Imizol 85 mg/ml Solution for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Imidocarb dipropionate

Tersedia dari:

Intervet Ireland Limited

Kode ATC:

QP51AE01

INN (Nama Internasional):

Imidocarb dipropionate

Dosis:

85 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Cattle

Area terapi:

imidocarb

Indikasi Terapi:

Endoparasiticide

Status otorisasi:

Authorised

Tanggal Otorisasi:

1999-10-01

Karakteristik produk

Health Products Regulatory Authority
24 January 2022
CRN00CRN6
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Imizol 85 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Imidocarb 85 mg
(equivalent to 121.1 mg imidocarb dipropionate)
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to brownish-yellow coloured solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of bovine babesiosis (Redwater fever
- _Babesia divergens_ infection) only.
4.3 CONTRAINDICATIONS
Do not administer intravenously or intramuscularly.
Do not administer repeat doses.
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When used for prevention, the product should be administered when
clinical signs of the disease are observed in one or two
cattle of a group or at the time of moving susceptible cattle into an
area of known Babesia challenge.The entire group should
be dosed to provide protection against babesiosis, and all must be
kept to the withhold times indicated.The product gives
protection for a period of up to four weeks depending on the severity
of the challenge.During this time, only if the challenge is
adequate will immunity be established.
Estimate bodyweight carefully and do not exceed the recommended
dosage.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Do not use if under medical advice not to work with compounds which
may exhibit anti-cholinesterase activity.
Wash splashes of the product off the skin and eyes immediately. Wear
suitable protective clothing when using the product.
Health Products Regulatory Authority
24 January 2022
CRN00CRN6
Page 2 of 4
Seek medical advice immed