active substance: 1 ml 20 mg iron as iron (iii) hydroxide sucrose complex;
excipients: water for injection.
Solution for intravenous injections.
Antianemic agents for parenteral administration. Iron preparation. Code PBX. B0ZA C02.
Iron deficiency States:
if it is necessary to quickly replenish the iron
patients who can not tolerate or are not complied with regular intake of oral iron preparations
in the presence of active inflammatory diseases of the digestive tract, when oral iron preparations are ineffective.
Anemia not related to iron deficiency (e.g. hemolytic anemia, megaloblastic anemia, erythropoiesis disorders, bone marrow hypoplasia);
the oversaturation of the body with iron (hemosiderosis, hemochromatosis) or violation of the process of recycling of iron (for example, sideroahrestical anemia, anemia caused by poisoning
lead, leather porphyria, thalassemia)
hypersensitivity to the components of the drug
The first trimester of pregnancy;
severe disorders of hemostasis (hemophilia).
Method of application and doses
Sufer is administered only intravenously. You can perform the injection with a slow injection, drip intravenous injection or direct injection into the venous area of the dialysis system. The tool is not intended for intramuscular administration. Before starting treatment with the first therapeutic dose of Sufer, a test dose should be carried out. It is necessary to have resuscitation facilities. If during the observation period, which should last at least 15 minutes, there were no side effects, you can enter part of the therapeutic dose remained.
Intravenous drip. Super is preferably administered by drip infusion to reduce the risk of arterial hypotension and the risk of contact with okolovenoznoe space. Immediately before the introduction of the Sufer must be diluted in 0.9% sodium chloride solution in a maximum ratio of 1: 20, for example
1 ml of Superu (20 mg iron) in maximum 20 ml of sterile 0.9% solution of sodium
5 ml of Superu (100 mg iron) in maximum of 100 ml of sterile 0,9% solution of sodium
25 ml of Superu (500 mg iron) in maximum 500 ml sterile 0.9% solution of sodium
To ensure the stability of the solution, dilute the Sufer in larger than recommended volumes of saline is not allowed. The resulting solution is recommended to be administered at a rate of:
100 mg iron for at least 15 minutes;
200 mg iron for at least 30 minutes;
300 mg of iron for at least 1 ? hours;
400 mg of iron for at least 2 ? hours;
500 mg iron at least 3 ? hours.
The introduction of the maximum allowable single dose is 7 mg of iron per 1 kg of body weight, should be carried out for at least 3.5 hours regardless of the total dose. In the form of infusion of the maximum tolerated dose to appoint not more than 1 time a week.
Before starting the first drip infusion, it is necessary to conduct a test dose of 20 mg of iron for adults and children weighing more than 14 kg and half of the daily dose (1.5 mg of iron/kg) for children with a body weight of less than 14 kg, for 15 minutes.in the absence of adverse events, a part of the solution can be administered at the recommended speed, remained.
Intravenous jet injection. The souffer can be administered slowly as an undiluted solution at a rate of 1 ml per minute (5 ml Souffer (100 mg iron) is injected in 5 minutes), but the maximum volume of the solution should not exceed 10 ml Souffer (200 mg iron) per 1 injection. Before you start typing, you need to take a test dose is: adults and children weighing more than 14 kg - 1 ml (20 mg iron), and children with body weight less than 14 kg and half the daily dose (1.5 mg iron/kg) slowly over 1-2 min. If during the observation period, which lasts for at least 15 minutes, there are no side effects, you can enter part of the therapeutic dose remained.
The sufer can be injected directly into the venous area of the dialysis system, strictly observing the rules described for intravenous injection. The calculation of the dose. The dose is calculated individually according to the total iron deficiency in the patient according to the formula: total iron deficiency (mg) = body weight (kg ) x (normal level Hb (g/l) - level HB patient (g/l)) x 0.24 * + deposited iron (mg). For patients weighing less than 35 kg: normal level Hb-130 g/l, the amount of iron deposited - 15 mg/kg body weight. For patients weighing more than 35 kg: normal level Hb-150 g/l, the amount of iron deposited - 500 mg.Coefficient 0.24 = 0.0034 x 0.07 x 1000 (iron content in Hb = 0.34%, blood volume = 7% of body weight, coefficient 1000 = transfer "g" in "mg").
The total amount of the drug Sufer , which must be administered (in ml)
= Total iron deficit (mg)
weight calcualation therapeutic dose Super to enter
(Kg)Hb 60 g/LHB 75 g/LHB 90 g/LHB 105 g/l
Super , млFe, msuper , млFe, msuper , млFe, msuper , млFe, mg
In the case when the total necessary dose exceeds the maximum allowed single dose,
it is recommended to administer the drug in parts. If 1-2 weeks after the start of treatment there is no improvement in hematological parameters, the initial diagnosis should be reviewed.
Calculation of the dose to replenish the level of iron after blood loss or donation.
The dose Sufer, necessary to compensate for iron deficiency, is determined by the following
if the amount of blood lost is known: intravenous 200 mg iron (= 10 ml
Superu) leads to the same increase in the concentration of Hb and the transfusion of 1 unit blood (= 400 ml with the concentration of Hb 150 g/l);
The amount of iron that needs to be compensated (mg) = the number of units of lost blood x 200 or the required volume of the drug Sufer (ml) = the number of units of lost blood x 10.
When reducing the level of Hb: use the previous formula, but keep in mind that the iron depot is not necessary to replenish.
Amount of iron to be compensated (mg) = body weight (kg) x 0.24 x (normal level Hb (g/l) - patient's level Hb) (g/l). For example: body weight-60 kg, deficiency Hb = 10 g/l ? the required amount of iron = 150 mg ? the required amount of the drug Sufer =
The standard dosage.
Adults and elderly patients 5-10 ml of Superu (100-200 mg iron) 1-3 times a week depending on Hb level.
Children: there are only limited data on the use of the drug in children. In case of clinical necessity (for rapid replenishment of the body with iron), it is recommended to inject no more than 0.15 ml of Sufer (3 mg of iron) per 1 kg of body weight 1-3 times a week, depending on the level of hemoglobin.
Maximum single dose :
Adults and elderly patients
for injection 10 ml Superu (200 mg iron), the duration of injection at least 10 min, no more than 3 times a week.
for infusion, depending on the indications, a single dose can reach 500 mg of iron. The maximum portable single dose is 7 mg of iron per 1 kg of body weight and is administered once a week, but it should not exceed 25 ml of Souffer (500 mg of iron). Time of administration of the drug and the method of breeding the above.
The most common adverse reactions to the drug, which were reported, included dysgeusia, hypotension, pyrexia and chills, the reactions at the injection site, nausea, observed in 0.5% to 1.5% of patients.
Adverse reactions mainly depend on the dose of the drug. Anaphylactoid reactions occur rarely, but can be the most serious adverse events (see section "Peculiarities of application"). Acute severe anaphylactoid reactions usually occur within the first few minutes after administration of the drug and are generally characterized by difficulty breathing and/or cardiovascular collapse, there have been reports of fatal cases. If there are signs of anaphylactoid reactions introduction of the drug should be discontinued immediately.
Side effects by frequency of occurrence are classified into the following categories: very often (?1/10), often (? 1/100, <1/10), infrequently (?1/1000, <1/100), rarely (? 1/10000, <1/1000), very rarely (1/10000), unknown (available data do not allow to estimate the frequency, since such phenomena were reported exclusively during postmarketing studies, rather than clinical trials).
From the immune system.
Rarely anaphylactoid reactions.
From the nervous system .
Often transient distortion of taste sensations, especially taste (dysgeusia).
Infrequently: headache, dizziness.
Rarely paresthesia, fainting, loss of consciousness, burning sensation of the skin.
Unknown: disturbance of consciousness, confusion, blurred vision, numbness, convulsions, excitement, tremor.
From the cardiovascular system:
Infrequently, tachycardia, palpitations, arrhythmias, pain and feeling of pressure (discomfort) in the chest.
Not known: bradycardia.
From the vascular system:
Uncommon: hypotension, circulatory collapse,
Rare: arterial hypertension.
From the respiratory system, chest and mediastinal organs.
Not often bronchospasm, shortness of breath, respiratory arrest.
From the digestive tract .
Infrequently vomiting, nausea, abdominal pain, diarrhea.
On the part of the skin and subcutaneous tissue.
Uncommon: pruritus, urticaria, rash, exanthema, erythema, purpura.
From the side of musculoskeletal system and connective tissue.
Infrequently muscle spasms, myalgia, arthritis.
Rarely swelling of the joints, arthralgia.
On the part of the blood and lymphatic system: hemolysis, lymphadenopathy, leukocytosis, bleeding.
On the part of hearing and labyrinth: short-term deafness.
General disorders and reactions at the injection site.
Uncommon: fever, chills; hot flashes; chest discomfort.
Reactions at the injection site: including storey phlebitis, burning, bulge. In the case of accidental extravascular drug administration (expiration), pain, inflammation, tissue necrosis and skin color change to brown may occur.
Rarely angioneurotic edema, peripheral edema, fatigue, asthenia, malaise, heat sensation,
Very rarely: pallor, increased sweating, back pain.
Unknown: chromaturia, formation of abscesses, changes in mental state.
The described reactions of the delayed type to the drug (from several hours to 4 days after administration), which can be severe. Symptoms can last 2-4 days and stop spontaneously or after the use of conventional analgesics. It is possible to increase joint pain in rheumatoid arthritis.
Overdose can lead to severe over-saturation of the body with iron,
which could show up as hemosiderosis. In case of overdose it is recommended to use
symptomatic agents and, if necessary, substances that bind iron (chelates).
Application during pregnancy and lactation
There are limited data on the use of
the preparation of pregnant women who showed no undesirable effects of iron hydroxide sucrose complex during pregnancy and the health of the fetus/child. Until now, there have been no well-controlled studies among pregnant women. The results of studies of therapeutic doses in animals did not reveal direct or indirect harmful effects on pregnancy, embryo/fetus development, childbirth or postnatal development.
However, the risk/benefit ratio should be assessed before use in the II and III trimesters of pregnancy. The drug is contraindicated to use in the first trimester of pregnancy.
Penetration ametabolian saharata of iron in breast milk is unlikely. However should
assess the risk/benefit ratio before use during breast-feeding.
There is only limited data on the use of the drug to children (see section "dosage and Administration"). The appointment of the drug in children is recommended only for health reasons (to quickly replenish the body's iron).
Super should be administered only to those patients, the diagnosis of anaemia which was confirmed by the results of relevant research (e.g. the results of determination of ferritin in blood serum, or hemoglobin (Hb), or hematocrit (Ht), or counting the number of erythrocytes, or determination of the parameters - average corpuscular volume , average content of Hb in the erythrocyte or an average concentration of Hb in the erythrocyte). If the anemia is caused by infection or malignant neoplasm, iron, is introduced into the body, accumulates in reticuloendothelial system and used by the body only after treatment of the underlying disease.
Before using the ampoule should be examined for the presence of sediment and damage.
Apply can be only brown color of water care solution, not containing a residue.
The sufer should be administered immediately after opening the ampoule.
Intravenous iron preparations can cause allergic or anaphylactic reactions, a potentially life-threatening. Therefore, anti-allergenic treatments should be carried out in a room with appropriate equipment for the cardiopulmonary
resuscitations. Due to the high risk of allergic reactions in patients with bronchial asthma, eczema, polyvalent Allergy, allergic reactions to other parenteral iron preparations, the drug should be administered with caution. A special group of risk of allergic reactions are patients with Crohn's disease, progressive chronic polyarthritis, as well as persons with low ability to bind iron and/or folic acid deficiency. With extreme caution Sufer should be used in patients with liver function disorders, including those caused by elevated levels of ferritin, as well as patients with acute or chronic infection. Caution should be exercised when administering the drug to patients with allergic reactions in history, as well as liver and renal failure. Side effects, resulting in patients with cardiovascular disease can aggravate the course of underlying disease.
Parenteral iron administration can negatively affect the course of bacterial or viral infection. Also care is required when administering the drug to individuals with a low ability of serum to bind iron and/or folic acid deficiency.
The results of studies in patients who have hypersensitivity reactions to iron dextran showed no complications on the background of treatment with the drug Super.
Should strictly abide by speed the introduction of drug, to not allow development arterial hypotension. The high frequency of undesirable side effects (especially hypotension) is associated with an increase in the dose or rate of administration of the drug.
Avoid okolovenoznoe origins, because this leads to pain, inflammation, necrosurgery and skin coloring in brown color.
The ability to influence the reaction rate when driving motor transport or operating other mechanisms.
Unlikely. But in the case of side reactions such as dizziness, confusion, you should refrain from driving vehicles or operating other mechanisms to symptoms.
Interaction with other medicinal products and other forms of interaction
The sufer should not be used simultaneously with iron-containing oral agents, since the absorption of iron used inside is reduced. Therefore, treatment with oral iron preparations should begin no earlier than 5 days after the last injection Superu.
Pharmacodynamics. The active component of iron sucrose consists of multicore centers of iron (iii) hydroxide, surrounded from the outside by a large number of non-covalently bound sucrose molecules. The weight of the complex is the average molecular weight (mV), which is about 43 CD, is quite high and does not allow its excretion by the kidneys.
The multicore iron center has a structure similar to that of the ferritin center, which is a physiological iron-containing protein. The complex was designed to provide a controlled way to digest iron for transporting iron and preserving protein in the body (transferrin and ferritin, respectively).
Evaluation of ferrokinetic 100 mg of iron hydroxide sucrose complex, is designated 59 Fe 52 and Fe, was conducted among 6 patients with iron deficiency anemia, renal anemia and functional iron deficiency. During the period from 2 to 4 weeks after the introduction of the maximum absorption of red blood cells 59 Fe ranged from 59% to 97%.
Distribution. After the introduction of a single dose of Sufer, containing 100 mg of iron, the maximum concentration of iron was observed 10 minutes after administration and reached an average value of 538 mmol/l.the volume of distribution of the Central chamber is well matched to the volume of plasma (about 3 liters).
Entered the iron is rapidly released from the plasma, and the terminal half-life was 6:00. The volume of distribution at equilibrium of concentration was 8 litres, which pointed to a weak distribution of iron in biological fluids. Iron, transported by transferin, was about 31 mg of iron/24 hours.
Metabolism. After the introduction of iron from complex is keen on predominantly liver, spleen and bone marrow. In the second stage, iron is used for the synthesis of hemoglobin, myoglobin and other iron-containing enzymes, or stored in the liver as ferritin.
Conclusion. The withdrawal of iron by the kidneys during the first 4:00 after injection was less than 5% of the total clearance. After 24 hours, the total concentration of iron in the serum was reduced to the entry level (before administration) , and the withdrawal of sucrose kidneys
was about 75% of the administered dose.
Basic physico-chemical properties
aqueous solution of brown.
The sufer can only be mixed with a sterile 0.9% sodium chloride solution. No other solutions for intravenous administration and therapeutic preparations are allowed to be added, since there is a risk of precipitation and/or other pharmaceutical interaction. Compatibility with polyethylene and polyvinyl chloride containers has not been studied.
Shelf life of the medicinal product is 3 years.
Shelf life of the drug package complete with a solvent (sodium chloride solution-Soluven, 9 mg/ml, 100 ml) 2 years.
Do not use after the expiry date indicated on the package.
Shelf life after opening the bottle. From the microbiological point of view, the drug should be used immediately.
Shelf life after dilution with physiological saline. Chemical and physical stability after breeding at room temperature is 12: 00.
Store in a dark place. Store at a temperature not exceeding 25 ° C. do not freeze.
5 ml glass vial, № 1 in package made of cardboard; 10 ml glass vial, № 1 in package made of cardboard; 20 ml glass vial, № 1 in package made of cardboard;
5 ml ampoules, glass No. 5 in a contour acheikova packing; 1 blister in cardboard pack;
5 ml glass vial; 1 vial in a kit with 1 container 100 ml with the solvent (sodium chloride solution-Soliven, 9 mg/ml) in a contour acheikova packing; 1 blister in a pack;
10 ml glass vial; 1 vial in a kit with 1 container 100 ml with the solvent (sodium chloride solution-Soliven, 9 mg/ml) in a contour acheikova packing; 1 blister in a pack.
Category home away from home
Open Company "Yuri-Farm".
Ukraine, 18030, m. Cherkassy, ul Verbickogo, 108. Tel. (044) 281-01-01
A SOLUTION OF AMINOCAPROIC ACID 5%
Aminocapronic ACID SOLUTION 5% 100 ML is a solution which is available in the form of infusion, the main component of which is aminocaproic acid. The drug is used to eliminate the bleeding after the surgical surgery. It is used in a variety of pathological conditions that are associated with an increase in fibrinolytic activity of the blood or tissues. In addition, the drug can be used for the treatment of ODS or flu. Among the contraindications noted: thromboembolism, coagulopathy, renal failure, circulatory disorders in the brain, hematuria, a tendency to thrombosis. It is not prescribed for coronary heart disease in severe form, as well as during pregnancy or during childbirth.
Among the adverse reactions caused by this drug, noted:
Blood clotting disorders.
The pain in the head.
Manifestation of allergy.
The medicine can be used in two variants intravenously or intramuscularly. The drug is prescribed internally for 5 grams, after which every hour for 1 gram for 8 hours. If there is a need to achieve a quick result, the tool should be used drip no more than 100 ml of 5% solution. The drug is introduced at a rate from fifty to sixty drops per 60 seconds for 15 to 30 minutes.