Ciproventor powder for oral use

Product benefits:

•  Combined antibacterial drug which is active against most of bacterial infections in farm animals and poultry.
•  Combined action of two different group antibiotics increases term of resistant pathogenic microorganism appearance.
•  Convenient oral dosage form.

Chemical composition and pharmacological properties

1 g of powder contains ciprofloxacin (equivalent to base) - 100 mg and apramycin sulfate - 500 mg (as active ingredients), as well as lactose - to 1 g (as an excipient).

Ciproventor is a combined antibacterial drug. Ciprofloxacin (a component of the drug) is a fluroquinolone compound. It has broad-spectrum antibacterial and antimycoplasmal properties. It is active against gram-positive and gram-negative bacteria (including Echerichia coli, Salmonella spp., Shigella spp., Klebsiella spp., Enterobacter spp., Proteus spp., Yersinia spp., Haemophilus spp., Pseudomonas aeruginosa, Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium spp., Corynebacterium diphtheriase, Staphylococcus aureus, Streptococcus spp. and Mycoplasma spp.). Mainly, apramycin provides antibacterial effect on gram-negative and several gram-positive bacteria including Еsсherichia coli, Salmonella spp., Pseudomonas spp., Staphylococcus spp., Streptococcus spp., Proteus spp., Bordetella bronchiseptica, Klebsiella spp., Shigella spp., Campylobacter spp., Brachyspira hyodysenteriae and some types of mycoplasma (Мycoplasma hyopneumoniae). It is not active against anaerobic microorganisms. Mechanism of ciprofloxacin action is based on inhibition of gyrase activity which provides DNA replication in bacterial cell. Mechanism of apramycin antibacterial action is caused by inhibition of microorganism protein synthesis by irreversible binding with 30 S ribosomal subunit. Ciprofloxacin obtains peak serum concentration in 1.5-2 hours. Therapeutic concentration remains within 24 hours after oral administration. After oral administration apramycin poorly absorbs and obtains high antibacterial concentration in gastrointestinal tract which is maintained within 24 hours. Сiprofloxacin is mainly excreted unchanged and partially as metabolites in urine and bile. Apramycin does not undergo biotransformation. After oral administration it is excreted active and unchanged mainly in feces and partially in urine.

Indications

Use to treat piglets, calves, colts, lambs and poultry with bacterial respiratory and gastrointestinal infections (including salmonellosis, pasteurellosis, mycoplasmosis, colibacillosis) and others, agents of which are susceptible to ciprofloxacin and apramycin.

Contraindications

Increased individual sensitivity to the drug components. Do not use in laying hens, lactating females and animals with frank renal impairment.
  
It is not allowed to use in combination with aminoglycosides (streptomycin, neomycin, kanamycin and gentamicin) due to potential ototoxic and nephrotoxic action, as well as with beta-lactam antibiotics, mineral supplements and drugs containing salts of calcium, magnesium, iron and aluminium (in view of potential decrease in antibacterial drug activity).

Administration

Oral administration with drinking water within 5 days. Daily doses are listed in the table.

Type of animal	Dose of Ciproventor, g / 10 kg of body weight	Dose of ciprofloxacin, mg / kg of body weight	Dose of apramycin sulfate, mg / kg of body weight
Piglets	0.45	4.5	22.5
Calves, colts	0.6	6	30
Lambs	0.2	2	10
Poultry	0.5-1.0 (0.5-1.0 kg/ton of water)	5-10	25-50

Adverse events

Adverse events and complications are not generally observed in case of administration as per this package insert.

In case of allergic reactions, stop drug administration. Use antihistaminic and symptomatic drugs.

Waiting period

Pigs are allowed to be slaughtered for meat not earlier than 14 days after the last drug administration. This term is 28 days in calves and colts, 30 days in lambs and 12 days in poultry.

Storage

Store in closed original package. Protect from direct sunlight and moisture. Keep out of the reach of children and animals. Store separately from food and animal feeding at 5-25°С.

Pharmaceutical form

The drug is manufactured in 0.5 kg multilayer polyethylen sachet bags in multilayer paper bags; 1.0 kg polymeric cans and 10 kg buckets sealed with closure of appropriate size.