Country: Philippines
Language: English
Source: FDA (Food And Drug Administration)
Human Albumin
New Makerlink Pharmaceutical Corporation; Distributor: Metro Drug, Inc.
Human Albumin
200g/L (20% w/v)
Solution For Iv Infusion
50mL Glass vial (Box of 1's), 50mL Glass vial in a box
Kedrion S.P.A., Italy
2023-12-31
KEDRIALB 200g / L (20% w/v) Solution for IV infusion Blood Substitutes and Plasma Protein Fractions FORMULATION ACTIVE INGREDIENT 200 g / L of plasma proteins containing at least 95% of human albumin. LIST OF EXCIPIENTS 1 LITRE OF SOLUTION FOR INFUSION CONTAINS Sodium Chloride 4.52 g/L Sodium caprylate 2.660 g/L (16 mmol/L) Acetyltryptophan 3.940 g/L (16 mmol/L) Water for injections up to 1000 mL Total concentration of sodium 123.5 – 136.5 mmol/L PHARMACEUTICAL FORM Solution for infusion. PHARMACOTHERAPEUTICAL CATEGORY Solution of human albumin. THERAPEUTIC INDICATIONS Albumin replacement in patients with major albumin deficiency. CONTRAINDICATIONS • Hypersensitivity to human albumin preparations or to any of the excipients. • Allergic reactions to this preparation. • All conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient. Examples of such conditions are: - Decompensated cardiac insufficiency - Hypertension - Oesophageal varices - Pulmonary oedema - Haemorrhagic diathesis - Severe anaemia - Renal and post-renal anuria - Dehydration (unless sufficient fluid is infused simultaneously). SPECIAL PRECAUTIONS FOR USE If allergic reactions occur, the infusion should be stopped immediately. If allergic reactions persist, then appropriate treatment is recommended. In anaphylactic reactions, treatment should follow the current recommendations for shock therapy. The colloid-osmotic effect of human albumin 20% is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. If the required volume of Human Albumin (Kedrialb) 20% exceeds 200 mL, appropriate additional electrolyte solutions should be administered to maintain normal fluid balance. Alternatively, therapy may be continued with 5% human albumin so Read the complete document