Other products

Marbocyl 2%

1 x 100 ml
Liquid for injection, solution
IM
IV
SC
B

Species

- Cattle: pre-ruminants up to 100 kg b.w.

- Pigs

Indications

In cattle and pigs

Indicated in the treatment of respiratory infections caused by susceptible strains of organisms.

Dose to be administered and administration route

The recommended dosage is 2 mg/kg/day (1 ml/10 kg) in a single daily injection by subcutaneous or intravenous routes in cattle and by intramuscular route in pigs.

Treatment duration is as follows:

- cattle, IV route : 3 to 5 days

- cattle, SC route : 3 days

- pigs, IM route : 3 to 5 days

In order to reduce the risk of particulate contamination of the veterinary medicinal product, it is recommended that a draw-off needle be used to reduce the number of times the septum is punctured.

Adverse reactions

Calves and swine:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Injection site inflammation1

1 Transitory inflammatory reaction are sometimes observed at the injection site, but without clinical impact. No severe side-effects are to be expected at doses up to 5 times the recommended dose in cattle and pigs. In particular, no lesions of the articular joints are encountered.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian

EMA Categorisation

B

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Marbocyl 2% Solution for Injection for Cattle and Pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Marbofloxacin 20.0 mg

Excipients:

Qualitative composition of excipients and other constituents

Quantitative composition if that information is essential for proper administration of the veterinary medicinal product

Disodium edetate

0.1 mg

Thioglycerol

0.5 mg

Metacresol

2 mg

Gluconolactone

Water for injection

Mannitol

Yellow greenish to yellow brownish solution.

3. CLINICAL INFORMATION

3.1 Target species

- Cattle: pre-ruminants up to 100 kg b.w.

- Pigs

3.2 Indications for use for each target species

In cattle and pigs

Indicated in the treatment of respiratory infections caused by susceptible strains of organisms.

3.3 Contraindications None.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

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

People with known hypersensitivity to fluoroquinolones, such as marbofloxacin, should avoid contact with this veterinary medicinal product. Wash hands after use.

Special precautions for the protection of the environment:

Manure and slurry containing marbofloxacin should not be spread on the same area of land in successive years.

3.6 Adverse events Calves and swine:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Injection site inflammation[1]

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Not applicable.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

The recommended dosage is 2 mg/kg/day (1 ml/10 kg) in a single daily injection by subcutaneous or intravenous routes in cattle and by intramuscular route in pigs.

Treatment duration is as follows:

- cattle, IV route : 3 to 5 days

- cattle, SC route : 3 days

- pigs, IM route : 3 to 5 days

In order to reduce the risk of particulate contamination of the veterinary medicinal product, it is recommended that a draw-off needle be used to reduce the number of times the septum is punctured.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Overdosage may cause acute signs in the form of neurological disorders which should be treated symptomatically.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Preruminating calves (up to 100kg bodyweight)

Meat and offal: 6 days

Pigs

Meat and offal: 4 days

The volume of injection should be limited to 10 ml at each site of injection for pigs.

4. PHARMACOLOGICALINFORMATION

4.1 ATCvet code: QJ01MA93

4.2 Pharmacodynamics

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase. It is effective against a wide range of

Gram positive bacteria (in particular Staphylococci) and Gram negative bacteria

(Escherichia coli, Salmonella typhimurium,Campylobacter jejunii, Citrobacter,

Enterobacter, Proteus spp, Klebsiella spp, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Pasteurella haemolytica, Pasteurella multocida, Haemophilus spp, Moraxella spp, Pseudomonas aeruginosa) as well as Mycoplasma (Mycoplasma bovis, Mycoplasma dispar, Mycoplasma hyopneumoniae).

Resistance to Streptococcus spp. may occur.

4.3 Pharmacokinetics

After subcutaneous administration in cattle and pigs at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and its bioavailability is close to 100 %. It is weakly bound to plasma proteins (less than 10 % in pigs and 30 % in cattle), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, uterus digestive tract) it achieves higher concentrations than in plasma.

In cattle, marbofloxacin is eliminated slowly in pre-ruminating calves (t1/2β = 5-9 h) predominantly in the active form in urine (3/4) and faeces (1/4).

In pigs, marbofloxacin is eliminated slowly (t1/2β = 8-10 h) predominantly in the active form in urine (2/3) and faeces (1/3).

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

None known.

5.2 Shelf life

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

Shelf life after first opening the immediate packaging: 28 days.

Discard unused material.

5.3 Special precautions for storage

Do not store above 25°C. Protect from light.

5.4 Nature and composition of immediate packaging

Packaged in amber type II glass vials of 10, 20, 50 ml, 100 ml and 250 ml.

The vials are closed with a chlorobutyl rubber stopper oversealed with aluminium caps.

Each vial is packaged in a cardboard box. Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Vetoquinol UK Limited

7. MARKETING AUTHORISATION NUMBER

Vm 08007/5031

8. DATE OF FIRST AUTHORISATION

25 June 1998

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 19 June 2026



[1] Transitory inflammatory reaction are sometimes observed at the injection site, but without clinical impact. No severe side-effects are to be expected at doses up to 5 times the recommended dose in cattle and pigs. In particular, no lesions of the articular joints are encountered.

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Art. Nr. 08007/4148
GTIN • • • • • • • • • 7387
PACKAGES
Marbocyl 2%
Vetoquinol
1 x 100 ml
08007/4148
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