ADDIPHOS

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE
Available from:
Fresenius Kabi Limited
ATC code:
B05XA30
INN (International Name):
POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE
Dosage:
170. 133.5 14.0 g/20ml
Pharmaceutical form:
Concentrate for Soln for Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
combinations of electrolytes
Authorization status:
Not marketed
Authorization number:
PA0566/005/001
Authorization date:
1983-04-01

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

Code lines:

1076

Colour coding:

Black

Size:

360 x 84 mm folded to 120 x 48 mm

08.22.B

Prepared by: Sven-Erik Arneberg

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

Addiphos.

Addiphos should not be used if it has got particles in it. The doctor, pharmacist or nurse will

check that the solution is particle free before it is administered to you.

Other medicines and Addiphos

Tell your doctor or pharmacist is you are taking, have recently taken or might take any other

medicines.

Inform your doctor or pharmacist if you are taking heart drugs such as digoxin or digitoxin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask you doctor or pharmacist for advise before using this medicine.

Driving and using machines

Addiphos has no effect on the ability to drive and use machines.

1076

3. HOW TO USE ADDIPHOS

You will receive your medicine by infusion (IV drip).

Your doctor or pharmacist will decide on the correct dose for you to receive.

Dosage

The recommended dose of Addiphos for adults is 5 millilitres up to 20 millilitres each day.

Children and Adolescents

Addiphos may be used in children and adolescents, and your doctor or pharmacist will reduce the

dose for your child, according to their age and weight.

If you use more Addiphos than you should

It is very unlikely that you will receive more Addiphos than you should as your doctor, pharmacist

or nurse will monitor you during the treatment. An overdose of Addiphos

may lead to

hyperkalaemia (high potassium levels), symptoms may include:

Nausea

Fatigue

Muscle weakness

Tingling sensations

If you think that you have received too much Addiphos, inform your doctor, pharmacist or nurse

immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or

nurse.

15801017D.indd 1

2016-03-04 08:11:59

01-58-01-017D V002

4. POSSIBLE SIDE EFFECTS

Although no known undesirable effects have been reported with the use of Addiphos, like all

medicines, this medicine may cause side effects..

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly;

For UK - Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland – Via;

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ADDIPHOS

Keep this medicine out of the sight and reach of children.

Your doctor, pharmacist and nurse are responsible for the correct storage, use and disposal of

Addiphos.

Do not use this medicine after the expiry date stated on the carton and vial label. The expiry date

refers to the last day of that month.

Do not store above 25 °C.

Do not use this medicine if it is cloudy or contains particles.

Any unused solution should be discarded. Do not throw away any medicines via wastewater. Ask

your pharmacist how to throw away medicines that you no longer used. These measure will help

protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Addiphos infusions contains

1 millilitre of Addiphos contains the following active ingredients:

Potassium Dihydrogen Phosphate

170.1 mg

Disodium Phosphate Dihydrate

133.5 mg

Potassium Hydroxide

14 mg

One vial (20 ml Addiphos) provides the following:

Phosphate

40 mmol

Potassium

30 mmol

Sodium

30 mmol

Addiphos also contains water for injections.

What Addiphos looks like and contents of the pack

Addiphos is a clear, almost colourless solution of salts. It is available in plastic ampoules that

contain 20 ml of the concentrate for solution for infusion.

Marketing Authorisation Holder

Manufacturer:

Fresenius Kabi Limited

Fresenius Kabi Norge AS

Cestrian Court

NO-1753 Halden

Eastgate Way

Norway

Manor Park

Runcorn

Cheshire

WA7 1NT

This leaflet was last revised in January 2016

15801017D.indd 2

2016-03-04 08:11:59

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

mmol

Potassium

mmol

Sodium

mmol

For the full list of excipients, see section 6.1

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Use in patients with hyperkalaemia such as is associated with adrenal insufficiency or severe renal insufficiency.

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 used with extreme caution in patients with cardiac disease, renal dysfunction,

hepatic insufficiency or diabetes mellitus.

Simultaneous infusion of potassium and dextrose will lower the serum potassium levels attained.

The addition of Addiphos should be performed aseptically immediately before the start of the infusion and should be

used within 24 hours.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

No hazard is expected if used in pregnancy at the recommended dose.

No animal studies have been performed,

however, successful outcomes with administration during pregnancy have been recorded.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

There have been no reported undesirable effects observed during the administration of Addiphos.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via:

HPRA Pharmacovigilance,

Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

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4.9 Overdose

Addiphos in overdosage may lead to hyperkalaemia, depressing cardiac function.

Insulin may be required to reverse

this effect, administered intravenously concomitant with glucose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: electrolytes in combination with other drugs

ATC Code: B05XA31

Addiphos is formulated to supply phosphate, potassium and sodium in a concentrate form suitable for addition to

parenteral nutrition regimens.

5.2 Pharmacokinetic properties

Addiphos is an electrolyte supplement without interest for pharmacokinetic studies.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other

sections of the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for Injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Polypropylene vials, containing 20 ml of a clear, colourless, aqueous, sterile solution in boxes of 10 vials.

6.6 Special precautions for disposal and other handling

For single use only.

Ensure the preparation is well mixed immediately after addition to the infused solution.

Any unused solution should be discarded.

This preparation must not be administered undiluted.

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A cloudy solution or one containing a precipitate must not be used.

In regimens including Intralipid, it should be noted that 500 ml Intralipid 10%, 20% or 30% provides approximately 7.5

mmol organic phosphate.

Compatibility

Addiphos must only be added to solutions where compatibility is known.

The addition of Addiphos should be performed aseptically immediately before the start of the infusion and should be

used within 24 hours unless the mixture is refrigerated when it may be used within 48 hours of preparation.

Compatibility has been demonstrated with the following solutions up to the maximum levels indicated.

Addiphos must not be added to recommended infusants in the presence of Addamel/Additrace because of precipitation

risk.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA 566/5/1

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

April 1983

Date of last renewal:

April 2008

10 DATE OF REVISION OF THE TEXT

July 2016

Infusion Solution

(500 ml volume)

Maximum volume of Addiphos which

may be added to 500 ml of infusion

solution

Vamin 9 Glucose

Vamin 14

30ml

20ml

Vamin 14 Electrolyte-Free

30ml

Vamin 18 Electrolyte-Free

30ml

Glucose 5-60%

30ml

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