Ringer

PATIENT INFORMATION LEAFLET: USER INFORMATION

Ringer, solution for infusion

Active substances: sodium chloride, potassium chloride, and calcium chloride dihydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse.

Table of contents of the leaflet:

• 1. What is Ringer solution and what is it used for
• 2. Important information before using Ringer solution
• 3. How to use Ringer solution
• 4. Possible side effects
• 5. How to store Ringer solution
• 6. Package contents and other information

1. What is Ringer solution and what is it used for

Ringer solution for infusion is an aqueous solution containing the following substances:

• sodium chloride,
• potassium chloride,
• calcium chloride dihydrate.

Ringer solution for infusion is used to treat loss of water from the body (dehydration) and chemicals (e.g., due to excessive sweating, kidney disorders).

2. Important information before using Ringer solution

DO NOT USE Ringer solution, solution for infusion, if the patient has any of the following conditions:

• premature infants and newborns born at term (up to 28 days of age): the antibiotic ceftriaxone should not be administered by intravenous infusion simultaneously with this solution;
• in cases where fluid accumulates excessively in the spaces around cells (extracellular overhydration);
• in cases of increased blood volume in the vessels (hyperolemia);
• severe kidney failure (when the kidneys do not work properly and the patient requires dialysis);
• uncontrolled heart failure. This is heart failure that is not being treated properly and causes symptoms such as:
• shortness of breath;
• swelling around the ankles;
• in cases of excessive fluid in the body due to high salt content in the blood (hypertonic dehydration);
• high potassium levels in the blood (hyperkalemia);
• high sodium levels in the blood (hypernatremia);
• high calcium levels in the blood (hypercalcemia);
• high chloride levels in the blood (hyperchloremia);
• very high blood pressure (hypertension);
• fluid accumulation under the skin, covering the entire body (generalized edema);
• liver disease causing fluid accumulation in the abdominal cavity (liver cirrhosis with ascites);
• in cases of taking cardiac glycosides (cardiotonic drugs) used to treat heart failure, such as digitalis or digoxin (see also "Other medicines and Ringer").

Warnings and precautions

Inform your doctor or nurse about the following circumstances and diseases that are currently present or have occurred in the past:

• respiratory failure (lung disease) (in the above cases, the patient may need to be closely monitored);
• any forms of heart disease or cardiac disorders;
• kidney disorders;
• high blood pressure (hypertension);
• fluid accumulation under the skin, especially around the ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• high blood pressure during pregnancy (pre-eclampsia);
• diseases causing high levels of a hormone called aldosterone (aldosteronism);
• any other conditions related to sodium retention (when the body retains too much sodium) such as steroid treatment (see also "Other medicines and Ringer");
• disorders of cerebrospinal fluid (e.g., due to meningitis, intracranial hemorrhage, or brain damage);
• conditions that may cause high vasopressin activity, a hormone that regulates fluid in the body, such as:
• -sudden and severe illness or injury;
• -recent surgery;
• -brain disease;
• -taking certain medications. These conditions may increase the risk of low sodium levels in the blood and cause headache, nausea, seizures, drowsiness, coma, and brain edema. Patients at higher risk of brain edema are:
• children;
• women (especially of childbearing age);
• conditions where the adrenal glands produce insufficient amounts of certain hormones (adrenal insufficiency);
• water loss from the body (acute dehydration, e.g., due to vomiting or diarrhea);
• widespread tissue damage (e.g., after severe burns);
• diseases associated with high levels of vitamin D (e.g., sarcoidosis, skin and internal diseases);
• diseases associated with kidney stones;
• the antibiotic ceftriaxone should not be mixed or administered simultaneously with any solutions containing calcium, in case of intravenous administration. This solution contains calcium. In patients over 28 days of age, ceftriaxone and a calcium-containing solution may be administered sequentially, one after the other, provided the doctor takes action to avoid a reaction between the medicines. In cases where the adult or child patient has a small blood volume, the doctor will avoid administering calcium and ceftriaxone sequentially;
• heart failure.

In patients receiving this infusion, blood and urine tests will be performed, and the doctor will also monitor:

• the amount of fluid in the body;
• vital signs;
• the amount of substances such as sodium, potassium, calcium, and chlorides (serum electrolytes).

Although Ringer solution for infusion contains potassium and calcium, their amount is not sufficient to:

• maintain adequate levels of these substances;
• treat very low levels of potassium (severe hypokalemia) or calcium (severe hypocalcemia) in the blood.

After correcting dehydration with Ringer solution, the doctor will use another infusion solution to provide the body with adequate amounts of potassium and calcium. The doctor will consider whether the patient is receiving parenteral nutrition (nutrition administered through a vein). In cases where Ringer solution is administered for a long time, the patient will receive nutrients from an additional source.
Calcium chloride can be harmful if injected into body tissues. Therefore, Ringer solution should not be injected into muscles (intramuscular injection). The doctor will also make every effort to avoid the solution leaking into the tissues surrounding the vein.
Ringer solution for infusion should not be administered through the same needle as a blood transfusion. This can cause damage to red blood cells or their clumping.

Ringer solution and other medicines

Inform your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It is especially important to inform your doctor about the use of:

• ceftriaxone (an antibiotic) administered intravenously (see Warnings and precautions);
• cardiac glycosides (cardiotonic drugs) such as digitalis or digoxin used to treat heart failure; they should not be used in combination with Ringer solution (see also the point "DO NOT USE Ringer solution if the patient has..."). The action of these drugs may be enhanced by calcium, which can lead to life-threatening changes in heart rhythm.

The following medicines may cause sodium and water retention in the body, leading to tissue swelling and increased blood pressure:

• corticosteroids (anti-inflammatory drugs);
• carbenoxolone (an anti-inflammatory drug used to treat stomach ulcers).

The following medicines may increase potassium levels in the blood. This effect can be life-threatening. Increased potassium levels in the blood are more likely to occur in patients with kidney disease:

• potassium-sparing diuretics (certain diuretic drugs, e.g., amiloride, spironolactone, triamterene) (note that these drugs may be part of combination products);
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure);
• angiotensin II receptor antagonists (used to treat high blood pressure);
• tacrolimus (used to prevent transplant rejection and treat certain skin diseases);
• cyclosporine (used to prevent transplant rejection).

Some medicines may increase the risk of side effects due to low sodium levels in the blood. These medicines may include:

• diuretic drugs;
• -pain-relieving and (or) anti-inflammatory drugs (also known as NSAIDs);
• -antipsychotic drugs;
• -drugs used to treat depression (selective serotonin reuptake inhibitors);
• -drugs that produce effects similar to morphine (opioids);
• -some drugs used to treat epilepsy (antiepileptic drugs);
• -the hormone oxytocin (causes uterine contractions);
• -some drugs used to treat cancer (chemotherapy);
• -cholesterol-lowering drugs;
• -antidiabetic drugs.

Other medicines that may affect the action of Ringer solution or be affected by it include:

• thiazide diuretic drugs such as hydrochlorothiazide or chlorthalidone;
• vitamin D.

Using Ringer solution with food and drink

Ask your doctor what foods and drinks you can consume during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or nurse before using this medicine.
Ringer solution for infusion can be used safely during pregnancy or breastfeeding, provided that electrolyte and fluid balance is monitored by a doctor. The doctor will pay special attention when using oxytocin in a patient during labor.
Calcium can pass into the baby's body through the placenta, and after birth, through breast milk. The doctor will monitor the levels of substances and fluids in the patient's body.
If it is necessary to add another medicine to the infusion solution during pregnancy, especially during labor or breastfeeding, you should:

• consult a doctor;
• read the patient information leaflet of the medicine to be added.

Driving and using machines

Ringer solution does not affect the ability to drive or use machines.

3. How to use Ringer solution

Ringer solution for infusion is administered by a doctor or nurse. The doctor will decide what dose of the medicine to use and when to administer it. This will depend on the patient's age, weight, and treatment conditions and reasons. The amount of medicine administered may also depend on other medicines used by the patient.

DO NOT USE Ringer solution if the solution contains visible particles or if the packaging is damaged in any way.

Ringer solution is usually administered through a plastic tube connected to a needle inserted into a vein.
Typically, this solution is administered through a vein in the arm. However, the doctor may use a different method to administer the medicine to the patient.
In patients receiving Ringer solution for infusion, the doctor will perform blood tests to evaluate:

• sodium, potassium, calcium, and chloride levels in the blood;
• fluid levels.

Any unused remains of the solution should be discarded. Partially used bags of Ringer solution MUST NOT be reconnected.

Using more Ringer solution than recommended

In case of using too much Ringer solution (overdose) or administering the solution too quickly, the following symptoms may occur:

• fluid overload and (or) sodium overload with excessive fluid accumulation in tissues (edema) causing swelling;
• tingling sensation in hands and feet (paresthesia);
• muscle weakness;
• inability to move (paralysis);
• irregular heartbeats (cardiac arrhythmia);
• heart block (very slow heart rate);
• cardiac arrest (heart stops beating: life-threatening condition);
• confusion;
• loss of appetite (anorexia);
• nausea;
• vomiting;
• constipation;
• abdominal pain;
• mental disorders such as irritability or depression;
• excessive thirst;
• producing more urine than normal (polyuria);
• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis);
• kidney stones;
• coma (loss of consciousness);
• chalky taste in the mouth;
• flushing (hot flashes with facial flushing);
• peripheral vasodilation (peripheral vasodilation);
• acidosis of the blood (acidosis) causing fatigue, confusion, lethargy, and rapid breathing.

If the patient experiences any of these symptoms, they should immediately inform their doctor. The infusion will be discontinued, and the doctor will provide treatment depending on the symptoms.
If another medicine has been added to the Ringer solution, it may also cause symptoms before the symptoms of Ringer solution overdose occur. You should read the patient information leaflet of the medicine administered with Ringer solution to learn about possible symptoms.

Stopping Ringer solution treatment

The doctor will decide when to discontinue the infusion.
In case of any further doubts about using this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, Ringer solution can cause side effects, although not everybody gets them.
Side effects are listed according to their frequency of occurrence.
Very common(occurring in more than 1 in 10 patients):

• changes in blood substance levels (electrolyte disorders).

In patients with heart disease or fluid in the lungs (pulmonary edema):

• excessive fluid in the body (overhydration);
• heart failure.

Other

• reactions caused by the method of administering the medicine:
• fever (febrile response);
• infections at the infusion site;
• pain or reaction at the injection site (redness or swelling at the infusion site);
• irritation and inflammation of the vein into which the medicine was infused (phlebitis). This can cause redness, pain, or a burning sensation and swelling along the vein into which the medicine was infused;
• blood clots in the veins (thrombophlebitis), at the infusion site, causing pain, swelling, or redness in the area of the clot;
• leakage of the solution into the tissues surrounding the vein (extravasation). This can cause tissue damage and scarring;
• low sodium levels in the blood (hyponatremia);
• brain edema, which can cause brain damage (cerebral edema).

If another medicine has been added to the infusion solution, it may also cause side effects. These depend on the medicine added. You should read the patient information leaflet of the medicine administered with Ringer solution to learn about possible side effects.
If you experience any side effects, including any side effects not listed in this leaflet, you should consult a doctor or nurse.

Reporting side effects

If you experience any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ringer solution

Store the medicine out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the infusion bag. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice visible particles or if the packaging is damaged in any way.

6. Package contents and other information

What Ringer solution contains

The active substances are:

• sodium chloride: 8.60 g per liter
• potassium chloride: 0.30 g per liter
• calcium chloride dihydrate: 0.33 g per liter

Other substances are:

• water for injections
• sodium hydroxide

What Ringer solution looks like and what the package contains

Ringer solution for infusion is a clear solution free from visible particles.
It is available in polyolefin/polyamide plastic bags (Viaflo). Each bag is placed in a closed protective outer plastic package.
Bag sizes:

• 500 ml
• 1000 ml

Bags are supplied in cardboard boxes. The cardboard box may contain the following quantities:

• 1 bag of 500 ml
• 20 bags of 500 ml
• 1 bag of 1000 ml
• 10 or 12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturers

Marketing authorization holder:

Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturers:

Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Date of last revision of the leaflet:January 2023
Baxter and Viaflo are trademarks of Baxter International Inc.

The following information is intended for healthcare professionals only:

Method of handling and preparation

Use only if the solution is clear, free from visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove from the protective packaging until use.
The inner bag ensures the sterility of the product.
Plastic containers should not be connected in series. Such use could cause an air embolism due to residual air drawn into the first container before the infusion of the solution from the second container is completed. Applying additional pressure on intravenous solutions in flexible plastic containers to increase the flow rate may cause an air embolism if the residual air is not completely removed from the container before administration.
Using infusion sets with air vents, with the air vent valve in the open position, may cause an air embolism. Infusion sets with air vents, with the air vent valve in the open position, should not be used with flexible plastic containers.

• 1. Opening
• a. Remove the Viaflo bag from the protective packaging immediately before use.
• b. By squeezing the inner bag firmly, check for leakage. If leakage is detected, the bag should be discarded, as the contents may not be sterile.
• c. Check if the solution is clear and free from visible particles. If the solution is not clear or contains visible particles, it should be discarded.
• 2. Preparation for administration During preparation and administration, use sterile materials.
• a. Hang the bag on a stand.
• b. Remove the plastic cover from the transfer port at the bottom of the bag:
• grasp the smaller wing on the neck of the port with one hand;
• grasp the larger wing on the plug with the other hand and twist;
• the plug will come off.
• c. When connecting the infusion set, follow aseptic techniques.
• d. Connect the infusion set according to the instructions provided with the set, regarding connection, filling the set, and administering the solution.
• 3. Methods of adding other medicines Note: Added medicines may be incompatible (see below, point 5 "Incompatibility of added medicines").

Adding medicines before administration

• a. Disinfect the medicine addition port.
• b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• c. Mix the solution with the added medicine thoroughly. For preparations with high density, such as potassium chloride, gently tap the ports with the bag ports facing upwards and mix.

Note: Do not store bags containing added medicines.
Adding medicines during administration

• a. Close the infusion set clamp.
• b. Disinfect the medicine addition port.
• c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• d. Remove the bag from the stand and (or) turn it over with the ports facing upwards.
• e. Empty both ports by gently tapping them with the bag ports facing upwards.
• f. Mix the solution with the medicine thoroughly.
• g. Hang the bag in its previous position, reopen the clamp, and continue the infusion.
• 4. Shelf life during use (added medicines) Before use, the chemical and physical stability of each added medicine should be established in the pH range of Ringer solution in the Viaflo container. From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions before use, and storage should not exceed 24 hours at a temperature between 2°C and 8°C, unless the medicine is dissolved under controlled and validated aseptic conditions.
• 5. Incompatibility of added medicines As with any solution for intravenous administration, the compatibility of the added medicine with the solution in the Viaflo container should be checked before addition. The doctor is responsible for assessing the incompatibility of the added medicine with Ringer solution by checking for any change in color and (or) the appearance of a precipitate, insoluble complexes, or crystals. You should read the instructions for the medicine to be added to the solution. Before adding the medicine, check if it is soluble and stable in water at the pH of Ringer solution (pH 5.0 to 7.5). Incompatibilities have been reported between calcium salts and a large number of drugs. Complexes may form, resulting in precipitation.
• Concomitant administration of ceftriaxone and Ringer solution is contraindicated in premature infants and newborns born at term (up to 28 days of age), even if separate infusion lines are used.
• In patients of any age, ceftriaxone should not be mixed or administered simultaneously with any intravenous solutions containing calcium, even through different infusion lines or at different infusion sites.
• If the same infusion line is used for subsequent administration, it should be thoroughly flushed with a compatible fluid between infusions.
• In cases of hypovolemia, ceftriaxone and calcium-containing solutions should be avoided one after the other.

Consider that the following substances are incompatible with Ringer solution ( list is not exhaustive):

• amphotericin B
• cortisone
• erythromycin lactobionate
• etamivan
• ethanol
• thiopental sodium
• disodium edetate

Do not use substances known to be incompatible.
Baxter and Viaflo are trademarks of Baxter International Inc.