SODIUM CHLORIDE PHYSAN 0.9% SOLUTION FOR INFUSION

1. What is Sodium Chloride Physan 0.9% and what is it used for

Sodium Chloride Physan 0.9% belongs to the group of medicines called electrolyte solutions. It is used as an electrolyte supplement in cases where there is dehydration with loss of salts. In hypovolemic states (decreased blood volume). Mild alkalosis. As a vehicle for the administration of medications and electrolytes.

2. What you need to know before you start using Sodium Chloride Physan 0.9%

Do not use Sodium Chloride Physan 0.9%solution for infusion:

• If you are allergic to sodium chloride or any of the other ingredients of this medicine (listed in section 6).

• If you have ever been diagnosed with or detected high blood pressure, edema, kidney or liver disease, or have any heart disorder.
• If you have hypernatremia (increased sodium blood concentration), hyperchloremia (increased chloride blood concentration), hypokalemia (decreased potassium blood level), or acidosis (pH below the normal range).
• In states of hyperhydration.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Sodium Chloride Physan 0.9%.

In prolonged therapies and in patients with acid-base imbalance, congestive heart failure, severe renal insufficiency, decompensated cirrhosis, as well as in patients treated with corticosteroids or ACTH, frequent ionogram checks should be performed.

If it is administered continuously in the same infusion site, pain, infection, and phlebitis may occur.

Your doctor may request that blood tests be performed to monitor your condition, as the balance of water and salts in the body must be controlled.

The perfusion of large volumes will require special monitoring in patients with heart or lung failure and in patients with non-osmotic release of vasopressin (including SIADH), due to the risk of hospital hyponatremia (see below).

Hyponatremia

Patients with non-osmotic release of vasopressin (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in cases of meningitis, intracranial hemorrhage, brain contusion, and cerebral edema) have a special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

Using Sodium Chloride Physan 0.9%with other medicines

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

Before mixing with other medicines, compatibility tables should be checked, pH should be taken into account, and ions should be controlled.

The administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in its therapeutic effect.

It should be administered with caution in patients treated with corticosteroids or ACTH, as they may retain water and sodium.

Medicines that potentiate the effect of vasopressin The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital hyponatremia after insufficiently balanced treatment with i.v. infusion solutions.

• Medicines that stimulate the release of vasopressin are, among others, the following: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.

• Medicines that potentiate the action of vasopressin are, among others, the following: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs are, among others, the following: desmopressin, oxytocin, vasopressin, terlipressin.

Other medicines that are known to increase the risk of hyponatremia are diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy and Breastfeeding:

Sodium Chloride Physan 0.9% should be administered with special caution in pregnant women during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Provided that administration is correct and controlled, no adverse effects are expected during pregnancy and breastfeeding.

To date, there are no relevant epidemiological data available, so it is recommended that if this medicine is used during this period, it should be done with caution.

Driving and Using Machines:

Not applicable

3. How to use Sodium Chloride Physan 0.9%

Your doctor will indicate the most suitable dose for your needs. It is usually recommended to administer intravenously, drop by drop, according to your age, body weight, clinical condition, fluid balance, electrolytes, and acid-base balance.

It is usually recommended to administer drop by drop at 120-180 ml/hour, at a rate of 40-60 drops/minute.

It must be administered intravenously.

If you have been given too much Sodium Chloride Physan 0.9%:

In case of overdose, hypernatremia may appear (characterized by diarrhea, muscle contractions, hyperreactivity, confusion, stupor, seizures, or coma).

Administration will be discontinued and symptomatic treatment will be initiated.

Consult your doctor or pharmacist.

In case of overdose, consult the Toxicology Information Service. Telephone: 91 562 04 20.

4. Possible Side Effects

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

Inadequate or excessive administration can cause hyperhydration (excess water), hypernatremia (excess sodium), hyperchloremia (excess chloride), and related manifestations such as metabolic acidosis (blood pH below normal), heart overload, and edema formation.

If it is used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

If you notice any of these side effects or any other not mentioned in this leaflet, consult your doctor or pharmacist.

Adverse Reactions:

• Hospital hyponatremia*
• Acute hyponatremic encephalopathy*

*Hospital hyponatremia can cause irreversible and potentially fatal brain damage due to the occurrence of acute hyponatremic encephalopathy, frequency not known.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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.

5. Storage of Sodium Chloride Physan 0.9%

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Sodium Chloride Physan 0.9%

• The active ingredient is sodium chloride, each 100 ml of solution contains 0.9 g of sodium chloride.
• The other ingredients (excipients) are: water for injectable preparations and hydrochloric acid (for pH adjustment).

Ionic composition:

Sodium 154 mmol/l (154 meq/l)

Chloride 154 mmol/l (154 meq/l)

Theoretical osmolality: 308 mosm/l.

pH: 4.5 to 7.0

Appearance of the Product and Contents of the Pack

Clear and colorless solution, without visible particles, sterile and apyrogenic.

Sodium Chloride 0.9% Physan is a solution for infusion that comes in packs of 100 ml containing 50 ml or 100 ml of solution, packs of 250 ml, 500 ml, and 1000 ml.

For Unit Packs:

It comes in Type II glass vials, PVC, and polypropylene (PP).

Also in bags: Polypropylene (PP) and polyvinyl chloride (PVC).

In the following capacities:

• Vial and bag of 100 ml containing 50 ml or 100 ml of solution.
• Vial and bag of 250 ml
• Vial and bag of 500 ml
• Vial and bag of 1000 ml.

For Clinical Packs:

With the following presentations:

1. Glass Vials:

• 30 vials of 100 ml containing 50 ml or 100 ml of solution. - 20 vials of 100 ml containing 50 ml or 100 ml of solution.
• 24 vials of 250 ml
• 10 vials of 250 ml
• 10 vials of 500 ml
• 10 vials of 1000 ml.

2. PP Vials:

• 50 vials of 50 ml
• 50 vials of 100 ml
• 30 vials of 100 ml containing 50 ml of solution
• 30 vials of 100 ml
• 20 vials of 250 ml
• 24 vials of 250 ml
• 10 vials of 500 ml
• 20 vials of 500 ml
• 10 vials of 1000 ml.

3. PVC Bags:

• 50 bags of 100 ml containing 50 ml or 100 ml of solution.
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml.

It may be that only some pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LAPHYSAN S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D

28108 Alcobendas

MADRID

Manufacturer

S.M. FARMACEUTICI SRL

Zona industriale

85050 TITO – POTENZA, Italy

or

SALF SPA LABORATORIO FARMACOLOGICO

Via Marconi 2

24069 Cenate Sotto (Bergamo), Italy

or

PARACELSIA INDUSTRIA FARMACEUTICA

Rua Antero de Quental, 639

P-4200-068 Porto, Portugal

or

LABORATORIOS BASI - INDUSTRIA FARMACÉUTICA, S.A. Parque Industrial Manuel Lourenço Ferreira, Nº 8, Nº 15 y Nº 16 3450-232 Mortágua – Portugal

Date of Last Revision of this Leaflet: April 2019

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This information is intended only for healthcare professionals:

This medicine will always be administered by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

The solution must be clear and particle-free and not contain precipitates. Do not administer otherwise.

The content of each vial, bottle, or bag is for single perfusion; the unused fraction must be discarded.

An aseptic method must be used to administer the solution and in the case of preparation of mixtures.

Before adding medicines to the solution or administering them simultaneously with other medicines, it must be checked that there are no incompatibilities.

Discard after a single use.

Discard partially used packs.

Do not reconnect partially used packs.

The water balance, serum electrolytes, and acid-base balance must be monitored before and during administration, with special attention to serum sodium in patients who present an increase in non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients who receive concomitant medication with vasopressin agonists due to the risk of hyponatremia. Monitoring of serum sodium is especially important with hypotonic solutions.

Tonicity of Sodium Chloride 0.9% PHYSAN: isotonic

The perfusion rate and volume depend on age, weight, and clinical condition (e.g., burns, surgery, head injury, infections); the responsible doctor, with experience in pediatric treatments with intravenous infusion solutions, must decide on the need for concomitant treatment.