Ringer's Lactate according to Hartmann B. Braun infusion solution

Ringer's Lactate according to Hartmann B. Braun infusion solution. Indications: if you need to receive fluids and salts. This applies if your acid-base balance is normal or your blood is slightly too acidic (mild acidosis), if you have lost water, if you have lost water and salts, if you have lost blood and this needs to be replaced for a short time, if your doctor wants to give you salts or certain medicines that need to be dissolved or diluted.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ringer's Lactate according to Hartmann B. Braun infusion solution

Read the entire package leaflet carefully before you start using this medicine because it contains important information.

• Keep this leaflet. You may want to read it again later.
• If you have any further questions, please ask your doctor or healthcare professional.
• This medicine has been prescribed for you personally. Do not share it with anyone else. It may harm others, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• WHAT IS RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN AND WHAT IS IT USED FOR?
• WHAT SHOULD YOU CONSIDER BEFORE USING RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN?
• HOW SHOULD RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN BE USED?
• WHAT SIDE EFFECTS ARE POSSIBLE?
• HOW SHOULD RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN BE STORED?
• CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN AND WHAT IS IT USED FOR?

Ringer's Lactate according to Hartmann B. Braun is a solution for administering fluids and salts to the body. It is administered via a vein drip (an infusion). Its salt composition is similar to that of human blood. You will receive this solution when you need to receive fluids and salts. This applies if your acid-base balance is normal or your blood is slightly too acidic (mild acidosis), if you have lost water, if you have lost water and salts, if you have lost blood and this needs to be replaced for a short time, or if your doctor wants to give you salts or certain medicines that need to be dissolved or diluted.

2. WHAT SHOULD YOU CONSIDER BEFORE USING RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN?

Ringer's Lactate according to Hartmann B. Braun must not be used:

• if your body's ability to utilize lactate is impaired, resulting in high lactate levels in your blood (see also section "Warnings and Precautions"%%%).
• if you have too much water in your body (water intoxication).

Your doctor will not give you this medicine to correct metabolically increased acidity in the blood (severe metabolic acidosis).

Warnings and Precautions:
Your doctor will take special care:

• if you have lost water while salt is retained in the body.
• if you have high blood levels of potassium, sodium, calcium or chloride.
• if you have an abnormally elevated base content in your blood due to metabolism (severe metabolic alkalosis).
• if you have heart, liver, kidney or lung failure.
• if you have excess water in your body (peripheral edema, extracellular overhydration).
• if you suffer from a condition in which sodium is retained in the body, such as high blood pressure or pregnancy-related septicemia (see "Pregnancy and Breastfeeding"%%%), if you have too high aldosterone levels in your body or are receiving treatment with cortisone.
• if you suffer from a condition in which potassium is retained in the body, such as acute water deficiency in the body or extensive tissue destruction, as occurs in severe burns.
• if you have a condition associated with high levels of vitamin D in the blood, such as sarcoidosis.
• if you have or have had kidney stones.

If you have persistently low sodium levels in your blood, your doctor will take special care to administer this solution slowly. This can help avoid possible brain damage (osmotic demyelination syndrome).

Children:
Your doctor will take special care if your child is 3 months old or younger when receiving this solution.

Use as a carrier solution:
Note: If this solution is used as a carrier solution, follow the manufacturer's safety instructions for the medicine to be mixed. While you are receiving this solution, the following values will be checked to ensure they are normal:
Your blood salt and lactate levels
Your acid-base balance
Your fluid balance.

Use of Ringer's Lactate according to Hartmann B. Braun with other medicines:
Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or intend to take/use any other medicines. Your doctor will administer this solution with caution if you are taking any of the following medicines:

• Cortisone or carbenoxolone
• Medicines for the treatment of heart failure (e.g. digitalis preparations, digoxin)
• Medicines that cause an increase in serum potassium levels (see list below):
• Medicines that increase your urine flow and retain potassium (e.g., triamterene, amiloride, spironolactone, alone or in combination)
• Medicines used to treat high blood pressure (ACE inhibitors, e.g. captopril, enalapril, angiotensin II receptor antagonists, e.g. valsartan, losartan)
• some medicines used to suppress your immune system (e.g. tacrolimus, cyclosporine)
• a special medicine called suxamethonium, which is used to relax your muscles
• when taking thiazide diuretics and vitamin D at the same time
• when taking medicines for the treatment of brittle bone disease (e.g. bisphosphonates, fluorides) or certain antibiotics (e.g. fluoroquinolones, tetracyclines)
• stimulant drugs (e.g. ephedrine, pseudoephedrine, desamphetamine sulfate, fenfluramine hydrochloride).

Lactate alkalizes your urine. This could alter the excretion of certain active ingredients (e.g. salicylic acid). Some medicines must not be mixed with Ringer's Lactate according to Hartmann B. Braun. These include medicines containing oxalate, phosphate, or carbonate/bicarbonate. Doctors will only add medicines to Ringer's Lactate according to Hartmann B. Braun if they are sure that it is safe to do so.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
There is no or very limited experience with the use of Ringer's Lactate according to Hartmann B. Braun in pregnant women. Your doctor will only give you this infusion solution if they consider it necessary. Your doctor will be particularly careful if you have a pregnancy-specific illness resulting from metabolic imbalance under the stress of pregnancy (pregnancy toxemia).

Breastfeeding:
Ingredients/metabolism products of Ringer's Lactate according to Hartmann B. Braun are excreted in breast milk, but at therapeutic doses of Ringer's Lactate according to Hartmann B. Braun, no effects on the breastfed infant are to be expected. Ringer's Lactate according to Hartmann B. Braun can be used while breastfeeding.

Driving and using machines:
This medicine has no or negligible influence on the ability to drive and use machines.

3. HOW SHOULD RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN BE USED?

Dosage:
This medicine will be administered to you by a doctor or medical staff. The correct dose of Ringer's Lactate according to Hartmann B. Braun for you will be determined by your doctor based on your fluid and electrolyte requirements. Your age, weight, clinical, and physiological (acid-base) status are taken into account. The recommended dosages are:

Adults and adolescents:
Maximum daily dose up to 40 ml per kg body weight per day. Maximum infusion rate: The infusion rate is adjusted according to your clinical condition. The infusion rate should generally not exceed the following values: 5 ml per kg body weight per day.

Children:
20 ml to 100 ml per kg body weight per day. Maximum infusion rate: on average 5 ml per kg body weight per day. The amount given therefore depends on the patient's age:
6–8 ml per kg body weight per hour for infants1
4–6 ml per kg body weight per hour for toddlers1
2–4 ml per kg body weight per hour for school children2.

1 Infants and toddlers: Age group between 28 days and 23 months.
2 School children: Age group between 2 years and 11 years.

Elderly patients:
In principle, the dosage is the same as for adults, but caution is advised if you have other conditions such as heart failure or impaired kidney function, which can be common in older people.

Patients with burns:
Adults: During the first 24 hours, you will receive 4 ml of solution per kg and percent burn.
Children: During the first 24 hours, your child will receive 3 ml of solution per kg and percent burn. The following volume is added as maintenance therapy for children according to their weight:

• For children weighing 0-10 kg, the amount is 4 ml per kg body weight per hour.
• For children weighing 10-20 kg, the amount is 40 ml per hour + 2 ml per kg body weight per hour
• For children weighing more than 20 kg, the amount is 60 ml per hour + 1 ml per kg body weight per hour.

Use as a carrier solution:
If Ringer's Lactate according to Hartmann B. Braun is used as a carrier solution for compatible electrolyte concentrates and medicinal products, the instructions for use for the medicinal product to be admixed must be observed.

If you have received more Ringer's Lactate according to Hartmann B. Braun than you should:
An overdose can lead to hyperhydration (excess fluid in the body), followed by increased skin tension, venous congestion, tissue swelling, water in the lungs or brain, disturbances in fluid, salt and acid-base balance, and high salt concentration in the blood.
If an overdose occurs, your doctor will administer the necessary treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them. However, as long as this medicine is used as directed, it is unlikely that any adverse effects will occur.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD RINGER'S LACTATE ACCORDING TO HARTMANN B. BRAUN BE STORED?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after "Exp. date". The expiry date refers to the last day of that month. Do not store above 25°C. The containers are for single use only. Dispose of the container and any unused contents after use. No special disposal requirements. Use only if the solution is clear and colorless and the container and cap show no visible signs of damage. Do not reuse partially used containers.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ringer's Lactate according to Hartmann B. Braun contains:
The active ingredients are: 1000 ml of solution contains: Sodium chloride 6.00 g, sodium lactate solution (50% w/w) 6.24 g (equivalent to sodium lactate, 3.12 g), potassium chloride 0.40 g, calcium chloride dihydrate 0.27 g. Electrolyte concentrations: Sodium 131 mmol/l, potassium 5.4 mmol/l, calcium 1.8 mmol/l, chloride 112 mmol/l, lactate 28 mmol/l. The other ingredient is: Water for injections. Theoretical osmolarity: 277 mOsm/l. Titration acidity: < 1 mmol/l. pH: 5.0-7.0.

What Ringer's Lactate according to Hartmann B. Braun looks like and contents of the pack:
It is a solution for infusion, i.e. for administration via a venous drip. It is a clear, colorless solution of salts in water. It is available in:

• Glass bottles, contents: 250 ml, 500 ml, 1000 ml, available in packs of: 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml.
• Polyethylene bottles, contents: 500 ml, 1000 ml, available in packs of: 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 10 × 1000 ml.
• Plastic bags, contents: 500 ml, 1000 ml, available in packs of: 1 × 500 ml, 20 × 500 ml, 1 × 1000 ml, 10 × 1000 ml.

Not all pack sizes may be marketed.

Pharmaceutical Entrepreneur:
B. Braun Melsungen AG,
Carl-Braun-Straße 1,
34212 Melsungen , Germany.

Postal Address:
34209 Melsungen, Germany.


Manufacturer:
B. Braun Melsungen AG,
Carl-Braun-Straße 1,
34212 Melsungen , Germany

or

B. Braun Medical SA,
Carretera de Terrassa 121,
08191 Rubí (Barcelona), Spain.

This leaflet was last revised in May 2025.

Source: Information from the package leaflet
. Version: 08/2025.

Indications: If you need to receive fluids and salts. This applies if your acid-base balance is normal or your blood is slightly too acidic (mild acidosis), if you have lost water, if you have lost water and salts, if you have lost blood and this needs to be replaced for a short time, or if your doctor wants to give you salts or certain medications that need to be dissolved or diluted.