Sodium Chloride 0.45% w/v Solution for Infusion

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Sodium chloride

Доступна с:

Baxter Healthcare Limited

код АТС:

B05XA; B05XA03

ИНН (Международная Имя):

Sodium chloride

дозировка:

0.45 percent weight/volume

Фармацевтическая форма:

Solution for infusion

Тип рецепта:

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

Терапевтические области:

Electrolyte solutions; sodium chloride

Статус Авторизация:

Marketed

Дата Авторизация:

2010-07-02

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.45 % Solution for Infusion
Active substance: sodium chloride
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 nurse.
•
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
This medicine is called `Sodium Chloride 0.45%
Solution for Infusion’, but will be referred to as
`Sodium 0.45 Infusion’ throughout the remainder of
this leaflet.
What is In this leaflet:
1.
What Sodium 0.45 Infusion is and what it is
used for
2.
What you need to know before you are given
Sodium 0.45 Infusion
3.
How you will be given Sodium 0.45 Infusion
4.
Possible side effects
5.
How to store Sodium 0.45 Infusion
6.
Contents of the pack and other information.
1.
What Sodium 0.45 Infusion is and
what it is used for
Sodium 0.45 Infusion is a solution of sodium chloride
in water. Sodium chloride is a chemical substance
(often called “salt”) found in the blood.
Sodium 0.45 Infusion is used to treat:
•
a loss of body water, for example after being
sick or having diarrhoea (hypertonic extracellular
dehydration)
•
a lower than normal volume of blood in the body
(hypovolaemia)
Sodium 0.45 infusion may also be used to deliver or
to dilute other medicines for infusion.
2.
What you need to know before you
are given Sodium 0.45 Infusion
Do NOT receive Sodium 0.45 Infusion
if you are suffering from any of the
following conditions
•
lower levels of chloride in the blood than normal
(hypochloraemia)
•
lower levels of sodium in the blood than normal
(hyponatraemia)
•
severe kidney problems causing lower than
normal or no urine production (oliguria or anuria)
•
higher than normal levels of water or sodium in
the blood (fluid or sodium retention)
•
uncompensated heart failure. This is heart
failure that is not

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride:
4.5 g/l
Each ml contains 4.5 mg sodium chloride.
Na
+
Cl
-
mmol/l
77
77
mEq/l
77
77
154 mOsm/l (approx.)
pH:
4.5 – 7.0
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.45% w/v Solution for Infusion is indicated for the
treatment of hypertonic extracellular dehydration
or hypovolaemia in cases where the intake of fluids and electrolytes
by normal routes is not possible.
It can also be used as a vehicle or diluent of compatible medicinal
products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults,_ older people_, Adolescents and Children:
The dosage, rate and duration of administration is to be
individualised as determined by several factors including age,
weight, clinical condition, concomitant treatment and in particular
the patient’s hydration state, clinical and laboratory
response to treatment. Fluid balance and plasma electrolyte
concentrations must be monitored during treatment.
_Recommended dosage:_
-
For adults, older people and adolescents: 500 ml to 3 litres/24h,
-
For babies and children: 20 to 100 ml per 24 h and per kg of body
weight, depending on the age and the total
body mass.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of medicinal product to
be administered.
_Administration rate:_
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