Sodium Chloride 0.9% W/V Injection Bp
Patient Information Leaflet Sodium Chloride 0.9% w/v Injection BP Sodium Chloride
Please read all of this leaflet carefully. It includes important information on how you
should take this medicine correctly and safely.
• Keep this leaflet. You may need to read it again.
• If you are the parent of a child who is to be given this medicine, read the leaflet replacing ‘you' with ‘your child' throughout.
• This medicine is 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 get serious, or you notice any side effects not listed in the leaflet please tell your doctor, nurse or pharmacist.
• If you have any further questions, please ask your doctor, nurse or pharmacist.
The name of your medicine is Sodium Chloride 0.9% w/v Injection BP.
In the rest of this leaflet Sodium Chloride 0.9% w/v Injection is called Sodium Chloride.
In this leaflet:
1. What Sodium Chloride is and what it is used for
2. Before you take Sodium Chloride
3. How to take Sodium Chloride
4. Possible side effects
5. How to store Sodium Chloride
6. Further information_
1. What Sodium Chloride is and what it is used for
Sodium Chloride is a type of medicine called an electrolyte. It is a sterile salt liquid which can be used for a number of different reasons as it is very similar to your body fluids.
The main use for Sodium Chloride injection is to dissolve or dilute other medicines so they can be given as an injection or an infusion (a drip) into veins, muscles or other tissues in the body. Sodium Chloride can also be used for preparation for a number of surgical and medical procedures as follows:
• to clean out catheters (small devices put in your vein to inject your medicine).
• as a priming solution to fill intravenous lines (long tubes which are connected to your veins). This is to make sure there is no air being injected such as during haemodialysis (a procedure to clean blood when you have kidney disease).
• as a priming solution at the beginning and end of blood transfusions without causing damage to the blood cells.
Sodium Chloride can also be added to other medicines such as infusions (drips) for example sugar solutions. In this case, Sodium Chloride works as an electrolyte to help keep the water levels in different parts of your body in the right balance.
2. Before you take Sodium Chloride
The doctor or nurse giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.
Do not take Sodium Chloride
• If you have hypernatremia.
• If you have hyperchloremia.
Take special care with Sodium Chloride Tell your doctor or nurse before treatment starts if
• You have problems with your heart.
• You have problems with your blood pressure.
• You have problems with your kidneys.
• You have problems with sodium retention.
Please make sure you read the leaflets for all your medicines, as Sodium Chloride is sometimes added to another medicine such as to dissolve or dilute it.
Taking other medicines
Please tell your doctor about any medicines you may be taking or have recently been taking. Remember also any medicines you may be taking that do not need a prescription.
If you are taking any of the following medicines it is very important to tell your doctor:
• Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone.
Pregnancy and breast-feeding
Sodium Chloride is not known to cause problems during pregnancy or breast-feeding.
As Sodium Chloride is sometimes given with other medicines, it is important that:
• If you are pregnant, or think you may be pregnant you must tell your doctor.
• If you are breast-feeding you must tell your doctor.
Your doctor will advise you if you should have this medicine.
3. How to take Sodium Chloride
A doctor or a nurse will usually give you this medicine. Your doctor or nurse will use the correct amount of Sodium Chloride depending on what it is being used for. Your doctor will decide the amount (dose) of your medicine that you should receive and how long you will need to take it for. The dose will depend on what Sodium Chloride is being used for such as to dissolve or dilute another medicine or as a priming solution.
Please read the other side of this leaflet.
Sc-----------------------------------
Technical Information Leaflet
SODIUM CHLORIDE 0.9%
This leaflet provides information for the healthcare professional. There is a separate Patient Information Leaflet.
i. name of the medicinal product
Sodium Chloride 0.9% w/v Injection BP.
2. qualitative and quantitative composition
Sodium Chloride 9mg/ml or 0.9% w/v. For a full list of excipients, see section 6.1.
3. pharmaceutical form
Solution for injection and solvent for parenteral use. A clear colourless liquid.
clinical particulars
4.1 Therapeutic Indications: Sodium chloride injection is indicated as a pharmaceutical aid and diluent for the infusion of compatible drug additives and for diluting or dissolving drugs for parenteral administration. Other indications for sodium chloride injection include flushing of IV catheters, as a priming solution in haemodialysis procedures and to initiate and terminate blood transfusions without haemolysing red blood cells. Sodium chloride injection may be added to compatible carbohydrate solutions such as dextrose in water to produce electrolytes.
4.2 Posology and Method of Administration:
Dosage: The volume given and administration rate are dependent upon the additive. Administration: For parenteral use. The directions for use of the additive will dictate the administration route.
4.3 Contraindications: Hypernatremia, hyperchloremia and those contraindications related to the additive.
4.4 Special Warnings and Precautions for Use: Newborn babies, both premature and at term, may exhibit excessively high sodium levels due to immaturity of renal function. As a result, in newborn babies, both premature and at term, repeated injections of sodium chloride may only be given after determining blood serum levels. Sodium Chloride must be used with caution in patients with hypertension, heart failure, pulmonary or peripheral oedema, impaired renal function, pre-eclampsia, hyperaldosteronism, and other diseases and treatments (eg corticosteroids) associated with sodium retention.
4.5 Interaction with other Medicinal Products and other Forms of Interaction: None known when used as a diluent or priming solution.
4.6 Pregnancy and Lactation: This solution does not present any hazard to pregnant women, to the foetus or to the breast-fed child.
4.7 Effects on Ability to Drive and Use Machines: None stated.
4.8 Undesirable Effects: Unwanted reactions may be associated with the administration technique and consist of fever, infection at the injection site, local pain or reaction, venous irritation, venous thrombosis or phlebitis spreading from the injection site, extravasation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via:
For UK: Yellow Card Scheme, Website: www.mhra.gov.uk/vellowcard.
For IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
If you take more Sodium Chloride than you should
A doctor or a nurse will usually give you this medicine. If you think you may have received too much medicine, please tell your doctor or nurse at once. As this medicine comes in a small volume (maximum 20 millilitres per container), it is unlikely that you will take too much. Sodium Chloride is sometimes given with other medicines, so make sure you read the leaflets for all your medicines.
If you forget to take Sodium Chloride
A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, Sodium Chloride can cause side effects, but not everyone gets them. The expected benefit of your medicine will usually be greater than the risk of you suffering any harmful side effects. Side effects known for Sodium Chloride when used for dissolving and diluting other medicines or when it is used as a priming solution are too much sodium in your blood, too much chloride in your blood. Remember that you may also get side effects from the other medicines that Sodium Chloride is being used to dissolve or dilute. Make sure you read the leaflets for all your medicines. If you notice any troublesome symptoms which you think may be side effects, please tell your doctor, nurse or pharmacist.
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 this leaflet. You can also report side effects directly via:
For UK: Yellow Card Scheme, Website: www.mhra.gov.uk/vellowcard.
For IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sodium Chloride
Keep your medicine out of the reach and sight of children. Do not use your medicine after the expiry date (EXP) given on the carton and the label on the plastic container (ampoule). The expiry date is the last day of the month written on the packaging. This medicinal product does not require any special storage conditions.Only use your medicine if it is a clear and colourless liquid. Open it and use it straight away. Any unused product should be discarded after opening. Give any leftover medicine to your doctor, nurse or pharmacist. If you do this, it will help protect the environment. Do not put it down the drain or in the dustbin.
6. Further information
What Sodium Chloride contains
The active medicine is Sodium Chloride. The other ingredient is Water for Injections. The medicine contains 0.9 %w/v (9 mg per ml) of Sodium Chloride.
What Sodium Chloride looks like Sodium Chloride is a clear, colourless liquid.
Contents of the pack
Each plastic ampoule will contain 5 ml (millilitres), 10 ml or 20 ml of your medicine.
50 ampoules come in a box of 5 ml and 10 ml. 20 ampoules come in a box of 20 ml. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit.115, 1065 Nicosia, Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Athens, Greece.
This medicinal product is authorised in the Member States if the EEA under the following names:
Denmark:
Germany:
Ireland:
Norway:
Portugal:
Sweden:
Spain:
United
Kingdom:
Austria:
Greece:
Netherlands:
Natriumchlorid “Noridem”, solvens til parenteral anvendelse/ injektionsv^ske, oplosning 9mg/mL Natriumchlorid Noridem 0.9% Injektionslosung Sodium Chloride 0.9% (w/v) Injection BP
Natriumklorid Noridem 9mg/mL injektjonsv^ske, opplosning "Noridem" Cloreto de sodio Noridem, 9mg/mL, Solugao injectavel Natriumklorid Noridem 9mg/mL injektionsvatska, losning Cloruro de sodio KERN PHARMA 9mg/mL (0,9%) solucion inyectable Sodium Chloride 0.9% (w/v) Injection BP
Natriumchlorid Noridem 0.9% Injektionslosung oder Losungsmittel zur Herstellung von Parenteralia
SODIUM CHLORIDE 0,9%/NORIDEM, AiaAinr|g Yia napsvTEpiKn XPHCTrl 9mg/mL
Natriumchloride Noridem 0.9%, oplossing voor injectie en oplosmiddel voor parenteraal gebruik 9mg/mL
This leaflet was approved in November 2016.
If this leaflet is difficult to see or read, please contact the following address for help:
Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland, Tel: +353-9066-61109, Email: medical@athlone-laboratories.com.
Sc-----------------------------------
4.9 Overdose: Administration of quantities which may have adverse effects is very unlikely as vials contain a maximum of 20ml.
5. pharmacological properties
5.1 Pharmacodynamic Properties: Pharmacotherapeutic group: B05BB01.
Sodium chloride is the principal salt involved in the maintenance of plasma and other tissues tonicity. Solutions of sodium chloride closely approximate the composition of the extracellular fluid of the body; more than 90% of the cation of the extracellular fluid is sodium and more than 60% of the anion is chloride. Furthermore, a 0.9% solution of sodium chloride is approximately isotonic with body fluids. Thus, an injection of 0.9% sodium chloride will not appreciably affect the osmotic pressure of the body or the chemical composition of the extracellular fluid. A 0.9% solution of sodium chloride is therefore the choice of solvent for many drugs which have to be administered parenterally. The solution has the added advantage of being non-irritating to tissue.
5.2 Pharmacokinetic Properties: Not appropriate.
5.3 Preclinical Safety Data: There is no preclinical data of relevance to the prescriber which are not included in other sections of the SPC.
6. pharmaceutical particulars
6.1 List of Excipients: Water for Injections.
6.2 Incompatibilities: Compatibility should be checked when sodium chloride injection is used as a diluent or solvent. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life: 5 years.
Discard after single use, discard any unused portion. From a microbiological point of view, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.
6.4 Special Precautions for Storage
Unopened product: This medicinal product does not require any special storage conditions. Opened product: For storage conditions of the opened, reconstituted or diluted medicinal product, see section 6.3.
6.5 Nature and Contents of Container: Polypropylene ampoules of 5 or 10ml, packed into cartons of 50 ampoules, or of 20ml packed into cartons of 20 ampoules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling: Use only if the solution is clear without visible particles. Discard after single use. Discard any unused portion.
marketing authorisation holder
Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit. 115, 1065 Nicosia, Cyprus.
8. marketing authorisation number
38073330-6
PL 24598/0002 PA 1122/2/1