Medicinal Products

HUMAN ALBUMIN BAXT 200 g / L 200 mg / mL

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

Injection solution for IV infusion
Box of 1 bottle of 50 ml
All forms

Indication

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.

Dosage

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,

· Diuresis,

Electrolytes,

· Hematocrit / hemoglobin.

· Clinical signs of respiratory / cardiac failure (eg dyspnea)

· Clinical signs of increased intra-cranial pressure (eg headache)

Administration mode

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.

Against indications

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)

Very common

Frequent

Rare

Rare

Very rare

Immune system disorders

Anaphylactic shock

Gastrointestinal disorders

nausea

Skin and subcutaneous tissue disorders

flushing,

skin rash

General disorders and administration site conditions

fever

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 .

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