SODIUM CHLORIDE 0.45% W/V AND GLUCOSE 2.5% W/VIV INFUSION BP - patient leaflet, side effects, dosage

Sodium Chloride 0.45% w/v

Sodium Chloride, Glucose

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

What is in this leaflet:

• 1. What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) is and what it is used for

• 2. What you need to know before you use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %)

• 3. How to use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %)

• 4. Possible side effects

• 5. How to store Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ ml (2.5 %)

• 6. Contents of the pack and other information

• 1. What Sodium Chloride 4.5 mg/ml (0.45%) and

Glucose 25 mg/ml (2.5 %) is and what it is used for

Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) is an infusion solution, which will be given to you as a venous infusion (drip) by your doctor.

It will be given to you

• if you are dehydrated and lose water (hypertonic dehydration) This solution may also be used to dissolve or dilute medicines that are to be given to you by a venous infusion (drip).

2. what you need to know before sodium chloride

• 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) is given to you. Do not use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %):

• if you are allergic to sodium chloride or glucose or any of the other ingredients of this medicine (listed in section 6).
• if you have excessively high body fluid level (hyperhydration)
• if you have fluid and sodium deficit (hypotonic dehydration)
• if you have a head trauma (first 24 hours)
• if you have abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled

Warnings and precautions

Patients who are acutely ill, with pain, postoperative stress, infections, burns, nervous system, heart, liver and kidney diseases and patients who are on medicines increasing the effect of vasopressin (a hormone which regulates the amount of body fluids), when given Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) are at particular risk of developing abnormally low levels of sodium in the blood (acute hyponatraemia) which can lead to swelling of the brain (encephalopathy).

Children, women of childbearing potential and patients with serious brain conditions like meningitis (infection of the membranes surrounding the brain) or brain injury are at particular risk of severe and life-threatening brain swelling caused by an acute decrease in blood sodium levels.

This medicine must not be used to treat fluid deficits without adequate administration of salts, since this may markedly reduce the salt concentration in your blood. A lack of salts can lead to problems with your heart and damage your brain.

Special care should be taken if you have abnormally low level of sodium or potassium in the blood. Then an adequate supply of salts (in particular potassium and sodium) will be ensured.

In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified.

You should not normally receive this medicine if you suffer or have recently suffered from stroke except your doctor considers it essential for your recovery.

Your levels of blood sugar, electrolytes (especially potassium) and acidbase and water balance will be checked to make sure that these are correct before and during infusion.

After major operations or severe injuries (post-traumatic and post-operative conditions or in the presence of tissue oxygen deficiency, high blood acidity or organ failure) you may not be able to metabolise glucose properly (impaired glucose tolerance). Then your blood sugar level will be regularly monitored.

Please note: If this solution is used to dilute or dissolve medicines that are to be given to you by a venous drip your doctor will take into account the safety information of the additive.

Other medicines and Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %)

Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines, especially the following medicines which increase the effect of vasopressin and the risk of a low sodium level (hyponatraemia):

• Carbamazepine and Oxcarbazepine used to treat epilepsy
• Vincristine and Ifosfamide used as anticancer treatments
• Cyclophosphamide to treat cancer and autoimmune diseases
• Selective Serotonin Reuptake Inhibitors (SSRIs) to treat depression
• Antipsychotics for mental health disorders
• Opioid pain killers to relieve severe pain
• Non-steroidal anti-inflammatory drugs (NSAIDs) to relieve mild to moderate pain and to treat inflammation in your body,
• Desmopressin for the treatment of diabetes insipidus (extreme thirst and the continuous production of large volumes of dilute urine)
• Oxytocin used during labour
• Vasopressin and terlipressin used to treat ‘bleeding oesophageal varices’ (enlarged veins in your food pipe caused by liver problems)
• Diuretics or water tablets (medicines which increase the amount of urine you excrete)

Your doctor will adjust your dosage if you receive cortisone. Cortisone may cause an accumulation of sodium and fluid in your body.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your doctor will decide carefully whether or not you should receive this solution if you are pregnant.

Thus special care will be taken if you have a specific disorder that may occur during pregnancy, called eclampsia, with the following symptoms: high blood pressure, cramps, swelling.

Blood sugar levels will be checked regularly.

Breast-feeding

This medicine can be given while you are breast feeding.

Driving and using machines

Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) has no influence on the ability to drive and use machines.

3. how to use sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5 %)

Dosage

Adults

The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight, clinical and biological (acid-base-balance) condition and concomitant therapy. Thus your individual requirements of fluid, electrolytes and energy will be taken into account.

B|BRAUN

The normal maximum dosage for an adult is 40 ml/kg body weight/day. ______ The maximum infusion rate is 5 ml per kg body weight per hour.

Elderly patients

Basically the same dosage as for adults applies. But your doctor will take caution if you are suffering from other diseases often seen with advanced age.

Other special patient groups

If you have an impaired glucose tolerance (e.g. after surgery, severe injury, organ failure, tissue oxygen deficiency etc.) the dosage should be adjusted to keep the blood glucose level close to normal values.

In those cases your blood glucose level will be monitored while you receive this solution.

Use in children and adolescents

Children will receive a dosage dependent upon their age, weight and clinical and biological (acid-base-balance) condition and concomitant therapy. Thus the individual daily requirements of fluid and glucose of your child will be taken into account.

If you received more Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) than you should

It is unlikely that this occurs because your doctor will determine your daily doses.

Your doctor will monitor chemical and fluid balance, glucose and electrolyte levels (including sodium) in your blood before and during treatment, especially in patients with disrupted vasopressin release (a hormone which regulates the amount of body fluids) and in patients taking medicines increasing the action of vasopressin due to the risk of abnormal low sodium level in your blood (hyponatraemia).

Symptoms

An overdose may lead to excess fluid in the body (hyperhydration), electrolyte imbalances (especially hypokalaemia and hyponatraemia), acidbase imbalances, and high blood sugar (hyperglycaemia).

Clinical symptoms of water intoxication may also occur, such as nausea, vomiting, spasms.

Treatment

The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion, supervision of blood, salt level, acid-base imbalances and administration of suitable medicines to treat the symptoms observed (e.g. diuretics, insulin). In extreme situations you may also need dialysis.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may develop an imbalance in the level of fluid and of certain minerals in your body. You may develop low sodium (hyponatraemia), potassium, phosphate and magnesium blood levels.

Abnormally low sodium level in your blood can lead to a serious condition called hospital acquired hyponatraemia. It may cause irreversible brain damage and death due to the development of brain oedema (acute hyponatraemic encephalopathy). The symptoms of brain oedema include: headache, feeling sick (nausea), vomiting, seizures, tiredness and lack of energy.’

If the product is used as directed, no side effects are to be expected.

Yet if you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package 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.

5. how to store sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5 %)

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container and carton labels.

The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Only to be used if solution is clear and colourless up to faintly strawcoloured and the container and its closure are undamaged.

This medicine is for single use only. After use discard container and any unused medicine. Containers once opened must be used immediately and must not stored for later use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information what sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5 %) contains

The active substance are sodium chloride and glucose. 1000 ml of the solution contain

Sodium chloride

Glucose monohydrate equivalent to anhydrous glucose

Energy

Theoretical osmolarity:

Acidity (titration to pH 7.4):

pH:

The other ingredient is water for injections.

What Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml

(2.5 %) looks like and contents of the pack

It is a clear, colourless up to faintly straw-coloured aqueous solution of sodium chloride and glucose in water.

It is supplied in

• Polyethylene (LDPE) bottles, contents: 250, 500 ml, 1000 ml available in packs of 10 × 250, 10 × 500 ml, 10 × 1000 ml
• Plastic bags made of a five layer laminate sealed with halogenbutyl rubber stoppers, and an outer bag content 250 ml, 500 ml and 1000 ml available in packs of 20 × 250, 20 × 500 ml, 10 × 1000 ml.

• B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen Germany