StorageIf removed from the overwrap and the contents are not mixed, CLINIMIX Injection solutions may be stored under refrigeration for up to 9 days.

Upon mixing of bag contents, CLINIMIX Injection solutions remain stable when stored under refrigeration, not to exceed 9 days from when the product was originally removed from the overwrap.

CLINIMIX Injection solutions containing additives should be used promptly after admixture. Any storage should be under refrigeration and limited to a brief period of time, less than 24 hours.

To add Fat Emulsion for 3-in-1 admixture:See WARNINGS section regarding incompatible additives including fat emulsions.

Prior to adding fat emulsion, mix amino acid and dextrose injection as shown in Figure 2.
Prepare fat emulsion transfer set following instructions provided.
Attach transfer set to fat emulsion bottle, using aseptic technique.
Twist off protector on the additive port of the CLARITY container.
Attach the transfer set to the exposed additive port.
Open clamp on transfer set.
After completing transfer, use appropriate plastic clamp or metal ferrule to seal off additive port tube.
Remove transfer set.
Mix contents of CLARITY container thoroughly. Check for leaks.
Storage: Storage of the 3-in-1 admixture must be under refrigeration and limited to a brief period of time, no longer than 24 hours. See WARNINGS section regarding incompatible additives.

To Add MedicationWARNING: Additives may be incompatible.

Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.

Prepare medication port.
Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Mix solution and medication thoroughly. For high density medication, such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
Check for leaks.

Preparation for AdministrationSuspend container from eyelet support.
Twist off protector from outlet port at bottom of container.
Attach administration set. Refer to complete directions accompanying set.
HOW SUPPLIED

See Table 1.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C/104°F does not adversely affect the product.

 

Refrigerated storage is limited to 9 days once overwrap has been opened.

Do not use if overwrap has been previously opened or damaged.

Table 1 - Contents of Admixed Product   Composition
 Dextrose Hydrous, USP1
(g/100 mL) Amino Acids
(g/100 mL) Total Nitrogen
(mg/100 mL) Essential Amino Acids
(mg/100 mL) Nonessential Amino Acids
(mg/100 mL) Anion Profile
(mEq/L)2   Caloric Content
(kcal/L)
How Supplied Leucine -
(CH3)2 CHCH2CH (NH2) COOH Isoleucine -
CH3CH2CH (CH3) CH (NH2) COOH Valine -
(CH3)2 CHCH (NH2) COOH Lysine (added as the hydrochloride salt) -
H2N (CH2)4 CH (NH2) COOH Phenylalanine -
(C6H5) CH2 CH (NH2) COOH Histidine -
(C3H3N2) CH2CH (NH2) COOH Threonine -
CH3CH (OH) CH (NH2) COOH Methionine -
CH3S (CH2)2 CH (NH2) COOH Tryptophan -
(C8H6N) CH2 CH (NH2) COOH Alanine -
CH3CH (NH2) COOH Arginine -
H2NC (NH) NH (CH2)3 CH (NH2