Rompun: Product Information (Page 2 of 2)

WARNINGS

Human Safety: Not for human use. Keep out of reach of children.

  • Strictly avoid self-injection, oral intake and any contact with skin, eyes or mucosa.
  • In the case of accidental contact wash exposed skin or eyes abundantly with water. If symptoms occur, seek medical advice.
  • In the case of accidental oral intake or self-injection, seek the advice of a physician and show the package insert but DO NOT DRIVE.
  • If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure.
  • Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product.
  • Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.

Note to physician: Xylazine is an alpha2-adrenergic agonist with sedative, some analgesic and muscle relaxant properties. Symptoms after absorption may include dose-dependent respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycemia. Ventricular arrhythmias have also been reported.

The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call Dechra at 1-(866)-933-2472.

For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Animal safety: This drug should not be administered to domestic food-producing animals. Do not use in horses intended for human consumption.

In Cervidae , occasional capture-associated deaths occur. Clinical trials reveal a mortality rate of approximately 3.5% attendant with the administration of xylazine.

HOW SUPPLIED: Rompun (xylazine injection) 100 mg/mL Injection for intravenous or intramuscular use is available in 50 mL multiple dose vials.

STORAGE: Do not Freeze. Store at 20°C — 25°C (68°F — 77°F), excursions permitted up to 40°C (104°F).

REFERENCES:

  1. Detweiler, D.K.: “The Diagnosis and Significance of Cardiac Arrhythmias.” Progress In Equine Practice. Edited by E.J. Catcott and J.F. Smithcors.American Veterinary Publications, Inc., Santa Barbara. California and Wheaton, Illinois, (1966), 280-281.
  2. Glazier, D.B.: “Atrioventricular Heart Block.” Irish Vet. J, Vol. 12, (1958), 194-198.
  3. Holmes, J.R., Alps, B.J.: “Observations on Partial Atrioventricular Heart Block in the Horse.” Can. Vet. J., Vol. 7, No. 12, (1966), 280-290.
  4. Smetzer, D.L., Smith, C.R., Senta, T: “Second Degree Atrioventricular Block in the Horse.” Am. J. Vet. Res., Vol. 30, No. 6, (1969), 933-946.

Manufactured for:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Made in Latvia

Approved by FDA under NADA # 047-956

1000001151 B2L2

Rompun® is a registered trademark of Dechra Limited.
© 2022 Dechra Limited

Rev. January 2022

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Carton

Rompun®
(xylazine injection)
100 mg/mL

Sedative and Analgesic
For Use In Horses
and Cervidae Only

CONTAINS PER ML: Xylazine (base
equivalent) 100 mg (present as the
hydrochloride) with methylparaben
0.9 mg; propylparaben 0.1 mg; water for
injection; citric acid and sodium citrate for
pH adjustment to 5.5 ± 0.3.

Approved by FDA under NADA # 047-956

Net Contents:50 mL

Dechra

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Carton
(click image for full-size original)
ROMPUN xylazine injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-099
Route of Administration INTRAMUSCULAR, INTRAVASCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XYLAZINE (XYLAZINE) XYLAZINE 100 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17033-099-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (17033-099-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA047956 05/07/2014
Labeler — Dechra Vet Products, LLC (362142734)

Revised: 06/2022 Dechra Vet Products, LLC

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