DBL POTASSIUM PHOSPHATE

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

dibasic potassium phosphate, Quantity: 183 mg/mL; monobasic potassium phosphate, Quantity: 54 mg/mL

Доступна с:

Pfizer Australia Pty Ltd

Фармацевтическая форма:

Injection, concentrated

состав:

Excipient Ingredients: water for injections

Администрация маршрут:

Intravenous

Штук в упаковке:

10 x 10mL Pack

Тип рецепта:

Not scheduled. Not considered by committee

Терапевтические показания :

INDICATIONS AS AT 24 March 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.

Обзор продуктов:

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

Статус Авторизация:

Registered

Дата Авторизация:

1991-10-08

тонкая брошюра

DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen
Phosphate Concentrated Injection
Page 1
DBL™ POTASSIUM DIHYDROGEN PHOSPHATE
AND DIPOTASSIUM HYDROGEN PHOSPHATE
CONCENTRATED INJECTION
_ _
Potassium phosphate dibasic and potassium phosphate monobasic
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™
Potassium Dihydrogen
Phosphate and Dipotassium
Hydrogen Phosphate
Concentrated 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™
Potassium
Dihydrogen Phosphate and
Dipotassium Hydrogen
Phosphate Concentrated Injection
against the benefits this medicine
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL™
POTASSIUM
DIHYDROGEN
PHOSPHATE AND
DIPOTASSIUM
HYDROGEN PHOSPHATE
CONCENTRATED
INJECTION IS USED FOR
DBL™
Potassium Dihydrogen
Phosphate and Dipotassium
Hydrogen Phosphate
Concentrated Injection is a
mixture of simple phosphate salts
used to quickly increase the
amount of phosphate in your
body.
It works 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
DBL™
POTASSIUM DIHYDROGEN
PHOSPHATE AND DIPOTASSIUM
HYDROGEN PHOSPHATE
CONCENTRATED INJECTION HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor’s prescription.
This medicine is not addictive._ _
BEFORE YOU ARE GIVEN
DBL™
POTASSIUM
DIHYDROGEN
PHOSPHATE AND
DIPOTASSIUM
HYDROGEN PHOSPHATE
CONCENTRATED
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
YOU SHOULD NOT BE GIVEN DBL™
POTASSIUM DIHYDROGEN
PHOSPHATE

Характеристики продукта

Version: pfppotai10121
Supersedes pfppotai10719
Page 1 of 8
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ POTASSIUM PHOSPHATE - MONOBASIC
AND
POTASSIUM
PHOSPHATE
-
DIBASIC
(MONOBASIC
POTASSIUM
PHOSPHATE,
DIBASIC
POTASSIUM
PHOSPHATE),
CONCENTRATED INJECTION
1.
NAME OF THE MEDICINE
Monobasic potassium phosphate
Dibasic potassium phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL ampoule contains 540 milligrams of potassium phosphate
monobasic (KH
2
PO
4
)
and 1.83 g of potassium phosphate dibasic (K
2
HPO
4
) in Water for Injection. The pH of the
solution is approximately 7.5. Each mL of injection contains 2.5 mmol
of potassium ions, 1.45
mmol of phosphate ions and 1.84 mmol of hydrogen ions.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen 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: pfppotai10121
Supersedes pfppotai10719
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 recommended adult dose. The rate of infusion should not exceed
0.2 mmol/kg/h.
_Renal Impairment: _dose should be reduced. Use of phosphates in
severe renal impairment is
contraindicated (see Section 4.3 CONTRAINDICATIONS).
METHOD OF ADMINISTRATION
DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate
Concent