Patient leaflet - Phybag 9 mg/ml, solution for injection
1. What Phybagis and what it is used for
What Phybag is ?
This medicine contains sodium chloride (also known as salt) which is naturally in your body.
What it is used for ?
This medicine is used during some imaging procedures with contrast agents to push them into your body through your vein.
It is used in adults.
2. What you need to know before you use Phybag
Warnings and precautions
Talk to your doctor or pharmacist before using Phybag if you have:
- a heart disease
- a kidney disease
- swellings (excess of liquid in your body also called edema)
- salt retention (sodium retention)
- high sodium level in blood (hypernatremia or pseudohyponatremia).
Children
Do not give this medicine to children.
Elderly
Caution should be taken in case of administration of this medicine to elderly.
Other medicines and Phybag
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
As some imaging procedures (e.g. involving X-ray) and some contrast agents are not recommended during pregnancy and lactation, it is preferable to avoid the use of Phybag during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No specific risk identified to date. However, if you feel unwell after the examination, you should not drive or use machines.
Phybag contains sodium
This medicinal product contains 0.154 mmol (or 3.54 mg) of sodium per ml.
For dose up to 6.5 ml
This medicinal product contains less than 1 mmol sodium (23 mg), i.e. it is essentially “sodium-free”.
For doses of more than 6.5 ml
To be taken into consideration for patients on a controlled sodium diet.
3. How to use Phybag
This medicine will be administered by your doctor into your vein.
Your doctor will decide the appropriate dosage for you.
If you use more Phybag than you should
If you notice overdose symptoms such as tissue swelling caused by excess fluid after receiving Phybag, inform your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can occur with the following frequency:
Not known: the frequency cannot be estimated from the available data
- air bubbles circulating in your blood
- leakage of fluid out of your vein
- infection (generalised)
- infection at the injection site
- obstruction of your vein by a clot
- inflammation of your vein at the injection site
- fever
- excess of liquid in your body
- nausea, vomiting or diarrhoea.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Phybag
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Do not freeze.
Do not use this medicine if you notice damages or leakages on the soft bag.
Do not use if the solution is not clear, not colorless or contains visible particles.
6. Contents of the pack and other information
What Phybag contains
The active substance is sodium chloride.
1 ml contains 9 mg sodium chloride.
100 ml contains 15.4 mmol (equivalent to 354 mg) of sodium.
The other ingredients are water for injection, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
What Phybag looks like and contents of the pack
This medicine is a clear and colourless solution.
This medicine is supplied in soft bag of 100, 150, 200 or 500 mL with an overpouch.
Phybag is available in presentation of 1 or 10 bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Guerbet
BP 57400
95943 Roissy CdG Cedex
France
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal Spain, Sweden, United-Kingdom: Phybag.
This leaflet was last revised in December 2015
Detailed information on this medicine is available on the website www.gov.uk/government/organisations/ medicines-and-healthcare-products-regulatory-agency.
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The following information is intended for healthcare professionals only:
Prior to use, inspect the overpouch and the soft bag for signs of damages or leakages.
Do not use if any of them shows any signs of damages or leakages.
Do not use if the solution is not clear and colorless or contains particulate matter.
Remove the overpouch.
Remove the cap and connect the soft bag to the injection line.
To contain the risk of contamination, connect each Phybag once only.
Break the seal (breakable luer) to establish the liquid flow.
Proceed with the injection.
Discard any unused product at the end of the examination session.
Use immediately after opening.