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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Vascace Tablets (2012)

Εκδότης

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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Περιεχόμενα

Name of the medicinal product

Vascace 0.5 mg Film-coated Tablets. Vascace 1 mg Film-coated Tablets. Vascace 2.5 mg Film-coated Tablets. ...

Qualitative and quantitative composition

Each film-coated tablet contains: 0.522 mg cilazapril equivalent to 0.5mg cilazapril anhydrous 1.044 ...

Pharmaceutical form

Film-coated tablet: White, oval, biconvex film-coated tablets with a score on one side and imprinted ...

Therapeutic indications

Vascace is indicated for the treatment of hypertension. Vascace is indicated for the treatment of chronic ...

Posology and method of administration

Posology Hypertension: The initial dose is 1 mg/day. Blood pressure should be assessed, and dosage adjusted ...

Contraindications

Hypersensitivity to cilazapril or any components of the product, or to other ACE inhibitors. History ...

Special warnings and precautions for use

Pregnancy ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy ...

Interaction with other medicinal products and other forms of interaction

Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant ...

Pregnancy and lactation

Pregnancy The use of ACE inhibitors such as cilazapril is not recommended during the first trimester ...

Effects on ability to drive and use machines

When driving and operating machines, it should be taken into account that occasionally dizziness and ...

Undesirable effects

(a) Summary of the safety profile The most frequent drug-attributable adverse events observed in patients ...

Overdose

Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors ...

Pharmacodynamic properties

Pharmacotherapeutic group: ACE inhibitor ATC code: C09AA08 Mechanism of action Vascace is a specific, ...

Pharmacokinetic properties

Absorption Cilazapril is efficiently absorbed and rapidly converted to the active form, cilazaprilat. ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, ...

List of excipients

In the tablet core: Lactose monohydrate Maize starch Hypromellose 3cP Talc Sodium stearyl fumarate In ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

0.5 mg: Do not store above 25°C. 1 mg: Do not store above 25°C. 2.5 mg: Do not store above 25°C. 5 mg: ...

Nature and contents of container

ALU/ALU blisters containing 14, 20, 28, 30, 50, 56, 60, 98 film-coated tablets. Amber glass bottles containing ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

0.5mg Tablets: PL 00031/0244 1.0mg Tablets: PL 00031/0245 2.5mg Tablets: PL 00031/0246 5.0mg Tablets: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 October 1990 Date of last renewal: 7 December 2001

Date of revision of the text

08 August 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.