Side Effects. Each party shall advise the other as promptly as reasonably practical by telefax or overnight delivery service addressed to the attention of its Vice President, International Regulatory Affairs and Drug Safety and Surveillance (or, in LeukoSite's case, the party with similar responsibilities), of any unexpected side effect, adverse reaction or injury which has been brought to that party's attention at any place and which is alleged to have been caused by a Warner-LeukoSite Product. Warner shall have all rights and responsibility timely to report such side effects, adverse reaction or injury to regulatory authorities and others as appropriate.
Side Effects. Each Party shall advise the other within the time ------------ limit required by applicable Agency laws and regulations (or similar foreign laws and regulations) by telefax or overnight delivery service addressed to the attention of its Vice President, Medical Affairs (or, in GenVec's case, the employee with similar responsibilities), of any unexpected side effect, adverse reaction or injury which has been brought to that Party's attention at any place and which is alleged to have been caused by a Collaboration Product. Warner shall have all rights and responsibility to report such side effects, adverse reaction or injury in the Territory to regulatory authorities and others as appropriate.
Side Effects. I understand that the common side effects of opioid medication include feeling sick (nausea), vomiting, constipation, drowsiness, dry mouth, and itchiness of the skin. With extended use I am likely to become tolerant to these side effects, except for constipation. Constipation is a very common side effect and I may be ordered medication to help with this problem. Other side effects which are rare include muscle jerks or shaking, muscle spasm, feeling weak, confusion, hallucinations, feeling disoriented, chills, changes in vision, difficulty passing urine, headaches, skin rashes, difficulty in thinking clearly, decreased sexual function, swelling of hands or feet, sweating, and decreased immune function.
Side Effects. Each party shall promptly advise the other by telefax or overnight delivery service addressed to the attention of its Vice President, Medical Affairs (or, in Onyx's case, the party with similar responsibilities), of any unexpected side effect, adverse reaction or injury which has been brought to that party's attention at any place and which is alleged to have been caused by a Collaboration Product. Warner shall have all rights and responsibility to report such side effect, adverse reaction or injury to regulatory authorities and others as appropriate.
Side Effects. Side effects are normal physical reactions to medications. Common side effects of opioids/narcotics include mood changes, drowsiness, dizziness, constipation, nausea, and confusion. Many of these side effects will resolve over days or weeks. Constipation often persists and may require additional medication. If other side effects persist, different opioids may be tried or they may be discontinued. You should NOT:
Side Effects. I am to notify my provider of any adverse effects that I might experience while taking narcotic medications. Adverse effects include but are not limited to: over-‐sedation, nausea, vomiting, constipation, euphoria, dysphoria, dizziness, sweating, itching, rashes, swelling, difficulty breathing, dysuria, dry mouth, insomnia, disorientation, decreased sex drive, and potency and abnormal jerking motions in the arms and legs. While on Narcotic medications, I will not operate a motor vehicle of any type or any other form of machinery that could cause injury to others or myself.
Side Effects. The MG vaccination group reported side effects in 30.4% (7/23) at T1, the placebo group in 37.5% (9/24) at T1 (p=0.6). At T2, 4 weeks after unblinded influenza vaccination of the placebo group 52% (12/23) reported side effects. At T1 healthy controls reported significantly more side effects (70%; 33/42) than the MG vaccination or placebo group (p<0.01). The most commonly reported side effects for MG or HC were local redness and soreness at the injection site. No change in MG symptoms was reported in the MG group at T1. In the placebo group, 3 patients reported a mild exacerbation of their MG symptoms during the T1-T2 period. Exacerbation of symptoms lasted 1 day to 1 week after vaccination and did not lead to a change in medication.
Side Effects. See SPC or BNF for complete list of adverse effects Side effects may be short term and are usually dose dependent. They can often be prevented or relieved by a moderate reduction in dose. Type of adverse effect Action to be taken GI disturbances e.g. nausea, diarrhoea, dry mouth Ensure patient aware of need for fluid replacement Weight gain Monitor – Advise to avoid crash diets & sugary drinks. Oedema Monitor – may respond to dose reduction. Fine tremor Consider slight reduction in dose Polyuria (frequent urination) Polydipsia (frequent thirst) Advise re: fluid intake. May require investigation for diabetes insipidus if persistent Hypothyroidism Consider thyroid replacement if clinically indicated Signs of toxicity: Blurred vision, muscle weakness, drowsiness, coarse tremor, dysarthria, ataxia, confusion, convulsions, nausea & vomiting, ECG changes. Stop lithium immediately, measure lithium, creatinine, urea and electrolytes. Refer to hospital if clinical condition warrants MONITORING Serum Lithium monitoring Serum lithium must be monitored 5-7 days after initiation, then weekly until steady state is reached, then 3 monthly when stable (more frequently, typically 2 monthly in the elderly). More frequent monitoring is required following alteration of dosage; on development of intercurrent disease; in those with or at risk of cardiac, renal or thyroid disease; signs of manic or depressive relapse; following significant change in sodium or fluid intake; if an interacting drug is being taken or if signs of lithium toxicity occur. Lithium serum levels should be measured 12 hours after the previous dose. Patients taking lithium once daily at night should have the level measured in the morning 12 hours after the previous night time dose. Patients taking lithium twice daily should have the level measured in the morning 12 hours after the previous night time dose. The morning dose must be postponed until after the sample has been taken. Cardiac, renal, thyroid and calcium monitoring- minimum requirements Baseline ECG for those with existing cardiac disease or risk factors. Renal function- baseline and then every 6 months. Calcium- baseline and then every 6 months Thyroid function -TSH and T4 baseline and then every 6 months More frequent monitoring may be indicated in those with or at risk of cardiac, renal or thyroid disease. Weight should also be monitored Drug Interactions Refer to SPC or BNF appendix 1 for complete list Some medicines may result in increased li...
Side Effects. Each party shall advise the other as promptly as reasonably practical by telefax or overnight delivery service addressed to the attention of its Vice President, International Regulatory Affairs and Drug Safety and Surveillance (or, in LeukoSite's case, the party with similar responsibilities), of any unexpected side effect, adverse reaction or injury which has been brought to that party's attention at any place and which is alleged to have been caused by a Warner-LeukoSite Product. Warner shall have all rights and responsibility timely to report such side effects, adverse reaction or injury to regulatory authorities and others as appropriate. The parties agree to amend this Section 6.1 by setting forth a more detailed set of drug safety reporting requirements between the parties if an NDA, MAA or jNDA is filed for a Warner-LeukoSite Product.
Side Effects. The most frequently reported side effects with sevelamer are all in the gastrointestinal category Common ( ≥1?100 <1/10) : Diarrhoea, dyspepsia, flatulence, abdominal pain Very common ( ≥1/10) : Nausea, vomiting, upper abdominal pain, constipation Full information on side effects is available in the Summary of Product Characteristic for Renagel® or Renvela® at the links below. Drug Interactions Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as Renvela, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single dose study. Consequently, Renvela should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving sevelamer carbonate and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Renvela to patients also taking these medicinal products. In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as Renvela, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Renvela is not absorbed compound and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renvela, or the physician should consider monitoring blood levels. Cost (Exc...
