Sodium citrate S.A.L.F.

Patient Information Leaflet: Information for the User

SODIUM CITRATE S.A.L.F. 38 mg/ml anticoagulant solution for equipment, 76 mg/2 ml anticoagulant solution for equipment, 190 mg/5 ml anticoagulant solution for equipment, 380 mg/10 ml anticoagulant solution for equipment

Sodium citrate dihydrate
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What SODIUM CITRATE S.A.L.F. is and what it is used for
2. What you need to know before using SODIUM CITRATE S.A.L.F.
3. How to use SODIUM CITRATE S.A.L.F.
4. Possible side effects
5. How to store SODIUM CITRATE S.A.L.F.
6. Contents of the pack and other information

1. What SODIO CITRATO S.A.L.F. is and what it is used for

SODIO CITRATO S.A.L.F. contains the active substance sodium citrate dihydrate, which is used for
the preservation of blood intended for transfusions.
SODIO CITRATO S.A.L.F. is a medicine used to prevent blood clotting (anticoagulant) in blood intended for transfusions. This medicine is added to blood contained in laboratory tubes and is used to rinse syringes and blood collection bags.

2. What you need to know before using SODIUM CITRATE S.A.L.F.

Do not use SODIUM CITRATE S.A.L.F.

• if you are allergic to sodium citrate or to any of the other ingredients of this medicine (listed in section 6);
• for direct intravenous injections of the medicine.

Warnings and precautions
Talk to your doctor or nurse before using SODIUM CITRATE S.A.L.F.
This medicine must be used immediately after opening the container and only if the solution is clear, colourless and free from visible particles.
Other medicines and SODIUM CITRATE S.A.L.F.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
There are no available data on interactions between SODIUM CITRATE S.A.L.F. and other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
There are no available data on the use of SODIUM CITRATE S.A.L.F. during pregnancy and breastfeeding.
Driving and using machines
There are no available data regarding the effects of SODIUM CITRATE S.A.L.F. on the ability to drive vehicles and operate machinery.

3. How to use SODIO CITRATO S.A.L.F.

This medicinal product will be used by specialized healthcare personnel. If you have any doubts, consult your doctor or nurse.
This medicinal product must not be injected directly into the vein.
This medicinal product is used to prevent clotting of blood intended for transfusion and to wet blood collection bags.
In laboratory test tubes, add 1 part SODIO CITRATO S.A.L.F. for every 9 parts of blood.
Use this medicinal product immediately after opening the container; after use, discard the container (and any remaining medicinal product), even if partially used.
SODIO CITRATO S.A.L.F. must not be mixed with other medicinal products.
If you have any doubts about the use of this medicinal product, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
There are no data available regarding side effects of SODIO CITRATO S.A.L.F.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIO CITRATO S.A.L.F.

Medical and nursing staff are aware of the storage conditions for this medicinal product.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not freeze. Keep the container tightly closed to protect the medicine from light and heat.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SODIO CITRATO S.A.L.F. contains

• The active substance is sodium citrate dihydrate. Each ml of solution contains 38 mg of sodium citrate dihydrate (pH 7.5 - 8.8).
• The other component is water for injections.

Description of the appearance of SODIO CITRATO S.A.L.F. and package contents
Box containing 5 vials of 1 ml, 2 ml, 5 ml or 10 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italy.