Millophyline-V 100 mg Oral Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Etamiphylline Camsylate

Available from:

Dechra Limited

ATC code:

QR03DA06

INN (International Name):

Etamiphylline Camsylate

Authorization status:

Expired

Summary of Product characteristics

Revised: March 2011
Amended pages
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Millophyline-V 100 mg Oral Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Etamiphylline Camsilate
100 mg per tablet
Excipients
Titanium Dioxide
1.50 mg per tablet
Ponceau 4R Lake (E124)
2.08 mg per tablet
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Red coated biconvex tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cardiac and respiratory stimulant. As an aid in the management of
coughing,
respiratory distress or cardiac conditions in dogs and cats.
May be used as an adjunct to antibiotic therapy.
4.3
CONTRAINDICATIONS
Do not administer concomitantly with other CNS stimulants.
Do not use in animals less than 3 kg bodyweight.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None.
Page 1 of 5
Revised: March 2011
Amended pages
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Wash hands after use.
In the event of accidental ingestion, seek medical attention, taking
the pack
with you to show the doctor what has been taken.
iii.
Other precautions
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Occasional central nervous system stimulation, which is readily
countered by the use
of a suitable hypnotic.
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
For oral administration.
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