ЗЕНАЛЬБ-20
Active material: Albumin
When ATH: B05AA01
CCF: Plasma-drug
ICD-10 codes (testimony): E77.8, E86, K72, N00, P55, R57.1
When CSF: 21.05.02
Manufacturer: BIO PRODUCTS Laboratory (Great Britain)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Solution for infusion in the form of a transparent, slightly opalescent liquid from light yellow to yellow, allowed greenish tint.
| 1 ml | |
| protein (incl. human albumin, not less than 96%) | 200 mg |
Excipients: sodium chloride, caprylic acid, acetic acid, Sodium hydroxide, hydrochloric acid, sodium acetate trihydrate, ethanol, water d / and.
50 ml – colorless glass vials (1) – packs cardboard.
100 ml – colorless glass vials (1) – packs cardboard.
Pharmacological action
Plazmozameshchath means. Represents 20% sterile aqueous solution of albumin and produced from human blood plasma.
All donor plasma passes by approved methods and does not contain HBsAg, and antibodies to HIV-1, HIV-2 and HCV.
Zenalb 20 is hyperoncotic protein solution and on / in a bcc increases, due to diffusion of fluid from the interstitial space (provided, that the volume of the latter in the normal or increased). 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; from this quantity of 40-45% are in the bloodstream, and 55-60% – in the extravascular space. Under these pathological conditions, as severe burns or septic shock, normal distribution of albumin broken, which is associated with a significant increase in capillary permeability.
Deduction
The average T1/2 albumin is 19 days. Elimination takes place with the participation of intracellular lysosomal proteases. In healthy volunteers <10% introduced into / output from the albumin in 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
- a comprehensive treatment of hypovolemic shock;
- treatment and prevention of hypovolemia and hypoproteinemia (incl. with major surgical operations, sepsis, acute respiratory distress syndrome adults; removal of body fluids, protein rich / ascites /, pleural effusion; transfusion of large amounts of unfrozen washed erythrocytes);
- in the treatment of hemolytic disease of the newborn in order to reduce the level of free bilirubin in the blood (therapeutic plasma exchange);
- in acute liver failure to maintain plasma oncotic pressure and binding the excess amount of free bilirubin in the blood plasma;
- for preoperative hemodilution (receiving the additional volume of blood to fill cardiopulmonary bypass during coronary artery bypass surgery);
- to improve the therapeutic response in patients with acute nephritis, resistant to treatment with steroids or cyclophosphamide;
- the development of shock or hypotension in patients undergoing hemodialysis.
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 be assessed bcc, rather than the level of albumin in plasma.
Single dose for Adult is 100 ml / drip. The infusion rate should be chosen depending on the condition of the patient and indications.
The recommended rate of administration to patients with normal amounts bcc 12 ml / min (60-120 ml / h). Patients with severe hypovolemia drug should be administered at a rate of not more than 120 ml / h. The solution may be administered by infusion using a suitable kit for on / in the filter.
Dose set individually, taking into account the evidence, the clinical status and body weight of the patient. The recommended dose for single children It is between 0.5 to 1.0 g / kg.
Side effect
In conventional infusion 20% side effects are minimal albumin.
From the digestive system: nausea, vomiting, increased salivation.
Allergic reactions: mild transient urticaria to severe anaphylactic shock (suspend infusion, carry out a complex of medical measures).
Other: chills, hyperthermia, pain in the lumbar region. Treatment of patients with hypovolemia can lead to hemodilution, which lasts for a few hours.
Contraindications
- chronic heart failure decompensation phase;
- Pulmonary edema;
- Severe anemia;
- Gipervolemia;
- Hypersensitivity to albumin or other components of the drug.
FROM caution use in patients with chronic renal failure, chronic heart failure in the compensation phase, compensated chronic anemia, hypertension, oesophageal varices, hemorrhagic diathesis, vascular thrombosis, ongoing internal bleeding, senile patients and infants.
Pregnancy and lactation
Safety of the drug Zenalb-20 when used 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, fetus or newborn, since human albumin is a normal component of human blood plasma.
Effect Zenalb-20 on reproductive function in animals not studied.
Cautions
Prior to use, each vial is necessary to carefully examine: cloudy, freezes solutions, partially used vials should be destroyed.
Before infusion Zenalb-20 should be warmed to room temperature.
After puncture caps required dose should be administered within 3 h or immediately, if a small dose volume.
During the infusion should be carefully monitored for clinical condition of the patient to prevent fluid overload. The function of the circulatory system and respiratory depression should be monitored during and after treatment Zenalbom-20. The selection and screening of blood donors, and heat treatment of the preparation at 60 ° C for 10 h virtually eliminate the risk of infection by viruses contained in blood. However, to completely eliminate the risk of infection by viruses contained in the blood can not.
In Zenalb-20 is not necessary to add other drugs.
Effects on ability to drive vehicles and management mechanisms
Influence Zenalba-20's ability to not drive a car or work with mechanisms identified.
Overdose
Symptoms: dose at discrepancy, infusion rate of the patient's circulatory parameters, may develop fluid overload and its characteristic symptoms of overload the cardiovascular system (incl. breathlessness, swelling of veins yaremnыh, headache). It is also possible increase in blood pressure and / or central venous pressure, the development of pulmonary edema.
Treatment: should immediately stop the introduction of the drug and to constantly monitor the parameters of the patient's circulatory. According to the testimony – symptomatic therapy. There are no specific antidotes.
Drug Interactions
Do not mix Zenalb-20 with other drugs.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored in its original packaging away from children, dark place at a temperature of 2 ° to 25 ° C; Do not freeze. Shelf life – 3 year.
