Примери за използване на Parenteral formulations на Английски и техните преводи на Български
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Parenteral formulations with concentration higher than 5mg/ml.
Acute bacterial meningitis(For parenteral formulations authorised for Acute bacterial meningitis).
Parenteral formulations of calcitonin were first licensed in Europe in 1973.
The revocation of the marketing authorisation for the parenteral formulations of medicinal products referred to in annex I.
For parenteral formulations authorised for intraperitoneal use: Intraperitoneal administration.
Zinacef was first approved in Europe in the early 1980's andis available as parenteral formulations.
For parenteral formulations authorised for intraperitoneal administration, include the wording as follows.
The Committee also concluded that the benefit-risk balance of tolperisone-containing parenteral formulations is not positive, and recommends the revocation of the corresponding marketing authorisations.
For parenteral formulations authorised for perioperative antibacterial prophylaxis, include the wording as follows.
As part of the risk minimisation measures the PRAC proposed revised indications for the parenteral formulations taking all the data into account, and making clear the conditions for which these products are indicated.
Parenteral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week.
The CHMP also carried out a separate assessment of the safety of the parenteral formulations of buflomedil, which are used in the hospital setting for the treatment of severe chronic ischaemia of the lower limbs.
Parenteral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week and oncologic indication.
The Committee also concluded that, in the absence of relevant data to support the efficacy in the dosing recommendations approved,the potential benefit of tolperisone-containing parenteral formulations is outweighed by the identified risk of hypersensitivity.
IF NECESSARY{For parenteral formulations, a warning e.g. in red should be implemented once in a prominent place on the intermediate packaging.
The Committee concluded that there was need for further risk minimisation measures such as information to healthcare professionals to inform on the outcome of the review andthe safe use of the parenteral formulations in the obstetric indications.
Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.
The company that holds these marketing authorisations was asked to submit any existing data in support of its safety and dosing recommendations, but no relevant data was submitted for assessment as the marketing authorisation holder concluded itself that the data is insufficient to conclude that the benefits outweigh the risks andproposed that the marketing authorisations for the parenteral formulations be revoked.
For parenteral formulations(solution for injection in prefilled syringes or pens), the warning should be implemented once in a prominent place of the immediate packaging if space allows.}.
The PRAC further agreed during its April 2018 plenary meeting to extend the scope to include also parenteral formulations of methotrexate, in view of a number of cases reported with these formulations as well, and due to the fact that for a high number of cases reported as“incorrect schedule of dose administration” with methotrexate, the route of administration and the pharmaceutical form had not been specified.
For parenteral formulations authorised for the following indications:- acute bacterial meningitis- bacteraemia that occurs in association with, or is suspected to be associated with, any of the above.
Considering the newly recommended posology, parenteral formulations with concentration higher than 5mg/ml currently approved in the European Union(mainly for the management of acute CINV) will not be suitable for administration of the 10mg dose, are therefore considered to have a negative benefitrisk balance and should be revoked.
For parenteral formulations authorised for intraperitoneal use:- In patients receiving peritoneal dialysis, vancomycin is used in adults and children for the treatment of infections related to peritoneal dialysis.
For the parenteral formulations, the PRAC having considered all the available data and specifically for the management of uncomplicated premature labour recommends that these active substances should be given for short term management(up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Parenteral formulation.
Bacterial meningitis- Parenteral formulation.
There are a few studies where a parenteral formulation was used.
Bacteraemia that occurs in association with or is suspected to be associated with,any of the infections listed above- Parenteral formulation.
Severe infections of the ear, nose and throat(such as mastoiditis, peritonsillar infections, epiglottitis, andsinusitis when accompanied by severe systemic signs and symptoms)- Parenteral formulation.
No clinically relevant interactions are expected to occur with these transporters, with the administration of the parenteral formulation.