Hartmann’s Solution for Infusion, PSEB bag

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Compra

Scarica Scheda tecnica (SPC)
07-09-2017

Principio attivo:

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

Commercializzato da:

Fresenius Kabi Limited

Codice ATC:

B05BB; B05BB01

INN (Nome Internazionale):

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

Dosaggio:

%v/v

Forma farmaceutica:

Solution for infusion

Tipo di ricetta:

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

Area terapeutica:

Solutions affecting the electrolyte balance; electrolytes

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2005-05-20

Scheda tecnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann’s Solution for Infusion, PSEB bag
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 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.
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
0.04
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
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
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_
                                
                                Leggi il documento completo