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Description

The instruction for medical use

of Aktiferrin medicine ®

the Trade name
of Aktiferrin®

the International unlicensed name
Is not present

the Dosage form

of the Structure One Capsule Capsule contains
active agents: gland (II) sulfate of dry 104.267-109.116 mg,
D, L-serine of 129.00 mg,
excipients: the oil rape purified, lecithin (E 322), wax yellow, the oil soy hydrogenated, oil soy partially hydrogenated,
structure of the capsule: sorbitol the solution of 70% which is dried up, glycerin of 85%, gelatin, ferrous oxide black (E 172), ferrous oxide red (E 172).
Description
Soft gelatin capsules, oblong shape, brown color, opaque, 6 in size. Contents of capsules: light-beige oily paste.

Pharmacotherapeutic group
hematopoiesis Stimulators. Iron preparations. Iron preparations (II) for oral administration.
The ATX B03AA code

the Pharmacological

Pharmacokinetics Later properties of intake the iron which is a part of the drug Aktiferrin® rather fully is absorbed from digestive tract in a system blood stream. Extent of absorption depends on expressiveness of deficiency of iron (the more deficit, the absorption is higher). The maximum concentration of iron in blood serum is reached within the first 2-4 hours after administration of drug. It is removed with a stake, urine and then.
A pharmacodynamics
Iron is necessary for activity of an organism: it is a part of hemoglobin, a myoglobin, various enzymes, reversibly connects oxygen and participates in a number of redoxreactions, stimulates an erythrogenesis. Aktiferrina® which is a part alpha amino acid serine promotes more effective absorption of iron and its receipt in a system blood stream, leading to fast recovery of its normal contents in an organism. It provides the best tolerance of drug and allows to reduce a necessary dose of iron. Administration of drug of Aktiferrina® of the capsule stimulates an erythrogenesis, normalizes hematologic indicators, contributes to normalization of concentration of iron in blood serum that leads to gradual regression clinical (weakness, fatigue, dizziness, tachycardia, dryness of integuments) and laboratory symptoms.

Indications
– treatment of an iron deficiency anemia

accept the Route of administration and doses of Aktiferrin® of the capsule inside just before food or at meal time, washing down with enough water or fruit juice.
To adults and teenagers from 15 years at the beginning of therapy usually appoint on 1 capsule 1-2 times a day, however, at bad tolerance of drug reduce a dose to the most transferable. In this case therapy course duration increases (to normalization of level of hemoglobin).
To children 6 years up to 15 years are more senior appoint on 1 capsule daily.
After achievement of normal indicators of hemoglobin the Aktiferrin® drug treatment is continued within not less than 8 weeks. At the subsequent normalization of indicators of hemoglobin the administration of drug has to be continued within several weeks for completion of depot of iron.

Side effects
of the Aktiferrin® Capsule are usually well transferred by patients of any age.
Often
– nausea, feeling of weight in epigastric area, the meteorism, constipations or diarrhea disappearing at reduction of a dose or at administration of drug with food
Seldom
– allergic skin reactions

of the Contraindication
– hypersensitivity to drug components
– hemochromatosis, a hemosiderosis
– other types of anemias which are not caused by deficiency of iron in an organism (for example, sideroakhrestichesky anemia, anemia in a plumbism, a thalassemia, hemolytic, megaloblastny, aplastic anemias)
– congenital intolerance of fructose, deficiency of invertase-isomaltase, a syndrome of glyukozo-galaktozny malabsorption
– children’s age up to 6 years

Medicinal interactions
At simultaneous use of Aktiferrin® and:
– tetracyclines, giraza inhibitors (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), biphosphonates, Penicillaminum, a levodopa, karbidopa and Methyldopums – their absorption decreases,
– thyroxine – thyroxine absorption decreases,
– zinc – zinc absorption decreases,
– vitamin E at children – the efficiency of vitamin E decreases.
– the holestiramina, antacids (containing aluminum, magnesium, calcium or bismuth), additives, calciferous and magnesium – decreases iron absorption,
– non-steroidal anti-inflammatory drugs – the irritating effect of iron on a mucous membrane of digestive tract can increase.
The above-stated means are recommended to be accepted in 2-3 hours prior to reception of Aktiferrina®.
Vitamin C or citric acid increase iron absorption.
Glucocorticoids perhaps strengthen stimulation эритропоэзаАктиферрином®.

Special instructions
With care
It is necessary to be careful at combined use of iron preparations with the dietary products and additives containing iron salts (possible risk of overdose).
At patients with inflammation and ulcers of a mucous membrane of digestive tract, it is necessary to estimate a ratio of advantage of treatment and risk of development of exacerbations of gastroenterological diseases against the background of therapy of iron preparations.
If necessary degree of deficiency of iron and the subsequent requirement of a zameshchaniye of iron should be monitorirovat on the following laboratory indicators with intervals of about 4 weeks: hemoglobin, erythrocytes, reticulocytes, serumal iron, transferrin. Ferritin level indicates less than 15 mkg/l lack of reserves of iron in an organism.
The Aktiferrin® capsule is not washed down with black tea, coffee, milk in order to avoid decrease in absorption of iron. Besides, reduction of absorption can be caused: firm food, bread, crude cereals, dairy products, eggs. At reception of the Aktiferrin® capsules the calla in black color is noted coloring that is not clinically significant.
Pregnancy and the period of a lactation
of Preclinical trial on reproductive function it was not carried out.
Use at pregnancy and in the period of a lactation perhaps if the potential advantage for mother exceeds potential risk for a fruit and the child.
The feature of influence on ability to run the vehicle and potentially dangerous mechanisms
does not influence ability to run transport or other moving mechanical equipment.

The overdose
is available For children high risk of intoxication iron preparations, zhizneugrozhayushchy states can arise at reception of 1 g of ferrous sulfate. Therefore iron preparations have to be stored out of children’s reach.
Symptoms: nausea, an abdominal pain, diarrhea, vomiting, in hard cases – cyanosis, confusion of consciousness, hyperventilation symptoms, in 12-48 h the development of shock with Cheyna-Stokes’s breath, oligurias, jaundices because of toxic hepatitis, a toxic liver failure is possible. In certain cases – disturbances of the central nervous system, such as paralysis, spasms, coma, disturbances of blood clotting.
Treatment: before transportation in hospital – intake of milk, crude egg. Before performing specific therapy – a measure for removal of drug from a GIT (calling of vomiting, gastric lavage with bicarbonate and phosphatic solutions), symptomatic therapy of shock and acidosis. Specific therapy carry out at concentration of serumal iron 300-350 mkg/dl by prescribing of Deferoxaminum (Desferal) of 1-2 g intravenously by drop infusion at the rate of 15 mg/kg of body weight an hour each 3-12 hour. In acute poisonings for the iron binding which is not soaked up from digestive tract yet give in 5-10 g of drug by dissolution of contents of 10-20 ampoules in drinking water.
To patients with oligo and an anury at overdose by salts of iron appoint peritoneal or a hemodialysis.

A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and printing aluminum foil. On 2 or 5 planimetric packs together with the instruction for medical use in the state and Russian languages put in a box of cardboard.

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

3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

the Producer/packer
of “Katalent Germaniya Eberbah GmbH”, Germany

the Owner of the registration certificate
“ratiofarm GmbH”, Germany

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of ratiofarm Kazakhstan LLP, Almaty, Al-Farabi Ave. 19, BC Nurly-Tau, 1B, office 603, ph. (727) 3110915, fax: (727) 3110734, e-mail:

To Develop Safety.Kazakhstan@tevapharm.com

Additional information

Ingredient

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