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Transcript of Pharmacy Ma nual - Home - Critical Care Nutrition · 2017-03-01 · ltrin® M100 altrin® M10...
Versi
on: 02-Sept
A
In
tember-2016
Random
Phantended Aud
This sIde
6
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armadience: Pha
study is regisentification n
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Glutamine
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1
Versi
Doc
Vers
Versi
Versi
Versi
on 2: 02-Se
cument H
ion: Date
on 1: 15-Ja
on 1.1: 09-F
on 2: 02-Se
ptember-20
istory
an-2016
Feb-2016
eptember-20
16
016
Supers
Origina
15-Jan
09-Feb
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al version
n-2016
b-2016
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2
Versi
TabDocu
Study
Study
Ov
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Stu
Stu
Ou
Tria
Diagr
Roles
CE
The
Study
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IP Dis
on: 02-Sept
le of Contument Histor
y Contacts ..
y Synopsis .
verview ........
udy Design .
tting ...........
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udy Interven
utcomes ......
al Duration .
ram of Study
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entral Rando
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stigational Pr
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anges in IP
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utamine ......
utrestore (
Nutrestore
altodextrin (p
altrin® M100
Maltrin® M10
spensing ....
tember-2016
tents ry .................
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on ..............
tion .............
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y Overview .
sibilities .......
onsible for th
Research Ph
n ................
Authority Log
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mization Sy
on ................
ria ...............
eria ..............
roduct .........
udy Interven
Dosing .......
...................
...................
L Glutamin
(L Glutamin
placebo) ......
Maltodextrin
00 maltodex
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Versi
Centr
Admi
Orde
APPE
Ap
Ap
Ap
Ap
Ap
Ap
Ap
on: 02-Sept
ral Randomi
nistration of
ring of Inves
ENDICES ...
pendix A:
pendix B:
pendix C:
pendix D:
pendix E:
pendix F:
pendix G:
tember-2016
zation Syste
f IP ..............
stigational P
...................
Pharmacy
Pharmacy
NutreStore
Maltrin M-1
IP Dispens
IP Account
IP Account
6
em (CRS) P
...................
roduct .........
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Delegation
Central Ran
e™ (L-glutam
100® maltod
sing Log
tability Log -
tability Log -
rocedures ..
...................
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and Training
ndomization
mine) monog
extrin mono
- Glutamine
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g Log
System acc
graph
ograph
in
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cess Log
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4
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Versi
Stud Name
Dr. D
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ting ee burns reqgeon/physici
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3
4
5
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1
on: 02-Sept
) Patient ma. Pab. Pac. Pa
usion Crite) > 72 hour
This referfacility, thwould be post burn
) Patients y
) In patientscreatinineml/last 4 h In patientsincrease ooutput of
Patients w
) Liver cirrh
) Pregnancchildbeari
) Contra-indinjury. (Being NP
) Patients w
) Patients wjudgemenNote that
) Patients wIdeally BMthat therethe side of
0) Enrollmenin all non-forward aapproval
1) Received
tember-2016
meets one oatients 18 – atients 18 – atients > 60
eria rs from admirs to admissie clock starta patient wh prior to adm
younger than
s without kne >171 mmohours if a 24
s with acuteof >80 mmo<500 ml/last
with chronic
hosis -Child’s
cy (urine/blooing age by e
dication for
PO is not co
with injuries
who are mornt of the Sitean isolated
with extremeMI should bee may be somf including t
nt in another-randomized synopsis orof the study
glutamine s
6
of the follow59 years of 59 years of years of age
ission to Acuion to your Ats form the tiho has beenmission to yo
n 18 years o
nown renal l/L or a urine
4 hour period
e on chronil/L from bast 24 hours (o
c renal failu
s class C liv
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EN: intestina
nsidered a c
from high vo
ribund (not ee Investigato
DNR does n
e body sizese calculated
me subjectivithe patient.
r industry spd academic sr abstract of to which yo
supplement f
wing 3 criterage with TBage with TBe with TBSA
ute Care UnACU. If a patime of admis
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of age
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pregnancy wpart of stand
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expected to sr or delegatenot fulfil this
: BMI < 18 od using the pa
ty involved i
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ria: BSA > 20% BSA > 15% WA > 10%
it (ACU) to ttient is transssion to you
ed period of t
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ation is not av
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sis will be ex
will be done dard of ACU
or perforatio
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survive the ned doctor in criteria.
or > 50 kg/matient’s pre-in the determ
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xception ther facility
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-enrollment emic RCTs, btain pre-
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10
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InvePatie
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on: 02-Sept
This referto randomlabel glut
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ation of Stuents will receCU discharge
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EPTION: If tdosage of cmacy will beht.
tember-2016
rs to consistemization. If thtamine, disco
lergy to malt
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dy Weight (A+ [(p
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ent administrhe patient reontinue the g
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MI <35 will rer estimated).
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ABW) = Ideapre-burn dry
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System is prered on the d on the BMs Dosing We
ention om randomiths from ACU
se calculatioe initially calch one noted
has a changements, the stthe site inve
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eceive 0.5 g
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tation and it ned from a f
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MI. IP dosing eight.
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on is based oculated dosaexception.
e in body wetudy treatmeestigator/dele
utamine overdom or intermrior to rando
orn, corn pro
ll receive on
rvention
tamine
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al product (IP
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eight (IBW) IBW) x 0.25]
is likely confamily memb
to calculate mization form
is then calc
gh 7 days pn, whichever
on the patienage of IP for
eight sufficieent should alegate if ther
r the 24 hr pmittent doseomization.
oducts or glu
ne of the follo
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P), either glu
P based on
P based on t
based on a]
nsistent with ber.
the patient’sm, and then culated and d
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nt’s pre-burnr the duratio
ent for the cllso be adjusre is a chang
period prior s of open
utamine.
owing:
utamine or
pre-burn dry
the adjusted
BMI of 25
the usual
s BMI basedcalculate thedisplayed in
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n dry weightn of their
inical team tted.
ge in dosing
11
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ClinThe aactive
GlutGluta NutreNutreboweimporegenbody studiecatabnutritdecrestates
GlutasuppAmerblindesimilashowon thpackeexposneedwhendosinapplie
on: 02-Sept
nical Suppactive and coe and contro
amine amine is the
estore (L Gestore is an ael syndrome rtant functioneration. Unby dietary in
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amine will belied to the Nrican sites ined packets ar to the pac
wn here. Thee back of eaet will be sed and will to be cover
n the patient ng label is ed.
tember-2016
plies ontrol produ
ol have the s
‘active’ arm
Glutamine) amino acid (by the FDAns in regulatder normal cntake and sythat the role trauma, and
ements for gsue glutaminglutamine is
e orth
n pre-
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(L Glutamine. L Glutamintion of gastroconditions, gynthesis fromof and nutrit
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restore (estore is aroved for oraer to producte Appendix
product is p
will be shiperica.
ORAGE: Nutruld be storedC (59° - 86°F
be suppliedappearance
t for the stud
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may differ sighealthy indivsm increasedered a "con
L Glutaminan amino acial use in shot InformationC).
pre-package
ped to you f
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dy.
hat is approved normally
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kaged 5g pa
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any catabolicssential" am
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vidual packe
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ackets. The
use in short y and has d ed in the m clinical uring burns, of and centrations c disease
mino acid.
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18
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34
56
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on: 02-Sept
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nt the receipt oedge receipt ohe Central Phta@epipharm
6
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shipped to sitr statutory ho
r your IP delivboth compon
subject recei
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y Depot will prTuesday, or Wof your shipm
of your order aharmacy Depom.com if you e
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Log. r study binder
20
a
r
Versi
APP
Appe
Appe
Appe
Appe
Appe
Appe
Appe
on: 02-Sept
PENDICE
endix A: Ph
endix B: Ph
endix C: Nu
endix D: M
endix E: IP
endix F: IP
endix G: IP
tember-2016
S
harmacy D
harmacy C
utreStore™
altrin M-10
P Dispensin
P Accounta
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6
Delegation
Central Ran
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21
Version: 24 August 2016 Reference: ICH GCP 4.1.5 and 8.3.24
Pharmacy Delegation & Training Log
The participating site pharmacy at ___________________________________________________________ has established a Standard Operating Procedure for the RE-ENERGIZE Study.
(site name) Pharmacy personnel listed in this log have been trained according to the Standard Operating Procedures. Name of Pharmacy contact*: __________________________________________ Signature of Pharmacy Contact: _________________________________________ *Pharmacy contact: is the main pharmacist/pharmacy technician that has been trained by the Methods Centre to carry out all pharmacy tasks related to the RE-ENERGIZE Study at the site.
Print Name
Signature
Initials Study Role
(Pharmacist, Technician,
etc)
Key
Delegated Tasks
(see above)
Training
Date of training
Trained by: Trainer, Webinar,
Self-Study, other - specify (if Trainer - provide name)
This log (or a similar log) is used by the Pharmacist at each site to: 1) Indicate the pharmacy staff that have been delegated duties/tasks related to The RE-
ENERGIZE Study and 2) Ensure that all pharmacy staff that have a material effect on The RE-ENERGIZE Study
have been trained on the study procedures. This log (or similar log) is to be kept by the Pharmacy and sent to the Sponsor upon request.
Key Delegated Tasks 1. Checking the treatment assignment on the Central Randomization System 2. Preparation and checking of Investigational Product 3. Labeling of Investigational Product 4. Maintaining Dispensing Logs 5. Maintaining Investigational Product Accountability & Destruction Records 6. Maintaining and managing inventory 7. Requesting resupply of inventory 8. Other (specify): ___________________________________________________
24 August 2016
Pharmacy Central Randomization System access Log
INSTITUTION: SITE NUMBER: INVESTIGATOR: Please complete the Central Randomization System (CRS) Access Log for the primary study Pharmacists/delegates at your site. A signature and email address is required to create a user account for the web based system for the RE-ENERGIZE Study.
DATE
NAME
TITLE
SIGNATURE
CERU Use Only
CR
S A
cces
s G
rant
ed
CR
S A
cces
s R
evok
ed
___ ___
___ ___
___ ___
___ ___
NOTE: By completing the information in the table above, the individual confirms they will have oversight responsibility for checking the randomization and dispensing/verifying study supplements for the RE-ENERGIZE Study. Pharmacy User ID and Password may be shared amongst all pharmacy staff using the CRS or each delegate may request her/his own accesss. Please complete and send to the Project Leader: Maureen Dansereau email: [email protected] or fax: 613-548-2428
MALTRIN® M100 Maltodextrin
DESCRIPTION
MALTRIN® maltodextrins are bland, minimally sweet white carbohydrate powders produced from corn of U.S. origin. They are products with varying length polymer profiles that provide a wide range of viscosity and solubility characteristics. REGULATORY
MALTRIN® maltodextrins are generally recognized as safe (GRAS) as direct food ingredients at levels consistent with good manufacturing practices (21 CFR 184.1444). The correct labeling is “maltodextrin”, but all label declarations should be reviewed with appropriate legal counsel. PACKAGING, STORAGE AND SHELF LIFE
• Packaged in: 50-pound net, multiwall paper bags that are individually shrink wrapped; 2,000-pound tote bags; 25-kilogram bags.
• Store under ambient conditions; protect from excessive heat and excessive humidity for extended periods of time.
• Under good storage conditions the shelf life should be a minimum of two years. • MALTRIN® maltodextrins will remain stable, but may pick up moisture if stored in excessive
humidity, so reevaluation for moisture is recommended after one year to confirm the product still meets desired specifications.
PRODUCT ATTRIBUTES
• Heated solutions at 30% solids remain clear • Minimal contribution to viscosity at solids below 30% • Very low hygroscopicity • Low sweetness APPLICATIONS
• Source of energy for nutritional products • Aids in spray drying flavors or other ingredients • Carrier and dispersant for dry-blend mixes and seasonings • Prevents sugar crystallization in confections, frostings and glazes • Contributes to total solids in frozen desserts LOT CODES
Lot codes can be interpreted as follows: The first alpha character represents the product, followed by the last two numbers of the year and then the Julian date. Numbers following the Julian date represent the product line and the lot of the day. Example: M1310801: M = MALTRIN®; 13 = 2013; 108 = Apr. 18; 01 = first lot
Grain Processing Corporation
1600 Oregon Street | Muscatine, Iowa 52761 USA p: 563.264.4265 | f: 563.264.4289 e: [email protected] | grainprocessing.com
MALTRIN® and MALTRIN QD® are registered trademarks of Grain Processing Corporation. The information presented in this document is believed to be correct. Any recommendations or suggestions are made without guarantee or representation as to results for any particular usage. You are responsible for determining that the use of any GPC product, as well as your product and its use, and any claims made about your product, all comply with applicable laws and regulations for your particular jurisdiction. The information contained in this document is offered solely for your independent investigation, verification and consideration. © 2014 Grain Processing Corporation
STANDARD SPECIFICATIONS*
• Dextrose Equivalent 9.0-12.0
• Moisture, % 6.0 max.
• Ash (sulfated), % 0.5 max.
• pH (20% solution) 4.0-4.7
• Bulk Density (packed), lb/cu ft 30.0-39.0
• Aerobic Plate Count, CFU/g 100 max.
• Yeast/Mold, CFU/g 100 max.
• E. coli Negative/10 g
• Salmonella Negative/25 g * Any specification different from or not listed above must be agreed upon between the
customer and Grain Processing during specification approval.
CARBOHYDRATE LABELING INFORMATION**
• DP1 (glucose) grams per 100 grams 1
• DP2 (maltose) grams per 100 grams 3 ** Carbohydrate information reported “as is”.
DEGREE OF POLYMERIZATION (DP PROFILE)***
• DP1-7, % 30
• DP8-25, % 35
• DP26-40, % 1
• Greater than DP40, % 34 *** DP profile data reported “as is”.
M100 TI 011314
MALTRIN® M100 Maltodextrin
TYPICAL NUTRITIONAL INFORMATION
Values per 100 grams of product
Calories 378
Calories from Fat 0 g
Total Fat 0 g
Saturated Fat 0 g
Trans Fat 0 g
Monounsaturated Fat 0 g
Polyunsaturated Fat 0 g
Protein 0 g
Total Carbohydrate 94.5 g
Sugars 4 g
Dietary Fiber 0 g
Soluble Fiber 0 g
Insoluble Fiber 0 g
Sugar Alcohols 0 g
Other Carbohydrates 90.5 g
Calcium 16 mg
Iron 0 mg
Sodium 90 mg
Magnesium 6 mg
Potassium 5 mg
Phosphorus 8 mg Mandatory Nutrition Facts listed in bold
The above information is considered to be typical and not part of the product specification. Each value represents the average analyses performed using samples from several product lots. All nutrient data is reported for 100 grams of "as is" product, assuming 5 percent moisture and 94.5 grams of carbohydrate.
NOT a significant source of Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Panthothenic Acid, Biotin, or minerals Chromium, Copper, Iodine, Manganese, Molybdenum, Selenium, Zinc.
29 January 2016
Site: ______________________________________________ Page _____ of ______
Patient ID#:_______________________ Patient Initials:____________Randomization #:______________________
1. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams
Did the prescription change ? 2. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams
3. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams
Date Glutamine Maltodextrin Initials Total Daily
Dose (g)
Quantity Dispensed
(# 5g packets)
Lot & Expiry Total Daily Dose (g)
Quantity Dispensed
(# 5g packets)
Lot & Expiry
Pre
pare
d By
Che
cked
B
y
Investigational Product Dispensing Log - Patient Treatment Allocation: Glutamine Maltodextrin (placebo)
Yes No
09 October 2016
Site: _______________________________________________________ Page ____ of ____
The Investigational Product Accountability Log should be completed by the Pharmacist/delegate
Date Quantity Lot # Expiry Date Quantity Dispensed
Patient Randomization
#
Balance of Product
Signature Received Destroyed
Investigational Product Accountability Log Glutamine
09 October 2016
Site: _______________________________________________________ Page ____ of ____
The Investigational Product Accountability Log should be completed by the Pharmacist/delegate
Date Quantity Lot # Expiry Date Quantity Dispensed
Patient Randomization
#
Balance of Product
Signature Received Destroyed
Investigational Product Accountability Log Maltodextrin