Parofor Crypto Cattle
Active substance
ATC code
Species
Cattle (pre-ruminant).
Indications
Reduction in the occurrence of diarrhoea due to diagnosed Cryptosporidium parvum.
Calves should only receive the veterinary medicinal product upon confirmation of cryptosporidial oocysts in their faeces and before the onset of diarrhoea.
Paromomycin reduces faecal oocyst shedding.
Dose to be administered and administration route
For oral use.
Dose rate: 35 000 IU of paromomycin/kg BW/day for 7 consecutive days, i.e.
2.5 ml of veterinary medicinal product / 10 kg BW/day for 7 consecutive days.
To ensure a correct dosage, the use of either a syringe or an appropriate device for oral administration is necessary and the veterinary medicinal product should be administered directly in the mouth of the animal.
To ensure a correct dosage, bodyweight should be determined as accurately as possible.
Adverse reactions
|
Undetermined frequency (cannot be estimated from available data) |
Nephropathy (nephrotoxicity) 1 Internal ear disorder (ototoxicity)1 |
1can be caused by aminoglycoside antibiotics such as paromomycin
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Parofor crypto 140 000 IU/ml oral solution for pre-ruminant cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
140 000 IU of paromomycin activity Excipients:
|
Methyl parahydroxybenzoate (E218) |
1.0 mg |
|
Propyl parahydroxybenzoate |
0.1 mg |
|
Sodium metabisulfite (E223) |
4.0 mg |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
A clear yellow to amber solution.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle (pre-ruminant calves).
4.2 Indications for use, specifying the target species
Reduction in the occurrence of diarrhoea due to diagnosed Cryptosporidium parvum. Calves should only receive the product upon confirmation of cryptosporidial oocysts in their faeces and before the onset of diarrhoea. Paromomycin reduces faecal oocyst shedding.
4.3 Contraindications
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.
4.4 Special warnings for each target species
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.
4.5 Special precautions for use
Special precautions for use in animals
The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation and no overstocking. Repeated use of the product on farms should be avoided by improving management practices and through cleaning 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.
The safety of the product has not been investigated in animals less than 3 days of age.
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.
4.6 Adverse reactions (frequency and seriousness)
Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 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.
4.9 Amounts to be administered and administration route
For oral use.
Dose rate: 35 000 IU of paromomycin/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 and the product should be administered directly in the mouth of the animal.
To ensure the correct dosage, bodyweight should be determined as accurately as possible.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not administer for more than 7 days since clinical signs associated with gastrointestinal lesions were observed after prolonged treatment duration. In 2 to 5 week old calves, overdoses in excess of 35 000 IU paromomycin/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.
4.11 Withdrawal period(s)
Due to accumulation of paromomycin in the liver and kidneys, any repeated course of treatment during the withdrawal period must be avoided. Meat and offal: 62 days
5. PHARMACOLOGICAL IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: intestinal anti-infectives; antibiotics. ATCvet code: QA 07 AA 06.
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic particulars
The bioavailability of paromomycin when administered as a single oral dose of 35 000 IU paromomycin/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 terminal half-life (t1/2, el) was 11.2 hours. The main part of the dose is eliminated unchanged in the faeces while 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.
5.3 Environmental properties
The active ingredient paromomycin is very persistent in soil.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate
Sodium metabisulfite (E223) Purified water
6.2 Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 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.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
White high density polyethylene bottle with tamper-evident screw polypropylene closure. Bottle sizes are:
125 ml
250 ml
500 ml
1 L.
Not all pack sizes may be marketed.
6.6 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.
7. MARKETING AUTHORISATION HOLDER
Huvepharma NV
Uitbreidingstraat 80
2600 Antwerpen
Belgium
8. MARKETING AUTHORISATION NUMBER
Vm 30282/4036
9. DATE OF FIRST AUTHORISATION
19 July 2018
10. DATE OF REVISION OF THE TEXT
February 2023
Approved: 17 February 2023
| Art. Nr. | |
|---|---|
| EAN | 5414916626431 |
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