Addamel N

Generic Name: chromic chloride, cuprous chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite and zinc chloride
Dosage Form: injection, solution

Addamel N

1.      QUALITATIVE AND QUANTITATIVE COMPOSITION

         1 ml of Addamel N contains:

         Active ingredients                        Quantity           

         Chromic chloride 6 H2O               5.33 µg           

         Copper chloride 2 H2O                 0.34 mg           

         Ferric chloride 6 H2O                   0.54 mg           

         Manganese chloride 4 H2O          99.0 µg           

         Potassium iodide                          16.6 µg            

         Sodium fluoride                            0.21 mg           

         Sodium molybdate 2 H2O            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

         •   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).

         If the treatment is continued for more than 4 weeks, checking of manganese levels is required.

         Addamel N must not be given undiluted.

3.5    Interaction with other medicaments and other forms of interaction 

         No interactions with other drugs have been observed.

3.6    Pregnancy and lactation

         Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Addamel N. However, the requirements of trace elements in a pregnant woman are slightly

         increased compared to non-pregnant women.

         No adverse events are to be expected when Addamel N is administered during pregnancy.

3.7    Effects on ability to drive and use machines 

         No effects on the ability to drive and use machines are to be expected.

3.8    Undesirable effects 

         No adverse effects related to the trace elements in Addamel N have been reported.

         Superficial thrombophlebitis has been observed when glucose containing Addamel N was given. However, it is not possible to deduce whether this reaction is attributable to the infused trace elements

         or not.

         Allergic reactions to iodine may occur following topical application. No adverse reactions are known to occur as a consequence of using the recommended intravenous iodide dosage levels.

3.9    Overdose 

         In patients with impaired renal or biliary function, there is an increased risk for accumulation of trace elements.

         In case of a chronic overload of iron there is a risk of haemosiderosis, which in severe and rare cases can be treated by venesection.

 

4.      PHARMACOLOGICAL PROPERTIES 

4.1    Pharmacodynamic properties 

         Addamel N is a mixture of trace elements in amounts normally absorbed from the oral diet and should have no pharmacodynamic effect besides maintaining or repleting the nutritional status.

4.2    Pharmacokinetic properties 

         When infused intravenously, the trace elements in Addamel N are handled in a similar way to trace elements from an oral diet. Individual trace elements will be taken up by tissues to different extents,

         depending on the requirements within each tissue to maintain or restore the concentration of each element for the metabolic requirements of that tissue.

         Copper and manganese are normally excreted via the bile, whereas selenium, zinc and chromium (especially in patients receiving intravenous nutrition) are mainly excreted via the urine.

         The main route of molybdenum excretion is the urine, although small amounts are excreted in the bile.

         Iron is eliminated in small amounts by superficial loss and desquamation of gut cells. Premenopausal women can lose 30-150 mg of iron in the monthly blood loss. Iron excretion follows all kinds of

         bleedings.

4.3    Preclinical safety data 

         The safety evaluation is based mainly on clinical experience and documentation.

 

5.      PHARMACEUTICAL PARTICULARS

5.1    List of excipients 

         Other ingredients                Quantity            Reference to standards

          Xylitol                                300 mg              Ph. Eur. + USP

         Hydrochloric acid 1 M        to pH 2.2           Ph. Eur.

         Water for injections             to 1 ml              Ph. Eur.

5.2    Incompatibilities 

         Addamel N may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6.

5.3    Shelf life 

         24 months

5.4    Special precautions for storage 

         Store below 25°C. Do not freeze.

5.5    Nature and contents of container 

         Ampoule, polypropylene

         Pack size: 20 x 10 ml

5.6    Instructions for use/handling 

         Addamel N must not be given undiluted.

 

         COMPATIBILITY

         Additions should be made aseptically.

         Up to 20 ml Addamel N can be added to 1000 ml Vamin Glucose, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free and glucose solutions 50 mg/ml-500 mg/ml.

 

         STABILITY

         When additions are made to an infusion solution, the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. The left over contents of opened

         bottles/vials/ampoules should be discarded and not kept for later use.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Addamel™ N 10 mL Ampule Label

10 ml

Addamel™ N

Concentrate for infusion

 

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Addamel™ N 10 mL Carton Panel

20 ampoules of 20 ml

Addamel™ N

Concentrate for infusion


 

 

Addamel N 
chromium, copper, iron, manganese, iodine, fluorine, molybdenum, selenium, and zinc injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-143
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHROMIC CHLORIDE (CHROMIC CATION) CHROMIC CATION 1 ug  in 1 mL
CUPROUS CHLORIDE (CUPRIC CATION) CUPRIC CATION 0.13 mg  in 1 mL
FERRIC CHLORIDE (FERRIC CATION) FERRIC CATION 0.11 mg  in 1 mL
MANGANESE CHLORIDE (MANGANESE CATION (2+)) MANGANESE CATION (2+) 0.027 mg  in 1 mL
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 0.013 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.095 mg  in 1 mL
SODIUM MOLYBDATE DIHYDRATE (MOLYBDATE ION) MOLYBDATE ION 1.9 ug  in 1 mL
SODIUM SELENITE (SELENITE ION) SELENITE ION 3.2 ug  in 1 mL
ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.65 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM 5.12 umol  in 1 mL
POTASSIUM 0.1 umol  in 1 mL
HYDROCHLORIC ACID  
XYLITOL 300 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:63323-143-97 20 AMPULE (20 AMPULE) in 1 CARTON
1 10 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 05/07/2013
Labeler - Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi Norge AS 731170932 MANUFACTURE(63323-143)
Revised: 05/2013
 
Fresenius Kabi USA, LLC



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