Australian public assessment for Enzalutamide
... Following submission, the product received marketing approval in the US, EU, Japan and South Korea, amongst a number of countries. Product information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer ...
... Following submission, the product received marketing approval in the US, EU, Japan and South Korea, amongst a number of countries. Product information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer ...
Effexor ℞
... medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and ...
... medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and ...
auspar-rilpivirine-1.. - Therapeutic Goods Administration (TGA)
... © Commonwealth of Australia 2012 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction fo ...
... © Commonwealth of Australia 2012 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction fo ...
Free PDF - European Review for Medical and
... loading dose of 150 mg diluted with 5% dextrose for slow bolus injection (10 min) in peripheral or central vein, followed if necessary by a second dose of 150 mg. In order to avoid acute side effects, the second bolus should be given after a period of 15 minutes. The therapeutic effects should becom ...
... loading dose of 150 mg diluted with 5% dextrose for slow bolus injection (10 min) in peripheral or central vein, followed if necessary by a second dose of 150 mg. In order to avoid acute side effects, the second bolus should be given after a period of 15 minutes. The therapeutic effects should becom ...
An in vitro study on the compatibility and precipitation of a
... the other hand, ciprofloxacin precipitated out irrespective of the presence of vancomycin (range: 20.25%–26.3%) and the medium of preparation (whether NS or BSS Plus). The precipitation process was stable till 72 hours of incubation. However, the precipitation was greatly enhanced when the initial c ...
... the other hand, ciprofloxacin precipitated out irrespective of the presence of vancomycin (range: 20.25%–26.3%) and the medium of preparation (whether NS or BSS Plus). The precipitation process was stable till 72 hours of incubation. However, the precipitation was greatly enhanced when the initial c ...
Does Oral Trenbolone Really Have the Best Steroid
... Oral Trenbolone PCT The drugs you will take during PCT include aromatase inhibitors and Selective Estrogen Receptor Modulators (SERM). Aromatase inhibitors stop androgens from binding with estrogen receptors and SERMs are supposed to prevent their effects. However, with oral Trenbolone, users are sp ...
... Oral Trenbolone PCT The drugs you will take during PCT include aromatase inhibitors and Selective Estrogen Receptor Modulators (SERM). Aromatase inhibitors stop androgens from binding with estrogen receptors and SERMs are supposed to prevent their effects. However, with oral Trenbolone, users are sp ...
Breast Chemotherapy Regimen v 3.5 Oct 2015
... Trastuzumab infusion related chills and/or fevers are commonly observed during the first infusion (but infrequently with subsequent infusions). Other symptoms may include nausea, hypertension, vomiting, pain, rigors, headache, cough, dizziness, rash, and asthenia. Some adverse reactions to trastuzum ...
... Trastuzumab infusion related chills and/or fevers are commonly observed during the first infusion (but infrequently with subsequent infusions). Other symptoms may include nausea, hypertension, vomiting, pain, rigors, headache, cough, dizziness, rash, and asthenia. Some adverse reactions to trastuzum ...
Amitriptyline Hydrochloride 10mg/5ml Oral Solution PL 29831/0460
... This is a summary of the public assessment report (PAR) for Amitriptyline Hydrochloride 10mg/5ml Oral Solution (PL 29831/0460). It explains how Amitriptyline Hydrochloride 10mg/5ml Oral Solution was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to p ...
... This is a summary of the public assessment report (PAR) for Amitriptyline Hydrochloride 10mg/5ml Oral Solution (PL 29831/0460). It explains how Amitriptyline Hydrochloride 10mg/5ml Oral Solution was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to p ...
PRIAPISM INDUCED WITH SINGLE ORAL DOSE OF SILDENAFIL: A RARE CASE REPORT Research Article
... lactose, triacetin, and FD & C Blue #2 aluminum lake. There may be a hypersensitivity to any component of the tablet. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. Based on effectiveness and toleration, the dose m ...
... lactose, triacetin, and FD & C Blue #2 aluminum lake. There may be a hypersensitivity to any component of the tablet. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. Based on effectiveness and toleration, the dose m ...
Epinefrina. Adrenalina. Monografia del farmaco.
... water for injection, with sodium chloride added for isotonicity. The ampoules contain not more than 0.1% sodium bisulfite as an antioxidant, and the air in the ampoule has been displaced by nitrogen. The Steri-Vials contain 0.5% Chlorobutanol (chloroform derivative) as a preservative and not more th ...
... water for injection, with sodium chloride added for isotonicity. The ampoules contain not more than 0.1% sodium bisulfite as an antioxidant, and the air in the ampoule has been displaced by nitrogen. The Steri-Vials contain 0.5% Chlorobutanol (chloroform derivative) as a preservative and not more th ...
Always refer to full prescribing information.
... 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with ELIDEL Cream, 1% in pregnant women. Therefore, ELIDEL Cream, 1% should be used during pregnancy only if the potential b enefit justifies the potential risk to the fetus. In dermal embryofetal developmental st ...
... 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with ELIDEL Cream, 1% in pregnant women. Therefore, ELIDEL Cream, 1% should be used during pregnancy only if the potential b enefit justifies the potential risk to the fetus. In dermal embryofetal developmental st ...
Preclinical Absorption, Distribution, Metabolism, and Excretion of an
... DNA [14,16]. The clearance of gemcitabine is driven by rapid and extensive inactivation by cytidine deaminase, which is present ubiquitously and at high levels in both plasma and in the liver, to its primary metabolite, 2',2'-difluoro-deoxyuridine (dFdU) [14,17]. Clinical studies have shown that eff ...
... DNA [14,16]. The clearance of gemcitabine is driven by rapid and extensive inactivation by cytidine deaminase, which is present ubiquitously and at high levels in both plasma and in the liver, to its primary metabolite, 2',2'-difluoro-deoxyuridine (dFdU) [14,17]. Clinical studies have shown that eff ...
to the Akten FAQs PDF
... have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses up to 50 mg/kg lidocaine (more than 800 fold greater than the human dose on a body weight basis) in the rat model. There are however, no adequate and well controlled studies in pregnant wom ...
... have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses up to 50 mg/kg lidocaine (more than 800 fold greater than the human dose on a body weight basis) in the rat model. There are however, no adequate and well controlled studies in pregnant wom ...
Product Monograph
... As with levodopa, SINEMET® may cause involuntary movements and mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. Because carbidopa permits more levodopa to reach the brain and thus, more dopamine to be formed, dyskinesias may ...
... As with levodopa, SINEMET® may cause involuntary movements and mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. Because carbidopa permits more levodopa to reach the brain and thus, more dopamine to be formed, dyskinesias may ...
Product Monograph - AstraZeneca Canada
... epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemiarelated adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycaemia-related adverse events in patients treated with atypical antipsychotics are not available. Pati ...
... epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemiarelated adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycaemia-related adverse events in patients treated with atypical antipsychotics are not available. Pati ...
aerius kids
... have not been established. Geriatrics (> 65 years of age): In a multiple dose study with AERIUS 5 mg, subjects >65 years of age (n=17) had AUC and Cmax values 20% greater and plasma elimination half-life approximately 30% longer than in younger subjects; however, these changes are not considered to ...
... have not been established. Geriatrics (> 65 years of age): In a multiple dose study with AERIUS 5 mg, subjects >65 years of age (n=17) had AUC and Cmax values 20% greater and plasma elimination half-life approximately 30% longer than in younger subjects; however, these changes are not considered to ...
(PSD) July 2016 PBAC Meeting
... 6.19 Mepolizumab is administered as a single 100 mg subcutaneous injection every four weeks. The maximum dose of omalizumab (750 mg) and a proportion of the 450 mg and 600 mg doses are required to be split into two equal doses to be administered every 2 weeks. This results in additional administrati ...
... 6.19 Mepolizumab is administered as a single 100 mg subcutaneous injection every four weeks. The maximum dose of omalizumab (750 mg) and a proportion of the 450 mg and 600 mg doses are required to be split into two equal doses to be administered every 2 weeks. This results in additional administrati ...
HIGHLIGHTS OF PRESCRIBING INFORMATION
... of these benzodiazepines. The potential exists for serious and/or life threatening events such as prolonged or increased sedation or respiratory depression. 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic ...
... of these benzodiazepines. The potential exists for serious and/or life threatening events such as prolonged or increased sedation or respiratory depression. 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic ...
Review of the Available Evidence on “Newer”
... When oral daily doses of LTG were given to pregnant rats during organogenesis, fetal, placental, and maternal folate concentrations were reduced. Significantly reduced concentrations of folate are associated with teratogenesis. Folate concentrations were also reduced in male rats given repeated oral ...
... When oral daily doses of LTG were given to pregnant rats during organogenesis, fetal, placental, and maternal folate concentrations were reduced. Significantly reduced concentrations of folate are associated with teratogenesis. Folate concentrations were also reduced in male rats given repeated oral ...
Sulfato de Atropina. Monografia.
... nursing woman. Pediatric Use A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups. The starting dose is 0.05 mg/kg IM every 5-20 minutes as needed to provide complete atropinization. (se ...
... nursing woman. Pediatric Use A review of published literature supports the safety and effectiveness of atropine in the setting of organophosphate insecticide poisoning in all pediatric age groups. The starting dose is 0.05 mg/kg IM every 5-20 minutes as needed to provide complete atropinization. (se ...
Read Document - MotherToBaby
... “The target market is primarily young adults, of whom half are women of reproductive age. The tragic consequences for pregnant users are isotretinoinexposed pregnancies that result in entirely preventable major birth defects and miscarriages. The FDA must step up its oversight. We have recommended t ...
... “The target market is primarily young adults, of whom half are women of reproductive age. The tragic consequences for pregnant users are isotretinoinexposed pregnancies that result in entirely preventable major birth defects and miscarriages. The FDA must step up its oversight. We have recommended t ...
Linköping University Post Print Effects of the oral, direct thrombin inhibitor
... atrial fibrillation, venous thrombosis and prosthetic heart valves. Despite their first use on humans in 1940, coumarins (Vitamin K antagonists, VKA) still are the only oral anticoagulants approved for antithrombotic treatment in atrial fibrillation and venous thrombosis. Millions of patients have b ...
... atrial fibrillation, venous thrombosis and prosthetic heart valves. Despite their first use on humans in 1940, coumarins (Vitamin K antagonists, VKA) still are the only oral anticoagulants approved for antithrombotic treatment in atrial fibrillation and venous thrombosis. Millions of patients have b ...
full prescribing information in pdf format
... sleep that occur almost daily for at least three months, plus sudden bilateral loss of postural muscle tone in association with intense emotion (cataplexy) or 2) a complaint of excessive sleepiness or sudden muscle weakness with associated features: sleep paralysis, hypnagogic hallucinations, automa ...
... sleep that occur almost daily for at least three months, plus sudden bilateral loss of postural muscle tone in association with intense emotion (cataplexy) or 2) a complaint of excessive sleepiness or sudden muscle weakness with associated features: sleep paralysis, hypnagogic hallucinations, automa ...
nitropress
... oxidative metabolism. In this situation, cells may be able to provide for their energy needs by utilizing anaerobic pathways, but they thereby generate an increasing body burden of lactic acid. Other cells may be unable to utilize these alternative pathways, and they may die hypoxic deaths. CN¯ leve ...
... oxidative metabolism. In this situation, cells may be able to provide for their energy needs by utilizing anaerobic pathways, but they thereby generate an increasing body burden of lactic acid. Other cells may be unable to utilize these alternative pathways, and they may die hypoxic deaths. CN¯ leve ...
Ofloxacin
Ofloxacin is a synthetic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone.Ofloxacin was first patented in 1982 (European Patent Daiichi) and received approval from the U.S. Food and Drug Administration (FDA) on December 28, 1990. Ofloxacin is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. Ofloxacin is also available for topical use, as eye drops and ear drops (marketed as Ocuflox and Floxin Otic respectively in the United States and marketed as Optiflox, eylox respectively in Jordan and Saudi Arabia).Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin.Ofloxacin has been associated with adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); tendon damage may manifest long after therapy had been completed, and, in severe cases, may result in lifelong disabilities.