Human albumin Grifols 5% solution for infusion 250ml bottles

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Albumin solution human

제공처:

Grifols UK Ltd

ATC 코드:

B05AA01

INN (국제 이름):

Albumin solution human

복용량:

50mg/1ml

약제 형태:

Solution for infusion

관리 경로:

Intravenous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 09020202

제품 특성 요약

OBJECT 1
HUMAN ALBUMIN GRIFOLS 50 G/L, SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 27-Jun-2017 | Grifols UK
Ltd
1. Name of the medicinal product
Human Albumin Grifols 50 g/l, solution for infusion.
2. Qualitative and quantitative composition
Human albumin
Human Albumin Grifols 50 g/l is a solution containing 50 g/l of total
protein of which at least 95% is
human albumin.
A vial of 100 ml contains 5 g of human albumin.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human Albumin Grifols 50 g/l is mildly hypooncotic to normal plasma.
The solution contains between 130 - 160 mmol/l of sodium and not more
than 2 mmol/l of potassium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless, yellow,
amber or green.
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 and 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
- haematocrit/haemoglobin
METHOD OF ADMINISTRATION
Human albumin can be directly administered by the intravenous route.
The infusion