DIPYRIDAMOLE Oral Suspension (2019)
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Περιεχόμενα
Name of the medicinal product
Dipyridamole 200mg/5ml Oral Suspension.
Qualitative and quantitative composition
Each 5ml of oral suspension contains 200mg dipyridamole. Excipients with known effect: Each 5ml of oral suspension contains 9mg of methyl parahydroxybenzoate (E218), 0.9mg of propyl parahydroxybenzoate ...
Pharmaceutical form
Oral Suspension. Yellow coloured suspension with orange flavor.
Therapeutic indications
An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves.
Posology and method of administration
<u>Adults:</u> 300-600mg (7.5-15ml) daily in three or four doses. <u>Children:</u> Dipyridamole is not recommended for children. Dipyridamole should usually be taken before meals. Method of administration ...
Contraindications
Hypersensitivity to Dipyridamole or any of the excipients listed in section 6.1. In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section ...
Special warnings and precautions for use
Among other properties, dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, ...
Interaction with other medicinal products and other forms of interaction
Dipyridamole increases plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage should be considered if use with dipyridamole is unavoidable. There is evidence that the effects ...
Fertility, pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy, but Dipyridamole has been used for many years without apparent ill-consequence. Animal studies have shown no hazard. Medicines should ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness during treatment ...
Undesirable effects
Adverse effects at therapeutic doses are usually mild and transient. The following side effects have been reported, frequencies have been assigned based on a clinical trial (ESPS-2) in which 1654 patients ...
Overdose
Symptoms Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-thrombotic ATC code: B01AC07 Dipyridamole inhibits the uptake of adenosine into erythrocytes, platelets and endothelial cells in vitro and in vivo; the inhibition amounts ...
Pharmacokinetic properties
Absorption After dosing with the sugar-coated tablets there is a lag time of 10-15 min associated with disintegration of the tablet and gastric emptying. Thereafter the drug is rapidly absorbed and peak ...
Preclinical safety data
Dipyridamole has been extensively investigated in animal models and no clinically significant findings have been observed at doses equivalent to therapeutic doses in humans.
List of excipients
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Polysorbate 80 (E433) Simeticone emulsion 30% (containing polydimethylsiloxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, silicon ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
21 months. Discard after 60 days of first opening.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
*<u>ottle:</u> Ph.Eur Type III Amber glass <u>Closure:</u> Tamper evident, child resistant, plastic (Polypropylene/Polyethylene) cap with an EPE liner. <u>Dosing Device:</u> Double ended white polypropylene ...
Special precautions for disposal and other handling
This product may settle during storage. Shake the bottle well before use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Marketing authorization number(s)
PL 39307/0041
Date of first authorization / renewal of the authorization
06/01/2016
Date of revision of the text
29/07/2019
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