Sodium Chloride 0.9% Intravenous Infusion BP

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine is called ‘Sodium Chloride 0.9% w/v Intravenous Infusion BP’, but will be referred to as ‘Sodium 0.9 Infusion’ throughout the remainder of this leaflet.

1. What Sodium 0.9 Infusion is and what it is used for
2. What you need to know before you are given Sodium 0.9 Infusion
3. How you will be given Sodium 0.9 Infusion
4. Possible side effects
5. How to store Sodium 0.9 Infusion
6. Contents of the pack and other information

• higher levels of chloride in the blood than normal (hyperchloraemia)
• higher levels of sodium in the blood than normal (hypernatraemia)

If a medicine has been added to Sodium 0.9 Infusion, the Package Leaflet of the added medicine must be consulted to determine whether or not you can receive the solution.

Please tell your doctor if you have or have had any of the following medical conditions:

• any type of heart disease or poor heart function
• poor kidney function
• acidification of the blood (acidosis)
• when there is a larger volume of blood in the blood vessels than there should be hypervolaemia)
• high blood pressure (hypertension)
• build-up of fluid under the skin, particularly around the ankles (peripheral oedema)
• build-up of fluid in the lungs (pulmonary oedema)
• liver disease (eg cirrhosis)
• high blood pressure during pregnancy (pre-eclampsia)
• raised production of the hormone 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 0.9 Infusion”).
• if you have a condition that could cause high levels of vasopressin, a hormone regulating fluid in your body. You may have too much vasopressin in your body because, for example:
  • you have had a sudden and serious illness
  • you are in pain
  • you have had surgery
  • you have infections, burns or brain disease
  • you have diseases linked to your heart, liver, kidneys or central nervous system
  • because you are taking certain medicines (see also below “Other medicines and Sodium 0.9 Infusion”).

This may increase the risk of low levels of sodium in your blood and can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain and death. Brain swelling increases the risk of death and brain damage. People who are at higher risk of brain swelling are:

• children
• women (particularly if you are of a fertile age)
• people who have problems with their brain fluid levels, for example, because of meningitis, bleeding in the skull or a brain injury

When you are given this infusion, your doctor will take blood and urine samples to monitor:

• the amount of fluid in your body
• your vital signs
• the amount of chemicals such as sodium and potassium in your blood (your plasma electrolytes)

This is especially important for children and (premature) babies as they can retain too much sodium due to their immature kidney function.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). During long term treatment with Sodium 0.9 Infusion you may need to be given extra nutrition.

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

It is particularly important that you inform your doctor if you are taking:

• corticosteroids (anti-inflammatory medicines)

These medicines can cause the body to accumulate sodium and water, leading to tissue swelling due to fluid collection under the skin (oedema) and high blood pressure (hypertension).

• lithium (used to treat psychiatric illness)
• Some medicines act on the hormone vasopressin. These may include:
  • anti-diabetic medication (chlorpropamide)
  • cholesterol medicine (clofibrate)
  • some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used to treat depression)
  • antipsychotics
  • opioids for severe pain reliefmedicines for pain and/or inflammation (also known as NSAIDs)
  • medicines that imitate or strengthen the effects of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding of the gullet) and oxytocin (used to induce labour)
  • anti-epileptic medication (carbamazepine and oxcarbazepine)
  • diuretics (water tablets).

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

If you are pregnant or breast-feeding, 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 medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should:

• consult your doctor
• read the Package Leaflet of the medicine that is to be added

Ask your doctor or nurse for advice before driving or using machines.

If you are given too much Sodium 0.9 Infusion (over-infusion), this may lead to the following symptoms:

• nausea (feeling sick)
• vomiting
• diarrhoea (loose stools)
• stomach cramps
• thirst
• dry mouth
• dry eyes
• sweating
• fever
• rapid heart rate (tachycardia)
• raised blood pressure (hypertension)
• kidney failure (renal failure)
• fluid collection in the lungs making it difficult to breathe (pulmonary oedema)
• fluid collection under the skin, particularly around the ankles (peripheral oedema)
• stopping breathing (respiratory arrest)
• headache
• dizziness
• restlessness
• irritability
• weakness
• muscular twitching and stiffness
• convulsions
• acidification of the blood (acidosis), leading to tiredness, confusion, lethargy and increased breathing rate
• higher levels of sodium in the blood than normal (hypernatraemia), which can lead to seizures, coma, swelling of the brain (cerebral edema) and death

If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.

If a medicine has been added to your Sodium 0.9 Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Package Leaflet of the added medicine for a list of possible symptoms.

Your doctor will decide when to stop giving you this infusion.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

Malta

If any side effects occur, the infusion must be stopped.

The active substance is sodium chloride: 9 g per litre The only other ingredient is water for injections

Sodium 0.9 Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Pack sizes:

• 50 bags of 50 ml per carton
• 75 bags of 50 ml per carton
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 60 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 12 bags of 1000 ml per carton
• 1 bag of 1000 ml

Not all pack sizes may be marketed

Marketing Authorisation Holder:

United Kingdom

Ireland and Malta

Manufacturers for Great Britain:

Manufacturers for Ireland and Malta: