Sodium Chloride 0.45% Solution for Infusion

• 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 0.45% Solution for Infusion’, but will be referred to as `Sodium 0.45 Infusion’ throughout the remainder of this leaflet.

1. What Sodium 0.45 Infusion is and what it is used for
2. What you need to know before you are given Sodium 0.45 Infusion
3. How you will be given Sodium 0.45 Infusion
4. Possible side effects
5. How to store Sodium 0.45 Infusion
6. Contents of the pack and other information

• lower levels of chloride in the blood than normal (hypochloraemia)
• lower levels of sodium in the blood than normal (hyponatraemia)
• severe kidney problems causing lower than normal or no urine production (oliguria or anuria)
• higher than normal levels of water or sodium in the blood (fluid or sodium retention)
• uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
  • shortness of breath
  • swelling of the ankles
• build up of fluid under the skin, affecting all parts of the body (general oedema)
• liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)

If a medicine has been added to Sodium 0.45 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
• respiratory failure (lung disease)
  (special monitoring may be required in the above conditions)
• raised production of the hormone aldosterone (aldosteronism)
• when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
• high blood pressure (hypertension)
• high blood pressure during pregnancy (pre-eclampsia)
• any other condition associated with sodium and fluid retention (when the body retains too much sodium or water), such as treatment with steroids (See also below “Taking other medicines”)
• 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 0.45 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.

Some patients are at higher risk for having or developing a too low sodium concentration in your blood (hyponatraemia). In general this applies to:

• young and old people
• women
• anyone with a condition such as low levels of oxygen in your blood (hypoxemia)
• drinking a lot due to a dry mouth (psychogenic polydipsia)
• if you have recently been operated on
• if you have certain diseases of the nervous system
• if you are taking certain antiepileptic and psychiatric medicines

Please 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)
• carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)
  These medicines can cause the body to accumulate sodium and water, leading to:
  • tissue swelling due to fluid collection under the skin (oedema)
  • 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).

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.

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 0.45 Infusion (over-infusion), or it is given too fast, this may lead to the following symptoms:

• build up of water in the body (oedema)
• too much water in the blood (haemodilution)
• heart problems
• acidification of the blood (acidosis), leading to tiredness, confusion, lethargy and increased breathing rate

If Sodium 0.45 Infusion is given too fast when you have higher than normal levels of salts in the blood (hypertonicity), swelling of the brain (brain oedema) is possible, especially if you often have higher than normal levels of sodium in the blood (hypernatraemia).

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 0.45 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 effect, talk to your doctor or nurse. This includes any possible side effect 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

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

The active substance is sodium chloride: 4,5 g per litre.

The only other ingredient is water for injections

Sodium Chloride 0.45% Solution for 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 size is 500 ml

The bags are supplied in cartons. Each carton contains 20 bags of 500 ml

Marketing Authorisation Holder for the United Kingdom:

Marketing Authorisation Holder for Ireland:

Manufacturers for Great Britain:

Manufacturers for Ireland:

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland, UK: Sodium Chloride 0.45 % Solution for Infusion

Finland: Natriumklorid Baxter Viaflo 4,5 mg/ml infuusioneste, liuos