9 mg / ml solution for infusion
sodium chloride
What Sodium Chloride Fresenius Kabi is and what it is used for
Sodium chloride Fresenius Kabi solution for infusion is a clear solution of salt for intravenous infusion (slow injection ), also called drip into a vein. It is used when the body has lost a lot of water ( dehydration ) or in sodium deficiency. It can also be used to dissolve or dilute drugs before the drugs are given as an intravenous infusion.
What you need to know before using Sodium Chloride Fresenius Kabi
Do not use Sodium Chloride Fresenius Kabi
- if you are allergic to sodium chloride or any of the other ingredients of this medicine (listed in section 6).
Or if you have one or more of the following:
- High levels of sodium in the blood ( hypernatremia ).
- High levels of chloride in the blood ( hyperchloraemia ).
- Too much water in the body (hyperhydration).
- Severe impaired cardiac function.
- Severe renal impairment.
Your doctor will check this.
Warnings and cautions
Talk to your doctor or nurse before using Sodium Chloride Fresenius Kabi. Nursing staff will monitor you at the beginning of administration one.
Sodium chloride should be given with special caution if you have:
- Decreased heart function ( heart failure ).
- High blood pressure ( hypertension ).
- Fluid retention ( edema ) in the body or lungs.
- Renal impairment (your doctor will monitor the levels of various electrolytes in your blood during and after the infusion ).
- Low levels of potassium in the blood ( hypokalaemia ).
- Too much acid in the body (metabolic acidosis ).
- High blood pressure and protein in the urine if you are pregnant (pregnancy poisoning).
- Excessive production of aldosterone from the adrenal glands (hyperaldosteronism).
- Corticosteroid treatment is .
- Other conditions or treatments in connection with sodium retention.
If you are dehydrated ( hypertonic dehydration ), healthcare professionals will check that the infusion is not given too quickly. Rapid infusion of large amounts can also lead to too much acid in the body with high levels of chloride (hyperchloremic acidosis ).
Children
Newborn babies may have immature kidneys and may therefore have too high sodium levels in their blood. Therefore, healthcare professionals will check the sodium levels in the blood before starting administration.
Other drugs and Sodium Chloride Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Increased levels of sodium or chloride may occur during concomitant treatment with corticosteroids.
Pregnancy, breastfeeding and fertility
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. Sodium chloride can be used by pregnant and lactating women, provided the advice in this information is followed.
Healthcare professionals will use Sodium Chloride Fresenius Kabi with caution if you have high blood pressure and protein in your urine during pregnancy (pregnancy poisoning).
Driving and using machines
Sodium chloride Fresenius Kabi has no or negligible effect on the ability to drive and use machines.
How to use Sodium Chloride Fresenius Kabi
Sodium chloride Fresenius Kabi will be given to you by a doctor or nurse. It will be given to you as a drip into a vein ( intravenous infusion ). Your doctor will decide the right dose for you and when and how it should be given. Your doctor will take into account your age, weight, physical condition, and what other treatments you are receiving.
If you use more sodium chloride Fresenius Kabi than you should
Sodium chloride Fresenius Kabi is given by healthcare professionals, so it is unlikely that you will receive a larger dose than you should. If you accidentally overdose, your administration will be stopped and you will receive treatment depending on the symptoms.
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.
Possible side effects include:
Rare (may affect up to 1 in 1,000 people)
- Damaged nerve cells (Central pontin myelinolysis).
Has been reported (occurs in an unknown number of users)
- Excess fluid in the body ( hypervolemia ), high levels of sodium in the blood ( hypernatremia ) in heart and kidney failure , rapid infusion of large amounts can lead to too much acid in the body with high levels of chloride (hyperchloraemic acidosis ).
- Fever, injection site infection , local pain or reaction, venous irritation, inflammation of the vein where the solution is given ( venous thrombosis or phlebitis ), accidental administration of the solution outside the vein (extravasation).
When Sodium Chloride Fresenius Kabi solution for infusion is used for the preparation of other medicines, the frequency of side effects depends on the product being added. Your doctor will be able to advise you on this.
You can be monitored by healthcare professionals during treatment. If any side effects get worse, your doctor or nurse will help you. If side effects are of concern to you, talk to a doctor or nurse.
How to store Sodium Chloride Fresenius Kabi
The doctor and the pharmacy staff at the hospital are responsible for the correct storage, use, and destruction of this product.
Keep this medicine out of the sight and reach of children.
Freeflex 50 ml: Do not store above 25 ° C.
Another packaging: No special storage instructions
Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you see visible particles or if the container is damaged.
When a drug is added, an aseptic technique should be used and the solution should be mixed thoroughly.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sodium chloride.
- The other ingredients are hydrochloric acid ( pH adjustment), sodium hydroxide ( pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Sodium chloride Fresenius Kabi is a sterile, clear, colorless solution with no visible particles.
It is available in the following containers and pack sizes:
Freeflex (polypropylene bag) with injection port for a needle, alternatively Freeflex + with injection port for Luer cap:
| 40 x 50 ml | 40 x 100 ml | 20 x 250 ml | 15 x 500 ml | 10 x 1000 ml |
| 60 x 50 ml | 50 x 100 ml | 30 x 250 ml | 20 x 500 ml | |
| 65 x 50 ml | 55 x 100 ml | 35 x 250 ml | ||
| 70 x 50 ml | 60 x 100 ml | 40 x 250 ml |
Freeflex (polypropylene bag) with injection port for vial (ProDapt):
| 40 x 50 ml | 40 x 100 ml | 20 x 250 ml |
| 60 x 50 ml | 50 x 100 ml | 30 x 250 ml |
| 65 x 50 ml | 55 x 100 ml | 35 x 250 ml |
| 70 x 50 ml | 60 x 100 ml | 40 x 250 ml |
KabiPac (polyethylene bottle):
| 10 x 100 ml | 10 x 250 ml | 10 x 500 ml | 10 x 1000 ml |
| 40 x 100 ml | 20 x 250 ml | 20 x 500 ml | |
| 30 x 250 ml | 30 x 500 ml |
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Fresenius Kabi Norge AS, Halden, Norway or
Fresenius Kabi Deutschland GmbH, Friedberg, Germany or
Fresenius Kabi France, Louviers Cedex, France or
Fresenius Kabi Polska Sp. z oo, Kutno, Poland