Infusion solution

What Ringer-Acetate Baxter Viaflo is and what it is used for

What is Ringer-Acetate Baxter Viaflo used for?

Ringer-Acetate Baxter Viaflo is an aqueous solution of the following substances:

– sodium chloride

potassium chloride

calcium chloride dihydrate

– magnesium chloride hexahydrate

sodium acetate trihydrate

Sodium, potassium, calcium, magnesium, chloride, and acetate are chemical substances found in the blood.

Ringer-Acetate Baxter Viaflo is used:

  • to replace body fluid and certain salts ( electrolytes ) that may have been lost due to illness or injury
  • as short-term treatment in case of decreased blood volume

What you need to know before you get Ringer-Acetate Baxter Viaflo

You should NOT receive Ringer-Acetate Baxter Viaflo if you have any of the following conditions:

– if you are allergic to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, or any of the other ingredients of this medicine (listed in section 6).

– premature infants and newborns (≤ 28 days of age): Your baby should not be given ceftriaxone (a type of antibiotic ) as a drip into a blood vessel at the same time as this medicine.

– too much fluid in the areas around the body’s cells ( extracellular hyperhydration).

– a larger amount of blood than normal in the body ( hypervolemia ).

Warnings and cautions

Talk to your doctor or nurse if you have or have had any of the following medical conditions:

– in all patients, regardless of age, ceftriaxone (a type of antibiotic ) must not be mixed or given concomitantly with calcium-containing solutions when given as a drip into a vein. Your doctor will know about this and will not give them together to you even through different infusion tubes or at different infusion sites.

  • however, in patients older than 28 days, the physician may administer calcium and ceftriaxone consecutively if infusion tubes are used at different infusion sites, or if the infusion tubes are replaced or rinsed thoroughly with a physiological saline solution between infusions to avoid particle formation (precipitation). If you or your child have low blood volume, your doctor will avoid giving you calcium and ceftriaxone one after the other.
  • heart failure (especially if this is treated with digitalis )
  • breathing difficulties (lung disease)
  • swelling due to accumulation of fluid in the body ( edema )
  • fluid accumulation in the stomach (abdomen) due to certain liver disease (ascitic cirrhosis )
  • renal impairment (renal insufficiency / renal impairment)
  • high blood pressure ( hypertension ).
  • accumulation of fluid under the skin, especially in the ankles (peripheral edema )
  • fluid accumulation in the lungs ( pulmonary edema )
  • high blood pressure during pregnancy ( preeclampsia or eclampsia )
  • aldosteronism (a disease that causes high levels of the hormone et alaldosterone )
  • other conditions associated with sodium retention (when the body retains too much sodium ), such as treatment with steroids (see also “Other medicines and Ringer-Acetate Baxter Viaflo”).
  • any condition that causes you to be likely to have high levels of potassium in your blood (hyperkalemia), eg:
  • kidney failure
  • a disease of the adrenal glands that affects the hormones that regulate the body’s content of various chemical substances (adrenal cortex insufficiency)
  • acute dehydration (loss of fluid from the body eg due to vomiting or diarrhea)
  • extensive tissue damage (eg in case of severe burns)
  • (in these cases close monitoring of the potassium level in the blood is required)
  • any disease that causes higher levels of vitamin D than normal, e.g. sarcoidosis
  • myasthenia gravis (a disease that causes progressive muscle weakness)
  • recovery after surgery
  • if you have problems with the fluid level in your brain (for example due to meningitis, bleeding in the skull, or brain damage)
  • if you have a disease that can cause high levels of vasopressin, a hormone that regulates fluid levels in the body, such as:
    • an acute and serious illness or injury
    • you have had surgery
    • the disease of the brain
    • you are taking certain medicines (see section “Other medicines and Ringer-Acetate Baxter Viaflo”). This can increase the risk of low sodium levels in the blood and can lead to headaches, nausea, seizures, fatigue, coma, and swelling of the brain.

Your doctor will take blood and urine samples when the infusion is given to monitoring:

  • the amount of fluid in your body (fluid balance)
  • the levels of chemical substances such as sodium, potassium, calcium, magnesium, and chloride that you have in your blood and urine ( plasma and urine electrolytes) and your acid-base balance (acidity in the blood and urine).

This is especially important in children as they may have limited ability to regulate fluids and electrolytes.

If you have any of the condition problems, you should be closely monitored if you are going to be infused with a large volume of Ringer-Acetate Baxter Viaflo.

Although Ringer-Acetate Baxter Viaflo contains potassium, it does not contain sufficient amounts to treat very low plasma levels in the blood (severe potassium deficiency).

Ringer-Acetate Baxter Viaflo contains substances that can make the blood too alkaline ( metabolic alkalosis ). However, it does not contain enough to treat you if your blood is too acidic (metabolic acidosis ).

If long-term treatment is required, your doctor will also give you other types of infusion. These will cover the body’s need for other chemical substances and nutrients (food).

If you notice any changes in your condition or how you feel during or after an infusion, tell your doctor or nurse at once.

Ringer-Acetate Baxter Viaflo with food and drink

You should ask your doctor what you can eat or drink.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. You can get Ringer-Acetate Baxter Viaflo while you are pregnant.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You can get Ringer-Acetate Baxter Viaflo while you are breastfeeding.

Driving and using machines:

Ringer-Acetate Baxter Viaflo does not affect your ability to drive or use machines.

You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Other medicines and Ringer-Acetate Baxter Viaflo

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

The use of the following medicines is not recommended while you are receiving an infusion of Ringer-Acetate Baxter Viaflo:

– ceftriaxone (an antibiotic ), when given intravenously (see Warnings and Precautions).

– suxamethonium, vecuronium, and tubocurarine (muscle relaxants used during surgery)

potassium ( one of the salts that occur naturally in the body).

Other medicines that can affect or be affected if used in combination with Ringer-Acetate Baxter Viaflo:

– corticosteroids (anti-inflammatory drugs)

other steroids, such as estrogen

– certain diuretics (potassium preservatives )

– ACE inhibitors ( antihypertensive agents )

– tacrolimus (used to prevent transplant rejection and to treat certain skin conditions)

ciclosporin (used to prevent transplant rejection ).

These can lead to elevated levels of potassium and/or sodium in your blood.

The effect of medicine against heart disease ( digitalis ) may be increased by the calcium found in Ringer-Acetate Baxter Viaflo. This can lead to serious changes in your heart rate.

Some medicines can increase the level of calcium in the blood. These medicines may include:

  • certain diuretics (thiazide diuretics)
  • vitamin D.

The removal (excretion) of certain drugs from your body may increase or decrease the Ringer-Acetate Baxter Viaflo and alter their effect. These include:

quinidine ( used to treat irregular heartbeat, and arrhythmia )

salicylate (used to treat inflammation, eg acetylsalicylic acid )

lithium (used to treat mental illness, such as bipolar disorder )

stimulants ( sympathomimetics ) such as ephedrine and pseudoephedrine, which are used in medicines for coughs and colds.

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

  • certain cancer drugs
  • selective serotonin reuptake inhibitors (used to treat depression)
  • certain drugs for the treatment of psychiatric disorders (antipsychotics)
  • morphine-like drugs ( opioids )
  • medicines for pain and/or inflammation (also called non-steroidal anti-inflammatory drugs ( NSAIDs ))
  • certain medicines for epilepsy
  • oxytocin (a medicine used in women during pregnancy and during or after childbirth)
  • diuretics.

How to get Ringer-Acetate Baxter Viaflo

Dosage

Ringer-Acetate Baxter Viaflo is given to you by a doctor or nurse. Your doctor will decide how much you need and when it should be given. This depends on your age, weight, your condition, and the reason for the treatment. The amount you are given may also be affected by other concomitant treatments.

Your doctor will decide when to stop your infusion.

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

Ringer-Acetate Baxter Viaflo must NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.

Administration

Ringer-Acetate Baxter Viaflo is usually given to you through a plastic tube as with a needle in a vein. Usually, a vein in the arm is used to give the infusion. However, your doctor may use another method to give you the medicine.

Any remaining solution must be discarded. You must NOT be given an infusion of Ringer-Acetate Baxter Viaflo from a bag that has been partially used.

If you take more Ringer-Acetate Baxter Viaflo than you should:

If you happen to get too much Ringer-Acetate Baxter Viaflo, your doctor and healthcare professional will know what action to take.

If you take too much Ringer-Acetate Baxter Viaflo (over-infusion), or if it is given too fast, the following symptoms may occur:

  • accumulation of fluid in tissue one (hyperhydration) which is manifested by the skin becoming tense
  • accumulation of blood in the legs (left)
  • swelling ( edema ), which can affect the lungs, breathing, or brain and cause headaches
  • altered acidity or salinity in your blood
  • increased concentration of salts in the blood (serum hyperosmolarity).

If any of these side effects occur, tell your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.

If a drug is to be added to Ringer-Acetate Baxter Viaflo before infusion, that drug can also cause symptoms. You can read about any symptoms in the package leaflet for the added medicine.

If you stop taking Ringer-Acetate Baxter Viaflo

Your doctor will decide when to stop your infusion.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following symptoms, tell your doctor or nurse immediately. They may be signs of a rare but very serious or even life-threatening allergic reaction (hypersensitivity):

– swelling of the skin of the face, lips, or swelling of the throat

– difficulty breathing

– skin rash

redness of the skin ( erythema ).

Treatment will be given depending on the symptoms.

Other side effects are listed according to how common they are.

Common (may affect up to 1 in 10 people):

  • Heart failure can occur in patients who already have heart disease
  • water accumulation in the lungs ( pulmonary edema )
  • fever, infection ( redness, swelling), local pain, blood clot, inflammation or irritation of the vein at the injection site
  • leakage of infusion fluid into surrounding tissue (extravasation).

Rare (may affect up to 1 in 1,000 people):

  • the feeling of tightness or pain in the chest
  • slow heart rhythm ( bradycardia ) or fast heart rhythm ( tachycardia ).

Very rare (may affect up to 1 in 10,000 people):

  • seizures (cramps) while the solution is given.

Has been reported (occurs in an unknown number of users):

  • hypersensitivity reaction er
  • local or widespread hives ( urticaria ) with rash and itching
  • too much fluid in the blood vessels (overhydration)
  • altered salinity and/or acid-base balance in the blood
  • low sodium levels in the blood ( hyponatremia )
  • swelling of the brain which can cause brain damage.

If a drug has been added to the infusion solution, this added drug can also cause side effects. These side effects depend on the drug that has been added. You can read about any symptoms in the package leaflet for the added medicine.

If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information.

How to store Ringer-Acetate Baxter Viaflo

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. or EXP. The expiration date is the last day of the specified month.

Do not use this medicine if there are particles in the solution or if the packaging is damaged in any way.

Contents of the pack and other information

The active substances are:

sodium chloride 5.86 g per liter

potassium chloride 0.30 g per liter

calcium chloride dihydrate 0.29 g per liter

magnesium chloride hexahydrate 0.20g per liter

sodium acetate trihydrate 4.08 g per liter

Other ingredients are:

water for injections

saltstra (for pH -jutation)

What the medicine looks like and the contents of the pack

Ringer-Acetate Baxter Viaflo is a clear solution without visible particles.

It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag has a sealed, protective outer bag made of plastic.

Bag sizes:

  • 500 ml
  • 1,000 ml

The bags are delivered in cartons. Each carton contains one of the following numbers:

  • 20 bags of 500 ml
  • 10 bags of 1,000 mlNot all pack sizes may be marketed.

Marketing Authorisation Holder:

Baxter Medical AB

Box 63

164 94 Kista

Manufacturer:

Bieffe Medital SA

Ctra de Biescas, Senegüé

22666 Sabiñánigo (Huesca)

Spain

Muhammad Nadeem

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