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SPC, UK: PANTOPRAZOLE Powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pantoprazole 40 mg powder for solution for injection.

Qualitative and quantitative composition

Each vial contains 40mg of pantoprazole (as sodium sesquihydrate).

Pharmaceutical form

Powder for solution for injection. White to almost white powder.

Therapeutic indications

Reflux oesophagitis. Gastric and duodenal ulcer. Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

Posology and method of administration

Posology Intravenous administration of Pantoprazole 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 ...

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

In presence of alarm symptoms In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is ...

Interaction with other medicinal products and other forms of interaction

Medicinal products with pH Dependent Absorption Pharmacokinetics Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of pantoprazole. Studies in animals have shown reproductive ...

Effects on ability to drive and use machines

Pantoprazole has no or negligible influence on the ability to drive and use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients ...

Undesirable effects

Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADR is injection site thrombophlebitis. Diarrhoea and headache occurred in approximately ...

Overdose

There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated. Pantoprazole is extensively protein bound, it is not readily ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders, Proton pump inhibitors ATC code: A02BC02 Mechanism of action Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric ...

Pharmacokinetic properties

General Pharmacokinetics Pharmacokinetics do not vary after single or repeated administration. In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous ...

Preclinical safety data

Pre-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. In the two-year carcinogenicity studies in rats neuroendocrine ...

List of excipients

None.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 18 months. 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, unless ...

Special precautions for storage

Store below 25°C. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Nature and contents of container

10 ml type-I tubular colourless glass vial with grey bromobutyl rubber stopper, sealed with a red flip-off tear-off aluminium seal. Pantoprazole 40 mg powder for solution for injection is supplied in packs ...

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization number(s)

PL 31750/0011

Date of first authorization / renewal of the authorization

01/07/2015

Date of revision of the text

24/01/2019

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