- Country of manufactureFrance
active ingredients: 1000 ml of solution contain to acid lemon (monohydrate) of 8 g, sodium of citrate (dihydrate) of 22 g, glucose of monohydrate (dextrose) of 24,5 g;
excipient: water for injections.
Dosage form. Solution.
Pharmacological group. An auxiliary way for hemotransfusions. Code of automatic telephone exchange V07A C.
Indications. For carrying out an automatic aferez of blood or its components.
Contraindications. Hypersensibility to preparation components. For a cellular aferez to check a hemostasis. To apply only to the automated plasma exchange or procedures of a tsitoferez.
It is impossible to carry out aferez at a serious illness of blood with haemo static problems, violations of brain blood circulation, a pericardiac or endokardialny disease of heart, the postoperative period after intervention on the central nervous system and a spinal cord.
Method of application and doses.
Not to apply solution to direct intravenous administration.
Solution is intended for application only in the equipment for a plasma exchange. Procedure of blood sampling and processing of its components need to be carried out according to the instruction for use of the equipment with observance of strict rules of an asepsis.
At the transfusion of blood or its components containing dextrose citrate Anticoagulant solution A such collateral reactions can be observed.
From immune system: approximately in 1% of transfusions fever and a fever are noted.
Allergic reactions are usually shown in the form of the small tortoiseshell, but occasionally can also include difficulty of breath and angioneurotic hypostasis.
Anafilaktoidny reactions, heavy short wind, hypostasis of lungs and/or hypostasis of a throat, bronchospasm and/or laryngospasm can be very rare, but dangerous collateral reactions.
From system of blood and lymphatic system: at a high speed of introduction or a transfusion of large volumes of blood it can be observed to the tsirkulyatoyena of an overload that leads to hypostasis of lungs. Patients of advanced age and such are exposed to the greatest risk that suffer on heavy chronic anemia.
From warm system: fast infusion of a large amount of cold blood can reduce the body temperature of the patient that can lead to cardiac arrhythmia and even to cardiac arrest.
From nervous system: in isolated cases a paresteziya, generally around a mouth, and also muscular twitching was reported about neurotoxic side effects, such as.
Metabolic violations and violations from heart: at introduction of large volumes of blood or its components the following metabolic complications can be noted.
At patients with a serious illness of a liver or kidneys the tsitratna toxicity can be observed that leads to decrease in level of the ionized calcium owing to presence at blood circulation of a large amount of tsitratny anticoagulant. Tsitratna blood that is entered with a high speed, can quickly get into heart and cause ventrikulyarny arrhythmia. The electrocardiogram and control of level of the ionized calcium in plasma are necessary for identification of physiologically essential changes of level of calcium.
Other metabolic complications that occasionally meet, especially at patients with violations are blood circulation or a metabolism, include acidosis or alkaloz, and also hyper - or a gipokaliyemiya.
General frustration: seldom - nausea and vomiting; very seldom - a headache.
At emergence of collateral reactions it is necessary to stop transfusion, to estimate a condition of the patient and to accept the relevant therapeutic activities.
At fast transfusion (infusion speed - more than 5 ml/min. ) a large number of the components of blood prepared when using haemo preservative the tsitratna a nefrotoksichnost and a gepatotoksichnost, a gipokaliyemiya can develop; at fast massive transfusion of cold components of blood there can be a hypothermia with risk of development of arrhythmia, a hypoxia.
Spasms, vomiting, arterial hypotension, tachycardia are possible.
At overdose symptomatic therapy.
If necessary enter calcium, overdose symptoms will not disappear yet.
Application during pregnancy or feeding by a breast
Do not carry out aferez during pregnancy or feeding by a breast (except for a plasma exchange if there is a need).
Data are absent.
Special security measures
Not to apply a preparation if packing from aluminum foil is open or damaged. Not to apply if solution muddy.
Application term from the moment of opening of packing makes 10 days.
Features of application
Not to twist.
Before application to check an expiry date.
Septic risk, risk of the wrong application.
To store at a temperature not above 35 °C.
PVC corresponds to the European Pharmacopoeia. DEHP softener. The biological product, is stored and/or circulates in this device, contains phthalates.
The unused remains should be destroyed according to local rules on potentially dangerous biological products.
Calcium introduction is necessary for a thicket throughout a cellular aferez to limit decrease in level of the ionized calcium.
There is a possibility of complications at fast transfusion of a large amount of blood with a solution A dextrose citrate Anticoagulant dosage at patients with the broken function of a liver and kidneys or with heart diseases (the gipokaliyemiya can lead to warm frustration). In that case it is necessary to watch potassium level in an organism.
For prevention of emergence of a hypothermia as complication, it is necessary to warm up blood up to the temperature of 37 °C when passing via the device for blood transfusion.
The container with solution should be taken out from external packing just before application.
After removal of a protective bag it is necessary to check the container for lack of leak by strong compression within 1 min. At leak detection to merge solution as its sterility can be broken.
Ability to influence reaction speed at management of motor transport or work with other mechanisms
After carrying out an aferez rest therefore it is not necessary to operate motor transport is necessary or to work with other mechanisms.
Interaction with other medicines and other types of interactions
Are not established.
Farmakodinamika. Dextrose citrate anticoagulant solution A - sterile apirogenny solution which interferes with turning of blood and provides necessary nutrients for extension of a metabolism and stabilization of cages in a blood storage time. As in case of other live systems, integrity of blood cells in a storage time depends on exact biochemical balance of many substances, especially glucose, hydrogen ions (rn) and adenosine triphosphoric acid (ATP). For maintenance of continuous process of production of ATP by glycolysis glucose has to be available in necessary quantity. Amount of lemon acid and citrate of sodium it is sufficient for binding of the ionized calcium which is present at whole blood. Citrate prevents fibrillation by suppression of several stages of coagulative system, dependent on calcium.
Pharmacokinetics. It is not investigated.
The main physical and chemical svoystva: prozrachny colourless or slightly yellowish liquid.
Not to mix with any other medicines.
Before packing opening: 24 months.
After packing opening: 10 days.
To store at a temperature from 0 to 35 °C.
Solution of 500 ml in the container from PVC.
Category of holiday
It is applied only in the conditions of a hospital.