HUMAN ALBUMIN

Active material: Human albumin
When ATH: B05AA01
CCF: Preparation of human albumin
ICD-10 codes (testimony): E86, G93.6, R57.1, R57.8
When CSF: 21.05.02
Manufacturer: Octapharma Pharmazeutika Production company m.b.H. (Austria)

Pharmaceutical form, composition and packaging

Solution for infusion 5% clear, from nearly colorless to pale yellow, yellow or light green color.

Excipients: sodium chloride, acetyltryptophan, caprylic acid, hydrochloric acid, Sodium hydroxide, water d / and.

100 ml – glass bottles (1) and holder – packs cardboard.
250 ml – glass bottles (1) and holder – packs cardboard.
500 ml – glass bottles (1) and holder – packs cardboard.

Solution for infusion 20% clear, from nearly colorless to pale yellow, yellow or light green color.

Excipients: sodium chloride, acetyltryptophan, caprylic acid, hydrochloric acid, Sodium hydroxide, water d / and.

50 ml – glass bottles (1) and holder – packs cardboard.
100 ml – glass bottles (1) and holder – packs cardboard.

Pharmacological action

Plasma-drug, obtained by fractionating human plasma.

Albumin solution 5% a plasma izoonkoticheskim. Albumin solution 20% It is hyperoncotic, and the colloid-osmotic effect superior to that of the plasma is about 4 times. The on / in the introduction of the drug increased oncotic pressure in the intravascular space, which leads to an increase and maintain the bcc. The duration of the effect in different patients can vary. In some patients, the increase in the plasma can be maintained for a few hours. Albumin is also a transport protein, binding and transporting the hormones in the bloodstream, enzymes, medications.

Pharmacokinetics

Distribution

The total exchange rate of albumin fraction is 4-5 g / kg body weight; Of this amount, 40-45% They are in the bloodstream, and 55-60% - In the extravascular space. Under pathological conditions (severe burns or septic shock) normal distribution of albumin broken, which is associated with a significant increase in capillary permeability.

Metabolism and excretion

T_1/2 albumin averages 19 days. Breeding takes place with the participation of intracellular lysosomal proteases.

In healthy volunteers under 10% on / in the albumin derived from the vascular bed in the first 2 hours after infusion. However, patients, critically endangered, can save substantial amounts of albumin, the rate of loss from the vascular bed is unpredictable.

Testimony

- Replenishment and maintenance in cases of BCC, when there is a deficit, and shows the use of colloids, in particular, during hypovolemic shock and hemorrhagic;

- Therapeutic plasmapheresis (replacement of plasma exchange);

- As an aid in carrying out operations with the use of cardiopulmonary bypass;

- Preoperative hemodilution and harvesting autologous blood components;

- Swelling of the brain (hyperoncotic solution).

Dosage regimen

Drug concentration, the dose and rate of infusion should be adjusted individually in each case.

Dose, required for administration, It depends on body weight, severity of the injury or disease and the continuing loss of fluid and protein. To determine the required dose should assess the adequacy of the bcc, rather than the level of albumin in plasma.

The solution is introduced into the albumin / drip. The infusion rate should be chosen depending on the condition of the patient and indications.

To 5% solution Albumin average single dose of 200-300 ml, the maximum dose - 500-800 ml. The recommended rate of administration - no more 60 drops / min.

To 20% solution single dose of albumin 100 ml. The recommended rate of administration - no more 40 drops / min.

When replacement plasma exchange the infusion rate may be higher, and must comply with the rate of removal.

In children dose set individually, taking into account the evidence, the clinical status and body weight of the patient. The recommended single dose of 0.5-1 g / kg. The drug can be used at the preterm infants.

The drug can be used at the patients, hemodialysis.

Recommendations for treatment with the drug

Before applying a solution of the drug should be carefully inspect. If the solution is cloudy or contains inclusions, it can not be used, tk. such changes may be indicative of the decay of the protein or microbial contamination.

Before the introduction of the drug should be kept at room temperature. The drug should be administered immediately after opening the bottle. The unutilized balance of the drug must be destroyed.

Albumin solution 20% if necessary, can be diluted with saline or 5% dextrose (Glucose). For this purpose, it is impossible to apply the water for injection.

Side effect

For the period post-marketing use of the drug noted the following adverse reactions.

The incidence of adverse reactions is classified as follows:: Often (>1/10); often (>1/100, <1/10); infrequently (>1/1000, <1/100); rarely (>1/10 000, <1/1000); rarely (<1/10 000, incl. isolated reports).

In applying the drug adverse reactions are rare. They are usually alone or with a decrease in the rate of termination of administration. In severe reactions administration should stop and start the appropriate treatment.

On the part of the immune system: rarely - anaphylactic reaction; very rarely - anaphylactic shock.

From the nervous system and psyche: very seldom - a headache, confusion.

Cardio-vascular system: rarely - hypotension; very rarely - tachycardia, bradycardia, arterial hypertension, flushing.

The respiratory system: very rarely - shortness of breath.

From the digestive system: very rarely - nausea.

Dermatological reactions: rarely – hives, angioedema, erythematous rash, increased perspiration.

Other: very rare - fever, tremor, pain in the lumbar region.

Contraindications

- Chronic heart failure decompensation;

- Pulmonary edema;

- Severe anemia;

- Gipervolemia;

- Hypersensitivity to albumin or other components of the drug.

FROM caution the drug should be used in patients with chronic renal failure, chronic heart failure in the phase compensation, compensated chronic anemia, hypertension, esophageal varices, gemorragicheskim diatezom, thrombosis, ongoing internal bleeding.

In elderly patients, to avoid overloading the cardiovascular system is recommended to avoid administration 20% solution, but when administered 5% a solution to avoid the introduction of high speed.

Pregnancy and lactation

The safety of the drug in pregnant women in controlled clinical trials has not been studied. Available clinical experience with albumin solution gives no grounds to expect any harmful effect on pregnancy, fetal or neonatal, since human albumin is a normal component of human blood plasma.

The impact of the drug on reproductive function in animals have not studied.

Cautions

When an allergic or anaphylactic reactions should immediately stop administering the drug and begin the appropriate treatment. In the case of shock should begin antishock treatment in accordance with applicable standards of treatment.

During the infusion is necessary to ensure thorough and regular monitoring of the parameters of the circulatory, incl. FROM, Heart Rate, central venous pressure, pressure “jamming” pulmonary artery, diuresis, electrolyte concentrations in plasma, hematocrit / hemoglobin.

With the introduction of albumin should monitor the concentration of sodium and potassium in the blood plasma of the patient and to take appropriate measures to restore or maintain the balance of electrolytes. It should be borne, that the concentration of sodium 5% and 20% solutions of the same.

If necessary, replacement of the relatively large amounts required to control blood clotting parameters and hematocrit. It should ensure the appropriate substitution of other blood components (clotting factor, electrolytes, platelets and red blood cells).

Introduction albumin solution during dehydration is possible only after first ensuring an adequate supply of liquid (inside, parenterally).

Since 20% albumin solution can effectively increase colloid osmotic pressure, in the process of introducing the patient should be monitored for timely detection of circulatory overload and hyperhydration.

Albumin can not be diluted with water for injections, since the introduction of the solution to the patient may cause hemolysis.

Standard measures to prevent infection, drug- induced, produced from human blood or plasma, They include selection of donors, check individual portions and plasma pools for specific markers of infection, and the inclusion of effective manufacturing process for the inactivation / elimination of viruses. Nonetheless, when using drugs, produced from human blood or plasma, we can not completely exclude the possibility of transmission of infectious agents. This also applies to unknown or newly identified viruses and other pathogens.

There were no reports of the transfer of viruses from solutions of albumin, produced by conventional methods in accordance with the specifications of the European Pharmacopoeia.

Each administration of the drug the patient is recommended to register the name of the drug and the number of series in the history of the disease or the patient's medical record in order, so that you can trace the relationship of the patient with the introduction of a specific product series.

Effects on ability to drive vehicles and management mechanisms

There was no effect of the drug on the ability to drive and use machines.

Overdose

Symptoms: in cases, when the dose and infusion rate too high or does not match the patient's circulatory, may develop fluid overload and its characteristic symptoms of overload the cardiovascular system (breathlessness, swelling of veins yaremnыh, headache). It is also possible increase in blood and / or central venous pressure, the development of pulmonary edema.

Treatment: at the first symptoms overload the cardiovascular system, stop administering the drug and establish a permanent monitoring of parameters of blood circulation. According to the testimony - symptomatic therapy. There are no specific antidotes.

Drug Interactions

Specific interactions of human albumin with other drugs known.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 25 ° C; Do not freeze. Shelf life – 3 year.