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Recuvyra
fentanyl

19

authorised

no

Medicinal


Medicinal product no longer authorised

PACKAGE LEAFLET

Recuvyra 50 mg/ml transdermal solution for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder:


    Eli Lilly & Company Ltd Elanco Animal Health Lilly House

    Priestley Road Basingstoke, Hampshire RG24 9NL United Kingdom


    Manufacturer for batch release:


    McGregor Cory Cherwell 2 Middleton Close

    Banbury, Oxfordshire, OX16 4RS United Kingdom.


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Recuvyra 50 mg/ml transdermal solution for dogs


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    Recuvyra is a clear, colourless to light yellow solution containing 50 mg of fentanyl (the active substance) per ml of solution. Recuvyra also contains octyl salicylate and isopropyl alcohol. Recuvyra is supplied to your veterinarian in an amber glass bottle containing 10 ml of product.


  4. INDICATION(S)


    Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery.


  5. CONTRAINDICATIONS


    Your dog should not be given Recuvyra if it:


    • Has broken, damaged or diseased skin at the treatment site.

    • Has heart failure, low or high blood pressure, low blood volume, impaired breathing, has a history of epilepsy, non-aged related corneal pathology or has or might have a partial or completely stationary bowel.

    • Has an allergy to the active substance (fentanyl) or to any of the excipients.

    • Is lactating, pregnant or a dog used for breeding.

      Medicinal product no longer authorised

      Your veterinarian should not administer Recuvyra:


    • Except as a single dose at the recommended dose rate.

    • To anywhere except between your dogs shoulder blades.

    • To your dog if it has already had a dose of Recuvyra within the last 7 days.


      It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog’s shoulder blades where your veterinarian has applied Recuvyra for at least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.


  6. ADVERSE REACTIONS


    Recuvyra like any other medicine may cause adverse reactions. Your veterinarian can best describe these for you. It can cause:


    Very commonly (i.e. in more than 10% of treated dogs)

    • Mild sedation (sleepiness) for up to 24 hours after Recuvyra has been applied by your veterinarian.

    • Loss of appetite or drinking less water.

    • Decreased stool production and some temporary weight loss.


      Commonly (i.e. in 1 to 10% of treated dogs)

    • Your dog to feel cold when touched (for example the ears).

    • Lowering of heart and breathing rates.

    • Vomiting and diarrhoea.


      Rarely (i.e. in 0,01 to 0,1% of treated dogs)

    • Dysphoria and urinary retention.


    The above side effects can occur up to 3 days (72 hours) after Recuvyra was given to your dog.


    If necessary, your veterinarian may administer treatment to your dog (for example a reversal agent called naloxone which has a very rapid effect within 1 – 2 minutes). If needed, your veterinarian might administer more than one dose of naloxone to your dog.

    If your dog is more than mildly sedated, or has decreased appetite or water intake, you should contact your veterinary surgeon for advice.

    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Recuvyra is a solution designed to be carefully applied to your dog’s skin only by a veterinarian. Two to four hours before your dog has surgery, the recommended dose (2.6 mg fentanyl/kg bodyweight) of Recuvyra solution is applied directly on the skin between the dog’s shoulder blades. Within 5 minutes, the product dries on the skin. Fentanyl gradually moves through the skin into your dog’s bloodstream and then relieves pain. A single dose relieves pain for at least 4 days.

    Medicinal product no longer authorised

    If your dog weighs more than 20 kg, then it will remain in hospital for at least 48 hours following application of Recuvyra. Application of Recuvyra will not cause your dog any pain and your veterinarian will use a dosing table and a specially designed applicator to carefully apply the product onto the skin surface without using any needles.


  9. ADVICE ON CORRECT ADMINISTRATION


    Recuvyra is a solution designed to be applied to the skin between the shoulder blades of your dog (see picture) only by a veterinarian using a specially designed single use applicator, which does not involve any needles. Unless your dog has thick hair it will not usually be necessary to clip/ shave your dog’s hair between the shoulder blades for correct application.


    image


  10. WITHDRAWAL PERIOD


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    As Recuvyra contains fentanyl (the active substance), it will only ever be kept in a veterinarian’s surgery under secure conditions. Your veterinarian will ensure the product is stored correctly and safely for up to 3 years, but the contents of a bottle should be used within 30 days of the first dose being withdrawn.


  12. SPECIAL WARNING(S)


    Recuvyra should only be used for dogs.


    Recuvyra should not be used if your dog is pregnant, lactating or is used for breeding, or if your dog is less than 6 months old. You should tell your veterinarian if you know any of these applies about your dog before treatment is given.

    Tell your veterinarian if your dog is sick or was recently ill, if it has ever had breathing, heart or blood pressure problems or epilepsy, if it has ever had bowel or kidney problems or problems with its eyes, and what medicines your dog has taken, especially within the last month.

    Once Recuvyra has been administered, your veterinarian will carefully monitor your dog to ensure it responds safely to the product.

    Your dog will only be allowed to go home once it has recovered from its surgery, and is drinking and eating normally.

    Dogs weighing 20 kg or more will be kept at the veterinary clinic for at least 48 hours after treatment with Recuvyra.

    Your veterinarian should use Recuvyra with caution in conjunction with other morphine or other opioid pain relievers, or α-adrenergic agonists because the possible side-effects have not been studied.

    Medicinal product no longer authorised

    When using Recuvyra your veterinarian should use less anaesthetic agents and administer them only to achieve the desired effect.


    After the application site is dry, direct contact to the application site should not pose a risk to adults. However, for children such contact might still result in serious exposure to fentanyl. Therefore, special precautions should be taken by people whose dogs have been treated with Recuvyra.


    SMALL CHILDREN SHOULD NOT TOUCH THE DOG FOR 72 HOURS (3 days)

    AFTER RECUVYRA IS APPLIED TO THE DOG. If a small child touches the application site within 72 hours of application, the child’s skin that touched the dog (for example, fingers) should not contact the child’s mouth, and the skin should be washed with soap and water. If a child orally contacts the application site within 72 hours of application, medical attention should be sought immediately.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


  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 (EMA) .


  15. OTHER INFORMATION


Recuvyra is a strong and long-lasting painkiller, and should only be used for major surgery that requires opiate analgesia for a duration of at least 4 days.

Should subsequent surgery be intended in a dog previously treated with Recuvyra, a minimum of a 7 day dosing interval must be observed before administering another dose.

Your veterinarian received a separate information sheet (summary of product characteristics) with more details on the correct and safe administration of Recuvyra.


image

To help you remember when your dog was given Recuvyra by your veterinarian and how long you should not let children touch your dog in the place where the product was applied, your veterinarian will make a note in the spaces provided below. Keep this package leaflet in a safe place.


This dog was treated on:


Date Time


Children should not touch the dog before:


Date Time

Medicinal product no longer authorised

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.


België/Belgique/Belgien (Belgium)

Eli Lilly Benelux Stoofstraat 52

B-1000 Brussels Tel.: +32 2 548 8484

Belgium

Luxembourg/Luxemburg Eli Lilly Benelux Stoofstraat 52

B-1000 Brussels Tel.: +32 2 548 8484

Belgium


Република България

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Magyarország

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Česká republika (Czech republic) Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Malta

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Danmark (Denmark) Elanco Animal Health A/S Lyskær 3 E, 2 t.v.

2730 Herlev

Tel.: + 45 45 26 6060

Denmark

Nederland (the Netherlands)

Eli Lilly Nederland B.V.

Elanco Animal Health Grootslag 1-5 NL-3991 RA Houten

Tel.: +31 30 602 59 55

The Netherlands


Deutschland

Lilly Deutschland GmbH Abteilung Elanco Animal Health Werner-Reimers-Str 2-4

61352 Bad Homburg

Tel: +49 6172 273 2964

Germany

Norge (Norway)

Elanco Animal Health A/S Lyskær 3 E, 2 t.v.

2730 Herlev

Tel.: +45 45 26 6060

Denmark


Eesti

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Österreich (Ostrich)

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Medicinal product no longer authorised

Ελλάδα

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Polska (Poland)

Eli Lilly Polska Sp. z o.o. ul. Żwirki i Wigury 18a 02-092 Warszawa

Tel.: +48 22 440 33 00

Austria


España (Spain)

Elanco Valquimica S.A. Avda. de la Industria, 30

E-28108 Alcobendas (Madrid) Tel.: +34 91 663 5000

Spain

Portugal (Portugal)

Lilly Portugal – Produtos Farmacêuticos, Lda. Torre Ocidente

Rua Galileu Galilei, Nº2 Piso 7 Fracção A/D 1500 – 392 LISBOA

Portugal


Finland (Finland)

Elanco Animal Health A/S Lyskær 3 E, 2 t.v.

2730 Herlev

Tel.: +45 45 26 6060

Denmark

România

Eli Lilly Romania SRL Str. Menuetului nr. 12

Cladirea D, et 2, 013713, sector 1, Bucuresti, Tel:

+40-21-4023000,

fax: +40-21-4023001

Romania


France (France) Lilly France S.A.S. Elanco Santé Animale

24 Boulevard Vital Bouhot 92200 Neuilly sur Seine Paris Tel. : +33/(0)1 55 49 35 29

France

Slovenija (Slovenia)

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Ireland (Ireland)

Eli Lilly & Company Ltd.

Elanco Animal Health Priestley Road Basingstoke

Hampshire RG24 9NL Tel.: +44 1256 35 31 31

United Kingdom

Slovenská republika (Slovac Republic) Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Ísland (Iceland)

Elanco Animal Health A/S Lyskær 3 E, 2 t.v.

2730 Herlev

Tel.: +45 45 26 60 60

Denmark

Sverige (Sweden)

Elanco Animal Health A/S Lyskær 3 E, 2 t.v.

2730 Herlev

Tel.: + 45 45 26 60 60

Denmark


Italia (Italy)

Eli Lilly Italia S.p.A Via Gramsci, 731- 733 SestoFiorentino

I-50019 Firenze

Tel.: +39 0 55 42 57031

Italy

United Kingdom

Eli Lilly & Company Ltd Elanco Animal Health Priestley Road; Basingstoke Hampshire RG24 9NL

Tel.: + 44 1256 35 31 31

United Kingdom

Medicinal product no longer authorised

Κύπρος

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria

Lietuva (Lithuania)

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Latvija (Latvia)

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria


Hrvatska (Croatia)

Eli Lilly Regional Operations GmbH Elanco Animal Health

Kölblgasse 8-10 A-1030 Wien

Tel.: +43 1 711 78 0

Austria