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Date: Thursday, December 2, 2021 16:05

Release 2.148
Metrobactin® Tablets for Dogs and Cats
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Metronidazole
Product:Metrobactin® tablets for dogs and cats
Product index: Metrobactin tablets for dogs and cats
Qualitative and quantitative composition
Metrobactin 250 mg tablets for dogs and cats
1 tablet contains: Active substance:
Metronidazole 250 mg
Metrobactin 500 mg tablets for dogs and cats
1 tablet contains: Active substance:
Metronidazole 500 mg
Pharmaceutical form
Tablet. Light brown with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side.
Tablets can be divided into 2 or 4 equal parts.
Clinical particulars
Target species
Dogs and cats
Indications for use
Treatment of gastrointestinal tract infections caused by Giardia spp. and Clostridia spp. (i.e. C. perfringens or C. difficile).
Treatment of infections of the urogenital tract, oral cavity, throat and skin caused by obligate anaerobic bacteria (e.g. Clostridia spp.) susceptible to metronidazole.
Contraindications
Do not use in case of hepatic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of metronidazole resistant bacteria, bacteriological sampling and susceptibility testing are recommended.
Whenever possible, the product should only be used based on susceptibility testing. Official, national and regional anitmicrobial policies should be taken into account when the veterinary medicinal product is used.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.
Especially after prolonged treatment with metronidazole neurological signs could occur.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has possible carcinogenic effects in humans. However, there is inadequate evidence in humans for the carcinogenicity of metronidazole.
Metronidazole may be harmful for the unborn child. Avoid contact with the skin or mucous membranes including hand-to-mouth contact.
To avoid such contact wear impervious gloves when handling the product and/or for direct administration into the animal's mouth.
Do not allow treated dogs to lick persons immediately after intake of the medication.
In case of skin contact, wash thoroughly the affected area.
To avoid accidental ingestion, particularly by a child, unused parts of the tablets should be returned to the open blister space, inserted back into the outer packaging and kept in a safe place out of the sight and reach of children. The remaining part should be used at the time of next administration.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after use. Metronidazole may cause hypersensitivity reactions. People with known hypersensitivity to metronidazole should avoid contact with the veterinary medicinal product.
Adverse reactions
The following adverse reactions may occur after administration of metronidazole: vomiting, hepatotoxicity, neutropenia. In very rare cases neurologic signs may cccur.
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).
Use during pregnancy and lactation
Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, use of this product during pregnancy is not recommended. Metronidazole is excreted in milk and use during lactation is therefore not recommended.
Interactions
Metronidazole may have an inhibitory effect on the degradation of other drugs in the liver, such as phenytoin, cyclosporine and warfarin.
Cimetidine may decrease the hepatic metabolism of metronidazole resulting in increased serum concentration of metronidazole.
Phenobarbital may increase hepatic metabolism of metronidazole resulting in decreased serum concentration of metronidazole.
Amounts to be administered and administration route
For oral administration.
The recommended dose is 50 mg metronidazole per kg body weight per day, for 5-7 days. The daily dose may be divided equally for twice daily administration (i.e. 25 mg/kg body weight twice daily).
To ensure administration of the correct dosage body weight should be determined as accurately as possible.
Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
Halves: press down with your thumbs on both sides of the tablet.
Quarters: press down with your thumb in the middle of the tablet.
Overdose
Adverse events are more likely to occur at doses and treatment durations in excess of the recommended treatment regimen. If neurological signs occur, treatment should be discontinued and the patient should be treated symptomatically.
Pharmacological particulars
Pharmacotherapeutic group: Antiprotozoals, agents against protozoal diseases, nitroimidazole derivatives
ATCvet code: QP51AA01
Pharmacodynamic properties
After metronidazole has penetrated the bacteria the molecule is reduced by the sensitive bacteria (anaerobe). The metabolites that are created have a toxic effect on the bacteria through binding to the bacterial DNA. In general metronidazole is bactericidal for sensitive bacteria in concentrations equal to or a little higher than the minimum inhibiting concentration (MIC).
Clinically metronidazole does not have any relevant effect on facultative anaerobe, obligate aerobe and microaerophilic bacteria.
Pharmacokinetic properties
Metronidazole is immediately and well absorbed after oral administration. After 1 hour a plasma concentration of 10 micrograms/ml was reached with a single dose of 50 mg. The bioavailability of metronidazole is almost 100% and the half life in the plasma is approximately 8-10 hours. Metronidazole penetrates well into the tissues and bodily fluids, such as saliva, milk, vaginal secretions and semen. Metronidazole is primarily metabolised in the liver. Within 24 hours after oral administration 35-65% of the administered dose (metronidazole and the metabolites thereof) es excreted in the urine.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life of divided tablets: 3 days
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
Aluminium - PVC/PE/PVDC blister
Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets
Cardboard box containing 10 boxes, each containing 1 or 10 blisters of 10 tablets
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Le Vet Beheer BV, Wilgenweg 7, 3421 TV Oudewater, The Netherlands.
Marketing Authorisation Number
Vm 41821/4029: 250 mg
Vm 41821/4030: 500 mg
Significant changes
Date of the first authorisation or date of renewal
18 December 2015
Date of revision of the text
February 2021
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Metrobactin 250 mg Tablets for Dogs and Cats 250 tablets:
GTIN:08717973562139
GTIN description:Metrobactin 500 mg Tablets for Dogs and Cats 250 tablets:
GTIN:08717973562160
GTIN description:Metrobactin 250 mg Tablets for Dogs and Cats 10 tablets:
GTIN:08718469442089
GTIN description:Metrobactin 500 mg Tablets for Dogs and Cats 10 tablets:
GTIN:08718469442119