Product Name: SPECTIN-1000

Type: Oral Water-Soluble Powder - Antibiotic Combination

COMPOSITION

Each gram contains:

• Lincomycin (as Lincomycin Hydrochloride USP) ...... 335 mg
• Spectinomycin (as Spectinomycin Sulfate BP) ...... 665 mg

Total antibiotic activity: 1 g antibiotic per gram of product (1:2 ratio of lincomycin:spectinomycin)

DESCRIPTION

SPECTIN-1000 is a high-concentration, broad-spectrum antibiotic combination powder containing lincomycin and spectinomycin in a 1:2 ratio. This potent formulation delivers a total of 1 gram of antibiotic activity per gram of product, providing exceptional efficacy against gram-positive and gram-negative pathogens, as well as Mycoplasma species. It is a cornerstone treatment for controlling respiratory diseases in poultry .

Lincomycin is a lincosamide antibiotic produced by Streptomyces lincolnensis that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, interfering with peptidyl transferase activity . Spectinomycin is an aminocyclitol antibiotic that binds to the 30S ribosomal subunit, blocking bacterial protein production . The combination delivers a powerful synergistic effect that halts bacterial growth and eradicates infections quickly and effectively, with the antimicrobial activity against Mycoplasma increasing significantly and the antibacterial spectrum expanding .

MECHANISM OF ACTION

Lincomycin:

• Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit
• Interferes with the peptidyl transferase reaction, preventing peptide bond formation
• Active against gram-positive bacteria, anaerobic bacteria, and Mycoplasma species

Spectinomycin:

• Binds to the 30S ribosomal subunit, blocking bacterial protein production
• Interferes with the initiation of protein synthesis and causes misreading of mRNA
• Particularly effective against gram-negative bacteria and Mycoplasma species

Synergistic Combination:

• Combined with lincomycin, the antimicrobial activity against Mycoplasma may increase significantly and expand the antibacterial spectrum
• The dual ribosomal binding sites (50S and 30S) provide enhanced bactericidal activity
• This combination is particularly effective against simultaneous infections caused by Mycoplasma gallisepticum and avian pathogenic E. coli (APEC)

ANTIMICROBIAL SPECTRUM

SPECTIN-1000 is effective against a broad range of microorganisms:

Mycoplasma:

• Mycoplasma gallisepticum - chronic respiratory disease (CRD)
• Mycoplasma synoviae - infectious synovitis, respiratory disease
• Mycoplasma meleagridis - in turkeys

Gram-Positive Bacteria:

• Staphylococcus spp.
• Streptococcus spp.
• Clostridium perfringens

Gram-Negative Bacteria:

• Escherichia coli - colibacillosis
• Salmonella spp. - salmonellosis
• Pasteurella multocida - fowl cholera
• Haemophilus paragallinarum - infectious coryza

INDICATIONS

SPECTIN-1000 is indicated for the control and treatment of infections caused by lincomycin and spectinomycin-sensitive bacteria in poultry .

Poultry (Chickens, Turkeys):

• Control of Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin
• Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin
• Treatment of Chronic Respiratory Disease (CRD) associated with mycoplasmal and coliform infections in growing chickens
• Prevention of CRD during the first days of life and during stress periods
• Infectious Synovitis caused by Mycoplasma synoviae
• Secondary bacterial infections associated with viral diseases

Disease Conditions:

• Chronic Respiratory Disease (CRD) - respiratory distress, nasal discharge, coughing, reduced feed intake
• Airsacculitis - inflammation of air sacs, often complicated by E. coli
• Infectious Synovitis - lameness, swollen hocks, reduced performance

PHARMACOKINETIC PROPERTIES

• Lincomycin: Rapidly absorbed after oral administration. Following oral administration at 10 mg/kg body weight in broiler chickens, lincomycin shows a good pharmacokinetic profile with a long elimination half-life (t½β) of 7.041 ± 0.402 hours . Widely distributed throughout the body, achieving therapeutic concentrations in respiratory tissues .
• Spectinomycin: Rapidly absorbed but also rapidly eliminated; achieves therapeutic concentrations in respiratory tissues .
• Distribution: Both antibiotics are widely distributed throughout the body, achieving therapeutic concentrations in respiratory tract tissues .
• Elimination: Excreted primarily in urine and bile .

DOSAGE & ADMINISTRATION

SPECTIN-1000 is administered via drinking water. For optimal results, fresh medicated water should be prepared daily.

Recommended Dosage:

• Poultry (Broilers, Layers, Breeders, Turkeys): Provide 2 grams (g) antibiotic activity per gallon of drinking water (approximately 0.53 g per liter)
• Product Calculation: At 2 g antibiotic activity per gallon, use 2 g of SPECTIN-1000 per gallon of drinking water (since 1 g product = 1 g antibiotic activity)
• Metric Conversion: 0.53 g of SPECTIN-1000 per liter of drinking water
• Alternative Dosage (body weight): 10-20 mg lincomycin + 20-40 mg spectinomycin per kg body weight per day
• Treatment Duration: 3-7 consecutive days

Prevention Program:

• Day 1-5: Administer for the first 3 to 5 days of life to prevent early CRD establishment
• Week 4: Administer again for 1-2 days at about 4 weeks of age to control stress-related flare-ups
• The longer period (5 days) of initial administration is recommended if disease has been a problem in the past on the premises

Administration Guidelines:

• Calculate total daily water consumption based on flock size, age, and environmental temperature
• Dissolve the required amount of SPECTIN-1000 in a small volume of water, then add to the main drinking water tank
• For use in automatic water proportioners, prepare stock solution according to manufacturer specifications
• Prepare fresh medicated water daily; discard any unused solution after 24 hours
• Ensure medicated water is the sole source of drinking water during treatment
• For best results, administer over 4-8 hours; may withhold water for 1-2 hours before treatment to encourage rapid consumption
• For use in chickens up to 7 days of age: administer as the sole source of water for the first 5 to 7 days of life

EFFICACY AND SYNERGY DATA

Synergistic Activity:

• Combined with lincomycin, the antimicrobial activity against Mycoplasma may increase significantly and expand the antibacterial spectrum
• In vitro studies confirm that the combination is effective against Mycoplasma gallisepticum and avian pathogenic E. coli (APEC)
• The dual ribosomal binding sites (50S and 30S) provide enhanced bactericidal activity

Pharmacokinetic Studies:

• Following oral administration of lincomycin at 10 mg/kg body weight in broiler chickens, the drug shows a good pharmacokinetic profile with a long elimination half-life (t½β) of 7.041 ± 0.402 hours
• This prolonged half-life supports once-daily or continuous dosing regimens

Field Efficacy:

• Proven effective for treatment and control of respiratory diseases in broilers and turkeys
• Reduces mortality, improves feed conversion, and enhances overall flock performance when used during disease outbreaks

DRUG INTERACTIONS

• Antagonistic: There is antagonism when combined with erythromycin and other macrolide antibiotics
• Interactions: The effect of anticholinesterase drugs may be reduced when combined with lincomycin
• Synergistic: The combination of lincomycin and spectinomycin itself is synergistic; no other significant synergistic interactions documented

CONTRAINDICATIONS & PRECAUTIONS

• Egg production: Do not use in laying hens producing eggs for human consumption. This product must not be used in laying birds
• Young birds: For use in chickens and turkeys only; some formulations restrict use to chickens up to 7 days of age
• Sensitive species: Do not allow rabbits, hamsters, guinea pigs, horses, dairy cattle, or other ruminants access to feeds and/or drinking water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects or metabolic disorders (i.e., ketosis in dairy cattle)
• Hypersensitivity: Do not use in animals with known hypersensitivity to lincosamides or spectinomycin
• Renal dysfunction: Use with caution in animals with impaired renal function
• Keep out of reach of children
• When handling the product, avoid inhalation, oral exposure, and direct contact with skin or eyes
• Store in a dry place between 15-30°C (59-86°F)
• Protect from direct sunlight and moisture
• Use within 28 days after first opening

ADVERSE REACTIONS

• At recommended doses, the combination is generally well tolerated in poultry
• No adverse reactions are observed at recommended dose
• If adverse reactions occur, discontinue use and consult a veterinarian

WITHDRAWAL PERIOD

• Meat (Poultry): 5 days (according to EU and other regulatory standards)
• Alternative Withdrawal: 72 hours (3 days) for chickens according to Canadian and other regulatory standards
• Eggs: Not for use in laying hens producing eggs for human consumption
• Note: Withdrawal periods may vary by country; always follow local regulatory requirements. For Canada: 72 hours; for EU: 5 days

STORAGE

• Store in a cool, dry place below 30°C
• Protect from direct sunlight and moisture
• Keep container tightly closed when not in use
• Do not freeze

Target Species: Poultry (Chickens, Turkeys, Ducks, Geese, Quail) - Primarily for growing chickens and turkeys

Pack Sizes: 1 Kg HDPE container

PRODUCT SUMMARY
SPECTIN-1000 Powder Antibiotic Lincomycin (as HCl) USP 335mg, Spectinomycin (as Sulphate) BP 665mg per gram Poultry 1 Kg

FOR VETERINARY USE ONLY