MACROLONG® (oral powder)

Powder from white to light brown in colour with a specific odour.

1 g of the product contains active substance:

- azithromycin dihydrate – 200,0 mg.

Excipient: tartaric acid.

ATC vet classification code: QJ01 – antibacterial veterinary medicinal products for systemic use. QJ01FA10 – Azithromycin.

Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is formed by insertion of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is inhibition of bacterial protein synthesis through binding to the 50S ribosomal subunit and inhibition of peptide translocation.

Azithromycin causes prolonged suppression of bacterial activity after short-term contact with the product. This effect is based on irreversible changes in the ribosomes of the microorganism, resulting in sustained blockade of protein translocation. As a result, the overall antibacterial effect of azithromycin is enhanced and prolonged, being maintained for the period required for resynthesis of new functional proteins of the microbial cell.

Azithromycin is characterised by a broad spectrum of antimicrobial activity against Gram-positive (Staphylococcus spp., Streptococcus spp., Erysipelothrix insidiosa) and Gram-negative (Campylobacter spp., Moraxella spp., Actinobacillus lignieresi, Haemophilus spp., Legionella pneumophila, Salmonella spp., Escherichia spp., Bordetella spp., Listeria spp., Enterococcus faecalis) bacteria, certain anaerobic bacteria (Clostridium perfringens, Fusobacterium spp., Pasteurella (Mannheimia) haemolytica, P. multocida, Haemophilus parasuis), mycoplasmas (Mycoplasma pneumoniae), chlamydiae (Chlamydia pneumoniae), spirochetes (Borrelia spp.).

After oral administration, azithromycin is well absorbed and rapidly distributed in the tissues of the body, reaching high concentrations which significantly exceed its concentration in blood plasma. High antibacterial activity is achieved due to the ability of azithromycin to penetrate and accumulate intracellularly in leucocytes, which transport it to the sites of inflammation, resulting in an antibiotic concentration 6 times higher in the inflammatory focus compared to intact tissues. After oral administration of azithromycin to dogs and pigeons, its bioavailability was 97% and 84%, respectively. Azithromycin concentrations in body tissues were higher than in blood plasma. The half-life of azithromycin in dogs was approximately 90 hours after five doses of 30 mg/kg body weight. High concentrations are maintained for a further 5–7 days after the last oral administration of azithromycin.

More than 50% of the dose is excreted unchanged, mainly in the bile and partly in the urine.

Dogs: treatment of animals with bronchitis, pneumonia, otitis, dermatitis, cystitis, urethritis, nephritis, gingivitis, gastritis, enteritis caused by microorganisms sensitive to azithromycin.

Pigeons: treatment of birds with ornithosis, mycoplasmosis, sinusitis, enteritis, colibacillosis, salmonellosis caused by microorganisms sensitive to azithromycin.

Pigeons (with drinking water): 1 g of the product per 3–6 L of drinking water or 33,3–66,6 mg of azithromycin dihydrate per 1 L of drinking water (corresponding to 2–4 mg of azithromycin dihydrate per 1 kg body weight) once daily for 3–5 days.

Dogs (with drinking water or feed): 0,25–0,5 g of the product per 10 kg body weight (corresponding to 5–10 mg of azithromycin dihydrate per 1 kg body weight) once daily; treatment course – 5–7 days.

Hypersensitivity to the components of the product or to other macrolide antibiotics.

Do not use in animals with severe hepatic or renal dysfunction, pronounced bradycardia, arrhythmia or severe heart failure.

Do not use in pregnant animals.

Do not use concomitantly with heparin.

Do not use in animals intended for human consumption (food‑producing animals).

At the recommended doses, adverse reactions are generally not observed. If adverse reactions occur (pruritus, nausea, vomiting, muscle tremor), discontinue use of the product and administer desensitising therapy.

Do not use in animals with severe hepatic or renal dysfunction, hepatic failure, pronounced bradycardia, arrhythmia or severe heart failure.

Treatment should be based on susceptibility testing of microorganisms to azithromycin.

Use of the product must be discontinued if resistance of the causative agent to the active substance is detected.

Do not use in pregnant animals.

Use of the product in lactating animals is allowed only when it is clearly established that the benefit of treatment outweighs the possible adverse effects.

Tetracyclines and chloramphenicol potentiate the effect of azithromycin (synergism).

Do not use concomitantly with heparin.

Lincosamides reduce the effect of azithromycin.

Antacids reduce the absorption of azithromycin.

Powder in polyethylene film bags or other polymer film bags of 1, 50, 100, 200 g.

Polymer containers of 100, 200 g.

Store in a dry, dark place out of the reach of children at a temperature from 5 °C to 25 °C.

2 years.

Shelf life after dilution of the product in drinking water – 24 hours.