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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Millophyline-V 140 mg/ml Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
Active substance
Etamiphylline Camsilate
140 mg per ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clean, bright, colourless, mobile solution.
4.
CLINICAL PARTICULARS
4.1
Target species
Horses, dogs and cats.
4.2
Indications for use, specifying the target species
A cardiac and respiratory stimulant for use in horses, dogs and cats.
The product is indicated as an adjunct in the treatment of pneumonia and infections of
the upper respiratory tract, equine flu and coughing, bronchitis, cardiovascular and
respiratory failure and collapse under general anaesthesia, myocardial degeneration,
pleurisy, pulmonary oedema and syncope, broncho-pneumonia and valvular lesions of
the heart in cats and dogs, and kennel cough in dogs.
The diuretic properties are low and concurrent use of a suitable diuretic may be
recommended.
4.3
Contraindications
Do not use in animals less than 3 kg bodyweight.
Do not administer concomitantly with other CNS stimulants.
4.4
Special warnings for each target species
Some racing authorities (including the British Jockey Club) regard Etamiphylline
camsilate as a prohibited substance under the rules of racing. The use of the product
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should be discontinued 7 days prior to racing. Under these circumstances all but the
most exceptional case will be catered for.
4.5
Special precautions for use
i.
Special precautions for use in animals
None.
ii.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Take care not to self-inject. When used in accordance with normal standards of
veterinary practice this product does not present a hazard to the user. If
accidental self-injection occurs, or signs of adverse effects are seen, seek
medical attention immediately, showing the product label to a doctor.
If splashed in the eye, wash with running water for at least 10 minutes.
Wash hands after use.
iii.
Other precautions
None.
4.6
Adverse reactions (frequency and seriousness)
Side-effects: occasional central nervous system stimulation, which may be countered
by the use of a suitable hypnotic drug.
4.7
Use during pregnancy, lactation or lay
There is no, or inadequate, evidence of safety during pregnancy, but the active
substance has been in use for many years without apparent ill consequence. If drug
therapy is required during pregnancy the drug should be the subject of a risk/benefit
assessment by the veterinary practitioner.
4.8
Interaction with other medicinal products and other forms of interaction
Do not administer concomitantly with other CNS stimulants.
4.9
Amounts to be administered and administration route
Horses:
Injection (intramuscular or subcutaneous) 10 ml, repeated every eight hours if
necessary.
Dogs and cats:
3-5 kg
0.5 ml
6-10 kg
1.0 ml
11-20 kg
2.0 ml
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21-30 kg
31-40 kg
3.0 ml
5.0 ml
Dogs and cats: Injection (intramuscular or subcutaneous).
Large and medium sized dogs: 3-5 ml repeated every eight hours if necessary.
Small dogs and cats: 1-2 ml repeated every eight hours if necessary.
Strict dosage according to bodyweight may need adjusting after assessing the clinical
signs. In acute cases the treatment is best commenced by injection, with subsequent
therapy being given orally by use of the product with the tablet or powder formulations.
The product may also be administered by slow intravenous injection in acute cases,
after dilution with an equal volume of Water for injections. The product should only be
diluted immediately prior to use and any remaining diluted injection be discarded. In
cases of complete cardiac collapse the diluted injection may be given intracardially.
The duration of treatment depends on clinical response.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Treatment as for Theophylline and its derivatives.
Treat hypokalaemia with intravenous infusion of Potassium Chloride and administer a
tranquiliser to control convulsions.
4.11
Withdrawal periods
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under
national horse passport legislation.
5.
PHARMACOLOGICAL PARTICULARS
Pharmacotherapeutic group: Other systemic drugs for obstructive airway diseases
ATC Vet Code: QR03DA06
5.1
Pharmacodynamic properties
Etamiphylline camsilate is a cardiac and respiratory stimulant with the following
actions:
Cardiovascular system:
Increases cardiac amplitude without increasing rate; stimulates cardiac muscle;
dilates coronary arteries, thus increasing blood flow.
Respiratory system:
Increases rate and depth of respiration; relaxes smooth muscle of bronchi and
bronchioles.
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5.2
Pharmacokinetic properties
No data available.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Chlorocresol
Water for injections
6.2
Incompatibilities
Incompatible with alkaline products.
6.3
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4
Special precautions for storage
Store in a dry place.
Do not store above 25°C.
6.5
Nature and contents of immediate packaging
Container: 50 ml amber multi-dose type I glass vial.
6.6
Special precautions for the disposal of unused veterinary medicinal product or
waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
Dechra Limited,
Dechra House,
Jamage Industrial Estate,
Talke Pits,
Stoke-on-Trent,
Staffordshire,
ST7 1XW,
UK.
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8.
MARKETING AUTHORISATION NUMBER
Vm 10434/4023
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/08/2003
10.
DATE OF REVISION OF THE TEXT
March 2011
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