Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease

Exclusion Criteria

• •1. Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
• •2. Any major protocol deviation in Lead-in Study.
• •3. Pregnancy and nursing \[To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches\].
• •4. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
• •5. Patients with a Harvey-Bradshaw Index \>8 or Partial Mayo Score (excluding Endoscopy Sub-score) \>6 at End of Study Visit of Lead-in Study.
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