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SPC, UK: OMEPRAZOLE Powder for solution for infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Omeprazole 40 mg Powder for Solution for Infusion.

Qualitative and quantitative composition

Each vial of powder for solution for infusion contains omeprazole sodium, equivalent to 40 mg omeprazole. After reconstitution (see section 6.6), each 1 ml contains 0.4 mg omeprazole. For a full list of ...

Pharmaceutical form

Powder for solution for infusion. The powder for solution for infusion is a white to almost white powder. The reconstituted solution has a pH of about 9-10.5. The osmolarity of the solution reconstituted ...

Therapeutic indications

Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications i.e. Adults Treatment of duodenal ulcers. Prevention of relapse of duodenal ulcers. Treatment ...

Posology and method of administration

Posology Alternative to oral therapy In patients where the use of oral medicinal products is inappropriate, Omeprazole IV 40 mg once daily is recommended. In patients with Zollinger-Ellison Syndrome the ...

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients. Omeprazole like other proton pump inhibitors (PPIs) should not be used concomitantly with nelfinavir (see section ...

Special warnings and precautions for use

In the presence of any alarm symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should ...

Interaction with other medicinal products and other forms of interaction

Effects of omeprazole on the pharmacokinetics of other active substances Active substances with pH dependent absorption The decreased intragastric acidity during treatment with omeprazole might increase ...

Pregnancy and lactation

Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse events of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can ...

Effects on ability to drive and use machines

Omeprazole is not likely to affect the ability to drive or use machines. Adverse reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive ...

Undesirable effects

Summary of the safety profile The most common adverse events (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. Tabulated list of adverse reactions ...

Overdose

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders, Proton pump inhibitors ATC code: A02BC01 Mechanism of action Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion ...

Pharmacokinetic properties

Distribution The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight. Omeprazole is 97% plasma protein bound. Metabolism Omeprazole is completely metabolised by the ...

Preclinical safety data

Gastric ECL-cell hyperplasia and carcinoids have been observed in life-long studies in rats treated with omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. ...

List of excipients

Sodium hydroxide (for pH adjustment) Disodium edetate

Incompatibilities

Omeprazole powder for solution for infusion should not be mixed with other medicinal products than those mentioned in section 6.6.

Shelf life

Shelf life Powder for solution for infusion: 2 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 12 hours when dissolved in NaCl 0.9% solution and for 6 hours ...

Special precautions for storage

Powder for solution for infusion: do not store above 25°C. Keep vials in the outer carton in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3. ...

Nature and contents of container

10 ml colourless glass vial Type I with a red bromobutyl rubber stopper, and an aluminium cramping cap with polypropylene cap. Pack sizes: 1, 5, 10 or 20 vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

The entire contents of each vial is to be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution ...

Marketing authorization holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/0701

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 April 2008 Date of latest renewal: 19 December 2011

Date of revision of the text

11/05/2017

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