DELFLEX NEUTRAL PH- dextrose monohydrate, sodium chloride, calcium chloride, magnesium chloride, sodium lactate solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Inapatikana kutoka:

Fresenius Medical Care North America

Njia ya uendeshaji:

INTRAPERITONEAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

DELFLEX® peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate. None known.

Bidhaa muhtasari:

DELFLEX® peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX® peritoneal dialysis solutions have overfills declared on the bag label. The flexible bags have the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX® Neutral pH peritoneal dialysis solutions are available in flexible bags as shown in Table 2 in the Description section. Storage Conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep DELFLEX® and all medicines out of the reach of children. Fresenius Medical Care Fresenius Medical Care North America 920 Winter Street Waltham, MA 02451 1-800-323-5188                                                     Revised Patent Pending                           04/25/2013 Not for Intravenous Injection. Do not microwave. Warm solution as directed by your health care provider. Directions for Use (Aseptic technique is required) Get Ready Inspect DELFLEX® Solution Bags: Do Not Microwave Figure A Do not use DELFLEX® Neutral pH solution if: NOTE: Retain DELFLEX® Neutral pH peritoneal dialysis bag sample for manufacturer evaluation and notify your healthcare provider if any of the above defects are found. Mix DELFLEX ® Neutral pH Solution Important: Mix the Mini-Bag and Main Bag solutions thoroughly. Use the solution within 24 hours after mixing. 1. With the Main Solution Bag laying on the work surface; break the Red frangible “Cone” by placing the thumb firmly on the Red frangible and pressing down upon it until the end of it breaks off. See Figure B. Figure B 2. Fold the Mini-Bag in half. Firmly squeeze the solution from the Mini-Bag into the Main Solution Bag by pressing the two halves together until the Mini-Bag is empty. See Figure C. Figure C 3. Push down on the Main Solution Bag to flush solution back into the Mini-Bag. Completely refill the Mini-Bag with solution. See Figure D. Figure D 4. Repeat Step 2 (Figure C) and Step 3 (Figure D) above, at least one time, to make sure that all of the contents of the Mini-Bag have been completely flushed into the Main Solution Bag. 5. Grasp the bottom end of the Main Solution Bag. While keeping the hanger end (top) portion of the bag on the table, flip the bag lengthwise using a back and forth motion to mix the solutions. See Figure E. Repeat this step to mix solution thoroughly. Figure E 6. With the Main Solution Bag still on the table, position it so that the “slit” in the white slide-lock connector cover is facing up. 7. Fold Mini-Bag in half and squeeze it empty of solution. 8. Slide the folded Mini-Bag into the “slit” of the white slide-lock connector cover. Ensure that the entire “grip” area of the Blue Safe-Lock® connector is exposed. If the square “grip” area is not exposed slide the slide-lock connector cover further onto the folded Mini-Bag to expose the “grip”. See Figures F and G. Solution may flow back into the Mini-Bag slightly, this is normal. NOTE: The protective cap should remain on the connector during this step to avoid touch contamination. Figure F Figure G The solution is now ready for use. Administer DELFLEX ® Neutral pH Peritoneal Dialysis Solution NOTE: The white slide-lock connector cover may not allow you to see the entire lower portion (connector “Cone”) of the Blue Safe-Lock® connector. Figure H 5. Look at the drained fluid for cloudiness. Throw away the fluid and used set as instructed by your healthcare provider. In case of cloudiness, save the fluid and the used set and immediately contact your healthcare provider. Fresenius Medical Care, triangle logo, stay•safe, Delflex, Safe-Lock are trademarks of Fresenius Medical Care Holding, Inc. or its affiliated companies

Idhini hali ya:

New Drug Application

Tabia za bidhaa

DELFLEX NEUTRAL PH- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, CALCIUM
CHLORIDE,
MAGNESIUM CHLORIDE, SODIUM LACTATE SOLUTION
FRESENIUS MEDICAL CARE NORTH AMERICA
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DELFLEX NEUTRAL PH
PERITONEAL DIALYSIS SOLUTIONS
FOR INTRAPERITONEAL ADMINISTRATION ONLY
NO LATEX
DES CRIPTION
DELFLEX Neutral pH peritoneal dialysis solutions, (standard, low
magnesium and low
magnesium/low calcium) are sterile, non-pyrogenic formulations of
dextrose and electrolytes in water
for injection, USP, for use in peritoneal dialysis. These solutions do
not contain antimicrobial agents or
additional buffers. In comparison to conventional peritoneal dialysis
solutions, DELFLEX Neutral pH
solutions are formulated to lower levels of glucose degradation
products and provide a neutral pH of
7.0 ± 0.4, which is closer to physiologic pH. The osmotic and buffer
solutions are stored separately
and mixed by the patient prior to use. Composition, calculated
osmolarity, pH and ionic concentrations
of the mixed solutions are shown in Table 2.
Dextrose, USP, is chemically designated D-glucose monohydrate (C H O
•H O) a hexose sugar
freely soluble in water. The structural formula is shown here:
Calcium chloride, USP, is chemically designated calcium chloride
dihydrate (CaCl
•2H O) white
fragments or granules freely soluble in water.
Magnesium chloride, USP, is chemically designated magnesium chloride
hexahydrate (MgCl
•6H O)
colorless flakes or crystals very soluble in water.
Sodium lactate solution, USP, is chemically designated (CH
CH(OH)COONa), a 60% aqueous solution
miscible in water.
Sodium chloride, USP, is chemically designated (NaCl), a white,
crystalline compound freely soluble in
water.
Water for injection, USP, is chemically designated (H O).
Hydrochloric acid, and sodium hydroxide may be added for pH
adjustment. pH is 7.0 ± 0.4.
Exposure to temperatures above 25°C (77°F) during transport and
storage will lead to minor losses in
moisture content. Higher temperatures lead to greater losses. It is
unlikely that these minor losses wil