Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Human albumin
Injection solution for IV infusion
Box of 1 bottle of 50 ml
Restoring and maintaining the volume of circulating blood when a volume deficit has been established and the use of a colloid is appropriate.
The choice of albumin preferentially to a synthetic colloid will depend on the clinical state of each patient, based on official recommendations.
Dosage HUMAN ALBUMIN BAXT 200 g / L 200 mg / mL Solution for injection for IV infusion Box of 1 bottle of 50 ml
The concentration, dosage and infusion rate should be appropriate for each particular case.
The dose required depends on the size of the patient, the severity of the trauma or condition, and the persistence of fluid and protein losses. The adequacy of the circulating volume and not the plasma albumin levels should be measured to determine the dose required.
If human albumin is to be administered, hemodynamic parameters should be regularly monitored, and may include:
· Blood pressure and pulse,
· Central venous pressure,
· Pulmonary artery occlusion pressure,
· Hematocrit / hemoglobin.
· Clinical signs of respiratory / cardiac failure (eg dyspnea)
· Clinical signs of increased intra-cranial pressure (eg headache)
Human albumin Baxter 200 g / l solution for infusion can be administered directly intravenously, or also diluted in isotonic solution (eg 5% glucose or 0.9% sodium chloride).
The infusion rate must be adapted to each particular case and to the different indications.
In plasma exchange, the infusion rate must be adjusted to the purification rate.
Hypersensitivity to albumin preparations or to any of the excipients.
Adverse effects Albumin Human Baxt 200 G / L
The frequency was assessed using the following criteria: very common (≥1 / 10), frequent (≥1 / 100, ≤1 / 10), uncommon (≥1 / 1, 000, ≤1 / 100), rare (≥1 / 10, 000, ≤1 / 1, 000), very rare (<1 / 10, 000), frequency unknown (can not be estimated from available data)
Immune system disorders
Skin and subcutaneous tissue disorders
General disorders and administration site conditions
In case of a severe reaction, the infusion must be stopped and appropriate treatment initiated.
The following side effects have been reported during post-marketing surveillance.
These adverse effects are presented according to the MedDRA organ-class system classification, then by preferential terms in order of severity.
Immune system disorders: anaphylactic reactions, hypersensitivity / allergic reactions
Nervous system disorders: headaches
Cardiac disorders: tachycardia
Vascular disorders: hypotension
Respiratory, thoracic and mediastinal disorders : dyspnoea
Gastrointestinal disorders: vomiting, dysgeusia
Skin and subcutaneous tissue disorders : urticaria, pruritus
General disorders and administration site conditions: chills.
No data are available on adverse effects from controlled clinical trials with human albumin.
For information on viral safety, see the Warnings and Precautions section .