49663C-25 SPINAL 25G PENCIL POINT- anesthesia conduction kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

EPINEPHRINE

Composition:

EPINEPHRINE 1 mg in 1 mL

Therapeutic indications:

MARCAINE Spinal is indicated for the production of subarachnoid block (spinal anesthesia). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. MARCAINE Spinal is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. The following conditions preclude the use of spinal anesthesia: 1. Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output. 2. Local infection at the site of proposed lumbar puncture. 3. Septicemia. Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these

Product summary:

Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as follows: Unit of Sale Concentration Each NDC 0409-1761-02 Package of 10 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-19 Uni-Amp™ NDC 0409-1761-62  Bulk package of 800 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-18 Uni-Amp™ Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter. Revised: 8/2015                                                                                  EN-3993 Hospira, Inc., Lake Forest, IL 60045 USA              Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Single-dose NDC 0409-4278-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4278-16 Glass Teartop Vial NDC 0409-4713-02 Carton of 25 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-12 Glass Ampul NDC 0409-4713-32 Carton of 50 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-42 Glass Ampul NDC 0409-4713-62 Case of 800 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-72 Glass Ampul NDC 0409-4713-65 Case of 800 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-75 Glass Ampul NDC 0409-4279-02 Carton of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4279-16 Glass Teartop Vial NDC 0409-4270-01 Case of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4270-11 Sterile Glass Teartop Vial NDC 0409-4776-01 Carton of 25 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4776-10 Glass Ampul NDC 0409-4056-01 Carton of 5 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4056-11 Sterile Glass Ampul NDC 0409-4282-01 Bundle of 25 2% 40 mg/2 mL (20mg/mL) NDC 0409-4282-11 Glass Ampul NDC 0409-4282-02 Carton of 25 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4282-12 Glass Ampul Unit of Sale Concentration Each Multiple-dose: NDC 0409-4275-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4275-16 Plastic Fliptop Vial NDC 0409-4276-01 Tray of 25 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-16 Plastic Fliptop Vial NDC 0409-4276-02 Tray of 25 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4276-17 Plastic Fliptop Vial NDC 0409-4277-01 Tray of 25 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-16 Plastic Fliptop bottle NDC 0409-4277-02 Tray of 25 2% 1000 mg/50 mL (20 mg/mL) NDC 0409-4277-17 Plastic Fliptop Vial Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: 1/2015                                                                               EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA      Unit of Sale Total Strength/ Total Volume (Concentration) Each NDC 0409-7241-61  Case of 800 1 mg/mL NDC 0409-7241-60 1 mL single dose Ampule Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: 11/2015                                                                                  EN-4114                                                                    Hospira, Inc., Lake Forest, IL 60045 USA            

Authorization status:

Premarket Notification

Summary of Product characteristics

49663C-25 SPINAL 25G PENCIL POINT- ANESTHESIA CONDUCTION KIT
SMITHS MEDICAL ASD, INC.
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bupivacaine hydrochloride in dextrose injection, USP
STERILE HYPERBARIC SOLUTION
FOR SPINAL ANESTHESIA
Rx only
Bupivacaine hydrochloride is 2-Piperidinecarboxamide,
1-butyl-N-(2,6-dimethylphenyl)-,
monohydrochloride, monohydrate, a white crystalline powder that is
freely soluble in 95 percent
ethanol, soluble in water, and slightly soluble in chloroform or
acetone. It has the following structural
formula:
Dextrose is D-glucopyranose monohydrate and has the following
structural formula:
MARCAINE™ Spinal is available in sterile hyperbaric solution for
subarachnoid injection (spinal
block).
Bupivacaine hydrochloride is related chemically and pharmacologically
to the aminoacyl local
anesthetics. It is a homologue of mepivacaine and is chemically
related to lidocaine. All three of these
anesthetics contain an amide linkage between the aromatic nucleus and
the amino or piperidine group.
They differ in this respect from the procaine-type local anesthetics,
which have an ester linkage.
Each mL of MARCAINE Spinal contains 7.5 mg bupivacaine hydrochloride
(anhydrous) and 82.5 mg
dextrose (anhydrous). The pH of this solution is adjusted to between
4.0 and 6.5 with sodium hydroxide
or hydrochloric acid.
The specific gravity of MARCAINE Spinal is between 1.030 and 1.035 at
25°C and 1.03 at 37°C.
MARCAINE Spinal does not contain any preservatives.
Local anesthetics block the generation and the conduction of nerve
impulses, presumably by increasing
the threshold for electrical excitation in the nerve, by slowing the
propagation of the nerve impulse, and
by reducing the rate of rise of the action potential. In general, the
progression of anesthesia is related to
the diameter, myelination, and conduction velocity of affected nerve
fibers. Clinically, the order of loss
of nerve function is as follows: (1) pain, (2) temperature, (3) touch,
(4) proprioception, and (5) skeletal
muscle tone.
Systemic absorption of local anesthetics pro