SUMMARY OF PRODUCT CHARACTERISTICS

DIMINAVETo Granules

1. Name of the veterinary medicinal product

DIMINAVETo

2. Qualitative and quantitative composition

2.1. Active substances
Diminazene diaceturate 445 mg/g
Antypirine (phenazone) 555 mg/g
2.2. Excipients
None

3. Pharmaceutical form
Granules

4. Clinical particulars
4.1. Target species
Cattle, sheep

4.2. Indications for use, specifying the target species

The main fields of application are both mixed infections caused by tryanosome and piroplasma infections
caused by resistant strains of malaria parasites. In case of infection with Trypanosoma congolense and
Trypanosoma vivax, one administration will result in a complete cure. In case of infection with Babesia on
the other hand, a normal dose produces a rapid clinical recovery, but does not completely eliminate the
parasites from the blood. In this way, animals can develop a state of premunition.

4.3. Contraindications
Hypersensitivity to diminazene or phenazone.
Administration to animals with impaired renal and hepatic function.
Do not use in camels and dogs.

4.4. Special warnings for each target species

None

4.5. Special precautions for use in animals

It is advised not to exceed a total dose of 4 g.

4.6. Special precautions to be taken by the person administering the veterinary medicinal product
to animals.
Not applicable.

4.7. Adverse reactions (frequency and seriousness)

Hypersensitivity reactions.
Salivation, sweating, tremors can occur.

4.8. Use during pregnancy, laction or lay

Can be used during pregnancy and lactation. The withdrawal period for milk must be strictly observed.

4.9. Interaction with other medicinal products and other forms of interaction
Not known
4.10. Amounts to be administerd and administration route
The administration is by deep intramuscular injection. If the injection volume is big, it is recommended to
split the amount by injecting at two different locations.
The therapeutic dose for each animal is 3.5 mg diminazene per kg body weight. This dose will be
doubled in case of infection with Trypanosoma brucei. If the causative organism is particularly strong, the
dose may be increased to 8 mg/kg body weight. However, it is advisable not to exceed a total dose of 4 g.
Dissolve the contents of one pack of 2.36 g in 12.5 ml of water, which allows to obtain 15 ml of an 7 %
concentrated injectable solution. DIMINAVETo granules dissolve quickly. The resulting solution is stable
for 5 days when stored at room temperature and for 14 days if kept cool. It must be kept in a tightly
closed container, protected from light.

4.11. Overdose (symptoms, emergency procedures, antidotes), if necessary

It is advised not to exceed a total dose of 4 g.
Following administration of multiple therapeutic doses, degenerative fatty infiltration may occur in the
liver, kidneys, myocardium and muscles.
Multiple therapeutic doses can produce large hemorrhagic lesions and malacia of the cerebellum and
thalamus in cattle.

4.12. Withdrawal periods

Meat: 21 days after treatment
Milk: 5 days after treatment

5. Pharmacological properties
The antiparasitic activity of the aromatic diamidines may be related to the interference with aerobic
glycolysis as well as interference with synthesis of deoxyribonucleic acid (DNA) in the parasite. All these
drugs give rise to hypoglycemia in the treated host. Babesia as well as many other forms of parasites like
trypanosomes depend upon host glucose for aerobic glycolyses. Specifically, the mechanism of
trypanocidal action of pentamidine, INN, is said to depend on the drug's inhibition of aerobic glycolysis
and denaturing of nulceoproteins of the parasite.

Selective blocking of kinetoplast DNA replication appears to be the mode of acitivity of diminazene, INN.
It is rapidely and irreversibly bound by the DNA-containing organelles of the trypanosome, first in the
kinetoplast and subsequently in the nucleus. The ratio of binding is 1 molecule of diminazene for every
4 - 5 DNA nucleotides. Further studies strongly suggest that the drug-DNA complex inhibits kinetoplasts
DNA synthesis. The exact relation of this to the death of the trypanosomes is not known, nor is the
significance of nuclear DNA binding of the drug. Thus many questions are still unanswered relative to the
activity of the diamidines; practically no studies of this nature have been conducted with babesial
organisms.

In addition to tripanocidal activity diminazene also acts babesicidal and bactericidal (mainly Brucella and
Streptococcus species).
As a trypanocide, diminazene is effective against T. vivax and T. congolense but less effective agains
T. brucei, necessitating an increased dosage rate against this species.

6. Pharamceutical particulars

6.1. List of excipients

None

6.2. Incompatibilities
None known

6.3. Shelf life

The drug expires the first day of the month and the year clearly printed after the "Exp". Sign on the
sachet and on the box with sachets.

6.4. Special precautions for storage

Store in a dry cool place below 30°C.
6.5. Nature and composition of immediate packaging
One carton contains 10 sachets of 2.36 g or 23.6 g or 100 sachets of 2.36 g.

6.6. Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.

7. Marketing Authorization Holder (Name, address, country)

V.M.D. nv, Hoge Mauw 900, 2370 Arendonk, Belgium

8. Manufacturer (Name, address, country)

Laboratoria Smeets nv, Fotografielaan 42, 2610 Wilrijk, Belgium

Prohibition of sale, supply and/or use

Delivery: On veterinary prescription only

VMD - Hoge Mauw 900 - 2370 Arendonk - Belgium