Übersetzung für "Einzelwirkstoff" in Englisch

The adverse events seen with the adjunctive therapy have been observed with each active substance alone.

Travoprost on its own has already been approved in the European Union under the name TRAVATAN.

Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?

In patients taking amlodipine alone the following additional side effects have been reported:

In patients taking telmisartan alone the following additional side effects have been reported:

No dose adjustment of linagliptin is recommended in patients with renal impairment; therefore, linagliptin may be continued as a single entity tablet at the same total daily dose of 5 mg if Jentadueto is discontinued due to evidence of renal impairment.

Combination therapy of dapagliflozin 10 mg and prolonged-release exenatide resulted in significantly greater reductions in 2-hour post-prandial glucose at Week 28 compared to either agent alone.

The combination of dapagliflozin 10 mg and prolonged-release exenatide demonstrated significantly greater weight reductions compared to either agent alone (Table 8).

It is noted that single component glycopyrronium, formulated as pressurised metered dose inhaler, which was used in the PK studies, is not available on the market.

However, based on the data assessed during this procedure, it is possible to make a recommendation to have a 107-day withdrawal period for sheep (meat and offal) for the concerned products containing 50 mg closantel per ml (as a single active substance) presented as a solution for injection for subcutaneous use in sheep.

Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I)

It has been noted that there are different approved withdrawal periods for sheep (meat and offal) for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solution for injection for subcutaneous use in sheep across the EU, i.e., between 28 days and 107 days.

The CVMP was requested to review all available residue depletion data for the veterinary medicinal products containing 50 mg closantel per ml (as a single active substance), presented as a solution for injection for subcutaneous use in sheep and recommend withdrawal periods for meat and offal derived from treated sheep.

Therefore the cardiovascular effects of Qsiva cannot be implied from data for higher doses of phentermine as a single agent.

Having considered all the overall package of data submitted the CVMP concluded that the benefit-risk balance for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as single active substances (see Annex I) was positive provided that adequate instructions concerning use in dairy animals are included in section 4.11 Withdrawal period(s) of the SPC of the relevant products based on the time spans shown in the above table.

On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection.

Although the amount of phentermine in the high dose of Qsiva is half of that currently licensed for use as a single agent in the US and the UK, the addition of topiramate was shown to increase exposure to phentermine by 40% in the PK studies.

In cattle injectable veterinary medicinal products containing ivermectin, either as a single active ingredient or in combination with a second active substance, are used against infestations with endoparasites and ectoparasites by administering 200 ?g ivermectin/kg bw subcutaneously.

In this respect, the PRAC further noted that not only the efficacy data is limited but it does not actually demonstrate the superiority of the combination over the single component product.

Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety.

Overall, results suggest that single agent encorafenib has the potential to cause mild increases in heart rate.

If binimetinib is temporarily interrupted, encorafenib should be reduced at 300 mg once daily during the time of binimetinib dose interruption (see section 4.2 of binimetinib Summary of Product Characteristics [SmPC]) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.

Across pooled combination studies of encorafenib and binimetinib at the recommended doses and a single-agent encorafenib study, results suggest that encorafenib has the potential to result in small increases in QTc interval (see section 5.1).

Creatinine elevation has been commonly reported with encorafenib as single agent or in combination with binimetinib.

Administration of encorafenib at a dose of 450 mg once daily as a single agent is not recommended.

They are available as tablets containing meprobamate on its own or in combination with other medicines.

The following information is derived from the clinical experience on single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see Lenvima SmPC).