Haemodialysis Concentrate HDM 303 (Acid) For Bicarbonate Haemodialysis & Haemodiafiltration

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Produktets egenskaber Produktets egenskaber (SPC)
26-09-2017

Aktiv bestanddel:

SODIUM CHLORIDE (SALT); POTASSIUM CHLORIDE; Magnesium Chloride; Calcium chloride; GLACIAL ACETIC ACID

Tilgængelig fra:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (International Name):

SODIUM CHLORIDE (SALT); POTASSIUM CHLORIDE; Magnesium Chloride; Calcium chloride; GLACIAL ACETIC ACID

Enheder i pakken:

5000ml mL; 10000ml mL

Fremstillet af:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

Produktets egenskaber

                                INDICATIONS
INDICATIONS
INDICATIONS
INDICATIONS
INDICATIONS
The indications below apply exclusively to the ready-for-use
bicarbonate haemodialysis solution prepared
from acid concentrate and bicarbonate concentrate following the
specified dilution procedure:
-
Acute renal failure
-
Chronic renal failure
-
Overhydration
-
Intoxications
-
Adjustment of acid-base and electrolyte balance
CONTRAINDICATIONS
CONTRAINDICATIONS
CONTRAINDICATIONS
CONTRAINDICATIONS
CONTRAINDICATIONS
Hyperkalaemia
Intractable coagulopathy
In patients with unstable circulation and/or unstable blood pressure,
another extracorporeal haemodialysis
method may be indicated.
USAGE IN PREGNANCY
USAGE IN PREGNANCY
USAGE IN PREGNANCY
USAGE IN PREGNANCY
USAGE IN PREGNANCY
Safety of HDM303 for haemodialysis treatment has not been determined
in pregnant women.
The products should be used only when clearly needed as prescribed by
the physician.
ADVERSE REACTIONS
ADVERSE REACTIONS
ADVERSE REACTIONS
ADVERSE REACTIONS
ADVERSE REACTIONS
During haemodialysis, hypotension, nausea, vomiting and convulsions
may occur.
DOSAGE
DOSAGE
DOSAGE
DOSAGE
DOSAGE
Unless otherwise directed, mix 1L HDM303 (acid concentrate) and 2.1L
5% bicarbonate concentrate or 1.222L
8.4% bicarbonate concentrate with 34L water of suitable quality (see
Composition of the ready-for-use
bicarbonate haemodialysis solution).
ADMINISTRATION
ADMINISTRATION
ADMINISTRATION
ADMINISTRATION
ADMINISTRATION
For extracorporeal bicarbonate haemodialysis or bicarbonate
haemodiafiltration.
The duration of administration must be determined on an individual
basis.
PRECAUTION
PRECAUTION
PRECAUTION
PRECAUTION
PRECAUTION
• HDM303 (acid concentrate) may only be used in combination with 5%
bicarbonate concentrate or 8.4%
bicarbonate concentrate following a specified dilution procedure.
• The ready-for-use bicarbonate haemodialysis solution must be
tested before use by a suitable gas analysis
method.
• Acid concentrate and bicarbonate concentrate should be diluted
only immediately before use.
Discard unused po
                                
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