PHYSIOLOGICAL SALINE 0.9% VANTIVE (CLEAR-FLEX) SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Physiological serum 0.9% Vantive (Clear-Flex) solution for infusion

Active ingredient: sodium chloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine is called “Physiological serum 0.9% Vantive (Clear-Flex) solution for infusion” but will be referred to as Physiological serum 0.9% throughout the rest of this leaflet.

Contents of the pack:

1. What Physiological serum 0.9% is and what it is used for
2. What you need to know before you are given Physiological serum 0.9%
3. How you will be given Physiological serum 0.9%
4. Possible side effects
5. Storage of Physiological serum 0.9%
6. Contents of the pack and other information

1. What Physiological serum 0.9% is and what it is used for

Physiological serum 0.9% is a solution of sodium chloride in water. Sodium chloride is a chemical substance (commonly called salt) that is found in the blood.

Physiological serum 0.9% is used to treat:

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

The situations that can cause loss of water and sodium include:

• when you cannot eat or drink due to illness or after surgery,
• excessive sweating caused by high fever,
• extensive skin loss, such as in severe burns.

Physiological serum 0.9% can also be used to administer or dilute other medicines for infusion.

2. What you need to know before you are given Physiological serum 0.9%

YOU WILL NOT BE GIVEN Physiological serum 0.9% IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS:

• If your blood contains high levels of chloride above normal (hyperchloremia).
• If your blood contains high levels of sodium above normal (hypernatremia).

If another medicine has been added to Physiological serum 0.9%, you should consult its package leaflet to determine if you can receive the solution.

Warnings and precautions

Tell your doctor or nurse if you have or have had any of the following medical 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 greater than it should be (hypervolemia).
• High blood pressure (hypertension).
• Accumulation of fluid under the skin, particularly under the ankles (peripheral edema).
• Accumulation of fluid in the lungs making breathing difficult (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 Physiological serum 0.9%).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates fluid in your body. You may have too much vasopressin in your body because, for example:

• you have had a sudden and severe illness,
• you are in pain,
• you have had surgery,
• you have infections, burns, or head injury,
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medicines (see below Other medicines and Physiological serum 0.9%). This can increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, lethargy, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of inflammation are:

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

When you are being given this solution, your doctor may take blood and urine samples to check:

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

This is especially important in children and babies (premature babies), as they may retain too much sodium due to their immature kidney function.

Your doctor will consider whether you are receiving parenteral nutrition (nutrition given by infusion into a vein). During prolonged treatment with Physiological serum 0.9%, you may need to receive extra nutrition.

Other medicines and Physiological serum 0.9%

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

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

• Corticosteroids (anti-inflammatory medicines)

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

• Lithium (used to treat psychiatric diseases).
• Some medicines act on the hormone vasopressin. These may include:

• antidiabetic medication (chlorpropamide)

cholesterol medication (clofibrate)

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

Using Physiological serum 0.9% with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and using machines

Ask your doctor or nurse for advice before driving or using machines.

3. How you will be given Physiological serum 0.9%

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

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

DO NOT receive Physiological serum 0.9% if there are particles floating in the solution or if the container is damaged in any way.

Physiological serum 0.9% is usually given to you through a plastic tube connected to a needle in a vein, almost always in your arm; however, your doctor may use another method to administer the medicine.

Before and during the infusion, your doctor will check:

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

Any unused solution should be discarded. You MUST NOT receive Physiological serum 0.9% from a bag that has been used partially.

If you receive more Physiological serum 0.9% than you should

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

• Nausea (discomfort).
• Vomiting.
• Diarrhea (loss of stools).
• Stomach cramps.
• Thirst.
• Dry mouth.
• Dry eyes.
• Sweating.
• Fever.
• Fast heart rate (tachycardia).
• High blood pressure (hypertension).
• Kidney failure (renal failure).
• Fluid accumulation in the lungs making breathing difficult (pulmonary edema).
• Fluid accumulation under the skin, particularly under the ankles (peripheral edema).
• Difficulty breathing (respiratory arrest).
• Headache.
• Dizziness.
• Restlessness.
• Irritability.
• Weakness.
• Muscle twitching and numbness.
• Seizures.
• Acidification of the blood (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.
• High sodium levels in the blood (hypernatremia), which can cause seizures, coma, brain inflammation (cerebral edema), and death.

If you notice any of these symptoms, you should inform your doctor immediately. Your infusion will be stopped and you will be treated depending on the symptoms.

If another medicine has been added to Physiological serum 0.9% before the overdose, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop the infusion of Physiological serum 0.9%

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, consult the Toxicology Information Service. Telephone 915.620.420

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of these effects is unknown.

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

Low sodium levels in the blood that can be acquired during hospitalization (hospital-acquired hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy).

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

Side 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 in which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein in which the solution is infused,
• formation of a blood clot (thrombosis) at the infusion site, which can cause pain, swelling, or redness in the area of the clot,
• leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage tissues and cause scarring,
• excess fluid in the blood vessels (hypervolemia),
• itching at the infusion site (urticaria),
• fever (pyrexia),
• chills.

Other side effects that have been reported with similar products (other solutions containing sodium) include:

• High sodium levels in the blood (hypernatremia),
• Low sodium levels in the blood (hyponatremia),
• Acidification of the blood related to high chloride levels in the blood (metabolic acidosis with hyperchloremia).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

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

5. Storage of Physiological serum 0.9%

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 which is stated on the bag after EXP. The expiry date is the last day of the month shown.

You MUST NOT receive this medicine if there are particles floating in the solution or if the container is damaged in any way.

6. Container Contents and Additional Information

Composition of 0.9% Sodium Chloride Solution

The active ingredient is sodium chloride: 9 g per liter.

The only excipient is water for injectable preparations.

Appearance of the Product and Container Contents

0.9% Sodium Chloride Solution is a clear, particle-free solution. It is presented in polypropylene/polyamide/polyethylene plastic bags (Clear-Flex). Each bag is packaged in a sealed protective plastic overbag.

The bag sizes are:

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

The bags are supplied in boxes, 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 some package 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 Last Revision of this Leaflet: November 2018

Detailed and updated 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/

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This information is intended only for healthcare professionals

Handling and Preparation

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

Do not remove the bag from its overbag until it is ready for use.

The inner bag maintains the sterility of the solution.

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to gas embolism if the residual air in the container is not fully evacuated before administration.

The solution must be administered with sterile equipment using an aseptic technique. The equipment must 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 medication is necessary. Solutions containing medications should be used immediately and not stored.

The addition of other medications or the use of incorrect administration techniques can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In the event of an adverse reaction, the infusion should be interrupted immediately.

Discard after a single use.

Discard any remaining portion.

Do not reconnect partially used bags.

1. To open

1. Remove the bag from the protective overbag immediately before use.
2. Check for small leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.
3. Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

1. Preparation for Administration

Use sterile material for preparation and administration.

1. Hang the container by the tab
2. - Remove the plastic protector from the outlet port at the bottom of the container.

• Hold the small wing of the outlet tube neck with one hand.
• Hold the large wing of the closure cap with the other hand and turn.
• The cap will come off.

1. Use an aseptic technique to prepare the infusion.
2. Connect the administration equipment. Consult the instructions accompanying the equipment for connection, priming, and administration of the solution.

1. Techniques for Injecting Added Medication

Warning: Added medications may be incompatible. (See section 5 "Incompatibilities of Added Medications" below)

To Add Medication Before Administration

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

Precaution: Do not store bags with added medication.

To Add Medication During Administration

1. Close the equipment clamp.
2. Disinfect the injection point.
3. Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection point and inject.
4. Remove the container from the intravenous support and/or turn it to put it in a vertical position.
5. Empty both tubes by gently tapping them while the container is in a vertical position.
6. Mix the solution and medication carefully.
7. Return the container to its original position, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

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

From a microbiological point of view, the diluted product must be used immediately unless the addition of medications has been carried out under aseptic and validated conditions. If not used immediately, the conditions and storage times used before use are the responsibility of the user.

1. Incompatibilities of Added Medications

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

In the absence of compatibility studies, this solution should not be mixed with other medications.

It is the responsibility of the physician to judge the incompatibility of the added medication to 0.9% Sodium Chloride Solution by examining any eventual change in color and/or precipitate, appearance of insoluble complexes or crystals. The leaflet of the medication to be added should be consulted.

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

Medications known to be incompatible should not be used.