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 Ојg,
which corresponds to a Cr 3 + content of 1 Ојg (0.02 Ојmol)
copper chloride dihydrate 340 mcg,
which corresponds to a Cu 2+ content of 130 Ојg (2 Ојmol)
iron chloride hexahydrate 540 Ојg,
which corresponds to a Fe 3+ content of 110 Ојg (2 Ојmol)
manganese chloride tetrahydrate 99 Ојg,
which corresponds to a Mn 2+ content of 27 Ојg (0.5 Ојmol)
potassium iodide 16.6 Ојg,
which corresponds to the content of I - 13 Ојg (0.1 Ојmol)
sodium fluoride 210 Ојg,
which corresponds to a content of F - 95 Ојg (5 Ојmol)
sodium molybdate dihydrate 4.85 Ојg,
which corresponds to a content of Mo 6+ of 1.9 Ојg,
which corresponds to the content of MoO 4 2- 0.02 Ојmol
sodium selenite 6.9 mcg,
which corresponds to a content of Se 4+ of 3.2 Ојg
which corresponds to the content of SeO 3 2- 0.04 Ојmol,
zinc chloride 1.36 mg,
which corresponds to a Zn 2+ content of 650 Ојg (10 Ојmol)
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 В° C.
Do not freeze. Keep out of the reach of children.
Shelf life 2 years
