The efficacy of Carfentanil
as an immobilizing agent for members of Cervidae family has been demonstrated
in 19 well controlled pivotal and corroborative clinical field trials
conducted with 158 moose, 295 elk, 18 Axis deer, 9 Sika deer and 29 exotic
Cervidae.
Due to the readily observable
effect (immobilization), each animal served as its own control as provided
under 21 CFR 514.111(a)(5)(ii)(a)(2)(iii). A summary of the data follows.
A. Studies in Moose
1. Study One in Moose
Type of Study: Field
study.
Name and Address of Investigator:
Dr. Albert W. Franzmann
Alaska Department of Fish & Game
Soldotna, Alaska
Study Design:
Purpose: Evaluation
of Carfentanil as an immobilization agent for moose with antagonism by
diprenorphine.
Test Animals:
1) Number: 92
2) Age and Sex: Adults of both sexes
3) Free-ranging moose.
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: Not applicable
Dose Forms:
Injectable liquid. Active
chemical and vehicle are identical to formulation for which approval is
requested.
Route of Administration:
Intramuscular
Dosage Used: 0.006
to 0.014 mg/kg body weight
Test Duration: 12
months, March 1983 to March 1984
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
Total dosage per moose varied
from 2.5 to 5 mg Carfentanil (0.006 to 0.014 mg/kg). Mean induction time
for moose receiving at least 3 mg was 5.0 minutes. Diprenorphine was used
as the antagonist. During 1983, the dosage used was 14 mg IV and 6 mg
IM. In 1984, the antagonist dosage was increased and 20 mg were given
IV and 10 to 20 mg IM. Mean recovery time was 4.2 minutes. Hyperthermia,
acute capture myopathy and/or narcotic recycling were attributed to 6
mortalities (6.5%) directly associated with immobilization.
Statistical Analysis:
None conducted.
Conclusions:
The data gathered during
this study show that Carfentanil citrate administered at dose ranges of
0.006 - 0.014 mg/kg body weight intramuscularly to moose produces rapid
immobilization and that the immobilization may be reversed by diprenorphine
at a total dose range of 20 to 40 mg per moose.
Adverse Reactions:
Six mortalities were observed
(6.5%) some of which may have been treatment related. These were a result
of hyperthermia, acute capture myopathy and narcotic recycling.
Special Issues: None
2. Study Two in Moose
Type of Study: Field
Study
Names and Addresses of
Investigators:
Mr. John Kimball
Utah Game & Fish Department
Ogden, Utah
Dr. Ted Stanley
Department of Anesthesiology
University of Utah Medical Center
Salt Lake City, Utah
Study Design:
Purpose: Evaluation
of Carfentanil as an immobilization agent for moose.
Test Animals:
1) Species Used: Moose (Alces
alces)
2) Number: 9
3) Age: 4 adults, 4 calves and 1 yearling
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Forms: Injectable
liquid.
Route of Administration:
Intramuscular
Dosages Used: 0.006
- 0.015 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose administered
2) Time to immobilization
3) Amount of antagonist
4) Time to recovery
5) Adverse effects
Results: Mr. Kimball,
Regional Biologist for Utah Game and Fish utilized Carfentanil under "real
world" situations to rapidly immobilize and remove moose in situations
were they had locked antlers or had wandered near towns. Seven of the
9 moose that were immobilized were reversed with Diprenorphine at a ratio
of approximately 7 mg of Diprenorphine per 1 mg Carfentanil. One of the
nine was euthanized due to a fractured limb.
Statistical Analysis:
None conducted.
Conclusions: Carfentanil
citrate administered at 0.006 to 0.015 mg/kg produces immobilization in
moose.
Adverse Reactions:
None
Special Issues: None
3. Study Three in Moose.
Type of Study: Field
Study
Names and Addresses of
Investigators:
T. Newman, J. D. Port, T.H.
Stanley and K. F. Willard
Department of Anesthesiology
University of Utah Medical Center
Salt Lake City, Utah
J. Kimball
Utah Division of Wildlife Resources
Ogden, Utah
Study Design:
Purpose: The 3 moose
reported in this study were immobilized by aerial dart from a capture
gun in order to investigate injuries or to relocate the animals.
Test Animals:
1) Number: 3
2) Age and Sex: 1 cow, 1 calf and 1 adult bull
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Forms: Injectable
liquid.
Route of Administration:
Intramuscular
Dosages Used: 0.005
- 0.012 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results and Conclusions:
The 3 moose (cow, calf and
adult bull) which received 5.5 or 12 micrograms/kg were immobilized within
6 to 22 minutes. Except for a slightly elevated temperature (40.6°
C) no other problems were observed. The animals were removed or released
1 hour following immobilization. One animal had to be destroyed due to
physical injuries received prior to the immobilization.
Statistical Analysis:
None conducted
Adverse Reactions:
Elevated body temperature
Special Issues: None
4. Study Four in Moose.
Type of Study: Field
Study
Name and Address of Investigator:
Dr. William Taylor
Alaska Department of Game & Fish
Anchorage, Alaska
Study Design:
Purpose: Determine
efficacy of Carfentanil in moose under field conditions.
Test Animals:
1) Species: Moose (Alces
alces)
2) Number: 38
3) Age and Sex: Adults and subadults of both sexes.
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
Liquid
Route of Administration:
Intramuscular
Dosage Used: 0.008-0.020
mg/kg
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
In these 38 animals with
an average weight of 467 kg Carfentanil administered at an average dose
of 0.012 mg/kg body weight produced immobilization in an average of 4
minutes. The immobilization was effectively reversed with a narcotic antagonist.
Statistical analysis:
None conducted
Conclusions:
The data gathered by Dr.
Taylor in Alaska support the label dose range for Carfentanil in moose
of 0.005 - 0.020 mg/kg body weight.
Adverse Reactions:
None
Special Issues: None
5. Study Five in Moose.
Type of Study: Field
Study
Name and Address of Investigator:
Mr. William Dalton
Department of Natural Resources
Fort Francis, Ontario, Canada
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil in moose.
Test Animals:
1) Moose (Alces alces)
2) Number: 16
3) Age and Sex: Adults and subadults of both sexes
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage Used: 0.0067
mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
Thirteen (13) of the 16 animals
had acceptable induction times. Three (3) animals showed excessive induction
times. These were interpreted by the investigator as being due to improper
injection of Carfentanil because of the type of dart used. All immobilized
animals were successfully reversed within an average time of 4.5 minutes
with the use of a narcotic antagonist.
Statistical Analysis:
None conducted
Conclusions:
The data gathered by Mr. Dalton
in Canada, support the recommended label dose range of Carfentanil in
moose of 0.005 - 0.020 mg/kg body weight.
Adverse Reactions:
None
Special Issues: None
B. Studies Conducted in
Elk
1. Trial One in Elk.
Type of Study: Dose
Determination
Names and Addresses of
Investigators:
Thomas Meuleman, J.D. Port,
T.H. Stanley and K.F. Williard
Department of Anesthesiology
University of Utah Medical Center
Salt Lake City, Utah 84132
John Kimball
Utah Division of Wildlife Resources
Ogden, Utah 84403
Study Design:
Purpose: Determine
appropriate effective dose of Carfentanil in elk with antagonism by diprenorphine.
Test Animals:
1) Species: Cervus elaphus
2) Number: 58
3) Age and Sex: Adults of both sexes
4) Semi-confined facilities
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosages Used:
1.25 to 12 micrograms per
kilogram body weight (0.00125 - 0.012 mg/kg body weight). Six milligrams
of diprenorphine were used as an antagonist in each animal.
Test Duration: 72
hours
Parameters Measured:
1) Dose Administration
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
(Eds. note: The following table consists of two columns.)
Results of Meuleman Trials:
Dose Induction ---Micrograms/kg--- ---Time--- 1.25 (l0)* (a) 4.3 minutes
2.00 (14) (a) 3.5 minutes 5.00 (7) (a) 3.8 minutes 10.00 (6) (a) 1.8 minutes
4.4 to 6.6 (6) (b) 3.9 minutes 7.4 to 12.0 (7) (b) 1.8 minutes 7.9 (8)
(c) 7.8 minutes *Numbers in ( ) indicate the number of elk administered
each dose. (a) These animals were dosed by means of a hand-held syringe.
(b) These animals were dosed by means of a jab stick. (c) These animals
were administered the drug by a dart syringe. Statistical Analysis:
None conducted.
Conclusion:
The data show a dose-related
response and indicate that 0.010 mg/kg delivered by hand-held syringe
produces immobilization rapidly in this species. Data in eight animals
indicate the need for higher doses in animals injected by aerial dart
syringes. Six milligrams of diprenorphine effectively antagonized the
immobilization effects of this dose range of Carfentanil.
Adverse Reactions:
None Observed
Special Issues: None
2. Trial Two in Elk.
Type of Study: Field
Names and Addresses of
Investigators:
Dr. Peter L. Bailey, J.D.
Post, J.L. Giese, P. Zwanikken, N.L. Pace, T. H. Stanley and John Kimball
University of Utah Medical Center
Salt Lake City, Utah 84132
Study Design:
Purpose: Evaluate
appropriate safe and effective dose of Carfentanil in elk with antagonsim
by diprenorphine.
Test Animals:
1) Number of Animals: 18
2) Age and Sex: Adult and subadults of both sexes.
3) Semi-confined conditions after capture.
Type of Control:
Each animals served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage Used:
0.00025 - 0.020 mg/kg body
weight. Effects were reversed with 5.2 to 10.0 mg diprenorphine.
Test Duration: 24
hours
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results of Bailey, et
al. Trials:
Dose in Induction Reversal Agent
Micrograms/Kg Time and Recovery Time
0.25 (1)* Ataxia-never immobilized
0.30 (1) Ataxia-never immobilized
0.50 (4) Ataxia-never immobilized
0.60 (4) (1) 22 minutes Treatment with
M50-50 gave
recovery in 3-7
minutes.
0.75 (3) Mean time to immobilization Treatment with M50-
1.00 (2) was 16.2 minutes 50 gave recovery in
3-7 minutes.
6.00 (1) Mean time to immobilization Treatment with M50-
20.00 (1) was 1.6 minutes 50 was successful.
20.00 (1)
* Figures in ( ) indicate the number of elk administered each dose.
Statistical Analysis:
None conducted
Conclusions:
Doses of 0.006 mg/kg or higher
produced satisfactory immobilization in elk. Doses of 0.001 mg/kg or lower
did not produce immobilization.
Adverse Reactions:
One of the three elk dosed at 0.0075 mg/kg was found dead 2 days later.
Special Issues: None
3. Third Study in Elk.
Type of Study: Field
Study
Name and Address of Investigator:
Dr. Albert W. Franzmann
Alaska Department of Fish & Game
Soldotna, Alaska
Study Design:
Purpose:
Determine the effectiveness
of Carfentanil to immobilize free-ranging elk following helicopter pursuit.
Test Animals:
1) Number: 8
2) Age and Sex: Adults females
3) Free-ranging
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular following helicopter pursuit.
Dosage Used: 0.015
mg/kg to 0.030 mg/kg
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
Carfentanil administered
at an average dose of 0.020 mg/kg body weight (0.015 to 0.029 mg/kg range)
produced an average time to immobilization of 4 minutes. These immobilizations
were effectively antagonized by a narcotic antagonist.
Statistical Analysis:
None conducted
Conclusions:
Free-ranging elk, pursued
by helicopter, were effectively immobilized with Carfentanil at an average
dose rate of 0.020 mg/kg body weight.
Adverse Reactions:
None
Special Issues: None
4. Fourth Study in Elk.
Type of Study: Field
Study
Name and Address of investigator:
Dr. Ted Kistner
Oregon Department of Game & Fish
Corvallis, Oregon
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil in free-ranging Roosevelt Elk following helicopter
pursuit.
Test Animals:
1) Number 13
2) Age and Sex: Adults of both sexes
3) Free-ranging
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
Route of Administration:
Intramuscular
Dosage Used: 0.010
- 0.026 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
An average dose of 0.0159
mg/kg body weight produced immobilization in these elk in an average of
2.5 minutes. Reversal was effectively accomplished with a narcotic antagonist.
Statistical Analysis:
None conducted.
Conclusions:
This study supports the recommended
label dose range of 0.010 - 0.026 mg/kg body weight.
Adverse Reactions:
None
Special Issues: None
5. Fifth Study in Elk.
Type of Study: Field
Study
Name and Address of Investigator:
Dr. Ted Kistner
Oregon Department of Game & Fish
Corvallis, Oregon
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil to immobilize free-ranging elk.
Test Animals:
1) Number: 70
2) Age and Sex: Adults and subadults of both sexes.
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage Used: 0.009
- 0.025 mg/kg body weight (0.015 mg/kg body weight, average)
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to Immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
This group of animals was
effectively immobilized at an average of 0.015 mg/kg body weight with
a dose range of 0.009 - 0.025 mg/kg. Average time to immobilization was
4.6 minutes in this group of 70 animals. The immobilization effectively
antagonized with a narcotic antagonist. Two mortalities occurred due to
non-drug related injuries.
Statistical Analysis:
None conducted.
Conclusions: This
study supports the recommended label dose range of Carfentanil in elk.
Adverse Reactions:
None
Special Issues: None
6. Sixth Study in Elk.
Type of Study: Field
Study
Name and address of Investigator:
Dr. Ted Kistner
Oregon Department of Game & Fish
Corvallis, Oregon
Study Design:
Purpose:
Demonstrate efficacy of Carfentanil
in free-ranging elk following helicopter pursuit.
Test Animals:
1) Number: 60
2) Age and Sex: Adult and subadult females
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: Average
0.011 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
An average dose rate of 0.011
mg/kg body weight of Carfentanil produced an average time-to-immobilization
of free-ranging elk of 5.13 minutes. All immobilized animals were effectively
reversed with a narcotic antagonist. One mortality occurred that was not
drug related.
Statistical Analysis:
None conducted
Conclusions:
Free-ranging elk in this
study were effectively immobilized at an average dose rate of 0.011 mg/kg
body weight and reversed with a narcotic antagonist.
Adverse Reactions:
None
Special Issues: None
7. Seventh Study in Elk.
Type of Study: Field
Study
Name and Address of Investigator:
Dr. Ted Kistner
Oregon Department of Game & Fish
Corvallis, Oregon
Study Design:
Purpose: Determine
the efficacy of Carfentanil to immobilize free-ranging elk
Test Animals:
1) Number: 12
2) Age and Sex: Adults and subadults of both sexes
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular following helicopter pursuit.
Dosage used: 0.013
- 0.029 mg/kg body weight (0.017 mg/kg body weight average).
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
Eight of the twelve elk dosed
at an average of .017 mg/kg were immobilized within an average time of
4.6 minutes. The remaining elk were immobilized within an average time
of 16 minutes.
Statistical Analysis:
None conducted
Conclusions:
The data gathered during
this study are consistent with the data from previous studies on immobilization
of free-ranging elk with Carfentanil and supports the recommended dose
range.
Adverse Reactions:
None
Special Issues:
The initial results in some
of the elk in this study underscore the need for adequate injection of
Carfentanil for maximum efficacy of the drug. Inadequate injection results
in prolonged induction times as occurred in four of these elk.
8. Eighth Study in Elk.
Type of Study: Field
Study
Name and address of Investigator:
Mr. Jim Unsworth
Idaho Game & Fish Department
Boise, Idaho
Study Design:
Purpose: Determine
efficacy of Carfentanil in free-ranging elk.
Test Animals:
1) Number: 35
2) Age and Sex: Adults and subadults of both sexes
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.012
- 0.021 mg/kg body weight (0.011 mg/kg body weight average).
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
Elk under the conditions
of this study were immobilized with an average dose rate of 0.010 mg/kg
body weight in an average time of 4.7 minutes. The immobilization was
effectively reversed with a narcotic antagonist.
Statistical Analysis:
None conducted
Conclusions: These
data support the recommended dose range for Carfentanil in elk.
Adverse Reactions:
None
9. Ninth Study in Elk.
Type of Study: Field
Study
Name and address of Investigator:
Dr. Jim Peek
University of Idaho
Moscow, Idaho
Study Design:
Purpose: Determine
efficacy of Carfentanil in free-ranging elk.
Test Animals:
1) Number: 10
2) Age and Sex: Adult males
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.008
- 0.013 mg/kg body weight (0.010 mg/kg body weight average).
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
An average dose of 0.010
mg/kg body weight produced immobilization in 4.4 minutes in 9 out of 10
animals. The time to initial effect was not available on the tenth animal.
Average time to reversal of the immobilization effect with a narcotic
antagonist was 6.15 minutes.
Statistical Analysis:
None conducted
Conclusions: This
data supports the 0.005 - 0.020 mg/kg body weight dose range in elk.
Adverse Reactions:
Re-narcotization was observed in one animal.
Special Issues: None
10. Tenth Study in Elk.
Type of Study: Field
Study
Name and address of Investigator:
Dr. Jim Oosterhuis
San Diego Zoo
San Diego, California
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil in Eurasian species of elk under confined conditions.
Test Animals:
1) Number: 8
2) Age and Sex: Adults of both sexes
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.004
- 0.009 mg/kg body weight (0.006 mg/kg body weight average).
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
All animals were immobilized
with Carfentanil at the indicated dose range and effectively reversed
with a narcotic antagonist.
Statistical Analysis:
None conducted
Conclusions:
The data gathered during
this study support the recommended dose range for Carfentanil in elk.
Adverse Reactions:
None
Special Issues: None
11. Eleventh Study in
Elk.
Type of Study: Field
Study
Names and Addresses of
Investigators:
Mr. Jim Peek/Francis Cassier
Montana Cooperative Research Unit
Montana
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil in elk.
Test Animals:
1) Number: 3
2) Age and Sex: Adult females
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.010
- 0.022 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
All three elk were successfully
immobilized within these dose ranges and effectively reversed with narcotic
antagonists within 3 minutes.
Statistical Analysis:
None conducted
Conclusions: The data
supports the recommended dose range for Carfentanil.
Adverse Reactions:
None
Special Issues: None
C. Study in Axis Deer.
Type of Study: Field
Study
Name and Address of Investigator:
James Oosterhuis, DVM
San Diego Zoo
San Diego, California
Study Design:
Purpose: Demonstrate
efficacy of Carfentanil in axis deer with antagonism by diprenorphine.
Test Animals:
1) Number: 16
2) Age and Sex: Adults and subadults of both sexes
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.005
- 0.018 mg/kg body weight
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
All deer were effectively
immobilized with an average of 0.010 mg/kg Carfentanil within an average
of 6.5 minutes. All animals were reversed with Diprenorphine within 1
to 8.5 minutes.
Statistical Analysis:
None conducted
Conclusions:
Axis deer may be effectively
immobilized with Carfentanil at dose ranges from 0.0054 to 0.018 mg/kg
body weight. Immobilization can be antagonized by a ratio of 11 mg diprenorphine
per mg of carfentanil.
Adverse Reactions:
None
Special Issues: None
D. Study in Sika Deer.
Type of Study: Field
Study
Name and Address of Investigator:
Dr. Jim Oosterhuis
San Diego Wild Animal Park
San Diego, California
Study Design:
Purpose: Determine
efficacy of Carfentanil in Sika deer with antagonism by diprenorphine.
Test Animals:
1) Number: 9
2) Age and Sex: Adults and subadults of both sexes
3) Confined Sika deer in a large animal park.
Type of Control:
Each animal served as its
own control. No treatment type of control was deemed appropriate.
Diagnosis: N/A
Dose Form: Injectable
liquid
Route of Administration:
Intramuscular
Dosage used: 0.005
to 0.010 mg/kg body weight (0.008 average).
Test Duration: N/A
Parameters Measured:
1) Dose Administered
2) Time to immobilization
3) Amount of Antagonist
4) Time to Recovery
5) Adverse Effects
Results:
The Sika deer in this study
weighed an average weight of 90 kilograms. These nine deer were immobilized
with an average dose of 0.00825 mg/kg Carfentanil with an average of time
to effect of 12.33 minutes. Three deer had extremely long induction times.
Extremely long induction times were due to incomplete discharge of the
aerial dart or subcutaneous injection of the drug. Carfentanil was reversed
by diprenorphine at an average ratio of 10 mg diprenorphine per 1 mg of
Carfentanil administered. Reversal times ranged from 2-6 minutes with
a 3.79 minute average.
Statistical Analysis:
None conducted
Conclusions: The data
support the label dose range for deer.
Adverse Reactions:
None
Special Issues:
This study demonstrates the
need for special care in the administration of Carfentanil. Inadequate
injection results in prolonged induction times as occurred in three of
these deer.
E. Exotic Cervidae
These data were gathered
from the use of Carfentanil in several exotic species of Cervidae immobilized
primarily in captivity at average doses ranging from 0.005 mg/kg to 0.064
mg/kg.
(Eds. note: The following
table consists of 5 columns.)
Species Number Investigator Average Dose Average Time
Used to Immobilization
Indian Hog 16 Oosterhuis 0.018 mg/kg 3.67 minutes
Deer
Pampas Deer 1 Oosterhuis 0.043 mg/kg 2.0 minutes
Red Deer 2 Oosterhuis 0.005 mg/kg 2.5 minutes
Muntjac 1 Oosterhuis 0.064 mg/kg 3.0 minutes
Axis 2 Oosterhuis 0.008-0.016 mg/kg 2.2 minutes
Barasingha 5 Oosterhuis 0.007 mg/kg 3.5 minutes
Eld's 4 Oosterhuis 0.020 mg/kg 2.5 minutes
