Label: information for the user

Sodium Chloride Physan 0.9% solution for infusion

Sodium chloride

Read this label carefully before starting to use this medication, as it contains important information for you.

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

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

No use Cloruro de Sodio Physan 0.9% solution for perfusion:

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

• If you have been diagnosed or detected with high blood pressure, edema, kidney or liver disease, or have any heart disorder.

• If you present with hypernatremia (elevated sodium blood concentration), hyperchloremia (elevated chloride blood concentration), hypokalemia (decreased potassium blood concentration), or acidosis (pH below the normal range).

• In states of hyperhydration.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useCloruro de Sodio 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 controls should be performed.

If administered continuously in the same perfusion site, it may cause pain, infection, and phlebitis

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

Large volume perfusion will require special monitoring in patients with heart or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia

Patients with non-osmotic vasopressin release (e.g., in the presence of 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, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) have a special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

Use of Cloruro de Sodio Physan 0.9% with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Before mixing with other medications, check the compatibility tables, consider the pH, and control the ions.

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.

Medications that potentiate the effect of vasopressin The following medications increase the effect of vasopressin, reducing renal water excretion without electrolytes and increasing the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced treatment with IV perfusion solutions.

• Medications that stimulate vasopressin release, including but not limited to: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

• Medications that potentiate the action of vasopressin, including but not limited to: chlorpropamide, NSAIDs, cyclophosphamide

• Vasopressin analogs, including but not limited to: desmopressin, oxytocin, vasopressin, terlipressin

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

Pregnancy and lactation:

Cloruro de Sodio Physan 0.9% should be administered with special caution in pregnant women during delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As long as administration is correct and controlled, no adverse effects are expected during pregnancy and lactation.

There are no relevant epidemiological data available at this time, so it is recommended that if used during this period, it be done with caution.

Driving and operating machinery:

Not applicable

Your doctor will tell you the most suitable dose for your needs. Generally, intravenous administration drop by drop is recommended according to your age, body weight, clinical condition, fluid balance, electrolyte balance, and acid-base balance.

Generally, administration drop by drop of 120-180 ml/hour at a speed of 40-60 drops/minute is recommended.

It must be administered intravenously.

If you have been administered more Sodium Chloride Physan 0.9% than you should:

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

The administration will be suspended and symptomatic treatment will be sought.

Consult with your doctor or pharmacist.

In case of overdose, consult the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inadequate or excessive administration may produce 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 used as a vehicle for administering other medications, the nature of the added medications will determine the probability of other adverse reactions.

If these adverse effects or any other not described in this prospectus are observed, consult with your doctor or pharmacist.

Adverse Reactions:

- Hospital-acquired hyponatremia*

- Acute hypnatremic encephalopathy*

*Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the occurrence of acute hypnatremic encephalopathy, unknown frequency

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Sodium Chloride Physan 0.9%

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

Ionic composition:

Sodium154 mmol/l (154 meq/l)

Chlorine154 mmol/l (154 meq/l)

Theoretical osmolarity: 308 mosm/l.

pH: 4.5 to 7.0

Aspect of the product and contents of the packaging

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

Sodium Chloride 0.9% Physan is a perfusion solution that is presented in 100 ml containers containing 50ml or 100 ml of solution, 250 ml, 500 ml, and 1000 ml containers.

For single-dose containers:

It is presented in Type II glass bottles, PVC, and polypropylene (PP) containers.

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

In the following capacities:

-100 ml bottle and bag containing 50 ml or 100ml of solution.

-250 ml bottle and bag

-500 ml bottle and bag

-1000 ml bottle and bag.

For Clinical Containers:

With the following presentations:

1.- Glass bottles:

- 30 bottles of 100 ml containing 50 ml or 100 ml of solution.-20 bottles of 100 ml containing 50 ml or 100 ml of solution.

-24 bottles of 250 ml

- 10 bottles of 250 ml

-10 bottles of 500 ml

-10 bottles of 1000 ml.

2.- PP bottles:

- 50 bottles of 50 ml

- 50 bottles of 100 ml

-30 bottles of 100 ml containing 50 ml of solution

-30 bottles of 100 ml

-20 bottles of 250 ml

-24 bottles of 250 ml

-10 bottles of 500 ml

-20 bottles of 500 ml

-10 bottles of 1000 ml.

3.- PVC bags:

- 50 bags of 100 ml containing 50 ml or 100ml of solution.

-30 bags of 250 ml

-20 bags of 500 ml

-10 bags of 1000 ml.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

LAPHYSAN S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D

28108 Alcobendas

MADRID

Responsible for the manufacture

S.M. FARMACEUTICI SRL

Industrial Zone

85050 TITO – POTENZA, Italy

or

SALF SPA LABORATORY

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.
Manuel Lourenço Ferreira Industrial Park, Nº 8, Nº 15 and Nº 16
3450-232 Mortágua – Portugal

Date of the last review of this prospectus: April 2019

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This information is intended solely for healthcare professionals:

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

The solution must be transparent without particles and not contain precipitates. Do not administer otherwise.

The contents of each bottle, vial, or bag are for a single perfusion, discard the unused portion.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for incompatibilities.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used containers.

Monitor the water balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia. Serum sodium monitoring is especially important with hypotonic solutions.

Osmolarity 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 physician, with experience in pediatric treatments with intravenous perfusion solutions, must decide on the need for concomitant treatment.