Revised: 20th January 2009
AN: 01382/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF VETERINARY MEDICINAL PRODUCT:
Vetzyme Combined Wormer Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Roundwormer Tablet contains:
Active substance(s)
mg
Piperazine Citrate……………………………..375
Excipient(s)
Indigo Carmine Lake………………………….002
Each Tapewormer Tablet contains:
Active substance(s)
mg
Dichlorophen…………………………………..750
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Tablets
Tapewormer Tablets:
White to pink coloured, round, flat, bevelled edged tablets, quarter-scored
on one-side
Roundwormer Tablets:
Light blue coloured, round, flat, bevelled edged tablets, quarter scored on
one side
Revised: 20th January 2009
AN: 01382/2008
4. CLINICAL PARTICULARS:
4.1
Target Species
Dogs
4.2
Indications for use, specifying the target species
For the treatment of roundworms (Ascarids) and tapeworm infestation in
dogs and puppies
4.3
Contra-indications
i) Do not repeat the treatment if vomiting occurs shortly after dosing
ii) Do not treat animals under 6 months of age
iii) Do not administer more than 6 tablets as a single dose. If no vomiting
occurs, remaining dose can be given after 3 hours.
4.4
Special warnings for each target species
i) Consult a veterinary surgeon before dosing pregnant animals or those
with a history of epilepsy or severe renal dysfunction
ii) Tapeworm infestation can be spread by fleas. As a precaution, dogs
should be `treated with suitable insecticidal products.
iii) Dichlorophen (white tablets) is normally well tolerated, but although not
toxic in the recommended dosage, it may produce an adverse reaction
in some dogs. In such cases, veterinary advice should be sought.
iv) It is important that puppies are treated for roundworms (Ascarids) at 2
weeks of age and every 2 weeks until 12 weeks of age with a suitably
approved product. Thereafter, they should be treated every 3 months.
v) Nursing bitches should be treated for roundworms 2 weeks after giving
birth and every 2 weeks until weaning
vi) It is advisable to treat the bitch at the same time as the puppies.
Revised: 20th January 2009
AN: 01382/2008
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 medicinal products to animals
Wash hands after handling tablets.
In the case of accidental eye contact – rinse thoroughly with clean
running water. If irritation persists, seek medical advice.
In the case of accidental ingestion – drink plenty of water and seek
medical advice.
4.6
Adverse reactions (frequency and seriousness)
Dichlorophen can induce nausea, vomiting and gastrointestinal colic
and diarrhoea when ingested.
4.7
Use during pregnancy, lactation or lay
i) Consult a veterinary surgeon before dosing pregnant animals or those
with a history of epilepsy or severe renal dysfunction.
ii) Nursing bitches should be treated for roundworms (Ascarids) 2 weeks
after giving birth and every 2 weeks until weaning.
iii) It is advisable to treat the bitch at the same time as the puppies.
4.8
Interaction with other medicinal products and other forms of
interaction
There are no recorded cases of any interaction with other
medicaments.
4.9
Amounts to be administered and administration route
Oral administration
Dosage Schedule
The treatment consists of 3 doses given over a period of 15 days.
The tablets may be crushed and added to food.
Revised: 20th January 2009
AN: 01382/2008
The dosage is based on the dog’s bodyweight at time of dosing: i.e. for
every 3.75 kg (8 lbs) give 1 tablet, increasing according to weight of dog.
Dosage (approximate guide only): 1/2 tablet per 1.8 kg (4 lbs) bodyweight.
Dog’s weight on day of Number of Tablets per dose
dosing
First Dose
Second Dose
st
1 day
8th day
BLUE
WHITE
TABLETS
TABLETS
Small
Dogs
Medium
Dogs
Large
Dogs
Third Dose
15th day
BLUE
TABLETS
Kg
1.8
lbs
4
3.6
8
1
1
1
7.3
16
2
2
2
10.9 24
3
3
3
14.5 32
4
4
4
18.2 40
5
5
5
21.8 48
6
6
6
25.5 56
7
7
7
29.1 64
8
8
8
32.7 72
9
9
9
36.4 80
10
10
10
40.0 88
11
11
11
1/
2
1/
2
1/
2
For very large dogs over 40 kg (88 lbs) add one tablet per dose for every
3.75 kg (8 lbs) bodyweight.
Dogs and puppies weighing less than 1.8 kg (4 lbs) bodyweight should
not be treated.
Young puppies rapidly gain weight and the dosage should relate to the
bodyweight at time of dosing.
Revised: 20th January 2009
AN: 01382/2008
Dogs should be treated at 3 month intervals.
4.10
Overdose (symptoms, emergency procedures, antidotes) if
necessary
There is very little likelihood of any acute overdosage.
4.11
Withdrawal period(s)
Not applicable.
5.
PHARMACOLOGICAL PROPERTIES:
ATCvet Code QP52AHO1, QP52AGO1
5.1
Pharmacodynamic properties
Piperazine citrate is a veterinary anthelmintic effective against intestinal
roundworms and threadworms, but has no significant effects on
hookworms, tapeworms or whipworms.
In the case of roundworms, piperazine citrate produces narcosis which
takes at least five hours to develop. The worms are then easily
dislodged by the movement of the alimentary tract and are expelled in
the faeces.
Piperazine citrate affects all stages of the parasite in the alimentary
tract, but appears to have little or no effect on the larvae in the tissues.
Little is known about the mode of action of piperazine citrate on
threadworms.
Dichlorophen is a taenicide (anthelmintic used in the treatment of
infestation by tapeworms). It has a direct lethal action on the
tapeworm, and, after the tapeworm has been killed, the segments are
partially digested in the intestine.
Dichlorophen also exhibits anti-protozoan, fungicidal and bactericidal
effects.
The result of this multiple anthelmintic activity is control of the helminth
population within the alimentary tract.
5.2
Pharmacokinetic properties
No information available.
Revised: 20th January 2009
AN: 01382/2008
6.
PHARMACEUTICAL PARTICULARS:
6.1
List of excipients
Tapewormer Tablets
Povidone (K30)
Cellulose Microcrystalline
Magnesium Stearate
Sodium Starch Glycollate
Beef Flavour (PFW 610398E)
Monosodium Glutamate Monohydrate
Roundwormer Tablets
Indigo Carmine Lake (E132)
Maize Starch
Pregelatinised Maize Starch
Gelatin
Dibasic Calcium Phosphate Anhydrous
Magnesium Stearate
Sodium Starch Glycollate
Beef Flavour (PFW 610398E)
Monosodium Glutamate Monohydrate
6.2
Incompatibilites
Not applicable.
6.3
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
4 years.
6.4
Special Precautions for Storage
i)
ii)
iii)
iv)
v)
Do not store above 25°C
Store in a dry place
Protect from light
Do not remove tablets from strip-packing until required for use
Any part used tablets should be discarded.
Revised: 20th January 2009
AN: 01382/2008
6.5
Nature and composition of immediate packaging
Clear, colourless regenerated cellulose strip-packs containing either 4
or 12 Tapewormer tablets and either 8 or 24 Roundwormer tablets.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused medicinal
products 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:
Bob Martin (UK) Ltd.
Wemberham Lane
Yatton
Somerset
BS49 4BS
U.K.
8.
MARKETING AUTHORISATION NUMBER:
Vm 00715/4085
9.
DATE OF THE FIRST AUTHORISATION:
28th July 1994
10.
DATE OF REVISION OF THE TEXT:
January 2009