Hartmann's Solution for Infusion, PE bottle

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate (as 50% solution)

Disponible desde:

Fresenius Kabi Deutschland GmbH

Código ATC:

B05BB; B05BB01

Designación común internacional (DCI):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate (as 50% solution)

formulario farmacéutico:

Solution for infusion

Área terapéutica:

Solutions affecting the electrolyte balance; electrolytes

Estado de Autorización:

Not marketed

Fecha de autorización:

2009-07-24

Información para el usuario

U15720/A IE
PACKAGE LEAFLET: INFORMATION FOR THE USER
HARTMANN'S SOLUTION
For Infusion
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 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.
IN THIS LEAFLET:
1.
What HARTMANN’S SOLUTION is and what it is used for?
2.
What you need to know before you receive Hartmann's solution
3.
How you are given HARTMANN’S SOLUTION?
4.
Possible side effects
5.
How to store HARTMANN’S SOLUTION?
6. Contents of the pack and other information
1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR ?
HARTMANN’S SOLUTION is a sterile, colourless solution for infusion.
It is used for the treatment of extracellular dehydration (water
loss), hypovolaemia (sudden drop in volume of circulating blood) and
metabolic acidosis
(increased acid in the body).
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE HARTMANN'S SOLUTION
You should not receive HARTMANN’S SOLUTION if you have:
-
hyperhydration (too much fluid)
-
decompensated congestive cardiac failure (your heart can't pump enough
blood throughout the body)
-
hyperkalemia (too much potassium in your blood),
-
hypercalcemia (too much calcium in your blood),
-
metabolic alkalosis (too much alkalis such as bicarbonate in the
blood),
-
in combination with digitalis (medicine used as cardiac stimulant)
(see "Using other medicines" section).
Your doctor will check these.
SPECIAL CARE WILL BE TAKEN IF YOU:
- suffer from swelling with sodium retention.
- suffer from acute illness, pain, post-operative stress, infections,
burns, or diseases of the central nervous system
- have any type of heart, liver or kidney disease
- have been treated with a medicine increasing the effect of
vasopressin (a hormone regulating the body's water retention) because
this may increase the r

Ficha técnica

Health Products Regulatory Authority
17 July 2020
CRN008J2H
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann's Solution for Infusion, PE bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bag :
50 ml
100 ml
250 ml
500 ml
1000 ml
Sodium chloride (g)
0.30
0.60
1.50
3.00
6.00
Potassium chloride (g)
0.020
0.040
0.10
0.20
0.40
Dihydrated calcium chloride (g)
0.01
0.03
0.07
0.14
0.27
50% sodium lactate solution (g)
0.32
0.63
1.59
3.17
6.34
For full list of excipients, see section 6.1.
Molar formula
Bag :
50 ml
100 ml
250 ml
500 ml
1000 ml
Sodium (mmol)
6.55
13.09
32.73
65.45
130.90
Potassium (mmol)
0.27
0.54
1.35
2.70
5.40
Calcium (mmol)
0.09
0.18
0.46
0.92
1.84
Chloride (mmol)
5.59
11.17
27.93
55.85
111.70
Lactate (mmol)
1.42
2.83
7.08
14.15
28.30
3 PHARMACEUTICAL FORM
Solution for infusion.
Osmolarity: 279 mOsm/l
Osmolarity: 255 mOsm/kg
pH: 5.5 to 6.3
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- 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:
This is determined by the physician according to clinical status, age
and weight of the patient and according to laboratory
findings.
METHOD OF ADMINISTRATION:
This solution must be given by slow intravenous infusion under
strictly aseptic conditions.
Fluid balance, serum electrolytes and acid-base balance may need to be
monitored before and during administration, with
particular attention to serum sodium in patients with increased
non-osmotic vasopressin release (syndrome of inappropriate
antidiuretic hormone secretion, SIADH) and in patients co-medicated
with vasopressin agonist drugs, due to the risk of hospital
acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).
Monitoring of serum sodium is particularly important for products with
lower sodium concentration compare