itric acid monohydrate
Sodium citrate
Water for injections.
6.2 Incompatibilities
This medicinal product must not be mixed or concomitantly administered in the same intravenous line with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
3 years.
After opening the ampoule, the product should be used immediately.
From a microbiological point of view, when administered with solutions for infusion the product should be used immediately after dilution by aseptic technique.
Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25°C and at 2-8°C.
6.4 Special precautions for storage
This medicinal product does not require any special storage condition.
For storage conditions of the diluted medicinal product see section 6.3
6.5 Nature and contents of container
Type I clear glass 1 ml ampoule
Pack size of 10 ampoules.
6.6 Special precautions for disposal and other handling
Aseptic technique must be strictly observed throughout handling of the medicinal product since no preservative is present.
Caffeine citrate should be inspected visually for particulate matter and discoloration prior to administration. Discard ampoules containing discoloured solution or visible particulate matter.
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule.
The diluted solution must be clear and colourless. All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if it is discoloured or foreign particulate matter is present.
For single use only. Discard any unused portion left in the ampoule. Do not save unused portions for later administration.
No special requirements for disposal.
7. MARKETING AUTHORISATION HOLDER
CHIESI FARMACEUTICI SpA
Via Palermo 26/A
I-43100 Parma
ITALY
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/09/528/002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/07/2009
10. DATE OF REVISION OF THE TEXT
01/2012
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Link to this document from your website:
http://www.medicines.ie/medicine/15380/SPC/Peyona+(caffeine+citrate)+20+mg+ml+solution+for+infusion+and+oral+solution/
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