Sodium Chloride Injection BP 0.9% w/v

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

What is in this leaflet

1. What Sodium Chloride Injection BP 0.9% w/v is and what it is used for
2. What you need to know before you are given Sodium Chloride Injection BP 0.9% w/v
3. How you will be given Sodium Chloride Injection BP 0.9% w/v
4. Possible side effects
5. How to store Sodium Chloride Injection BP 0.9% w/v
6. Further information

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

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

Talk to your doctor or nurse before being given the injection if you have had any of the following medical conditions:

• heart disease or heart failure
• impaired kidney function
• acidification of the blood (acidosis)
• liver disease (e.g. cirrhosis)
• when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
• high blood pressure (hypertension)
• pre-eclampsia (high blood pressure during pregnancy)
• fluid retention resulting in swelling of parts of the body, particularly your feet and ankles (peripheral oedema) or build-up of fluid in the lungs (pulmonary oedema).
• 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 Injection BP 0.9% w/v ”)
• raised production of the hormone aldosterone (aldosteronism)
• 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 Chloride Injection BP 0.9% w/v ”)
  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

Tell your doctor or nurse if you are taking, have recently taken or might take 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 relief
  • medicines 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).

If you are pregnant or breast feeding think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine. If another medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should consult your doctor and read the Package Leaflet of the medicine that is to be added.

You should not drive or use machinery if you are affected by the administration of Sodium Chloride Injection BP 0.9% w/v.

If you are given too much Sodium Chloride Injection BP 0.9% w/v, this may lead to the following symptoms:

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

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

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is sodium chloride (common salt) in a sterile solution. Each 1 ml of solution contains 9 mg of sodium chloride.

The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.

Sodium Chloride Injection BP 0.9% w/v is supplied in:

Clear glass ampoules, 2 ml, 5 ml, 10 ml and 20 ml. Packed in cardboard cartons to contain 10 ampoules.

Clear glass vials (33 ml, 100 ml and 200 ml) with bromobutyl rubber stopper, plastic outer cap and inner aluminium ring. Clear glass vials 50 ml with chlorbutyl rubber stopper, plastic outer cap and inner aluminium ring.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the Marketing Authorisation Holder