PANTOPRAZOLE Pdr for Soln for Injection 40 Milligram
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
04-05-2024
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Viambatanisho vya kazi:
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Inapatikana kutoka:
Pliva Pharma Limited
Kipimo:
40 Milligram
Dawa fomu:
Pdr for Soln for Injection
Idhini ya tarehe:
2012-03-30
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole 40 mg Powder for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate)
_Excipients_
Each vial contains 5.0 mg of sodium citrate dihydrate and sodium hydroxide q.s.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially "sodium free".
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White or almost white, uniform porous cake.
For the solution reconstituted with 10 ml of 0.9% NaCl solution the pH is approximately 10 and the osmolality is
approximately 382 mOsm/Kg
For the solution reconstituted with a further 100 ml of 0.9% NaCl solution or 5% glucose solution the pH is
approximately 9 and 8.5, respectively
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Reflux oesophagitis
- Gastric and duodenal ulcer
- Zollinger – Ellison Syndrome and other pathological hypersecretory conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
The intravenous administration of pantoprazole is recommended only if oral application is not appropriate. Data
are available on intravenous use for up to 7 days. Therefore as soon as oral therapy is possible, treatment with
pantoprazole i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
_Recommended dose_:
Gastric and duodenal ulcer, reflux oesophagitis
The recommended intravenous dose is one vial of pantoprazole (40 mg) per day.
Zollinger-Ellison Syndrome and other pathological hypersecretory conditions
For the long-term management of Zollinger-Ellison Syndrome and
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