Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
Kindred Biosciences, Inc.
TOPICAL
PRESCRIPTION
Mirataz™ is contraindicated in cats with a known hypersensitivity to mirtazapine or to any of the excipients. Mirataz™ should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor (MAOI) [e.g. selegiline hydrochloride (L-deprenyl), amitraz], as there may be an increased risk of serotonin syndrome.
Mirataz™ is supplied in a 5 gram aluminum tube.
New Animal Drug Application
MIRATAZ- MIRTAZAPINE OINTMENT KINDRED BIOSCIENCES, INC. ---------- MIRATAZ™ (MIRTAZAPINE TRANSDERMAL OINTMENT) Each 1 g of Mirataz™ contains 20 mg mirtazapine (2%). Each 5 g tube contains 100mg (0.1 g) of mirtazapine. For topical application in cats only. Not for oral or ophthalmic use. CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Mirataz™ (mirtazapine transdermal ointment) is a white to off-white ointment containing 2% (w/w) of mirtazapine suitable for transdermal (topical) administration. Mirataz™ contains the following inactive ingredients: Polyethylene Glycol (PEG) 400, PEG 3350, Diethylene Glycol Monoethyl Ether, PEG-8 Caprylic/Capric Glycerides, Oleyl Alcohol, Butylated Hydroxytoluene, Dimethicone, and Dry Flo TS. The structural formula of mirtazapine is: Molecular Formula: C H N MolecularWeight: 265.35 INDICATION: Mirataz™ is indicated for the management of weight loss in cats. DOSAGE AND ADMINISTRATION: Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg/cat) on the inner pinna of the cat's ear once daily for 14 days (see Diagrams below). Wear disposable gloves when applying Mirataz™. Dispose of used gloves after each application. Alternate the daily application of Mirataz™ between the left and right inner pinna of the ears. Do not administer into the external ear canal. If desired, the inner pinna of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose. If a dose is missed, apply Mirataz™ the following day and resume daily dosing. To demonstrate the method of administering the dose, the veterinarian or trained personnel at the clinic should apply the first dose in the presence of the owner. 17 19 3 This ruler measures 1.5 inches. Use this ruler to measure the 1.5 inch ribbon of ointment to be applied. CONTRAINDICATIONS: Mirataz™ is contraindicated in cats with a known hypersensitivity to mirtazapine or to any of the excipients. Mir Прочитайте повний документ