Addiphos
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 |
Ph. Eur. |
|
170.1 mg | |
|
Disodium Phosphate Dihydrate |
Ph. Eur. |
|
133.5 mg | |
|
Potassium Hydroxide | |
|
Ph. Eur. |
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
To provide a source of phosphate during parental nutrition, by its addition to infusion fluids e.g. Vamin solutions and glucose solutions. It also provides potassium and sodium.
4.2 Posology and method of administration
Posology
Adults
A daily requirement for phosphate during complete intravenous nutrition would normally be within the range 10-40 mmol. This can be met by using 5-20 ml of Addiphos.
5-20 ml Addiphos also provides 7.5-30 mmol each of potassium and sodium. The infusion should be given intravenously at a rate corresponding to not more than 10 mmol K+ per hour so as to avoid hyperkalaemia and also within the maximum infusion rate for Vamin.
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
This preparation should not be administered undiluted.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Addiphos should not be used in patients with hyperkalaemia such as is associated with adrenal or severe renal insufficiency. It should not be given in the presence of dehydration without fluid replacement.
A cloudy solution or one containing a precipitate must not be used.
4.3 Special warnings and precautions for use
Care should be exercised in patients with cardiac disease, diabetes mellitus, renal dysfunction or hepatic insufficiency.
Infusion of potassium may depress cardiac function and counteract the effects of digitalis.
Simultaneous infusion of potassium and glucose will achieve a lower serum potassium level than when potassium is given alone.
Plasma levels and clinical signs suggesting hyperkalaemia require discontinuation.
The addition of Addiphos should be performed aseptically immediately before the start of the infusion and should be used within 24 hours.
Each vial of Addiphos is for single use only. It should be mixed well immediately after addition to the infusion solution.
4.5 Interactions with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Addiphos is a solution for use as a supplement in parenteral nutrition regimens, providing phosphate, potassium and sodium. 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.
4.4 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 the Yellow Card Scheme at:
4.5 Overdose
Addiphos in over dosage may lead to hyperkalaemia, depressing cardiac function. Insulin may be required to reverse this effect, administered intravenously concomitant with glucose.
PHARMACOLOGICAL PROPERTIES
5.
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 Ph Eur
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.
6.2 Special precautions for storage
Do not store above 25°C.
Keep vial in outer carton.
6.5 Nature and contents of container
Plastic vials of polypropylene Pack size: 10 x 20ml
6.2 Special precautions for disposal and other handling
For single use only.
Ensure the preparation is well mixed immediately after addition to the infusion solution.
Any unused solution should be discarded.
This preparation must not be administrated undiluted.
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. Contact Fresenius Kabi Ltd for full information on complete and balanced regimens.
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.
Infusion Solution (500 ml Maximum volume of Addiphos which may be
volume)
Added to 500 ml of infusion solution
|
Vamin 9 |
30ml |
|
Vamin 9 Glucose |
30ml |
|
Vamin 14 |
20ml |
|
Vamin 14 Electrolyte-Free |
30ml |
|
Vamin 18 Electrolyte-Free |
30ml |
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
8 MARKETING AUTHORISATION NUMBER
PL 08828/0101
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 31 May 1999 Date of latest renewal: 19 February 2009
10 DATE OF REVISION OF THE TEXT
25/05/2016