albumin 20%
Sanquin
TRADE NAME OF THE MEDICINAL PRODUCT
The trade name of product is Cealb®.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Cealb® consists of a protein fraction prepared from human venous plasma. The preparation is delivered as a sterile and pyrogen-free solution and has a protein concentration of 200 g/l, of which at least 95% is albumin.
Description
Cealb® is packing a glass bottle containing a slightly viscous, yellowish liquid, which has a rubber bung and a sealed cup. The glass bottle will be filled with 50 ml or 100 ml of liquid.
ACTION
Cealb® consists of a protein fraction prepared from human venous plasma. The preparation is delivered as a sterile and pyrogen-free solution and has protein concentration of 200 g/l of which at least 95% is albumin.
Albumin is the most important protein fraction in the circulation; approximately 60% of all plasma protein consists of albumin. The average concentration in plasma is 42 g/l. Albumin has water binding capacity: 1 gram of albumin binds 18 grams of water. This help to explain one of the most important physiological functions of albumin, the maintenance of colloid osmotic pressure. In this way, the blood volume is maintained.
As a result, the product has a four times higher colloid osmotic effect as compared to plasma and thereby a relatively strong fluid retention capacity.
In addition, albumin has a transportation function for metabolism products and some drugs. Also important is its capacity to buffer blood.
Albumin solution can be applied in situations of plasma or blood volume deficit and in situations of an oncotic deficit.
Viral safety
Cealb® is prepared from venous plasma by means of ethanol fractionation. The plasma has to be derived from voluntary, non-remunerated donors who satisfy the requirements of the Blood Transfusion Council of the Netherlands Red Cross. This means, among other things, that every individual donation has been tested and found negative for hepatitis B surface antigen (HbsAg), for antibodies against human immunodeficiency viruses 1 and 2 ( HIV-1 and HIV-2, the inducers of AIDS) and for antibodies against hepatitis C virus. Manufacturing by means of ethanol fractionation and the pasteurization of Cealb® (heating of the infusion solution at 60°C during 10 hours) ensure that the risk of transmission of viral diseases, in particular AIDS, hepatitis B and hepatitis non-A, non-B (including hepatitis C) will be extremely small.
Pharmaceutical form
Cealb® is delivered as a solution for infusion for intravenous use.
CLINICAL PARTICULARS
Therapeutic indications
Cealb® is indicated especially for application in clinical situations where large amounts of plasma protein with low sodium levels must be administered.
After dilution to an iso-oncotic solution Cealb® can be applied in cases of volume deficit.
Cealb® is indicated in the following situations:
- Imminent or existing cases of shock, such as during severe bleeding and burns.
- As adjuvant in the treatment of hyperbilirubinemea of pre-mature babies or newborns.
- Nephrotic syndrome
- Severe postoperative hypoalbuminemia
- Severe albuminemia in premature babies or newborns.
Posology and method of administration
The dosage and the duration of therapy depend upon the severity of the clinical situation of the patient and on the type of illness.
It is recommended that the undiluted product be administered at a rate 120 ml/h. Diluted to an iso-oncotic solution the product should be administered at a rate of 200-250 ml/h.
Cealb® should be administered intravenously. During administration of Cealb® the central venous pressure should be monitored.
Contra-indications
Cealb® is contraindicated in the following situations:
- proven hypersensitivity to albumin preparations
- every situation in which hypervolaemia or haemodilution can form a special risk; this has to be judged in each individual case. Examples of such conditions are:
- heart failure
- hypertension
- oesophageal varices
- pulmonary oedema
- haemorrhagic diathesis
- severe anaemia
- renal and postrenal anuria
- dehydrated patients, unless at the same time sufficient fluid is administered to the patient orally or by infusion.
In the administration of Cealb®, the blood group of the patient does not need to be considered.
If large quantities are administered, coagulation's parameters and haematocrit should be monitored. If necessary, other blood components (coagulation factors, electrolyte, platelets and erythrocyte) should be replaced insufficient measure. If the haematocryte drops below 30%, packed red cells should be given to maintain the oxygen transport capacity of the blood.
In older patients and in potential heart failure situations: beware of hypervolaemia. If allergic reactions occur, the infusion should be stopped immediately. If the allergic reaction persists or in case of an anaphylactic reaction, appropriate measures should be taken.
When components of human blood or plasma are administered, the transmission of infectious diseases or pathogens cannot be completely ruled out. This is also true for potential pathogens, which are as yet unknown. To limit the risk of transmission of pathogens, appropriate measures are taken. The rise in blood pressure which may follow rapid administration of albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at the lower blood pressure, otherwise new haemorrhage and shock may occur. Immediately before administration, a visual check should be made whether the contents of the vial are not turbid and do not contain any sedimentation. If this is the case, do not use the vial! If kept at lower temperatures, the product must be brought to room temperature before administration.
Interactions with other medicaments and other forms of interaction
Clinically relevant undersirable interactions of Cealb® with other drugs are not known.
Pregnancy and lactation
The safety of human albumin for use in human pregnancy has not been established in controlled clinical trials. Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or the foetus, the course of the pregnancy and the peri and postnatal development. However, albumin is a normal constituent of human blood. As for as known, Cealb® can be used according to prescription in pregnancy and lactation, without harm to foetus.
Effect on ability to drive and use machines
Cealb® has no influence on the ability to drive and use machines
Undesirable effects
Side effects are rare during or after infusion of albumin preparations. Mild reactions such as flush, urticaria, fever and nausea usually disappear quickly if the infusion is decreased if the infusion rate is temporarily stopped. Severe hypersensitivity reactions with shock are very rare. In these cases the administration should be stopped and appropriate measures must be taken.
Overdose
Cealb® should be administered while monitoring the central venous pressure in a dose dependent upon the clinical situation of the patient and the type of underlying illness. In this way overdose can be prevented.
Overdosing with plasma substitution fluids is expressed by hypervolaemia. This can cause the following symptoms: headache, dyspnoea, increased central venous pressure, increase in blood pressure and pulmonary oedema.
In such situations, the administration of Cealb® should be stopped immediately. Depending upon the clinical situation, the treatment consists of, among others, fluid restriction, increasing cardiac output and the induction of increased diuresis.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Cealb® is a plasma volume expander. Albumin is the most important protein fraction in the circulation. Approximately 60% of all plasma protein consists of albumin. The average concentration in plasma is 42 g/l. Albumin has water binding capacity: 1 gram of albumin binds 18 grams of water. This helps to explain one of the most important physiological function of albumin, the maintenance of colloid osmotic pressure. In this way, the blood volume is maintained.
Cealb® contains 200 g/l of protein, of which at least 95% is albumin. As a result, the product has a four times higher colloid osmotic effect as compared to plasma and thereby a relatively strong fluid retention capacity. In addition, albumin has transportation function for metabolism products and some drugs. Also important is its capacity to buffer blood.
Albumin solutions can be applied in situations of plasma or blood volume deficit and in situations of an oncotic deficit.
Pharmacokinetic properties
Absorption: because Cealb® is to be administered intravenously, there is no absorption phase. The bioavailability of albumin administered to the patient will be 100%.
Distribution: the albumin administered to the patient will be distributed like native albumin. Under normal circumstances, the body contains 4-5 g/kg of albumin, of which 40-45% is present intravascularly and 55-60% in the extravascular compartment. Under normal circumstances, less than 10% of the albumin administered will leave the intravascular compartment during the first two hours. As a result, the circulating volume will increase during 1 to 3 hours after administration. An abnormal distribution of albumin can occur under certain circumstances such as during the first 24 hours after severe burns and during septic shock.
Metabolism/elimination: albumin is broken down into freely available amino acids. It is unknown where this breakdown process takes place. In healthy individuals, the half life is 18 days. The albumin catabolism may be increased under certain circumstances, such as during infections, malignancy and stress situations such as surgery and serious diseases. Albumin is not excreted by the healthy kidney.
Preclinical safety data
Not applicable.
PHARMACEUTICAL PARTICULARS
List of excipients
Cealb® consists of a protein fraction prepared from human venous plasma. The preparation is delivered-as a sterile ond pyrogen-free solution and has a protein concentration of 200 g/l, of which at least 95% is albumin. In addition to albumin, small amounts of other plasma protein are present, such as pre-albumin and haptoglobin. The solution contains 145 mmol/l sodium, less than 0.05 mmol/l potassium per gram of protein, 20 mmol/I caprylate and 20 mmol/I mandelate as stabilizers.
Incompatibilities
No drugs should be added to Cealb®. Because of the possibility of the occurrence of incompatibilities, Cealb® should also not be administered simultaneously with drugs, that is to say in the same infusion.
In case of volume suppletion Cealb® should be diluted with an isotonic solution (e.g, 0.9% sodium chloride) in view of its four times higher colloid osmotic effect as compared to plasma. In this case there exists no incompatibility.
Self life
Cealb® has a shelf life of 4 years. When stored according to the instructions, the product can be kept until the date indicated on the package. After this date, it may no longer be used.
Cealb® must be intravenously administered as soon as possible, but ultimately within 3 hours after puncturing the stopper. If the contents are only partially used, the remainder must be destroyed.
Special precautions for storage
Cealb® must be stored at 2°C to 25°C, protected from light.
Nature and contents of container
Cealb® 50 ml and 100 ml, is supplied in clear glass vials (glass type II ) fitted with a bromobutyl rubber stopper, sealed with an aluminium cap.
Instructions for use/ handling
In case of volume suppletion Cealb® in view of its four times higher colloid osmotic effect as compared to plasma should be diluted with an isotonic solution (e.g. 0.9% sodium chloride) to an iso-oncotic solution.
NAME OR STYLE AND PERMANENT ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE HOLDER OF THE MARKETING AUTHORIZATION
Manufacturered by:
Sanquin
Amsterdam, the Netherlands, tel. +31 20 512 3355
Imported by:
PT. Graha Farma,
Solo - Indonesia
HARUS DENGAN RESEP DOKTER
Reg. No.: DKI0706700249A1
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