Примери за използване на Lartruvo на Английски и техните преводи на Български
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Lartruvo contains sodium.
The therapeutic indication of Lartruvo is.
Why is Lartruvo approved?
Doxorubicin is given on day 1 of each cycle following the Lartruvo infusion.
What is Lartruvo and what is it used for?
The Committee considered the procedure underArticle 20 of Regulation(EC) No 726/2004 for Lartruvo.
Lartruvo and doxorubicin may decrease your platelet count.
It is not known if Lartruvo will affect your ability to drive.
Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab.
There is no experience with Lartruvo overdose in human clinical trials.
Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma.
A doctor experienced in the use of anti-cancer medicines will supervise your Lartruvo therapy.
Handling instructions Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisation for Lartruvo.
Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone.
If you have an infusion-related reaction during treatment,your doctor or nurse may slow down or stop your Lartruvo infusion.
Infusion reactions Lartruvo has been associated with infusion reactions(see section 2 â Warnings and precautionsâ).
Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusionrelated reactions.
If you are already being treated with Lartruvo, your doctor will consider the most appropriate treatment for you.
For patients already on treatment with Lartruvo, doctors should consider the available treatment options.
The marketing authorisation of Lartruvo will therefore be withdrawn and no new patients will be treated with the medicine.
In the ITT population, the median OS was 20.37 months in the investigational arm and 19.75 months in the control arm(HR=1.047[95% CI: 0.841, 1.303]; p=0.69), and the OS KM curves are completely overlapping,indicating that adding Lartruvo to doxorubicin had no favourable effect on OS. Further OS analyses showed that in most subgroups HR estimates ranged from 0.9 to 1.1, consistent with the overall OS results.
In summary, no benefit of adding Lartruvo to doxorubicin in patients with advanced STS was observed in the ANNOUNCE study.
As a consequence, the marketing authorisation of Lartruvo will be revoked and no new patients will be able to receive Lartruvo.
However, that study showed that Lartruvo with doxorubicin is no better than doxorubicin alone at prolonging patients' lives.
The Committee, as a consequence, concluded that Lartruvo lacks therapeutic efficacy and that the benefit-risk of Lartruvo is not favourable.
In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin(26.5 versus 14.7 months, respectively).
In total, 509 patients were randomised to treatment either with Lartruvo+ doxorubicin(followed by Lartruvo monotherapy until progression) or with placebo+ doxorubicin(followed by placebo monotherapy until progression).