Название документа

Solution to infusions "Plazmoven ® " is applied to substitution of losses of intercellular liquid in case of isotonic dehydration at existence or threat of acidosis.

Structure

1 ml of solution contains (active ingredients):

  • sodium of chloride - 6.80 mg;
  • potassium of chloride - 0.30 mg;
  • Calcii chloridum of a dihydrate - 0.37 mg;
  • magnesium of chloride of hexahydrate - 0.20 mg;
  • sodium of acetate of trihydrate - 3.27 mg;
  • L-malic acid of 0.67 mg.

Excipients: sodium hydroxide, water for injections.

Concentration of electrolytes:

  • sodium - 145.0 mmol/l;
  • potassium - 4.0 mmol/l;
  • calcium - 2.5 mmol/l;
  • magnesium - 1.0 mmol/l;
  • chlorides - 127.0 mmol/l;
  • acetates - 24.0 mmol/l;
  • malates - 5.0 mmol/l.

Contraindication

  • hypersensitivity to any acting or to the excipient which is a part of medicine;
  • overhydratation;
  • heavy stagnant heart failure;
  • a renal failure with an oliguria or an anury;
  • heavy general hypostasis;
  • a hyperpotassemia in a severe form;
  • hypercalcemia;
  • metabolic Alkalosis;
  • heavy metabolic acidosis.

Route of administration

Dose should be determined by

depending on the real need for replenishment of water level and electrolytes.

Adult

Maximum daily dose. The volume of the entered solution should not exceed 40 ml/kg of body weight a day (that corresponds to 5.8 mmol of sodium on 1 kg of body weight and 0.16 mmol of potassium on 1 kg of body weight). Additional losses of liquid (for example, in connection with fever, diarrhea, vomiting) should be compensated depending on the volume and composition of the lost liquid. In case of dehydration the dose of 40 ml/kg of body weight a day can be exceeded. The dose should be calculated taking into account weight of dehydration and a clinical condition of the patient. At treatment of the acute shortage of liquid namely expressed or life-threatening hypovolemic shock, application of higher doses, for example by fast infusion is allowed (under pressure).

Maximum speed of infusion. Speed of infusion of medicine should not exceed 100 ml an hour. At treatment of dehydration the maximum speed of infusion is 5 ml/kg of body weight an hour that corresponds to 0.7 mmol of sodium on 1 kg of body weight an hour and 20 µmol of potassium on 1 kg of body weight an hour. At short-term replenishment of intravascular volume the maximum speed of infusion depends on a clinical situation of the patient. In situations, life-threatening, it is possible to enter quickly 500 ml of medicine under manual pressure.

Solvent. At use of medicine "Plazmoven ® " as solvent the dosing and speed of infusion define mainly on the basis of characteristics and the mode of dosing of the dissolved means.

Pediatric population

appoints the Dose by

doctor. The dose depends on age, body weight, laboratory indicators, a clinical condition and the accompanying therapy of the patient.

Maximum daily dose. It is not necessary to exceed the following daily doses:

  • 28 days of life - 160 ml/kg of body weight a day;
  • 2 months - 150 ml/kg of body weight a day;
  • 1–2 years - 120 ml/kg of body weight a day;
  • 3-5 years - 100 ml/kg of body weight a day;
  • 6-12 years - 80 ml/kg of body weight a day;
  • 13-18 years - 70 ml/kg of body weight a day.
Additional losses of liquid (for example, in connection with fever, diarrhea, vomiting) should be compensated to

depending on the volume and composition of the lost liquid. In case of dehydration or at short-term replenishment of intravascular volume the above-stated doses can be raised. The dose should be calculated taking into account weight of dehydration and a clinical condition of the patient.

infusion Speed. Maximum speed of infusion:

  • 0-10 kg - 4 ml/kg of weight body/hour;
  • 10-20 kg - 40 ml/hour + 2 ml/kg of weight body/hour> 10 kg;
  • > 20 kg - 60 ml/hour + 1 ml/kg of weight body/hour> 20 kg.

At treatment of dehydration the maximum speed of infusion is 5 ml/kg of body weight an hour that corresponds to 0.7 mmol of sodium on 1 kg of body weight an hour and 20 µmol of potassium on 1 kg of body weight in hour

Method of administration

Only for intravenous administration by infusion. "Plazmoven ® " can be entered into peripheral veins (relatively pH and theoretical osmolarity). At introduction by fast infusion under pressure for introduction it is necessary to remove all air before infusion as otherwise there is a risk of developing of an air embolism during infusion from a plastic container and a system. At introduction it is necessary to carry out monitoring of liquid balance, plasma concentration of electrolytes and pH. "Plazmoven ® " can be entered while there are indications for liquid substitution.

Feature of application

Pregnant

Data on use of medicine "Plazmoven ® " to pregnant women and mothers who nurse, no. Within the recommended indications it is not necessary to expect any risk if the volume of the entered solution, the level of electrolytes and acid-base indicators are carefully controlled.

"Plazmoven ® " should be applied with care at toxicosis at pregnant women.

Drivers

"Plazmoven ® " does not influence or has insignificant impact on ability to drive the car or to work with other mechanisms.

Overdose

can lead Excess or too fast introduction of solution to a water or sodium overload with increase in turgor of skin, venous stagnation and with edematization, especially in case of sodium removal violations by kidneys. In this case the additional hemodialysis can be required.

Side effects

Can appear signs of overdose.

Reaction of hypersensitivity, including an urtikariya.

overhydratation, a fluid lungs, electrolytic frustration Is possible

.

Though oral administration of salts of magnesium stimulates with

a vermicular movement, after intravenous administration of magnesium of sulfate was in rare instances reported about paralytic intestinal impassability.

Side reactions can be connected by

with technology of introduction, including the febrile answer, infections in the injection site, local pain or local reactions, irritation of veins, the vein thrombosis or phlebitis extending from the site of input and an ekstravazation. Side reactions can be also connected with the medicines added to solution, the nature of the added substances will define type of any other undesirable effects.

Interaction

can lead

Mixing of this medicine with the medicines containing carbonates, phosphates, sulfates or tartrates to formation of a deposit.

Storage conditions

to Store

in original packing at a temperature not above 25 °C, out of children's reach. Not to freeze.

Expiration date - 1.5 years.

Characteristics
Active ingredients To L-apple acid, Potassium chloride, Calcii chloridum, Magnesium chloride, Sodium acetate trihydrate, Sodium chloride
Applicant Darnitsa
Code of automatic telephone exchange B05BB01 Electrolytes
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Generic-generic
Origin Chemical
Prescription status According to the prescription
Primary packing bottle
Producer DARNITSA CIAO PHARMACEUTICAL. FIRM
Quantity in packing 500 ml
Release form solution for infusions
Route of administration Infusional
Sign Domestic
Storage temperature from 5 °C to 25 °C
Trade name Plazmoven

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Plazmoven solution for inf. fl. 500 ml

  • Product Code: 176683
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  • $15.96


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