Medine.co.uk

Twinox 400 Mg/100 Mg Tablets For Dogs

Issued: June 2015

AN: 01330/2013

SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF THE VETERINARY MEDICINAL PRODUCT


Twinox 400 mg/100 mg tablets for dogs


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Each tablet contains:


Active substances

Amoxicillin (as amoxicillin trihydrate) 400 mg

Clavulanic acid (as potassium clavulanate) 100 mg


Excipients

Erythrosine (E127) 0.5 mg


For the full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Tablet.

Pale pink, rounded, one side scored, uncoated and divisible tablet.


4. CLINICAL PARTICULARS


Target species


Dogs.


Indications for use, specifying the target species


Treatment of infections caused by micro-organisms sensitive to the combination amoxicillin/clavulanic acid, especially:

- dermatitis (superficial and deep pyoderma) caused by Staphylococcus (pseud)intermedius.

- urinary tract infections caused by E. coliand Staphylococcusspp.

- respiratory tract infections caused by Streptococcusspp.

- enteritis caused by E. coli.


4.3 Contraindications


- Do not use in animals with known hypersensitivity to penicillin or other substances of the

beta-lactam group or to any of the excipients.

- Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria.

- Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils


4.4 Special warnings for each target species


None known.


4.5 Special precautions for use


Special precautions for use in animals


ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity reactions (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.


Adverse reactions (frequency and seriousness)



Use during pregnancy or lactation or lay


Laboratory studies in rats and mice have not produced any evidence of teratogenic or foetotoxic effects. No studies have been conducted in pregnant or lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian.


Interaction with other medicinal products and other forms of interaction


Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effects of penicillins.

The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.


Amounts to be administered and administration route


Oral use.


Amounts to be administered:

The recommended dose rate is 10 mg amoxicillin/2.5 mg clavulanic acid per kg bodyweight (= 12.5 mg of combined active substances) twice a day by the oral route in dogs, i.e. 1 tablet per 40 kg body weight every 12 h.


Body weight (kg)

Number of tablets

(twice daily)

< 30

Use 40 mg/10 mg tablets or 200 mg/50 mg tablets

(30.1 – 40.0)

1

(40.1 – 60.0)

1 ½

(60.1 – 80.0)

2


In case of complicated infections, especially respiratory infections, a better cure rate is obtained with a double dose, up to 25 mg of the combination of the active substances per kg weight, twice daily.


Treatment duration:

In the majority of cases, a treatment of 5 to 7 days is sufficient.

For chronic and refractory infections, longer courses of antibacterial therapy may be required. Treatment length should be adapted by the veterinarian, and should be long enough to ensure complete bacteriological cure.


To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under-dosing


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


Mild gastrointestinal symptoms (diarrhoea, vomiting) may occur more frequently after overdose of the product


Withdrawal period


Not applicable.


5. PHARMACOLOGICAL PROPERTIES


Pharmacotherapeutic group: Antibacterials for systemic use,amoxicillin and enzyme inhibitor

ATCvet code: QJ01CR02.


Pharmacodynamic properties


Amoxicillin is a beta-lactam antibiotic, and as such interferes with the synthesis of cell wall peptidoglycan; it has a bactericidal activity on growing bacteria. It is considered as a broad-spectrum penicillin; it is active in vitro against many aerobic and anaerobic, Gram+ and Gram- bacteria, However it is inactivated in bacteria producing beta-lactamases. Susceptible bacterial species include:Staphylococcus (pseud) intermedius, β-haemolytic streptococci andEscherichia coli.

Clavulanic acid is a potent inhibitor of many β-lactamases produced by Gram positive and Gram negative bacteria, of plasmid or chromosomal origin. Inhibition is allowed by structural similarity with beta-lactams, and occurs through the formation of a stable molecule-enzyme complex. During this process, clavulanic acid is destroyed leading to the protection of amoxicillin against inactivation by these enzymes.


Acquired resistance may be high in E. coli. Resistance notably develops through the production of inhibitor-resistant beta-lactamases or the hyperproduction of beta-lactamases.


In some strains of Staphylococcus aureus (methicillin-resistant S. aureus, MRSA), and of Staphylococcus (pseudo)intermedius,resistance to all beta-lactams is conferred by the alteration of the cell wall target proteins (Penicillin-Binding Proteins). This is often associated to resistance to multiple other antimicrobial compounds.


Pseudomonas aeruginosaand Enterobacter spp. can be regarded as intrinsically resistant to the combination.


Pharmacokinetic particulars


Amoxicillin is well absorbed after oral intake. The bioavailability associated with the tablets is 60-70% in dogs. Following absorption the highest concentrations are found in the kidneys (urine) and the bile, then the liver, the lungs, the heart and the spleen. The distribution of amoxicillin in the cerebrospinal fluid is limited, unless the meninges are inflamed.


Clavulanic acid is also well absorbed after oral administration.The distribution to the cerebrospinal fluid is limited, unless the meninges are inflamed. Clavulanic acid is excreted mainly through the kidneys (unchanged in the urine).


The main pharmacokinetic parameters after a single dose of 25 mg of the combination of active substances per kg body weight to dogs are summarised in the following table:


Parameter

Mean value


Amoxicillin

Clavulanic acid

Cmax (µg/mL)

12.49

4.23

Tmax (hr)*

1

1

t1/2 (hr)

1.56

0.52

AUC (µg.h/ml)

31.1

5.54

* median value

**harmonic mean


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


- Erythrosine (E127)

- Silica, colloidal anhydrous

- Sodium starch glycolate, type A

- Microcrystalline cellulose

- Magnesium stearate


6.2 Incompatibilities


Not applicable


6.3 Shelf life


Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life of halved tablets: 24 hours


6.4. Special precautions for storage


Do not store above 25°C.

Any unused divided tablet portion should be returned to the blister, kept within the outer carton.


6.5 Nature and composition of immediate packaging


Alu-Alu-blister packs consisting of laminated aluminium foil (PE-aluminium-lacquer or PE-aluminium-PET), heat sealed, in strips of 2 tablets.

Cartons containing 10 or 100 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


VIRBAC

1ère avenue – 2065 m – L.I.D.

06516 Carros

FRANCE

Tel.: + +33 4 92 08 73 04

Tel.: + +33 4 92 08 73 48
e-mail: darprocedure@virbac.com


8. MARKETING AUTHORISATION NUMBER


Vm05653/4193


9. DATE OF FIRST AUTHORISATION


24 June 2015


10. DATE OF REVISION OF THE TEXT


June 2015


PROHIBITION OF SALE, SUPPLY AND/OR USE


Delivery: veterinary prescription only.


Approved: 24/06/2015


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