Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
HUMAN PLASMA, PROTEIN
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
B05AA01
HUMAN PLASMA PROTEIN 200 g/l
SOLUTION FOR INFUSION
HUMAN PLASMA PROTEIN 200 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Withdrawn
2005-10-04
INSTRUCTIONS FOR USE HUMAN ALBUMIN 20 % BIOTEST LOW SALT CONTENT Active ingredient: Human albumin COMPOSITION 1000 ml solution contain: - ACTIVE INGREDIENTS: Human plasma protein 200 g of which albumin at least 96 % - EXCIPIENTS: Caprylate* 2.31 g (16 mmol) N-Acetyl-DL-tryptophanate* 3.94 g (16 mmol) Sodium 2.80 g (122 mmol) Chloride ≤ 3.90 g ( ≤ 110 mmol) Water for injections ad 1000 ml _*Stabilizer_ PRESENTATION Solution for intravenous infusion. Vial with 50 ml Vial with 100 ml PHARMACOTHERAPEUTIC GROUP / MODE OF ACTION Plasma protein fraction, plasma substitute The most important physiological functions of albumin result from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. NAME AND ADDRESS OF AUTHORIZATION HOLDER AND MANUFACTURER Biotest Pharma GmbH Landsteinerstraße 5 63303 Dreieich Germany INDICATIONS Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations. CONTRAINDICATIONS Hypersensitivity to albumin preparations or to any of the excipients. PREGNANCY AND LACTATION The safety of Human Albumin 20 % Biotest low salt content for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, Διαβάστε το πλήρες έγγραφο
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Human Albumin 20 % Biotest low salt content 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin 1000 ml solution contain 200 g human plasma protein of which at least 96 % is human albumin The product has a hyperoncotic effect. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements. POSOLOGY The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: − arterial blood pressure and pulse rate − central venous pressure − pulmonary artery wedge pressure − urine output − electrolyte − haemaotcrit / haemoglobin Human Albumin 20% Biotest low salt content is suitable for use in dialysis patients and premature infants. Page 2 of 5 METHOD OF ADMINISTRATION Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 0.9 % sodium chloride). The infusion rate should be adjusted according to the individual circumstances and the indication. 4.3 CONTRAINDI Διαβάστε το πλήρες έγγραφο