Examples of using Additional monitoring in English and their translations into Croatian
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Computer
Additional Monitoring Tools.
Does the change in the additional monitoring status i.e.
Additional monitoring during different seasons of the same year shall be carried out, where necessary, to achieve this objective.
List of medicinal products under additional monitoring Signal management.
Instructions to marketing authorisation holders on inclusion of information as regard the medicinal product status under additional monitoring.
In the prepartum period, additional monitoring should be considered.
If hypocalcaemia occurs while receiving XGEVA, additional calcium supplementation and additional monitoring may be necessary.
In the prepartum period, additional monitoring should be considered.
Therefore it is recommended to include a standardised text of the information on medicinal product status under additional monitoring in the promotional material.
Your doctor may request additional monitoring during your INCIVO treatment.
Additional monitoring of QTc, electrolytes and renal function are required especially in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance and/or impaired renal function.
Transactions longer to process due to additional monitoring from Mastercard.
Caution is advised and additional monitoring may be appropriate in patients receiving medicinal products metabolized primarily or partly by CYP3A4 see section 4.4.
Transactions longer to process due to additional monitoring from Mastercard.
Additional monitoring of calcium level should be considered during therapy in patients with risk factors for hypocalcaemia, or if otherwise indicated based on the clinical condition of the patient.
The newest list of medicinal products under additional monitoring is accessible on the EMA webpages, or here.
If a woman underwent the first and second prenatal ultrasound on time, then at the 22nd week of pregnancy it is usually not prescribed,unless with an increased risk of certain complications and the need for additional monitoring.
Under these conditions, no additional monitoring of the compliance with the limit value is required.
Inclusion of information as regard the medicinal product status under additional monitoring Adverse Drug Reactions Reports.
Caution should be exercised and additional monitoring of digoxin is recommended when digoxin(a transporter substrate) is used concomitantly with dabrafenib and at discontinuation of dabrafenib see section 4.5.
Of 1 March 2016 amending Implementing Regulation(EU) No 680/2014 with regard to additional monitoring metrics for liquidity reporting.
List of medicinal products under additional monitoring- Medicinal Products under Additional Monitoring Pharmacovigilance.
However, as there was a trend toward increased incidence of adverse reactions in patients with moderate hepatic impairment, additional monitoring of adverse reactions is advised in these patients.
Member States should be allowed to apply current and additional monitoring measures or administrative formalities which are deemed to be effective and necessary- while avoiding"gold-plating.
A medicinal product can be included on the list when it is approved for the first time or at any time during its lifecycle.It remains under additional monitoring for five years or until the PRAC decides to remove it from the list.
In patients undergoing peritoneal dialysis additional monitoring of fat- soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Patients, together with rabeprazole receiving ketoconazole or digoxin,require additional monitoring It may need a dose adjustment of these drugs.
Additional monitoring of haematological parameters bilirubin, alkaline phosphatase, aminotransferases and CPK should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.
Information on medicinal products under additional monitoring is also available on the EMA webpages, or here.
Youth or adult sectors may not have the necessary financial solidity or sophisticated management structures and capacity for managing Union funds, andwould be subject to additional monitoring and checks based on risk assessment.