AMPRES 10 mg/ml Solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Ampres 10 mg/ml solution for injection.
Qualitative and quantitative composition
1 ml of solution for injection contains 10 mg of chloroprocaine hydrochloride. 1 ampoule with 5 ml solution, contains 50 mg of chloroprocaine hydrochloride. Excipients with known effect: 1 ml of solution ...
Pharmaceutical form
Solution for injection. Clear, colourless solution. The pH of the solution is comprised between 3.0 and 4.0. The osmolality of the solution is comprised between 270–300 mOsm/kg.
Therapeutic indications
Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.
Posology and method of administration
Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, take into consideration the patients physical condition ...
Contraindications
hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anaesthetics or to any of the excipients listed in section 6.1. general ...
Special warnings and precautions for use
Spinal anaesthesia must only be administered by anaesthetists with the necessary knowledge and experience in the intrathecal anesthesia domain. The doctor in charge is responsible for taking the measures ...
Interaction with other medicinal products and other forms of interaction
Concurrent administration of vasopressor drugs (e.g. for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular ...
Fertility, pregnancy and lactation
Pregnancy Animal studies are insufficient with respect to effects on pregnancy and foetal development (see 5.3). Therefore, Ampres is not recommended during pregnancy and in women of childbearing potential ...
Effects on ability to drive and use machines
Ampres has major influence on the ability to drive and use machines. The doctor is responsible for deciding in each individual case if the patient can drive or use machines.
Undesirable effects
The possible undesirable effects due to the use of Ampres are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the ester group. The undesirable effects ...
Overdose
It is unlikely that Ampres, at the recommended posology by intrathecal administration, will induce plasma levels capable of inducing systemic toxicity. Acute systemic toxicity Systemic undesirable effects ...
Pharmacodynamic properties
Pharmacotherapeutic group: anaesthetics, local; esters of aminobenzoic acid ATC code: N01BA04 Chloroprocaine, is an ester-type local anaesthetic. Chloroprocaine, blocks the generation and the conduction ...
Pharmacokinetic properties
Absorption and Distribution The plasma concentration should be negligible for intrathecal use. Biotransformation Chloroprocaine is rapidly metabolized in plasma by hydrolysis of the ester linkage by pseudocholinesterase. ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. No studies in animals to evaluate ...
List of excipients
Hydrochloric acid 1N (for pH adjustment) Sodium chloride Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
24 months. The medicinal product has to be used immediately after first opening.
Special precautions for storage
Do not refrigerate or freeze. Please do not store above 25°C. Store in original package in order to protect from light.
Nature and contents of container
Type I clear colourless glass ampoule. Box of 10 ampoules each containing 5 ml of solution for injection.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sintetica Limited, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom
Marketing authorization number(s)
PL 46926/0001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19/04/2012 Date of latest renewal: 09/03/2017
Date of revision of the text
09/03/2017
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