Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Cepetor KH 1 mg/ml Injektionslösung für Hund und Katze
MODULE 1
PRODUCT SUMMARY
| EU Procedure number | DE/V/0116/001/MR |
| Name, strength and pharmaceutical form | Cepetor KH, 1mg / ml, solution for injection |
| Applicant | CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Germany |
| Active substance(s) | Medetomidine hydrochloride |
| ATC Vetcode | QN05CM91 |
| Target species | Dog, Cat |
| Indication for use | In dogs and cats: Sedation to facilitate handling. Premedication prior to general anaesthesia. In cats: In combination with ketamine for general anaesthesia for minor surgical procedures of short duration. |
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the Heads of Veterinary Medicines Agencies website.
MODULE 3
PUBLIC ASSESSMENT REPORT
| Legal basis of original application | Generic application in accordance with Article Article 13 (1) of Directive 2001/82/EC as amended. |
| Date of completion of the original Mutual recognition procedure Decentralised procedure | 22 December 2006 |
| Date product first authorised in the Reference Member State (MRP only) | 07 June 2005 |
| Concerned Member States for original procedure | AT, BE, CZ, DK, EL, ES, ET, FI, FR, HU, IE, IT, LT, LV, NL, NO, PO, PT, SE, UK |
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I. SCIENTIFIC OVERVIEW
Cepetor from CP-Pharma, Germany, is a generic product to Domitor (German reference number 32457.00.00) marketed in Germany since1995. Cepetor is a solution for injection and approved for sedation to facilitate handling and as a premedication prior to general anaesthesia in dogs and cats. In cats it is also indicated for general anaesthesia for minor surgical procedures of short duration in combination with ketamine.
Essential similarity of Cepetor and the reference product Domitor was demonstrated according to the relevant EU guidelines. The initial application for Domitor was assessed before there was a requirement to have a public assessment report. Therefore, no details in this section are available.
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II. QUALITY ASPECTS
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A. Composition
The product contains Medetomidine hydrochloride 1 mg / ml and Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium chloride and Water for injections.
The product is filled into 10 ml uncoloured glass vials. The Bromobutyl-rubber stoppers are secured with aluminium crimp caps. The particulars of the containers and controls performed are provided and conform to the regulation.
The choice of the formulation and the presence of preservative are justified.
The product is an established pharmaceutical form and its development is adequately described in accordance with the relevant European guidelines.
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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 is Medetomidine hydrochloride, an established active substance. The active substance is manufactured in accordance with the principles of good manufacturing practice.
The active substance specification is considered adequate to control the quality of the material. Batch analytical data demonstrating compliance with this specification have been provided.
An Active Substance Master File (ASMF) has been provided by the manufacturer.
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D. Specific Measures concerning the Prevention of the Transmission
of Animal Spongiform Encephalopathies
There are no substances within the scope of the TSE1 Guideline present or used in the manufacture of this product.
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E. Control on intermediate products
Not applicable.
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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.
Satisfactory validation data for the analytical methods have been provided.
Batch analytical data from the proposed production site have been provided demonstrating compliance with the specification.
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G. Stability
Stability studies on the active substance are presented in the open part of the ASMF. Stability data have been provided in accordance with applicable European guidelines, demonstrating the stability of the active substance when stored under the approved conditions.
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 when stored under the approved conditions.
The claim of a 28 day stability after broaching is based on the demonstration of stability for a batch broached and stored 28 days at 20 – 25°C.
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H. Genetically Modified Organisms
Not applicable.
J. Other Information
None.
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III. SAFETY AND RESIDUES ASSESSMENT (PHARMACOTOXICOLOGICAL)
As this is a generic application according to Article 13 of Directive 2001/82/EC as amended based on the essential similarity of Cepetor and the reference product Domitor, results of pharmacological and toxicological tests are not required.
The applicant has made full reference to the SPC of the reference product Domitor granted in Germany. However, as this was not completely identical to the SPCs authorised for this product in other concerned member states, efforts have been made during the mutual recognition procedure to produce a harmonised overall accepted product literature for Cepetor. Warnings and precautions as listed in the product literature are adequate to ensure safety of Cepetor to the users and the environment.
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IV. CLINICAL ASSESSMENT (EFFICACY)
MODULE 4
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 veterinary 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.
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