Zodon 25 mg/ml oral solution for cats and dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Clindamycin
Available from:
Ceva Santé Animale
ATC code:
QJ01FF01
INN (International Name):
Clindamycin
Dosage:
25 milligram(s)/millilitre
Pharmaceutical form:
Oral solution
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cats, Dogs
Therapeutic area:
clindamycin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10815/038/001
Authorization date:
2016-04-22

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Health Products Regulatory Authority

21 March 2019

CRN000Z32

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Zodon 25 mg/ml oral solution for cats and dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Clindamycin

(equivalent to 27.17 mg clindamycin hydrochloride)

Excipients:

Ethanol 96% (E1510)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution.

Clear, amber solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Cats and dogs.

4.2 Indications for use, specifying the target species

Cats:

For the treatment of infected wounds and abscesses caused by clindamycin-susceptible species of Staphylococcusspp and

Streptococcus spp.

Dogs:

​For the treatment of infected wounds, abscesses and oral cavity/dental infections caused by or associated with

clindamycin-sensitive species of Staphylococcus spp, Streptococcus spp, Bacteroides spp, Fusobacterium

necrophorum, Clostridium perfringens

Adjunctive treatment of mechanical or surgical periodontal therapy in the treatment of infections of the gingival

and periodontal tissues

For the treatment of osteomyelitis caused by Staphylococcus aureus

4.3 Contraindications

Do not use in hamsters, guinea pigs, rabbits, chinchillas, horses or ruminants because clindamycin ingestion by these species

may cause severe gastrointestinal disorders.

Do not use in cases of hypersensitivity to either clindamycin or lincomycin, or to any of the excipients.

4.4 Special warnings for each target species

None.

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4.5 Special precautions for use

Special precautions for use in animals

Inappropriate use of the product may increase the prevalence of bacteria resistant to clindamycin. Whenever possible,

clindamycin should only be used based on susceptibility testing including the D-zone test.

Official national and local antimicrobial policies should be taken into account when the product is used.

Clindamycin is likely to favour the proliferation of non-susceptible organisms such as resistant Clostridia spp and yeasts. In case

of secondary infection, appropriate corrective measures should be taken based on clinical observations.

Clindamycin shows parallel-resistance with lincomycin and co-resistance with erythromycin. There is a partial cross-resistance

to erythromycin and other macrolides.

In case of administration of high doses of clindamycin or during prolonged therapy of one month or greater, tests for liver and

renal functions and blood counts should be performed periodically

In dogs and cats with kidney problems and/or liver problems, accompanied by severe metabolic aberrations, the dose to be

administered should be carefully determined and their condition should be monitored by performing appropriate blood tests

during treatment.

The use of the product is not recommended in neonates.

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

Wash hands carefully after use.

People with known hypersensitivity to lincosamides (clindamycin and lincomycin) should avoid contact with the veterinary

medicinal product.

Care should be taken to avoid accidental ingestion as this may result in gastro-intestinal effects such as abdominal pain and

diarrhoea.

In case of accidental ingestion, particularly by a child, or allergic reaction seek medical advice immediately and show the

package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and/or diarrhoea have been reported very rarely.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

While high dose studies in rats suggests that clindamycin is not a teratogen and does not significantly affect the breeding

performance of males and females, the safety of the veterinary medicinal product in pregnant bitches/queens or breeding male

dogs/cats has not been established.

Use only according to the benefit/risk assessment by the responsible veterinarian.

Clindamycin can pass the placenta and blood-milk barrier. As a consequence, treatment of lactating females can cause

diarrhoea in puppies and kittens.

4.8 Interaction with other medicinal products and other forms of interactions

​Aluminium salts and hydroxides, kaolin and Aluminium-Magnesium-Silicate complex may reduce the

gastrointestinal absorption of lincosamides. Products containing these substances should be administered at least

2 hours before clindamycin.

Cyclosporin: clindamycin may reduce levels of this immunosuppressive drug with a risk of lack of activity.

​Neuro-muscular blocking agents: Clindamycin possesses intrinsic neuromuscular blocking activity and should be

used cautiously with other neuromuscular blocking agents (curares). Clindamycin may increase neuromuscular

blockade.

​Do not use clindamycin simultaneously with chloramphenicol or macrolides as they both target the ribosome 50S

subunit and antagonist effects may develop.

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When using clindamycin and aminoglycosides (e.g. gentamicin) simultaneously, the risk of adverse interactions

(acute renal failure) cannot be excluded.

4.9 Amounts to be administered and administration route

For oral administration only

Recommended dose:

Cats:

- Infected wounds, abscesses: 11mg of clindamycin per kg of body weight per 24h or 5.5 mg /kg per 12h for 7 to 10 days

The treatment should be stopped if no therapeutic effect is observed after 4 days.

Dogs:

- Infected wounds, abscesses and oral cavity/dental infections: 11 mg clindamycin per kg of body weight per 24h or 5.5 mg /kg

per 12h for 7 to 10 days.

The treatment should be stopped if no therapeutic effect is observed after 4 days.

- Treatment of bone infections (osteomyelitis): 11 mg clindamycin per kg of body weight every 12 hours during for a period of

28 days minimum. The treatment should be discontinued if no therapeutic effect is observed in the first 14 days.

-Dosage

-Volume to be administered per kg bodyweight

-5.5 mg/kg

-Corresponding approximately to 0.25 ml per kg

-11 mg/kg

-Corresponding approximately to 0.5 ml per kg

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

A 3 ml graduated syringe is provided to facilitate the administration of the veterinary medicinal product.

The solution is flavoured. The solution can be administered directly into the mouth of the animal or added to a small quantity

of food.

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

No adverse effects have been reported in dogs after administration of high dosage up to 300 mg/kg clindamycin.

Vomiting, loss of appetite, diarrhoea, leukocytosis and elevated liver enzymes have been observed occasionally. In such cases,

discontinue the treatment and administer a symptomatic treatment.

4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-infectives for systemic use, lincosamides.

ATCvet code: QJ01FF01

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5.1 Pharmacodynamic properties

Clindamycin is mainly a bacteriostatic antibiotic belonging to the group of lincosamides. Clindamycin is a chlorinated analogue

of lincomycin. It works by inhibiting bacterial protein synthesis. The reversible coupling to the sub-unit 50-S bacterial ribosome

inhibits translation of amino acids linked to the tRNA, thereby preventing elongation of the peptide chain. That is why the

mode of action of clindamycin is predominantly bacteriostatic.

Clindamycin and lincomycin have cross-resistance, which is also common between erythromycin and other macrolides.

Acquired resistance can occur, by methylation of the ribosomal binding site via chromosomal mutation in gram positive

organisms, or by plasmid-mediated mechanisms in gram negative organisms

Clindamycin is active in vitro against many Gram-positive bacteria, Gram positive and Gram-negative anaerobic bacteria. Most

aerobic Gram-negative bacteria are resistant to clindamycin.

CLSI clindamycin veterinary breakpoints are available for dogs in Staphylococcus spp. and Streptococci-ß-haemolytic group in

skin and soft tissue infections: S ≤0.5μg/ml; I=1-2μg/ml; R ≥ 4μg/ml. (CLSI July 2013).

The incidence of resistance to lincosamides in Staphylococcus spp. appears to be wide-ranging in Europe. Literature data (2016)

report an incidence between 25 to 40%.

5.2 Pharmacokinetic particulars

Clindamycin is almost completely absorbed after oral administration. After oral administration of 11mg/kg, maximum plasma

concentrations of 8µg/ml are reached within one hour (without any influence of food).

Clindamycin is widely distributed and may concentrate in some tissues.

Elimination half life of clindamycin is around 4 hours. Approximately 70% is excreted in faeces and 30% in the urine.

Clindamycin is approximately 93% bound to plasma proteins.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol 96% (E1510)

Glycerol

Sorbitol liquid (non crystallising)

Sucrose

Propylene glycol

Grilled note flavour

Citric acid monohydrate

Purified water

6.2 Major incompatibilities

In the absence of compatibilitystudies, this veterinary medicinal product must not be mixed with otherveterinary medicinal

product.

6.3 Shelf-life

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

Shelf life after first opening the immediate packaging: 28 days

6.4 Special precautions for storage

Do not store above 30

6.5 Nature and composition of immediate packaging

A cardboard box containing:

- a 20 mL amber translucent multidose bottle made in glass material (type III),

- a childproof white cap equipped with an inviolability ring, made in high density polyethylene; fitted with a transparent low

density polyethylene part inside (insert)

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- a 3 mL syringe for oral use equipped with a tip cannula (transparent natural barrel made of polypropylene and white plunger

made of high density polyethylene material)

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the

use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Ceva Santé Animale

10, avenue de La Ballastière

33500 Libourne

France

8 MARKETING AUTHORISATION NUMBER(S)

VPA10815/038/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 4 April 2014

Date of last renewal: 15 March 2019

10 DATE OF REVISION OF THE TEXT

March 2019

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