DBL PHOSPHATE IONS 0.67 Molar/20mL Injection

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

dibasic sodium phosphate dodecahydrate, Quantity: 192 mg/mL; monobasic potassium phosphate, Quantity: 17.4 mg/mL

Доступно од:

Pfizer Australia Pty Ltd

Фармацеутски облик:

Injection, concentrated

Састав:

Excipient Ingredients: water for injections

Пут администрације:

Intravenous

Јединице у пакету:

5x20mL

Тип рецептора:

Not scheduled. Not considered by committee

Терапеутске индикације:

INDICATIONS AS AT 30 April 2004: Treatment of severe hypophosphataemia (serum levels less than 0.3 mmol/L) and other degrees of hypophosphataemia when oral therapy is not possible. The cause of hypophosphataemia should be identified and treated.

Резиме производа:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

1991-10-08

Информативни летак

DBL™ Sodium Phosphate and Potassium Phosphate Concentrated Injection
Page 1
DBL™ SODIUM PHOSPHATE AND
POTASSIUM PHOSPHATE
CONCENTRATED INJECTION
_ _
Sodium phosphate and potassium phosphate
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Sodium Phosphate and
Potassium Phosphate Injection. It
does not contain all the available
information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given DBL™ Sodium Phosphate
and Potassium Phosphate
Injection against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL™ SODIUM
PHOSPHATE AND
POTASSIUM PHOSPHATE
INJECTION IS USED FOR
DBL™ Sodium Phosphate and
Potassium Phosphate Injection is
a mixture of simple phosphate
used to quickly increase the
amount of phosphate in your
body.
Sodium phosphate and potassium
phosphate work by providing a
source of phosphate for your body
to use.
_ _
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions about why Sodium
Phosphate and Potassium
Phosphate has been prescribed
for you.
This medicine is available only
with a doctor’s prescription.
DBL™ Sodium Phosphate and
Potassium Phosphate Injection is
not addictive._ _
BEFORE YOU ARE GIVEN
DBL™ SODIUM
PHOSPHATE AND
POTASSIUM PHOSPHATE
INJECTION
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
SODIUM PHOSPHATE AND
POTASSIUM PHOSPHATE IF:
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING
•
THE EXPIRY DATE ON THE PACK
HAS PASSED.
If this medicine is used after
the expiry date has passed, it
may not work as well.
•
YOU HAVE ANY OF THE
FOLLOWING MEDICAL
CONDITIONS:
•
kidney disease
�

Карактеристике производа

Version: pfpsodpi10619
Supersedes Version: 5.0
Page 1 of 8
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ SODIUM PHOSPHATE AND POTASSIUM
PHOSPHATE CONCENTRATED INJECTION
1.
NAME OF THE MEDICINE
Dibasic sodium phosphate dodecahydrate
Monobasic potassium phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
20
mL
ampoule
contains
3.840
g
dibasic
sodium
phosphate
dodecahydrate
(Na
2
HPO
4
.12H
2
O) and 348 mg monobasic potassium phosohate (KH
2
PO
4
) in Water for
Injection. The pH of the solution ranges between 6.5 and 8.0. Each mL
of injection contains
0.13 mmol (5 mg) of potassium ions, 1.07 mmol (24.6 mg) of sodium
ions, 0.67 mmol (63 mg)
of phosphate ions and 0.79 mmol (0.79 mg) of hydrogen ions.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Dibasic sodium phosphate dodecahydrate appears as colourless,
transparent, very efflorescent
crystals. It is very soluble in water and practically insoluble in
alcohol. Monobasic potassium
phosohate is a white odourless granular or crystalline powder or
colourless crystals. It is freely
soluble in water and practically insoluble in alcohol.
DBL™ Sodium Phosphate and Potassium Phosphate Concentrated Injection
is a clear,
colorless, sterile solution.
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.
The cause of hypophosphataemia should be identified and treated.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
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.
Version: pfpsodpi10619
Supersedes Version: 5.0
Page 2 of 8
_Children: _
0.15 to 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