mg in 1 mL
OLEIC ACID 0.6 mg in 1 mL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-5206-1 5 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (54771-5206-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141098 10/01/2015
Labeler — Zoetis Inc. (828851555)
Registrant — Zoetis Inc (828851555)

Revised: 04/2023 Zoetis Inc.

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