Mirataz For Cats (Mirtazapine Transdermal Ointment)

The first and only licensed veterinary medical product with transdermal application for weight loss therapy in cats. Stimulates appetite and significantly increases weight in less than 14 days.

Innovative pharmaceutical form in innovative packaging. Mirataz is a transdermal pharmaceutical form that is easy to apply. The product is contained in an innovative packaging that is child-resistant. This allows Mirataz to be prescribed for use by pet owners in a home environment.

Each dose of 0.1 g contains: Active substance: Mirtazapine (as hemihydrate) 2 mg Excipients: Butylhydroxytoluene (E321) 0.01 mg, Macrogol 400, Macrogol 3350, Diethylene glycol monoethyl ether, Caprylocaproyl polyoxiglycerides, Oleyl alcohol, Dimethicone, Tapioca starch, polymethylsilsesquioxane Types of animals for which the VMP is intended: Cats. Therapeutic indications defined for the individual species of animals: For weight gain in cats with poor appetite and weight loss due to chronic medical conditions. Dosage and route of administration: Transdermal application. The veterinary medicinal product is applied topically to the inner surface of the pinna (inside of the ear) once daily for 14 days at a dosage of 0.1 g ointment per cat (2 mg mirtazapine per cat). This corresponds to a line of 3.8 cm ointment. To apply the veterinary medicinal product:

Step 1: Put on waterproof gloves.
Step 2: Twist the cap of the tube counterclockwise to open it.
Step 3: Apply even pressure on the tube and squeeze out a 3.8 cm strip of ointment onto your finger, using the measuring line on the cardboard/bottle or leaflet as a guide.
Step 4: Gently rub the ointment onto the inner surface of the cat’s ear (inside of the pinna), spreading it evenly over the surface. If it comes into contact with the skin, wash it with soap and water.
Alternate between the left and right ear during daily application. Optionally, the inner surface of the cat’s ear can be cleaned by wiping it with a dry tissue or cloth immediately before the next planned dose. If you miss a dose, apply the veterinary medicinal product the next day and continue with daily application.
The recommended fixed dose has been tested in cats weighing between 2.1 kg and 7.0 kg.

Contraindications: Do not use in breeding, pregnant, or lactating cats. Do not use in animals under 7.5 months of age or weighing less than 2 kg. Do not use in animals with hypersensitivity to the active substance or any of the excipients. Do not use in cats treated with cyproheptadine, tramadol, or monoamine oxidase inhibitors (MAOI), or treated with MAOI within 14 days prior to treatment with the veterinary medicinal product, as there may be an increased risk of serotonin syndrome. Special precautions for each type of animal for which the VMP is intended: The efficacy of the veterinary medicinal product has not been established in cats under 3 years of age. The efficacy and safety of the veterinary medicinal product have not been established in cats with severe kidney disease and/or neoplasia.

The correct diagnosis and treatment of the underlying condition are crucial for the treatment of weight loss, and treatment options depend on the severity of weight loss and the underlying condition(s). Treating any chronic condition associated with weight loss should include providing appropriate nutrition and monitoring body weight and appetite. Mirtazapine therapy should not replace the necessary diagnosis and/or treatment regimens needed for the treatment of the underlying condition(s) causing unwanted weight loss. The efficacy of the product has only been demonstrated for a 14-day application, in line with current recommendations (see section 4.9). Repeating the treatment has not been studied and should only be carried out after the veterinarian’s benefit/risk assessment. The efficacy and safety of the veterinary medicinal product have not been established in cats weighing less than 2.1 kg or over 7.0 kg.

Special precautions for use: The veterinary medicinal product should not be applied to damaged skin. In liver disease cases, increased liver enzyme levels may be observed. Kidney disease may lead to reduced clearance of mirtazapine, which may result in higher exposure to the product. In these cases, liver and kidney biochemical parameters should be regularly monitored during treatment. The effects of mirtazapine on glucose regulation have not been evaluated. In the case of use in cats with diabetes mellitus, blood glucose levels should be regularly monitored. Supportive treatment (fluid therapy) should be applied when used in hypovolemic cats. Care should be taken to prevent other animals in the household from coming into contact with the application site until it is dry. Special precautions for administering the veterinary medicinal product to animals: The product can be absorbed through skin or oral routes and may cause drowsiness or sedation. Avoid direct contact with the product. Avoid contact with the treated animal within the first 12 hours after each daily application until the site is dry. Therefore, it is recommended that the animal be treated in the evening. Treated animals should not be allowed to sleep with owners, especially with children and pregnant women, throughout the treatment period. Waterproof single-use protective gloves should be provided with the product at the point of sale and worn when working with or applying the veterinary medicinal product. Thoroughly wash hands immediately after applying the veterinary medicinal product or in case of skin contact with the product or treated cat.

Limited data are available on the reproductive toxicity of mirtazapine. Considering that pregnant women are considered more sensitive, pregnant women or women attempting to conceive are advised to avoid working with the product and to avoid contact with treated animals throughout the treatment period. The product can be harmful if swallowed. Do not leave the tube outside its child-resistant container except during the application phase. Children should not be present during the treatment of cats. After application, the tube should be placed back into its child-resistant container, which should be immediately closed. Do not eat, drink, or smoke while using the veterinary medicinal product. The veterinary medicinal product is a skin sensitizer. People with established hypersensitivity to mirtazapine should not work with the veterinary medicinal product. This veterinary medicinal product may irritate the eyes and skin. Avoid hand-to-mouth and hand-to-eye contact until hands are thoroughly washed. In case of eye contact, rinse your eyes thoroughly with clean water. In case of skin contact, wash thoroughly with soap and warm water. If skin or eye irritation occurs, or in case of accidental ingestion, seek medical advice immediately, providing the product label.

Adverse reactions (frequency and seriousness): Reactions at the application site (erythema, crusts/scabs, deposits, flaking/dryness, peeling, head shaking, dermatitis or irritation, alopecia, and itching) and changes in behavior (increased vocalization, hyperactivity, disoriented state or ataxia, lethargy/weakness, attention-seeking, and aggression) are very common in safety studies and clinical trials. Vomiting, and polyuria associated with decreased urine specific gravity, increased blood urea nitrogen (BUN), and dehydration are often observed in safety studies and clinical trials. Depending on the severity of vomiting, dehydration, or changes in behavior, the application of the product may be discontinued based on the veterinarian’s assessment of the benefit/risk ratio. These adverse reactions, including local reactions, generally resolve at the end of the therapeutic period without specific treatment. In rare cases, hypersensitivity reactions may occur. In these cases, treatment should be stopped immediately.

The frequency of adverse reactions is classified as follows:

• very common (more than 1 in 10 treated animals displaying adverse reactions)
• common (more than 1 but less than 10 animals out of 100 treated animals)
• uncommon (more than 1 but less than 10 animals out of 1,000 treated animals)
• rare (more than 1 but less than 10 animals out of 10,000 treated animals)
• very rare (less than 1 animal out of 10,000 treated animals, including isolated reports).

Use during pregnancy, lactation, or lay: Mirtazapine has been identified as potentially toxic to reproduction in rats and rabbits. Safety during pregnancy and lactation has not been demonstrated. Pregnancy and lactation: Use is not recommended during pregnancy and lactation. Fertility: Do not use on animals for breeding purposes.

Interaction with other veterinary medicinal products and other forms of interaction: Do not use in cats treated with cyproheptadine, tramadol, or monoamine oxidase inhibitors (MAOI), or treated with MAOI within 14 days prior to treatment with the veterinary medicinal product, as there may be an increased risk of serotonin syndrome. Mirtazapine may enhance the sedative properties of benzodiazepines and other substances with sedative properties (H1 antihistamines, opioids). Plasma concentrations of mirtazapine may also increase when used concurrently with ketoconazole or cimetidine. The product is intended for veterinary use only.