IONOLYTE

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

SODIUM ACETATE TRIHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE ; SODIUM HYDROXIDE

Tillgänglig från:

Fresenius Kabi Limited

ATC-kod:

B05BB01

INN (International namn):

SODIUM ACETATE TRIHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE ; SODIUM HYDROXIDE

Dos:

Unknown

Läkemedelsform:

Solution for Infusion

Administreringssätt:

For intravenous use

Enheter i paketet:

10 x 500 ml, 20 x 500 ml, 10 x 1000 ml

Receptbelagda typ:

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

Tillverkad av:

Fresenius Kabi Deutschland GmbH

Terapeutisk grupp:

Electrolytes

Terapiområde:

electrolytes

Terapeutiska indikationer:

Ionolyte is indicated for: - Predominantly extracellular dehydration, regardless of cause (vomiting, diarrhea, fistulas, etc.) - Hypovolemia regardless of cause (hemorrhagic shock, burns, peri-operative water and electrolyte loss) - Mild metabolic acidosis

Bemyndigande status:

Not Marketed

Tillstånd datum:

2015-10-02

Bipacksedel

IONOLYTE SOLUTION FOR INFUSION
V001/FB
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 or pharmacist.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ionolyte is and what it is used for
2. What you need to know before you are given Ionolyte
3. How you are given Ionolyte
4. Possible side effects
5. How to store Ionolyte
6. Contents of the pack and other information
1.
WHAT IONOLYTE IS AND WHAT IT IS USED FOR
Ionolyte is a Solution for infusion.
Ionolyte is used for the treatment of:
•
extracellular dehydration (water loss)
•
hypovolaemia (sudden drop in volume of circulating blood)
•
mild metabolic acidosis (increased acid in the blood caused by a
metabolic
disorder).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IONOLYTE
DO NOT USE IONOLYTE
•
if you are allergic to Sodium acetate trihydrate, Sodium chloride,
Potassium
chloride, Magnesium chloride hexahydrate or any of the other
ingredients of
this medicine (listed in section 6).
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 1
YOU SHOULD NOT RECEIVE IONOLYTE IF YOU HAVE
•
hyperhydration (too much fluid in the body), especially in cases of
pulmonary
oedema (fluid accumulation in the lungs) and congestive cardiac
failure (your
heart cannot pump enough blood througout the body)
•
severely impaired kidney function
•
metabolic alkalosis (decreased acidity of the blood caused by a
metabolic disorder)
•
hyperkalaemia (too high blood levels of potassium)
Your doctor will check these.
Special care will be taken with Ionolyte if
•
you have heart failure
•
you have severe heart rate disorders
•
you have impaired kidney function
•
you have severe electrolyte abnormalities (e.g. too high

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ionolyte solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains:
500 ml 1000 ml
Sodium acetate trihydrate
2.32 g
4.63 g
Sodium chloride
3.01 g
6.02 g
Potassium chloride
0.15 g
0.30 g
Magnesium chloride hexahydrate
0.15 g
0.30 g
Electrolytes:
Na+
137.0 mmol/l
K+
4.0 mmol/l
Mg++
1.5 mmol/l
Cl-
110.0 mmol/l
CH3COO-
34.0 mmol/l
Theoretical osmolarity:
286.5 mOsm/l
Titrable acidity:
< 2.5 mmol NaOH/l
pH:
6.9 – 7.9
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
A clear and colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ionolyte is indicated for:
- Predominantly extracellular dehydration, regardless of cause
(vomiting, diarrhea, fistulas, etc.)
- Hypovolemia regardless of cause (hemorrhagic shock, burns,
peri-operative water and electrolyte loss)
- Mild metabolic acidosis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and paediatric patients
The dose and rate of administration depends on age, body weight,
clinical and biological conditions of the patient
(including acid-base balance) and the concomitant therapy.
Recommended dosage:
The maximum daily dose corresponds to the fluid and electrolyte needs
of the patient. To temporary restore blood
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