Universal reference book for medicines
Product name: ADDAMEL N (ADDAMEL N)

Active substance: comb.
drug
Type: Microelements for addition to solutions for parenteral nutrition

Manufacturer: FRESENIUS KABI DEUTSCHLAND (Germany) manufactured by FRESENIUS KABI NORGE (Norway)
Composition, form of production and packaging
Concentrate for the preparation of a solution for infusions is
transparent, from colorless to light yellow color.

1 ml

chromium chloride hexahydrate 5.33 μg,

which corresponds to a Cr 3 + content of 1 μg (0.02 μmol)

copper chloride dihydrate 340 mcg,

which corresponds to a Cu 2+ content of 130 μg (2 μmol)

iron chloride hexahydrate 540 μg,

which corresponds to a Fe 3+ content of 110 μg (2 μmol)

manganese chloride tetrahydrate 99 μg,

which corresponds to a Mn 2+ content of 27 μg (0.5 μmol)

potassium iodide 16.6 μg,

which corresponds to the content of I - 13 μg (0.1 μmol)

sodium fluoride 210 μg,

which corresponds to a content of F - 95 μg (5 μmol)

sodium molybdate dihydrate 4.85 μg,

which corresponds to a content of Mo 6+ of 1.9 μg,

which corresponds to the content of MoO 4 2- 0.02 μmol

sodium selenite 6.9 mcg,

which corresponds to a content of Se 4+ of 3.2 μg

which corresponds to the content of SeO 3 2- 0.04 μmol,

zinc chloride 1.36 mg,

which corresponds to a Zn 2+ content of 650 μg (10 μmol)

Excipients: xylitol - 300 mg, hydrochloric acid - up to pH 2.2, water d / u - up to 1 ml.

10 ml - polypropylene ampoules (20) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

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.

DOSING MODE

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 adults with a normal or moderately increased requirement for trace elements is 1 ampoule (10 ml).

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 EFFECT

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.

CONTRAINDICATIONS

- total obstruction of the biliary tract;

hypersensitivity;

- Children's age (up to 10 years).

With caution : 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.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution : kidney failure


APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution : liver failure


APPLICATION FOR CHILDREN

Contraindication: children's age (up to 10 years).

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.
DRUG 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.
TERMS OF RELEASE FROM PHARMACY

According to doctor's prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 25 ° C.

Do not freeze.
Keep out of the reach of children.
Shelf life 2 years


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