For Veterinary Use Only Undesirable Effects
Undesirable effects include those typically observed following surgery.
FUCOIDAN CONCENTRATE MEDICAL DEVICE Hemorrhaging has been observed at high concentrations of fucoidan.
(50 mL of 5 % w/v fucoidan concentrated solution) In vitro infection potentiation studies showed no increase in risk of
A Sterile Medical Device for the infection in contaminated fields.
Prevention of Surgical Adhesions in Horses DIRECTIONS FOR USE
DESCRIPTION 50 mL of Fucoidan Concentrate is mixed with 5 L of Lactated Ringer's
Fucoidan Concentrate is a single use, sterile, clear, colorless fluid Injection USP and administered into the peritoneal cavity during
containing fucoidan at a concentration of 5% w/v in a physiologically abdominal surgery in horses including foals. After the surgeon has
normal solution for dilution in Lactated Ringer's Injection USP and completed the surgical procedure(s) and removed all sponges and
intraperitoneal administration in horses including foals. packs the peritoneal cavity is aspirated of all remaining fluid. A final
volume of 1 L of diluted Fucoidan Concentrate per 100 kg body weight
Each 50 mL of Fucoidan Concentrate contains:
is then introduced into the cavity before closure of the cavity. Diluted
Fucoidan (ARC Equine Standard) 2.5 g Fucoidan Concentrate should be warmed to approximately body
Sodium chloride USP 300 mg temperature before use by using a device specifically intended for
Sodium lactate anhydrous USP 155 mg warming solutions in operating rooms. Using standard operating
Potassium chloride USP 15 mg technique:
Calcium chloride dehydrate USP 10 mg
1. Thoroughly mix 50 mL of Fucoidan Concentrate into a 5 L bag of
Water for injection USP q.s.
Lactated Ringer's Injection USP until clear.
May contain hydrochloric acid or sodium hydroxide for pH adjustment;
2. Warm diluted Fucoidan Concentrate to approximately body
pH 6.0-7.5. Salts per 1.0 L (not including ions for adjusting pH):
temperature.
Sodium 130 mEq; Potassium 4 mEq; Calcium 2.7 mEq; Chloride 109
mEq; Lactate 28 mEq; calculated osmolarity 272 mOsm·L-1. 3. Hang the sterile bag(s) of solution on an intravenous stand.
Fucoidan is a branched, sulfated, complex polysaccharide. It is 4. Remove the twist-off tab from the port and in the case of
extracted from the brown seaweed Undaria pinnatifida and purified to laparotomy insert a standard set for dispensing the solution
a specific molecular weight and sulphate content. directly into the peritoneal cavity or in the case of laparoscopy
insert a standard set for connection to a laparoscope.
INDICATIONS 5. Remove any fluid remaining in the peritoneal cavity.
Following dilution, Fucoidan Concentrate is intended for use as an 6. Prior to the closure of the abdominal incision or removal of the
intraperitoneal instillate for the reduction of adhesions following laparoscope direct the appropriate amount of solution at the
abdominal surgery in horses including foals. operative sites and distribute the remainder of the contents of the
bag throughout the peritoneal cavity.
ACTIONS
Following dilution into Lactated Ringer's Injection USP, Fucoidan PRECAUTIONS FOR USE
Concentrate performs its function by separating tissue and organ Fucoidan Concentrate must be used as directed by a veterinarian. It
surfaces during the early stages of peritoneal repair by providing a must not be used unless the solution is clear and the vial undamaged.
coating of fucoidan polymer on the peritoneal surfaces. Any unused portion of solution should be discarded.
Following dilution, Fucoidan Concentrate has been shown to Fucoidan Concentrate is not to be used for intravenous injection.
significantly reduce the incidence, extent and severity of post-surgical
adhesions when used as an instillate post-operatively in the following VIGILANCE
animal models: rat uterine horn; rabbit uterine horn; rabbit double For adverse events reporting, medical or product concerns, general
uterine horn; and foal intestine abrasion. inquires, and feedback, telephone +1-604-222-9577 or email
feedback@arcpharma.com.
EFFECTIVENESS
In a controlled field study, 12 foals were treated with either diluted STORAGE
Fucoidan Concentrate (6 horses) or control Lactated Ringer's Fucoidan Concentrate should be stored between 2 to 8 °C or between
Injection USP (6 horses). Results showed that animals treated with 36 to 46 °F. Protect from freezing.
diluted Fucoidan Concentrate had a 64% decrease in the number of
adhesions and a 74% decrease in the severity of adhesions HOW SUPPLIED
compared to control instillate. Diluted Fucoidan Concentrate had no Fucoidan Concentrate is a sterile solution packaged in single use
clinically significant effect on the hematologic, biochemistry or other glass vials with a rubber stopper and aluminum crimp and contains 50
parameters investigated in this study. The investigators concluded mL of solution.
that the use of diluted Fucoidan Concentrate was well tolerated and
Fucoidan Concentrate Is Manufactured For
effective in the prevention of surgical adhesions.
ARC Pharmaceuticals Inc., Vancouver, BC, Canada, V6T 1Z3
CONTRAINDICATIONS Fucoidan Concentrate is manufactured under US Patent # 6,812,220,
Fucoidan Concentrate should not be used in horses with a known US Patent # 7,163,930, granted European patent application
allergen to sugar based polymers or polysaccharides including fucose # 02758008.3-2107, Australia Patent # 2002325113 and New Zealand
and galactose. Patent # 532015. Related patents have been issued, granted,
allowed or applied for in additional territories.
WARNINGS
Not for use in horses intended for human consumption. REFERENCES
1. Podium presentation: Evaluation of abdominal instillation of 0.03%
User Safety: Keep out of reach of children. Not for human use. fucoidan solution for the prevention of experimentally induced
Animal Safety: For intraperitoneal use in horses only. abdominal adhesions in healthy pony foals. S.Z. Yamout, L.P. Bouré,
et al. America College of Veterinary Surgeons' Symposium (Oct.
PRECAUTIONS 2007).
2. Poster presentation: Evaluation of abdominal instillation of 0.03%
Pregnancy and Lactation fucoidan solution for the prevention of experimentally induced
There are no data available on the effects of fucoidan on reproduction abdominal adhesions in healthy pony foals. S.Z. Yamout, L.P. Bouré,
or lactation and therefore Fucoidan Concentrate should not be used et al. European College of Veterinary Surgeons' Scientific Meeting
during pregnancy or lactation in horses. (Jun. 2007).
Issued November 2008 by ARC Pharmaceuticals Inc.
Interactions with Medications
There are no data available from studies on the compatibility of
medications with Fucoidan Concentrate.