ADDAMEL N chromium copper iron manganese iodine fluorine molybdenum selenium and zinc injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CHROMIC CHLORIDE

Composition:

CHROMIC CATION 1 ug in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

ADDAMEL N- CHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORINE,
MOLYBDENUM, SELENIUM,
AND ZINC INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ADDAMEL N
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of ADDAMEL N contains:
Active ingredients Quantity
Chromic chloride 6 H O 5.33 µg
Copper chloride 2 H O 0.34 mg
Ferric chloride 6 H O 0.54 mg
Manganese chloride 4 H O 99.0 µg
Potassium iodide 16.6 µg
Sodium fluoride 0.21 mg
Sodium molybdate 2 H O 4.85 µg
Sodium selenite anhydrous 6.90 µg
Zinc chloride 1.36 mg
The active ingredients in 1 ml of ADDAMEL N correspond to:
Cr 0.02 µmol
Cu 2 µmol
Fe 2 µmol
Mn 0.5 µmol
I 0.1 µmol
F 5 µmol
Mo 0.02 µmol
Se 0.04 µmol
Zn 10 µmol
The content of sodium and potassium correspond to
Sodium 118 µg 5.12 µmol
Potassium 3.9 µg 0.1 µmol
PRODUCT PROPERTIES
2
2
2
2
2
• Osmolality: approx. 3100 mosm/kg water
• pH: 2.2
2. PHARMACEUTICAL FORM
Concentrate for solution for infusion
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
ADDAMEL N is indicated in patients as a supplement in intravenous
nutrition to meet basal to
moderately increased requirements of trace elements.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADDAMEL N must not be given undiluted.
The recommended daily dosage of ADDAMEL N in adult patients with basal
to moderately
increased requirements is 10 ml (one ampoule).
For children weighing 15 kg or more, the recommended dosage is 0.1 ml
ADDAMEL N/kg body
weight/day.
3.3 CONTRAINDICATIONS
Total biliary obstruction.
3.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
ADDAMEL N should be used with caution in patients with impaired
biliary and/or renal function
in whom the excretion of trace elements may be significantly
decreased.
ADDAMEL N should also be used with caution in patients with
biochemical or clinical evidence
of liver dysfunction (especially cholestasis).