PHYBAG

Posology The volume and injection rate of Phybag flush needs to be determined for each patient individually based on: - the imaging protocol - the location of the intravenous access device, the length of tubing between the soft bag and the patient - and the body weight, fluid status and concomitant medical conditions of the patient.

2/6 Phybag flush volume following contrast agent administration is usually 20 to 50 ml per injection at a rate of 3 to 5 ml/sec and should normally not exceed 100 ml. Injection rate should not exceed 10 ml/sec. Elderly No dosage adjustment is considered necessary.

4). Paediatric Population The safety and efficacy of Phybag administered by power injector in pediatric patients have not been established. Administration of Phybag by power injector to pediatric patients is not recommended. Method of administration Intravenous use delivered by an appropriate power injector.

Use aseptic techniques. Remove the overpouch. Remove the cap and connect the bag to the injection line. To contain the risk of contamination, connect each Phybag once only. Break the seal (breakable luer) to establish the liquid flow. Proceed with the injection.

Discard any unused product at the end of the examination session.

The adverse reactions are listed in the table below by SOC (System Organ Class) and by frequency with the following guidelines: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 4/6 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).

System Organ Class Frequency: adverse reaction Infections and infestations Not known: infection (sepsis) Metabolism and nutrition disorders Not known: fluid overload Vascular disorders Not known: air embolism, venous thrombosis Gastrointestinal disorders Not known: nausea, vomiting, diarrhoea General disorders and administration site conditions Not known: extravasation, injection site infection, injection site thrombosis, injection site phlebitis, pyrexia These adverse reactions may be associated with the technique of administration.

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 the Yellow Card Scheme.

uk/yellowcard.

Fluid overload Sodium chloride may cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. In the at risk patients the sodium chloride volume should be adjusted to the clinical cardiovascular and fluid status.

Consider each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure to determine if use of sodium chloride is appropriate. Care should be taken when used in elderly patients, in patients with known cardiac or renal disease, as well as in conditions which may give rise to spurious hyponatremia such as pseudohyponatremia.

Air Embolism Remove all air from the injection devices prior to injection, to avoid air embolism and related complications (risk of stroke, organ ischemia and/or infarction, and death). 6). Extravasation Extravasation of sodium chloride may cause mechanical compression of neurovascular structures.

Establish intravascular catheter patency prior to the administration of sodium chloride. Paediatric Population The safety and efficacy of Phybag administered by power injector in pediatric patients have not been established. Administration of Phybag by power injection to pediatric patients is not recommended.

Elderly 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.

e. it is essentially “sodium-free”. 5 ml To be taken into consideration for patients on a controlled sodium diet.