VOLUVEN 6% %w/v Solution for Infusion

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE

제공처:

Fresenius Kabi Limited

ATC 코드:

B05AA07

INN (International Name):

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE

복용량:

6% %w/v

약제 형태:

Solution for Infusion

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Blood substitutes and plasma protein fractions

승인 상태:

Authorised

승인 날짜:

2006-02-03

환자 정보 전단

VOLULYTE 6% SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
0xxxxx1/00 UK
 This medicine is subject to additional monitoring. This will allow
quick
identification of new safety information. You can help by reporting
any
side effects you may get. See the end of section 4 for how to report
side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Volulyte is and what it is used for
2.
What you need to know before you use Volulyte
3.
How to use Volulyte
4.
Possible side effects
5.
How to store Volulyte
6.
Contents of the pack and other information
1. WHAT VOLULYTE IS AND WHAT IT IS USED FOR
Volulyte is a plasma volume substitute that is used to restore the
blood
volume
when
you
have
lost
blood
when
other
products
called
crystalloids are not considered sufficient alone.
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
0xxxxx1_Volulyte_06_UK_PB 08.08.2017 08:11 Seite 1
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLULYTE
DO NOT USE VOLULYTE IF YOU:
•
are allergic to any of the active substances or any of the other
ingredients of this medicine
•
suffer from serious generalised infection (sepsis)
•
suffer from burn injury
•
have kidney impairment or receive dialysis
•
suffer from bleeding in the brain (intracranial or cerebral bleeding)
•
are critically ill (e.g. you need to stay in an intensive care unit)
•
have too much fluid in your body and you have been told that you
have a condition known as hyperhydration
•
have fluid in t

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Voluven 6% Solution for Infusion (PVC Bag)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Poly(O-2-hydroxyethyl)starch (Ph.Eur.)
60.0 g
- Molar substitution_:_ 0.38 - 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
Sodium chloride
9.00 g
Na
+
154 mmol
Cl
-
154 mmol
Theoretical osmolarity
308 mosmol/l
pH
4.0 - 5.5
Titratable acidity
< 1 mmol NaOH/l
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
A clear to slightly opalescent solution, colourless to slightly
yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypovolaemia due to acute blood loss when crystalloids
alone are not considered sufficient (see sections
4.2, 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use as infusion_._
USE OF HES SHOULD BE RESTRICTED TO THE INITIAL PHASE OF VOLUME
RESUSCITATION WITH A MAXIMUM TIME INTERVAL OF 24
H.
The
first
10-20
ml
should
be
infused
slowly
and
under
careful
monitoring
of
the
patient
so
that
any
anaphylactic/anaphylactoid reaction can be detected as early as
possible.
The daily dose and rate of
infusion depend on the patient’s
blood loss,
on the maintenance or
restoration of
haemodynamics and on the haemodilution (dilution effect).
The maximum daily dose is 30 ml/kg for Voluven 6%.
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