Each ml contains:

Active substance: 140 000 IU of paromomycin activity (as paromomycin sulfate)

Excipients:

Methyl parahydroxybenzoate (E218) 1.0 mg

Propyl parahydroxybenzoate 0.1 mg

Sodium metabisulfite (E223) 4.0 mg

Oral solution.

A clear yellow to amber solution.

Sheep (pre-ruminant lambs) and goats (pre-ruminant kids).

Reduction of the severity and the duration of diarrhoea associated with Cryptosporidium parvum in individual animals confirmed to have cryptosporidial oocysts in their faeces. Paromomycin reduces faecal oocyst shedding.

Do not use in animals with known hypersensitivity to paromomycin, other aminoglycosides or any of the excipients.

Do not use in cases with impaired function of the kidneys or liver.

Do not use in ruminating animals.

Lambs and goat kids should only receive the treatment upon confirmation of cryptosporidial oocysts in their faeces and as soon as possible after the onset of diarrhoea. In field studies investigating the effect of the product on diarrhoea associated with cryptosporidiosis, the median duration of clinically relevant diarrhoea was 3 days for treated lambs compared to 6 days for untreated lambs and 4 days in treated kid goats compared to 7 days for the untreated goats, during the 7-day treatment period.

Since the product is potentially ototoxic and nephrotoxic, it is recommended to assess kidney function, especially when considering administration of the product to newborn animals due to the known higher gastrointestinal absorption of paromomycin in neonates. This higher absorption could lead to an increased risk of oto- and nephrotoxicity. The use of the product in neonates should be based on a benefit/risk assessment by the responsible veterinarian. The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking and through cleansing and disinfection.

Aminoglycosides are considered as critically important in human medicine. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to paromomycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.

This product contains paromomycin, which can cause allergic reactions in some people. People with known hypersensitivity (allergy) to paromomycin or any other aminoglycosides should avoid contact with the veterinary medicinal product.

Avoid contact with the skin and eyes.

In the event of accidental contact with the skin or eyes, rinse with plenty of water. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Personal protective equipment consisting of protective clothing and impervious gloves should be worn when handling the veterinary medicinal product. Do not eat, drink and smoke when handling the product. Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the label to the physician.

Wash hands after use.

Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.

Not applicable.

General anaesthetics and muscle relaxing products increases the neuro-blocking effect of aminoglycosides. This may cause paralysis and apnoea.

Do not use concurrently with strong diuretics and potentially oto- or nephrotoxic substances

For oral use.

Dose rate: 35 000 IU of paromomycin /kg BW /day for 7 consecutive days, i.e. 0.25 ml of product / 1 kg BW/day for 7 consecutive days.

The consecutive treatment should be done at the same time each day.

To ensure correct dosing, the bodyweight should be determined as accurately as possible and the use of either a syringe or any appropriate device for oral administration is necessary.

Only a single course of treatment should be administered to an individual animal.

At 5 times the dose and 3 times the duration, no adverse effects have been observed in lambs.

Meat and offal: 24 days

Pharmacotherapeutic group: other antiprotozoal agents.

ATCvet code: QA 07 AA 06.

Paromomycin has antiprotozoal activity, although its mechanism of action is unclear. In in vitro studies using HCT-8 and Caco-2 cell lines inhibitory activity against C. parvum was observed. Resistance of cryptosporidia to paromomycin has not been described to date. Nevertheless, the use of aminoglycosides is associated with the occurrence of bacterial resistance. Paromomycin may select for cross-resistance to other aminoglycosides.

IV injection in lambs at a dose rate of 7 000 IU / kg showed that paromomycin is rapidly eliminated (T1/2 = 4.58 hours) and that the clearance (2.49 ml/min/kg) was relatively low showing probably limited liver metabolism.

The bioavailability of paromomycin when administered as a single oral dose of 50 mg paromomycin sulphate/kg bodyweight to lambs was 13%. With regard to the absorbed fraction, the mean peak plasma concentration (Cmax) was 2.68 mg/l, the mean time to attain the peak plasma concentration (Tmax) was 4 hours and the mean terminal half-life (t1/2, el) was 27.4 hours. The main part of the dose is eliminated unchanged in the faeces.

The active ingredient paromomycin is very persistent in the environment.

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate

Sodium metabisulfite (E223)

Purified water

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 3 months.

Do not store above 25°C.

White high-density polyethylene bottles with tamper-evident polypropylene screw closures. Pack sizes are:

125 ml

250 ml

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Vm 30282/4042

20 June 2019