DBL™ Potassium Dihydrogen Phosphate Concentrated Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Monobasic potassium phosphate 1 mmol/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Dibasic potassium phosphate 1 mmol/mL

Dosage:

1.361g/10mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Monobasic potassium phosphate 1 mmol/mL Excipient: Water for injection

Units in package:

Ampoule, glass, 10mL, 10 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Merck KGaA

Therapeutic indications:

Treatment of severe hypophosphataemia (serum levels less than 0.3 mmol/L) and other degrees of hypophosphataemia when oral therapy is not possible.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C

Authorization date:

1989-02-09

Summary of Product characteristics

Version: pfdpotdi10821
Supersedes: Version 3.0
Page 1 of 9
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
TM
Potassium Dihydrogen Phosphate Concentrated Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The molecular formula of potassium phosphate monobasic is KH
2
PO
4
. Its molecular weight is
136.1. The CAS Registry number of potassium phosphate monobasic is
7778-77-0.
Each DBL Potassium Dihydrogen Phosphate Concentrated Injection 10 mL
ampoule contains
1.361 g of potassium phosphate monobasic (KH
2
PO
4
) in Water for Injection. Each mL of
injection contains 1 mmol of potassium ions, 1 mmol of phosphate ions
and 2 mmol of
hydrogen ions.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Potassium Dihydrogen Phosphate Concentrated Injection is a clear,
colorless, sterile
solution for injection. The pH of the solution is approximately 4.5.
Potassium phosphate monobasic is a white, odourless, granular or
crystalline powder, or
colourless crystals. It is freely soluble in water and practically
insoluble in alcohol.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of severe hypophosphataemia (serum levels less than 0.3
mmol/L) and other degrees
of hypophosphataemia when oral therapy is not possible.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
DBL Potassium Dihydrogen Phosphate Concentrated Injection is
administered by slow
intravenous infusion. The injection must be diluted before use. For
the treatment of severe
hypophosphataemia, the following doses are suggested.
_Adults: _up to 10 mmol phosphate administered over 12 hours. The dose
may be repeated at 12
hour intervals until serum phosphate exceeds 0.3 mmol/L.
_Children:_ 0.15-0.33 mmol/kg administered over 6 hours. The dose may
be repeated at 6 hour
intervals until serum phosphate exceeds 0.6 mmol/L. The dose should
not exceed the maximum
recommended adult dose. The rate of infusion should not exceed 0.2
mmol/kg/h.
Version: pfdpotdi10821
Supersedes: Version 3.0
Page 2 of 9
_Renal Impairment: _dose should be reduced. Use of