Parofor Crypto 140 mg/ml oral solution

Target species
Pre-ruminant calves.
Indications for use
Reduction in the occurrence of diarrhoea due to diagnosed Cryptosporidium parvum.
Dosage and administration
For oral use.
Dose rate: 50 mg of paromomycin sulphate /kg BW /day for 7 consecutive days, i.e. 2.5 ml of product / 10 kg BW / day for 7 consecutive days.
To ensure correct dosing, the use of either a syringe or an appropriate device for oral administration is necessary.
To ensure the correct dosage, bodyweight should be determined as accurately as possible.
Contra-indications, warnings, etc
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.
Special warnings for each target species
Animals should receive sufficient colostrum according to good breeding practice.
Calves should only receive the product upon confirmation of cryptosporidial oocysts in their faeces and before the onset of diarrhoea.
In field studies investigating the effect of the product on diarrhoea associated with cryptosporidiosis, 23% to 32% of calves in treated groups presented with diarrhoea, in comparison to 53% to 73% of calves in untreated groups, during the 7-day treatment period.
Special precautions for use in animals
Since the product is potentially ototoxic and nephrotoxic, it is recommended to assess kidney function.
Special care should be taken 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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 product.
Avoid contact with the skin and eyes.
Personal protective equipment consisting of protective clothing and impervious gloves should be worn when handling the veterinary medicinal product.
In the event of accidental contact with the skin or eyes, rinse with plenty of clean 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.
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.
Adverse reactions (frequency and seriousness)
On rare occasions, soft faeces have been observed.
Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.
Use during pregnancy, lactation or lay
The safety of the product has not been established in pregnant or lactating cattle. Therefore, the use of the product is not recommended in these animals.
Overdose (symptoms, emergency procedures, antidotes)
Do not administer for more than 7 days. In 2 to 5 week old calves, overdoses in excess of 50 mg paromomycin sulphate/kg bodyweight may induce gastrointestinal lesions (ulceration, pustules, chronic hyperplastic inflammation) mostly in the rumen and reticulum. Bruxism and poor appetite have been reported. Repeated overdose may be associated with death.
Withdrawal Periods
Cattle Meat: 62 days.
Pharmaceutical precautions
List of excipients
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate
Sodium metabisulfite
Purified water
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Interaction with other medicinal products and other forms of interaction
General anaesthetics and muscle relaxing products increase 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.
Pharmacological Immunological Properties
Pharmacotherapeutic group: intestinal anti-infectives; antibiotics.
ATCvet code: QP 51 AA 06.
Pharmacodynamic properties
Paromomycin has antiprotozoal activity, although its mechanism of action is unclear. The optimal in vitro concentration of paromomycin exerting inhibitory activity against C. parvum was 400 µg /ml.
Paromomycin reduces faecal oocyst shedding.
Pharmacokinetic particulars
The bioavailability of paromomycin when administered as a single oral dose of 50 mg paromomycin sulphate/kg bodyweight to 2 - 6 week old calves was 2.75%.
With regard to the absorbed fraction, the mean peak plasma concentration (Cmax) was 1.48 mg/l, the mean time to attain the peak plasma concentration (Tmax) was 4.5 hours and the mean apparent elimination half-life (t1/2, el) was 11.2 hours. The clearance was low (1.65 ml/kg/min) and the volume of distribution (0.84 l/kg) suggests that paromomycin is not restricted to the extracellular fluid space. The absorbed fraction is excreted almost exclusively in urine as unchanged paromomycin.
Paromomycin displays age-related pharmacokinetics, with the greatest systemic exposure occurring in newborn animals.
Environmental properties
The active ingredient, paromomycin sulphate, is persistent in soil.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category:POM-V
Packaging quantities
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 months.
Special precautions for storage: Do not store above 25°C.
Nature and composition of immediate packaging:
White HDPE bottle of 125 ml, 250 ml, 500 ml and 1 L with tamper-evident screw PP closure.
Not all pack sizes may be marketed.