ADDIPHOS

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE

متاح من:

Fresenius Kabi Limited

ATC رمز:

B05XA30

INN (الاسم الدولي):

POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE

جرعة:

170. 133.5 14.0 g/20ml

الشكل الصيدلاني:

Concentrate for Soln for Inf

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

combinations of electrolytes

الوضع إذن:

Not marketed

تاريخ الترخيص:

1983-04-01

نشرة المعلومات

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.
01-58-01-017D
Addiphos
®
Concentrate
for Solution for Infusion
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MASTER ARTWORK/LABEL SPECIFICATION
Halden article number:
FBV 1992
Label spec. number:
01-58-01-017D
Code 128
653
Code lines:
1076
Colour coding:
Black
Size:
360 x 84 mm folded to 120 x

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Addiphos concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
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