Sodium Chloride Injection USP 120mmol/30ml Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Sodium Chloride Injection USP 120mmol/30ml Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of Injection contains:
Sodium Chloride USP………………4mmol
(23.4%)

For excipients, see 6.1.

PHARMACEUTICAL FORM

solution for infusion. The product is a sterile, clear, colourless solution.

CLINICAL PARTICULARS

4.1 Therapeutic indications

The product is used for rehydration only when diluted. Before administration, the concentrate must be diluted and thoroughly mixed with a larger volume of fluid.

4.2 Posology and method of administration

When concentrations of 3 and 5% w/v are indicated, the solution should be administered into a large vein, at a rate not exceeding 100mL per hour.

Adults, Children and the elderly

Concentration and Sodium Chloride Injection USP 120mmol/30ml Taj Pharma dosage for intravenous use are determined by several factors, including age, weight and clinical condition of the patient. The usual sodium and chloride requirements for adults can be satisfied by infusion of the equivalent of 1 litre of Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 0.9% w/v daily.

Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 30% w/v Concentrate for Solution for Infusion should be diluted sufficiently to obtain an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by diluting 30 mL Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 30% w/v Concentrate for Solution for Infusion to 1 litre with a non-electrolyte solution or water for injections.

Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 0.9% w/v injections are often used as diluents for the infusion of drug additives, and 0.9% w/v solutions of Sodium Chloride Injection USP 120mmol/30ml Taj Pharma are widely used for sterile irrigation and dilution purposes.

4.3 Contraindications

Caution: Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 30% w/v Concentrate for Solution for Infusion is a hypertonic solution, and should be diluted before use.

4.4 Special warnings and precautions for use

Sodium Chloride Injection USP 120mmol/30ml Taj Pharma should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Care should also be taken when administering Sodium Chloride Injection USP 120mmol/30ml Taj Pharma intravenously to very young or elderly patients. Excessive administration may result in hypokalaemia and should be avoided.

Pseudohyponatraemia, a condition where spuriously low concentrations of sodium are found, occurs when a high concentration of solid matter (such as lipids and protein) are present in the plasma. This condition has been reported in patients with diabetes mellitus. False reading for plasma concentrations may be obtained as sodium is present only in the aqueous phase of plasma. Correct values are obtained by referring the concentration to plasma water, in order to avoid unnecessary, and possibly dangerous, treatment with Sodium Chloride Injection USP 120mmol/30ml Taj Pharma.

Only use the solution if it is particle free.

4.5 Interaction with other medicinal products and other forms of interaction

See section 6.2. for streptomycin incompatibility.

4.6 Pregnancy and lactation

It is safe to use in pregnancy and lactation after risk assessment.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The following general adverse effects may occur due to excess Sodium Chloride Injection USP 120mmol/30ml Taj Pharma in the body: nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

Infants may appear not to be severely dehydrated, but coma and convulsions may persist due to vascular injury. They may show respiratory distress with tachypnoea and flaring nostrils.

Intra-amniotic injection of hypertonic solutions of Sodium Chloride Injection USP 120mmol/30ml Taj Pharma can lead to serious adverse effects such as disseminated intravascular coagulation, renal necrosis, cervical and uterine lesions, haemorrhage, pulmonary embolism, pneumonia and death.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Excessive administration of Sodium Chloride Injection USP 120mmol/30ml Taj Pharma causes hypernatraemia, the most serious effect of which is dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage.

Normal serum-sodium concentrations should be carefully restored at a rate not exceeding 10-15mmol per day by administration of hypotonic saline solutions intravenously.

Dialysis may be necessary if there is a significant renal impairment, the patient is moribund, or if the serum-sodium concentration is greater than 200mmol per litre. Serum electrolyte levels need to be monitored and any imbalance corrected.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group Sodium is the principal cation in the extracellular fluid and is the main osmotic component in the control of blood volume.

5.2 Pharmacokinetic properties

The body contains 40 – 60mmol of sodium per kg body weight, approximately 40% of which is found in the skeleton. The normal concentration range for extracellular fluid is 135 – 154mmol per litre. The intracellular sodium concentration is about 5 – 10mmol per litre.

There are between 0.1 – 1.0% chloride irons in the body, contained in extracellular fluid surrounding the nerve cell and in gastric juices. 0.6% is found in the urine.

5.3 Preclinical safety data

There are no additional data of significance to the prescriber.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for Injections.

6.2 Incompatibilities

Streptomycin sulfate is stated to be incompatible with Sodium Chloride Injection USP 120mmol/30ml Taj Pharma.

The addition of Sodium Chloride Injection USP 120mmol/30ml Taj Pharma to mannitol 20 – 25% may cause precipitation of the mannitol.

As with all parenteral concentrate solutions, incompatibility of diluting fluids with the concentrate should be assessed before addition. In the absence of compatibility studies, this concentrate must not be mixed with other medicinal products.

6.3 Shelf life

3 years

Discard any unused solution immediately after first use.

From a microbiological point of view, the product should be used immediately. 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 (etc) has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Colourless type 1 glass ampoules containing 10mL and colourless type 1 glass vials containing 50mL and 100mL of solution. Vials are closed with bromobutyl rubber stoppers and sealed with aluminium tamper-proof flip-top seals. The product is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.

6.6 Special precautions for disposal and other handling

Sodium Chloride Injection USP 120mmol/30ml Taj Pharma 30% w/v Concentrate for Solution for Infusion is a concentrate.

Once opened the product should be used immediately and any unused drug discarded.

This product must be diluted before administration (see section 4.2.).

MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM CHLORIDE INJECTION USP
120MMOL/30ML
TAJ PHARMA

Sodium chloride

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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

What Sodium Chloride Injection USP 120mmol/30ml Taj Pharmais and what it is used for
What you need to know before you use Sodium Chloride Injection USP 120mmol/30ml Taj Pharma
How to use Sodium Chloride Injection USP 120mmol/30ml Taj Pharma
Possible Side Effects
How to store Sodium Chloride Injection USP 120mmol/30ml Taj Pharma
Contents of the pack and other information
1. WHAT SODIUM CHLORIDE INJECTION USP 120MMOL/30ML TAJ PHARMA IS AND WHAT IT IS USED FOR

This medicine is a concentrated electrolyte solution for infusion into a large vein. When diluted and mixed thoroughly with another fluid it is used for rehydration.

WHAT YOU NEED TO KNOW BEFORE YOU USE SODIUM CHLORIDE INJECTION USP 120MMOL/30ML TAJ PHARMA

You will be given this medicine in hospital by a doctor or nurse.

Do not use this medicine if you:

Have suffered with heart disease
Have suffered with high blood pressure
Have suffered with diabetes mellitus

Check with your doctor if you are concerned about any of the above.

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before using Sodium Chloride Injection USP 120mmol/30ml Taj Pharmaif:

You are suffering from congestive heart failure
You have problems with your kidneys
You have suffered from pulmonary oedema (fluid on the lungs)
You have suffered from pre-eclampsia (high blood pressure associated with pregnancy)
You have suffered from peripheral oedema (swelling of hands and feet)
If you have high blood pressure, swelling and protein in the urine during the last 3 months of pregnancy (toxaemia of pregnancy)
This medicine is being used in a child
This medicine is being used in an elderly person

This medicine should be given with care if any of the above applies to you.

Check with your doctor if you are concerned about any of the above.

Other Medicines and Sodium Chloride Injection USP 120mmol/30ml Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important if you are taking:

Streptomycin

HOW TO USE SODIUM CHLORIDE INJECTION USP 120MMOL/30ML TAJ PHARMA

The doctor will decide what dose of this medicine you should be given. Check with your doctor if you are not sure.

This medicine is a concentrated solution and must be diluted before use. It is given by infusion into a large vein at a rate not exceeding 100mL/hr. Doses will be adjusted by the doctor, but the usual Sodium Chloride requirements for an adult can be satisfied by infusion of the equivalent of 1 litre of Sodium Chloride 0.9% w/v daily.

If a dose of this medicine is not given at the correct time – the dose should be given as soon as remembered. The next dose should be given at the usual time. A double dose should not be given.

If more of this medicine is given than should be – tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Characteristics.

POSSIBLE SIDE EFFECTS

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

Serious side effects are:

Kidney failure
Convulsions
Respiratory arrest
Coma

Tell your doctor, pharmacist or nurse immediately if you think you have symptoms related to the above.

Other side effects

The most common side effects are:

Nausea or vomiting
Diarrhoea
Stomach cramps
Dry mouth or stuffy nose
Sweating and high temperature (fever)
Low blood pressure when standing. This may make you feel dizzy or faint
Fluid on the lungs
Headache
Rapid heartbeat
Feeling weak
Restlessness or irritability

Very rare side effects are:

Muscular twitching

Tell your doctor, pharmacist or nurse immediately if you think you have any of the above symptoms or other problems.

Reporting Side Effects

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

HOW TO STORE SODIUM CHLORIDE INJECTION USP 120MMOL/30ML TAJ PHARMA

Keep this medicine out of the sight and reach of children.
This medicine has an expiry date printed on the ampoule, vial and carton. Do not use this medicine after the expiry date. The expiry date refers to the last day of the month. Before use the doctor or nurse will check that the medicine has not passed this date and the medicine does not show signs of deterioration.
Store this medicine below 25°C.
Do not throw away any medicines via waste water. These measures will help to protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Sodium Chloride Injection USP 120mmol/30ml Taj Pharma contains

The active substance is sodium chloride at a strength of 300mg per mL (5mmol sodium and chloride per mL).
The other ingredient is Water for Injections.

What Sodium Chloride Injection USP 120mmol/30ml Taj Pharmalooks like and contents of pack:

This medicine is a clear and colourless solution. This medicine is available in a 10mL ampoule containing 3g of Sodium Chloride; a 50mL vial containing 15g Sodium Chloride and a 100mL vial containing 30g Sodium Chloride. The medicine is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.