Alburex 20% solution for infusion 100ml vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Albumin solution human

থেকে পাওয়া:

CSL Behring UK Ltd

এটিসি কোড:

B05AA01

INN (আন্তর্জাতিক নাম):

Albumin solution human

ডোজ:

200mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 09020202; GTIN: 5028360000718

তথ্য লিফলেট

1
CSL BEHRING
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUREX
® 5, 50 G/L, SOLUTION FOR INFUSION &
ALBUREX
® 20, 200 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or healthcare
professional.
•
If you get any side effects, talk to your doctor or healthcare
professional. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Alburex is and what it is used for
2.
What you need to know before you are given Alburex
3.
How to use Alburex
4.
Possible side effects
5.
How to store Alburex
6.
Contents of the pack and other information
1.
WHAT ALBUREX IS AND WHAT IT IS USED FOR
WHAT ALBUREX IS
Alburex is a plasma substitute.
HOW ALBUREX WORKS
Albumin stabilises the circulating blood volume. It is a carrier of
hormones, enzymes, medicines
and toxins. The albumin protein in Alburex is isolated from human
blood plasma. Therefore the
albumin works exactly as if it was your own protein.
WHAT ALBUREX IS USED FOR
Alburex is used to restore and stabilise the circulating blood volume.
It is normally used under
intensive care situations, when your blood volume has decreased
critically. This may be the case
e.g.:
•
due to severe loss of blood after an injury,
_or_
•
due to a large surface burn
The choice of using Alburex will be made by your doctor. It will
depend on your individual
clinical situation.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALBUREX

Read this section carefully. The information given should be taken
into consideration by
you and your doctor before you are given Alburex.
DO NOT USE ALBUREX
•
If you are allergic (hypersensitive) to human albumin or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS

Talk to your doctor or healthcare professional before you are given
Alburex.
Which circu

পণ্য বৈশিষ্ট্য

OBJECT 1
ALBUREX 20, 200G/L, SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 20-Feb-2015 | CSL Behring
UK Limited
1. Name of the medicinal product
Alburex
®
20, 200 g/l, solution for infusion
2. Qualitative and quantitative composition
Alburex 20 is a solution containing 200 g/l of total protein of which
at least 96% is human albumin.
One vial of 50 ml contains 10 g of human albumin.
One vial of 100 ml contains 20 g of human albumin.
Alburex 20 is hyperoncotic to normal plasma.
Excipient with known effect:
Alburex 20 contains approximately 3.2 mg sodium per ml of solution
(140 mmol/l).
For the 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
_Paediatric population_
The posology in children and adolescents (0-18 years) should be
adjusted to the patient's individual
requirements.
Method of administration
Human albumin can be direct