Medicinal Products

ALBUNORM 5%, 50 g / L 50 mg / mL

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Human albumin
laboratory: Octapharma France

Injection solution for IV infusion
Box of 1 bottle of 500 ml
All forms

Indication

Restoration and maintenance of circulating blood volume when volume loss has been demonstrated and use of a colloid is appropriate.

The choice of an albumin rather than a synthetic colloid depends on the clinical situation of each patient, based on the official recommendations.

Dosage ALBUNORM 5%, 50 g / L 50 mg / mL Solution for IV infusion Pack of 1 vial of 500 ml

The concentration of the albumin preparation, the dosage and the infusion rate must be individually adapted to the patient's needs.

Dosage

The dose required depends on the size of the patient, the severity of the trauma or pathology, and the extent of fluid and protein losses. Adequate measurement of circulating volume and not albumin should be taken into account when determining dosage.

If administration of human albumin is necessary, the hemodynamic parameters of the patient should be monitored regularly, including:

· Blood pressure and pulse;

· Central venous pressure;

· Pulmonary artery occlusion pressure;

· Urinary flow;

Electrolytes;

· Hematocrit / hemoglobinemia.

Administration mode

Human albumin can be administered directly intravenously.

The infusion rate must be adapted to each particular case and to the indication.

In plasma exchange, the infusion rate should be adjusted to the rate of elimination.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Albunorm side effects 5%, 50 G / L

Mild reactions, such as flushing, hives, fever and nausea, occur in rare cases. Normally, these reactions disappear rapidly when the infusion rate is reduced or the infusion is interrupted. Very rarely, severe shock-like reactions can occur. In the case of severe reactions, the infusion should be discontinued and appropriate treatment initiated.

The following adverse reactions have been observed with human albumin solutions after marketing and are therefore likely to occur with Albunorm 5%, 50 g / l.

Class of organ systems

reactions

(frequency not known) *

Immune system disorders

anaphylactic shock, anaphylactic reaction

hypersensitivity

Psychiatric disorders

state of confusion

Nervous system disorders

headaches

Heart conditions

tachycardia

bradycardia

Vascular disorders

hypotension

hypertension

flushing

Respiratory, thoracic and mediastinal disorders

dyspnea

Gastrointestinal disorders

nausea

Skin and subcutaneous tissue disorders

urticaria

Quincke's edema

erythematous rash

hyperhidrosis

General disorders and administration site conditions

pyrexia

chills

* Can not be estimated from the available data.

For information on the safety of transmissible infectious agents, see Warnings and Precautions for Use .

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