Ferrum Lek 100 mg/2 ml 10s solution for injection in ampoules

The instruction for medical use

of Ferrum Лек medicine

the Trade name
Ferrum Лек

the International unlicensed name
Is not present

the Dosage form
Solution for intramuscular introduction of 100 mg / 2 ml

Structure
One ampoule (2 ml) contains
active agent – iron (III) (in the form of iron (III) hydroxide in a complex with a dextran) 100 mg,
excipients: sodium hydroxide, Acidum hydrochloricum concentrated, water for injections.

The description
Opaque solution of brown color, without deposit.
Pharmacotherapeutic group
hematopoiesis Stimulators. Iron preparations. Iron preparations (III) for parenteral use. Ferrous oxide dextran complex.
The ATX B03AC06 code

the Pharmacological


Pharmacokinetics Absorption Later properties of an intramuscular injection a complex of ferrous hydroxide (III) with a dextran is absorbed, mainly, through lymphatic system and diffuses in blood approximately in 3 days. Data on bioavailability are absent, but it is known that quite most part of a complex is not absorbed from muscle tissue during the long period. Ferrous hydroxide complex T½ (ІІІ) with a dextran — 3–4 days.
Distribution and metabolism
the Macromolecular complex of ferrous hydroxide (ІІІ) with a dextran comes to a reticuloendothelial system where it breaks up to a ferriferous component and a dextran. Iron then contacts ferritin or hemosiderin and to a lesser extent — transferrin and is applied to hemoglobin synthesis, i.e. in an erythrogenesis. The dextran is metabolized or removed.
Removal
Amount of the removed iron insignificant.
The pharmacodynamics
After intramuscular administration of drug Ferrum of Lek® a part of iron (III) hydroxide is deposited in a liver in a complex with ferritin. The molecule of ferritin consists of a fibrous casing — an apoferritin where iron is present at a form of a mycelium of phosphate of the hydrated iron oxide.
In blood plasma iron is transferred by β-globulin transferrin which is synthesized in a liver. Each molecule of transferrin contacts two atoms of iron. In a complex with transferrin iron is transferred to organism cells where it reversibly contacts ferritin and applied to synthesis of hemoglobin, a myoglobin and some enzymes. Transferrin is also indirectly included in the system of protection of an organism against an infection.
After parenteral administration of a complex of ferrous hydroxide (III) with a dextran the level of hemoglobin increases quicker, than after administration of salts of iron (ІІ) inside, despite the lack of dependence of kinetics of incorporation of iron on a way of its introduction. The ferrous hydroxide complex sizes (ІІІ) with a dextran rather big therefore its removal by kidneys is impossible. This complex is stable and in physiological conditions there is no release of iron in the form of ions.
Iron in a multinuclear complex is connected in the structure similar to structure of natural compound of iron — ferritin. Thanks to this similarity, iron of this complex is absorbed only by active absorption.

Indications
Treatment of all forms of iron deficiency states at which fast completion of a reserve of iron, including the following is necessary:
- the heavy deficiency of iron owing to blood loss
- states, at which treatment by iron preparations for intake is inefficient or impracticable

the Route of administration and doses
Ferrum Лек, solution is intended only for intramuscular introduction!
Intravenous administration of drug is not allowed (both in the form of injections, and in the form of infusions)!
Before introduction of the first therapeutic dose Ferrum Лек each patient should enter a test dose, a component 1/4 - 1/2 ampoules Ferrum Лек (25-50 mg of iron). In the absence of side reactions within 60 minutes it is possible to enter the rest of a daily dose.
Doses Ferrum Лек need to be selected individually according to the general deficiency of iron which is calculated by the following formula:





The general deficiency of iron, mg

=

the body weight (kg) × (target level of hemoglobin (g/l) – the valid level of hemoglobin (g/l) × 0.24 + the deposited iron (mg),


At the body weight & lt, 35 kg

–

the target level of hemoglobin = 130 g/l, the deposited iron = 15 mg/kg of body weight,


At the body weight & gt, 35 kg

–

the target level of hemoglobin = 150 g/l, the deposited iron = 500 mg,


the Factor of correction 0.24

=

0.0034 × 0.07 × 1000,
where: 0.34% — iron content in hemoglobin, 7% — the total amount of blood percentage of the body weight, 1000 — coefficient of recalculation of grams in milligrams.
Example of calculation:





Body weight

= 70 kg


the Valid concentration of hemoglobin

= 80 g/l


the Iron included in hemoglobin

= 70 × 0.24 × (150-80) = in 1200 mg


the Deposited iron

= 500 mg


the General deficiency of iron

= 1700 mg

the General deficiency of iron (mg)
Total number of ampoules Ferrum Lek® on a course =-------------------------------------------
100 mg
of TablitsaRaschet of total number of ampoules of drug for one patient depending on body weight and the level of hemoglobin





the Body weight, kg

Total number of ampoules Ferrum of Lek® on a course of treatment


of Hb=60 of g/l

of Hb=75 of g/l

of Hb=90 of g/l

of Hb=150 of g/l



































































































































35 12,5 11,5 10,0 9,0 40 13,5 12,0 11,0 9,5 45 15,0 13,0 11,5 10,0 50 16,0 14,0 12,0 10,5 55 17,0 15,0 13,0 11,0 60 18,0 16,0 13,5 11,5 65 19,0 16,5 14,5 12,0 70 20,0 17,5 15,0 12,5 75 21,0 18,5 16,0 13,0 80 22,5 19,5 16,5 13,5 85 23,5 20,5 17,0 14,0 90 24,5 21,5 18,0 14,5

If the total number of ampoules Ferrum Лек which needs to be entered exceeds the maximum daily dose, it is necessary to divide them for several days (see the maximum daily doses and instructions on use and introduction).
If 1-2 weeks later after the beginning of introduction Ferrum Лек hematologic parameters do not change, it is necessary to specify the made diagnosis.
Calculation of the general dose for compensation of iron owing to blood loss
the Required number of ampoules Ferrum Лек for compensation of the posthemorrhagic zhelezodefitsit is calculated by the following formula:
· If the amount of the lost blood is known: introduction of 200 mg in oil (2 ampoules Ferrum Лек) leads to increase in level of hemoglobin which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Iron which it is necessary to compensate (mg) = number of the lost units of blood × 200
or
Necessary number of ampoules Ferrum Лек = number of the lost units of blood × 2
· If the reduced level of hemoglobin is known: the following formula is used taking into account that the deposited iron does not need to be compensated.
Iron which it is necessary to compensate (mg) = the body weight (kg) × (target level of hemoglobin (g/l) - the valid level of hemoglobin (g/l) × to 0.24

Patient with the body weight of 60 kg and deficiency of hemoglobin of 10 g/l it is necessary to compensate 150 mg of iron that makes 1.5 ampoules Ferrum Лек.
Adults and patients of advanced age
1–2 ampoules of drug (100–200 mg of iron) a day, depending on hemoglobin level.
Children since 14 years
of 0.06 ml of drug on 1 kg of body weight a day (3 mg of iron/kg a day). The maximum daily doses of drug
Children since 14 years
of 0.14 ml of the drug Ferrum Лек on 1 kg of body weight a day (7 mg of iron/kg a day).
Adults and patients of advanced age
of 4 ml (2 ampoules) of the drug Ferrum Лек.
Indications for the use/address and introduction
enter Intramuscular injections of the drug Ferrum Лек every other day deeply into an upper external quadrant of a gluteus — alternately in left and right. Solution for injections in oil should be used right after opening of an ampoule. In order to avoid pain and coloring of skin it is very important to carry out injections in oil with care and properly. The minimum length of a needle for adults - 50 mm, for patients with excess body weight - from 80 to 100 mm, for children - 32 mm. Before an injection after disinfection of skin it is necessary to shift hypodermic fabrics down on 2 cm for prevention of the subsequent outflow of drug. After administration of drug, hypodermic fabrics should be released, and the place of an injection to press and hold in such situation within 1 minute.

Side effects
Approximately at 5% of patients can be observed side effects which usually dose-dependent. Allergic reactions meet infrequently and include: urticaria, skin rashes, itching, nausea and fever.
Anaphylactic reactions belong to very rare side reactions sharp, heavy degree. They are usually shown the first minutes of use of drug and, as a rule, are characterized by sudden emergence of difficulty of breath and/or cardiovascular insufficiency, cases of a lethal outcome were recorded.
At emergence of the first signs of anaphylactic reactions the use of drug has to be immediately stopped.
The delayed reactions of hypersensitivity are characterized by an arthralgia, anaphylactic myalgia and sometimes fever which can last from several hours to 4 days after administration of drug.
Symptoms are shown usually within 2-4 days and pass spontaneously, or after use of usual analgetics.
In a pseudorheumatism there can be an exacerbation of a joint pain.
Local manifestation of reactions, such as painful feelings and inflammation in the place of an injection was noted. Local complications in the place of an injection after carrying out an intramuscular injection, such as coloring of skin, bleeding, formation of sterile abscess, necrosis of fabric or atrophy and pain can be observed.
By-effects are classified by frequency: very often (≥1/10), it is frequent (≥1/100, & lt, 1/10), infrequently (& gt, 1/1000 and & lt, 1/100), is rare (≥1/10000, & lt, 1/1000), is very rare (& lt, 1/10000) and unknown frequency (which frequency cannot be determined on the basis of the available data).
Infrequently
- misting of sight, numbness
- a bronchospasm, dispnoe
- nausea, vomiting, an abdominal pain
- an itching, urticaria, rash, a dieback, an erythema
- spasms
- inflows
Seldom
- arrhythmia, tachycardia, pain and feeling of weight in a breast, an asthenia
- dizziness, concern, a tremor, a loss of consciousness
- fatigue, apathy
- diarrhea
- a Quincke's edema, perspiration, pain and coloring of skin in the place of an injection
- myalgia
Very seldom
- bradycardia at a fruit, heartbeat strengthening
- acute, heavy anaphylactoid reactions (the sudden complicated breath and/or cardiovascular insufficiency)
- a headache, paresthesias
- hypotension, hypertensia
- tranzitorny relative deafness
- fervescence, fall of temperature of a body
- hemolysis, a hyperadenosis
- changes of a mental condition
of Unknown frequency
- tranzitorny disturbance of flavoring feelings
- fever
- a chromaturia
-

the Contraindication joint pain
- hypersensitivity to drug components, including iron mono - and disakharidny complexes and a dextran
- the anemia which is not caused by deficiency of iron
- an overload iron (hemochromatosis, a hemosiderosis)
- disturbance of mechanisms of utilization of iron (the anemia caused by poisoning with lead, sideroakhrestichesky anemia)
- the I trimester of pregnancy
- heavy disturbances of a hemostasis (hemophilia) because of formation of a hematoma
- children's age up to 14 years
- infectious diseases of kidneys in the acute stage, an acute renal failure
- dekompensirovanny cirrhosis, hepatitis
- acute or persistent infection since parenteral intake of iron can lead to exacerbation of bacterial or viral infections
- a pseudorheumatism with symptoms or signs of active inflammation

Medicinal interactions
Simultaneous use of the drug Ferrum Lek® with APF inhibitors can cause strengthening of system effects of parenteral iron preparations.
It is impossible to mix solution for introduction in oil with other medicines, as well as other iron preparations for parenteral use, Ferrum Lek® do not appoint along with iron preparations for intake. The interval between parenteral use of drug and the beginning of use of oral dosage forms of iron has to make not less than 5 days.

Special instructions
Iron preparations for parenteral use can cause reactions of hypersensitivity, including serious and potentially deadly anaphylactic/anaphylactoid reactions. The risk increases at patients with the known form of an allergy, including allergy to medicines, including patients with a severe form of asthma, eczema or other atopic allergy. There is also increased risk of reaction of hypersensitivity at parenteral use of complexes of iron for patients with immune
or inflammatory diseases (for example, a system lupus erythematosus, a pseudorheumatism).
Iron preparations for parenteral use have to be appointed only when there are the trained personnel which can estimate and control anaphylactic reactions, a complete set of means of resuscitation. It is necessary to watch each patient on presence of side effects, at least, within 30 minutes after each injection. If at introduction reactions of hypersensitivity are observed, treatment has to be immediately stopped. Means of cardiorespiratory resuscitation and the equipment for removal sharp anaphylactic/anaphylactoid have to be available to reaction, including adrenaline 1:1000 solution. In appropriate cases the additional treatment using antihistamines and/or corticosteroids is necessary.
To patients with liver dysfunction, iron for parenteral administration has to be appointed only after carrying out the corresponding assessment of risks/advantage. Use of iron for parenteral administration should be avoided to patients with liver dysfunction when the overdose of iron is a provocative factor, in particular, of a late skin porphyria. It is recommended to conduct careful monitoring of concentration of iron not to allow iron overdose.
Iron for parenteral administration has to be appointed with care in case of an acute or chronic infectious disease. It is recommended to stop intake of iron for parenteral administration for patients with constant bacteremia. For patients with a chronic form of an infectious disease it is necessary to carry out the risks/advantage assessment taking into account suppression of an erythrogenesis.
It is not necessary to appoint iron preparations for parenteral administration along with oral iron preparations as iron absorption will be reduced. Iron administration of drugs inside should not be begun earlier, than in 5 days after the last injection of iron.
Pregnancy and the period of a lactation
Ferrum Лек should not be appointed in the first trimester of pregnancy. In the second and third trimesters the intramuscular injections Ferrum Лек are appointed only in case of emergency when the expected advantage exceeds risk of negative impact on a fruit. It is preferable not to use drug during breastfeeding, nemetabolizirovanny dextrans of iron get into breast milk
of Feature of influence of drug on ability to run motor transport or potentially dangerous mechanisms
of Data on influence on ability to run motor transport or potentially dangerous mechanisms is not present.
Overdose
Symptoms: the overdose of iron preparations can lead to a sharp overload iron, shown a hemosiderosis.
Treatment: symptomatic. Specific antidote of iron is the chelate agent Deferoxaminum (the chelate agent connecting iron) of 1 g in/in (at most 15 mg/kg/h). The hemodialysis is inefficient.

A form of release and packing
On 2 ml of solution in ampoules from colourless glass (class I EF) with a red dot and a ring of red color above a neck.
On 10 ampoules in blister strip packaging from a film polyvinylchloride.
On 5 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.


To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach.



Not to use a period of storage of 5 years after the expiry date specified on packing.

Prescription status
According to the prescription


the Producer / Packer Lek Pharmasyyutikals of d, Slovenia
Verovskova 57, Ljubljana, Slovenia

the Owner of the registration certificate
Lek Pharmasyyutikals of d, Slovenia
Verovskova 57, Ljubljana, Slovenia

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of JSC Sandoz Pharmasyyutikals d. d. in
Republic of Kazakhstan Republic of Kazakhstan, 050051, Almaty, Luganskogo St., 96, Business center "Keruyen", ph. +7 (727) 2581048 Fax: +7 (727) 2581047,
e-mail: kzsdz.drugsafety@sandoz.com
8 800 080 0066 – free number of dialing across Kazakhstan








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