Neocell

Penethaone 236.3 mg/ml powder and solvent for suspension for injection for cattle

STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 ml of the reconstituted suspension contains:
Active substance
Penethamate hydriodide    236.3 mg (equivalent to 182.5 mg penethamate)    
Equivalent to 250,000 IU of penethamate hydriodide

5,000,000 IU presentation
Powder vial contains 4.75 g of powder
Active substance
Penethamate hydriodide    4726 mg (equivalent to 3649 mg of penethamate)
Equivalent to 5,000,000 IU of penethamate hydriodide
Excipients, q.s.f.

Solvent vial contains 18 ml
Excipients, q.s.f.

Total amount of reconstituted suspension    20 ml

10,000,000 IU presentation
Powder vial contains 9.50 g of powder
Active substance
Penethamate     hydriodide            9452 mg (equivalent to 7299 mg of penethamate)
Equivalent to 10,000,000 IU of penethamate hydriodide
Excipients, q.s.f.

Solvent vial contains 36 ml
Excipients, q.s.f.

Total amount of reconstituted suspension    40 ml


PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
Powder vial: white-cream fine powder
Solvent vial: clear colourless solution
Reconstituted suspension: white-cream suspension


PACKAGE SIZE
5,000,000 IU powder vial and 18 ml solvent vial or 10,000,000 IU powder vial and 36 ml solvent vial.

TARGET SPECIES
Cattle (lactating cows)

INDICATION(S)
Treatment of mastitis in lactating cows caused by Streptococcus uberis, Streptococcus dysgalactiae, Streptococcus agalactiae and Staphylococcus aureus (beta-lactamase non-producing), sensitive to penicillin.

METHOD AND ROUTE(S) OF ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Administer by deep intramuscular injection.
Directions for use: Reconstitute the suspension using the entire contents of the solvent vial.

To provide the correct dose:

Use the powder vial, which contains penethamate hydriodide 5,000,000 IU with the solvent vial, which contains 18 ml of a sterile solvent.
Or alternatively, use the powder vial, which contains penethamate hydriodide 10,000,000 IU with the solvent vial, which contains 36 ml of a sterile solvent.

 Shake well after reconstitution.  A minimum of 10 inversions of vials can be necessary.
Each ml of suspension contains 250,000 IU (236.3 mg) of penethamate hydriodide.

Dose: 15,000 IU (14.2 mg) of penethamate hydriodide per kg of body weight / day (equivalent to 6 ml of reconstituted medicinal product / 100 kg body weight) for three to four consecutive days. Shake well before use.

Administer the recommended daily dose every 24 hours, for three to four consecutive administrations.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
The recommended maximum volume to be administered at a single injection site is 20 ml.
The stopper should not be punctured more than 10 times.


WITHDRAWAL PERIOD
Meat and offal: 4 days
Milk: 60 hours


SPECIAL WARNING(S), IF NECESSARY
This veterinary medicinal product does not contain any antimicrobial preservative.

Special precautions for use in animals
Using penethamate hydriodide for the treatment of mastitis must be accompanied by hygienic measures to prevent reinfection.
Where local (regional, farm-level), epidemiological information indicate possible reduced susceptibility of the relevant strains of the bacterial species involved in mastitis, use of the product should be based on susceptibility testing on bacteria isolated from diseased animals.
The veterinary medicinal product is not effective against beta-lactamase producing organisms.
Official national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other beta-lactam antimicrobials due to the potential for cross resistance.

User Warnings: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa.  Allergic reactions to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure.
Wear gloves when handling the veterinary medicinal product to avoid contact sensitization.
In case of accidental self-injection or if you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the package leaflet or the label to the doctor
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.

Overdose: In cases of overdose, adverse reactions such as those described in Section 4.6 may occur..

SPECIAL STORAGE CONDITIONS
Before reconstitution, the powder and solvent vials do not require any special storage conditions.
The reconstituted suspension should be stored in the refrigerator (2-8°C).

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.  

THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the sight and reach of children.
 
FURTHER INFORMATION
Veterinary medicinal product subject to veterinary prescription.

Registration Number: 28114 / 29-3-2016