Beipackzettel - Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the Heads of Veterinary Medicinal Agencies website.
MODULE 3
PUBLIC ASSESSMENT REPORT
| Legal basis of original application | Application in accordance with Article 13(1) of Directive 2001/82/EC as amended. |
| Date of completion of the original decentralised procedure | 22 July 2009 |
| Date product first authorised in the Reference Member State (MRP only) | n.a. |
| Concerned Member States for original procedure | Austria, Germany (RMS), Ireland, Netherlands, United Kingdom (previous RMS) |
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I. SCIENTIFIC OVERVIEW
Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats enrofloxacin contains the active substance enrofloxacin. The product is authorised to be used in cattle, pigs, dogs and cats. In cattle, the product is used in the treatment of respiratory and alimentary tract diseases of bacterial or mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis and coli-septicaemia) and secondary bacterial infections subsequent to viral conditions (e.g. viral pneumonia). In pigs, the product is used in the treatment of respiratory and alimentary tract diseases of bacterial or mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis and coli-septicaemia) and multifactorial diseases such as enzootic pneumonia. In dogs and cats, it is used in treatment of bacterial diseases of the respiratory (Pasteurella spp., Haemophilus spp.), alimentary (E.coli., Salmonella spp.) and urogenital tracts (E. coli), skin and secondary wound infections (Staphylococcus spp.).
The product is produced and controlled using validated methods and tests which ensure the consistency of the product released on the market. It has been shown that the product can be safely used in the target species and the slight reactions observed are indicated in the SPC. The product is safe for the user, the consumer of foodstuffs from treated animals and for the environment, when used as recommended. Suitable warnings and precautions are indicated in the SPC. The efficacy of the product was demonstrated according to the claims made in the SPC..
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II. QUALITY ASPECTS
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A. Qualitative and quantitative particulars
The product contains enrofloxacin as active substance and n-butyl alcohol, potassium hydroxide and water for injection as excipients.
The product is packaged in an amber Type 1 glass vial with a grey bromobutyl rubber stopper and aluminium cap.
The particulars of the containers and controls performed are provided and conform to the regulation.
The choice of the formulation is justified.
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B. Method of Preparation of the Product
The product is manufactured fully in accordance with the principles of good manufacturing practice from a licensed manufacturing site.
Process validation data on the product have been presented in accordance with the relevant European guidelines.
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C. Control of Starting Materials
The active substance enrofloxacin is an established active substance and supporting data have been provided in the form of an Active Substance Master File (ASMF). It is considered that the manufacturing process is adequately controlled and the active substance specification has been suitably justified.
There are three excipients used in the formulation and each has been used previously in veterinary medicines. Potassium hydroxide and water for injections have monographs in the Ph. Eur. and each comply with the requirements of the current edition of the Ph. Eur. In the absence of a monograph in the European Pharmacopoeia, the requirements of the monograph in the United States Pharmacopoeia National Formulary are applied in the raw material specification for n-butyl alcohol.
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D. Specific Measures concerning the Prevention of the Transmission of
Animal Spongiform Encephalopathies
Scientific data has been provided which states that Powerflox 50 mg/ml Solution for Injection for cattle, pigs, dogs and cats complies with the combined CVMP/CPMP note for guidance on TSE risk (EMEA/410/01) and the CVMP position paper (EMEA/CVMP/121/01).
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E. Control on intermediate products
There are no intermediate products.
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F. Control Tests on the Finished Product
The finished product specification controls the relevant parameters for the pharmaceutical form. The tests in the specification, and their limits, have been justified and are considered appropriate to adequately control the quality of the product. The satisfactory validation data for the analytical methods have been provided.
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G. Stability
Stability data on the finished product have been provided in accordance with applicable European guidelines, demonstrating the stability of the product throughout its shelf life. The shelf-life of the veterinary medicinal product as packaged for sale is 2 years. An inuse shelf life of 28 days is justified.
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H. Genetically Modified Organisms
Not applicable
J. Other Information
Special Precautions for Storage:
Do not store above 25ºC.
Keep the vial in the outer carton in order to protect from light.
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III. SAFETY AND RESIDUES ASSESSMENT (PHARMACOTOXICOLOGICAL)
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III. A Safety Testing
Pharmacological Studies
Since the application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, data on pharmacodynamics and pharmacokinetics are not required.
Toxicological Studies
Since the application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, data on toxicology are not required.
Other Studies
Since the application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, applicant has not submitted any data for this section.
User Safety
The following operator warnings are included in the SPC and product literature:
This product is an alkaline solution. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves. Wash hands after use. Wash any splashes from skin and eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately.
Environmental Risk Assessment
The applicant provided a first phase environmental risk assessment in compliance with the relevant guideline. In accordance with the Phase I decision tree, the treatment of cats and dogs does not result in extensive exposure of the environment. The assessment can end at Phase I for cats and dogs. Since the product is also indicated to be used in cattle and pigs, it was necessary to calculate PECsoil values. PECsoil values were calculated for all types of cattle and pigs raised intensively using the equations provided by the CVMP guideline. The default value of 50 % of animals treated for bacterial infections provided by the CVMP guideline was used. The dose and duration of treatment together with the PECsoil values are shown in the following table:
| Target animal | Dose (mg/kg bodyweight) | Duration of treatment (days) | PEC soil ( µ g/kg) |
| Dairy cow | 5 | 5 | 40.1 |
| Calf | 71.4 |
| Target animal | Dose (mg/kg bodyweight) | Duration of treatment (days) | PEC soil ( µ g/kg) |
| Cattle (0–1 year) | 63.0 | ||
| Cattle (>2 years) | 72.9 | ||
| Weaner pig | 5 | 3 | 65.2 |
| Fattening pig | 44.2 | ||
| Sow | 15.7 |
The assessment ended at Phase I as all the PECsoil values are below 100 µg/kg. The warnings and precautions as listed on the product literature are adequate to ensure safety to the environment when the product is used as directed
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III.B Residues documentation
Residue Studies
As the product has same pharmaceutical form and the same qualitative and quantitative composition as the reference product, it was not necessary to provide any data on bioequivalence in accordance with paragraph 4b of the CVMP guidelines for the conduct of bioequivalence studies for veterinary medicinal products (EMEA/CVMP/016/00-corr-FINAL).
MRLs
All the excipients are listed in Annex II of Regulation 2377/90, with the exception of Water for Injection.
MRLs are listed below:
| Bovine | Porcine | |
| Muscle | 100 µg/kg | 100 µg/kg |
| Liver | 300 µg/kg | 200 µg/kg |
| Kidney | 200 µg/kg | 300 µg/kg |
| Fat / skin | 100 µg/kg | 100 µg/kg |
Withdrawal Periods
Cattle: Meat and offal: 14 days
Pigs: Meat and offal: 10 days
Not permitted for use in lactating animals producing milk for human consumption.
IV. CLINICAL ASSESSMENT (EFFICACY)
Pharmacology
Since the application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, data on pharmacodynamics and pharmacokinetics are not required.
Tolerance in the Target Species of Animals
As the product has same pharmaceutical form and the same qualitative and quantitative composition as the reference product, no new target species tolerance data have been presented. This complies with exemptions specified under Article 13 (2)(b) of Directive 2001/82/EC as amended by 2004/28/EC.
Resistance
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to potential crossresistance.
IV.B Clinical Studies
Since the application is made in accordance with Article 13 (1) of Directive 2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, data on clinical efficacy are not required.
OVERALL CONCLUSION AND BENEFIT– RISK ASSESSMENT
The data submitted in the dossier demonstrate that when the product is used in accordance with the Summary of Product Characteristics, the risk benefit profile for the target species is favourable and the quality and safety of the product for humans and the environment is acceptable.
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POST-AUTHORISATION ASSESSMENTS
The SPC and package leaflet may be updated to include new information on the quality, safety and efficacy of the veterinary medicinal product. The current SPC is available on the Heads of Veterinary Medicinal Agencies website.
This section contains information on significant changes which have been made after the original procedure which are important for the quality, safety or efficacy of the product.
| | 13 April 2015 | Deletion of a non-significant specification parmameter |
| | 13 April 2015 | Submission of a new certificate of suitability |
| | 13 April 2015 | Submission of a new certificate of suitability |
| | 30 January 2018 | RMS transfer from UK to DE |
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