Kedrialb 200g/L (20% w/v) Solution For Iv Infusion

Страна: Филипини

Език: английски

Източник: FDA (Food And Drug Administration)

Активна съставка:

Human Albumin

Предлага се от:

New Makerlink Pharmaceutical Corporation; Distributor: Metro Drug, Inc.

INN (Международно Name):

Human Albumin

дозиране:

200g/L (20% w/v)

Лекарствена форма:

Solution For Iv Infusion

Броя в опаковка:

50mL Glass vial (Box of 1's), 50mL Glass vial in a box

Произведено от:

Kedrion S.P.A., Italy

Дата Оторизация:

2023-12-31

Листовка

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