Active ingredients: Albumin
Behring Human Albumin 200 g / l
Why is Human Albumin used? What is it for?
Pharmacotherapeutic group: blood substitutes and plasma protein fractions, Albumin.
Behring Human Albumin 200 g / l is used for the restoration and maintenance of circulating blood volume in patients who have lost blood and / or body fluids for some reason and where the use of a colloid is appropriate.
The doctor may decide to use albumin rather than an artificial colloid based on the clinical situation of the individual patient and on the basis of official recommendations.
Contraindications When human albumin should not be used
Hypersensitivity to albumin preparations or to any of the excipients
Precautions for use What you need to know before taking Human albumin
Suspicion of an anaphylactic or allergic type reaction (symptoms may include swelling of the face, lips and throat, wheezing, feeling faint, shortness of breath, itching or redness) requires immediate interruption of the injection. In the event of shock, standard medical treatments for shock should be in place.
Albumin should be used with caution in conditions where hypervolemia (increased blood volume) and its consequences or hemodilution (dilution of the blood) may pose a risk to the patient. Examples of these situations are:
- Decompensated heart failure (severe heart failure)
- High blood pressure (increased blood pressure)
- Esophageal varices (dilation of the veins in the esophagus)
- Pulmonary edema (accumulation of fluid in the lungs)
- Hemorrhagic diathesis (predisposition to bleeding)
- Severe anemia (severe red blood cell deficiency)
- Renal and post-renal anuria (absence of urine production)
The colloid osmotic effect of albumin 200 g / l is approximately 4 times that of normal human plasma. Therefore, when administering concentrated albumin, care must be taken to ensure adequate hydration (fluid supply) to the patient. The patient must be carefully monitored in order to avoid circulatory overload and overhydration (increase in the total volume of water). in the body).
The 200 g / l albumin solution has a relatively low electrolyte content compared to human albumin solutions of 40 g / l. When albumin is administered, the patient's electrolyte status should be monitored (see section "Posology and method of administration") and all necessary measures to restore or maintain electrolyte balance should be taken.
Concentrated albumin solutions should not be diluted with water for injections, as this can cause haemolysis (destruction of red blood cells) in the patient.
If relatively large volumes are to be replenished, coagulation and hematocrit parameters must be monitored. Care should be taken to ensure adequate replenishment of other blood components (coagulation factors, electrolytes, platelets and erythrocytes).
If the dose and infusion rate are not adapted to the patient's circulatory situation, hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular congestion), arterial hypertension, venous hypertension or pulmonary edema, the "infusion must be stopped immediately.
Attention for those who practice sports: the active ingredient contained in this preparation is included in the list of substances prohibited for doping.
Behring Human Albumin 200 g / l contains 125 mmol / L sodium. This should be borne in mind in patients on a low-salt (hyposodic) diet.
Interactions Which drugs or foods can modify the effect of human albumin
No specific interaction of albumin with other medicinal products is known.
Human albumin must not be mixed with other drugs (except for the diluents recommended in the section "Posology and method of administration"), whole blood or red blood cell concentrate.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breastfeeding, tell your doctor. Your doctor will decide whether Behring Human Albumin can be used during pregnancy or breastfeeding.
The safety of Behring Human Albumin use during pregnancy has not been established in controlled clinical trials.
However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, the fetus or the newborn are to be expected as albumin is a normal constituent of human blood.
Available animal studies are insufficient to demonstrate safety with respect to reproduction, embryo and fetal development during pregnancy and peri or postnatal development.
Viral security
When medicines are made from human blood or plasma, specific measures are put in place to prevent infections being passed on to patients. These measures include "careful selection of blood and plasma donors to ensure that potentially infected donors are excluded and the screening of each donation and pool for any presence of viruses / infections.
Furthermore, the manufacturers of these drugs introduce certain steps in the processing of blood and plasma that can inactivate or remove viruses.
Despite these measures, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This also applies to viruses or other types of infectious agents, whether emerging or unknown.
There are no reports relating to viral transmissions with albumin produced according to consolidated processes and with specifications conforming to those of the European Pharmacopoeia.
It is strongly advised that each time you receive a dose of Behring Human Albumin, both the name and the batch number of the product are recorded, in order to maintain the traceability of the batch used.
Dosage and method of use How to use Human albumin: Dosage
The dose required depends on the patient's weight, the severity of the trauma or illness, and the protracted loss of fluids and proteins.
To determine the required dose, circulating volume rather than plasma albumin levels should be measured.
When administering human albumin, regular monitoring of haemodynamic parameters is recommended, such as:
- blood pressure and heart rate
- central venous pressure
- pulmonary artery wedge pressure
- urine production
- electrolytes
- hematocrit / hemoglobin.
Overdose What to do if you have taken too much human albumin
If the dose and infusion rate are not adapted to the patient's circulatory situation, hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular congestion), arterial hypertension, venous hypertension or pulmonary edema , the infusion must be stopped immediately and the patient's haemodynamic parameters carefully monitored.
Human Albumin should be administered intravenously, directly or diluted with an isotonic solution (eg 5% glucose or 0.9% sodium chloride). Mix with electrolyte solutions under aseptic conditions.
The rate of infusion depends on individual conditions and indications.
During plasmapheresis, the infusion rate should be adjusted according to the rate of elimination.
If large volumes are to be administered, the product should be brought to room or body temperature prior to use.
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or with deposits. This may indicate that the protein is unstable or that the solution has been contaminated. Once the bottle is opened, the contents should be infused immediately.
Side Effects What are the side effects of human albumin
Like all medicines, Behring Human Albumin can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The undesirable effects reported below are based on experience gained from post-market surveillance of the product and have been observed very rarely (less than 1 to 10,000 people treated, including single reported cases):
- General malaise and infusion site conditions: chills, fever, nausea, vomiting, headache, malaise and skin redness (flushing).
- Immune system disorders: hypersensitivity, allergic or anaphylactic reactions including skin rash, skin reactions, urticaria, dyspnoea, tachycardia, bradycardia, hypotension. In individual cases, these disorders can progress to shock and pose a particular risk to the patient.
Mild side effects usually disappear rapidly when the infusion rate is decreased or stopped. In the event of a serious event (such as anaphylactic shock) the infusion should be stopped immediately and appropriate treatment initiated.
For information on viral safety, see the section "Special warnings and special precautions for use"
Expiry and Retention
Store at a temperature below 30 ° C. Do not freeze.
Keep the bottle in the outer carton to protect it from light.
Do not use Behring Human Albumin after the expiry date which is stated on the label and carton after "EXP" The expiry date refers to the last day of the month.
Keep Behring Human Albumin out of the reach and sight of children.
Once the container has been opened, the contents should be used immediately.
All unused products or waste materials must be disposed of according to local laws in force. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BEHRING HUMAN ALBUMIN 200 g / l SOLUTION FOR INFUSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Behring Human Albumin 200 g / l is a solution containing 200 g / l of total protein, consisting of at least 96% human albumin.
A 50 ml bottle contains not less than 9.6 g of human albumin
The solution is hyper-oncotic compared to normal plasma.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution for infusion.
Clear and slightly viscous liquid; almost colorless, yellow, amber or green.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Restoration and maintenance of circulating blood volume, when hypovolaemia has been demonstrated and the use of a colloid is appropriate.
The choice of albumin rather than an artificial colloid depends on the patient's clinical situation, according to official recommendations.
04.2 Posology and method of administration
The concentration of the albumin preparation, the dose and the infusion rate must be adapted to the individual needs of the patient.
Dosage
The dose required depends on the patient's weight, the severity of the trauma or illness, and the protracted loss of fluids and proteins.
To determine the required dose, circulating volume rather than plasma albumin levels should be measured.
When administering human albumin, regular monitoring of haemodynamic parameters is recommended, such as:
• blood pressure and heart rate
• central venous pressure
• wedge pressure in the pulmonary artery
• urine production
• electrolytes
• hematocrit / hemoglobin.
Method of administration
Human albumin should only be administered intravenously directly or diluted in an isotonic solution (eg 5% glucose or 0.9% sodium chloride). See section 3 and section 6.6.
The rate of infusion should be determined according to the patient's status and indications.
In plasmapheresis the rate of infusion should be adjusted according to the rate of elimination.
04.3 Contraindications
Hypersensitivity to albumin preparations or to any of the excipients.
For special warnings on excipients, see section 4.4.
04.4 Special warnings and appropriate precautions for use
Suspicion of allergic or anaphylactic-type reactions requires immediate discontinuation of the infusion. In case of shock, treatment should follow current prescriptions for shock treatment.
Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution may pose a particular risk to the patient. Examples of such conditions are:
• decompensated heart failure
• hypertension
• esophageal varices
• pulmonary edema
• bleeding diathesis
• severe anemia
• renal and post-renal anuria
The colloid osmotic effect of albumin 200 g / l is approximately 4 times that of normal human plasma. Therefore, when administering concentrated albumin, it is recommended to pay particular attention to ensure adequate hydration to the patient. Patients should be carefully monitored in order to avoid circulatory overload and overhydration.
200 g / l albumin solutions are relatively low in electrolytes compared to 40 g / l human albumin solutions. When albumin is administered, the patient's electrolyte status must be monitored (see section 4.2) and all necessary measures must be taken to restore or maintain electrolyte balance.
Albumin solutions should not be diluted with water for injections, as this can cause hemolysis in the patient.
If relatively large volumes are to be replenished, coagulation and hematocrit parameters must be monitored. Care should be taken to ensure adequate replenishment of other blood components (coagulation factors, electrolytes, platelets and erythrocytes).
If the dose and infusion rate are not adapted to the patient's circulatory situation, hypervolemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular congestion), arterial hypertension, venous hypertension or pulmonary edema, the "infusion must be stopped immediately.
Behring Human Albumin 200 g / l contains 125 m / mol of sodium. This should be borne in mind in patients on a low-salt (hyposodic) diet.
Viral security
Standard measures taken to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the "inactivation / removal of viruses.
However, when medicinal products prepared from human blood or plasma are administered, the possibility of transmission of infectious agents cannot be totally excluded. This also applies to viruses and other emerging or unknown pathogens.
There are no reports relating to the transmission of viruses with albumin produced through procedures adhering to the specifications of the European Pharmacopoeia.
It is strongly advised that each time you receive a dose of Behring Human Albumin 200 g / l, both the name and the batch number of the product are recorded, in order to maintain the traceability of the batch used.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions of human albumin with other medicinal products.
04.6 Pregnancy and breastfeeding
The safe use of Behring Human Albumin 200 g / l during pregnancy has not been established in controlled clinical studies.
However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, the fetus or the newborn are to be expected as albumin is a normal constituent of human blood.
No animal reproduction studies have been conducted with Behring Human Albumin 200 g / l.
Available animal studies are insufficient to establish safety with respect to reproduction, development of the embryo and fetus, during pregnancy and peri- or postnatal development.
04.7 Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
04.8 Undesirable effects
Very rarely (less than 1 to 10,000 people treated, including individual cases reported), the following adverse reactions have been observed which are based on post-marketing surveillance:
Generalized malaise and infusion site conditions
chills, fever, nausea, vomiting, headache, malaise and skin redness (flushing).
Disorders of the immune system
Hypersensitivity, allergic or anaphylactic reactions including skin rash, skin reactions, urticaria, dyspnoea, tachycardia, bradycardia, hypotension. In individual cases, these disorders can progress to shock and pose a particular risk to the patient.
Mild side effects usually disappear rapidly when the infusion rate is decreased or stopped. In the event of a serious event (such as anaphylactic shock) the infusion should be stopped immediately and appropriate treatment initiated.
For information on viral safety, see section 4.4.
04.9 Overdose
If the dose or rate of infusion is too high, hypervolemia may occur.
At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular congestion), increased blood pressure, increased venous pressure and pulmonary edema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: blood substitutes and plasma protein fractions.
ATC code: B05AA01.
From a quantitative point of view, human albumin constitutes more than half of the total plasma proteins and represents about 10% of the liver protidosynthetic activity.
Physico-chemical data: Human albumin 200g / l has a hyperoncotic effect compared to normal plasma.
The most important physiological functions of albumin are represented by its contribution in maintaining the oncotic pressure of the blood and by its transport function. Albumin stabilizes the circulating blood volume and has a transport function for hormones, enzymes, drugs and toxins.
05.2 Pharmacokinetic properties
Under normal conditions, the total volume of replaceable albumin is 4-5 g / kg of body weight, of which 40-45% is present in the intravascular space and 55-60% in the extravascular space. An increase in capillary permeability alters albumin kinetics and abnormal distribution may occur after severe burns or during septic shock.
Under normal conditions, the mean albumin half-life is approximately 19 days. The balance between synthesis and catabolism is normally achieved by a feedback mechanism. Elimination is mainly intracellular, by lysosomal proteases.
In healthy subjects less than 10% of the infused albumin leaves the intravascular compartment during the two hours following the infusion. There may be considerable individual variations in the effect on plasma volume. In some patients the plasma volume may be increased for a few hours. However, in critically ill patients, albumin may escape from the intravascular space in significant quantities, for example an unpredictable speed.
05.3 Preclinical safety data
Human albumin is a normal constituent of human plasma and acts like physiological albumin.
In animals, single dose toxicity testing is of little relevance and does not allow for the assessment of toxic or lethal dose or a dose-effect relationship. Repeated dose toxicity testing is impractical for the development of antibodies against heterologous proteins in animal models.
To date, no cases of association between human albumin and embryo-fetal toxicity, or mutagenic or oncogenic potential, have been reported.
No signs of acute toxicity have been described in animal models.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium ion 125 mmol / liter
Chlorine ion max 100 mmol / liter
Caprylate ion 16 mmol / liter
N-acetyl-DL-tryptophanate ion 16 mmol / liter
HCl or NaOH (in small quantities for pH correction)
Water for injections
06.2 Incompatibility
Behring 200g / l human albumin must not be mixed with whole blood, red blood cell concentrates and other drugs (apart from the diluents recommended in section 6.6).
06.3 Period of validity
36 months.
Behring Human Albumin 200g / L should not be used beyond the expiration date stated on the outer carton and bottle label.
Once opened, the content must be used immediately.
06.4 Special precautions for storage
Store at a temperature below 30 ° C. Do not freeze.
Keep the container in the outer carton to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
1 x 50ml clear glass infusion bottle (Type II) with aluminum seal, rubber stopper and plastic flipp-off disc.
06.6 Instructions for use and handling
The solution can be administered directly intravenously.
Albumin 200 g / l can optionally be diluted in an isotonic solution (eg 5% glucose or 0.9% sodium chloride).
Albumin solutions should not be diluted with water for inept preparations, as this can cause haemolysis in the patient.
If large volumes are to be administered, the product should be brought to room or body temperature prior to use.
Do not use solutions that are cloudy or have deposits. Such conditions could indicate that the protein is not stable or that the solution has been contaminated.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
CSL BEHRING S.p.A.
Piazzale S. Turr, 5
20149-Milan
08.0 MARKETING AUTHORIZATION NUMBER
BEHRING HUMAN ALBUMIN 200 g / l - AIC n. 011544020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
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10.0 DATE OF REVISION OF THE TEXT
April 2010
