Patient leaflet - Recuvyra
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT
Vial Label
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Recuvyra 50 mg/ml transdermal solution for dogs. Fentanyl
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2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Fentanyl 50 mg/ml
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3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMB ER O F DOSES 10 ml
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4. ROUTE(S) OF ADMINISTRATION
For transdermal use.
Store the Summary of Product Characteristics together with the vial, and read before use
Not applicable.
Lot {number}
EXP:MM/YYYY
Once broached, use
5. WITHDRAWAL PERIOD
6. BATCH NUMBER
7. EXPIRY DATE
8. THE WO
OR ANIMAL TREATMENT ONLY
only.
PACKAGE LEAFLET
Recuvyra 50 mg/ml transdermal solution for dogs
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AN THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR 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.
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Recuvyra 50 mg/ml transdermal solution for do
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Recuvyra is a clear, colourless to light substance) per ml of solution. Recuv is supplied to your veterinarian in an
olution containing 50 mg of fentanyl (the active contains octyl salicylate and isopropyl alcohol. Recuvyra
glass bottle containing 10 ml of product.
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4. INDICATION(S)
Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery.
Your dog shoul
5. CONTRAIN
IONS
given Recuvyra if it:
Has broken, damaged or diseased skin at the treatment site.
art failure, low or high blood pressure, low blood volume, impaired breathing, has a of epilepsy, non-aged related corneal pathology or has or might have a partial or tely stationary bowel.
allergy to the active substance (fentanyl) or to any of the excipients.
ctating, pregnant or a dog used for breeding.
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 ontact
with the area between your dog’s shoulder blades where your veterinarian has applied Re a for at
least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.
best describe
6. ADVERSE REACTIONS
Recuvyra like any other medicine may cause adverse reactions. Your veteri these for you. It can cause:
Very commonly (i.e. in more than 10% of treated dogs)
applied by your
Mild sedation (sleepiness) for up to 24 hours after Recuvyra 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 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 admireatment 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.
Dogs.
8. DOS
7. TARGET S
R EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Recuvyraution designed to be carefully applied to your dog’s skin only by a veterinarian. Two to fours 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 dstream and then relieves pain. A single dose relieves pain for at least 4 days.
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 prod onto the skin surface without using any needles.
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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.
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10. WITHDRAWAL PERIOD
Not applicable.
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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.
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12. SPECIAL WARNING(S)
Recuvyra should only be used for dogs.
Recuvyra should not b less than 6 months old dog before treatment i
used if your dog is pregnant, lactating or is used for breeding, or if your dog is ou should tell your veterinarian if you know any of these applies about your iven.
Tell your veteri pressure proble and what medic Once Recuvyra
your dog is sick or was recently ill, if it has ever had breathing, heart or blood s or epilepsy, if it has ever had bowel or kidney problems or problems with its eyes, nes your dog has taken, especially within the last month.
respo Your eating Dogs
has been administered, your veterinarian will carefully monitor your dog to ensure it o the product.
g will only be allowed to go home once it has recovered from its surgery, and is drinking and rmally.
ighing 20 kg or more will be kept at the veterinary clinic for at least 48 hours after treatment uvyra.
r veterinarian should use Recuvyra with caution in conjunction with other morphine or other
id pain relievers, or a-adrenergic agonists because the possible side-effects have not been studied.
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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANYAny unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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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).
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15. OTHER INFORMATION