CUROSURF 120mg

Future date agreed between HPRA and MAH during the approval of renewal application. 06-Oct-2020

An administrative renewal application has been submitted in IE following the completion of MA transfer from Chiesi Ltd to Chiesi Farmaceutici S.p.A due to Brexit.  The Marketing Authorisation has been given unlimited validity and the only changes made were to section 9 (Date of last Renewal) and section 10 (date of revision of the text) of the SmPC.

9          DATE OF FIRST AUTHORISATION/RENEWAL OF THE

            AUTHORISATION

            Date of first Authorisation: 8^th September 1994

            Date of last Renewal: 08 September 2004 06^th February 2020

10        DATE OF REVISION OF THE TEXT

            April 2019 February 2020

Please be informed a new version of the Curosurf PIL has been uploaded following the approval of an Article 61(3) application to update the current UK and IE combined PIL with the addition of Malta specific information, this would result in a joint UK, IE and MT PIL. The new code for Curosurf PIL is CP001/12 superseding CP001/11.

MARKETING AUTHORISATION HOLDER

Chiesi Farmaceutici S.p.A

Via Palermo 26/A

Parma 43122

Italy

8          MARKETING AUTHORISATION NUMBER(S)

PA 0584/005/002

9          DATE OF FIRST AUTHORISATION/RENEWAL OF THE

           AUTHORISATION

            Date of first Authorisation: 8^th September 1994

            Date of last Renewal: 8^th September 2004

10        DATE OF REVISION OF THE TEXT

            April 2019

Section 4.1 - Therapeutic indications

For the treatment, including early rescue of Respiratory Distress Syndrome (RDS) or hyaline membrane disease in newborn babies with birth weight over 700g.

Prophylactic use in premature infants requiring intubation for stabilisationbetween 24 and 31 weeks estimated gestational age at risk from RDS or with evidence of surfactant deficiency where the mother had not received appropriate ante-natal corticosteroids.

Section 10        DATE OF REVISION OF THE TEXT

            October 20162018

A Type II Variation was submitted to register the addition of a new administration method: the LISA method (Less Invasive Surfactant Administration)

4.2. Method of administration

d.               Less Invasive Surfactant Administration with a thin catheter (LISA)

Alternatively, in spontaneously breathing preterm infants Curosurf can also be administered through the Less Invasive Surfactant Administration (LISA) technique using a thin catheter. Doses are the same indicated for modalities under points a) , b) and c). A small diameter catheter is placed into the trachea of infants on CPAP, ensuring continuous spontaneous breathing, with direct visualisation of the vocal cords by laryngoscopy. Curosurf is instilled by a single bolus over 0.5-3 minutes. After Curosurf® instillation, the tube is immediately removed. CPAP treatment should be continued during the whole procedure.

Thin catheters CE marked for this intended use should be used for surfactant administration. Special population

Renal or Hepatic impairment

The safety and efficacy of CUROSURF in patients with renal or hepatic impairment have not been evaluated. When Curosurf is administered with the LISA technique, an increase in frequency of bradycardia, apnoea and reduced oxygen saturation has been reported. These events are generally of brief duration, without consequences during administration and easily managed. If these events become serious, stop the surfactant treatment and treat the complications.

4.8        Undesirable effects LISA technique:

In clinical trials, some transient and mild adverse events, without consequences during administration, were more frequent in the LISA groups than in the standard treatment control groups; in particular: oxygen desaturation (57.4% LISA group vs 26.6% standard group) , apnoea ( 21.8% vs 12.8%) , bradycardia ( 11.9% vs 2.8%), froth at the mouth ( 21.8 vs 2.8%) , coughing (7.9% vs 0.9%), choking ( 6.9%vs 1.8 %) and sneezing ( 5% vs 0). This difference between the two groups could be justified by the less frequent use of sedation in the LISA groups vs. standard of care. The majority of these events were easily managed. 

During a spontaneous comparative clinical trial (NINSAPP) some cases of necrotizing enterocolitis  requiring surgery (8.4% in the  group with LISA method and  3.8%  in the group with standard administration-intubation/MV ) and  focal intestinal perforation requiring surgery (11.2.%  in the  LISA  group  and 10.6%  in the standard group ) were reported, with no statistically significant difference between groups. These events could be either complications of prematurity or consequences of other treatments used in these preterm babies.

5.1        Pharmacodynamic properties

Clinical efficacy and safety

A  spontaneous clinical trial ( NINSAPP) has compared  the administration of Curosurf  with the LISA technique and  the standard one ( intubation, administration  and mechanical ventilation) in two groups of  preterms newborns with RDS and gestational age between 23 and 27 weeks  ( LISA group: N.108 , control group: N. 105 ). LISA technique was not inferior to the standard one  on the primary end-point ( survival without bronchopulmonary dysplasia at 36 gestational weeks). On the secondary end-points LISA was superior in increasing survival without major complications and in reducing the frequency of other morbidities associated with prematurity.The need of mechanical ventilation was significantly reduced with LISA.

6.1        List of excipients

Sodium hydrogen carbonate (for pH adjustment)

6.4 Special precautions for storage

Store in the original package in order to protected from light.

10         DATE OF REVISION OF THE TEXT

July 2015 changed to October 2016 

Marketing Authorisation Holder: Chiesi Ltd, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK. Changed to Chiesi Limited, 333 Styal Road, Manchester, M22 5LG  UK

Date of revision of text – changed from February 2015 to July 2015

Section 2 – Qualitative and Quantitative Composition – For excipients see 6.1 changed to the full list of excipients see section 6.1

Section 4.3 Contraindications – listed in section 6.1 – added also corrections to spelling

Section 4.6 – Pregnancy and Lactation – Fertility added

Section 4.8 - Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie -  added

Section 9 – the word THE has been added

Section 10 – Date of revision of the text – Changed from 24.08.2010 to February 2015