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Date: Monday, September 28, 2020 19:59

Release 4.59
Zodon® 25 mg/ml oral solution for cats and dogs
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Clindamycin
Product:Zodon® 25 mg/ml oral solution for cats and dogs
Product index: Zodon oral solution
Qualitative and quantitative composition
One ml contains:
Active substance:
Clindamycin 25 mg (equivalent to 27.15 mg clindamycin hydrochloride
Excipients:
Ethanol 96% (E1510) 72 mg
For the full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Clear, amber oral solution
Clinical particulars
Target species
Cats and dogs
Indications for use, specifying the target species
Cats:
For the treatment of infected wounds and abscesses caused by clindamycin-sensitive species of Staphylococcus spp. 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.
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
Special warnings for each target species
None.
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 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 (lincomycin and clindamycin) 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.
Adverse reactions (frequency and seriousness)
Vomiting and/or diarrhoea have been reported very rarely
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.
Interaction with other medicinal products and other forms of interaction
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.
When using clindamycin and aminoglycosides (i.e gentamicin) simultaneously, the risk of adverse interactions (acute renal failure) cannot be excluded.
Amounts to be administered and administration routes
For oral administration only
Recommended dose:
Cats:
Infected wounds, abscesses: 11mg of clindamycin per kg of bodyweight 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 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, bodyweight 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.
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.
Withdrawal period(s)
Not applicable
Pharmacological particulars
Pharmacotherapeutic group: Anti-infectives for systemic use, lincosamides. ATCvet code: QJ01FF01
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 ≤0.5 μg/ml; I=1-2 μg/ml; R ≥ 4 μg/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%.
Pharmacokinetic properties
Clindamycin is almost completely absorbed after oral administration. After oral administration of 11 mg/kg, maximum plasma concentrations of 8 µg/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.
Pharmaceutical particulars
List of excipients
Ethanol 96% (E1510), Glycerol, Sorbitol liquid (non crystallising), Sucrose, Propylene glycol, “Grilled note” flavour, Citric acid monohydrate, Purified water
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal product.
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
Special precautions for storage
Do not store above 30oC
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)
- 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)
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 product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 15052/4125
Significant changes
Date of the first authorisation or date of renewal
16th April 2014
Date of revision of the text
30 August 2019
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Zodon 25 mg/ml oral solution
GTIN:03411112279951