Parofor 70 000 IU/g Powder for Use in Drinking Water, Milk or Milk Replacer for Pre-Ruminant Cattle and Pigs

Cross-resistance has been shown between paromomycin and some antimicrobials in
the aminoglycosides class in Enterobacterales
product should be carefully considered when susceptibility testing has shown
resistance to aminoglycosides because its effectiveness may be reduced.
Paromomycin selects for resistance and cross-resistances at high frequency against
a variety of other aminoglycosides among intestinal bacteria..

Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on identification and
susceptibility testing of the target pathogen(s) isolated from the animal. If this is not
possible, therapy should be based onon epidemiological information and knowledge
of susceptibility of the target pathogen at farm level or at local/regional level. Use of
the veterinary medicinal product should be in accordance with official, national and
regional antimicrobial policies.
The uptake of medication by animals can be altered as a consequence of illness. In
case of insufficient uptake of water/milk animals should be treated parenterally using
a suitable injectable veterinary medicinal product following the advice of the
veterinarian.
The use of the veterinary medicinal product should be combined with good
management practices e.g. good hygiene, proper ventilation, no overstocking.
Since the veterinary medicinal product is potentially ototoxic and nephrotoxic, it is
recommended to assess kidney function.
Special care should be taken when considering administration of the veterinary
medicinal 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 veterinary medicinal product
in neonates should be based on benefit-risk assessment by the responsible
veterinarian. Prolonged or repeated use of the veterinary medicinal product should be
avoided by improving management practices and through cleansing and disinfection.
Use of the veterinary medicinal 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
crossresistance.
Aminoglycosides are considered as critical in human medicine. Consequently, they
should not be used as a first line treatment in veterinary medicine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product contains paromomycin, which can cause allergic
reactions in some people. People with known hypersensitivity to paromomycin
should avoid contact with the veterinary medicinal product. If you develop symptoms
following exposure, such as skin rash, you should seek medical advice and show the
package leaflet or the label to the physician. Swelling of the face, lips and eyes or
AN: 01290/2024 & 01291/2024
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 veterinary medicinal product. Wash
hands after use. In case of accidental ingestion, seek medical advice immediately
and show the package leaflet or the label to the physician.
When handling this veterinary medicinal product, inhalation of the dust must be
avoided by wearing a disposable half-mask respirator conforming to European
Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a
filter to EN 143.
Use in a well-ventilated area. Avoid inhaling the powder while preparing the
medicated water or milk
replacer. Avoid contact with the skin and eyes. In case of accidental contact with the
skin or eyes, rinse with plenty of water and seek medical attention if irritation persists.
Special precautions for the protection of the environment:
Not applicable.