Sodium chloride 0.9% Vantive (Clear-Flex) solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9% Vantive (Clear-Flex) solution for infusion

Active substance: sodium chloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse effects, talk to your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

This medicine is called "Sodium Chloride 0.9% Vantive (Clear-Flex) solution for infusion", but will be referred to as Sodium Chloride 0.9% throughout the rest of this leaflet.

Contents of the leaflet:

1. What Sodium Chloride 0.9% is and what it is used for
2. What you need to know before Sodium Chloride 0.9% is administered to you
3. How Sodium Chloride 0.9% will be administered to you
4. Possible adverse effects
5. Storage of Sodium Chloride 0.9%
6. Contents of the pack and other information

1. What Suero fisiológico 0.9% is and what it is used for

Suero fisiológico 0.9% is a solution of sodium chloride in water. Sodium chloride is a chemical substance (commonly known as salt) that is found in the blood.

Suero fisiológico 0.9% is used to treat:

• loss of body water (dehydration),
• loss of sodium from the body (sodium depletion),

Situations that may cause loss of water and sodium chloride include:

• when you are unable to eat or drink due to illness or after surgery,
• excessive sweating caused by high fever,
• extensive loss through the skin, as occurs in severe burns.

Suero fisiológico 0.9% may also be used to administer or dilute other medicinal products for infusion.

2. What you need to know before you are given Sodium Chloride 0.9% Solution

You must NOT be given Sodium Chloride 0.9% Solution if you have any of the following clinical conditions:

• If your blood has abnormally high levels of chloride (hyperchloremia).
• If your blood has abnormally high levels of sodium (hypernatremia).

If another medicine has been added to Sodium Chloride 0.9% Solution, you must consult its package leaflet to determine whether or not you can receive the solution.

Warnings and precautions

Inform your doctor or nurse if you have or have had any of the following clinical conditions:

• Any type of heart disease or impaired heart function.

• Impaired kidney function.

• Acidification of the blood (acidosis).

• When the volume of blood in the blood vessels is higher than normal (hypervolemia).

• High blood pressure (hypertension).

• Fluid accumulation under the skin, particularly under the ankles (peripheral edema).

• Fluid accumulation in the lungs (pulmonary edema).

• Liver disease (cirrhosis).

• High blood pressure during pregnancy (preeclampsia).

• Increased production of the hormone aldosterone (aldosteronism).

• Any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also Other medicines and Sodium Chloride 0.9% Solution).

• If you have a condition that could cause elevated levels of vasopressin, a hormone that regulates the fluid in your body. You may have too much vasopressin in your body, for example, if:

• you have had a sudden and serious illness,

• you have pain,

• you have undergone surgery,

• you have infections, burns, or brain injury,

• you have diseases affecting your heart, liver, kidneys, or central nervous system,

• you are taking certain medicines (see below under Other medicines and Sodium Chloride 0.9% Solution).

This may increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. People at higher risk of brain swelling include:

• children
• women (particularly if they are of childbearing age)
• people who have problems with their cerebral fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

While you are receiving this solution, your doctor may take blood and urine samples to monitor:

• The amount of fluid in your body
• Your vital signs
• The levels of chemical substances such as sodium and potassium in your body (your plasma electrolytes)

This is especially important for children and premature infants, as they may retain too much sodium due to immature kidney function.

Your doctor will take into account whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). During prolonged treatment with Sodium Chloride 0.9% Solution, you may require additional nutrition.

Other medicines and Sodium Chloride 0.9% Solution

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking:

• Corticosteroids (anti-inflammatory medicines)

These medicines may cause the body to retain sodium and water, leading to tissue swelling due to fluid accumulation under the skin (edema) and high blood pressure (hypertension).

• Lithium (used to treat psychiatric disorders).

• Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medicines (chlorpropamide)

cholesterol-lowering medicines (clofibrate)

• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioid medicines for severe pain relief
• pain and/or anti-inflammatory medicines (also known as NSAIDs)
• medicines that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Use of Sodium Chloride 0.9% Solution with food and drinks

Ask your doctor about what you may eat or drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse.

However, if another medicine is added to the infusion solution during pregnancy or breastfeeding, you must:

• Consult your doctor.
• Read the package leaflet of the medicine to be added.

Driving and use of machines

Ask your doctor or nurse for advice before driving or operating machinery.

3. How Sodium Chloride 0.9% Will Be Administered to You

Sodium Chloride 0.9% will be administered to you by a doctor or a nurse. Your doctor will decide how much you need and when it will be given. This will depend on your age, weight, clinical condition, the reason for your treatment, and whether the infusion is being used to administer or dilute another medicine.

The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Sodium Chloride 0.9% if particles are floating in the solution or if the container is damaged in any way.

Sodium Chloride 0.9% is usually administered through a plastic tube connected via a needle to a vein, most commonly in your arm; however, your doctor may use another method to administer the medicine.

Before and during the infusion, your doctor will monitor:

• The amount of fluid in your body
• The acidity of your blood and urine
• The levels of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medicines that increase the effect of vasopressin).

Any unused portion of the solution must be discarded. You MUST NOT receive Sodium Chloride 0.9% from a bag that has already been partially used.

If you receive more Sodium Chloride 0.9% than you should

If you are given too much Sodium Chloride 0.9% (overdose), the following symptoms may occur:

• Nausea (feeling unwell)
• Vomiting
• Diarrhea (passing of stools)
• Stomach cramps
• Thirst
• Dry mouth
• Dry eyes
• Sweating
• Fever
• Rapid heartbeat (tachycardia)
• Increased blood pressure (hypertension)
• Kidney failure (renal failure)
• Fluid accumulation in the lungs, making breathing difficult (pulmonary edema)
• Fluid accumulation under the skin, particularly around the ankles (peripheral edema)
• Shortness of breath (respiratory arrest)
• Headache
• Dizziness
• Restlessness
• Irritability
• Weakness
• Muscle twitching and numbness
• Seizures
• Acidification of the blood (acidosis), leading to fatigue, confusion, lethargy, and increased breathing rate
• Higher-than-normal levels of sodium in your blood (hypernatremia), which may cause seizures, coma, brain swelling (cerebral edema), and death

If you notice any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped, and you will be treated according to the symptoms present.

If any medicine has been added to the Sodium Chloride 0.9% solution before the overdose occurred, that medicine may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

If the infusion of Sodium Chloride 0.9% is interrupted

Your doctor will decide whether you should stop receiving this infusion.

If you have any further questions about the use of this product, ask your doctor or nurse.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The frequency of these effects is unknown.

• Tremor,
• decrease in blood pressure (hypotension),
• hives (urticaria),
• skin rash,
• itching (pruritus).

Low levels of sodium in the blood that may develop during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy).

• Hyponatremia may cause irreversible brain damage and death due to swelling (cerebral edema/inflammation) (see also section 2 “Warnings and precautions”).

Adverse effects that may occur due to the administration technique include:

• infection at the injection site,
• local pain or reaction (redness or swelling at the administration site),
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain or burning, and swelling along the vein where the solution has been infused,
• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling or redness in the area of the clot,
• leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and lead to scarring,
• excess fluid in the blood vessels (hypervolemia),
• itching at the infusion site (urticaria),
• fever (pyrexia),
• chills.

Other adverse effects reported with similar products (other solutions containing sodium) include:

• Higher than normal levels of sodium in the blood (hypernatremia),
• Lower than normal levels of sodium in the blood (hyponatremia),
• acidification of the blood related to higher than normal levels of chloride in the blood (hyperchloremic metabolic acidosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

If any of these occur, the infusion should be stopped.

5. Storage of 0.9% Sodium Chloride Solution

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

DO NOT use this medicine after the expiry date stated on the bag following EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you see particles floating in the solution or if the container is damaged in any way.

6. Contents of the pack and other information

Composition of Sodium Chloride 0.9% Solution

The active substance is sodium chloride: 9 g per litre.

The only excipient is water for injections.

Appearance of the product and pack contents

Sodium Chloride 0.9% Solution is a clear, particle-free solution. It is supplied in plastic bags made of polypropylene/polyamide/polyethylene (Clear-Flex). Each bag is contained within a sealed protective overpouch made of plastic.

The bag sizes are:

• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml
• 2000 ml

The bags are supplied in cartons, each containing the following quantities:

• 50 bags of 50 ml
• 50 bags of 100 ml
• 36 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 6 bags of 2000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Vantive Health, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia), Spain

Manufacturer:

Bieffe Medital S.p.A.

Via Nuova Provinciale

I-23034 Grosotto (SO)

Italy

Date of the most recent revision of this leaflet: November 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Handling and preparation

Use only if the solution is clear, free from visible particles, and the container is intact. Administer immediately after connecting the infusion set.

Do not remove the bag from its overpouch until ready for use.

The inner bag maintains the sterility of the solution.

Do not connect plastic containers in series. This type of use may result in gas embolism due to residual air being drawn from the primary container before completion of administration of the fluid in the secondary container.

Pressurization of intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if residual air in the container is not completely evacuated prior to administration.

The solution must be administered using sterile equipment and aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

When adding medications, verify isotonicity before parenteral administration. Complete and careful aseptic mixing of any added medication is required. Solutions containing added drugs should be used immediately and must not be stored.

The addition of other medications or the use of incorrect administration techniques may cause febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

Discard after single use.

Discard any remaining portion.

Do not reconnect partially used bags.

1. Opening instructions

2. Remove the bag from the protective overpouch immediately before use.

3. Check for leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as it may no longer be sterile.

4. Check the solution for clarity and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

5. Preparation for administration

Use sterile materials for preparation and administration.

1. Hang the container by the hanger loop.
2. • Remove the plastic protector from the outlet port at the bottom of the container.

• Hold the small fin on the neck of the outlet tube with one hand.
• Hold the large fin on the closure cap with the other hand and twist.
• The cap will detach.

1. Use aseptic technique when preparing the infusion.

2. Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

3. Techniques for adding medication

Warning: Added medications may be incompatible. (See section 5 below, “Incompatibilities of added medications”)

To add medication prior to administration

1. Disinfect the injection site.
2. Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection site and inject the medication.
3. Mix the medication and solution carefully. For high-density medications such as potassium chloride, gently invert the bag while in vertical position and mix.

Caution: Do not store bags with added medication.

To add medication during administration

1. Close the clamp on the administration set.

2. Disinfect the injection site.

3. Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection site and inject the medication.

4. Remove the container from the intravenous stand and/or rotate it to place it in an upright position.

5. Empty both tubes by gently tapping them while the container is in upright position.

6. Mix the solution and medication carefully.

7. Return the container to its administration position, reopen the clamp, and continue administration.

8. In-use shelf life (with added medications)

Prior to use, the physical and chemical stability of any added medication at the pH of Sodium Chloride 0.9% Solution in the Clear-Flex bag must be established.

From a microbiological standpoint, the diluted product should be used immediately unless the addition of medication has been carried out under validated aseptic conditions. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

1. Incompatibilities of added medications

As with all parenteral solutions, compatibility of medications added to the solution in the Clear-Flex bag must be verified before addition.

In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

It is the physician's responsibility to assess incompatibility of added medication by checking for any change in colour and/or precipitation, formation of insoluble complexes, or crystals. The package leaflet of the medication to be added should be consulted.

Before adding any medication, verify that it is soluble and stable in water at the pH of Sodium Chloride 0.9% Solution.

Medications known to be incompatible must not be used.