RINGER-HARTMANN'S SOLUTION BRAUN PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Ringer Hartmann Lactate Solution Braun

Perfusion Solution

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What Ringer Hartmann Lactate Solution Braun is and what it is used for
2. Before you use Ringer Hartmann Lactate Solution Braun
3. How to use Ringer Hartmann Lactate Solution Braun
4. Possible side effects
5. Storage of Ringer Hartmann Lactate Solution Braun
6. Further information

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

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

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

2. Before using Ringer Hartmann Lactate Solution Braun

Do not use Ringer Hartmann Lactate Solution Braun:

• If you have hyperhydration (excess fluid in the body)
• If you have severe renal failure or uncompensated heart failure
• In severe hepatocellular failure or impaired lactate metabolism
• In case of general edema or ascitic cirrhosis
• If you are being treated with digitalis drugs (see interaction with other medicines).
• If you have high potassium levels in the blood (hyperkalemia).
• High sodium levels in the blood (hypernatremia)
• High chloride levels in the blood (hyperchloremia)
• High calcium levels in the blood (hypercalcemia)
• If you have hypertonic dehydration
• Lactic acidosis, severe metabolic acidosis, and metabolic alkalosis

Be cautious when using Ringer Hartmann Lactate Solution Braun:

If you have any disease that requires reduced sodium intake, such as heart or kidney disorders, fluid overload in the lungs, hypertension, etc., or other conditions associated with sodium retention.

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

Since this medicine contains potassium and calcium salts, caution is recommended in patients prone to high potassium and calcium levels in the blood (hyperkalemia or hypercalcemia).

Administration of this medicine may cause metabolic alkalosis.

Patients with severe diseases, pain, postoperative stress, infections, burns, nervous system diseases, heart, liver, and kidney diseases, and patients taking medicines that increase the effect of vasopressin (hormone that regulates body fluids), when administered this solution, have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to brain inflammation (encephalopathy).

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Interaction with other medicines

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

• Interactions related to the presence of sodium:
  • Corticosteroids (anti-inflammatory) and carbenoxolone (for ulcers), which are associated with sodium and water retention (with edema and hypertension)

• Interactions related to the presence of potassium:
  • Amiloride, spironolactone, triamterene, alone or in combination (to increase the normal amount of urine eliminated)
  • ACE inhibitors and, by extrapolation, angiotensin II receptor antagonists (antihypertensives)
  • Tacrolimus, cyclosporin (to prevent transplant rejection) which increase plasma potassium concentration and may lead to potentially fatal potassium levels, especially in case of renal failure.

• Interactions related to the presence of calcium:
  • Digitalis cardiac stimulants (for the heart), whose effects are potentiated by the presence of calcium and may lead to serious or fatal heart alterations
  • Thiazide diuretics (to increase the normal amount of urine eliminated) or vitamin D, which may lead to excessively 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 drugs such as salicylates (for pain), barbiturates (sedatives), and lithium, which are eliminated by the kidneys more quickly
  • Alkaline drugs, mainly sympathomimetics (stimulants) (e.g., ephedrine, pseudoephedrine) and stimulants (e.g., dextroamphetamine sulfate, fenfluramine hydrochloride) which are eliminated by the kidneys more slowly.

• Interaction with medicines that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

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

Drugs containing oxalate, phosphate, or carbonate/bicarbonate may cause precipitation if mixed with Ringer Hartmann Lactate Solution 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 the addition of blood or blood components due to the risk of coagulation caused by the presence of calcium.

3. How to use Ringer Hartmann Lactate Solution Braun

Follow the administration instructions of Ringer Hartmann Lactate Solution Braun exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Ringer Hartmann Lactate Solution Braun will be administered by healthcare personnel only by intravenous perfusion.

Your doctor will indicate the duration of your treatment with Ringer Hartmann Lactate Solution Braun. Do not stop treatment before. If it is estimated that the action of Ringer Hartmann Lactate Solution 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 every 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 not exceeding 5 ml per kg of body weight per hour (1.7 drops/kg/minute).

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

Elderly:Ringer Hartmann Lactate Solution Braun can be administered by adjusting the doses to individual requirements.

If you use more Ringer Hartmann Lactate Solution Braun than you should:

Symptoms of an overdose include hyperhydration (excess body fluid) 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 (hormone that regulates body fluids) and in patients taking medicines that increase the action of vasopressin due to the risk of abnormally low sodium levels in the blood (hyponatremia).

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

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

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

4. Possible side effects

Like all medicines, Ringer Hartmann Lactate Solution Braun can cause side effects, although not everybody gets them:

• Very common (more than 1 in 10 patients)

• Allergic reactions or symptoms such as localized or generalized rashes, redness, swelling, or irritation around the injection site
• Fluid accumulation (edema) at the facial and/or laryngeal level and/or alteration of electrolytes in the blood (sodium, potassium, calcium, chlorides)
• Nasal congestion, cough, sneezing, contraction of bronchial muscles and/or difficulty breathing.

• Common (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. Feeling of anxiety.

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

• Panic attacks and convulsions.
• Adverse reactions may occur at the injection site, such as pain, infection, phlebitis.
  • Frequency not known
  • • Imbalance in fluid and mineral levels in the body. May present with low sodium levels (hyponatremia).

Abnormally low sodium levels in the blood can lead to a serious condition called hyponatremia. It can cause irreversible brain damage and death due to the development of brain edema (acute hyponatremic encephalopathy). Symptoms of brain edema include: headache, nausea, vomiting, convulsions, fatigue, and lack of energy.

Adverse effects related to any medicine that has been added to the solution should be considered.

Adverse reactions associated with the administration technique, such as infection at the injection site, fever, local reaction or pain, venous irritation, thrombosis, or phlebitis, may occur.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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.

5. Storage of Ringer Hartmann Lactate Solution Braun

Keep out of the reach and sight of children.

No special storage conditions are required.

Store in the original package.

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

Do not use Ringer Hartmann Lactate Solution Braun if you notice turbidity or sedimentation or if the package shows visible signs of deterioration.

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

6. Further information

Composition of Ringer Hartmann Lactate Solution Braun

The active ingredients are:

The other ingredients are: water for injectable preparations.

The electrolyte composition per 1000 ml is:

Appearance of the product and package contents

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

Marketing Authorization Holder and Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in July 2018.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

This information is intended only for healthcare professionals:

Incompatibility should be checked in case any other medicine 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 under usual asepsis conditions for the use of solutions for intravenous perfusion.

Once the package is opened, discard the unused portion of the solution.