HIGHLIGHTS OF PRESCRIBING INFORMATION
Hepatic failure has been reported in patients with pre-existing liver
These highlights do not include all the information needed to use
disease. Use caution when treating patients with liver disease. (5.4)
CANASA safely and effectively. See full prescribing information for ------------------------------ADVERSE REACTIONS-------------------------------
The most common adverse reactions occurring in more than 1% of
CANASA® (mesalamine) rectal suppository
mesalamine suppository treated patients are: dizziness, rectal pain, fever,
Initial U.S. Approval: 1987 ----------------------------INDICATIONS AND USAGE--------------------------- To report SUSPECTED ADVERSE REACTIONS, contact Aptalis
CANASA is an aminosalicylate indicated for the treatment of mild to
Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or
moderately active ulcerative proctitis. Safety and effectiveness of Canasa
beyond 6 weeks have not been established. (1)
------------------------------DRUG INTERACTIONS------------------------------- ----------------------DOSAGE AND ADMINISTRATION-----------------------
Nephrotoxic agents including NSAIDs: renal reactions have been
The dosage is one 1000 mg rectal suppository once daily at bedtime. (2)
Azathioprine or 6-mercaptopurine: blood disorders have been
---------------------DOSAGE FORMS AND STRENGTHS---------------------- -----------------------USE IN SPECIFIC POPULATIONS------------------------ -------------------------------CONTRAINDICATIONS------------------------------
Renal impairment: Use CANASA with caution in patients with a
Hypersensitivity to mesalamine or to any components of the formulation (4)
history of renal disease. (5.1, 7.1, 8.5, 13.2)
Nursing Women: Caution should be exercised when administered
-----------------------WARNINGS AND PRECAUTIONS------------------------
Renal impairment may occur. Assess renal function at the
Geriatric Patients: Monitor blood cell counts in geriatric patients.
beginning of treatment and periodically during treatment. (5.1)
Mesalamine-induced acute intolerance syndrome has been
reported. Observe patients closely for worsening of these
See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling.
Use caution when treating patients who are hypersensitive to
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. (5.3)
_______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION 10 OVERDOSAGE DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION CONTRAINDICATIONS 12 CLINICAL PHARMACOLOGY WARNINGS AND PRECAUTIONS
5.2 Mesalamine-Induced Acute Intolerance Syndrome
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
5.5 Drug-Laboratories Test Interactions
14 CLINICAL STUDIES ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS
*Sections or subsections omitted from the full prescribing information are not
_______________________________________________________________________________________________________________________________________ ADVERSE REACTIONS FULL PRESCRIBING INFORMATION
The most serious adverse reactions seen in CANASA clinical trials or
with other products that contain or are metabolized to mesalamine are:
INDICATIONS AND USAGE
Renal impairment, including renal failure [See Warnings and
CANASA 1000 mg suppositories are indicated for the treatment of mild
to moderately active ulcerative proctitis. Safety and effectiveness of Canasa
Mesalamine-induced acute intolerance syndrome [See Warnings and
beyond 6 weeks have not been established.
Hypersensitivity reactions [See Warnings and Precautions (5.3)] DOSAGE AND ADMINISTRATION
Hepatic impairment, including hepatic failure [See Warnings and
The dosage of CANASA 1000 mg suppositories is one rectal suppository
The suppository should be retained for one to three hours or longer, if
possible. The usual course of therapy is from three to six weeks depending on
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions,
If a patient misses a dose of CANASA, it should be administered as
adverse reaction rates observed in the clinical trials of a drug cannot be
soon as possible, unless it is almost time for next dose. Patients should not use
directly compared to rates in the clinical trials of another drug and may not
two CANASA suppositories at the same time to make up for a missed dose.
The most frequent adverse reactions observed in the double-blind,
DOSAGE FORMS AND STRENGTHS
placebo-controlled trials are summarized in the Table 1 below.
CANASA 1000 mg suppositories for rectal administration are available
as bullet shaped, light tan to grey suppositories containing 1000 mg
Table 1: ADVERSE REACTIONS OCCURRING IN MORE THAN 1% OF MESALAMINE SUPPOSITORY TREATED PATIENTS (COMPARISON TO PLACEBO) CONTRAINDICATIONS Mesalamine
CANASA suppositories are contraindicated in patients who have
demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the
suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin) [See Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)].
WARNINGS AND PRECAUTIONS 5.1 Renal Impairment
Renal impairment, including minimal change nephropathy, acute and
chronic interstitial nephritis, and, rarely, renal failure, has been reported in
In a multicenter, open-label, randomized, parallel group study
patients given products such as CANASA that contain mesalamine or are
comparing the CANASA 1000 mg suppository administered nightly to that of
converted to mesalamine. It is recommended that patients have an evaluation
the CANASA 500 mg suppository twice daily, the two treatment groups had
of renal function prior to initiation of CANASA therapy and periodically
similar adverse event profiles. The most frequent AEs were headache
while on therapy. Exercise caution when using CANASA in patients with
(14.4%), flatulence (5.2%), abdominal pain (5.2%), diarrhea (3.1%), and
known renal dysfunction or a history of renal disease. In animal studies, the
nausea (3.1%). Three (3) patients had to discontinue medication because of an
kidney was the principal organ for toxicity [See Drug Interactions (7.1) and
adverse reaction; one of these adverse reactions (headache) was deemed
5.2 Mesalamine-Induced Acute Intolerance Syndrome 6.2 Postmarketing Experience
Mesalamine has been associated with an acute intolerance syndrome that
In addition to the adverse reactions reported above in clinical trials
may be difficult to distinguish from an exacerbation of ulcerative colitis.
involving CANASA, the adverse reactions listed below have been identified
Although the exact frequency of occurrence has not been determined, it has
during post-approval use of CANASA and other mesalamine-containing
occurred in 3% of patients in controlled clinical trials of mesalamine or
products. Because these reactions are reported voluntarily from a population
sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody
of uncertain size, it is not always possible to reliably estimate their frequency
diarrhea, and sometimes fever, headache, and rash. Observe patients closely
or establish a causal relationship to drug exposure.
for worsening of these symptoms while on treatment. If acute intolerance
Body as a Whole: drug fever, fatigue, lupus-like syndrome,
syndrome is suspected, promptly discontinue treatment with CANASA.
Cardiac Disorders: myocarditis, pericarditis, pericardial effusion5.3 Hypersensitivity Reactions
Some patients who have experienced a hypersensitivity reaction to
Disorders: abdominal cramps, abdominal
sulfasalazine may have a similar reaction to CANASA tablets or to other
distension, anal pruritus, anorectal discomfort, constipation, feces
compounds that contain or are converted to mesalamine.
discolored, flatulence, frequent bowel movements, gastrointestinal
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and
bleeding, mucus stools, nausea, painful defecation, pancreatitis,
pericarditis) have been reported with CANASA and other mesalamine
proctalgia, rectal discharge, rectal tenesmus, stomach discomfort,
medications. Caution should be taken in prescribing CANASA to patients
with hypersensitivity to 5-ASA products.
Hepatic Disorders: cholestatic jaundice, hepatitis, jaundice,
Kawasaki-like syndrome including changes in liver enzymes, liver
5.4 Hepatic Impairment
There have been reports of hepatic failure in patients with pre-existing liver
disease who have been administered other products containing mesalamine.
Caution should be exercised when administering CANASA to patients with
Neurological/Psychiatric Disorders: Guillain-Barre syndrome,
peripheral neuropathy, transverse myelitisRenal Disorders: interstitial nephritis
5.5 Drug-Laboratories Test Interactions Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity
There have been several reports of possible interference with measurements,
by liquid chromatography, of urinary normetanephrine in patients exposed to
pneumonitis, interstitial pneumonitis)
sulfasalazine or its metabolite, mesalamine/mesalazine.
Skin and subcutaneous tissue Disorder: alopecia, erythema,
erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticariaUrogenital: reversible oligospermia12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action
The mechanism of action of mesalamine is not fully understood, but
appears to be topical rather than systemic. Although the pathology of
No investigations of interaction between CANASA and other drugs have
inflammatory bowel disease is uncertain, both prostaglandins and leukotrienes
been performed. However, the following interactions between mesalamine
have been implicated as mediators of mucosal injury and inflammation.
medications and other drugs have been reported.
12.3 Pharmacokinetics 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Absorption: Mesalamine (5-ASA) administered as a rectal suppository
is variably absorbed. In patients with ulcerative colitis treated with
The concurrent use of mesalamine with known nephrotoxic agents,
mesalamine 500 mg rectal suppositories, administered once every eight hours
including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the
for six days, the mean mesalamine peak plasma concentration (Cmax) was
353 ng/mL (CV=55%) following the initial dose and 361 ng/mL (CV=67%) at
steady state. The mean minimum steady state plasma concentration (Cmin) was
7.2 Azathioprine or 6-mercaptopurine
89 ng/mL (CV=89%). Absorbed mesalamine does not accumulate in the
The concurrent use of mesalamine with azathioprine or 6-
mercaptopurine may increase the risk for blood disorders.
Distribution: Mesalamine administered as rectal suppositories
distributes in rectal tissue to some extent. In patients with ulcerative proctitis
USE IN SPECIFIC POPULATIONS
treated with CANASA 1000 mg rectal suppositories, rectal tissue
concentrations for 5-ASA and N-acetyl-5-ASA have not been rigorously
Pregnancy Category B: Reproduction studies have been performed in
rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended
Metabolism: Mesalamine is extensively metabolized, mainly to N-
human intra-rectal dose, based on body surface area) and in rabbits at oral
acetyl-5-ASA. The site of metabolism has not been elucidated. In patients
doses up to 495 mg/kg/day (about 5.4 times the recommended human intra-
with ulcerative colitis treated with one 500 mg mesalamine rectal suppository
rectal dose, based on body surface area) and have revealed no evidence of
every eight hours for six days, peak concentration (Cmax) of N-acetyl-5-ASA
impaired fertility or harm to the fetus due to mesalamine. There are, however,
ranged from 467 ng/mL to 1399 ng/mL following the initial dose and from
no adequate and well controlled studies in pregnant women. Because animal
193 ng/mL to 1304 ng/mL at steady state.
reproduction studies are not always predictive of human response, this drug
Elimination: Mesalamine is eliminated from plasma mainly by urinary
should be used in pregnancy only if clearly needed.
excretion, predominantly as N-acetyl-5-ASA. In patients with ulcerative
proctitis treated with one mesalamine 500 mg rectal suppository every eight
8.3 Nursing Mothers
hours for six days, ≤ 12% of the dose was eliminated in urine as unchanged 5-
Mesalamine and its N-acetyl metabolite have been detected in human
ASA and 8-77% as N-acetyl-5-ASA following the initial dose. At steady state,
breast milk. The clinical significance of this has not been determined.
≤ 11% of the dose was eliminated as unchanged 5-ASA and 3-35% as N-
Caution should be exercised when Canasa is administered to a nursing
acetyl-5-ASA. The mean elimination half-life was five hours (CV=73%) for
5-ASA and six hours (CV=63%) for N-acetyl-5-ASA following the initial
dose. At steady state, the mean elimination half-life was seven hours for both
8.4 Pediatric Use
5-ASA and N-acetyl-5-ASA (CV=102% for 5-ASA and 82% for N-acetyl-5-
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use 13 NONCLINICAL TOXICOLOGY
Reports from uncontrolled clinical studies and postmarketing reporting
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
systems suggested a higher incidence of blood dyscrasias (i.e., neutropenia
Mesalamine caused no increase in the incidence of neoplastic lesions
and pancytopenia) in patients who were 65 years or older who were taking
over controls in a two-year study of Wistar rats fed up to 320 mg/kg/day of
mesalamine-containing products such as CANASA. Caution should be taken
mesalamine admixed with diet (about 1.7 times the recommended human
to closely monitor blood cell counts during mesalamine therapy.
intra-rectal dose, based on body surface area).
Clinical trials of CANASA did not include sufficient numbers of patients
Mesalamine was not mutagenic in the Ames test, the mouse lymphoma
aged 65 and over to determine whether they respond differently from younger
cell (TK+/-) forward mutation test, or the mouse micronucleus test.
patients. Other reported clinical experience has not identified differences in
No effects on fertility or reproductive performance of the male and
responses between the elderly and younger patients. Systemic exposures are
female rats were observed at oral mesalamine doses up to 320 mg/kg/day
increased in elderly subjects [See Clinical Pharmacology (12.3)]. In general,
(about 1.7 times the recommended human intra-rectal dose, based on body
dose selection for an elderly patient should be cautious, usually starting at the
low end of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concurrent disease or other drug
13.2 Animal Toxicology and/or Pharmacology
Toxicology studies of mesalamine were conducted in rats, mice, rabbits
and dogs, and the kidney was the main target organ of toxicity. In rats,
adverse renal effects were observed at a single oral dose of 600 mg/kg (about
There have been no documented reports of serious toxicity in man
3.2 times the recommended human intra-rectal dose, based on body surface
resulting from massive overdosing with mesalamine suppository. Under
area) and at IV doses of >214 mg/kg (about 1.2 times the recommended
ordinary circumstances, mesalamine absorption from the colon is limited.
human intra-rectal dose, based on body surface area). In a 13-week oral
gavage toxicity study in rats, papillary necrosis and/or multifocal tubular
injury were observed in males receiving 160 mg/kg (about 0.86 times the
The active ingredient in CANASA 1000 mg rectal suppositories is
recommended human intra-rectal dose, based on body surface area) and in
mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA).
both males and females at 640 mg/kg (about 3.5 times the recommended
Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified
human intra-rectal dose, based on body surface area). In a combined 52-week
as an anti-inflammatory drug. Each CANASA rectal suppository contains
toxicity and 127-week carcinogenicity study in rats, degeneration of the kidneys and hyalinization of basement membranes and Bowman’s capsule
1000 mg of mesalamine (USP) in a base of Hard Fat, NF.
were observed at oral doses of 100 mg/kg/day (about 0.54 times the
7H7NO3, representing a molecular weight of
recommended human intra-rectal dose, based on body surface area) and
above. In a 14-day rectal toxicity study of mesalamine suppositories in rabbits, intra-rectal doses up to 800 mg/kg (about 8.6 times the recommended human intra-rectal dose, based on body surface area) was not associated with any adverse effects. In a six-month oral toxicity study in dogs, doses of 80 mg/kg (about 1.4 times the recommended human intra-rectal dose, based on body surface area) and higher caused renal pathology similar to that described for the rat. In a rectal toxicity study of mesalamine suppositories in dogs, a
dose of 166.6 mg/kg (about 3.0 times the recommended human intra-rectal
dose, based on body surface area) produced chronic nephritis and pyelitis. In the 12-month eye toxicity study in dogs, keratoconjunctivitis sicca (KCS)
occurred at oral doses of 40 mg/kg (about 0.72 times the recommended human
experience cramping, abdominal pain, bloody diarrhea, fever,
intra-rectal dose, based on body surface area) and above.
have a history of myocarditis or pericarditis;
14 CLINICAL STUDIES
Two double-blind, placebo-controlled, multicenter studies were
conducted in North America in patients with mild to moderate active
are pregnant, intend to become pregnant or are breast-feeding.
ulcerative proctitis. The primary measures of efficacy were the same in both
trials (clinical disease activity index (DAI) and histologic evaluations). The
FDA-Approved Patient Labeling
DAI is a composite index reflecting rectal bleeding, stool frequency, mucosal
appearance at endoscopy, and a physician’s global assessment of disease. The
main difference between the studies was dosage regimen: 500 mg three times
Read the Patient Information leaflet that comes with CANASA before you
daily (1.5 g/d) in Study 1; and 500 mg twice daily (1.0 g/d) in Study 2. A total
start taking it and each time you get a refill. There may be new information.
of 173 patients were studied (Study 1, N=79; Study 2, N=94). Eighty-nine
This leaflet does not take the place of talking with your doctor about your
(89) patients received mesalamine suppositories, and eighty-four (84) patients
medical condition or treatment. If you have any questions about CANASA,
received placebo suppositories. Patients were evaluated clinically and
sigmoidoscopically after three and six weeks of suppository treatment. In
Study 1, patients were 17 to 73 years of age (mean = 39 years), 57% were
What is CANASA?
female, and 97% were white. Patients had an average extent of proctitis (upper
CANASA is a prescription medicine used to treat active ulcerative proctitis
disease boundary) of 10.8 cm. Eighty-four percent (84%) of the study patients
had multiple prior episodes of proctitis. In Study 2, patients were 21 to 72
years of age (mean = 39 years), 62% were female, and 96% were white.
It is not known if CANASA is safe and effective for use for longer than 6
Patients had an average extent of proctitis (upper disease boundary) of 10.3
cm. Seventy-eight percent (78%) of the study patients had multiple prior
It is not known if CANASA is safe and effective in children.
Compared to placebo, mesalamine suppository treatment was
statistically (p<0.01) superior to placebo in both trials with respect to
Who should not use CANASA?
improvement in stool frequency, rectal bleeding, mucosal appearance, disease
severity, and overall disease activity at three and six weeks of treatment. The
Do not use CANASA if you are:
effectiveness of mesalamine suppositories was statistically significant
allergic to medicines that contain salicylates, including aspirin.
irrespective of sex, extent of proctitis, duration of current episode, or duration
allergic to mesalamine or any of the ingredients in CANASA. See
the end of this leaflet for a complete list of ingredients in
An additional multicenter, open-label, randomized, parallel group study
in ninety-nine (99) patients diagnosed with mild to moderate ulcerative
Ask your doctor if you are not sure if your medicine is listed above.
proctitis compared the clinical efficacy of the CANASA 1000 mg suppository
to that of the CANASA 500 mg suppository. The primary measures of
What should I tell my doctor before using CANASA?
efficacy included the clinical disease activity index (DAI) and histologic
evaluations. Patients were randomized to one of two treatment groups, with a
Before using CANASA, tell your doctor if you:
dosage regimen of one 500 mg mesalamine suppository twice daily, morning
have a history of allergic reaction to the medicine sulfasalazine
and at bedtime, or one 1000 mg mesalamine suppository at bedtime for 6
weeks. Patients were evaluated clinically and sigmoidoscopically at three and
six weeks of suppository treatment. Of the eighty-one (81) patients in the Per
Protocol population, forty-six (46) patients received mesalamine 500 mg
have ever had inflammation of the sac around your heart
suppositories twice daily, and thirty-five (35) patients received mesalamine
The efficacy of the 1000 mg at bedtime treatment was not different at 6
are pregnant or plan to become pregnant. It is not known if
weeks from the 500 mg twice daily treatment, and both were effective in the
CANASA can harm your unborn baby.
treatment of ulcerative proctitis. Both treatments resulted in a significant
are breastfeeding or plan to breastfeed. CANASA can pass into
decrease at 6 weeks in DAI. In the 500 mg twice daily group, the mean DAI
your milk. Talk to your doctor about the best way to feed your
value decreased from 6.6 to 1.6, and in the 1000 mg at bedtime group, the
mean DAI value decreased from 6.2 to 1.3 over 6 weeks of treatment,
representing a decrease of greater than 75% in both groups. Seventy-eight
Tell your doctor about all the medicines you take, including prescription
percent (78%; 36/46) of patients in the 500 mg twice daily group and 86%
and non-prescription medicines, vitamins and herbal supplements.
(30/35) of the patients in the 1000 mg at bedtime group achieved a DAI score
of less than 3 after 6 weeks of treatment.
Know the medicines you take. Keep a list of them to show your doctor and
16 HOW SUPPLIED/STORAGE AND HANDLING
CANASA 1000 mg suppositories for rectal administration are available
How should I use CANASA?
as bullet shaped, light tan to grey suppositories containing 1000 mg
Use CANASA exactly as prescribed by your doctor. Your doctor
mesalamine supplied in boxes of 30 and 42 individually plastic wrapped
will tell you how long to continue using CANASA.
suppositories (NDC 58914-501-56 and 58914-501-42).
CANASA comes as a suppository that you insert into your rectum.
Store below 25ºC (77ºF), may be refrigerated. Keep away from direct
CANASA is used 1 time each day, at bedtime.
After CANASA is inserted in your rectum, you should try to keep
CANASA suppositories will cause staining of direct contact surfaces,
(retain) the suppository in your rectum for 1 to 3 hours, or longer if
including but not limited to fabrics, flooring, painted surfaces, marble, granite,
CANASA can cause staining of surfaces including, clothing and
other fabrics, flooring, painted surfaces, marble, granite, vinyl and
PATIENT COUNSELING INFORMATION
enamel. Keep CANASA away from these surfaces to prevent
See FDA-approved patient labeling (Patient Information)
Instruct patients not to take CANASA if they have hypersensitivity to
What are the possible side effects of CANASA?
salicylates (e.g., aspirin) or other mesalamines.
CANASA may cause serious side effects, including:
Inform patients to let their physicians know all medications they are taking
Allergic type reactions. This can include sudden symptoms called
“Acute intolerance syndrome.” When this happens, it is usually in
are allergic to sulfasalazine, salicylates or mesalamine;
people who have had an allergic reaction to medicines containing
are taking non-steroidal anti-inflammatory drugs (NSAIDs) or
sulfasalazine. Stop using CANASA and tell your doctor right away if
are taking azathioprine or 6-mercaptopurine;
Inflammation of the sac around the heart (pericarditis). Tell your doctor right away if you get chest pain or shortness of breath. Your doctor may tell you to stop using CANASA if you get pericarditis. The most common side effects of CANASA include:
rectal pain (pain in the final portion of the large intestine)
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of CANASA. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store CANASA?
Keep CANASA away from direct heat, light, or humidity.
Keep CANASA and all medicines out of the reach of children. General information about CANASA Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CANASA for a condition for which it was not prescribed. Do not give CANASA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about CANASA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CANASA that is written for health professionals. For more information, go to www.canasa.com, or call 1-800-472-2634. What are the ingredients in CANASA? Active ingredients: Mesalamine Inactive ingredients: Hard fat base Distributed by: Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard Bridgewater, NJ 08807 USA www.aptalispharma.com This Patient Information has been approved by the U.S. Food and Drug Administration. CANASA® is a registered trademark of Aptalis Pharma Canada Inc., an affiliate of Aptalis Pharma US, Inc. 2013 Aptalis Pharma US, Inc.
T r a v e l P o l i c y Approved Dec 20, 2007 IT IS THE INTENT OF THE RED RIVER NORDIC SKI CLUB TO OFFER HEALTHY AND SAFE TRAVEL-TO-EVENT OR TRAINING CAMP EXPERIENCES FOR OUR ATHLETES. TO FACILITATE THIS, THE FOLLOWING GUIDELINES HAVE BEEN DESIGNED TO OUTLINE EXPECTATIONS FOR MEDICATION AND ATHLETE AVAILABILITY ON TRIPS: THE ATHLETE'S PARENT OR GUARDIAN MUST PROPERLY FILL OUT A ME
2:09-cv-13201-SJM-MJH Doc # 137 Filed 12/27/13 Pg 1 of 16 Pg ID 3558THE BOARD OF TRUSTEES OF THECITY OF BIRMINGHAM EMPLOYEES’RETIREMENT SYSTEM, et al., OPINION GRANTING PLAINTIFFS’ MOTION FOR FINAL APPROVAL OF CLASS ACTION SETTLEMENT AND PLAN OF ALLOCATION OF SETTLEMENT PROCEEDS (document no. 134), AND GRANTING PLAINTIFFS’ MOTION FOR AWARD OF ATTORNEYS’ FEES AND EXPENSES (