Potassium Phosphate 1mmol/ml + 0.6mmol/ml Concentrate for Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
14-06-2017
Summary of Product characteristics
(SPC)
11-09-2019
Active ingredient:
Dipotassium phosphate ; Potassium dihydrogen phosphate
Available from:
B. Braun Medical Limited
ATC code:
B05XA; B05XA06
INN (International Name):
Dipotassium phosphate ; Potassium dihydrogen phosphate
Dosage:
1mmol/ml + 0.6 millimole(s)/millilitre
Pharmaceutical form:
Concentrate for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Electrolyte solutions; potassium phosphate, incl. combinations with other potassium salts
Authorization status:
Marketed
Authorization date:
1993-02-24
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Medical Limited, Dublin 12
POTASSIUM PHOSPHATE 1 MMOL/ML + 0.6 MMOL/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Dipotassium Phosphate, Potassium Dihydrogen Phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them,even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Potassium Phosphate is and what it is used for
2. What you need to know before you use Potassium Phosphate
3. How to use Potassium Phosphate
4. Possible side effects
5. How to store Potassium Phosphate
6. Contents of the pack and other information
1.
WHAT POTASSIUM PHOSPHATE IS AND WHAT IT IS USED FOR
Potassium Phosphate is a concentrated solution of potassium phosphate
intended for the
intravenous supply of phosphate (intravenous = administration by a
vein drip)..
Potassium Phosphate is used if you are lacking both potassium and
phosphate at the same
time.
Potassium Phosphate is administered to you by a doctor or other health
professional.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
USE
POTASSIUM
PHOSPHATE
POTASSIUM PHOSPHATE SHOULD NOT BE GIVEN TO YOU IF YOU HAVE
• excessively high blood levels of phosphate or potassium
• abnormally low blood calcium level
• kidney impairment
• a disease or condition associated with an abnormally high blood
potassium level, such as
- lack of fluid
- high levels of acidic substances in your blood due to decompensated
diabetes (diabetic
ketoacidosis)
- kidney impairment with low urine excretion
-a specific disease of the adrenal gland (ADDISON’S disease),
- a certain inherited disease of potassium metabolism associated
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Phosphate 1mmol/ml + 0.6mmol/ml Concentrate for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule (=20 ml) of concentrate for solution for infusion contains
Dipotassium phosphate 1.394 g
Potassium dihydrogen phosphate 0.544 g
_Electrolyte concentrations_
Potassium 1 mmol/ml
Phosphate 0.6 mmol/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
Clear, colourless aqueous solution
Theoretical osmolarity 1600 mOsm/l
pH 6.8 – 7.2
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phosphate substitution in intensive-care patients, with co-existing
potassium deficiency, in whom close monitoring of serum
potassium and phosphate concentrations can be performed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The dose is adjusted according to the actual basic or correction
requirements, according to the analytical values of the serum
electrolyte concentrations.
_Adults_
In the setting of parenteral nutrition the basic phosphate requirement
in adults is 0.3 – 0.5 mmol per kg body weight (BW) per
day, corresponding to 0.5 – 0.8 ml per kg BW per day.
In therapy of severe hypophosphataemia the dose is adjusted according
to the serum phosphate concentration. Then higher
amounts than those stated above may be needed.
Per 0.6 mmol phosphate 1 mmol of potassium is administered.
The maximum daily dose of potassium is 2 – 3 mmol per kg BW
Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 2 of 8
_Paediatric patients_
The dose should be adjusted strictly according to the prevailing serum
potassium and phosphate concentrations which may be
affected by fluid retention, dehydration or excessive water losses.
In children potassium intake during parenteral nutrition is
recommended not to exceed 1 – 3 mmol/kg body weight per day.
Parenteral phosphat
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