Addiphos concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium dihydrogen phosphate; Potassium hydroxide; Disodium phosphate dihydrate

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05XA; B05XA30

INN (International Name):

Potassium dihydrogen phosphate; Potassium hydroxide; Disodium phosphate dihydrate

Dosage:

170.1mg/ml+133.5mg/ml+14 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Electrolyte solutions; combinations of electrolytes

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADDIPHOS
® CONCENTRATE FOR SOLUTION FOR INFUSION
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, pharmacist or
nurse
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Addiphos is and what it is used for
2.
What you need to know before you use Addiphos
3.
How to use Addiphos
4.
Possible side effects
5.
How to store Addiphos
6.
Contents of the pack and other information
1.
WHAT ADDIPHOS IS AND WHAT IT IS USED FOR
Addiphos provides salts into your blood stream when you cannot eat
normally. Salts are chemicals
required in small amounts for the body to work normally.
Addiphos is usually used as part of a balanced intravenous diet,
together with proteins, fats,
carbohydrates, other salts and vitamins.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADDIPHOS
DO NOT USE ADDIPHOS:
•
if you are allergic to the active substance(s) or any other of the
ingredients of this medicine (listed
in section 6).
IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING,
SWOLLEN LIPS OR
FACE OR SHORTNESS OF BREATH), PLEASE INFORM YOUR DOCTOR, PHARMACIST OR
NURSE.
•
have high potassium levels (hyperkalaemia)
•
have severely impaired kidneys
•
have problems with adrenal glands
•
are dehydrated (not enough water in your body)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Addiphos if you
suffer from:
- impaired liver and/or kidney function
- diabetes
- heart problems
Your doctor may want to do regular blood tests to check your
condition.
Addiphos
MUST BE DILUTED BEFORE USE.
It will be added to another solution before it is given to you.
Your doctor, pharmacist or nurse will make sure it is prepared
correctly before you receive Addipho

Summary of Product characteristics

Health Products Regulatory Authority
08 April 2019
CRN008RPP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Addiphos concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Addiphos contains:
Potassium Dihydrogen Phosphate
170.1 mg
Disodium Phosphate Dihydrate
133.5 mg
Potassium Hydroxide
14.0 mg
One vial (20 ml Addiphos) provides the following:
Phosphate
40 mmol
Potassium
30 mmol
Sodium
30 mmol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless aqueous sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a phosphate, potassium and sodium supplement during complete
intravenous nutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The total daily dosage is dependent upon the age, weight, clinical
state and degree of deficiency of the patient and must be
determined on an individual basis.
The usual daily dose is 5-20 ml of Addiphos.
_Paediatric population_
Dosage should be reduced appropriately according to age and weight.
Method of administration
Intravenous infusion after dilution
For instructions on dilution of the medicinal product before
administration. See section 6.6.
4.3 CONTRAINDICATIONS
Hypersensitvity to the active substance(s) or to any of the excipients
listed in section 6.1.
Use in patients with hyperkalaemia such as is associated with adrenal
insufficiency or severe renal insufficiency.
Health Products Regulatory Authority
08 April 2019
CRN008RPP
Page 2 of 5
Use in the presence of dehydration without fluid replacement.
Use of a solution which is cloudy, contains sediment, or is in any way
unusual.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This preparation must not be administered undiluted.
Infusion of potassium may depress cardiac function and counteract the
effects of digitalis.
Plasma levels and clinical signs suggesting hyperkalaemia require
discontinuation of this product.
Potassium replacement therapy should be