Ocnil 400 mg/g Powder for Use in Drinking Water

United Kingdom - English - VMD (Veterinary Medicines Directorate)

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Active ingredient:
Lincomycin
Available from:
Vetpharma Animal Health, S.L
ATC code:
QJ01FF02
INN (International Name):
Lincomycin
Pharmaceutical form:
Powder for use in drinking water
Prescription type:
POM-V - Prescription Only Medicine – Veterinarian
Therapeutic group:
Chickens, Pigs
Therapeutic area:
Antimicrobial
Authorization status:
Authorized
Authorization number:
32509/4021
Authorization date:
2017-07-19

Read the complete document

Revised: May 2019

AN: 01741/2018

Page 1 of 7

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

OCNIL 400 mg/g powder for use in drinking water (ES, CY, EL, IE, IT, PT, UK)

DOPHALIN 400 mg/g powder for use in drinking water (AT, EE, FR, LT, LV, RO, PL)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains:

Active substance:

Lincomycin ...................................................................................400 mg

(equivalent to 450 mg of lincomycin hydrochloride)

Excipients:

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Powder for use in drinking water.

White powder without lumps.

4.

CLINICAL PARTICULARS

4.1

Target species

Pigs and Chickens.

4.2

Indications for use, specifying the target species

Pigs

Treatment

metaphylaxis

enzootic

pneumonia

caused

Mycoplasma

hyopneumoniae.

The presence of the disease in the group must be established before the product is

used.

Chickens: Treatment and metaphylaxis of necrotic enteritis caused by Clostridium

perfringens.

The presence of the disease in the group must be established before the product is

used.

4.3

Contraindications

Do not use in cases of known hypersensitivity to the active substance or to any of

the excipients.

Do not administer, and do not allow access to water containing lincomycin, to

rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result

in severe gastrointestinal disturbances.

Revised: May 2019

AN: 01741/2018

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Do not use in cases of known resistance to lincosamides.

Do not use in cases of hepatic dysfunction.

4.4

Special warnings for target species

Medicated drinking water uptake can be affected by the severity of the disease. In

case of insufficient uptake of water, pigs should be treated parenterally.

The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult

to test in vitro owing to technical constraints. In addition, there is a lack of clinical

breakpoints for both M. hyopneumoniae and C. perfringens. Where possible,

therapy should be based on local (regional, farm level) epidemiological information

concerning the response of enzootic pneumonia/necrotic enteritis to treatment with

lincomycin.

4.5

Special precautions for use

Special precautions for use in animals

veterinary

medicinal

product

preferably

should

based

identification of the target pathogen and susceptibility testing of the bacteria

isolated from the animal. However, also see text under section 4.4.

Official, national and regional antimicrobial policies should be taken into account

when the veterinary medicinal product is used.

Use of the veterinary medicinal product deviating from the instructions given in the

SPC may increase the prevalence of bacteria resistant to lincomycin and may

decrease the effectiveness of treatment with other lincosamides, macrolides or

streptogramin B due to potential for cross-resistance.

Repeated or prolonged use should be avoided by improving the farm management

and hygiene practices.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

This product contains lincomycin and lactose monohydrate, either of which can

cause allergic reactions in some people. People with known hypersensitivity to

lincomycin or any other lincosamide, or to lactose monohydrate, should avoid

contact with the veterinary medicinal product.

Care should be taken not to raise and inhale any dust.

Contact with skin and eyes should be avoided.

Personal

protective

equipment

consisting

approved

dust

masks

(either

disposable half-mask respirator conforming to European Standard EN 149 or a

non-disposable respirator conforming to European Standard EN 140 with a filter to

EN 143), gloves and safety glasses should be worn when handling and mixing the

product. If respiratory symptoms develop following exposure, seek medical advice

and show this warning to the physician.

In case of accidental exposure to the skin, eyes or mucous membranes, wash the

affected area thoroughly with plenty of water. If symptoms such as skin rash or

persistent eye irritation appear after exposure, seek medical advice immediately

and show the package leaflet or label to the physician.

Wash hands and any exposed skin with soap and water immediately after use.

Do not eat, drink or smoke while handling the product.

Revised: May 2019

AN: 01741/2018

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Other precautions

Lincomycin is known to be toxic to terrestrial plants, cyanobacteria and

groundwater bacteria.

4.6

Adverse reactions (frequency and seriousness)

On rare occasions, pigs given lincomycin-medicated water may develop

diarrhoea/soft stools and/or mild swelling of the anus within the first 2 days after

onset of treatment. On rare occasions some pigs may show reddening of the skin

and mild irritable behaviour. These conditions are usually self-correcting within 5-8

days without discontinuing the lincomycin treatment. Allergic/hypersensitive

reactions occur on rare occasions.

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

very common (more than 1 in 10 animals treated displaying adverse

reactions)

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

Laboratory studies in rats have not produced any evidence of teratogenic effects,

although foetotoxicity has been reported. The safety of the veterinary medicinal

product has not been established during pregnancy, lactation or lay in the target

species. Use only according to the benefit-risk assessment by the responsible

veterinarian.

4.8

Interaction with other medicinal products and other forms of

interaction

Antagonism may exist between lincomycin and macrolides such as erythromycin

and other bactericidal antibiotics; concurrent use is therefore not recommended

due to competitive binding at the 50S ribosomal subunit of the bacterial cell.

The bioavailability of lincomycin may decrease in the presence of gastric antacids

or activated charcoal, pectin or kaolin.

Lincomycin

potentiate

neuromuscular

effects

anaesthetic

muscle

relaxants.

4.9

Amounts to be administered and administration route

For use in drinking water.

Dosing guidance and recommended doses:

To ensure a correct dosage, body weight should be determined as accurately as

possible to avoid underdosing.

The intake of medicated water depends on the physiological and clinical condition

of the animals. In order to obtain the correct dosage, the concentration of the

lincomycin has to be adjusted accordingly.

The uptake of water should be monitored frequently.

Revised: May 2019

AN: 01741/2018

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The medicated water should be the only source of drinking water for the animals

for the entire duration of the treatment period.

After the end of the medication period, the water supply system should be cleaned

appropriately to avoid intake of sub-therapeutic amounts of the active substance.

Dosage:

Pigs:

Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25

mg product per kg bodyweight) for 21 consecutive days.

Chickens:

Necrotic enteritis: 5 mg of lincomycin per kg body weight (corresponding to 12.5

mg product per kg body weight) for 7 consecutive days.

The concentration to be used depends on the actual body weight and the water

consumption of the animals and can be calculated according to the following

formula:

Dose (mg product per kg

body weight per day)

mean body weight (kg)

of animals to be treated

Average daily water intake (litre/animal)

= ___ mg product per

litre drinking water

The use of suitably calibrated weighing equipment is recommended if part packs

are used. The daily amount is to be added to the drinking water in such a way that

all medication will be consumed within 24 hours. Medicated drinking water should

be freshly prepared every 24 hours. No other source of drinking water should be

available.

The maximum solubility of finished product is 50 g/l in soft and hard water. For

stock solutions and when using a dosing pump, take care not to exceed the

maximum solubility which can be achieved under the given conditions. Adjust flow

rate settings of the dosing pump according to concentration of the stock solution

and water intake of the animals to be treated.

4.10

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

A dosage greater than 10 mg lincomycin per kg of body weight may cause

diarrhoea and loose stools in pigs.

In case of accidental overdose, the treatment must be stopped and restarted at the

recommended dose level.

There is no specific antidote, treatment is symptomatic.

4.11

Withdrawal periods

Pigs

Meat and offal: 1 day.

Chickens

Meat and offal:

5 days

Not authorised for use in laying birds producing eggs for human consumption.

Revised: May 2019

AN: 01741/2018

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5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial for systemic use, Lincosamides.

ATC Vet Code: QJ01FF02

5.1

Pharmacodynamic properties

Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis

which inhibits protein synthesis. Lincomycin binds to the 50S sub-unit of the

bacterial ribosome close to the peptidyl transfer centre and interferes with the

peptide chain elongation process by causing premature peptidyl-tRNA dissociation

from the ribosome.

Lincomycin is active against some gram-positive bacteria (Clostridium perfringens)

and mycoplasmas (Mycoplasma hyopneumoniae).

While the lincosamides are generally considered to be bacteriostatic agents, the

activity depends on the sensitivity of the organism and concentration of the

antibiotic. Lincomycin may be either bactericidal or bacteriostatic.

Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm

genes) coding for methylases modifying the ribosomal binding site and frequently

leading to cross-resistance to other antimicrobials of the macrolides, lincosamides

streptogramins

group.

However,

most

prevalent

mechanism

mycoplasmas

alteration

binding

site

through

mutational

events

(chromosomal resistance). Lincomycin resistance mediated by efflux pumps, or by

inactivating enzymes, has also been described. There is often complete cross-

resistance between lincomycin and clindamycin.

5.2

Pharmacokinetic particulars

In pigs, lincomycin is rapidly absorbed following oral administration. A single oral

administration of lincomycin hydrochloride, at dose levels of approximately 22, 55

and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum

levels, detected for 24-36 hours after administration. Peak serum levels were

observed at 4 hours after dosing. Similar results were observed following single

oral doses of 4.4 and 11.0 mg/kg body weight in pigs. Levels were detectable for

12 to 16 hours, with peak concentrations occurring at 4 hours. A single oral dose of

10 mg/kg body weight was administered to pigs to determine the bioavailability.

The oral absorption of lincomycin was found to be 53% +/- 19%.

Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight

days

indicated

accumulation

lincomycin

species,

with

detectable serum levels of antibiotic after 24 hours post administration.

Crossing the intestinal barrier, lincomycin is widely distributed to all tissues,

especially the lungs and joint cavities; the volume of distribution is about 1 litre.

The elimination half-life of lincomycin is greater than 3 hours. Approximately 50%

of lincomycin is metabolised in the liver. Lincomycin undergoes enterohepatic

circulation.

Lincomycin

eliminated

unchanged

form

various

metabolites in bile and urine. High concentrations of the active form are observed

in the intestine.

Chickens were administered lincomycin hydrochloride in the drinking water at a

level of approximately 34 mg/litre (5.1-6.6 mg/kg body weight) for seven days.

Metabolites comprised more than 75% of total residues in the liver. Unmetabolised

Revised: May 2019

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Page 6 of 7

lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.

Lincomycin and one unknown metabolite comprised >50% of the muscle residue at

zero hours. The excreta contained mostly unmetabolised lincomycin (60-85%)

during treatment.

5.3

Environmental properties

Lincomycin is known to be toxic to terrestrial plants, cyanobacteria and

groundwater bacteria.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Silica colloidal anhydrous

Lactose monohydrate

6.2

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not

be mixed with other veterinary medicinal products.

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: 6 months.

Shelf-life after dilution or reconstitution according to directions: 24 hours.

6.4

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5

Nature and composition of immediate packaging

Thermosealed

bags

made

polypropylene/metallized

polyester/low

density

polyethylene.

Pack size:

Bag of 150 g or 1kg

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

Dangerous to aquatic life (cyanobacteria). Do not contaminate surface waters or

ditches with product or used container. Any unused veterinary medicinal product or

waste

materials

derived

from

such

veterinary

medicinal

products

should

disposed of in accordance with local requirements.

Revised: May 2019

AN: 01741/2018

Page 7 of 7

7.

MARKETING AUTHORISATION HOLDER

Vetpharma Animal Health, S.L.

Les Corts, 23

08028 Barcelona

Spain

8.

MARKETING AUTHORISATION NUMBER

Vm 32509/4021

9.

DATE OF FIRST AUTHORISATION

19 July 2017

10.

DATE OF REVISION OF THE TEXT

May 2019

Approved: 07 May 2019

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