CIFOBAN 136 mmol/1 Infusion solution

Зміст інструкції

1. Cifoban 136 mmol/l solution for infusion
   1. What Cifoban is and what it is used for
   2. What you need to know before you are given Cifoban
   3. How Cifoban is administered
   4. Possible side effects
   5. How to store Cifoban
   6. Content of the pack and other information

Cifoban 136 mmol/l solution for infusion

sodium citrate

Read this leaflet carefully before you are given 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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Cifoban is and what it is used for
• 2. What you need to know before you are given Cifoban
• 3. How Cifoban is given
• 4. Possible side effects
• 5. How to store Cifoban
• 6. Contents of the pack and other information

1. What Cifoban is and what it is used for

Cifoban is an infusion solution, which contains the active substance sodium citrate.
Exclusively for infusion in the extracorporeal circuit (outside the body).
This medicine is used as an anticoagulant (to make the blood more fluid) during
regional citrate anticoagulation in the following renal replacement and plasma exchange therapies:

• continuous veno-venous hemodialysis (CVVHD)
• continuous veno-venous hemofiltration (CVVHDF)
• sustained low-efficiency dialysis (daily) (SLEDD)
• therapeutic plasma exchange (TPE) (removes and replaces plasma in the patient's blood).

This medicine is intended for use in adults and children of all age groups (except premature
newborns).

2. What you need to know before you are given Cifoban

You must not be given Cifoban

• if you are allergic to sodium citrate
• if a recent treatment with Cifoban has been stopped because your body was unable to adequately assimilate the required dose of Cifoban and, as a result, citrate has accumulated in the blood.

Warnings and precautions
Talk to your doctor before you are given Cifoban.
The doctor will:

• ensure that any reduced liver function, a reduction in blood oxygen or any abnormal use of oxygen in body tissues is checked before starting treatment and, if necessary, start treatment with an adjusted dose or with another anticoagulant method.
• ensure that any existing hypocalcemia (low concentration of ionized calcium in the blood) is treated before starting therapy.
• ensure that calcium, sodium and magnesium levels, as well as acid-base balance (deviation in blood pH) are corrected and carefully monitored during treatment.
• ensure that the anticoagulant effect is monitored during treatment and that any unexpected clotting in the filter is detected.
• if you are immobilised for a long period, ensure that any unusual change in calcium dose is noted and the status of calcium and other minerals in the bones (bone mass) is monitored.
• if necessary, discontinue regional anticoagulation with citrate if you have developed an accumulation of citrate.

Children
This medicine is not recommended in premature infants because there is insufficient experience in
this patient group.

Other medicines and Cifoban
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
The following interactions with medicines containing are possible:

• Calcium administered in an incorrect location of the extracorporeal circuit (outside the body), which may reduce the anticoagulant effect of citrate.
• Sodium-enriched products, which may increase the risk of hypernatremia (high concentration of sodium in the blood).
• Hydrogen carbonate (or precursors such as acetate), which may increase the risk of metabolic alkalosis (a high concentration of bicarbonate in the blood).
• Blood-derived medicinal products, which are another source of citrate, may increase the risk of hypocalcemia (a low concentration of ionized calcium in the blood) and metabolic acidosis (a high concentration of acid (citrate) in the blood) when citrate is not sufficiently assimilated, or may increase the risk of metabolic alkalosis (a high concentration of bicarbonate in the blood) once the citrate has been broken down into bicarbonate.

This medicine must not be mixed with other medicines, as the available data on
compatibility are insufficient.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before starting treatment with this medicine.
There are no documented clinical data on the use of Cifoban during pregnancy and breastfeeding.
Therefore, this medicine should only be used during pregnancy and breastfeeding if your doctor
considers the treatment necessary.

3. How Cifoban is administered

Extracorporeal use. Exclusively for infusion into the extracorporeal blood circuit (outside the
body).
This medicine must be administered using a dedicated extracorporeal device (outside the
body) for blood purification, an appropriate anticoagulation protocol and, if
possible, combined with dialysis applied with volemic replacement fluids.

Dose
The dose of Cifoban will be determined by the doctor. Briefly, Cifoban is administered in a
specific dose into the bloodstream of the extracorporeal circuit (outside the body) to induce locally
very low levels of ionized calcium, to make the blood more fluid (regional anticoagulation with
citrate). The blood flow used and the dose of this medicine will depend on your condition and
treatment. More information on dosage is contained in the information intended for
healthcare professionals reported below.
This medicine is given in hospital and is administered exclusively by qualified healthcare
professionals and may be used in an intensive care setting where it will be administered under close
medical supervision.

Use in children
The equipment used must support treatment in children and must support low blood flows
when neonatal use is desired. The doctor will ensure that a low blood flow is selected in relation to the
child's weight and will accordingly prescribe a reduced dose of
Cifoban. This medicine is prescribed by the doctor only if they have experience with renal replacement or
plasma exchange therapy prescribed in children.

If you have been given too much Cifoban
Since Cifoban will be administered to you exclusively by a doctor, it is unlikely that you will be given
too much or too little. However, if you think you have been given an excessive dose of this
medicine, inform the doctor or nurse.
Signs of an overdose may be symptoms of low calcium levels (such as cramps and muscle spasms and abnormal or irregular heartbeat) and symptoms of altered acid-base balance and
sodium (such as confusion, dizziness, headache, vomiting).
If you experience any of the symptoms mentioned above, inform the doctor or nurse immediately.
If you have any doubts about the use of this medicine, consult the doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following common adverse effects may occur:

• imbalances in electrolyte levels in the blood (e.g. low blood calcium levels, low blood magnesium levels, low blood sodium levels)
• disorders in the acid-base balance in the blood (blood pH too high or too low)

The following uncommon adverse effects may occur (the exact frequency is unknown):

• allergic reactions leading to e.g. low blood pressure, feeling unwell, back and abdominal pain, local reaction (itching, rash, skin redness)
• excess fluid in the body
• headache, convulsions, loss of consciousness
• abnormal heartbeat, cardiac arrest
• excess fluid in the lungs
• low blood pressure
• difficulty breathing, respiratory arrest
• unusually rapid breathing
• vomiting (feeling sick)
• muscle cramps, muscle spasms

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cifoban

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 after Scad. The expiry date
refers to the last day of that month.
Do not refrigerate or freeze.
Keep the bags in the outer packaging to protect the medicine from light.
The contents of the bag must be used immediately after opening.
The solution is for single use only. Unused solution and damaged container must
be discarded.

6. Content of the pack and other information

What Cifoban contains

• The active ingredient is sodium citrate. Each 1000 ml of solution contains 40.0 g of sodium citrate equivalent to 408 mmol of sodium and 136 mmol of citrate.
• The other components are water for injections and hydrochloric acid.

Description of the appearance of Cifoban and content of the pack
Cifoban is supplied in a 1500 ml bag of ready-to-use solution.
The solution is transparent and colourless and practically particle-free.
Each bag is equipped with a connecting cannula and a connector and is covered with a protective
wrapper.
Cifoban is supplied in the following connection systems and packs:
Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Medical Care Deutschland GmbH,
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.H.,
Germany

Manufacturer
Fresenius Medical Care Deutschland GmbH,
Frankfurter Straße 6-8,
66606 St. Wendel,
Germany

Local Representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following names:
AT, BG, CY, DK, EL, ES, FI, HU, IE, IT, LT, MT, NL, NO, PL PT, RO, SK, UK(NI): Cifoban
FR, HR, LV, SE: Civaron
BE, DE, LU: Cibastyn
CZ, EE, SI: Cigenta
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The following information is intended exclusively for physicians or healthcare professionals:
1000 ml of solution contains:
Sodium citrate 40.0 g

Na408 mmol
Citrate136 mmol
Theoretical osmolarity: 544 mOsm/l
pH: 7.1 – 7.5

Dosage
The extracorporeal administration of Cifoban must be titrated proportionally to the blood flow of the
extracorporeal circuit (e.g. 4 mmol of citrate per litre of blood treated) to achieve sufficient suppression of ionised calcium, where the target should generally be an ionised calcium concentration post-filter below 0.3-0.35 mmol/l. The application volume in adult patients should not exceed 10.4 l/day. The extracorporeal blood flow must be sufficient to achieve the objectives of therapy but must be kept sufficiently low to avoid unnecessary citrate infusion and promote citrate clearance within the applied filter. In renal replacement therapies or plasma exchange, the composition and volumes of other solutions must be considered when prescribing Cifoban. Further recommendations and restrictions apply to use in patients with impaired citrate metabolism and in geriatric and paediatric populations. For details, refer to the Summary of Product Characteristics.

Route of administration
Extracorporeal use. Exclusively for infusion into the extracorporeal blood circuit.
Exclusively for infusion via a pump integrated within an extracorporeal blood purification device, intended by the manufacturer for the infusion of a concentrated citrate solution into the pre-pump segment of the access cannula system (“blood access line”).
Observe the special warnings and precautions in the Summary of Product Characteristics.
In addition:

• Cifoban must be used exclusively according to an appropriate protocol for regional citrate anticoagulation (RCA). It must only be administered by a physician competent in the application of RCA, or under their direction, or by healthcare professionals sufficiently trained in the indicated therapies and in the application of the products involved.
• The manufacturer’s instructions for handling the extracorporeal blood purification device and the cannula system must be followed.
• Cifoban can be used for RCA in intensive care units or similar settings, where it must be used under strict medical supervision and continuous monitoring.

Disposal
The solution is for single use only. Unused solution and damaged container must be discarded.

Handling
The solution bags are equipped with a SecuNect connectoror a Safe●Lock connector.
Before using the solution, the following points must be considered:
Aseptic technique must be used throughout the duration of administration to the patient. The solution must be used immediately after opening to avoid microbiological contamination.
Extracorporeal use. Exclusively for infusion into the extracorporeal blood circuit.
For solution bags equipped with a SecuNect connector(transparent with a green ring):

• 1. Separate the two bags along the junction line without damaging the integrity of the wrapper.
• 2. Remove the wrapper only immediately before using the solution. Check the bag with the solution (label, expiry date, clarity of the solution, absence of damage to the bag and wrapper). Occasionally, plastic containers may be damaged during transport from the manufacturer to the dialysis or hospital outpatient clinic and within the clinic itself. This can lead to contamination and growth of bacteria or fungi in the solution. Therefore, it is essential to carefully inspect the bag and solution before use. Particular attention should also be paid to any minimal damage to the bag closure, welds and corners of the bag. The solution should only be used if it is colourless and clear and if the bag and connector are intact.
• 3. Place the bag in the dedicated holder in the bag pole hole.
• 4. Remove the protective cap from the SecuNect connectorwith its green ringand attach it to its corresponding counterpart of the same colour to avoid incorrect connections. Do not touch any of the internal parts, especially do not touch the top of the connector. The inside of the connector is supplied sterile and is not intended to be further treated with chemical disinfectants. Manually connect the bag connector to the cannula connector with a rotating movement, overcoming the protection resistance of the system until a “click” is heard and the connection is established.
• 5. Before starting treatment and in case of bag changes, break the breakable tip of the bag connector and ensure it is completely broken.
• 6. Proceed with the further steps as indicated in the applied RCA protocol for the treatment.

For solution bags equipped with a Safe●Lock connector(transparent):

• 1. Separate the two bags along the junction line without damaging the integrity of the wrapper.
• 2. Remove the wrapper only immediately before using the solution. Check the bag with the solution (label, expiry date, clarity of the solution, absence of damage to the bag and wrapper). Occasionally, plastic containers may be damaged during transport from the manufacturer to the dialysis or hospital outpatient clinic and within the clinic itself. This can lead to contamination and growth of bacteria or fungi in the solution. Therefore, it is essential to carefully inspect the bag and solution before use. Particular attention should also be paid to any minimal damage to the bag closure, welds and corners of the bag. The solution should only be used if it is colourless and clear and if the bag and connector are intact.
• 3. Place the bag in the dedicated holder in the bag pole hole.
• 4. Remove the protective cap from the transparent Safe●Lock connectorand attach it to its corresponding counterpart to avoid incorrect connections. Do not touch any of the internal parts, especially do not touch the top of the connector. The inside of the connector is supplied sterile and is not intended to be further treated with chemical disinfectants. Connect the bag connector to the corresponding counterpart and rotate together.

• 5. Before starting treatment and in case of bag changes, break the breakable tip of the bag connector and ensure it is completely broken.
• 6. Proceed with the further steps as indicated in the applied RCA protocol for the treatment.

The solution is not intended for the addition of medicinal products.