Hartmann's Solution for Infusion, PE bottle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate solution 50%

Available from:

Fresenius Kabi Limited

ATC code:

B05BB; B05BB01

INN (International Name):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate solution 50%

Dosage:

%v/v

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Not marketed

Authorization date:

2009-07-24

Patient Information leaflet

HARTMANN’S SOLUTION
For Infusion
V001-IE/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 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)
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
0xxxxx1_00_HartmannsSolution_IE_BP 07.02.2017 13:15 Seite 1
–
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
WARNINGS AND PRECAUTIONS.
Talk to your doctor or nurse before you are given Hartmann's Solution
if you suffer from:
–
heart failure
–
severely impaired kidney function
–
swelling with sodium retention.
Especially in these situations, your doctor or nurse will take samples
of blood and urine
Your doctor or nurse will make sure th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann's Solution for Infusion, PE bottle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For full list of excipients, see section 6.1.
Molar formula
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.
Bottle
250 ml
500 ml
1000 ml
Sodium chloride (g)
1.50
3.00
6.00
Potassium chloride (g)
0.10
0.20
0.40
Dihydrated calcium chloride
(g)
0.07
0.14
0.27
50% sodium lactate solution
(g)
1.59
3.17
6.34
Bottle
250 ml
500 ml
1000 ml
Sodium (mmol)
32.73
65.45
130.90
Potassium (mmol)
1.35
2.70
5.40
Calcium (mmol)
0.46
0.92
1.84
Chloride (mmol)
27.93
55.85
111.70
Lactate (mmol)
7.08
14.15
28.30
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_2_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_5_
_5_
_7_
_8_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
METHOD OF ADMINISTRATION :
This solution must be given by slow intravenous infusion under
strictly aseptic c