Label: ADDAMEL N- chromic chloride, cuprous chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite and zinc chloride injection, solution

  • NDC Code(s): 63323-143-97
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

Drug Label Information

Updated 05/13

If you are a consumer or patient please visit this version.

  • MEDICATION GUIDE

    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.

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  • PRINCIPAL DISPLAY PANEL

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

    10 ml

    Addamel™ N

    Concentrate for infusion

     

    vial-lya1941 

     

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

    20 ampoules of 20 ml

    Addamel™ N

    Concentrate for infusion


    carton-lya1941 

     

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  • INGREDIENTS AND APPEARANCE
    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 Marketing Start Date Marketing End Date
    1 NDC:63323-143-97 20 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 Business Operations
    Fresenius Kabi Norge AS 731170932 MANUFACTURE(63323-143)
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