mirtazapineOintment instruction manual draft

Veterinary prescription drugsexternal use

[Veterinary Drug Name]

Common name:mirtazapineointment

Product Name:

English name:Mirtazapine Ointment

Pinyin name:Midanping Room

【Main Ingredients】Mirtazapine.

[Characteristics] This product isWhite to off-white ointment。

[Pharmacological effects] Mirtazapine is aa2- Adrenergic receptor antagonists and serotonergic (5-HT) antidepressants. Mirtazapine is a potent antagonist of 5-HT2 and 5-HT3 receptors in the central nervous system and a potent inhibitor of histamine H1 receptors. Because mirtazapine blocks 5-HT2 and 5-HT3 receptors, only 5-HT1A-mediated serotonergic transmission is enhanced. The exact mechanism by which mirtazapine causes weight gain is not fully understood, but it appears to be a multifactorial result. Inhibition of 5-HT2 receptors may be the reason for mirtazapine's appetite-stimulating effect. Another reason mirtazapine induces weight gain may be related to leptin and tumor necrosis factor.a(TNF-aThis is related to system changes.

Indications Used to control weight loss in cats。

【Usage and Dosage】 WillApply a 3.8cm strip of ointment (length can be referenced from the scale below, equivalent to 2mg mirtazapine) evenly to the inside of the cat's ear once a day for 14 consecutive days, alternating between the left and right ear sides.

[Adverse Reactions]

1. Site reactions (erythema, crusting, drug residue, desquamation, dryness, dermatitis or irritation, hair loss and itching, etc.) and behavioral changes (increased vocalization, hyperactivity, disorientation or ataxia, somnolence/weakness, attention-seeking and aggressive behavior, etc.) are very common in safety and clinical studies.

2. Vomiting, decreased urine specific gravity-related polyuria, elevated blood urea nitrogen (BUN), and dehydration are common in safety and clinical studies. Dosage may be discontinued based on a veterinarian's benefit-risk assessment, depending on the severity of vomiting, dehydration, or behavioral changes.

3. Adverse reactions include local reactions, which resolve without special treatment at the end of treatment.

4. In rare cases, hypersensitivity reactions may occur. In such cases, treatment should be stopped immediately.

【Contraindications】

1. Not for use on breeding cats, pregnant cats, or cats that are nursing.

2. Not for use on cats under 6 months of age or weighing less than 2kg.

3. Do not use in cats that are allergic to mirtazapine or any of the excipients.

4. Because it may increase the risk of serotonin syndrome, this product should not be used in combination with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs), or with monoamine oxidase inhibitors (such as selegiline hydrochloride or amitraz) within 14 days before or after treatment.

【Precautions】1. This product must not be administered orally or through the eyes.

2. This product should not be applied to broken skin.

3. The efficacy and safety of this product in cats with severe kidney disease and/or tumors have not been established.

4. This product may cause elevated serum liver enzyme levels; use with caution in cats with liver disease; kidney disease may lead to decreased mirtazapine clearance.

Low concentration, which may lead to higher drug exposure; use with caution in cats with kidney disease. If this product must be used in these special circumstances, treatment...

Liver and kidney function biochemical parameters should be monitored regularly during treatment.

The effects of mirtazapine on glycemic regulation have not been evaluated. When used in cats with diabetes, glycemic blood glucose should be monitored regularly.

6. When used on cats with low blood volume, supportive treatment (fluid therapy) should be administered.

7. Current research has only confirmed the efficacy of the recommended 14-day dosing regimen for this product. No studies have been conducted on repeat treatment; therefore, only…

Repeat treatment can only be performed after a veterinarian has conducted a benefit-risk assessment.

8. The use of this product cannot replace the necessary diagnosis and/or treatment of the underlying disease causing the weight loss.

9. After discontinuing medication, it is essential to closely monitor the cat's food intake. If the food intake decreases significantly (more than 75%) within a few days, or if the cat stops eating for more than 48 hours, a veterinary reassessment is necessary.

10. If a dose is missed during treatment, continue the daily dose the following day or as directed by your doctor.

11 This product is a skin sensitizer. People known to be allergic to mirtazapine should not come into contact with this product.

12. Limited data exist regarding the reproductive toxicity of mirtazapine. Given that pregnant women are considered a more vulnerable group, it is recommended that pregnant women or women planning to conceive avoid exposure to this product throughout the treatment period and avoid contact with animals after treatment.

13. Avoid direct contact with this product. Avoid contact with the treated animal for 12 hours after each application, until the application site is dry. During the entire treatment period, the treated animal should not sleep with its owner, especially children and pregnant women. Other animals should avoid contact with the treated animal until the application site is dry.

14. This product can be absorbed through the skin or orally, causing drowsiness or sedation. Disposable protective gloves must be worn when handling or using this product to prevent accidental local exposure. After use, discard the gloves and wash hands with soap and water.

15. Keep out of reach of children. Children must not be present when administering this medication to a cat.

16. Do not eat, drink, or smoke while handling this product.

17. This product may cause eye and skin irritation. Avoid contact with mouth and eyes before hands are thoroughly washed. If contact with eyes occurs, rinse thoroughly with water. If contact with skin occurs, wash thoroughly with soap and warm water. If skin or eye irritation occurs, or if accidentally ingested, seek medical attention immediately and show the doctor the instructions or label of this product.

[Withdrawal period] No need to formulate。

【Specification】 5g：100mg

【Package】

Storage   Store in a sealed container below 25°C.。

[Validity Period]   24MonthsAfter opening30th。

[Approval Number]

Production Date

[Product Batch Number]

[Expiration Date]

[Manufacturing Company]Inner Mongolia Federal Animal Health Pharmaceutical Co., Ltd.

Address: Fuyuan South Road, Bayannur Economic and Technological Development Zone, Inner MongoliaNo. 1

post code:015000   

Telephone:400-033-8999