Recuvyra
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
12-07-2017
Valmisteyhteenveto
(SPC)
12-07-2017
Julkisesta arviointikertomuksesta
(PAR)
12-07-2017
Aktiivinen ainesosa:
fentanyl
Saatavilla:
Eli Lilly and Company Limited
ATC-koodi:
QN02AB03
INN (Kansainvälinen yleisnimi):
fentanyl
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Nervous system
Käyttöaiheet:
For the control of pain associated with orthopaedic and soft tissue surgery in dogs.
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2011-10-06
Pakkausseloste
Medicinal product no longer authorised
19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
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
21
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
Lue koko asiakirja
Valmisteyhteenveto
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Recuvyra 50 mg/ml transdermal solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Fentanyl
50 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal solution.
Clear, colourless to light yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of post-operative pain associated with major
orthopaedic and soft tissue surgery in
dogs.
4.3
CONTRAINDICATIONS
Do not administer to skin that does not have an intact
_stratum corneum_
due to injury or disease.
Do not administer to areas other than the dorsal scapular region.
Do not use in dogs with cardiac failure, hypotension, hypovolaemia,
respiratory depression,
hypertension, a history of epilepsy, non age related corneal pathology
or those who have or are
suspected of having a paralytic ileus.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not give a second dose of the veterinary medicinal product within 7
days. Accumulation of
fentanyl following repeated administration could result in severe
adverse reactions, including death.
Do not give more than the recommended dose of the veterinary medicinal
product.
Do not allow the dog or other animals to lick the site of application
as oral bioavailability following
licking is high in the first five minutes after application. Do not
allow other animals contact with the
application site for at least 72 hours after application. The
veterinary medicinal product should not
come into direct contact with the oral cavity or mucous membranes of
dogs. Mild side effects such as
sedation, may occur after a single accidental oral administration of
more than 20 µg/kg of fentanyl
(0.4 µl/kg Recuvyra). Higher oral doses may induce anaesthetic
effects and cardiopulmonary
depression.
Medicin
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