Captivon 98

CII

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

VETERINARY MEDICINE

SCHEDULING STATUS

S6

CAPTIVON 98 INJECTION

Each ml contains: Etorphine hydrochloride 9.8 mg
Preservative: Chlorocresol 0.1 % m/v

C 1.3.1 Opioid agonist

Etorphine is a highly potent, semi-synthetic opioid derivative of oripavine and is classified as a pure agonist. It acts stereospecifically on μ-, δ- and к-opioid receptors, inducing catatonia associated with analgesia at low doses.

Following intramuscular administration of optimal doses, onset of action in most wildlife species is observed within 2–8 minutes with the full effect reached in 15–30 minutes. In rodents, the analgesic effect peaks sharply at 15 minutes with a duration of action of approximately 50 minutes. In elephants, peak serum concentration is reached 30 minutes after intramuscular injection with a half-life of 66 minutes and clearance of 13.6 ml/min/kg.

Etorphine is primarily eliminated in the bile and excreted in the faeces with some excretion occurring in the urine. Full recovery from the effects of etorphine can take up to 7-8 hours if an opioid antagonist is not administered. Re-cycling of etorphine via enterohepatic circulation or redistribution from adipose depots may lead to re-narcotisation of the animal.

CAPTIVON 98 is indicated for immobilisation and anaesthesia of zoo animals, captive wildlife, and free-ranging wildlife species not intended for use as food.

Do not use CAPTIVON 98 in domestic animals and wild felids.
Do not use carcasses of animals treated with etorphine for human consumption.

CAPTIVON 98 residue studies have not been conducted in wildlife animals and consequently, human and predator consumption of carcasses from animals treated with CAPTIVON 98 is not advisable.

CAPTIVON 98 (etorphine hydrochloride) dosing is dependent on species, body mass and the condition of the wildlife animal being treated, and doses should be adjusted accordingly. Administration by intravenous or intramuscular injection is recommended. Refer to the table for CAPTIVON 98 dosing.

The effects of CAPTIVON 98 may be reversed by administering naltrexone hydrochloride 50 mg/mL at a ratio of 20 mg of naltrexone hydrochloride for every 1 mg of CAPTIVON 98 used.

The most serious adverse effect following CAPTIVON 98 administration is respiratory depression, usually observed within the first five minutes after administration. In cases of severe respiratory depression, CAPTIVON 98 should be reversed as soon as possible, and animals should not remain immobilised for longer than necessary to avoid complications.

The use of CAPTIVON 98 in elderly, diseased, emaciated and highly stressed animals carries a greater degree of risk and precautionary measures should be taken, including maintenance of airways and prevention of hyperthermia.

Equids and rhino:
• CAPTIVON 98 may result in a dramatic rise in blood pressure, tachycardia, hyperpyrexia and pronounced muscle tremors.
• Administration in rhino may lead to hypoventilation, hypoxaemia and metabolic acidosis.

Ungulates
• Significant hypertension due to an increase in total peripheral resistance, and moderate to severe bradycardia has been reported in ungulate    species.
• Excitement, increased muscle tone and resulting hyperthermia is particularly common in ungulates.
• Passive regurgitation of rumen contents is common, and ruminants should be kept in sternal recumbency with heads lifted and tilted     downwards to prevent aspiration pneumonia.
• Under-dosing may cause hyper-excitability, hyperventilation and severe alkalosis.

The safety of CAPTIVON 98 in pregnant and lactating wildlife animals has not been established. There is a risk of respiratory depression in the newborn if CAPTIVON 98 is given to a parturient animal. Rodent studies have shown that etorphine readily crosses the placental barrier. Etorphine administered in pregnant rats results in respiratory depression in the mother and depressed oxygen uptake in the newborn rats that is directly proportional to the maternal dose.

CAPTIVON 98 toxicity in wildlife animals results in respiratory depression and cardiac suppression. Rhinos are particularly sensitive to CAPTIVON 98.

An overdose can be treated with naltrexone hydrochloride and with analeptics such as doxapram hydrochloride. Oxygen supplementation is recommended in cases of severe respiratory depression. Butorphanol tartrate may be used to partially reverse respiratory depression and to lighten the plane of anaesthesia of large species such as rhino. In the latter case, the animals may be walked under sedation onto vehicles for transport.

Accidental exposure to CAPTIVON 98 could have serious effects on humans due to the high concentration of the medicine.
• The lethal CAPTIVON 98 dose in humans is estimated to be between 30-120 μg.

The following precautions should be taken by veterinarians when using CAPTIVON 98:
• Do not work with CAPTIVON 98 unaccompanied.
• Ensure that the antidote (naloxone), and a needle and syringe for administration of the antidote are readily available.
• An assistant capable of administering the antidote to humans should always be present and should be fully briefed on the procedure to follow in    the event of accidental exposure to CAPTIVON 98.
• Wear gloves when handling CAPTIVON 98.
• Eye protection should be utilised if there is a risk of CAPTIVON 98 splashing into the eyes.
• Ensure water or an appropriate irrigation solution is available to treat accidental exposure of the skin or eyes.
• CAPTIVON 98 should not be used in blowpipes or similar devices where the medicine solution is pressurised.
• Accidental jabbing with a needle containing CAPTIVON 98 could have serious effects. Once the required dose of CAPTIVON 98 has been    withdrawn from the vial, the needle should be immediately discarded into a closed container or sharps bin.

• Symptoms of toxicity in humans include dizziness, nausea, pinpoint pupils, respiratory depression, hypotension, loss of consciousness and    cardiac arrest.
• In the event of accidental topical exposure of the skin or eyes, wash the affected area immediately with copious amounts of water to prevent    absorption. Monitor for symptoms of toxicity.
• Should accidental injection occur, seek medical attention immediately.

BEFORE CALLING FOR MEDICAL ASSISTANCE, INJECT THE ANTIDOTE.

ADMINISTRATION OF THE ANTIDOTE FOR HUMANS

• Inject 0.8-1.2 mg naloxone preferably IV or alternatively IM and repeat at 2–3 minute intervals until symptoms are reversed. Monitor airway    and ventilation and initiate CPR as necessary until medical help arrives.

A clear, colourless solution for injection.

CAPTIVON 98 is supplied in an amber 10 mL glass vial filled to 5 mL.

Store at or below 25 °C. Protect from light.
Once the rubber stopper has been pierced, the contents of the vial should be used within two weeks.
KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

93/1.3.1/10

Wildlife Pharmaceuticals (Pty) Ltd
38 Wilken Street
Rocky Drift
White River 1240
South Africa

image description

                                                                                                                           CII

                                                                           CAPTIVON 98
                                                                  (etorphine hydrochloride)
                                                                        Injectable Solution
                                                                              9.8 mg/ml

                                                             VETERINARY INFORMATION SHEET

                                       PLEASE READ THIS ENTIRE VETERINARY INFORMATION SHEET
                                 AND THE ENTIRE CAPTIVON 98 PACKAGE INSERT PRIOR TO EACH USE.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Do not use this product without adequate amounts of reversal agent available.

HUMAN SAFETY WARNINGS:

Not for use in humans. Keep this and all medications out of reach of children.
Accidental exposure to CAPTIVON 98, especially in children, can result in a fatal overdose.

Human User Safety while handling CAPTIVON 98:
Because of the potential for adverse reactions associated with accidental exposure, CAPTIVON 98 should only be administered by veterinarians in zoo and wildlife practice, or individuals under such veterinary supervision, trained in the handling of potent opioids.

It is advisable to ONLY handle CAPTIVON 98 when accompanied by another person. Wear gloves. Do not spray, squirt, or spill the drug when filling the syringes. Wash at once with large volumes of water if CAPTIVON 98 comes in contact with eyes, skin, or mucous membranes.

At least two people in the field team should be able to recognize signs of toxicity if accidental exposure occurs. They should be familiar with emergency cardiopulmonary resuscitation procedures plus have FIRST AID KITS containing resuscitation aids available.

Information for Physicians
CAPTIVON 98 is a high concentration opioid agonist. Accidental human exposure may produce severe central nervous system depression resulting in respiratory depression or failure followed by coma and death. Treatment should start immediately by administering an appropriate opiate antagonist, providing airway support, and cardiopulmonary resuscitation techniques.

                                               ( See reverse side for animal use information).

                                               (See reverse side for Human Safety Warnings.)

INDICATION:
For immobilization and anesthesia of zoo animals, captive wildlife, and free-ranging wildlife species not intended for use as food.

Use only when there is a reasonable certainty that the treated animal will not be consumed by humans or food-producing animals (see CAPTIVON 98 package insert for details).

DOSING AND ADMINISTRATION:
See CAPTIVON 98 package insert for dosing table. Note that dosing of CAPTIVON 98 is provided in micrograms/kg(µg/kg) and/or total mg of CAPTIVON 98.

For animal reversal, see ANALGESIC ANTAGONIST FOR ANIMALS section of the CAPTIVON 98 package insert.

CONTRAINDICATIONS:
Do not use CAPTIVON 98 in domestic animals.

Do not use CAPTIVON 98 in feline species.

Do not use CAPTIVON 98 in animals that display clinical signs of disease unless its use is imperative to establish a diagnosis and/or administer therapeutic agents. The effects of CAPTIVON 98 on reproductive performance, pregnancy, and lactation have not been determined.

Do not use CAPTIVON 98 in domestic food-producing animals.

Do not use CAPTIVON 98 thirty (30) days before, or during, the hunting season in free-ranging wild animals that might be used for food. Carcasses of animals treated with CAPTIVON 98 are not to be used for human consumption.

ANIMAL SAFETY WARNINGS:
AN OPIOID ANTAGONIST SUCH AS NALTREXONE HYDROCHLORIDE SHOULD ALWAYS BE DRAWN UP, LABELED, AND READILY ACCESSIBLE TO BE USED AS AN ANIMAL REVERSAL AGENT PRIOR TO DRAWING UP CAPTIVON 98. See CAPTIVON 98 package insert for directions.

All species immobilized with CAPTIVON 98 may show signs of excitement, tachycardia or bradycardia, tachypnea or bradypnea, hypertension or hypotension, depressed respiration, cyanosis, poikilothermia, and reaction to sudden noise. Personnel should be advised of these potential opioid effects and trained to respond appropriately (see CAPTIVON 98 package insert).

CONTACT INFORMATION AND ADVERSE EVENT REPORTING:

To report suspected adverse drug experiences (ADEs) or to obtain additional information about this product, contact:

Clovis Davis Pharmaceuticals, LLC

1520 South Lapeer Rd,Suite 120

Lake Orion,Michigan 48360

Tel (toll-free): 1-833-878-0060

Email:safety@clovisdavis.com

Adverse events may also be reported to the U.S.Food and Drug Administration (FDA) at 1-888-FDA-VETS (1-888-332-8387) or via www.fda.gov/reportanimalae.

STORAGE:
CAPTIVON 98 is a Schedule II opioid. Store in a locked cabinet at or below 77 °F (25 °C) according to federal and state-controlled substance requirements/guidelines. Once the vial has been pierced, the contents must be used within two weeks. Protect from light and prolonged exposure to excessive heat. Any unused or expired vials must be destroyed by a reverse distributor. For further information, contact your local DEA field office or email Wildlife Pharmaceuticals (Pty) Ltd: pharmacist@wildpharm.co.za.

CAPTIVON 98 (etorphine hydrochloride) is not FDA approved. Due to a shortage of etorphine hydrochloride in the US, FDA is allowing temporary use of this South African product in the US. CAPTIVON 98 is authorized for marketing in South Africa for the immobilization and anesthesia of zoo animals, captive wildlife, and free-ranging wildlife species not intended for use as food.

NDC NO. 86204-098-05

Wildlife Pharmaceuticals (Pty) Ltd
38 Wilken Street
Rocky Drift
White River 1240, South Africa
+27 13 751 2328

Distributed by:
Clovis-Davis Pharmaceuticals, LLC
1520 South Lapeer Rd, Suite 120
Lake Orion, Michigan 48360
833-878-0060

CAPTIVON 98
ETORPHINE HCl 9.8 mg/mL

INJECTABLE SOLUTION

CII
IMMOBILIZATION AGENT
FOR IV / IM USE

NET CONTENTS: 5 mL NDC: 86204-098-05

Store at or below 25 ºC (77 ºF). Protect from light.
KEEP OUT OF REACH OF CHILDREN AND
UNINFORMED PERSONS.

CAPTIVON 98 (ETORPHINE HCl) is not FDA
approved. Due to a shortage in the USA, the FDA is
allowing temporary use of this South African authorized
product. CAUTION: Federal law restricts
this drug to use by or on the order of a licenced
veterinarian.

Manufactured by: Wildlife Pharmaceuticals (Pty) Ltd
Distributed by: Clovis-Davis Pharmaceuticals, LLC
1520 South Lapeer Rd, Suite 120 Lake Orion, Michigan 48360
833-878-006

image description

VETERINARY MEDICINE

CAPTIVON 98
ETORPHINE HCl 9.8 mg/mL
INJECTABLE SOLUTION

CII

Batch:

Exp.:

CAPTIVON 98 (ETORPHINE

HCl ) is not FDA approved. Due to a
shortage in the US, the FDA is
allowing temporary use of this
South African-authorized product.

CAUTION: Federal law restricts
this drug to use by or on the order
of a licensed veterinarian.

NDC NO. 86204-098-05

Net contents: 5 mL
Immobilization agent for IV / IM
injection in zoo & wildlife species.

Store at or below 25 °C (77 °F).
Protect from light. KEEP OUT OF
REACH OF CHILDREN AND
UNINFORMED PERSONS.

Once the vial is pierced, contents
must be used within two weeks.

Date first opened: ........................

Because of the potential for adverse
reactions associated with accidental
exposure, CAPTIVON 98 should only be
administered by veterinarians in zoo and
wildlife practice, or individuals under such
veterinary supervision, trained in handling of
potent opioids.

Do not use this product without adequate
amounts of reversal agent available.

Manufactured by:

WILDLIFE PHARMACEUTICALS (Pty)Ltd

38 Wilken Street

Rocky Drift

White River 1240, South Africa

Distributed by:
Clovis-Davis Pharmaceuticals, LLC
1520 South Lapeer Rd, Suite 120
Lake Orion, Michigan 48360
833-878-0060

image description