Mirataz

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

mirtazapine

Available from:

Dechra Regulatory B.V.

ATC code:

QN06AX11

INN (International Name):

mirtazapine

Therapeutic group:

Cats

Therapeutic area:

Psychoanaleptics, Antidepressants in combination with psycholeptics

Therapeutic indications:

For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-12-10

Patient Information leaflet

17
B.
PACKAGE LEAFLET
18
PACKAGE LEAFLET:
MIRATAZ 20 MG/G TRANSDERMAL OINTMENT FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Manufacturer responsible for batch release:
Genera Inc.
Svetonedeljska cesta 2
Kalinovica
10436 Rakov Potok
Croatia
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mirataz 20 mg/g transdermal ointment for cats
mirtazapine
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 0.1 g contains:
ACTIVE SUBSTANCE:
Mirtazapine (as hemihydrate) 2 mg
EXCIPIENTS:
Butylhydroxytoluene (E321; as antioxidant) 0.01 mg
Non-greasy, homogeneous, white to off-white ointment.
4.
INDICATION(S)
For body weight gain in cats experiencing poor appetite and weight
loss resulting from chronic
medical conditions (see “Other information”).
5.
CONTRAINDICATIONS
Do not use in breeding, pregnant or lactating cats.
Do not use in animals less than 7.5 months of age or less than 2 kg
body weight.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cats treated with monoamine oxidase inhibitors (MAOIs)
or treated with an MAOI
within 14 days prior to treatment with the veterinary medicinal
product due to an increased risk of
serotonin syndrome (see also “Special warnings”).
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6.
ADVERSE REACTIONS
Application site reaction(s) (erythema, crust/scab, residue,
scaling/dryness, flaking, head shaking,
dermatitis or irritation, alopecia, and pruritus) and behavioural
changes (increased vocalisation,
hyperactivity, disoriented state or ataxia, lethargy/weakness,
attention seeking and aggression)
occurred very commonly in safety and clinical studies.
Vomiting, polyuria associated with reduced urine specific gravity,
elevated blood urea nitrogen
(BUN) and dehydration were commonly observed in safety and clinical
studies. Depending on
the severity o

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mirataz 20 mg/g transdermal ointment for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.1 g contains:
ACTIVE SUBSTANCE:
Mirtazapine (as hemihydrate)
2 mg
EXCIPIENTS:
Butylhydroxytoluene (E321)
0.01 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal ointment.
Non-greasy, homogeneous, white to off-white ointment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For body weight gain in cats experiencing poor appetite and weight
loss resulting from chronic
medical conditions (see section 5.1).
4.3
CONTRAINDICATIONS
Do not use in breeding, pregnant or lactating cats.
Do not use in animals less than 7.5 months of age or less than 2 kg
body weight.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cats treated with cyproheptadine, tramadol or monoamine
oxidase inhibitors (MAOIs)
or treated with an MAOI within 14 days prior to treatment with the
veterinary medicinal product as
there may be an increased risk of serotonin syndrome (see section
4.8).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy of the veterinary medicinal product has not been
established in cats less than 3 years of
age.
The efficacy and safety of the veterinary medicinal product has not
been established in cats with
severe renal disease and/or neoplasia.
Proper diagnosis and treatment of the underlying disease is key to
managing weight loss, and
treatment options are dependent on the severity of weight loss and
underlying disease(s). The
management of any chronic disease associated with weight loss should
include providing
3
appropriate nutrition and monitoring body weight and appetite.
The therapy with mirtazapine should not replace necessary diagnostics
and/or treatment regimens
needed to manage the underlying disease(s) causing unintended weight
loss.
The efficacy of the product was only