Феринжект®

General characteristics. Structure:

Active agents:
gland карбоксимальтозат 156-208 mg,
it is equivalent to the content of iron of 50 mg;
Excipients: sodium hydroxide/Acidum hydrochloricum to рН 5,0-7,0; water for injections to 1 ml.

Description: Opaque solution of dark brown color.

Pharmacological properties:

Pharmacodynamics. The drug Ferinzhekt® presents itself iron preparation in the form of a karboksimaltozatny complex of multinuclear iron (III) - hydroxide. After parenteral administration, the macromolecular complex is taken reticuloendothelial system and breaks up to iron and a carboxymaltose.

Iron gets to a blood stream where it contacts transport protein transferrin. Iron in a complex with transferrin. it is transferred to organism cells where it is used for synthesis of hemoglobin, a myoglobin and a large amount of enzymes or collects in the form of ferritin.

Pharmacokinetics. After parenteral administration of drug iron is transferred from blood to marrow and deposited in a liver and a spleen.
After single intravenous administration of the drug Ferinzhekt© in doses from 100 to 1000 mg of iron the maximum concentration of serumal iron from 37 mkg/ml to 333 mkg/ml was reached 15 minutes later - 1,21 hours after an injection, respectively. The volume of distribution of the central camera almost completely corresponds to blood plasma volume - (about A Z-l).
The elimination half-life makes 7-12 hours, the average time of finding of drug in an organism made from 11 to 18 hours. Iron removal by kidneys was practically not observed.

Indications to use:

Iron deficiency anemia in that case when peroral iron preparations are inefficient or cannot be used.
The diagnosis has to be confirmed with laboratory researches.

Route of administration and doses:

Intravenously - struyno or kapelno and by direct introduction to the venous site of dialysis system.
Before opening it is necessary to examine bottles on existence of a possible deposit and damages. It is possible to use only homogeneous solution without deposit.
Drop introduction: Феринжект® it can be entered intravenously kapelno in the maximum single dose to 20 ml of the drug Ferinzhekt® (1000 mg of iron) that should not exceed 0,3 ml of the drug Ferinzhekt® (15 mg of iron) on 1 kg of body weight or the counted cumulative dose. It is impossible to appoint drop introduction of 20 ml of the drug Ferinzhekt® more than 1 time a week. Just before drop administration of the drug Ferinzhekt® it is necessary to part sterile 0,9% with chloride sodium solution for injections in the ratios specified in the table:

The guide to cultivation of the drug Ferinzhekt® for drop introduction 
Феринжект®         Iron                of Sterile 0,9% solution   Minimum time
                                                                            introduction chloride sodium time
                                                         for                       introduction injections
from 2 to <4 ml     from 100 to <200   mg no more than 50 ml                     -
from 4 to <10 ml   from 200 to <500   mg no more than 100 ml                   there are 6 min.
from 10 to. 20      ml from 500 to 1000 mg no more than 250 ml                   there are 15 min.

Note: For preservation of stability of drug cultivation to concentration, smaller, than 2 mg of iron/ml is not allowed.
Jet introduction: Феринжект® it can be entered intravenously struyno, in the maximum single dose to 4 ml (200 mg of iron) a day, but is not more often 3 weekly.
Calculation of a dose: The cumulative dose of drug in mg of elementary iron, necessary for recovery of level of Hb hemoglobin and completion of reserves of iron, is calculated individually according to the general deficit of iron in an organism on a formula:

Cumulative deficit of iron [mg] = the Body weight [kg] x (target Hb * - the actual Hb) [g/dl] ** x 2.4 *** + Reserve depot of iron [mg] ****

* Target Hb for body weight less than 35 kg = 13 g/dl, respectively 8,1 mmol/l. Target Hb for the body weight of 35 kg and more = 15 g/dl, respectively 9,3 mmol/l.

** To convert Hb [mm] into Hb [g/dl]: increase Hb [mm] by coefficient 1,61145.

*** Coefficient 2,4 = 0,0034 x 0,07 x 10000;
0,0034: content of iron of hemoglobin = 0,34%;
0,07: blood volume = 7% of body weight;
10000: coefficient of transformation of 1 g/dl =10000 mg/l.

**** iron of depot for body weight less than 35 kg = 15 mg/kg of body weight.
Iron of depot for the body weight of 35 kg and more = 500 mg.

For patients <66 kg: the calculated cumulative dose of iron has to be rounded down to the next 100 mg.
For patients> 66 kg: the calculated cumulative dose of iron has to be rounded up to the next 100 mg.
At the subsequent need of maintenance of the target objective of Hb and other laboratory indicators of a reserve of iron for acceptance limits treatment continuation by the drug Ferinzhekt® in the minimum maintenance dose is possible.
The most tolerable single dose: The adequate cumulative dose of drug has to be calculated for each patient individually and should not be exceeded.

Features of use:

Drug should not be used for intramuscular introduction!
Each bottle of the drug Ferinzhekt® is intended only for single use!
The drug Ferinzhekt® has to be appointed only by that patient at whom the diagnosis of anemia is confirmed with the corresponding datas of laboratory.
The iron preparations administered parenterally can cause hypersensitivity reactions, including anaphylactoid reactions which can be potentially life-threatening therefore appropriate means have to be available to performing cardiopulmonary resuscitation.
It is necessary to be careful at intravenous administration of drug not to allow penetration of drug into perivenous space as it can cause coloring of fabrics in brown color and inflammatory reactions on skin. At penetration of medicine into perivenous space it is necessary to stop administration of the drug Ferinzhekt® immediately.

Driving and work with mechanisms:
Does not influence.

Side effects:

During administration of drug. Феринжект® more often than other side effects the headache is registered (at 3,3% of all patients).
Frequency of the side reactions given below was defined according to the following:
Very often (> 1/10)
Often (> 1/100, <1/10)
Infrequently (> 1/1000, <1/100)
Seldom (> 1/10000, <1/1000)
Very seldom (<1/10000)
From immune system
Infrequently (> 1/1000, <1/100): hypersensitivity reactions, including anaphylactoid reactions.
From a nervous system
Often (> 1/100, <1/10): headache; dizziness.
Infrequently (> 1/1000, <1/100): paresthesias.
From cardiovascular system
Infrequently (> 1/1000, <1/100): a lowering of arterial pressure, "inflows" of blood to face skin.
From a respiratory organs
Seldom (> 1/10000, <1/1000): asthma.
From digestive tract
Often (> 1/100, <1/10): nausea, abdominal pain, diarrhea, lock.
Infrequently (> 1/1000, <1/100): taste change, vomiting, dyspepsia, meteorism.
Allergic reactions
Often (> 1/100, <1/10): rash.
Infrequently (> 1/1000, <1/100): itch, urticaria.
From a musculoskeletal system and connecting fabrics
Infrequently (> 1/1000, <1/100): mialgiya, dorsodynia, arthralgias.
General and local reactions
Often (> 1/100, <1/10): reactions in an injection site.
Infrequently (> 1/1000, <1/100): fever, fatigue, stethalgia, fever, feeling sick, peripheral hypostases.
Laboratory indicators
Often (> 1/100, <1/10): increase in blood serum of an indicator of alaninaminotranspherase (ALT), tranzitorny decrease in blood serum of an indicator of phosphates
Infrequently (> 1/1000, <1/100): increase in indicators of aspartate aminotransferase (ACT), gammaglyutamiltransferaza (γ-GT), lactate dehydrogenases (LDG).

Interaction with other medicines:

Any parenteral iron preparations should not be appointed along with dosage forms of iron for intake as it reduces absorption of iron from digestive tract.
Pharmaceutical compatibility: The drug Ferinzhekt® is compatible only from 0,9% chloride sodium solution. No other intravenous solutions and medicinal substances should be entered as there is a potential risk of loss of a deposit and/or interaction.

Contraindications:

Hypersensitivity to any of components. drug, the anemias which are not connected with deficit of iron, overload symptoms iron or iron utilization disturbances, pregnancy in the first trimester, children aged up to 14 years.

With care
Liver failure, acute or chronic infectious diseases (oppression of an erythrogenesis is possible), bronchial asthma, eczema, atopic allergy.
In order to avoid an overload iron recommends careful monitoring of a condition of iron.
One milliliter of drug contains up to 5,5 mg of sodium. It needs to be considered for patients about sodium - a controlled diet.
One milliliter of drug contains less than 75 mkg of aluminum. It needs to be considered for patients at long dialysis.

Use at pregnancy and during breastfeeding
Data on use of drug during pregnancy are absent. It is necessary to use drug during pregnancy only if the potential advantage for mother exceeds risk for a fruit. Experience of use of drug for nursing mothers is limited. Clinical trials showed that intake of iron from Ferinzhekta® in breast milk is insignificant (less than 1%).
Nevertheless, the feeding termination by a breast during drug use is recommended.

Overdose:

Administration of the drug Ferinzhekt® in quantity, exceeding requirements of an organism, can cause an overload iron which is shown by hemosiderosis symptoms. Definition of such indicators of exchange of iron as ferritin of serum and percent of saturation of transferrin can help with diagnosis of excessive adjournment of iron in an organism. Treatment: symptomatic, if necessary the iron complexon can be used (for example, Deferoxaminum).

Storage conditions:

To store in original packaging at a temperature not above 30 °C. Not to freeze. To store in the place, unavailable to children. Period of validity: 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous administration of 50 mg/ml.
On 2 ml or 10 ml of drug in bottles from transparent colourless glass like I (Ph.Eur.), hermetically corked by chlorbutyl rubber bungs and pressed out by aluminum caps with plastic inserts like "Flip off".
1 bottle on 2 ml or 10 ml with the application instruction in a cardboard pack.
5 bottles on 2 ml or 10 ml in the plastic pallet holder together with the application instruction in a cardboard pack.