Informations for option: Sodium Chloride 0.45% W/V And Glucose 5% W/V Iv Infusion Bp, show other option

Select option:

1. Sodium Chloride 0.45% W/V And Glucose 5% W/V Iv Infusion Bp
2. Sodium Chloride 0.45% W/V And Glucose 5% W/V Iv Infusion Bp

Document: leaflet MAH GENERIC_PL 00116-0016R change

• leaflet MAH GENERIC_PL 00116-0016R
• leaflet MAH GENERIC_PL 03551-0091

---

Sodium Chloride 0.45% w/v and Glucose 5% w/v Solution for Infusion BP

Active substances: sodium chloride, glucose_

Read all of this leaflet carefully before you start using 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This medicine is called Sodium Chloride 0.45% w/v and Glucose 5% w/v Solution for Infusion BP but will be called Sodium Chloride 0.45 & Glucose 5 Infusion throughout the remainder of this leaflet.

In this leaflet:

1.    What Sodium Chloride 0.45 & Glucose 5 Infusion is and what it is used for

2.    Before you are given Sodium Chloride 0.45 & Glucose 5 Infusion

3.    How you will be given Sodium Chloride 0.45 & Glucose 5 Infusion

4.    Possible side effects

5.    How Sodium Chloride 0.45 & Glucose 5 Infusion is stored

6.    Further information

1. What Sodium Chloride 0.45 & Glucose 5 Infusion is and what it is used for

Sodium Chloride 0.45 & Glucose 5 Infusion is a solution of the following substances in water:

•    sugar (glucose)

•    sodium chloride.

Glucose is one of the body's sources of energy.

This solution for infusion provides 200 kilocalories

per 1000 ml.

Sodium and chloride are chemical substances

found in the blood.

Sodium Chloride 0.45 & Glucose 5 Infusion is used:

•    as a source of carbohydrate (sugar)

•    to treat a loss of body water (dehydration) and chemicals, particularly sodium (e.g. by heavy sweating, kidney disorders)

•    to treat you, if the volume of blood in your blood vessels is low (hypovolaemia).

2. Before you are given Sodium Chloride 0.45 & Glucose 5 Infusion

You must NOT receive Sodium Chloride 0.45 & Glucose 5 Infusion if you are suffering from any of the following conditions:

•    when there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration)

•    when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)

•    more fluid and sodium than normal in the body (fluid and sodium retention)

•    severe kidney failure (when your kidneys do not work well and you require dialysis)

•    uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:

-    shortness of breath

-    swelling of the ankles.

•    lower levels of sodium in the blood than normal (hyponatraemia)

•    lower levels of chloride in the blood than normal (hypochloraemia)

•    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)

•    diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)

•    states of glucose intolerance, for example:

- metabolic stress (when the body's

metabolism does not function correctly, e.g. due to severe illness)

•    hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medicine

•    a higher amount of sugar in the blood than normal (hyperglycaemia)

•    higher levels of lactate in the blood than normal (hyperlactataemia).

Your doctor will take special care when giving

you Sodium Chloride 0.45 & Glucose 5 Infusion

Please tell your doctor if you have or have had any

of the following medical conditions.

•    heart failure

•    respiratory failure (lung disease)

(special monitoring may be required in the above conditions)

•    poor kidney function

•    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)

•    high blood pressure during pregnancy (pre-eclampsia)

•    any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (See also below, “Taking other medicines”)

•    diabetes (your blood sugar levels will be monitored closely and your insulin treatment may need to be modified)

•    stroke due to a clot in a blood vessel in the brain (ischaemic stroke).

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

•    the amount of chemicals such as sodium and chloride in your blood (your plasma electrolytes)

•    the amount of sugar (glucose).

Sodium Chloride 0.45 & Glucose 5 Infusion must not be given through the same needle as a blood transfusion. This can damage the red blood cells or cause them to clump together.

Sodium Chloride 0.45 & Glucose 5 Infusion should be given with special care to premature babies and babies less than 3 months of age.

Sodium Chloride 0.45 & Glucose 5 Infusion should be given with special care in the first 24 hours after a head injury. Your doctor should monitor your blood glucose levels if you have raised blood pressure within your skull (intracranial hypertension).

As Sodium Chloride 0.45 & Glucose 5 Infusion contains sugar (glucose), it can cause a high level of sugar in the blood (hyperglycaemia). If this occurs, your doctor may:

•    adjust the speed of infusion

•    give you insulin to reduce the blood sugar levels.

This is particularly important:

•    if you are diabetic

•    if you have recently had a stroke

(acute ischaemic stroke). High levels of sugar in the blood can worsen the effects of stoke and affect recovery

•    if you are being treated for low blood volume (hypovolaemia). Your doctor should adjust the rate of infusion to avoid causing raised blood sugar levels.

If you are diabetic or have had kidney problems (renal insufficiency), your doctor should carefully monitor your blood glucose levels. Your need for insulin or potassium may change while you are being given Sodium Chloride 0.45 & Glucose 5 Infusion.

During long-term treatment with Sodium Chloride

0.45 & Glucose 5 Infusion, you may need to be given extra nutrition. Your doctor should also monitor the level of potassium in your blood to avoid this becoming lower than normal (hypokalaemia).

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.

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).

Using Sodium Chloride 0.45 & Glucose 5 Infusion with food and drink

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before

taking any medicine.

Tell your doctor if you are pregnant or breast-feeding.

Sodium Chloride 0.45 & Glucose 5 Infusion can be used safely during pregnancy or breast-feeding. 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 Patient Information Leaflet of the medicine that is to be added.

Driving and using machines

Sodium Chloride 0.45 & Glucose 5 Infusion does

not affect your ability to drive or use machines.

3. How you will be given Sodium Chloride 0.45 & Glucose 5 Infusion

You will be given Sodium Chloride 0.45 & Glucose 5 Infusion by a doctor or nurse. Your doctor will decide on how much you need and when it is to be given. This will depend on your age, weight, clinical and biological conditions and the reason for treatment. The amount you are given may also be affected by other treatments you are receiving.

You should NOT be given Sodium Chloride 0.45 & Glucose 5 Infusion if there are particles in the solution or if the pack is damaged in any way.

Sodium Chloride 0.45 & Glucose 5 Infusion will usually be given to you through a plastic tube attached to a needle in a vein. Usually a vein in your arm is used to give you the infusion. However, your doctor may use another method to give you the medicine.

Any unused solution should be thrown away.

You should NOT be given an infusion of Sodium Chloride 0.45 & Glucose 5 Infusion from a bag that has been partly used.

If you receive more Sodium Chloride 0.45 & Glucose 5 Infusion than you should If your kidneys are less able to remove sodium from your blood than normal, Sodium Chloride 0.45 & Glucose 5 Infusion may cause an increase in your blood levels of sodium (hypernatraemia). This can lead to:

•    build up of fluid under the skin, particularly around the ankles (peripheral oedema)

•    build up of fluid in the lungs (pulmonary oedema).

High blood levels of sodium are rare with normal use of Sodium Chloride 0.45 & Glucose 5 Infusion. If they occur, the most serious effect is a reduction in the water content of the brain (dehydration of the brain). This causes drowsiness and confusion and may lead to fits (convulsions), unconsciousness (coma), stopping breathing (respiratory failure) and even death. Other symptoms include:

•    thirst

•    dry mouth and eyes

•    fever

•    rapid heart rate (tachycardia)

•    high blood pressure (hypertension)

•    headache

•    dizziness

•    restlessness

•    irritability

•    weakness.

If you are given too much Sodium Chloride 0.45 & Glucose 5 Infusion, your blood may become too acidic. This may lead to tiredness, confusion, lethargy and increased breathing rate.

If you are given too much Sodium Chloride 0.45 & Glucose 5 Infusion, or large amounts are infused too quickly you may develop:

•    increased concentration of the salts in the blood (hyperosmolarity)

•    lack of water in the body tissues (dehydration)

•    high levels of sugar in the blood (hyperglycaemia)

•    sugar in the urine (hyperglucosuria)

•    an increase in the amount of urine you produce (osmotic diuresis).

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. Your doctor will also make the necessary examinations. You may need hospital treatment if the symptoms are dangerous. If a medicine has been added to your Sodium Chloride 0.45 & Glucose 5 Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Patient Information Leaflet of the added medicine for a list of possible symptoms.

Stopping your Sodium Chloride 0.45 & Glucose 5 Infusion

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

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

4. Possible Side Effects

Like all medicines, Sodium Chloride 0.45 & Glucose 5 Infusion can cause side effects, although not everybody gets them.

The side effects are listed according to their frequencies. The side effects can be related to Sodium Chloride 0.45 & Glucose 5 Infusion itself. This includes:

Very common (occurring in more than 1 of every 10 patients)

•    changes in the concentrations of the chemicals in the blood (electrolyte disturbances)

If you suffer from heart disease or fluid in the lungs (pulmonary oedema):

•    too much fluid in the body (hyperhydration) which may lead to more frequent urination (polyuria)

•    heart failure.

Uncommon (occurring in less than 1 of every 100 patients but in more than 1 of every 1,000 patients)

•    low levels of sodium in the blood (hyponatraemia).

Not known (cannot be estimated from the available data)

•    The side effects can be related to the administration technique:

-    fever (febrile response)

-    infection at the site of infusion

-    local pain or reaction (redness or swelling at the site of infusion)

-    irritation and inflammation of the vein into which the solution is infused (phlebitis).

This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused

-    the formation of a blood clot in the injection vein (venous thrombosis) which causes pain, swelling or redness in the area of the clot

-    escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.

-    an excess of fluid in the blood vessels (hypervolaemia).

5. How Sodium Chloride 0.45 & Glucose 5 Infusion is stored

6. Further Information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about any thing, ask your healthcare professional.

What Sodium Chloride 0.45 & Glucose 5 Infusion contains

The active substances are:

•    sugar (glucose) 50 g per litre

•    sodium chloride 4.5 g per litre.

The other ingredients are:

•    water for injections

•    hydrochloric acid (for pH adjustment).

What Sodium Chloride 0.45 & Glucose 5 Solution for Infusion looks like and contents of the pack Sodium Chloride 0.45 & Glucose 5 Solution for Infusion is a clear solution, free from visible particles.

The solution is supplied in a plastic VIAFLEX infusion bag made from PVC. The bag contains either 500 ml or 1000 ml and is sealed in a protective plastic overpouch. The bags are supplied in cartons. Each carton contains one of the following quantities: 20 bags of 500 ml 10 bags of 1000 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:

Baxter Healthcare Ltd.

Caxton Way Thetford Norfolk IP24 3SE United Kingdom

Send all enquiries to this address.

Manufacturers

Baxter Healthcare Ltd.

Caxton Way Thetford Norfolk IP24 3SE United Kingdom Baxter S.A.

Boulevard Rene Branquart, 80

7860 Lessines

Belgium

Baxter Healthcare S.A.

Moneen Road Castlebar County Mayo Ireland

This leaflet was last approved in 12/2011

For information about Sodium Chloride 0.45 & Glucose 5 Infusion or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: 01635 206345.

Baxter and Viaflex are trademarks of Baxter International Inc.

Sodium Chloride 0.45% w/v and Glucose 5% w/v Solution for Infusion BP

The following information is intended for medical or healthcare professionals only:

Handling and Preparation

Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.

Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the product. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

Additives may be introduced before infusion or during infusion through the injection port.

When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Adding other medications or using incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately. Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

1. Opening

a.    Remove the VIAFLEX container from the overpouch just before use.

b.    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.

c. Check the solution for limpidity and absence of foreign matter. If solution is not clear or contains foreign matter, discard the solution.

2.    Preparation for administration

Use sterile material for preparation and

administration.

a.    Suspend container from base eyelet support.

b.    Use an aseptic technique to prepare the administration set.

c.    Remove blue protector from outlet port.

d.    Attach administration set. Refer to complete directions accompanying set for connection priming of the set and administration of the solution.

3.    Techniques for injection of additive medications

Warning: Additives may be incompatible.

To add medication before administration

a.    Disinfect the medication port.

b.    Using a syringe with a 20 gauge (0.9 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

c.    Mix the solution and medication thoroughly.

For high density medications such as potassium chloride, tap the ports gently while ports are upright and mix.

To add medication during administration

a.    Close clamp on the set.

b.    Disinfect medication port.

c.    Using a syringe with a 20 gauge (0.9 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

d.    Remove container from IV pole and/or turn to an upright position.

e.    Evacuate both ports by tapping gently while the container is in an upright position.

f.    Mix solution and medication thoroughly.

g.    Return container to in use position, re-open the clamp and continue administration.

4. In-use shelf-life: Additives

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

5. Incompatibilities of additive medicinal products

In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

The Instructions for Use of the medicinal product to be added must be consulted.

Before adding a drug, verify it is soluble and stable in water at the pH of Sodium Chloride 0.45 and Glucose 5 solution (pH: 3.5 - 6.5).

As a guidance the following medicinal products are incompatible with the Sodium Chloride 0.45 & Glucose 5 Infusion (non-exhaustive listing):

•    Ampicillin sodium

•    Mitomycin

•    Erythromycin lactobionate.

•    Amphotericin B

Those additives known to be incompatible should not be used.

Because of the presence of glucose, Sodium Chloride 0.45 & Glucose 5 Infusion should not be administered through the same infusion equipment as whole blood, as haemolysis and clumping can occur. Those additives known to be incompatible should not be used.

Baxter and Viaflex are trademarks of Baxter International Inc.

8