EN Qrd Veterinary Template V.8 En
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[Version 8, 10/2012]
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
{(Invented) name of veterinary medicinal product
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
4.3 Contraindications
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
<{Species} and unvaccinated {species} in contact with vaccinated {species} may react to the vaccine strain, presenting clinical signs such as ….>
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.> 4.6 Adverse reactions (frequency and seriousness) 3 - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).> 4.7 Use during pregnancy, lactation or lay 4.8 Interaction with other medicinal products and other forms of interaction 4 4.9 Amounts to be administered and administration route 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 4.11 Withdrawal period(s) 5. Pharmacotherapeutic group: {group}. ATCvet code: {lowest available level (e.g. subgroup for chemical substance)}. <5.1 Pharmacodynamic properties> <5.2 Pharmacokinetic particulars> 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients 6.2 Incompatibilities 6.3 Shelf life 5 <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.> 6.4. Special precautions for storage [* The stability data generated at 25 C/60 % RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary. The statement should only be used in exceptional cases. ** This statement should be used only when critical. *** E.g. for containers to be stored on a farm. **** The actual name of the container should be used (e.g. bottle, blister, etc.). ***** Depending on the pharmaceutical form and the properties of the product, there may be a risk of deterioration due to physical changes if subjected to low temperatures. Low temperatures may also have an effect on the packaging in certain cases. An additional statement may be necessary to take account of this possibility.] 6.5 Nature and composition of immediate packaging 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products <{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.> 7. MARKETING AUTHORISATION HOLDER {Name and address} 6 <{Tel.}> <{Fax}> <{E-mail}> 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). PROHIBITION OF SALE, SUPPLY AND/OR USE 7 ANNEX II[Not applicable for MRP/DCP] A. B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 8 A. {Name and address}> Name and address of the manufacturer {Name and address} B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs [For pharmaceutical products] The active substance Pharmacologically Marker Animal Target Other Therapeutic MRLs active substance residue species tissues provisions classification 9 [In case of MRLs not been published yet] The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of {name of the active substance(s)} in {name of the product} in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows: Pharmacologically Marker Animal Target Other Therapeutic MRLs active substance residue species tissues provisions classification [For immunological products] The active substance being a principle of biological origin intended to · CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT · Description Due date > · 10 Description Due date >> 11 ANNEX III LABELLING AND PACKAGE LEAFLET 12 A. LABELLING 13 PARTICULARS TO APPEAR ON {NATURE/TYPE} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 3. PHARMACEUTICAL FORM 4. PACKAGE SIZE 5. TARGET SPECIES 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 8. WITHDRAWAL PERIOD 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 14 11. SPECIAL STORAGE CONDITIONS [* The stability data generated at 25 C/60 % RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary. The statement should only be used in exceptional cases. ** This statement should be used only when critical. *** E.g. for containers to be stored on a farm. **** The actual name of the container should be used (e.g. bottle, blister, etc.)]. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and address} 15 <{Tel.}> <{Fax}> <{E-mail}> 16. MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000 17. MANUFACTURER’S BATCH NUMBER [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 4. ROUTE(S) OF ADMINISTRATION 5. WITHDRAWAL PERIOD 6. BATCH NUMBER For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 7. EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 8. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 17 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product 2. NAME OF THE MARKETING AUTHORISATION HOLDER {Name} 3. EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 4. BATCH NUMBER [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf] 5. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET FOR: {(Invented) name of veterinary medicinal product 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder 2. NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 4. INDICATION(S) 5. CONTRAINDICATIONS 6. ADVERSE REACTIONS If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 9. ADVICE ON CORRECT ADMINISTRATION 10. WITHDRAWAL PERIOD 20 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. [* The stability data generated at 25 C/60 % RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary. The statement should only be used in exceptional cases. ** This statement should be used only when critical. *** E.g. for containers to be stored on a farm. **** The actual name of the container should be used (e.g. bottle, blister, etc.). ***** Depending on the pharmaceutical form and the properties of the product, there may be a risk of deterioration due to physical changes if subjected to low temperatures. Low temperatures may also have an effect on the packaging in certain cases. An additional statement may be necessary to take account of this possibility.] Do not use this veterinary medicinal product after the expiry date which is stated on the 12. SPECIAL WARNING(S) 21 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). <15. OTHER INFORMATION> België/Belgique/Belgien Luxembourg/Luxemburg {Nom/Naam/Name} {Nom} <{Adresse/Adres/Anschrift } <{Adresse} BE-0000 {Localité/Stad/Stadt}> L-0000 {Localité/Stadt}> Tél/Tel: + {N° de téléphone/Telefoonnummer/ Tél/Tel: + {N° de téléphone/Telefonnummer} Telefonnummer} <{E-mail}> <{E-mail}> Република България Magyarország {Наименование} {Név} <{Адрес} <{Cím} BG {Град} {Пощенски код}> HU-0000 {Város}> Teл: + 359 {Телефонен номер} Tel.: + {Telefonszám} <{E-mail}> <{E-mail}> 22 Česká republika Malta Název {Isem} <Adresa <{Indirizz} CZ město> MT-0000 {Belt/Raħal}> Tel: +telefonní číslo Tel: + {Numru tat-telefon} <{E-mail}> <{E-mail}> Danmark Nederland {Navn} {Naam} <{Adresse} <{Adres} DK-0000 {by}> NL-0000 XX {stad}> Tlf: + {Telefonnummer} Tel: + {Telefoonnummer} <{E-mail}> <{E-mail}> Deutschland Norge {Name} {Navn} <{Anschrift} <{Adresse} DE-00000 {Stadt}> N-0000 {poststed}> Tel: + {Telefonnummer} Tlf: + {Telefonnummer} <{E-mail}> <{E-mail}> Eesti Österreich (Nimi) {Name} <(Aadress) <{Anschrift} EE - (Postiindeks) (Linn)> A-00000 {Stadt}> Tel: +(Telefoninumber) Tel: + {Telefonnummer} <{E-mail}> <{E-mail}> Ελλάδα Polska {Όνομα} {Nazwa/ Nazwisko:} <{Διεύθυνση} <{Adres:} EL-000 00 {πόλη}> PL – 00 000{Miasto:}> Τηλ: + {Αριθμός τηλεφώνου} Tel.: + {Numer telefonu:} <{E-mail}> <{E-mail}> España Portugal {Nombre} {Nome} <{Dirección} <{Morada} ES-00000 {Ciudad}> PT-0000000 {Cidade}> Tel: + {Teléfono} Tel: + {Número de telefone} <{E-mail}> <{E-mail}> France România {Nom} {Nume} <{Adresse} <{Adresă} FR-00000 {Localité}> {Oraş} {Cod poştal} – RO> Tél: + {Numéro de téléphone} Tel: + {Număr de telefon} <{E-mail}> <{E-mail}> Ireland Slovenija {Name} {Ime} <{Address} <{Naslov} IE - {Town} {Code for Dublin}> SI-0000 {Mesto}> Tel: + {Telephone number} Tel: + {telefonska številka} <{E-mail}> <{E-mail}> 23 Ísland Slovenská republika {Nafn} {Meno} <{Heimilisfang} <{Adresa} IS-000 {Borg/Bær}> SK-000 00 {Mesto}> Sími: + {Símanúmer} Tel: + {Telefónne číslo} <{Netfang}> <{E-mail}> Italia Suomi/Finland {Nome} {Nimi/Namn} <{Indirizzo} <{Osoite/Adress} IT-00000 {Località}> FI-00000 {Postitoimipaikka/Stad}> Tel: + {Numero di telefono}> Puh/Tel: + {Puhelinnumero/Telefonnummer} <{E-mail}> <{E-mail}> Κύπρος Sverige {Όνομα} {Namn} <{Διεύθυνση} <{Adress} CY-000 00 {πόλη}> SE-000 00 {Stad}> Τηλ: + {Αριθμός τηλεφώνου} Tel: + {Telefonnummer} <{E-mail}> <{E-mail}> Latvija United Kingdom {Nosaukums} {Name} <{Adrese} <{Address} {Pilsēta}, LV{Pasta indekss }> {Town} {Postal code} – UK> Tel: + {Telefona numurs} Tel: + {Telephone number} <{E-mail}> <{E-mail}> Lietuva {pavadinimas} <{adresas} LT {pašto indeksas} {miestas}> Tel: +370{telefono numeris} <{E-mail}> 24 AND> MANUFACTURER RESPONSIBLE FOR BATCH RELEASE AND> MANUFACTURER RESPONSIBLE FOR BATCH RELEASE responsible for batch release in {name of the product} as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: