Package leaflet: Information for the user

RINGER ACETATO BAXTER

6 mg/ml + 0.3 mg/ml + 0.2 mg/ml + 4 mg/ml
Infusion solution
Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Sodium Acetate
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What RINGER ACETATO BAXTER is and what it is used for
What you need to know before using RINGER ACETATO BAXTER
How to use RINGER ACETATO BAXTER
Possible side effects
How to store RINGER ACETATO BAXTER
Contents of the pack and other information

1. WHAT RINGER ACETATE BAXTER IS AND WHAT IT IS USED FOR

RINGER ACETATE BAXTER belongs to the class of electrolytes (substances essential
for all cells to maintain a condition that enables them to perform their functions optimally).
This medicinal product is used in replacement therapy for extracellular fluid and
electrolyte losses, when correction of mild or moderate, but not severe, acidotic states (increased blood acidity) is required.

2. WHAT YOU NEED TO KNOW BEFORE USING RINGER ACETATO BAXTER

Do not use RINGER ACETATO BAXTER

If you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, sodium acetate, or any of the other components of this medicine (listed in section 6).
If you have severe renal insufficiency (reduced kidney function).
If you have hypercalcemia (increased calcium levels in the blood), hypercalciuria (abnormal presence of calcium in the urine), or severe kidney diseases.
In case of hypernatremia (increased sodium concentrations in the blood).
In case of hydrosaline plethoric states (accumulation of fluids and salts).
In case of hyperkalemia (increased potassium concentrations in the blood) or in cases of potassium retention (reduced ability to excrete potassium).
In case of ventricular fibrillation (heart rhythm disorder). Calcium chloride may increase the risk of arrhythmias (irregular heartbeat).
In case of severe hepatic insufficiency (reduced liver function).
If you have kidney stones (the condition may worsen with calcium administration).
If you suffer from sarcoidosis (an inflammatory disease that may affect any organ). This condition may enhance the typical hypercalcemia.
In case of hypercoagulability (abnormal blood coagulation).
If you are concurrently receiving cardiac glycosides, medicines for heart diseases (see "Other medicines and RINGER ACETATO BAXTER").
If you have Addison's disease (a condition caused by reduced adrenal cortex function) and are not receiving treatment for it.
In case of heat cramps (muscle cramps due to physical exertion caused by excessive fluid intake without sodium replacement).

Concomitant treatment with ceftriaxone (an antibiotic), even when using separate infusion lines, is contraindicated in neonates under 28 days of age (see "Other medicines and RINGER ACETATO BAXTER", section 3 "How to use RINGER ACETATO BAXTER", and section 4 "Possible side effects").
When administering blood transfusions, this solution must not be administered through the same infusion catheter as whole blood due to the possible risk of coagulation.

Warnings and precautions
Talk to your doctor or nurse before using RINGER ACETATO BAXTER
This medicine must be administered via a very slow infusion, as rapid administration may cause potassium intoxication, which could lead to cardiac dysfunction (cardiac depression), cardiac arrhythmias, and even cardiac arrest, potentially resulting in death.
The RINGER ACETATO BAXTER solution is irritating and therefore must not be administered intramuscularly (into the muscle), subcutaneously (under the skin), or into the perivascular tissue (around blood vessels), as tissue necrosis (tissue death) may occur.
The medicine should not be used unless strictly necessary in the following cases:

If you suffer from an adrenal gland disorder characterized by excessive aldosterone production (primary or secondary hyperaldosteronism), or if you have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and protein in the urine, as it may cause sodium retention, fluid overload, or fluid accumulation (edema);
If you have excess potassium in the blood (hyperkalemia) or are predisposed to it, due to: severe kidney damage, adrenal gland disease (adrenocortical insufficiency), severe dehydration, extensive tissue damage or burns, or if you have heart problems (heart failure).

The medicine must be administered with caution in patients:

With renal insufficiency (reduced kidney function); administration of potassium-containing solutions in patients with impaired kidney function may cause potassium retention.
With heart failure (reduced heart function), especially if being treated with digitalis drugs (medicines that enhance heart function).
With adrenal insufficiency (reduced adrenal function).
With hepatic insufficiency (reduced liver function).
With familial periodic paralysis (a neuromuscular disorder with functional disturbances).
With congenital myotonia (a pathological condition present from birth characterized by prolonged muscle contraction).
In the early postoperative phase.
With kidney diseases, cor pulmonale (enlargement of the right ventricle of the heart caused by lung disease), respiratory failure, or respiratory acidosis (a condition characterized by increased respiratory rate and depth, irritability, headache, anorexia, drowsiness, potentially progressing to coma in untreated forms, caused by carbon dioxide accumulation in the blood due to diseases leading to respiratory failure). In these situations, the acidifying effect of calcium chloride may worsen the clinical picture.
Who are in a state of hypercalcemia or at risk of developing hypercalcemia (increased calcium levels in the blood), such as in chronic kidney failure, dehydration (excessive fluid loss), electrolyte imbalance, or with kidney stones, even in the past.
With heart diseases, as calcium salts may increase the risk of arrhythmias.
Who are in any of the following conditions that may cause elevated levels of vasopressin, a hormone regulating body fluids: acute illness, pain, recent surgery, infections, burns, brain diseases, liver, heart or kidney diseases, or who are taking certain medications (see also "Other medicines and RINGER ACETATO BAXTER").

This may increase the risk of low sodium levels in the blood (hyponatremia), leading to headache, nausea, seizures, lethargy, vomiting, and cerebral edema. Cerebral edema increases the risk of dangerous brain damage.
Individuals at higher risk of cerebral edema include:

Children
Women (especially those of childbearing age)
Individuals with altered fluid levels in the brain (e.g., due to meningitis, intracranial bleeding, or cerebral contusion).

Due to the presence of sodium, administer the medicine with caution:

In patients with congestive heart failure (a pathological condition caused by the heart's inability to pump sufficient blood to meet the body's needs).
In case of severe renal insufficiency (reduced kidney function).
In clinical conditions associated with edema (swelling) and hydrosaline retention (retention of water and salts).
In patients receiving cardiac inotropic drugs (which stimulate heart function) or corticosteroid drugs (anti-inflammatory agents) or corticotropin drugs (used to assess adrenal gland function or to treat diseases requiring corticosteroid therapy).
In patients with hypertension (high blood pressure).
In patients with aldosteronism.
In case of congestive heart failure.
In patients with liver diseases.
In patients with peripheral or pulmonary edema.
In patients with reduced kidney function.
In cases of pre-eclampsia (a specific pregnancy condition characterized by edema, protein in the urine, and high blood pressure), fluid overload, or other conditions associated with sodium retention (see "Other medicines and RINGER ACETATO BAXTER").

Due to the presence of calcium, the medicine must be used with great caution in patients:

With kidney diseases.
With heart diseases.
Who have received a blood transfusion, as calcium ion concentrations may differ from expected values.

Due to the presence of acetate, the medicine must be used with caution:

In patients with metabolic or respiratory alkalosis (a pathological condition characterized by decreased blood acidity).
In conditions involving increased levels or insufficient utilization of this ion, such as mild or moderate hepatic insufficiency (reduced liver function).

Administration of the medicine may cause vasodilation (dilation of blood vessels), resulting in a drop in blood pressure.
During administration, depending on the volume and rate of infusion, fluid accumulation (fluid overload, congestive state including pulmonary congestion and edema), disturbances in blood mineral salts (electrolytes), and blood pH (acid-base balance) may occur.
During treatment with this medicine, your doctor should periodically monitor your heart function using electrocardiograms and check blood electrolyte concentrations (plasma osmolarity), fluid status, and blood pH (acid-base balance).
Frequent monitoring of calcium levels in blood and urine is necessary to avoid hypercalciuria (excessive calcium loss in urine), as hypercalciuria may progress to hypercalcemia (excessively high calcium levels in blood).
Infusion must be stopped immediately if signs or symptoms of suspected hypersensitivity develop.

Children
Plasma electrolyte concentrations must be carefully monitored in the pediatric population, as this group may have a reduced ability to regulate fluids and electrolytes.

Elderly use
When selecting the type of infusion solution and the volume/rate of infusion for elderly patients, consider that elderly patients are more likely to have heart, kidney, or liver diseases and to be taking other medications.
Infusion of hypotonic fluids together with non-osmotic ADH secretion may cause hyponatremia, manifesting as headache, nausea, vomiting, seizures, lethargy (a state of deep complete sleep accompanied by muscle relaxation and total loss of sensation), muscle cramps, restlessness, disorientation, delayed reflexes, coma, cerebral edema, and death. Therefore, acute symptomatic hyponatremic encephalopathy (a brain disorder) is considered a medical emergency.
Concomitant treatment of RINGER ACETATO BAXTER with ceftriaxone is contraindicated in neonates under 28 days of age, even when using separate infusion lines, due to the risk of precipitation of ceftriaxone-calcium salt in the neonate's bloodstream, which may be fatal (see section 4 "Possible side effects").
In patients over 28 days of age (including adults), ceftriaxone must not be administered concurrently with intravenous solutions containing calcium, including RINGER ACETATO BAXTER, through the same infusion line (e.g., via a Y-connector) (see "Other medicines and RINGER ACETATO BAXTER").

Other medicines and RINGER ACETATO BAXTER
Inform your doctor if you are currently using, have recently used, or might use any other medicine.
This medicine must not be administered in combination with:
cardiac glycosides (digitalis), digoxin, and digitoxin, used for heart problems, as concomitant use may increase the risk of cardiac arrhythmias, considering that the inotropic effect (increased heart function) and toxic effects are synergistic (exert a potentiated action).
RINGER ACETATO BAXTER should be administered with caution in combination with:

Potassium-sparing diuretics (drugs that increase urine production); such combination may increase the risk of hyperkalemia (excessive potassium concentration in blood), especially in the presence of renal dysfunction. In such cases, close monitoring of blood potassium levels is required.
Medicines such as ACE inhibitors (drugs used to lower blood pressure), which reduce aldosterone levels and may lead to potassium retention; blood potassium levels must be closely monitored.
Angiotensin II receptor antagonists.
Immunosuppressants, such as tacrolimus and cyclosporine.
Corticosteroid drugs (anti-inflammatory agents), which may cause sodium and water retention, leading to edema (fluid accumulation) and hypertension (increased blood pressure) (see "Warnings and precautions").
Thiazide diuretics (used to treat high blood pressure) and vitamin D, as hypocalcemia (increased calcium levels in blood) may occur due to reduced renal calcium excretion.
Verapamil (and other calcium channel blockers), as concomitant use may reduce the antihypertensive effect of verapamil.
Medicines containing magnesium, as this may increase the risk of hypercalcemia or hypermagnesemia (increased magnesium concentration in blood), especially in patients with kidney disorders.
Neuromuscular blocking agents (drugs used to achieve muscle relaxation during surgery); calcium salts may counteract the effect of non-depolarizing blockers. In some cases, increased and prolonged action of tubocurarine, suxamethonium, or vecuronium has also been observed.
Acidic drugs, such as salicylates, barbiturates, and lithium, as their elimination may be increased.
Alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine), quinidine, and dextroamphetamine sulfate, as their elimination may be decreased.
Medicines acting on vasopressin hormone, e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, chlorpropamide, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin.
Diuretics in general and oxcarbazepine, as they may increase the risk of hyponatremia.

Concomitant treatment of RINGER ACETATO BAXTER with ceftriaxone is contraindicated in neonates under 28 days of age, even when using separate infusion lines, due to the risk of precipitation of ceftriaxone-calcium salt in the neonate's bloodstream, which may be fatal (see section 4 "Possible side effects").
In patients over 28 days of age (including adults), ceftriaxone must not be administered concurrently with intravenous solutions containing calcium, including RINGER ACETATO BAXTER, through the same infusion line (e.g., via a Y-connector).
If the same line is used for sequential administrations, the line must be flushed with a compatible fluid between infusions.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before this medicine is administered to you.
The medicine must not be used during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risk-benefit ratio.
If you are pregnant, RINGER ACETATO BAXTER must be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a labor-inducing medicine (oxytocin).

Driving and use of machines
This medicine does not affect the ability to drive or operate machinery.

RINGER ACETATO BAXTER contains sodium. This medicine contains 260 mmol (or 5,980 mg) of sodium per daily dose (these values refer to a 70 kg subject). This should be considered in individuals with reduced kidney function or those on a low-sodium diet.

RINGER ACETATO BAXTER contains potassium. This medicine contains 8 mmol (or 312.8 mg) of potassium per dose (these values refer to a 70 kg subject). This should be considered in individuals with reduced kidney function or those on a low-potassium diet.

3. HOW TO USE RINGER ACETATE BAXTER

Your treatment with RINGER ACETATE BAXTER will be supervised by a doctor. The doctor will decide the amount of RINGER ACETATE BAXTER to administer and will prepare the medicine.
The solution is isotonic (has the same concentration) as blood and must be administered directly into a vein (intravenous infusion) by trained medical personnel.
It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The medicine must be administered only if your kidney function is normal and at a rate not exceeding 10 milliequivalents of potassium per hour.
After administration of the medicine, remain lying down for a short period.
The dose will be adjusted by the doctor according to your age, body weight, health condition (only if kidney function is intact), clinical response, and laboratory test results.
The recommended dose in adults is approximately 20–30 ml of solution/kg body weight, which may be increased up to a maximum of 40 ml of solution/kg body weight.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to tolerance.
Administration must be stopped if you experience pain or redness at the injection site, as this could be due to leakage of the medicine from the vein (drug extravasation).
The solution must be used immediately after opening the container. The container is intended for single, uninterrupted administration, and any remaining solution must not be reused.
Shake well during preparation and before administration. Do not use the medicine if the solution is not clear and colourless or if it contains particles.
Ensure all precautions are taken to maintain sterility before and during intravenous infusion.
Do not use plastic containers connected in series, as they may cause gas embolism (obstruction of an artery or vein caused by a foreign body in the bloodstream, called an embolus, which can be a blood clot, an air bubble, or other gas), due to residual air from the primary container before completion of fluid administration from the secondary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent (a device used to expel air) in the open position must not be used with flexible plastic containers.

Incompatibilities with RINGER ACETATE BAXTER
The medicine is incompatible with:

Magnesium sulfate: formation of a precipitate (formation of an insoluble solid).
Medicines containing phosphate: formation of calcium phosphate precipitate.
Medicines containing carbonate: formation of calcium carbonate precipitate.
Medicines containing tartrate: formation of calcium tartrate precipitate.
Aminophylline: formation of a precipitate.
Amphotericin B: development of cloudiness.
Cefamandole.
Sodium ceftriaxone: formation of precipitate; administration of RINGER ACETATE BAXTER must not occur within 48 hours after administration of ceftriaxone.
Cephalothin: physical incompatibility.
Cefradine.
Chlorpheniramine: physical incompatibility.
Dobutamine: development of cloudiness.
Fat emulsion: flocculation (solid phase tends to separate forming flakes in suspension).
Sodium heparin.
Indomethacin: formation of precipitate.
Sodium nitrofurantoin.
Promethazine: formation of precipitate.
Propofol: formation of precipitate.
Streptomycin: calcium may inhibit the activity of streptomycin.
Tetracyclines: calcium salts may complex with tetracyclines.

Calcium salts may form complexes with many drugs, such as cortisone, erythromycin lactobionate, ethamivan, ethyl alcohol, sodium thiopental, disodium edetate, potentially leading to precipitate formation. Physical incompatibility has been reported with ceftriaxone (see sections “Do not use RINGER ACETATE BAXTER”, “Other medicines and RINGER ACETATE BAXTER”, and section 4 “Possible side effects”).

If you use more RINGER ACETATE BAXTER than you should
Following administration of an excessive dose of this medicine, the following may occur:

Fluid overload with risk of edema.
Increased levels of potassium in the blood (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
Increased levels of sodium (hypernatremia) and increased blood volume (hypervolemia). If sodium levels in the blood rise too much, loss of fluid from internal organs (dehydration) may occur, especially in the brain, and fluid accumulation may affect the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lung (pulmonary edema) or swelling in the legs and ankles (peripheral edema);
Increased levels of chloride leading to a reduction in blood pH (acidosis) due to decreased bicarbonate ion concentration;
Increased levels of calcium in the blood (hypercalcemia), especially in patients with kidney disease, resulting in symptoms such as thirst, nausea, vomiting, constipation, increased urine production (polyuria), abdominal pain, muscle weakness, mental disturbances, and in severe cases, heart problems (cardiac arrhythmia) and coma.

In case of administration of an excessive dose of RINGER ACETATE BAXTER, immediately discontinue the infusion and initiate corrective therapy to reduce blood levels of excess ions and restore, if necessary, acid-base balance (see “Warnings and precautions”).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, to ensure appropriate symptomatic and supportive measures as needed.
In case of marked hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of mild calcium chloride overdose, treatment involves immediate discontinuation of the infusion and of any other calcium-containing medication. In case of severe overdose (plasma concentrations greater than 2.9 mmol/L), the following measures should be taken:

Rehydration by administration of 0.9% sodium chloride solution.
Use of non-thiazide diuretics to promote calcium excretion.
Monitoring of potassium and calcium blood levels with immediate correction to normal values.
Monitoring of cardiac function, use of beta-blockers to reduce the risk of cardiac arrhythmia.
Possible resort to hemodialysis (a physical therapy replacing kidney function). High levels of electrolytes in the blood may require dialysis. When assessing overdose, additional supplements added to the solution must also be considered.

If you have any doubts about using this medicine, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur, the frequency of which cannot be determined from the available data:

Gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain, constipation, metallic taste, chalky taste.
Neuromuscular disturbances, muscle rigidity, paresthesia (altered sensation in limbs or other body parts), flaccid paralysis (loss of voluntary movement associated with decreased muscle tone), weakness, mental confusion, headache, dizziness, restlessness, irritability, seizures, coma, death; seizures may be accelerated by acetate-induced alkalosis, acute hyponatremic encephalopathy*.
Drowsiness, confusional states, psychiatric disorders.
Arrhythmias, tachycardia (increased heart rate), bradycardia (decreased heart rate), conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope (transient loss of consciousness), ventricular fibrillation (severe cardiac decompensation), cardiac arrest.
Hypotension, hypertension, peripheral edema, vasodilation, hot flushes.
Hypernatremia, hyponatremia, hypervolemia, hyperchloremia.
Dyspnea (difficulty breathing), respiratory arrest, pulmonary edema, pneumothorax (a condition with sudden onset characterized by accumulation of air in the space between the lung and the chest wall), chest tightness, chest pain.
Reduced tear production.
Renal failure, polyuria (excessive urine production).
Hypercalcemia, Burnett's syndrome (a condition caused by excessive milk consumption), hyperhydration, electrolyte imbalances, fluid overload, hyponatremia*.
Muscle weakness.
Febrile reactions, infection at the infusion site, pain or local reaction, redness, rash, venous irritation, thrombosis (a pathological process involving formation of blood clots within blood vessels, obstructing or preventing normal blood circulation) or venous phlebitis (vein inflammation) extending from the infusion site, extravasation, tissue necrosis, abscess formation (collection of pus within tissue), cutaneous calcification (calcium salt deposition in tissues).
Hypersensitivity reactions (allergy) to the infusion, including anaphylactic/anaphylactoid reactions (severe, rapidly occurring allergic reactions), urticaria.
Localized or generalized urticaria (skin rash with intense itching), such as skin rash, erythema (redness of the skin), and pruritus/itching.
* Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

If you experience any of the following potentially serious adverse reactions:

If you are in hospital: inform your doctor or nurse immediately.
After leaving hospital: go immediately to the Emergency Department of the nearest hospital.

Additional adverse reactions in children and adolescents
Severe, and in some cases fatal, adverse reactions have been rarely reported in preterm and full-term neonates (under 28 days of age) who were treated with intravenous ceftriaxone and calcium. Cases of renal precipitation have been reported, primarily in children over 3 years of age receiving high daily doses (e.g., ≥80 mg/kg/day) or total doses exceeding 10 grams, and who had other risk factors (e.g., fluid restriction, bedridden patients). The risk of precipitate formation increases in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal failure and anuria, and is reversible upon discontinuation of the drug.
Precipitation of calcium-ceftriaxone salt in the gallbladder has been observed, mainly in patients treated with doses exceeding the recommended standard dose. The incidence appears to be lower when infusions are administered slowly (over 20–30 minutes). This effect is generally asymptomatic, but in rare cases precipitations have been associated with clinical symptoms such as pain, nausea, and vomiting. Symptomatic treatment is recommended in such cases. Precipitation is generally reversible upon discontinuation of the drug.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RINGER ACETATE BAXTER

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of that month and to the product in its original intact packaging, properly stored.
The solution must be clear, colourless, and free from visible particles.
This medicinal product is intended for single and continuous administration; any remaining residue must not be used.
Use immediately after opening the container.
Store in the original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What RINGER ACETATE BAXTER contains
1000 ml of solution contain:
Active substances:
Sodium Chloride 6 g
Potassium Chloride 0,3 g
Calcium Chloride Dihydrate 0,2 g
Sodium Acetate 4 g
Other components:
Water for injections q.s.
Hydrochloric acid q.s. to adjust pH to 6.0 – 7.0
mEq/litre: Na 132
K 4
Ca 3
Cl 110
Acetate as HCO 29
Theoretical osmolarity: (mOsm/litre) 277
pH: 6.0 – 7.0

Description of the appearance of RINGER ACETATE BAXTER and package contents
Infusion solution, sterile and free from bacterial endotoxins.
Clear, colourless solution free from visible particles.
Various pack sizes are available:
Glass vials: 50, 100, 250 and 500 ml Single pack
Flexible bags ClearFlex: 100, 250, 500 and 1000 ml. Single pack
Glass vials 500 ml Pack size of 20 units
Flexible bags ClearFlex and Viaflo: 500 ml Pack size of 20 units
Flexible bags Viaflo: 500 ml Pack size of 24 units
Flexible bags Viaflo: 1000 ml Pack size of 10 units
Flexible bags Viaflo: 1000 ml Pack size of 12 units

Marketing Authorization Holder
BAXTER S.p.A. - Piazzale dell’Industria 20 – 00144 Rome, Italy.

Manufacturer
BIEFFE MEDITAL S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO), Italy.
BIEFFE MEDITAL S.A. Ctra de Biescas - 22666 Sabiñánigo (Spain).

Ringer acetate Baxter