Composition:

Each 1 gm contains:
Lincomycin (As Lincomycin Hydrochloride) 222 mg
Spectinomycin (As Spectinomycin Sulphate) 444.7 mg

Properties:

Lincogerm plus is a combination of two antibiotics, lincomycin and spectinomycin, having a complementary spectrum of activity.
Lincomycin: 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.
Spectinomycin: Spectinomycin is an antibiotic from the group of aminocyclitols derived from Streptomyces spectabilis, with bacteriostatic activity. Inhibits protein synthesis by binding to the subunit ribosomal 30S. It is active against Mycoplasma spp. and against some Gram-negative bacteria such as E. coli. In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis. Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.

Indications:

it is used for treatment of:
Pigs: Porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis. and associated enteric
pathogens (Escherichia coli) susceptible to lincomycin and spectinomycin.
Chickens: Chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli.

Target Species:

Pigs – Chickens

Dosage & route of administration:

Route of administration: For use in drinking water
For active ingredient:
Pigs: 3.33 mg lincomycin + 6.67 mg spectinomycin/kg bw/day, for 7 days.
Chickens: 16.65 mg lincomycin + 33.35 mg spectinomycin/kg bw/day, for 7 days.
For whole product:
Pigs: 0.75 g of product / 50 kg.b.wt. /day, for 7 days.
Chickens: 0.75 g of product / 1 liter drinking water /day, for 7 days

Special warnings for each target species:

• In E. coli, a significant part of the strains shows high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
• Due to technical constraints the susceptibility of L.intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.

Special precautions for use

Special precautions for use in animals:
• It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
• If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
• Use of the veterinary medicinal product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with macrolides due to the potential for cross-resistance.
• The oral use of preparations containing lincomycin is only indicated in swine and chickens.
• Do not leave access to the medicated water for other animals. Lincomycin may lead to severe gastrointestinal disturbances in other animal species.
• The repeated or prolonged use should be avoided, by improving the farm management and disinfection practices.
• Diagnosis should be reconsidered if improvement is not seen after 5 days.
• Sick animals have a reduced appetite and an altered drinking pattern, and severely affected animals may require parenteral treatment.
• This powder is for use in drinking water only and should be dissolved before use.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
• People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed 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 of approved dust masks and gloves and safety glasses should be worn when handling and mixing the product.
• Wash hands and any exposed skin with soap and water immediately after use.
• 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.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from 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.

Use during pregnancy, lactation or lay:
Pigs:
– The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
– Laboratory studies in dogs and rats have not produced any evidence of reproductive, foetotoxic. or teratogenic effects for lincomycin or spectinomycin.
– Lincomycin is excreted in milk.
– Use only accordingly to benefit-risk assessment by the responsible veterinarian.
Chickens:
– Do not use in birds in lay.

Contra-indication:

• Do not use in case of hypersensitivity to the active substances or any of the excipients.
• Do not use in case of hepatic dysfunction.
• Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea pigs), horses or ruminants to access to water or feeds. containing lincomycin.
• Ingestion by these species may result in severe gastrointestinal effects.
• Do not use in laying hens.

Drug–drug interaction:

• In general mixture with other medicines should be avoided.
• The combination of lincosamides and macrolides is antagonistic, due to competitive binding to
their target sites.
• Combination with anaesthetics may lead to possible neuromuscular blocking.
• Do not administer with kaolin or pectine as they impair lincomycin absorption. If co-administration is mandatory, respect a delay of two hours between intakes.

Side effects:

• Cases of diarrhoea or soft faeces and/or perianal region inflammation have been encountered in healthy pigs at the start of treatment.
• The symptoms disappeared within 5 to 8 days without interruption of the treatment.
• Rare cases of irritability/excitation, skin rash/pruritus were also observed.
• Allergic/hypersensitive reactions are rare but can occur and require stopping treatment with the veterinary medicinal product.
• A symptomatic treatment must be implemented.

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).

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

• In the event of overdose in pigs, a change in the consistency of the faeces (soft faeces and/or diarrhoea) may be observed.
• In chickens treated at several times the recommended dose, enlargement of the caecum and abnormal caecum content was observed.
• In case of accidental overdose, the treatment should be interrupted and restarted at the recommended dose.

Withdrawal Period(s):

Animals or birds must not be slaughtered for human consumption during treatment.
Pigs: Meat and offal: Zero days.
Chickens: Meat and offal: 5 days.
Not for use in birds producing or intended to produce eggs for human consumption.

Storage conditions:

• Store at temperature not more than 30°C
• Used immediately after opening & after reconstitution.
• Keep out from reach of children.

Packagings:

100,250,500 and1000 gm plastic jar.