Universal reference book for medicines
Product name: FERINJECT ® (FERINJECT ® )

Active substance: ferric carboxymaltose

Type: Antianemic drug for parenteral use

Manufacturer: VIFOR (International) (Switzerland) manufactured by VIFOR (International) (Switzerland)
Composition, form of production and packaging
Solution for intravenous administration of
dark brown light, opaque.

1 ml

iron carboxymethyltosate 156-208 mg,

which corresponds to an iron content of 50 mg

Excipients: sodium hydroxide / hydrochloric acid - to pH 5.0-7.0, water d / u - up to 1 ml.

2 ml - vials of colorless glass (1) - packs cardboard.

2 ml - bottles of colorless glass (5) - plastic pallets (1) - cardboard packs.

10 ml - vials of colorless glass (1) - packs cardboard.

10 ml - bottles of colorless glass (2) - plastic pallets (1) - cardboard packs.

10 ml - bottles of colorless glass (5) - plastic pallets (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

The preparation of iron.
Ferinzhect ® contains iron (III) in stable form as an iron complex consisting of a multinucleated iron hydroxide nucleus with a carbohydrate ligand. Because of the high stability of the complex, there is only a very small amount of loosely bound iron (also called labile or free iron). The complex is designed to provide a controlled source of recycled iron for iron-transporting and iron-depositing body proteins (transferrin and ferritin, respectively). Clinical studies have shown that the hematologic response and filling of the iron depot occurs faster after intravenous administration of the Ferinhect® preparation than in oral analogs.
Utilization of erythrocytes 59 Fe and 52 Fe from the radiolabeled drug Ferinzhect ® varied from 61% to 99%.
After 24 days, iron-labeled iron utilization was 91% to 99% in patients with iron deficiency, and in patients with anemia of renal genesis, the utilization of radio-labeled iron ranged from 61% to 84%.
PHARMACOKINETICS

Distribution

It was shown that 59 Fe and 52 Fe from the preparation Ferinzhekt ® were rapidly excreted from the blood and transferred to the bone marrow, and also deposited in the liver and spleen.

After a single intravenous injection of Ferinhect ® in doses of 100 mg to 1000 mg of iron, the C max of serum from 37 μg / ml to 333 μg / ml was achieved 15 minutes to 1.21 hours after injection, respectively.
V d of the central chamber almost completely corresponds to the volume of the blood plasma - about 3 liters.
Excretion

After injection or infusion, iron was quickly removed from the plasma.
T 1/2 is 7-12 hours. The average time of the drug in the body was from 11 to 18 hours. Excretion of iron by the kidneys was practically not observed


INDICATIONS

- iron deficiency anemia in the case when oral iron preparations are ineffective or can not be used.

The diagnosis should be confirmed by laboratory tests.

DOSING MODE

The drug should be injected IV (jet or drip) and by direct injection into the venous section of the dialysis system.

Before use, inspect the vials for possible sediment and damage.
You can use only a homogeneous solution without sediment.
Ferinzhekt ® should be used in departments that have the necessary equipment to provide emergency medical care in the event of anaphylactic reactions.
Each patient should be observed for signs or symptoms of hypersensitivity reactions for at least 30 minutes after each administration of the ferric iron carboxymethylate solution.
In / in infusion: Ferinzhect ® can be injected intravenously ( infuzionno) in the maximum single dose up to 1000 mg of iron (maximum to 20 mg of iron / kg of body weight).
Do not inject / in the drip (infusion) 1000 mg of iron (20 ml of Ferinhect ® ) more than 1 time per week. Immediately before the infusion introduction the drug should be diluted with sterile 0.9% solution of sodium chloride for injection in the ratios indicated in the table.
Guide for the dilution of the drug Ferinzhect ® for infusion

Ferinzhekt ® Iron Amount of sterile 0.9% solution of sodium chloride for injections Minimal administration time

> 2 to 4 ml> 100 to 200 mg 50 ml -

> 4 to 10 ml> 200 to 500 mg 100 ml 6 min

> 10 to <20 ml> 500 to 1000 mg 250 ml 15 min

Note: to maintain the stability of the drug, dilution to a concentration of less than 2 mg iron / ml is not permitted.

Ink jet: Ferinject ® can be injected intravenously in a maximum dose of up to 4 ml (200 mg of iron) 1 time / day, but not more than 3 times a week.

Determination of cumulative iron dose

The cumulative dose for replenishment of iron stores with iron carboxymethyltosate is determined based on the patient's body weight and hemoglobin level (Hb) and should not be exceeded.
When determining the cumulative dose of iron, the table below should be used.
The cumulative dose of iron based on the patient's body weight and hemoglobin level

Hb (g / dl) Patients with a body weight of 35 to <70 kg Patients weighing? 70kg

<10 1500 mg 2000 mg

? 10 1000 mg 1500 mg

Note: in patients with a body weight of less than 35 kg, a cumulative dose of 500 mg iron can not be exceeded.

In determining the need for iron in patients with excessive body weight should be based on the normal ratio of body weight and blood volume.

Patients with a Hb value of 14 g / dl should be given an initial dose of 500 mg of iron, and the iron content should be checked before further administration.

After replenishment, a regular assessment should be made to make sure that the iron level is normal and remains at an adequate level.

The maximum tolerable single dose: a single dose of the drug should not exceed 1000 mg of iron (20 ml) per day or 20 mg of iron (0.4 ml) per kg of body weight.
A dose of 1000 mg of iron (20 ml) can not be administered more than 1 time per week.
Do not exceed the maximum daily dose of 200 mg in patients with chronic kidney disease requiring hemodialysis.

SIDE EFFECT

Side effects from clinical trials (before and after drug registration, including safety studies after drug registration)

Side effects of the drug Ferinhect ® , observed in patients (n = 6755) according to clinical studies, are summarized in the table.
Most often (> 1/100, <1/10) there was nausea.
Often (? 1/100, <1/10) Not infrequently (? 1/1000, <1/100) Rarely (? 1/10 000, <1/1000)

From the immune system

- Hypersensitivity Anaphylactoid reactions

From the nervous system

Headache, dizziness Paresthesia, perversion of taste -

From the side of the cardiovascular system

- Tachycardia -

Increase in blood pressure Decrease in blood pressure, "tide" of blood to the face -

From the respiratory system

- Shortness of breath -

From the digestive system

Nausea Vomiting, indigestion, abdominal pain, constipation, diarrhea -

From the skin and subcutaneous tissue

- Itching, hives, erythema, rash 1 -

From the musculoskeletal system

- Myalgia, back pain, joint pain, muscle cramps -

From the side of metabolism

Hypophosphatemia - -

Laboratory results

Increase in ALT activity Increase in activity of AST, GGT, LDG, APF -

General reactions

Reactions at the injection site 2 Fever, weakness, chest pain, peripheral edema, pain, chills Shivering, malaise

1 - Includes the following preferred terms: rash (the individual frequency of this adverse drug reaction is estimated as infrequent) and erythematous rash, generalized, macular, maculopapular pruritus (the individual frequency of all unwanted drug reactions is estimated as rare).

2 - Includes the following preferred terms: burning sensation at the injection site, pain, bruises, discoloration, extravasation, irritation, reaction (the individual frequency of all adverse drug reactions is estimated as infrequent) and paresthesia (the individual frequency of the adverse drug reaction is estimated to be rare).

Spontaneous post-marketing reports of side effects

The following serious side effects were observed in the post-marketing control of Firinject ® .

Spontaneous post-marketing messages

System or organ Common symptoms 1

From the side of the nervous system Loss of consciousness and vertigo

Mental disturbance Anxiety

On the part of the cardiovascular system Fainting, pre-fainting condition

From the skin and subcutaneous tissue Angioneurotic edema, dermatitis, pallor and facial edema

From the respiratory system Bronchospasm

1 - The frequency is not defined, since the total number of patients taking the drug in postmarketing studies can not be accurately established.

CONTRAINDICATIONS

- hypersensitivity to the iron complex of carboxymethyltosate, iron solution of carboxymethyltosate or any of the components of the preparation;

- Anemia not associated with iron deficiency (eg, other microcytic anemia);

- symptoms of iron overload or impaired iron utilization;

- Children's age till 14 years.

With caution

In patients with impaired liver function, iron can be administered parenterally only after a thorough assessment of the benefit-risk ratio.
It is necessary to avoid the parenteral use of iron in patients with impaired liver function in the event that iron overload can accelerate the course of the disease, especially with late cutaneous porphyria. In order to avoid overloading with iron, careful monitoring of the iron content is recommended.
There are no data on safety of use in patients with chronic kidney disease who are on hemodialysis and who receive single doses of more than 200 mg of iron.
It is necessary to use iron with parenteral care with acute and chronic infection, bronchial asthma, eczema and atopic allergy.
It is recommended to stop the use of the drug Firinject ® in patients with ongoing bacteremia.
In patients with chronic infection, all risks and benefits of therapy need to be weighed, taking into account depressed erythropoiesis caused by chronic infection.
1 ml of the drug contains up to 5.5 mg of sodium.
This should be taken into account for patients on a diet with sodium restriction.
The use of the drug Ferinzhect ® has not been studied in children under the age of 14 years.

PREGNANCY AND LACTATION

Data on the use of the drug in pregnancy are absent.
The use of the drug in pregnancy is possible only in cases where the potential benefit of therapy for the mother exceeds the risk to the fetus. If the benefits of treatment with Firinject® are less than the potential risk to the fetus, it is recommended that therapy be limited to the second and third trimesters.
The experience of using the drug in the period of breastfeeding is limited.
Clinical studies have shown that the intake of iron from the drug Firinzhekt ® in breast milk is insignificant (less than 1%). Based on limited data on use in breastfeeding women, it is unlikely that the drug is dangerous for infants breastfed.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution , use the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 14 years.

SPECIAL INSTRUCTIONS

The drug is not intended for in / or injection.

Each vial of Ferinhect ® is intended for single use only.

Each vial of Ferinhect ® is intended for single use only.

The drug Ferinzhect ® should be prescribed only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data.

With parenteral administration of iron preparations, it is possible to develop a hypersensitivity reaction, including anaphylactoid reactions, which can be potentially life-threatening, therefore, the administration of the Ferinhect ® preparation should be performed with the availability of cardiopulmonary resuscitation.
If hypersensitivity reactions or signs of intolerance occur during the use of the drug, it is necessary to immediately stop treatment.
Also, hypersensitivity reactions have been reported after previous uncomplicated injections of any parenteral iron complexes, incl.
iron carboxymethyltosate. Each patient should be monitored for the development of adverse reactions for a minimum of 30 minutes after each administration of the iron solution of carboxymethyltosate.
Care should be taken with IV administration of the drug to prevent the drug from penetrating into the circumferential space,
this can cause skin irritation and possible long-term staining of the tissues at the point of introduction into the brown color. When the drug penetrates into the periovenous space, the drug should be discontinued immediately.
Impact on the ability to drive vehicles and manage mechanisms

There are no data on the effect of the drug on the ability to drive vehicles and mechanisms.
However, some side effects (including dizziness, fainting, or a pre-patch condition) can affect the ability to drive vehicles and mechanisms. Patients who report these side effects should not be advised not to drive vehicles and mechanisms until the symptoms disappear completely.
OVERDOSE

Symptoms: Ferinzhect ® in excess of the body's requirements, can cause iron overload, which is manifested by symptoms of hemosiderosis.
Determining such indicators of iron metabolism as serum ferritin and the percentage of transferrin saturation can help in the diagnosis of excessive iron deposition in the body.
Treatment: if cumulation of iron occurred, treatment should be performed in accordance with standard medical practice, for example, the use of chelating agents for iron binding can be considered.

DRUG INTERACTION

As well as any other parenteral preparations of iron, Ferinzhekt ® reduces the absorption of iron from the gastrointestinal tract with simultaneous use with iron preparations for oral administration.
Therefore, if necessary, oral iron therapy should be started no earlier than 5 days after the last injection of the Ferinhect® preparation.
Pharmaceutical compatibility

Ferinzhekt ® is compatible only with 0.9% sodium chloride solution.
No other intravenous solutions and medicinal substances should be administered, since there is a potential risk of precipitation and / or interaction.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, in the original package, at a temperature of no higher than 30 ° C.
Do not freeze. Shelf life - 3 years.
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