9 mg / ml solution for infusion
sodium chloride
What Baxter Sodium Chloride is and what it is used for
Sodium chloride Baxter is a solution of sodium chloride in water. Sodium chloride is a chemical substance (often called salt) found in the body.
Sodium chloride Baxter is used to treat:
- fluid loss (dehydration) leading to sodium loss
- metabolic alkalosis (elevated pH in the body caused by high levels of alkaline substances)
Situations that can cause sodium 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 can also be used to give or dilute other infusion drugs or as a priming fluid for hemodialysis.
What you need to know before you get Sodium Chloride Baxter
Warnings and cautions
If any medicine is added to Sodium Chloride Baxter, the package leaflet of the added medicine should be considered to determine if you can get the solution.
Tell your doctor if you have or have had any of the following conditions:
- abnormally high levels of chloride in the blood ( hyperchloremia )
- abnormally high levels of sodium in the blood ( hypernatremia )
- 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
- fluid accumulation in the tissues ( edema )
- liver disease (eg cirrhosis )
- high blood pressure during pregnancy ( preeclampsia )
- increased production of the hormone et aldosterone (hyperaldosteronism)
- any other condition associated with sodium retention (when the body retains too much sodium ), such as treatment with corticosteroids (see also below “Other medicines and Sodium Chloride Baxter”)
- 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 Baxter Sodium Chloride”).
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)
Children
Control of salt levels in the blood and urine is especially important for children and premature babies because their immature kidney function allows them to retain too much sodium.
Other drugs and Sodium Chloride Baxter
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). Such drugs can cause the body to accumulate too much sodium and water, which in turn can lead to high blood pressure and tissue swelling due to fluid accumulation under the skin ( edema ).
- lithium (used to treat mental illness). Sodium chloride Baxter may reduce the effect of lithium therapy.
- 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)
- drugs that relieve pain and / or inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ))
- drugs 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).
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.
If another medicine is added to Sodium Chloride Baxter, you should also read the package leaflet for the added medicine.
Driving and using machines
You are 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.
How to use Baxter Sodium Chloride
Sodium chloride Baxter 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 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 is usually given through a plastic tube with a needle into a blood vessel (vein). Usually, a blood vessel (vein) is used in the arm to give 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 in the body (especially sodium in patients with high levels of vasopressin, or in patients using drugs that enhance the effect of vasopressin ).
If you take more Baxter Sodium Chloride than you should
If you take too much Sodium Chloride Baxter (over-infusion) it may cause the following symptoms:
- fluid accumulation in the tissues ( edema )
- Abnormally high levels of sodium in the blood ( hypernatremia ), which can lead to convulsions, 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 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
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.
Hypersensitivity reactions (allergic reactions) with the following symptoms have been reported:
- hives ( urticaria ) which may be widespread or confined to a specific part of the body
- rash
- fever
- overindulge
- itching
- decreased blood pressure
- shaking
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”).
Tell your doctor or nurse immediately if the above side effects occur, as the infusion must be stopped immediately.
Side effects at the infusion site that may be caused by the administration technique:
- redness of the skin ( erythema )
- hives ( urticaria )
- streaks
- burning sensation
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 )
- blood becomes acidic due to abnormally high levels of chloride in the blood (hyperchloraemic metabolic acidosis )
If a drug has been added to the infusion solution, the added drug can also cause side effects. These side effects depend on the drug being added. You can read about any symptoms in the package leaflet for the added medicine.
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se
How to store Sodium Chloride Baxter
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
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.
Because of the risk of contamination, the contents of the opened package should be used immediately or no later than 12 hours after opening. Infusion fluid with an additive should not be stored.
Sodium chloride Baxter 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 other ingredients are: water for injections, sodium hydroxide (for pH adjustment), and concentrated hydrochloric acid (for pH adjustment).
What the medicine looks like and contents of the pack
Sodium chloride Baxter is a clear solution without visible particles.
The following packages are available:
Plastic container PVC:
30 x 100 ml with transfer adapter (minibag plus)
5 x 2000 ml
4 x 2500 ml
Plastic container Clear-Flex:
6 x 2000 ml with Emoluer coupling, Luer lock female, and clamps
140 x 2000 ml with Emoluer coupling Luer-lock-females and clamps (mainly intended for priming for hemodialysis )
6 x 2000 ml with Self-closing Emoluer coupling
140 x 2000 ml with Self-sealing Emoluer coupling, (mainly intended for priming for hemodialysis )
140 x 2000 ml with “Y” coupling unit with tip, Luer-lock female, and clamps (mainly intended as priming fluid for hemodialysis )
240 x 2000 ml with Emoluer coupling, Luer-lock female, and clamps
4 x 2500 ml with Emoluer coupling, Luer-lock females, and clamps
160 x 2500 ml with Emoluer coupling, Luer-lock females, and clamps
Mini Bag Plus is a standard dilution container with an integrated closed transfer adapter. The transfer adapter allows the mixing of medicinal products with bag contents after a 20 mm vial has been attached with a single dose of powder or liquid (up to 10 ml). A seal in the tube between the transfer adapter and the bag is broken so that the contents of the bag can pass down into the connected vial so that liquid and medicine are mixed (reconstituted).
When the vial is connected to the transfer adapter, the adapter prevents the transfer of contaminant particles in and out of the system, minimizing environmental and personal exposure.
The reconstituted medicine is transferred from the vial to the Minibag Plus bag, where it is further diluted before being administered to the patient.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Baxter Medical AB
Box 63
164 94 Kista