Sodium chloride 9 mg/ml solution for injection in pre-filled syringe Taj Pharma
- NAME OF THE MEDICINAL PRODUCT
Sodium chloride 9 mg/ml solution for injection in pre-filled syringe
- QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
9 mg sodium chloride, equivalent to 0.154 mmol Na+ and 0.154 mmol Cl–.
Each syringe of 50 ml contains
7.7 mmol (equivalent to 177 mg) of sodium.
Each syringe of 125 ml contains
19.3 mmol (equivalent to 443 mg) of sodium.
For a full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Sterile, non-pyrogenic, clear, colourless and odourless aqueous solution pH: 4.5 – 7.0
Theoretical osmolarity: 308 mOsm/l
- CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
Sodium chloride 9 mg/ml solution is indicated for use in flushing compatible contrast agents into indwelling intravascular access devices.
4.2 Posology and method of administration
Posology
Adults
The volume of the saline flush should be determined for each patient individually based, in part, on the imaging procedure, the location of the vascular access device, and the length of the tubing between the power injector and the vascular access device.
Infusion rates and flush volumes should also be individualized for each patient based on body weight, fluid status and concomitant medical conditions.
Typical sodium chloride solution flush volumes following contrast agent administration in adults are 10 to 60 ml per injection, at rates not to exceed 10 ml/sec.
Some power injectors allow for additional infusion of Sodium chloride 9 mg/ml solution to maintain the patency of vascular access. Typical infusion rates used for this purpose are in the range of 0.5 to 1 ml per minute.
Paediatric population
Sodium chloride 9 mg/ml solution is not recommended for use in children and adolescents up to 18 years due to the lack of sufficient data on safety and efficacy.
Method of administration
Intravenous or intraarterial use.
50 ml syringe: to administer the solution manually or by power injector; 125 ml syringe: to administer the solution by power injector.
Administration by power injector
If this medicinal product is intended to be used with a power injector, its suitability for the intended use has to be demonstrated by the manufacturer of the medical device.
Any additional instructions from the respective equipment manufacturer must also be strictly adhered to.
4.3 Contraindications
None known.
4.4 Special warnings and precautions for use
Air Embolism
Remove all air from the syringe and associated tubing prior to injection to avoid air embolus with the associated risk of stroke, organ ischemia and/or infarction or death.
Fluid Overload
Sodium chloride 9 mg/ml solution should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states with oedema, sodium retention, hypernatraemia or -chloraemia.
Each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure should be taken into account to determine if use of Sodium chloride 9 mg/ml solution is appropriate for him/her.
Extravasation
Mechanical compression of neurovascular structures may result from extravasation of the normal saline. Intravascular catheter patency must be established prior to the administration of Sodium chloride 9 mg/ml solution.
Paediatric population
Safety and efficacy of Sodium chloride 9 mg/ml solution in children and adolescents up to 18 years have not been established.
Elderly population
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug.
Special warnings
This medicinal product contains 0.154 mmol (or 3.54 mg) of sodium per ml.
For doses of up to 6.5 ml
This medicinal product contains less than 1 mmol sodium (23 mg), i.e. it is essentially ‘sodium-free’.
For doses of more than 6.5 ml
To be taken into consideration for patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, Pregnancy and lactation
Pregnancy
There are no data from the use of Sodium chloride 9 mg/ml solution in pregnant women. As a precautionary measure, it is preferable to avoid the use of Sodium chloride 9 mg/ml solution during pregnancy. Furthermore, procedures with ionizing radiation carried out in pregnant women also involve a radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Breast-feeding
Sodium chloride is excreted in human milk, but at therapeutic doses no effects on the breastfed newborns/infants are anticipated.
Fertility
No data are available. No effects are anticipated.
4.7 Effects on ability to drive and use machines
Sodium chloride 9 mg/ml solution has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
There may be reactions due to the technique of administration, which include infection at the site of injection, venous thrombosis or phlebitis extending from injection site, extravasation.
Frequencies for adverse drug reactions are defined as follows:
Very common (≥1/10)
Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Vascular disorders:
Not known Venous thrombosis; phlebitis
General disorders and administration site conditions:
Not known Injection site infection; 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
4.9 Overdose
Use of Sodium chloride 9 mg/ml solution may pose a threat of overdose marked by electrolyte disturbance and/or fluid overload, particularly in patients with compromised renal or cardiac function. In the event this should occur, discontinue the infusion, re-evaluate the patient and institute appropriate corrective action.
- PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions
Sodium is the primary cation of the extracellular space and together with various anions, regulates its size. Sodium and potassium are the major mediators of bioelectric processes within the body. The sodium content and the fluid status of the body are closely coupled to each other. Each deviation of the plasma sodium concentration from the physiological one simultaneously affects the fluid status of the body. An increase in the sodium content of the body also means reduction of the body’s free water content independent of the serum osmolality.
5.2 Pharmacokinetic properties
A 0.9 per cent sodium chloride solution has the same osmolarity as plasma. Administration of this solution primarily leads to a replenishment of the interstitial space which is about 2/3 of the entire extracellular space. Only 1/3 of the administered volume remains in the intravascular space. The solution, therefore, has a short-term haemodynamic effect.
The total sodium content of the body is ca. 80 mmol/kg of which ca. 97 % is extracellular and ca. 3 % intracellular. The daily turnover is ca. 100 -180 mmol (corresponding to 1.5 – 2.5 mmol/kg body weight).
The kidneys are the major regulator of the sodium and water balances in co-operation with the hormonal control mechanisms, renin-angiotensin-aldosterone system, antidiuretic hormone and the natriuretic hormone.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SmPC.
- PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.2 Incompatibilities
When mixing with other medicinal products, possible incompatibilities should be considered.
6.3 Shelf life
3 years
After use, discard the remaining solution
6.4 Special precautions for storage
Do not freeze.
Discard the solution in case of discolouration or particulate matter.
6.5 Nature and contents of container
Sodium chloride 9 mg/ml solution is supplied in pre-filled syringes (polypropylene) with tip cap and piston (natural rubber).
Pack sizes:
Pre-filled syringes:
1 x 50 ml and 10 x 50 ml
1 x 125 ml and 10 x 125 ml
Not all pack sizes may be marketed.
Special precautions for disposal
Pre-filled syringes:
The outside of the syringe is not sterile.
After screwing the push rod into the syringe piston, it is important to turn the pushrod an additional ½ turn so that the blue piston rotates freely
Prior to using the syringe, twist off blue tip cap and discard. Syringe is now ready for needle or infusion tubing attachment.Inspect the syringe for signs of leakage. Do not use if leakage is observed. Use of the pre-filled syringe (50 ml), manual use and use with power injector:
6.6 Special precautions for disposal
Pre-filled syringes:
The outside of the syringe is not sterile.
Inspect the syringe for signs of leakage. Do not use if leakage is observed.
Use of the pre-filled syringe (50 ml), manual use and use with power injector:
- After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the blue piston rotates freely.
- Prior to using the syringe, twist off blue tip cap and discard. Syringe is now ready for needle or infusion tubing attachment.
Use of the pre-filled syringe (125 ml) with a power injector:
- Load syringe into pressure jacket. To remove blue tip cap from syringe, push in and twist off, then discard. The area under the cap is sterile. Caution should now be used when handling.
- Next remove cap from luer locknut dust cover by twisting to break tamper evident seal. Discard cap. Attach luer locknut to syringe by holding dust cover and screwing to the stop. Remove and discard dust cover when ready to attach sterile connector tubing.
For single use. Discard syringe and unused portion of the solution after use.
Any unused product or waste material should be disposed of in accordance with local requirements.
Air Embolism
Remove all air from the syringe and associated tubing prior to injection to avoid air embolus with the associated risk of stroke, organ ischemia and/or infarction and death.
- 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
