Allopurinol Orion 300 mg tablet ENG SmPC
... reported. If such reactions do occur, it may be at any time during treatment, Allopurinol Orion should be withdrawn immediately and permanently. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivi ...
... reported. If such reactions do occur, it may be at any time during treatment, Allopurinol Orion should be withdrawn immediately and permanently. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivi ...
Citizen Petition to Investigate Polyethylene Glycol 3350
... currently 19 PEG products, prescription and over-the-counter (OTC), in the US approved for use as either as a bowel preparation prior to colonoscopy or for the treatment of constipation. All products approved for use prior to colonoscopy are prescription products with one product approved for use in ...
... currently 19 PEG products, prescription and over-the-counter (OTC), in the US approved for use as either as a bowel preparation prior to colonoscopy or for the treatment of constipation. All products approved for use prior to colonoscopy are prescription products with one product approved for use in ...
Xolair® (Omalizumab) - UnitedHealthcareOnline.com
... The Inner-City Anti-IgE Therapy for Asthma (ICATA) Study was a 60-week, randomized, double-blind, placebocontrolled, parallel-group trial (n=419) which evaluated the effectiveness of omalizumab (75-375 mg subcutaneously every 2-4 weeks), as compared with placebo, when added to guidelines-based thera ...
... The Inner-City Anti-IgE Therapy for Asthma (ICATA) Study was a 60-week, randomized, double-blind, placebocontrolled, parallel-group trial (n=419) which evaluated the effectiveness of omalizumab (75-375 mg subcutaneously every 2-4 weeks), as compared with placebo, when added to guidelines-based thera ...
Chloral hydrate
... Chloral hydrate (synthesized in 1832 and introduced into medicine 1869) is the oldest member of sedative-hypnotic drugs. To the same group belong paraldehyde, bromide, urethane, and sulfonal. Metabolite of chloral hydrate, trichloroethanol, is also an excellent hypnotic agent, but is not often used ...
... Chloral hydrate (synthesized in 1832 and introduced into medicine 1869) is the oldest member of sedative-hypnotic drugs. To the same group belong paraldehyde, bromide, urethane, and sulfonal. Metabolite of chloral hydrate, trichloroethanol, is also an excellent hypnotic agent, but is not often used ...
T3 Not 4 Me
... The Pharmacogenomics Journal 2007;7:257-65 Pharmacokinetics of codeine and its metabolite morphine in ultra-rapid metabolizers due to CYP2D6 2004 NEJM 351:27:2867-9 Genes and the response to drugs 2010 Oct 4 Cdn Press Consider abandoning codeine until more safety research ...
... The Pharmacogenomics Journal 2007;7:257-65 Pharmacokinetics of codeine and its metabolite morphine in ultra-rapid metabolizers due to CYP2D6 2004 NEJM 351:27:2867-9 Genes and the response to drugs 2010 Oct 4 Cdn Press Consider abandoning codeine until more safety research ...
Product Information for Aripiprazole Monohydrate
... of patients with psychosis associated with dementia have not been established. Abilify Maintena is not indicated for the treatment of patients with dementia-related psychosis. General During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. ...
... of patients with psychosis associated with dementia have not been established. Abilify Maintena is not indicated for the treatment of patients with dementia-related psychosis. General During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. ...
Clarithromycin increases linezolid exposure in multidrug-resistant tuberculosis patients
... Multidrug-resistant tuberculosis (MDR-TB) is an infectious disease of major concern, especially in countries with a high TB burden [1–3]. Treatment of MDR-TB poses challenges such as designing an effective second-line antituberculosis regimen, entailing a combination of multiple drugs and a long dur ...
... Multidrug-resistant tuberculosis (MDR-TB) is an infectious disease of major concern, especially in countries with a high TB burden [1–3]. Treatment of MDR-TB poses challenges such as designing an effective second-line antituberculosis regimen, entailing a combination of multiple drugs and a long dur ...
Buprenorphine and Naloxone: Clinical Pharmacology Abuse Liability
... opiate agonist effects A small dose of Naloxone is highly aversive in this population The Buprenorphine and Naloxone combination behaves like Naloxone Abuse potential of Suboxone probably very low in MMT patients ...
... opiate agonist effects A small dose of Naloxone is highly aversive in this population The Buprenorphine and Naloxone combination behaves like Naloxone Abuse potential of Suboxone probably very low in MMT patients ...
LM - Prevalite Powder - Upsher
... treated with cholestyramine resin had mean reduction in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the seven-year study period the cholestyramine resin group experienced a 19% reduction (relative to ...
... treated with cholestyramine resin had mean reduction in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the seven-year study period the cholestyramine resin group experienced a 19% reduction (relative to ...
Valerian (Valeriana officinalis) Nervousness Insomnia Anxiety
... inhibitory neurotransmitters in the central nervous system and GABA-A is the target of many drugs used to reduce anxiety or aid sleep, such as benzodiazepines. Valerenic acid and valerenol are two compounds in valerian root that have been shown to strongly bind GABA-A receptors and are likely to be ...
... inhibitory neurotransmitters in the central nervous system and GABA-A is the target of many drugs used to reduce anxiety or aid sleep, such as benzodiazepines. Valerenic acid and valerenol are two compounds in valerian root that have been shown to strongly bind GABA-A receptors and are likely to be ...
PRODUCT MONOGRAPH CEFAZOLIN FOR INJECTION 500 mg, 1
... (including fatal anaphylaxis after parenteral use). Clinical and laboratory evidence of partial cross-allergenicity of the two drug classes exists. Cefazolin sodium should be administered cautiously and then only when absolutely necessary to any patient who has demonstrated allergy, particularly to ...
... (including fatal anaphylaxis after parenteral use). Clinical and laboratory evidence of partial cross-allergenicity of the two drug classes exists. Cefazolin sodium should be administered cautiously and then only when absolutely necessary to any patient who has demonstrated allergy, particularly to ...
Desmopressin Acetate Nasal Spray, 10 mcg per 0.1 mL
... mutagenic potential or effects on fertility. Pregnancy Category B Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposu ...
... mutagenic potential or effects on fertility. Pregnancy Category B Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposu ...
PrZOFRAN® Tablets, Oral Solution and Injection PrZOFRAN® ODT
... cases of torsade de pointes have been reported in patients using ondansetron. Torsade de pointes is a polymorphic ventricular tachyarrhythmia. Generally, the risk of torsade de pointes increases with the magnitude of QTc prolongation produced by the drug. Torsade de pointes may be asymptomatic or ex ...
... cases of torsade de pointes have been reported in patients using ondansetron. Torsade de pointes is a polymorphic ventricular tachyarrhythmia. Generally, the risk of torsade de pointes increases with the magnitude of QTc prolongation produced by the drug. Torsade de pointes may be asymptomatic or ex ...
Melatonin - Sweetwater OB GYN
... Melatonin is a natural hormone nutrient that is synthesized from the amino acid tryptophan by the pineal gland in the back of the brain. Melatonin also occurs in small amounts in a variety of foods. In the body, melatonin appears to regulate sleep/wake cycles, support normal immune function, and pro ...
... Melatonin is a natural hormone nutrient that is synthesized from the amino acid tryptophan by the pineal gland in the back of the brain. Melatonin also occurs in small amounts in a variety of foods. In the body, melatonin appears to regulate sleep/wake cycles, support normal immune function, and pro ...
PRODUCT MONOGRAPH CEFAZOLIN FOR INJECTION 500 mg, 1
... (including fatal anaphylaxis after parenteral use). Clinical and laboratory evidence of partial cross-allergenicity of the two drug classes exists. Cefazolin sodium should be administered cautiously and then only when absolutely necessary to any patient who has demonstrated allergy, particularly to ...
... (including fatal anaphylaxis after parenteral use). Clinical and laboratory evidence of partial cross-allergenicity of the two drug classes exists. Cefazolin sodium should be administered cautiously and then only when absolutely necessary to any patient who has demonstrated allergy, particularly to ...
AusPAR Attachment 2: Extract from the Clinical Evaluation Report
... The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. ...
... The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. ...
ZOFRAN Tablets, Oral Solution and Injection PRODUCT MONOGRAPH
... Rare cases of transient visual disturbances (e.g. blurred vision) have been reported during or shortly after intravenous administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 minutes. Post-Market Adverse Drug Reactions Over 250 million patient treatment days of ZO ...
... Rare cases of transient visual disturbances (e.g. blurred vision) have been reported during or shortly after intravenous administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 minutes. Post-Market Adverse Drug Reactions Over 250 million patient treatment days of ZO ...
View Prescribing Details
... other alpha-adrenergic blocking agents have not been determined. However, interactions may be expected and Maxflo-U® should not be used in combination with other alpha-adrenergic blocking agents. Warning The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detecte ...
... other alpha-adrenergic blocking agents have not been determined. However, interactions may be expected and Maxflo-U® should not be used in combination with other alpha-adrenergic blocking agents. Warning The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detecte ...
2015.06.25_Vancomycin DS
... Vancomycin is poorly absorbed by mouth. It is given intravenously for the treatment of systemic infections. In subjects with normal renal function participating in a multi dose study 1g (1,000,000 IU) given over 60 minutes produced mean plasma levels of approximately 63 micrograms/mL immediately aft ...
... Vancomycin is poorly absorbed by mouth. It is given intravenously for the treatment of systemic infections. In subjects with normal renal function participating in a multi dose study 1g (1,000,000 IU) given over 60 minutes produced mean plasma levels of approximately 63 micrograms/mL immediately aft ...
AVELOX I.V. PRODUCT MONOGRAPH
... relevant heart failure with reduced left-ventricular ejection fraction or previous history of symptomatic arrhythmias. The magnitude of QT prolongation may increase with the infusion rate and with increasing plasma concentrations of the drug. Therefore, the recommended duration of infusion (60 minut ...
... relevant heart failure with reduced left-ventricular ejection fraction or previous history of symptomatic arrhythmias. The magnitude of QT prolongation may increase with the infusion rate and with increasing plasma concentrations of the drug. Therefore, the recommended duration of infusion (60 minut ...
Interventional Spine and Pain Procedures in Patients - cmp
... appropriate for the low- or intermediate-risk category, but the highrisk targets require a more intensive look at the issues specific to patient safety and improved outcomes. For example, SCS lead placement requires the use of large gauge needles with a long bevel and stiff styletted leads to enhanc ...
... appropriate for the low- or intermediate-risk category, but the highrisk targets require a more intensive look at the issues specific to patient safety and improved outcomes. For example, SCS lead placement requires the use of large gauge needles with a long bevel and stiff styletted leads to enhanc ...
Sacubitril / Valsartan salt complex
... used in this document. The combination product of the two active ingredients is also known as LCZ696. HF is associated with overstimulation of the renin-angiotensin-aldosterone system (RAAS) which promotes vasoconstriction and fluid overload mediated by angiotensin II and aldosterone. Angiotensin co ...
... used in this document. The combination product of the two active ingredients is also known as LCZ696. HF is associated with overstimulation of the renin-angiotensin-aldosterone system (RAAS) which promotes vasoconstriction and fluid overload mediated by angiotensin II and aldosterone. Angiotensin co ...
The GCC Data Requirements for Human Drugs Submission Content
... dissolution studies should ordinarily be provided in the clinical study reports. However, where a method is used in multiple studies, the method and its validation should only be included once in section 5.3.1.4 and referenced in the appropriate individual clinical study reports. 5.3.7 Case Report ...
... dissolution studies should ordinarily be provided in the clinical study reports. However, where a method is used in multiple studies, the method and its validation should only be included once in section 5.3.1.4 and referenced in the appropriate individual clinical study reports. 5.3.7 Case Report ...
diamorphine hydrochloride bp 5 mg lyophilisate for solution for
... suitable justification for the absence of an environmental risk assessment, stating that the proposed medicinal product will not be administered at higher dosage levels, for longer durations or for different indications than existing, marketed products. As such, the use of the proposed product is un ...
... suitable justification for the absence of an environmental risk assessment, stating that the proposed medicinal product will not be administered at higher dosage levels, for longer durations or for different indications than existing, marketed products. As such, the use of the proposed product is un ...
simvastatin tablets usp - Lupin Pharmaceuticals, Inc.
... In a study including 16 elderly patients between 70 and 78 years of age who received simvastatin 40 mg/day, the mean plasma level of HMG-CoA reductase inhibitory activity was increased approximately 45% compared with 18 patients between 18-30 years of age. Clinical study experience in the elderly (n ...
... In a study including 16 elderly patients between 70 and 78 years of age who received simvastatin 40 mg/day, the mean plasma level of HMG-CoA reductase inhibitory activity was increased approximately 45% compared with 18 patients between 18-30 years of age. Clinical study experience in the elderly (n ...