Примери за използване на Tetrazepam на Английски и техните преводи на Български
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Tetrazepam belongs to a group of medicines called benzodiazepines.
The PRAC also noted that current guidelines do not refer to the use of tetrazepam in the spasticity indication.
In particular, tetrazepam is used for its muscle relaxant effects.
The PRAC noted that serious adverse cutaneous reactions have been reported with tetrazepam, including fatal cases.
Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology or spasticity.
The PRAC therefore concluded that the benefit-risk balance of tetrazepam containing medicinal products is not favourable.
Tetrazepam affinity for skin could explain the localization of the hypersensitivity reaction.
This is confirmed by the results of the allergic tests for which in a number of cases only tetrazepam had positive results.
Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology and in spastic syndromes across the Members States.
Regarding its efficacy,four studies showed no difference between tetrazepam and other active medicines when used for spasticity.
If you are taking a tetrazepam-containing medicine,you should not suddenly stop taking tetrazepam without your doctor's advice.
Although the majority of cases occurred in patients taking concomitant medications,the causal link with tetrazepam was strong in a high number of cases.
Results of clinical studies with the use of tetrazepam in both indications have been published since the marketing authorisations of tetrazepam. .
Tetrazepam is a muscle relaxant used in painful conditions such as low back pain and neck pain as well as spasticity(excessive stiffness of muscles).
The review found that half of the reported reactions with tetrazepam are skin disorders, which are sometimes serious, life-threatening or fatal.
The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
This is possibly explained by a structural difference between tetrazepam and other benzodiazepines(i.e. the substituted cyclohexenyl ring of tetrazepam). .
Tetrazepam was the only suspected drug or had a causality score higher than the concomitant treatments in 18 out 81 cases of SJS, TEN or DRESS.
The Committee also noted that, in the light of the risks identified,the available data on the effectiveness of tetrazepam were not sufficiently robust to support its use in the authorised indications.
Overall, the efficacy of tetrazepam in the painful contractures indication is supported mainly by two small double blind placebo-controlled clinical trial Arbus 1987.
This review of pharmacovigilance concerned skin adverse drug reactions(ADRs)recorded in the French National Pharmacovigilance database since the granting of the first marketing authorisations of tetrazepam in 1967 in that Member State.
Taking into account the indications of tetrazepam, the effectiveness of a reduction of duration of treatment was questioned by the PRAC in view of the potential for repeated use.
Having assessed the totality of the risk minimisation measures proposed, the PRAC concluded that given the risk andthe unpredictability of serious cutaneous adverse reactions with tetrazepam the proposed measures were not sufficient to reduce the risk to a clinically acceptable level.
Based on the above, the PRAC concluded that tetrazepam is associated with safety concerns in relation to serious, potentially fatal, skin reactions and shows limited clinical efficacy.
The potential for nucleophilic attack proposed in the literature(by Barbaud et al, 2009) is consistent with the mechanism proposedby in silico analysis, and may explain the reported lack of cross-reactivity between tetrazepam and other benzodiazepines in patients with cutaneous hypersensitivity reactions.
Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures(such as in low back pain and neck pain) and spasticity(excessive stiffness of muscles).
In view of the serious, potentially fatal, skin reactions andthe limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Tetrazepam containing medicinal products are authorised in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain(see Annex I for the list of tetrazepam containing medicinal products authorised in the EU).
The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications.
In view of the above, the PRAC considered that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Erythema Multiform and DRESS syndrome which can be life threatening and fatal.