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Pazaworm

Main information

  • Trade name:
  • Pazaworm 440 mg Granules for Dogs
  • Available from:
  • Listow Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Pazaworm 440 mg Granules for Dogs
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4013
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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AN: 01027/2012

Revised: January 2013

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Pazaworm 440 mg Granules for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 2 g sachet contains

Active Substance(s) mg

Fenbendazole 440

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Granules.

White to off-white granules.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

Pazaworm is a broad-spectrum anthelmintic for the treatment and control of

common roundworms of the gastrointestinal tract.

4.3 Contraindications

None.

4.4 Special Warnings for each target species

Assess bodyweight as accurately as possible before calculating the dosage.

4.5.1 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

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AN: 01027/2012

Revised: January 2013

Direct contact with the skin should be kept to a minimum. Wash hands

after use. Avoid inhalation of dust.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Not recommended. For the treatment of pregnant dogs consult a veterinary

surgeon.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Part sachets should not be used.

Routine treatment of adult dogs:

Administer 1g Pazaworm per 2.2 kg (5 lbs) bodyweight as a single dose (=

100 mg fenbendazole per kg bodyweight).

Practical dosage recommendations:

2.2 to 4.4 kg (5-10 lbs) 2 grams

4.5 to 8.8 kg (10-20 lbs) 4 grams

8.9 to 13.2 kg (20-30 lbs) 6 grams

13.3 to 22 kg (30-50 lbs) 10 grams

22.1 to 35.2 kg (50-80 lbs) 16 grams

35.3 to 50 kg (80-110 lbs) 22 grams

For dogs weighing over 50 kg (110 lbs) an extra 1g is required for each

additional 2.2 kg bodyweight. The dose should be administered by mixing in

the feed.

Treatment should be repeated when natural re-infection with parasitic worms

occurs. Routine treatment of adult animals with minimal exposure to infection

is advisable 2 to 4 times per year. More frequent treatment at 6-8 weekly

intervals is advisable for dogs in kennels.

Weaned puppies under six months of age:

Administer 1g Pazaworm per 4.4 kg (10 lbs) bodyweight daily for 3

consecutive days mixed into the feed (= 50 mg fenbendazole per kg

bodyweight for 3 days).

Practical dosage recommendations:

2.2 to 4.4 kg (5-10 lbs) 1 gram daily for 3 days

4.4 to 8.8 kg (10-20 lbs) 2 grams daily for 3 days

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AN: 01027/2012

Revised: January 2013

8.8 to 13.2 kg (20-30 lbs) 3 grams daily for 3 days

13.3 to 22 kg (30-50 lbs) 5 grams daily for 3 days

For dogs/puppies weighing over 22 kg (50 lbs), an extra 1g is required daily

for each additional 4.4 kg (10 lbs) bodyweight.

Small or unweaned puppies should be treated with a suitable licensed product

up to 12 weeks of age.

Puppies should be treated at 2 weeks of age, 5 weeks of age and again

before leaving the breeder’s premises. Further treatments are recommended

at 8 and 12 weeks of age. Thereafter, frequency of treatment can be reduced

unless the pups remain in kennels where infection occurs more readily

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No treatment specified. Benzimidazoles have a wide safety margin.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic

ATC Vet Code: QP52AC13

5.1 Pharmacodynamic properties

Fenbendazole, [5-phenylthio)-2-benzimidazole-carbamic] acid methyl ester,

belongs to the broad-spectrum anthelmintic class of compounds, the

benzimidazoles.

Fenbendazole is believed to act by irreversibly inhibiting glucose uptake by

the parasites resulting in depletion of the parasites energy sources, glycogen

and ATP, and their consequent death and expulsion.

A relationship exists between plasma concentrations of active anthelmintic

metabolites, the duration of high plasma metabolite concentrations and

anthelmintic efficacy.

Oxfendazole is a sulphoxide identical to the sulphoxide metabolite of

fenbendazole, both are known to be anthelmintically active and metabolically

interconvertible.

Much of fenbendazole’s anthelmintic activity is attributed to oxfendazole, the

latter being more potent.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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AN: 01027/2012

Revised: January 2013

Povidone K30

Maize Starch

Lactose

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years

6.4 Special precautions for storage

Do note store above 25°C.

6.5Nature and composition of immediate packaging

Carton containing 4 x 2g or 100 x 2g sachets composed of

paper/aluminium/low density polyethylene.

Not all pack sizes may be marketed.

6.6Special 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 materials derived from

such veterinary medicinal products should be disposed of in accordance with

local requirements.

7. MARKETING AUTHORISATION HOLDER

Listow Limited

9 Belgrave Square

London

SW1X 8PH

8. MARKETING AUTHORISATION NUMBER(S)

Vm:

41687/4013

9. DATE OF FIRST AUTHORISATION

Date: 16 January 2002

10. DATE OF REVISION OF THE TEXT

Date: January 2013

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AN: 01027/2012

Revised: January 2013

Approved:

10/01/13

Page 5 of 5

There are no safety alerts related to this product.

There are no news related to this product.

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