LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Tersedia dari:

Fresenius Kabi USA, LLC

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent. As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer's Injection is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream). In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer's Injection, through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Lactated Ringer's Injection is contraindicated in patients with a known hypersensitivity to sodium lactate. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. Preparation for Administration - Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. - Use a non-vented infusion set or close the air-inlet on a vented set. - Close the roller clamp of the infusion set. - Hold the base of BLUE Infusion Port. - Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. To Add Medication Prior to Solution Administration - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additive Port horizontally. - Prepare medication site. - Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives. - Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To Add Medication During Solution Administration - Close the clamp on the set. - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additive Port horizontally. - Prepare medication site. - Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives. - Remove container from IV pole and/or turn to an upright position. - Mix container contents thoroughly. - Using aseptic technique, repeat steps 4-7 as necessary. - Return container to in use position and continue administration. WARNING: Do not use flexible container in series connections. Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451533 Issued: November 2018

Ringkasan produk:

Lactated Ringer's Injection, USP in a single dose flexible plastic container, is available as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
CALCIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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LACTATED RINGER'S INJECTION, USP
in FREE- _flex_
Bag
DESCRIPTION:
Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution
for fluid and
electrolyte replenishment in single dose containers for intravenous
administration. It
contains no antimicrobial agents. Composition, osmolarity, pH, ionic
concentration and
caloric content are shown in Table 1.
TABLE 1
Size
(mL)
Composition (g/L)
Ionic Composition (mEq/L)
Caloric
Content
(kcal/L)
Sodium
Chloride,
USP
(NaCl)
Sodium
Lactate,
USP
(C
H
NaO
)
Potassium
Chloride,
USP (KCl)
Calcium
Chloride,
USP
(CaCl
•2H
O)
Osmolarity
(mOsmol/L)
(calc)
pH SodiumPotassiumCalciumChlorideLactate
Lactated
Ringer's
Injection,
USP
250
6
3.1
0.3
0.2
273
6.5
(6.0
to
7.5)
130
4
2.7
109
28
9
500
1,000
The flexible container is fabricated from a specially formulated
non-plasticized, film
containing polypropylene and thermoplastic elastomers ( FREE_flex_
bag). The amount of
water that can permeate from inside the container into the overwrap is
insufficient to
affect the solution significantly. Solutions in contact with the
flexible container can leach
out certain of the container's chemical components in very small
amounts within the
expiration period. The suitability of the container material has been
confirmed by tests in
animals according to USP biological tests for plastic containers.
CLINICAL PHARMACOLOGY:
Lactated Ringer's Injection has value as a source of water and
electrolytes. It is capable
of inducing diuresis depending on the clinical condition of the
patient.
Lactated Ringer's Injection produces a metabolic alkalinizing effect.
Lactate ions are
metabolized ultimately to carbon dioxide and water, which requires the
consumption of
hydrogen cations.
INDICATIONS AND USAGE:
Lactated Ringer's Injection is indicated as a source of water and
electrolytes or as an
alkalinizing agent.
CONTRAINDICATIONS:
As for other calcium-containing inf