Zenalb 4.5, Human Albumin 4.5% Solution
国: マルタ
言語: 英語
ソース: Medicines Authority
情報リーフレット 有効成分:
ALBUMIN, HUMAN
から入手可能:
Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom
ATCコード:
B05AA01
INN（国際名）:
ALBUMIN, HUMAN
医薬品形態:
SOLUTION FOR INFUSION
構図:
ALBUMIN, HUMAN 4.5 percent weight/volume
処方タイプ:
POM
治療領域:
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
認証ステータス:
Authorised
承認日:
2006-03-24
情報リーフレット
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®
4.5
4.5% W/V SOLUTION FOR INFUSION
HUMAN ALBUMIN SOLUTION
ADL 18
REDE DESIGN LTD.
Tel: 020 8863 7676
JOB NO.
CLIENT:
CONTACT:
PROJECT NAME:
CLIENT ORDER NO.
DATE:
PROOF NO.
OPERATOR:
DOC. SIZE:
7754
BPL
Chidi Wek
Zenalb 4.5 PIL UK Leaflet UK
BPL233413
8/1/2008
7
Hema Joshi
150 x 220mm
PROOF APPROVED
PROOF UNAPPROVED
SIGNED
PLEASE READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
IN THIS LEAFLET:
1. WHAT ZENALB
®
4.5 IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN ZENALB
®
4.5
3. HOW YOU WILL BE GIVEN ZENALB
®
4.5
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZENALB
®
4.5
6. FURTHER INFORMATION
1. WHAT ZENALB
®
4.5 IS AND WHAT IT IS USED FOR
Zenalb 4.5
®
is a solution containing the active substance
called human albumin (a protein found naturally in your
blood which is needed for many different functions). Human
albumin is obtained from blood plasma from screened
donors selected from the USA.
Zenalb 4.5
®
is used to replace the blood or body fluids that
you have lost because of bleeding, surgery, or kidney
dialysis (blood “cleaning” by a machine). It contains a similar
amount of albumin as normal blood.
The product is given by injection into a vein (intravenous
infusion). It is only available on a doctor’s prescription.
This medicine is also suitable for premature babies and
patients on kidney dialysis as it contains only very small
quantities of aluminium.
2. BEFORE YOU ARE GIVEN ZENALB
®
4.5
DO NOT ALLOW ZENALB
®
4.5 TO BE GIVEN TO YOU IF YOU:
•
are allergic to albumin or any of the other ingredients of
Zenalb
®
4.5
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製品の特徴
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1.
NAME OF MEDICINAL PRODUCT
Zenalb
4.5, a Human Albumin 4.5% Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE INGREDIENTS
Human albumin is prepared from plasma from screened donors. Donors are selected from
the USA.
2.2
QUANTITATIVE COMPOSITION
Zenalb
4.5 is a clear, yellow to green, sterilised solution. It is a solution containing 40
- 50 g/L of plasma protein of which not less than 95% is albumin. Zenalb
4.5 is free from
the plasma proteins associated with the blood clotting mechanism and blood group
antibodies.
Zenalb
4.5 contains 100 - 160 mmol/L sodium. The assayed sodium content is stated on the
label of the bottle. For excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Zenalb
4.5 is an isotonic (and isooncotic) solution ready to be administered as an
intravenous infusion only.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zenalb
4.5 is used for restoration and maintenance of circulating blood volume where
volume deficiency has been demonstrated and use of a colloid, such as albumin, is
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zenalb
4.5 is given by intravenous infusion. In general the dosage and the infusion-rate
should be adjusted to the patient’s individual requirements.
In anaphylactic reactions, treatment should follow the current recommendations for shock
therapy.
4.2.1 POSOLOGY
The dose required depends on
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