Addamel H (Addamel N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspconcentrate for solution for infusion
Composition:

1 ml contains:


Active substances:


Chromium chloride hexahydrate

5.33 μg

Copper chloride dihydrate

0.34 mg

Iron chloride hexahydrate

0.54 mg

Manganese chloride tetrahydrate

99.0 μg

Potassium iodide

16.6 μg

Sodium Fluoride

0.21 mg

Sodium molybdate dihydrate

4.85 μg

Sodium selenite

6.90 μg

Zinc chloride

1.36 mg

Excipients:


Xylitol

300 mg

Hydrochloric acid

q.s.

(for pH correction)

Water for injections

up to 1 ml
The content of active substances in 1 ml of the preparation corresponds to:

FROMr3+

0,02

umol

1,0

mcg

FROMu2+

2

umol

0,13

mg

Fe3+

2

umol

0,11

mg

Mn2+

0,5

umol

0,027

mg

I-

0,1

umol

0,013

mg

F-

5

umol

0,095

mg

MoO42-

0,02

umol

1,9

μg (Mo6+)

SeO32-

0,04

umol

3,2

mcg (Se4+)

Zn2+

10

umol

0,65

mg
The content of sodium and potassium corresponds to:

Na+

5,12

umol

118

mcg

TO+

0,1

umol

3,9

mcg

Theoretical osmolality of 3100 mOsm / kg H2O pH ~ 2.5

Description:Clear solution from colorless to pale yellow.
Pharmacotherapeutic group:Additive for parenteral nutrition
ATX: & nbsp
  • Electrolytes
    • Pharmacodynamics:The contents of a single ampoule provide a daily requirement for micronutrients (chromium, copper, iron, manganese, molybdenum, selenium, zinc, fluoride, iodine) in normal or moderately increased requirements.
    Indications:As an additive, providing a daily requirement for microelements in adult patients with partial and complete parenteral nutrition.
    Contraindications:Total obstruction of the biliary tract, hypersensitivity, children's age (up to 10 years).



    Carefully:Renal and / or hepatic insufficiency (especially with cholestasis).
    Pregnancy and lactation:Possible use during pregnancy.
    There are no data on application during lactation. When using the drug in nursing mothers should refrain from breastfeeding the baby.
    Dosing and Administration:Intravenously. Before use, the drug must be diluted. Adult patients with a body weight of more than 40 kg 1 ampoule (10 ml) Addamel H are sterilely added to solutions of amino acids or glucose solutions 5-50%. The resulting solution is stirred by gentle shaking, then used for parenteral infusion. The resulting solution must be used within 24 hours. The recommended daily dose of Addamel H for adult patients with a normal or moderately increased requirement for trace elements is 1 ampoule (10ml). For patients with a body weight of 15-40 kg, the daily dose is 0.1 ml of Addamel H per 1 kg of body weight per day. With the increased need of an adult in trace elements, you can add up to 20 ml of Addamel N.
    Side effects:Allergic reactions.Rarely - nausea, thrombophlebitis at the site of infection.
    If the recommended speed of administration is exceeded, vomiting, hyperemia of the skin, increased sweating may occur.
    Interaction:Addamel H can be added only those drugs, compatibility with which there is no doubt. Recommended amino acid solutions and glucose solutions with a concentration of 5% to 50%. Mixing solutions should be carried out under aseptic conditions.
    Special instructions:In case the treatment lasts more than 4 weeks, it is necessary to monitor the concentration of manganese in the blood plasma. Addamel H can only be used diluted.
    Form release / dosage:Concentrate for the preparation of solution for infusion.
    Packaging:10 ml into polypropylene ampoules. On 20 ampoules in a cardboard pack together with the instruction on application.
    Storage conditions:Store at a temperature not exceeding 25 ° C.
    Do not freeze.
    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013377 / 01
    Date of registration:31.05.2010/17.01.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
    Information update date: & nbsp04.02.2017
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