infusion solution
What Baxter Viaflo Sodium Chloride is and what it is used for
Sodium chloride Baxter Viaflo is a solution of sodium chloride in water. Sodium chloride is a chemical substance (often called salt) found in the body.
Sodium chloride Baxter Viaflo is used to treat:
- fluid loss (dehydration)
- loss of sodium
Situations that can cause sodium chloride and fluid loss can be:
- when you can not eat or drink normally due to illness or after surgery
- excessive sweating caused by high fever
- extensive skin detachment that can occur in severe burns.
Sodium chloride Baxter Viaflo can also be used to give or dilute other infusion drugs.
What you need to know before you get Baxter Viaflo Sodium Chloride
Do not use Sodium Chloride Baxter Viaflo if you have any of the following conditions:
- abnormally high levels of chloride in the blood ( hyperchloraemia ).
- abnormally high levels of sodium in the blood ( hypernatremia ).
If any medicine is added to Sodium Chloride Baxter Viaflo, the package leaflet of the added medicine should be considered to determine if you can get the solution.
Warnings and cautions
Tell your doctor if you have or have had any of the following medical conditions.
- any type of heart disease or impaired heart function
- renal impairment
- for acidic blood ( acidosis )
- abnormally large blood volume in the blood vessels ( hypervolemia )
- high blood pressure
- accumulation of fluid under the skin, especially at the ankles (peripheral edema )
- fluid accumulation in the lungs ( pulmonary edema )
- – liver disease (eg cirrhosis )
- high blood pressure during pregnancy ( preeclampsia )
- increased production of the hormone et aldosterone (aldosteronism)
- any other condition associated with sodium retention (when the body retains too much sodium ), such as treatment with steroids (see also below “Other medicines and Sodium Chloride Baxter Viaflo”).
- if you have a disease or condition that causes high levels of vasopressin , a hormone that regulates the body’s fluid balance. You may have too much vasopressin in your body, e.g. if:- you had an acute and serious illness- you suffer from pain- you have had surgery- you have an infection , burn or disease in the brain- you have a disease that is linked to the heart, liver, kidneys or central nervous system- you are taking certain medicines (see also below “Other medicines and Sodium Chloride Baxter Viaflo”).
This can increase the risk of low sodium levels in the blood and can cause headaches, nausea, seizures, listlessness, coma, swelling of the brain, and death. Swelling of the brain increases the risk of death and brain damage. The following people are at higher risk of developing swelling of the brain:
– children
– women (especially of childbearing potential )
– people who have problems with fluid balance in the brain, e.g. due to meningitis, skull bleeding, or brain damage.
Your doctor will take blood and urine samples when the infusion is given to monitoring:
- the amount of fluid in your body
- general condition
- the amount of salt e.g. sodium and potassium in your blood (plasma electrolytes).
This is especially important for babies and premature babies because their immature kidney function allows them to accumulate too much sodium.
Your doctor will consider if you are already receiving nutrition as an infusion (nutrition given in a tube into a vein). During long-term treatment with Sodium Chloride Baxter Viaflo, you may need extra nutrition.
Other medicines and Sodium Chloride Baxter Viaflo
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- corticosteroids (anti-inflammatory drugs). These drugs can cause the body to accumulate sodium and water, which can lead to tissue swelling due to fluid accumulation under the skin ( edema ) and high blood pressure ( hypertension ).
- lithium (used to treat mental illness).
- Some medicines affect the hormone et vasopressin and may include:- diabetes medication (chloropropamide)- Cholesterol drugs (clofibrate)- certain cancer drugs (vincristine, ifosfamide, cyclophosphamide)- selective serotonin reuptake inhibitors (used to treat depression)- antipsychotics- opioids (used to treat severe pain)- medicines that relieve pain and / or inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ))- medicines similar to or enhancing the effect of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to initiate labor)- antiepileptics (carbamazepine and oxcarbazepine)- diuretics (diuretics).
Sodium chloride Baxter Viaflo with food and drink
You should consult your doctor about what you can eat or drink.
Pregnancy and breastfeeding
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.
However, if another drug is added to Sodium Chloride Baxter Viaflo you should
- consult a doctor
- read the package leaflet for the added medicine.
Driving and using machines
Consult your doctor or nurse before driving or using machines.
How to get Sodium Chloride Baxter Viaflo
Sodium chloride Baxter Viaflo is given to you by a doctor or nurse. Your doctor will decide how much you need and when to get it. This depends on your age, weight, general condition, the purpose of treatment, and whether the infusion solution is used to give or dilute another medicine.
The amount you are given may also be affected by other concomitant treatments.
Sodium chloride Baxter Viaflo should NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
Sodium chloride Baxter Viaflo is usually given through a plastic tube with a needle into a vein. Usually, a vein in your arm is used to give you an infusion, but your doctor may use another method to give you the medicine.
Before and during infusion, your doctor should check:
- the amount of fluid in the body
- the acidity of the blood and urine
- the amount of electrolyte is in the body (especially sodium in patients with high levels of vasopressin, or in patients using drugs that enhance the effect of vasopressin ).
Any remaining solution must be discarded. An infusion of Baxter Viaflo Sodium Chloride should NOT be given to you from a partially used bag.
If you take more Baxter Viaflo Sodium Chloride than you should
Taking too much Sodium Chloride Baxter Viaflo (over-infusion) may cause the following symptoms:
- nausea
- vomiting
- diarrhea
- stomach cramps
- thirst
- dry mouth
- dry eyes
- sweating
- fever
- palpitation
- high blood pressure
- kidney failure
- accumulation of water in the lungs that makes it difficult to breathe ( pulmonary edema )
- accumulation of water under the skin, especially at the ankles (peripheral edema )
- respiratory arrest
- headache
- dizziness
- restlessness
- irritability
- weakness
- muscle twitching and stiffness
- cramps
- acidification of the blood ( acidosis ) leading to fatigue, confusion, drowsiness and increased breathing
- abnormally high levels of sodium in the blood (hyperrnatremia), which can lead to seizures, coma , swelling of the brain (cerebral edema) and death.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.
If a medicine has been added to Sodium Chloride Baxter Viaflo and an overdose occurs, this medicine may also cause symptoms. You can read about any symptoms in the package leaflet for the added medicine.
If you stop taking Sodium Chloride 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. How often these side effects occur is not known.
- tremor
- lowered blood pressure
- hives ( urticaria )
- rash
- itching ( pruritus ).
Low levels of sodium in the blood can be caused by hospital treatment (hospitalized hyponatremia ) and a related neurological condition ( acute hyponatremic encephalopathy ). Hyponatremia can lead to permanent brain damage and death due to swelling of the brain (cerebral edema ) (see also section 2 “Warnings and precautions”).
Side effects that can be caused by the administration technique:
- infection at the infusion site
- local pain or reaction ( redness or swelling at the infusion site)
- irritation and inflammation of the vein in which infusion is given ( phlebitis ). It can cause redness , pain or burning sensation as well as swelling along the vein.
- a blood clot ( venous thrombosis ) forms at the infusion site and causes pain, swelling or redness in the area of the clot.
- leakage of the infusion fluid into the surrounding tissue (extravasation). It can damage tissue and cause scarring.
- excess fluid in the blood vessels ( hypervolemia )
- itching at the infusion site ( urticaria )
- fever ( pyrexia )
- overindulge.
Other side effects reported with similar products (other sodium solutions ):
- abnormally high levels of sodium in the blood ( hypernatremia )
- abnormally low levels of sodium in the blood ( hyponatremia )
- the blood becomes acidic due to abnormally high levels of chloride in the blood (hyperchloremic metabolic acidosis ).
If side effects occur, the infusion must be stopped.
How to store Baxter Viaflo Sodium Chloride
Keep this medicine out of the sight and reach of children.
50 ml and 100 ml bags: Do not store above 30 ° C.
250 ml, 500 ml, and 1000 ml bags: No special storage instructions.
Do not use this medicine after the expiry date which is stated on the bag after EXP. The expiration date is the last day of the specified month.
This medicine should not be given if there are particles in the solution or if the packaging is damaged in any way.
Contents of the pack and other information
Content declaration
The active substance is sodium chloride: 9 g per liter.
The only other ingredient is water for injections.
What the medicine looks like and contents of the pack
Sodium chloride 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:
- 50 ml
- 100 ml
- 250 ml
- 500 ml
- 1000 ml
Pack sizes:
- 50 bags with 50 ml per carton
- 75 bags with 50 ml per carton
- 1 bag with 50 ml
- 50 bags with 100 ml per carton
- 60 bags with 100 ml per carton
- 1 bag with 100 ml
- 30 bags with 250 ml per carton
- 1 bag with 250 ml
- 20 bags with 500 ml per carton
- 1 bag with 500 ml
- 10 bags with 1000 ml per carton
- 1 bag with 1000 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medical SA
Ctra de Biescas-Senegüé
22666 Sabiñanigo (Huesca)
Spain
Baxter Healthcare SA
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medical SPA
Via Nuovo Proviencale
230 34 Grosotto (SO)
Italy