For IV administration
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Adult Patients - Because of the residual effects of previous anesthetic or sedative agents, in most patients the initial infusion should be 5 µg/kg/min (0.3 mg/kg/h) for at least 5 minutes. Subsequent increments of 5 to 10 mcg/kg/min (0.3 to 0.6 mg/kg/h) over 5 to 10 minutes may be used until desired clinical effect is achieved. Maintenance rates of 5 to 50 mcg/kg/min (0.3 to 3 mg/kg/h) or higher may be required. Evaluation of clinical effect and assessment of CNS function should be carried out daily throughout maintenance to determine the minimum dose of DIPRIVAN Injectable Emulsion required for sedation. The tubing and any unused portions of DIPRIVAN Injectable Emulsion should be discarded after 12 hours because DIPRIVAN Injectable Emulsion contains no preservatives and is capable of supporting growth of microorganisms. (See WARNINGS, and DOSAGE AND ADMINISTRATION. ) 1
2 injection of DIPRIVAN, it is recommended that it be administered prior to DIPRIVAN 3 administration or that it be added to DIPRIVAN immediately before administration and in 4 quantities not exceeding 20 mg lidocaine/200 mg DIPRIVAN. 5 Compatibility and Stability: DIPRIVAN Injectable Emulsion should not be mixed with 6 other therapeutic agents prior to administration. 7 Dilution Prior to Administration: DIPRIVAN Injectable Emulsion is provided as a ready- 8 to-use formulation. However, should dilution be necessary, it should only be diluted with 45 1 5% Dextrose Injection, USP, and it should not be diluted to a concentration less than 2 2 mg/mL because it is an emulsion. In diluted form it has been shown to be more stable when 3 in contact with glass than with plastic (95% potency after 2 hours of running infusion in 4 plastic). 5 Administration with Other Fluids: Compatibility of DIPRIVAN Injectable Emulsion with 6 the coadministration of blood/serum/plasma has not been established. (See WARNINGS. ) 7 When administered using a y-type infusion set, DIPRIVAN Injectable Emulsion has been 8 shown to be compatible with the following intravenous fluids. 9 - 5% Dextrose Injection, USP 10 - Lactated Ringers Injection, USP 11 - Lactated Ringers and 5% Dextrose Injection 12 - 5% Dextrose and 0.45% Sodium Chloride Injection, USP 13 - 5% Dextrose and 0.2% Sodium Chloride Injection, USP 14
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General 16
Parenteral drug products should be inspected visually for particulate matter and discoloration 17
prior to administration whenever solution and container permit. 18
Clinical experience with the use of in-line filters and DIPRIVAN Injectable Emulsion during 19
anesthesia or ICU/MAC sedation is limited. DIPRIVAN Injectable Emulsion should only be 20
administered through a filter with a pore size of 5 mcm or greater unless it has been 21
demonstrated that the filter does not restrict the flow of DIPRIVAN Injectable Emulsion 22
and/or cause the breakdown of the emulsion. Filters should be used with caution and where 46
1 clinically appropriate. Continuous monitoring is necessary due to the potential for restricted 2 flow and/or breakdown of the emulsion. 3 Do not use if there is evidence of separation of the phases of the emulsion. 4 Rare cases of self-administration of DIPRIVAN Injectable Emulsion by health care 5 professionals have been reported, including some fatalities (See DRUG ABUSE AND 6 DEPENDENCE ). 7
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support the growth of microorganisms as it is not an antimicrobially preserved product 12
under USP standards. Accordingly, strict aseptic technique must still be adhered to. 13
Do not use if contamination is suspected. Discard unused portions as directed within 14
the required time limits (see dosage and administration, handling procedures ). There 15
have been reports in which failure to use aseptic technique when handling Diprivan 16
Injectable Emulsion was associated with microbial contamination of the product and 17
with fever, infection/sepsis, other life-threatening illness, and/or death. 18
Diprivan, with EDTA, inhibits microbial growth for up to 12 hours, as demonstrated by test 19
data for representative USP microorganisms. 47
1 Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation: 2 DIPRIVAN Injectable Emulsion should be prepared for use just prior to initiation of each 3 individual anesthetic/sedative procedure. The vial syringe rubber stopper should be 4 disinfected using 70% isopropyl alcohol. DIPRIVAN Injectable Emulsion should be drawn 5 into sterile syringes immediately after vials are opened. When withdrawing DIPRIVAN 6 Injectable Emulsion from vials, a sterile vent spike should be used. The syringe(s) should be 7 labeled with appropriate information including the date and time the vial was opened. 8 Administration should commence promptly and be completed within 12 hours after the vials 9 have been opened. 10 DIPRIVAN Injectable Emulsion should be prepared for single-patient use only. Any unused 11 portions of DIPRIVAN Injectable Emulsion, reservoirs, dedicated administration tubing 12 and/or solutions containing DIPRIVAN Injectable Emulsion must be discarded at the end of 13 the anesthetic procedure or at 12 hours, whichever occurs sooner. The IV line should be 14 flushed every 12 hours and at the end of the anesthetic procedure to remove residual 15 DIPRIVAN Injectable Emulsion. 16
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DIPRIVAN Injectable Emulsion should be prepared for single-patient use only. When 18
DIPRIVAN Injectable Emulsion is administered directly from the vial, strict aseptic 19
techniques must be followed. The vial rubber stopper should be disinfected using 70% 20
isopropyl alcohol. A sterile vent spike and sterile tubing must be used for administration of 21
DIPRIVAN Injectable Emulsion. As with other lipid emulsions, the number of IV line 22
manipulations should be minimized. Administration should commence promptly and must 48
1 be completed within 12 hours after the vial has been spiked. The tubing and any unused 2 portions of DIPRIVAN Injectable Emulsion must be discarded after 12 hours. 3 If DIPRIVAN Injectable Emulsion is transferred to a syringe or other container prior to 4 administration, the handling procedures for General anesthesia/MAC sedation should be 5 followed, and the product should be discarded and administration lines changed after 12 6 hours.
7 HOW SUPPLIED
8 DIPRIVAN Injectable Emulsion is available as follows: Product
No. 260920
NDC No. 63323-269-20 260950 63323-269-50 260965 63323-269-65 Strength 1% (10 mg/mL propofol) 20 mL ready-to–use single patient infusion vial. 1% (10 mg/mL propofol) 50 mL ready-to–use single patient infusion vial. 1% (10 mg/mL propofol) 100 mL ready-to–use single patient infusion vial. 9 Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore 10 packaged under nitrogen to eliminate this degradation path. 11 Store between 4-22°C (40-72°F). Do not freeze. Shake well before use. 12 All trademarks are the property of APP Pharmaceuticals, LLC. 49
1 Manufactured for: 2 3
4 5 451094A 6 Issued: February 2008 50
Dimensions: 7-19/32" x 7-5/32" x 3-7/16" Material/Plate No. 00000-00/APP62928A CR # XXXXX Plate Date 02/27/08 1:00 pm SZT Software: Illus. 11.0 Fonts: Helvetica Regular, Bold, Bold Oblique; Helvetica Cond. Medium, Bold, Oblique; Symbol; OCRB
Notes to Printer: Barcode:
The use of codes provided in artwork is optional; replace if code specifications do not meet press requirements. 8-digit I 2 of 5 - Magnification 83.5%, Narrow Bar .0334, Ratio 2.5, Bar Adjust -.002 Information encoded: 00000000 14-digit I 2 of 5 - Magnification 50%, Narrow Bar .0200, Ratio 2.5, Bar Adjust -.002 Information encoded: 2 03 63323 269 20 7 HRC: B29 AZ NDC 0310-0300-22 Black (100% & 60%) PMS 485 Red PMS 301 Blue Pattern Varnish Diprivan 1% 20 mL Vial Carton unvarnished area unvarnished area unvarnished area unvarnished area
2 03 63323 269 20 7 LOT EXP
00000-00
00000-00 00000-00 Dosage: Information Brochure. In addition to the active component, propofol, the formulation contains: soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL) and disodium edetate (0.005%); with sodium hydroxide to adjust pH. DIPRIV AN Injection should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Store between 4-22°C (40-72°F). Do not freeze. Rx only
Contains EDT A, which inhibits micr
obial gr owth up to 12 hours •
•
, infection/ sepsis, and/or other life-threatening illness •
within specified time limit (See package insert)
Tw en ty -fi ve 20 m L vi al s St er ile , n on py ro ge ni c Fo rs in gl e- pa tie nt us e on ly • Contains EDT A, which inhibits micr obial gr owth
up to 12 hours • Use strict aseptic technique • Contamination can cause fever , infection/sepsis, and/or other life- threatening illness • Begin use promptly after opening; Discard within specified time limit (See package insert) • Do not use if contamination is suspected
00000000 ®®
op ofo l INJECTABLE EMULSION FOR I.V. ADMINISTRATION 10 mg/mL propofol unvarnished area
NDC 63323-269-20 260920 For single-patient use only ® ® propofol INJECTABLE EMULSION FOR I.V. ADMINISTRATION 10 mg/mL propofol Tw ent y-fi ve 20 mL via ls Ste rile , n onp yro gen ic For
gle -pa tie nt u se onl y ® ®
pro pofo l INJECTABLE EMULSION FOR I.V. ADMINISTRATION 10 mg/mL propofol Tw en ty -fi ve 2 0 m L vi al s St er ile , n on py ro ge ni c • Contains EDT A, which inhibits micr obial
gr owth up to 12 hours • Us e st ric t a se pt ic t ec hn iq ue • Co nt am in at io n ca n ca us e fe ve r, in fe ct io n/ se ps is , a nd /o r ot he r l ife -th re at en in g ill ne ss • Be gi n us e pr om pt ly a fte r o pe ni ng ; D is ca rd w ith in s pe ci fie d tim e lim it (S ee p ac ka ge i ns er t) • Do n ot u se i f c on ta m in at io n is s us pe ct ed Fo rs in gl e- pa tie nt us e on ly ®®
pr op ofo l INJECTABLE EMULSION FOR I.V. ADMINISTRATION 10 mg/mL propofol NDC 63323-269-20 260920
NDC 63323-269-20 260920 NDC 63323-269-20 260920
62928A
Man uf actured f or : Made in Italy DIPRIV AN is a tr ademar k of
APP Phar maceuticals , LLC .
A, which inhibits microbial growth up to 12 hours
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ont am ina tio n c an cau se fev er, inf ect ion /se psi s, a nd/ or oth er l ife -th rea ten ing
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in spe cifi ed tim e l im it ( See
kag e i nse rt) • D o n ot u se if c ont am ina tio n i s s usp ect ed • Contains EDTA, which inhibits microbial gr owth up to 12 hours • Use strict aseptic technique • Contamination can cause fever, infection/sepsis, and/or other life-threatening illness • Begin use promptly after opening; Discard within specified time limit (See package insert) • Do not use if contamination is suspected 00000-00 402342A
Mfd. for: ® ® propofol INJECTABLE EMULSION NDC 63323-269-20 260920 Rx only FOR I.V. ADMINISTRATION 20 mL single-patient infusion vial Sterile, nonpyrogenic • Contains EDTA, which inhibits microbial growth up to 12 hours • Use strict aseptic Yüklə 0,53 Mb. Dostları ilə paylaş:
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