Concomitant medication. The following medications may only be administered as indicated: · ceftriaxone may not be administered during the 48 hours immediately prior to the administration of BL-1040, and for the 48 hours immediately following administration of BL-1040 · calcium solutions may not be administered during the first week of the study The introduction of any medication not allowed by the protocol at any point in the study will require a discussion between the Investigator and the Sponsor. If, in the opinion of the Investigator, it becomes necessary to administer any medication during the study, the Investigator will determine the dose and time of intake, and document the medication(s) in the patient’s CRF. Patients must be instructed not to begin any new medication before consulting with the Investigator (unless required for emergency medical use). The patient must be instructed that this prohibition applies to over-the-counter products as well as prescription drugs. All patients will receive optimal medical therapy according to the relevant, updated guidelines from the European Society of Cardiology [3,4,5]. Optimal therapy including aspirin, anticoagulation if indicated, angiotensin-converting-enzyme inhibition, beta-blockade, aldosterone antagonists, when appropriate, and lipid-lowering therapy, unless contraindicated. Clopidogrel therapy will be initiated before PCI and continued for 1 year after myocardial infarction [3].
Concomitant medication. The following medications may only be administered as indicated: · ceftriaxone may not be administered during the 48 hours immediately prior to the administration of BL-1040, and for the 48 hours immediately following administration of BL-1040 · calcium solutions may not be administered during the first week of the study The introduction of any medication not allowed by the protocol at any point in the study will require a discussion between the Investigator and the Sponsor. If, in the opinion of the Investigator, it becomes necessary to administer any medication during the study, the Investigator will determine the dose and time of intake, and document the medication(s) in the patient's CRF. Annotated Protocol incorporating Amendment 1, Amendment 2, Amendment 3, and Amendment 4 01 December 2008 Protocol BL-1040.01, Version 5.00 Safety and Feasibility study of BL-1040 Final CONFIDENTIAL Patients must be instructed not to begin any new medication before consulting with the Investigator (unless required for emergency medical use). The patient must be instructed that this prohibition applies to over-the-counter products as well as prescription drugs. All patients will receive optimal medical therapy according to the relevant, updated guidelines from the European Society of Cardiology [3,4,5]. Optimal therapy including aspirin, anticoagulation if indicated, angiotensin-converting-enzyme inhibition, beta-blockade, aldosterone antagonists, when appropriate, and lipid-lowering therapy, unless contraindicated. Clopidogrel therapy will be initiated before PCI and continued for 1 year after myocardial infarction [3]. Protocol BL-1040.01, Version 5.00 Safety and Feasibility study of BL-1040 Final CONFIDENTIAL
Concomitant medication. All medication taken by the subject during the study (from signing the informed consent form through post-study follow-up) is to be recorded on the Concomitant Medication form, except for study drug. Subject Diary The parent(s)/caregiver(s) have to document date and time of each individual stool of the subject and the stool consistency (watery, normal) of each evacuation continuously. The subject individual stool consistency before start of the diarrhea is defined as normal (e.g. taking into account the age and diet, e.g. breast feeding, of the individual subject). Recording can be stopped after the excretion of two consecutive normal stools. The date, time and dose of study drug intake as well as the amount ORS and other liquids (e.g. water, milk formula) consumed has to be recorded. Fever will be measured once daily by the parent(s)/caregiver(s) and documented in the diary including method, time and value.
