Ferinject vials 50 mg / ml, 10 ml, 1 pc. (iron karboksymaltozat)

Release form

Solution for intravenous

Indications

Iron deficiency anemia when oral iron preparations are ineffective or cannot be used.

The diagnosis must be confirmed by laboratory tests.

Composition

Active ingredient:

iron carboxymaltose

Excipients:

sodium hydroxide / hydrochloric acid up to pH 5.0–7.0

water for injection up to 1 ml.

Dosage and administration of the

I / O dose - by stream or by drop and by introducing into the venous section of the dialysis system.

Before opening, the vials should be inspected for possible sediment and damage.

You can use only a homogeneous solution without sediment.

Drip administration

You cannot administer a drip of 20 ml of Ferinject more than 1 time per week.

May be administered intravenously in a maximum single dose of up to 20 ml of Ferinject (1000 mg of iron), which should not exceed 0.3 ml of Ferinject (15 mg of iron) per 1 kg of body weight or calculated cumulative dose.

Inkjet administration

Ferinject can be administered iv in a maximum dose of 4 ml (200 mg of iron) per day, but not more than 3 times a week.

Calculation of the dose

The cumulative dose of the drug in mg of elemental iron required to restore hemoglobin (Hb) and replenish iron stores is calculated individually according to the total iron deficiency in the body according to the formula:

Cumulative iron deficiency [mg] = body weight [kg ]? (target Hb *? actual Hb) [g / dl] **? 2.4 *** + spare iron depot [mg] ****

-------------------------------- -------------------------------------

* Target Hb with body weight less than 35 kg = 13 g / dl (respectively 8.1 mmol / l). Target Hb with a body weight of 35 kg or more = 15 g / dl (respectively 9.3 mmol / L).

** To convert Hb [mM] to Hb [g / dl]: multiply Hb [mM] by a factor of 1.61145.

*** Coefficient 2.4 = 0.0034? 0.07? 10000, where:

0.0034 - the hemoglobin iron content is approximately 0, 34%

0.07 - blood volume is approximately equal to 7% of body weight

10000 - conversion coefficient: 1 g / dl = 10000 mg / l.

**** Iron deposited with body weight less than 35 kg = 15 mg / kg body weight iron deposited with body weight 35 kg and more = 500 mg.

For patients? 66 kg: the calculated cumulative dose of iron should be rounded down to the nearest 100 mg.

For patients> 66 kg: the calculated cumulative dose of iron should be rounded up to the nearest 100 mg.

If necessary the calculated cumulative dose of iron should be rounded down to the nearest 100 mg.

For patients> 66 kg: the calculated cumulative dose of iron should be rounded up to the nearest 100 mg.

If necessary the calculated cumulative dose of iron should be rounded down to the nearest 100 mg.

For patients> 66 kg: the calculated cumulative dose of iron should be rounded up to the nearest 100 mg.

If necessarymaintaining the target Hb level and other laboratory parameters of iron stores within acceptable limits, it is possible to continue treatment with Ferinject in the minimum maintenance dose.

Maximum tolerated single dose

An adequate cumulative dose of the drug should be calculated for each patient individually and should not exceed the calculated.

Drug Interactions

Any parenteral iron preparations should not be administered concomitantly with iron dosage forms for oral administration, as this reduces the absorption of iron from the digestive tract.

Storage conditions

Store at a temperature not exceeding 30 ° C.

Expiration

3 years

Deystvuyuschee substances

iron karboksymaltozat

Terms and conditions

prescription

dosage form

infusion solution

Appointment of

Adult on appointment

Indications

From anemia



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