Venofer

Venofer – the antianemic drug intended for parenteral use.

Form of release and structure

Drug is produced in the form of solution for intravenous administration (in ampoules on 2 and 5 ml, 5 ampoules in blister strip packagings, on 1 packaging in a cardboard pack).

Active ingredient of Venofer – iron (III) hydroxide a saccharose complex – 540 mg/ml that corresponds to the content of iron of 20 mg/ml.

As auxiliary components drug contains water for injections and sodium hydroxide.

Indications to use

Venofer's use is reasonable at iron deficiency states:

• Intolerance of the iron preparations intended for oral administration or non-compliance with the mode of therapy;
• Existence of active inflammatory diseases of intestines when efficiency of the iron preparations used orally is limited;
• Need of bystry completion of iron;
• Iron utilization process disturbance;
• Overload symptoms iron (hemochromatosis, hemosiderosis);
• The anemia which is not connected with deficit of iron;
• Hypersensitivity of the patient to drug components;
• I trimester of pregnancy.

Contraindications

With care drug is appointed in the presence at the patient of bronchial asthma, eczema, a liver failure, chronic and acute infectious diseases, a polyvalent allergy, allergic reactions to others parenteral iron preparations, and also at the increased content of ferritin in serum and at low iron-binding ability of serum and/or deficit of folic acid.

Route of administration and dosage

Drug is intended only for intravenous administration (slowly struyno or kapelno) or for introduction to the venous site of dialysis system. Single-step introduction of a full therapeutic dose of Venofer is inadmissible.

Before introduction of the first therapeutic dose purpose of a test dose is recommended. At emergence of any manifestations of intolerance during the period of observation it is necessary to stop administration of drug immediately.

Before use it is necessary to examine an ampoule on existence of damages, solution of brown color without any precipitations is suitable for use.

The most preferable option of introduction of Venofer – drop infusion as such way reduces risk of the expressed lowering of arterial pressure and a possibility of hit of drug in perivenous space. Before introduction it is necessary to part Venofer with solution of sodium of chloride 0,9% in a proportion 1:20. The amount of iron in solution defines time necessary for administration of drug:

• 500 mg – 3,5 hours;
• 400 mg – 2,5 hours;
• 300 mg – 1,5 hours;
• 200 mg – 30 minutes;
• 100 mg – not less than 15 minutes.

The most tolerable single dose makes 7 mg of iron on 1 kg of body weight, it is necessary to enter it not less than 3,5 hours, irrespective of the general dose of drug.

The first drop introduction of a therapeutic dose of Venofer is preceded by introduction of a test dose which for adult patients and children whose body weight more than 14 kg, makes 20 mg of iron, and for children with body weight less than 14 kg – a half of a day dose (1,5 mg of iron on 1 kg of body weight). It is necessary to enter a test dose within 15 minutes. If undesirable effects are absent, the rest of drug is entered with the recommended speed.

Jet introduction: at administration of drug intravenously slowly Venofer is used in not divorced look, speed at the same time makes 1 ml of drug a minute. The most admissible dose of drug for an injection – 10 ml (200 mg of iron).

Before the first jet introduction to the patient within 1-2 minutes the test dose is entered: 1 ml of drug for children with body weight more than 14 kg and adult patients, a half of a day dose (1,5 mg on 1 kg of body weight) – for children whose body weight is less than 14 kg. If after 15 minutes after introduction of a test dose undesirable reactions are absent, the remained solution is entered with the recommended speed. After the procedure the patient is recommended to record for some time a hand in the extended situation.

At administration of drug to the venous site of dialysis system it is necessary to observe strictly the recommendations described for an intravenous injection.

The dose is determined by a special formula individually and depends on the general deficit of iron in the patient's organism.

The standard dose of Venofer for elderly people and adult patients makes 5-10 ml of drug 1-3 times a week (depending on hemoglobin level). Data on use of drug for children which age less than 3 years, are limited. In this case no more than 0,15 ml of Venofer on 1 kg of body weights 1-3 times a week are entered (depending on hemoglobin level).

The most tolerable single dose for people of advanced age and adult patients:

• Struyno – 10 ml (200 mg of iron) introduction time – not less than 10 minutes;
• Kapelno – to 500 mg of iron (7 mg on 1 kg of body weight), is entered once a week.

Side effects

The side effects arising against the background of Venofer's use were noted very seldom.

• From cardiovascular system: a lowering of arterial pressure, tachycardia, heartbeat, feeling of heat, kollaptoidny conditions, "inflows" of blood to the person;
• From the alimentary system: pains in epigastric area, diffuse abdominal pains, nausea, vomiting, diarrhea, disturbance of flavoring feelings;
• From a musculoskeletal system: dorsodynias, extremity pains, arthralgia, mialgiya, hypostasis of joints;
• From a nervous system: headaches and dizziness, paresthesias, loss of consciousness;
• From a respiratory organs: asthma, bronchospasm;
• From integuments: rash, itch, pigmentation disturbances, excessive sweating, erythema;
• Allergic reactions: face edema, throat hypostasis, anaphylactoid reactions;
• Disturbances of the general character: stethalgias, feeling of weight in breasts, peripheral hypostases, fervescence, a fever, weakness, an adynamy, feeling of an indisposition, pallor;
• Local reactions: hypostasis and pain in the place of an injection.

Special instructions

Drug is recommended for appointment only to those patients, the diagnosis of anemia at whom is authentically confirmed with the corresponding laboratory researches.

It is necessary to observe strictly recommended drug rate of administering in order to avoid development of undesirable side reactions (especially lowerings of arterial pressure).

Venofer's penetration out of limits of a vessel can lead to a necrosis of fabrics and coloring of skin in brown color therefore it is necessary to avoid hit of drug in perivenous space. If the similar complication occurred, it is necessary to apply geparinsoderzhashchy drugs on the place of an injection that promotes acceleration of removal of iron and prevention of its further penetration into surrounding fabrics.

Use of intravenous iron preparations can promote development of allergic or anaphylactoid reactions, potentially life-threatening.

Among patients with hypersensitivity to a dextran of iron researches which showed lack of complications against the background of therapy by Venofer were conducted.

Physical and chemical stability of drug after cultivation by normal saline solution remains at the room temperature within 12 hours, but from the microbiological point of view, drug is recommended to be used immediately. If solution was not used right after preparation, all responsibility for conditions and storage time (which anyway should not exceed 3 hours at the room temperature and if cultivation was carried out in the guaranteed and controlled aseptic conditions) are born by the user.

Undesirable impact of Venofer on ability to driving of the car and to control of mechanisms is improbable.

Medicinal interaction

Co-administration of Venofer and peroral iron preparations is not recommended. The iron preparations intended for intake can be applied not less than in 5 days after the last parenteral administration.

Rolled into one drug can be mixed only with normal saline solution. Addition of other therapeutic drugs and solutions for intravenous administration is not allowed. Venofer's compatibility with containers from other materials, except polyethylene, polyvinylchloride and glass is not studied.

Terms and storage conditions

To store in original packaging at a temperature of 4-25 °C in the place, unavailable to children. Not to allow drug freezing.

Period of validity – 3 years.