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MR Contrast Medium Receives European Approval for Use in Children

By MedImaging International staff writers
Posted on 04 Feb 2010
A new contrast agent has been approved for the most frequently conducted magnetic resonance imaging (MRI) examinations enhanced by contrast media. These include blood vessel imaging and examinations of the central nervous system, the liver, and the kidney. Submission for approval for the pediatric indication is currently underway in all other countries in which the agent has been approved for adults.

Bayer Schering Pharma (Berlin, Germany) successfully completed the procedure for securing approval to use the contrast medium Gadovist 1.0 in children aged seven and above in Europe's main markets. Germany will start to introduce Gadovist 1.0 for this new indication in January 2010 In addition, the Swiss Regulatory Authorities have approved Gadovist 1.0 for the use in children aged two years and older.

"When it comes to drugs, children are not simply little adults. For this reason, we incorporated a new scientific approach within the study program that helped us to substantially reduce the number of samples per child and the number of patients,” said Prof. Hans Maier, head of diagnostic imaging at Bayer Schering Pharma. "We are very pleased that we will soon be able to provide radiologists with our all-rounder Gadovist for use in children aged seven and older. We will cooperate with the authorities and will submit further data if requested with the prospect of securing approval for the use of Gadovist 1.0 in children under the age of seven in Europe's main markets.”

Gadovist is approved for the most frequently conducted magnetic resonance imaging (MRI) examinations, which are enhanced by contrast media. These include blood vessel imaging and examinations of the central nervous system, the liver, and the kidney. Submission for approval for the pediatric indication is currently underway in all other countries in which Gadovist has been approved for adults.

The open multicenter study, which was necessary for securing an indication extension for Gadovist, involved 140 children and adolescents aged two to 17 who were scheduled for a contrast-enhanced MRI scan. The study investigated the pharmacokinetics (distribution and excretion) as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that the agent is well tolerated in this patient group too. The study also demonstrated that the dosage recommendation based on body weight, which is routine in adults, could also be applied in the case of children.

Gadovist is a modern, highly efficient MRI contrast agent. It is approved for the contrast-enhanced MRI of various parts of the body, including the brain, the spinal chord, the liver, the kidney, and the blood-vessel system. With its 1.0 mol/l concentration of gadobutrol, a stable macro-cyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market.

Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per ml of all gadolinium contrast media. This results in excellent image quality and offers practical advantages in the case of smaller injection volumes. Gadovist was approved for the first time in 1998 and is now approved in over 50 countries.

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89 (49.829483032227): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (82.015991210938): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (47.922134399414): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (77.962875366211): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (43.869018554688): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (45.061111450195): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (40.054321289062): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (36.001205444336): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (36.954879760742): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (39.100646972656): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (104.18891906738): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
105 (62.942504882812): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
106 (84.877014160156): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (79.154968261719): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (102.04315185547): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
109 (66.041946411133): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
110 (49.114227294922): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (632.04765319824): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (919.10362243652): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (!!!!! 4971.0273742676): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (125.88500976562): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
115 (65.803527832031): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
116 (82.015991210938): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
117 (43.869018554688): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
118 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
119 (39.100646972656): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
120 (50.067901611328): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
121 (40.054321289062): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
122 (272.03559875488): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 37496.089935303): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (604.86793518066): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294727809 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294727809 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 9201.0498046875): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (101.80473327637): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (65.088272094727): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (40.054321289062): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (62.942504882812): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (40.054321289062): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (483.03604125977): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (57.93571472168): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (56.028366088867): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (41.961669921875): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (558.85314941406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (580.0724029541): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (588.89389038086): SELECT name FROM jos_deeppockets WHERE id=212
138 (46.014785766602): SELECT name FROM jos_deeppockets WHERE id=212
139 (764.13154602051): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (732.1834564209): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (!!!!! 1025.915145874): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
142 (205.03997802734): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
143 (!!!!! 6497.859954834): TRUNCATE TABLE jos_trademed_module
144 (128.98445129395): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (84.877014160156): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294727809 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (472.06878662109): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (116.10984802246): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (87.02278137207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
149 (59.843063354492): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
150 (!!!!! 1448.8697052002): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (94.890594482422): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
152 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
153 (71.048736572266): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294727809 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294727809 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (47.922134399414): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
155 (36.001205444336): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
156 (56.028366088867): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (154.97207641602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
158 (66.041946411133): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294727809 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294727809 AND published='1' LIMIT 1
159 (73.909759521484): select jos_twitters.link from jos_twitters where cat=10
160 (38.862228393555): select jos_facebook.link from jos_facebook where cat=10
161 (36.954879760742): select jos_google_plus.link from jos_google_plus where cat=10
162 (33.855438232422): select jos_linkedin.link from jos_linkedin where cat=10
163 (297.06954956055): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (996.11282348633): insert into jos_banners_delta values (14615,'2025-06-28 12:45:38','216.73.216.249','view'),(14202,'2025-06-28 12:45:38','216.73.216.249','view'),(14203,'2025-06-28 12:45:38','216.73.216.249','view')