Recuvyra - summary of medicine characteristics

Summary of medicine characteristics - Recuvyra

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Recuvyra 50 mg/ml transdermal solution for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance: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 PARTICULARS4.1 Target species

Dogs

4.2

Indications for use, specifying the target s

For the control of post-operative pain associate dogs.

4.3 Contraindications

ajor orthopaedic and soft tissue surgery in

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 cardi hypertension, a history of ep suspected of having a paraly

us.

ilure, hypotension, hypovolaemia, respiratory depression, sy, non age related corneal pathology or those who have or are

Do not give a seco fentanyl followi Do not give m

Do not use in case o

ivity to the active substance or to any of the excipients.

ose of the veterinary medicinal product within 7 days. Accumulation of ted administration could result in severe adverse reactions, including death.

the recommended dose of the veterinary medicinal product.

Do not allow th licking is high i

e dog or other animals to lick the site of application as oral bioavailability following n the first five minutes after application. Do not allow other animals contact with the for at least 72 hours after application. The veterinary medicinal product should not

applica come i sedatio

to direct contact with the oral cavity or mucous membranes of dogs. Mild side effects such as n, may occur after a single accidental oral administration of more than 20 ^g/kg of fentanyl kg Recuvyra). Higher oral doses may induce anaesthetic effects and cardiopulmonary ion.

Do not use the veterinary medicinal product in lactating or pregnant bitches or breeding animals (se section 4.7).

4.4 Special warnings

ast

Recuvyra should only be used for major surgery that requires opiate analgesia for a durati 4 days.

Only use the syringes provided. The use of syringes not supplied with this veterinary medicinal product, or storage of this veterinary medicinal product in a syringe may lead to dosing inaccuracy. Do not re-use syringes or applicator tips.

The use of the veterinary medicinal product is intended as a single application administered 2 to 4 hours prior to surgery to provide analgesia for at least 4 days. Should subsequent surgery be intended in a dog previously treated with the veterinary medicinal product, a minimum of a 7 day dosing interval must be observed before administering another dose

4.5 Special precautions for use

Special precautions for use in animals

The veterinary medicinal product is strictly limited for use in bodyweight should remain in the hospital for a minimum of

of more than 20 kg s following application.

As a class, opioids, including this veterinary medicinal product, may cause low body temperature, slow respiratory rate, low blood pressure or slow heart rate. Therefore, dogs should be continuously monitored for rectal temperature, pulse rate, respirat rate and heart rhythm during surgical anaesthesia. Facilities for the maintenance of a patent aiay, intermittent positive pressure ventilation (IPPV) and oxygen supplementation should be

Additional class effects that may be observ and urinary retention, therefore appropriate

The use of the veterinary medicinal pro Appropriate eye lubrication should t until the dog resumes normal blink

The veterinary medicinal produ

following administration of fentanyl include dysphoria tionary measures should be in place.

y result in corneal drying during prolonged sedation. be applied prior to and following surgery and continued ion.

d not be used in animals with systemic illness.

The safety of the veterinary medicinal product in animals less than 6 months of age has not been established.

Before using the product it is recommended to consider the availability of an opiate antagonist, e.g. naloxone, in case reversal is required (see sections 4.6 and 4.10).

Dogs must not be discharged to owners until post-operative sedation is mild or absent and dogs are drinking water and eating voluntarily at an appropriate level for the condition that required surgery.

Dogs that a for dehydra Gastrointes reversal in c

oderately sedated and not drinking water and eating voluntarily should be evaluated and administered supplemental fluid and nutrition support as necessary.

stasis can result in serious complications and consideration should be given to opiate of excessive narcosis (see section 4.10).

Special precautions to be taken by the person administering the veterinary medicinal product to animals

The veterinary medicinal product should be administered with caution. Avoid contact wi Recuvyra can be absorbed by human skin. Also, the veterinary medicinal product might caus irritation.

Personal protective equipment consisting of latex or nitrile gloves, eye protection and suitabl protective clothing should be worn when handling this veterinary medicinal product. If there is a risk of contact with the application site, suitable protective gloves must be worn.

Do not use near a naked flame.

In case of accidental spillage onto skin , immediately flush the area with water, tsh the area with copious amounts of soap and water and seek prompt medical advice, showing the physician this warning, the package leaflet or the label.

In case of accidental exposure of protective clothing to the veterinary remove any contaminated clothing. Blot up any noticeable solution usi as paper tissues. The tissues should be discarded immediately followin contaminated clothing before reuse.

dicinal product, immediately

clean any

In case of accidental eye contact with the veterinary medicin of water and seek medical advice immediately.

nse with abundant quantities

In case of accidental ingestion of the veterinary medici

uct, seek medical advice immediately.

If symptoms develop following exposure to the veterinary medicinal product such as erythema, confusion, nausea or vomiting, medical advice should be sought immediately. The most common symptoms associated with fentanyl overdose in people include respiratory depression, sedation and myosis. At a high dose, fentanyl is known to cause a potentially fatal respiratory depression. This depression may be reversed by use of a suitable reversal agent, such as naloxone.

Following application to dogs, do not tou As a precaution, RECUVYRA should no This product should only be administere

For the attention of dog owner

After the application site is dry, di However, for small children Therefore, treated dogs of m

post-application. SMALL

AFTER RECUVYRA IS

site for 5 minutes.

ministered by pregnant women. a veterinary surgeon.

ontact to the application site should not pose a risk to adults. uch contact might still result in serious exposure to fentanyl. an 20 kg body weight have to be kept at the hospital for 48 hours

REN SHOULD NOT TOUCH THE DOG FOR 72 HOURS (3 days) ED 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.

4.6 Adver

Fentanyl

ions (frequency and seriousness)

monly causes dose-dependent sedation in dogs which is associated with potential decreased and water intake, decreased stool production and transient weight loss. Sedation may persist beyond 24 hours after application.

ctions in body temperature and heart and respiratory rates for up to 3 days following use are n. Vomiting and diarrhoea are also common adverse reactions. In rare cases, dysphoria and inary retention have also been observed.

In field trials, 2 % of dogs treated with the veterinary medicinal product required reversal of advers opiate effects with naloxone. See section 4.10.

The frequency of adverse reactions is defined using the following convention:

very common (more than 1 in 10 animals displaying adverse reactions during the cours treatment)

common (more than 1 but less than 10 animals in 100 animals)

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

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established dur lactation. Do not use the veterinary medicinal product in lactating or pregn animals.

gnancy and hes or breeding

Fertility:

Laboratory studies conducted in rats have not shown any eviden adverse effect on fertility or embryo-foetal development.

togenic effect, or any

4.8 Interaction with other medicinal products and other forms of interaction

Fentanyl is a potent anaesthetic sparing substance. To avoid anaesthetic overdose in dogs treated with the veterinary medicinal product, anaesthetic agents should be administered until the desired effect is produced.

The veterinary medicinal product should be used with caution in conjunction with morphine or other opioid type analgesics as the effects have not been studied.

The effects of the concomitant use of the v not been studied. Therefore, a2-adrenergi the veterinary medicinal product due to

4.9 Amounts to be administer

For transdermal use.

medicinal product and a-adrenergic agonists have agonists should be used with caution in animals dosed with ially additive or synergistic effects.

administration route

JZ>

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the event that any of the following observations are made following the application/overdose of the veterinary medicinal product, reversal should be initiated: severe sedation, unconsciousness, seizures, laboured or abdominal breathing or severe hypotension.

Severe overdose may result in renal failure secondary to hypotension produced by gastrointestinal hypomobility.

Administration of naloxone at 0.04 mg/kg may be used to reverse adverse reactions associated with topical fentanyl. Reversal should occur rapidly within 1–2 minutes. The duration of action of naloxone ranges between 45 minutes and 3 hours in the dog. The effects of transdermal fentanyl could last longer than the effects of the opioid reversal agent. If needed, re-administer naloxone.

Dogs that are moderately sedated, and are not drinking water and eating voluntarily at an appropriate level for the condition that required surgery, should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Analgesic, opioid, phenylpiperidene derivative.

ATCvet code: QN02AB03

5.1 Pharmacodynamic properties

Fentanyl exerts its analgesic action by binding to and activating ^ (mu ) opioid receptors that are predominantly found in the pain regulating areas of the brain and spinal cord. The analgesic effects of the veterinary medicinal product are related to the resulting fentanyl blood concentration achieved following application.

5.2 Pharmacokinetic particulars

The mean plasma fentanyl concentration from time 0 through 96 hours post-dose administration is approximately 1.32 ng/ml. The ranges (90% interval) of pharmacokinetic parameters in dogs are given below:

Terminal half-life (hrs)

Time to 1.0 ng/ml (hrs)

c V J max (ng/ml)

t max

(hrs)

t lag

(hrs)

68.7 – 79.8

1.3 – Not Reached

0.7 – 4.7

10.3 – 17.9

0.4 – 0.8

Following application to the skin, fentanyl is rapidly absorbed into the skin. At the moment of drying, approximately 2 to 5 minutes after application, fentanyl and octyl salicylate are absorbed into the stratum corneum. Fentanyl partitions from the stratum corneum through the deeper skin layers and into the systemic circulation over a period ofys. The maximum plasma fentanyl concentrations of 0.7 to 4.7 ng/ml are reached within 10 turs of dose administration. Plasma fentanyl concentrations reach 1.0 ng/ml, (whierally considered analgesic) in more than 60% of dogs within 4 hours of administration. ic bioavailability of the veterinary medicinal product is approximately 40%. The pharmacc profile of the veterinary medicinal product is primarily characterised by the long period o emic absorption. Fentanyl is highly lipid soluble and distributes rapidly into a variety of tissues readily crossing the blood-brain barrier in the dog. Fentanyl plasma protein binding is estimated at approximately 60% in dogs.

Fentanyl is extensively metabolised and excreted into the urine. The clearance of fentanyl ranges from 1.7 to 4.7 l/h/kg in dogs.

6. PHARM

CAL PARTICULARS

6.1

Octyl sali Isopropyl

ents

6.2

ompatibilities

nown.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first broaching the vial: 30 days.

6.4. Special precautions for storage

The unbroached vial does not require any special storage conditions.

Do not store or use near a naked flame.

Store the broached vial with the adaptor in an upright position.

Store the vial together with the Summary of Product Characteristics (SPC)

When the vial is broached for the first time, the date on which any product remaining in the vial should be discarded should be written in the space provided on the label, using the in-use shelf-life.

6.5 Nature and composition of immediate packaging

Vial: Q)

Type I amber glass vial containing 10 ml solution, closed with a grey butyl rubber stopper sealed with a two piece aluminium seal with a grey flip-off plastic disc.

Dosing device:

• A polycarbonate Robertsite vial adaptor (allowing needleless luer connection to the vial).
• A 2-pronged polycarbonate applicator tip.
• A 3 ml polypropylene syringe with a silicone O-ring fitted to the plunger.

Each pack is supplied with one vial adaptor, 15 syringes and 15 applicator tips, as well as 15 package leaflets for animal owners, and 1 SPC (for the veterinarian).

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke,

Hampshire RG24 9NL

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/127/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

{06/10/2011}

{MM/YYYY}

PROHIBITION OF SALE, SUPPLY AND/OR USE