Australien - Englisch - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47799 - cardioplegia cannula - delivery of cardioplegia solution these cannulae are intended for use in conjunction with cardiopulmonary bypass surgery for up to six hours or less for delivering cardioplegia solution.

Israel - Englisch - Ministry of Health

novartis israel ltd - canakinumab - solution for injection - canakinumab 150 mg / 1 ml - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is indicated for the treatment of hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd).►familial mediterranean fever (fmf)ilaris is indicated for the treatment of familial mediterranean fever (fmf) in patients in whom colchicine is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.ilaris can be given as monotherapy or in combination with colchicine.ilaris is also indicated for the treatment of:►still’s diseaseilaris is indicated for the treatment of active still’s disease including adult-onset still’s disease (aosd) and systemic juvenile idiopathic arthritis (sjia) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (nsaids) and systemic corticosteroids. ilaris can be given as monotherapy or in combination with methotrexate.►gouty arthritisilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (nsaids) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate

Singapur - Englisch - HSA (Health Sciences Authority)

covidien private limited - anaesthesiology - intended for use in providing tracheal access for airway management.

Singapur - Englisch - HSA (Health Sciences Authority)

covidien private limited - general hospital - this device is intended for use in providing tracheal access for airway management.

Singapur - Englisch - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - the ti500 globe-trotter™ neonatal transport system is a transport incubator system intended for the transport of high risk premature, low birth weight or critically ill newborns from point of birth to an appropriate center for care of such infants. the means of transportation may take the form of either ground or airborne (rotor or fixed wing) transport. the system is also suitable for either transport or stationary care within the hospital and may be made up of three system components. these components include a frame which houses the incubator and the pneumatic module assembly, and a facility for gas tank storage. the system is arranged to serve as a complete unit for the care of an infant in the need of transportation.

Singapur - Englisch - HSA (Health Sciences Authority)

draeger singapore pte ltd - general hospital - dräger caleo® neonatal incubator is a therapy system providing a controlled supply of warmth, humidity and o2 enrichment in the patient capsule for premature babies and sick neonates up to a body weight of 5 kg or a body length of 55 cm (when treating twins, the total body weight is limited to 5 kg).

Singapur - Englisch - HSA (Health Sciences Authority)

the baby specialist pte. ltd. - general hospital - the bilicare is a non-invasive transcutaneous bilirubin meter for neonates. it measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which correlates with serum bilirubin. the device is for use by medical / trained personnel to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. the device is not intended as a standalone for diagnosis of hyperbilirubinemia. it is to be used in conjunction with other clinical signs and laboratory measurements. newborn infants whose bilicare test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.

Singapur - Englisch - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - immunology - this kit is intended for the quantitative determination of human 17α-oh-progesterone kit in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (cah).

Singapur - Englisch - HSA (Health Sciences Authority)

medline industries asia pte. ltd. - general hospital - intended for administration of all volume nebulizer therapy during mechanical ventilation

Singapur - Englisch - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - immunology - this kit is intended for the quantitative determination of human 17α-oh-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (cah) using the gsp® instrument