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Amoxygen

Main information

  • Trade name:
  • Amoxygen 40 mg Tablets
  • Available from:
  • Listow Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Amoxygen 40 mg Tablets
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4007
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: October 2012

AN: 00754/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amoxygen 40 mg Tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

Each 0.228g tablet contains

Amoxicillin 40.00 mg

(as Amoxicillin Trihydrate) 45.92 mg

Excipients:

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet.

An off white circular tablet, scored on one face.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

Cats

4.2 Indications for use, specifying the target species

For use in the treatment of bacterial infections of the alimentary, respiratory

and urogenital tracts and in the eye, ear, skin and wound infections caused by

susceptible organisms. In vitro, Amoxicillin is effective against a range of

Gram-positive and Gram-negative bacteria, including:

Bacillus cereus

Bordetella bronchiseptica

Corynebacterium spp

Chromobacter spp

Citrobacter freundii

Escherichia coli

Flavobacter spp

Proteus mirabilis

Pasteurella spp including Pasteurella multocida

Salmonella spp

Staphylococci (penicillin sensitive strains)

Streptococci

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Revised: October 2012

AN: 00754/2012

4.3 Contraindications

Do not use in known cases of hypersensitivity to Amoxicillin.

Not for administration to rabbits, guinea pigs, hamsters or gerbils.

Caution is advised when used in other small herbivores.

4.4 Special Warnings for each target species

No special warnings.

4.5 Special precautions for use

i. Special precautions for use in animals

Wherever possible, Amoxygen 40mg Tablets should only be used

based on susceptibility testing.

ii. Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy)

following injection, inhalation, ingestion or skin contact.

Hypersensitivity to penicillins may lead to cross reactions to

cephalosporins and vice versa. Allergic reactions to these substances

may occasionally be serious.

1. Do not handle this product if you know you are sensitised, or if

you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure, taking all

recommended precautions.

3. If you develop symptoms following exposure such as a skin

rash, you should seek medical advice and show the doctor this

warning. Swelling of the face, lips or eyes or difficulty with

breathing are more serious symptoms and require urgent

medical attention.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

No known undesirable effects.

4.7 Use during pregnancy, lactation or lay

No known contra-indication exists for the use of Amoxygen 40mg Tablets

during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

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Revised: October 2012

AN: 00754/2012

4.9 Amounts to be administered and administration route

The recommended dose rate is 10 mg Amoxicillin/kg bodyweight (one tablet

per 4kg bodyweight) twice daily for 7 days.

To ensure the correct dosage, bodyweight should be determined as

accurately as possible to avoid underdosing.

Tablets are given orally by hand or crushed in food.

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

Penicillins have a remarkably good safety record and overdose is highly

unlikely.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use.

ATC Vet Code: QJ01CA04

5.1 Pharmacodynamic properties

Amoxicillin is a broad-spectrum semi-synthetic penicillin. Amoxicillin

predominately inhibits cell wall synthesis in susceptible bacteria. Amoxicillin

has a mode of action which directly and irreversibly disrupts cell wall

peptidoglycan.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cellulose microcrystalline

Lactose Monohydrate

Sodium Starch Glycollate

Povidone K17

Yeast Dried (Spray dried)

Magnesium Stearate

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Page 3 of 4

Revised: October 2012

AN: 00754/2012

6.4 Special precautions for storage

Do not store above 25ºC. Store in a dry place.

6.5 Nature and composition of immediate packaging

White, opaque, high density polypropylene tubs closed with white, opaque,

low density polypropylene (push fit) (tamper evident) caps.

100 x Amoxygen 40 mg Tablets

500 x Amoxygen 40 mg Tablets

Not all pack sizes may be marketed.

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 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

Vm

41687/4007

9. DATE OF FIRST AUTHORISATION

Date: 29 th June 1999

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Page 4 of 4

There are no safety alerts related to this product.

There are no news related to this product.

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