Label: information for the user

Ringer Hartmann Braun Lactate Solution

Perfusion solution

Read the label carefully before starting to use the medication

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1. What is Ringer Hartmann Braun Lactate Solution and how it is used

2. Before starting to use Ringer Hartmann Braun Lactate Solution

3. How to use Ringer Hartmann Braun Lactate Solution

4. Possible adverse effects

5. Storage of Ringer Hartmann Braun Lactate Solution

6. Additional information

Ringer Hartmann Braun Lactate Solution belongs to the group of electrolytes and is used as an electrolyte replenisher in the following clinical situations:

• Restoration of extracellular fluid and electrolyte balance or replacement of extracellular fluid loss when isotonic concentrations of electrolytes are sufficient.
• Short-term volume replacement (alone or associated with colloid) in cases of hypovolemia or hypotension.
• Regulation or maintenance of metabolic acid-base balance and/or treatment of mild to moderate metabolic acidosis (except lactic acidosis).
• Vehicle or support solution for compatible electrolyte concentrates and medications.

Do not use Ringer's Lactate Solution Hartmann Braun:

• If you have hyperhydration (excess of fluids in the body)
• If you have severe renal insufficiency or uncompensated heart failure
• In severe hepatocellular insufficiency or deteriorated lactate metabolism
• In case of general edema or ascitic cirrhosis
• If you are under treatment with digitalis medications (See use with other medications).
• If you have high levels of potassium in the blood (hyperkalemia).
• High levels of sodium in the blood (hypernatremia)
• High levels of chloride in the blood (hyperchloremia)
• High levels of calcium in the blood (hypercalcemia)
• If you have hypertonic dehydration
• Lactic acidosis, severe metabolic acidosis, and metabolic alkalosis

Be cautious with Ringer's Lactate Solution Hartmann Braun:

If you suffer from any disease that requires a reduced sodium intake, such as heart or renal disorders, excess fluids in the lungs, hypertension, etc., or other conditions associated with sodium retention.

Your doctor will monitor the patient, including serum electrolyte controls and water balance if you have certain diseases such as heart or pulmonary failure, hypertension, peripheral or pulmonary edema, renal function deterioration, pre-eclampsia, aldosteronism, or other conditions associated with sodium retention (see also Use of other medications).

Due to the presence of potassium and calcium in this medication, caution is recommended in patients predisposed to having high levels of potassium and calcium in the blood (hyperkalemia or hypercalcemia).

The administration of this medication may cause metabolic alkalosis.

Patients with severe diseases, pain, postoperative stress, infections, burns, neurological, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (hormone that regulates the amount of body fluids) have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to brain inflammation (encephalopathy).

Children, fertile women, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage have a certain risk of severe and potentially fatal brain inflammation caused by a sudden decrease in sodium levels in the blood.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Since no studies have been conducted with this medication in pregnant women, its administration during pregnancy is not recommended.

Use of other medications

Inform your doctor, nurse, or pharmacist if you are using, or have recently used, other medications, including those obtained without a prescription.

-Interactions related to the presence of sodium:

• Corticosteroids/steroids (anti-inflammatory) and carbenoxolone (for ulcers), which are associated with sodium and water retention (with edema and hypertension)

- Interactions related to the presence ofpotassium:

• Amiloride, spironolactone, triamterene, alone or in combination (to increase the normal amount of urine eliminated)
• ACE inhibitors and, by extrapolation, angiotensin II receptor antagonists (anti-hypertensive)
• Tacrolimus, cyclosporine (to prevent transplant rejection) which increase the concentration of potassium in plasma and can lead to potentially fatal potassium levels, especially in cases of renal failure.

-Interactions related to the presence of:calcium:

• Cardiac digitalis (for the heart), whose effects are potentiated by the presence of calcium and can lead to serious or fatal heart alterations
• Thiazide diuretics (to increase the normal amount of urine eliminated) or vitamin D, which can lead to high calcium levels when administered with calcium
• Bisphosphonates (for osteoporosis), fluorides, some fluoroquinolones, and tetracyclines (antibiotics) which are less absorbed when administered with calcium.

-Interactions related to the presence of lactate:

• Acidic medications such as salicylates (for pain), barbiturates (tranquilizers), and lithium, which are eliminated by the kidneys more quickly
• Alkaline medications, mainly sympathomimetics (stimulants) (e.g. ephedrine, pseudoephedrine) and stimulants (e.g. dexanfetamine sulfate, phenfluramine hydrochloride) which are eliminated by the kidneys more slowly.

-Interaction withmedications that increase the effect of vasopressin and the risk of having low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for the treatment of epilepsy
• Vincristine and ifosfamide used for cancer treatment
• Cyclophosphamide for cancer and autoimmune disease treatment
• Selective serotonin reuptake inhibitors (SSRIs) for depression treatment
• Antipsychotics for mental disorders
• Opioid analgesics for severe pain relief
• Non-steroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and to treat body inflammation.
• Desmopressin for diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine)
• Oxytocin used during childbirth
• Vasopressin and terlipressin used for treating esophageal varices (dilated veins in the esophagus caused by liver problems)
• Diuretics (medications that increase the amount of urine excreted)

Medications containing oxalate, phosphate, or carbonate/bicarbonate may cause precipitation if mixed withRinger's Lactate Solution Hartmann Braun. Calcium complexes inactivate tetracycline-type antibiotics, so they should not be mixed in parenteral administration.

Generally, solutions of this type are not recommended for adding blood or blood components due to the risk of coagulation caused by the presence of calcium.

Follow exactly the administration instructions for Solución Lactato de Ringer Braun as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Solución Lactato de Ringer Hartmann Braun will be administered by healthcare personnel only by intravenous infusion.

Your doctor will inform you of the duration of your treatment with Solución Lactato de Ringer Hartmann Braun. Do not discontinue treatment beforehand. If it is estimated that the action of Solución Lactato de Ringer Hartmann Braun is too strong or weak, inform your doctor or pharmacist.

The dose and administration schedule depend on the patient's age, body weight, and clinical condition.

Adults:The recommended dosage ranges from 500 ml to 3 liters per 24 hours. Do not administer more than 40 ml of solution per kg of body weight per day.

The infusion rate should be adjusted according to the patient's clinical condition: normally it will not exceed 5 ml per kg of body weight per hour (1.7 drops/kg/minute).

Infants and children:The recommended dosage ranges from 20-100 ml/kg per 24 hours

Seniors:Solución Lactato de Ringer Hartmann Braun may be administered by adjusting the doses to individual requirements.

If you use more Solución Lactato de Ringer Hartmann Braun than you should:

The symptoms of overdose include hyperhydration (excess fluid in the body) with increased tissue tension and venous congestion, alterations in electrolyte balance, edema, even in the lungs or brain.

Your doctor will monitor the chemical and fluid balance and electrolyte levels (including sodium) in the blood before and during treatment, especially in patients with alterations in vasopressin release and in patients taking medications that increase the action of vasopressin due to a risk of abnormally low sodium levels in the blood (hyponatremia).

Treatment consists of stopping the medication administration, administering diuretics, and correcting the electrolyte and acid-base state.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone (91) 562 04 20

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

Like all medications, Ringer Hartmann Braun Lactate Solution may cause adverse effects, although not everyone will experience them:

• Very common (affecting more than 1 in 10 patients)

-Allergic reactions or symptoms such as localized or generalized rashes, redness, swelling, or irritation around the site where the medication is administered

-Fluid accumulation (edema) in the face and/or larynx, alteration of blood electrolytes (sodium, potassium, calcium, and chloride)

-Nasal congestion, cough, sneezing, contraction of bronchial muscles, and/or difficulty breathing

• Common (affecting more than 1 in 100 but less than 1 in 10)

-Chest tightness, chest pain with tachycardia or bradycardia, anxiety

-In patients with heart problems or pulmonary edema, increased body fluids, and heart failure. Anxiety sensation.

• Uncommon (affecting more than 1 in 1,000 but less than 1 in 100 patients)

-Panic attacks and seizures

-Adverse reactions may occur at the injection site, such as pain, infection, phlebitis.

• Unknown frequency
• • Imbalance of fluid and electrolyte levels in the body. May present with low sodium levels (hyponatremia).

Abnormally low sodium levels in the blood may lead to a severe condition called hyponatremia, which can cause irreversible brain damage and death due to acute encephalopathy. Symptoms of encephalopathy include: headache, nausea, vomiting, seizures, fatigue, and lack of energy.

Consider the adverse effects related to any medication added to the solution.

Adverse reactions associated with the administration technique may include: infection at the injection site, fever, local reaction or pain, venous irritation, thrombosis, or phlebitis that may extend.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish 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 out of the reach and sight of children.

No special storage conditions are required.

Store in the original container.

Do not use Hartmann Braun Ringer's Lactate Solution after the expiration date indicated on the container. The expiration date is the last day of the month indicated.

Do not use Hartmann Braun Ringer's Lactate Solution if you observe turbidity or sedimentation or if the container shows visible signs of deterioration.

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

Composition of Ringer Hartmann Braun Lactate Solution

The active principles are:

The other components are: water for injectable preparations.

The electrolytic composition per 1000 ml is:

Appearance of the product and content of the packaging

Ringer Hartmann Braun Lactate Solution is an intravenous perfusion solution. It is presented in polyethylene containers of 250, 500, and 1000 ml capacity.

Holder of the Marketing Authorization and responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in July 2018.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices.

This information is intended solely for doctors or healthcare professionals:

Check for incompatibility in case any other medication is added to the solution.

Generally, solutions of this type are not recommended for the addition of blood or blood components due to the risk of coagulation caused by the presence of calcium.

Handle in the usual aseptic conditions for the use of intravenous perfusion solutions.

Discard the unused portion of the solution once the container has been opened.