Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
Intravenous administration of Protium is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Protium i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
The recommended intravenous dose is one vial of Protium (40 mg pantoprazole) per day.
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions patients should start their treatment with a daily dose of 80 mg Protium. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 × 80 mg Protium is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.
A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment (see section 4.4).
No dose adjustment is necessary in patients with impaired renal function (see section 5.2).
No dose adjustment is necessary in older patients (see section 5.2).
The safety and efficacy of Protium 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, Protium 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. For instructions for preparation see section 6.6. The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 55 mg/ml (5%) solution for injection.
After preparation the solution must be used within 12 hours.
The medicinal product should be administered intravenously over 2-15 minutes.
There are no known symptoms of overdose in man.
Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated.
As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Unopened vial: 2 years.
After reconstitution, or reconstitution and dilution, chemical and physical in use stability has been demonstrated for 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the reconstituted and diluted medicinal product see section 6.3.
10 ml clear glass (type I) vial with aluminium cap and grey rubber stopper containing 40 mg powder for solution for injection.
Pack sizes of 1 vial and 5 (5x1) vials with powder for solution for injection.
Hospital packs: 1 vial, 5 (5x1) vials, 10 (10x1) vials and 20 (20x1) vials with powder for solution for injection.
Not all pack sizes may be marketed.
A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into the vial containing the powder. The appearance of the product after reconstitution is a clear yellowish solution. This solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 55 mg/ml (5%) solution for injection. Glass or plastic containers should be used for dilution.
After reconstitution, or reconstitution and dilution, chemical and physical in use stability has been demonstrated for 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately.
Protium should not be prepared or mixed with solvents other than those stated.
The medicine should be administered intravenously over 2-15 minutes.
The contents of the vial are for single use only. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) should be disposed of in accordance with local requirements.
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