Venofer ampoules 100mg 5ml №1

Venofer

Dosage form

Venofer solution for intravenous administration

Active ingredient

active ingredient: iron (III) hydroxide sucrose complex 540 mg (equivalent to the iron content - 20 mg)
excipients: sodium hydroxide; water for injection up to 1 ml

Packing

5 pieces on 5 ml

Mechanism of action

VENOFER - compensates for iron deficiency, anti-anemic.

Indications and usage

Treatment of iron deficiency in the following cases:

the need for rapid replenishment of iron deficiency;

in patients who do not tolerate oral iron preparations or do not comply with the treatment regimen;

in the presence of active inflammatory bowel disease, when oral iron supplements are ineffective.

Contraindications

hypersensitivity to the drug Venofer® or its components;

anemia not related to iron deficiency;

signs of iron overload (hemosiderosis, hemochromatosis) or violation of the process of its utilization;

I trimester of pregnancy.

With care: bronchial asthma, eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations, low serum iron-binding ability and / or folic acid deficiency; liver failure, acute or chronic infectious diseases (due to the factthat parenterally administered iron may have an adverse effect in the presence of a bacterial or viral infection) and persons who have elevated serum ferritin levels.

Pregnancy and Breastfeeding

The limited experience of using Venofer® in pregnant patients has shown that there is no undesirable effect of iron saharath on the course of pregnancy and the health of the fetus / newborn. To date, no well controlled studies have been conducted in pregnant women. The results of reproduction studies in animals did not reveal direct or indirect effects of Venofer on the development of the embryo / fetus, childbirth or postnatal development. However, further research into the risk / benefit ratio is required.

The entry of unmetabolized iron saharath into breast milk is unlikely. Thus, Venofer® is not dangerous for breastfed babies.

Dosage and administration

In / in. Venofer is injected only in / in - slowly with a jet or drip, as well as into the venous area of ​​the dialysis system - and is not intended for intramuscular administration. The simultaneous administration of a full therapeutic dose of the drug Venofer is unacceptable.

Before the introduction of the first therapeutic dose of Venofer, you must assign a test dose. If intolerance occurs during the observation period, administration of the drug Venofer should be immediately discontinued.Before opening the ampoule, you need to inspect it for possible sediment and damage. You can use only brown solution without sediment.

Droplet introduction: Venofer is preferable to be administered during the drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of solution getting into the near-venous space. Immediately before the infusion, Venofer should be diluted with a 0.9% solution of sodium chloride in the ratio of 1:20, for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution. The resulting solution is injected at the following rate: 100 mg of iron - no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - for 1.5 hours; 400 mg of iron - for 2.5 hours; 500 mg of iron - for 3.5 hours. The maximum tolerated single dose of 7 mg of iron / kg should be administered for at least 3.5 hours, regardless of the total dose of the drug Venofer.

Before the first drip of a therapeutic dose of Venofer, a test dose must be administered: 20 mg of iron - for adults and children weighing more than 14 kg and half the daily dose (1.5 mg of iron / kg) - for children with a body weight less than 14 kg, within 15 min In the absence of adverse events, the remaining part of the solution should be injected at the recommended rate.

Injection: the drug Venofer can also be administered as an undiluted solution in / in slowly, at a rate of (normal) 1 ml of the drug Venofer (20 mg of iron) per minute, i.e. 5 ml of the drug Venofer (100 mg of iron) is injected for at least 5 minutes.The maximum volume should not exceed 10 ml of the drug Venofer (200 mg of iron) per injection.

Before the first jet injection of a therapeutic dose of Venofer, a test dose should be administered: 1 ml of Venofer (20 mg of iron) to adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron / kg) to children less than 14 kg for 1–2 minutes In the absence of adverse events over the next 15 minutes of observation, the remaining part of the solution should be injected at the recommended rate. After the injection, it is recommended that the patient fix the arm in an extended position for a while.

Introduction to the dialysis system: Venofer may be administered directly into the venous site of the dialysis system, strictly following the rules described for IV injection.

Dose calculation: The dose of Venofer is calculated individually, in accordance with the general iron deficiency in the body according to the formula:

Total iron deficiency, mg = body weight, kg × (normal Hb level - patient's Hb level), g / l × 0.24 * + deposited iron, mg.

For patients with a body weight less than 35 kg: normal level Hb = 130 g / l, the amount of deposited iron = 15 mg / kg.

For patients with a body weight of more than 35 kg: normal level Hb = 150 g / l, the amount of deposited iron = 500 mg.

* Coefficient 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%; blood volume = 7% of body weight; coefficient 1000 = translation from “g” to “mg”).

The total amount of the drug Venofer, which must be entered (in ml) = total iron deficiency (mg) / 20 mg / ml

In the case when the total therapeutic dose of Venofer exceeds the maximum permissible single dose, fractional administration of the drug is recommended.

If after 1-2 weeks after the start of treatment with Venofer, there is no improvement in hematological parameters, it is necessary to revise the initial diagnosis.

Dose calculation for replenishing iron levels after blood loss or autologous blood donation

The dose of the drug Venofer is calculated by the following formula:

- if the amount of lost blood is known: in / in the introduction of 200 mg of iron (10 ml of the drug Venofer) leads to the same increase in Hb concentration as transfusion of 1 unit of blood (400 ml with Hb concentration = 150 g / l).

The amount of iron that needs to be replenished (mg) = number of units of blood lost × 200

or

The required volume of the drug Venofer (ml) = the number of units of lost blood × 10.

- with a decrease in the level of Hb: use the previous formula, provided that the iron depot is not needed.

The amount of iron that needs to be replenished (mg) = body weight, kg × 0.24 × (normal Hb level is the patient's Hb level), g / l.

For example: body weight 60 kg, deficiency Hb = 10 g / l "required amount of iron" 150 mg "required amount of the drug Venofer = 7.5 ml.

Standard dosage

Adults and elderly patients: 5–10 ml Venofer® (100–200 mg of iron) 1-3 times a week, depending on the level of hemoglobin.

Children: there is only limited data on the use of the drug Venofer in children under 3 years of age. The recommended dose for children of other age groups is no more than 0.15 ml (3 mg of iron) per kg of body weight 1–3 times a week, depending on the level of hemoglobin.

Maximum tolerated single dose venofer

Adults and elderly patients:

- for jet injection: 10 ml of the preparation Venofer® (200 mg of iron), the duration of administration is at least 10 minutes.

- for drip: depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg / kg and is administered 1 time per week, but it should not exceed 500 mg of iron.

Currently, it is known about the following adverse events that have a temporary and possible causal relationship to the administration of Venofer®. All symptoms were observed very rarely (incidence less than 0.01% and greater than or equal to 0.001%).

On the part of the nervous system: dizziness, headache, loss of consciousness, paresthesia.

On the part of the cardiovascular system: palpitations, tachycardia, lowering blood pressure, collaptoid states, feeling of heat, flushing, peripheral edema.

On the part of the respiratory system: bronchospasm, shortness of breath.

On the part of the gastrointestinal tract: diffuse abdominal pain, pain in the epigastric region, diarrhea, taste perversion, nausea, vomiting.

On the part of the skin: erythema, pruritus, rash, pigmentation disorders, increased sweating.

On the part of the musculoskeletal system: arthralgia, back pain, swelling of the joints, myalgia, pain in the limbs.

On the part of the immune system: allergic, anaphylactoid reactions, including swelling of the face, swelling of the larynx.

General disturbances and reactions at the injection site: asthenia, chest pain, feeling of chest heaviness, weakness, pain and swelling at the injection site (especially if the drug is extravasated), feeling unwell, pallor, fever, chills.

Venofer should be administered only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data (for example, serum ferritin or hemoglobin and hematocrit, the red blood cell count and their parameters — the average red blood cell volume, the average red blood cell count).

In / in iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

It is necessary to strictly observe the rate of administration of the drug Venofer® (with the rapid introduction of the drug can reduce blood pressure). A higher incidence of undesirable side effects (especially a decrease in blood pressure), which can also be severe, is associated with an increase in dose. Thus, the time of administration of the drug Venofer, given in the section "Dosage and Administration", must be strictly observed, even if the patient does not receive the drug in the maximum tolerated single dose.

Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during treatment with the drug Venofer.

It is necessary to avoid penetration of the drug into the near-venous space, since entering Venofer® outside the vessel leads to tissue necrosis and brown staining of the skin. In case of development of this complication to speed up the excretion of iron and prevent its further penetration into the surrounding tissues, it is recommended to apply heparin-containing preparations to the injection site (gel or ointment is applied with light movements, without rubbing).

Shelf life after the first opening of the container: from a microbiological point of view, the drug Venofer should be used immediately.

Shelf life Venofer after dilution with saline: chemical and physical stability after dilution at room temperature is maintained for 12 hours. From a microbiological point of view, the solution should be used immediately. If the drug Venofer was not used immediately after dilution, the user is responsible for the conditions and storage time, which in any case should not exceed 3 hours at room temperature if the dilution was carried out under controlled and guaranteed aseptic conditions.

Influence on ability to driving of the car and work with mechanisms

It is unlikely that the drug Venofer may have an undesirable effect on the ability to drive a car and work with mechanisms.

Venofer should not be administered simultaneously with oral dosage forms of iron, because helps to reduce the absorption of iron from the gastrointestinal tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.

Venofer can be mixed in one syringe only with sterile saline. No other solutions for the on / in the introduction and therapeutic drugs are not allowed, because there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of materials other than glass, PE and PVC has not been studied.

An overdose of Venofer may cause acute iron overload, which is manifested by symptoms of hemosiderosis.

Treatment: It is recommended to use symptomatic agents and, if necessary, iron-binding substances (chelates), for example, deferoxamine IV.

B. List: At 4–25 ° C. In the original packaging (do not freeze).

3 years