Sodium Chloride 5% Intravenous Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.18% Intravenous Infusion
Sodium Chloride 0.45% Intravenous Infusion
Sodium Chloride 0.9% Intravenous Infusion
Sodium Chloride 1.8% Intravenous Infusion
Sodium Chloride 2.7% Intravenous Infusion
Sodium Chloride 5% Intravenous Infusion
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
in this leaflet:
1. What Sodium Chloride Intravenous Infusion is and what it is used for
2. Before you are given Sodium Chloride intravenous infusion
3. How you are given Sodium Chloride Intravenous Infusion
4. Possible side effects
5. How Sodium Chloride Intravenous Infusion is stored
6. Further information
1. WHAT SODIUM CHLORIDE INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR
Sodium Chloride (salt) helps to maintain the correct balance of fluid in and around the body's cells and tissues. Sodium Chloride Intravenous Infusions are given by Intravenous (into a vein) injection to patients suffering from water loss or lack of sodium.
Sodium Chloride 0.18% Intravenous Infusion and Sodium Chloride 0.45% Intravenous Infusion are used in patients where there has been water loss from the body and too much sodium in the blood.
Sodium Chloride 0.9% Intravenous Infusion is used to correct water and Sodium Chloride loss.
Sodium Chloride 1.8% intravenous Infusion, Sodium Chloride 2.7% intravenous Infusion and Sodium Chloride 5% Intravenous Infusion are used in patients where there has been a sudden fall in the sodium concentration of the blood caused by water overload.
2. BEFORE YOU TAKE SODIUM CHLORIDE INTRAVENOUS INFUSION
You should not receive Sodium Chloride Intravenous Infusion if:
• you are allergic (hypersensitive) to sodium chloride or any of the ingredients of Sodium Chloride Intravenous infusion mentioned in section 6 (for symptoms of an allergic reaction, please refer to section 4).
You should not receive Sodium Chloride (0.9%, 1.8%, 2.7%, 5%) intravenous infusion if
• you have very high sodium levels. Your doctor will check this.
You may not receive Sodium Chloride (0.18%, 0.45%) Intravenous infusion if
• you have kidney or heart disorders. Your doctor will check this.
Take special care with Sodium Chloride intravenous infusions if:
• you suffer from any type of heart or kidney disorders
• you suffer from hypertension (high blood pressure)
• you suffer from oedema (swelling of organs from excess liquid)
• you are pregnant and have been told you have complications in your pregnancy called eclampsia (symptoms include: convulsions, increased blood pressure, circulatory problems, severe headaches, vision problems, pain in your upper abdomen, vomiting, sudden swelling of your feet, ankles, face and hands and excessive weight gain).
The doctor or nurse will ensure that the infusion is not given to you too rapidly as this may cause heart and circulation problems.
You may lose potassium from your blood when treated with Sodium Chloride intravenous infusions. Your doctor may give you potassium supplements.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following drugs should not be mixed with any of the Sodium Chloride Intravenous Infusions:
• amiodarone (used for heart rhythm disorders)
• amphotericin B (for fungal infections)
• amsacrine (a chemotherapy drug)
• sodium nitroprusside (a drug used to reduce very high blood pressure) Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breastfeeding your baby. This is especially important if you have been told that you have complications in your pregnancy called eclampsia, Your doctor will decide if you should be given Sodium Chloride Intravenous Infusion,
Driving and using machines
Sodium Chloride Intravenous Infusion has no effect on driving or using machines,
3. HOW TO TAKE SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium Chloride Intravenous Infusion will be given to you in hospital.
You will receive your medicine by infusion (IV drip). The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive, For Sodium Chloride Intravenous Infusion 0.18%,
0.45%, and 0.9% your doctor will be able to check the effect of the treatment on dehydration by the relief of your symptoms, monitoring your blood pressure, and by measuring the volume and concentration of your urine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Chloride intravenous Infusion can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine you should contact your doctor immediately:
• skin rash
• swelling of the face, lips or mouth
• difficulty breathing
The following side effect has been reported:
• Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.
The symptoms of thrombosis include:
• pain, swelling and redness at the blood clot site
• an itchy rash at the clot site
• warm skin around the clot
• a mild fever
• major veins which stand out from your skin
if any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION
Keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sodium Chloride Intravenous Infusions.
Sodium Chloride Intravenous Infusions should be stored between 2°C and 25°C. The solution must not be used after the expiry date shown on the label.
The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of using the approved hospital procedures.
6. FURTHER INFORMATION
What Sodium Chloride intravenous infusions contain:
The infusions contain sodium chloride, water for injections, hydrochloric acid, and sodium hydroxide.
What Sodium Chloride intravenous infusion looks like and contents of the pack.
Sodium Chloride Intravenous Infusions are clear solutions of sodium chloride in water. The solutions are: contained in a sealed tube-shaped plastic container, known as a Polyfusor®. Sodium Chloride 0.9% Intravenous Infusion is also available in a sealed plastic container known as KabiPac® bottle.
All six strengths are available as 500 ml. Sodium Chloride 0.9% Intravenous Infusion is also available as 100, 250 and 1000 ml volumes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA71 NT. UK.
Manufacturer:
Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
This leaflet was last revised in March 2013.
V002/TM
Wv FRESENIUS III KABI
Sodium Chloride 0.18%
Intravenous Infusion
Sodium Chloride 0.45%
Intravenous Infusion
Sodium Chloride 0.9%
Intravenous Infusion
Sodium Chloride 1.8%
Intravenous Infusion
Sodium Chloride 2.7%
Intravenous Infusion
Sodium Chloride 5%
Intravenous Infusion_
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sodium Chloride Intravenous Infusion is and what it is used for
2. Before you are given Sodium Chloride Intravenous Infusion
3. How you are given Sodium Chloride Intravenous Infusion
4. Possible side effects
5. How Sodium Chloride Intravenous Infusion is stored
6. Further information 0687521/00 UK
1. WHAT SODIUM CHLORIDE INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR
Sodium Chloride (salt) helps to maintain the correct balance of fluid in and around the body's cells and tissues. Sodium Chloride Intravenous Infusions are given by Intravenous (into a vein) injection to patients suffering from water loss or lack of sodium.
Sodium Chloride 0.18% Intravenous Infusion and Sodium Chloride 0.45% Intravenous Infusion are used in patients where there has been water loss from the body and too much sodium in the blood.
Sodium Chloride 0.9% Intravenous Infusion is used to correct water and Sodium Chloride loss.
Sodium Chloride 1.8% Intravenous Infusion, Sodium Chloride 2.7% Intravenous Infusion and Sodium Chloride 5% Intravenous Infusion are used in patients where there has been a sudden fall in the sodium concentration of the blood caused by water overload.
2. BEFORE YOU TAKE SODIUM CHLORIDE INTRAVENOUS INFUSION
You should not receive Sodium Chloride Intravenous Infusion If:
• you are allergic (hypersensitive) to sodium chloride or any of the ingredients of Sodium Chloride Intravenous Infusion mentioned in section 6 (for symptoms of an allergic reaction, please refer to section 4).
You should not receive Sodium Chloride (0.9%, 1.8%, 2.7%, 5%)
Intravenous Infusion If
• you have very high sodium levels. Your doctor will check this.
You may not receive Sodium Chloride (0.18%, 0.45%) Intravenous Infusion If
• you have kidney or heart disorders. Your doctor will check this.
Take special care with Sodium Chloride Intravenous Infusions If:
• you suffer from any type of heart or kidney disorders
• you suffer from hypertension (high blood pressure)
• you suffer from oedema (swelling of organs from excess liquid)
• you are pregnant and have been told you have complications in your pregnancy called eclampsia (symptoms include: convulsions, increased blood pressure, circulatory problems, severe headaches, vision problems, pain in your upper abdomen, vomiting, sudden swelling of your feet, ankles, face and hands and excessive weight gain).
The doctor or nurse will ensure that the infusion is not given to you too rapidly as this may cause heart and circulation problems.
You may lose potassium from your blood when treated with Sodium Chloride intravenous infusions. Your doctor may give you potassium supplements.
Taking other medicines
Please tell vour doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following drugs should not be mixed with any of the Sodium Chloride Intravenous Infusions:
• amlodarone (used for heart rhythm disorders)
• amphotericin B (for fungal infections)
• amsacrine (a chemotherapy drug)
• sodium nltroprusslde (a drug used to reduce very high blood pressure) Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breastfeeding your baby. This is especially important if you have been told that you have complications in your pregnancy called eclampsia. Your doctor will decide if you should be given Sodium Chloride Intravenous Infusion.
Driving and using machines
Sodium Chloride Intravenous Infusion has no effect on driving or using machines.
3. HOW TO TAKE SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium Chloride Intravenous Infusion will be given to you in hospital.
You will receive your mediane by infusion (IV drip). The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose fa you to receive. For Sodium Chloride Intravenous Infusion 0.18%, 0.45%, and 0.9% your doctor will be able to check the effect of the treatment on dehydration by the relief of your symptoms, monitoring your blood pressure, and by measuring the volume and concentration of your urine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Sodium Chloride Intravenous Infusion can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine you should contact your doctor Immediately:
• skin rash
• swelling of the face, lips or mouth
• difficulty breathing
The following side effect has been reported:
• Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.
The symptoms of thrombosis include:
• pain, swelling and redness at the blood dot site
• an itchy rash at the clot site
• warm skin around the clot
• a mild fever
• major veins which stand out from your skin
If any of the side effects get serious or If you notice any side effects not listed In this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SODIUM CHLORIDE INTRAVENOUS INFUSION
Keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sodium Chloride Intravenous Infusions.
Sodium Chloride Intravenous Infusions should be stored between 2°C and 25°C. The solution must not be used after the expiry date shown on the label.
The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of using the approved hospital procedures.
6. FURTHER INFORMATION
What Sodium Chloride Intravenous Infusions contain:
The infusions contain sodium chloride, water for injections, hydrochloric acid, and sodium hydroxide.
What Sodium Chloride Intravenous Infusion looks like and contents of the pack.
Sodium Chloride Intravenous Infusions are clear solutions of sodium chloride in water. The solutions are: contained in a sealed tube-shaped plastic container, known as a Polyfusor®. Sodium Chloride 0.9% Intravenous Infusion is also available in a sealed plastic container known as KabiPac® bottle.
All six strengths are available as 500 ml. Sodium Chloride 0.9% Intravenous Infusion is also available as 100,250 and 1000 ml volumes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.
Manufacturer:
Fresenius Kabi Deutschland 61346 Bad Homburg v.d.H.
Germany
This leaflet was last approved in October 2009