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Research and Development at Sun Pharma
Research and Development at Sun Pharma

...  Key Features of technology developed Can produce controlled particle size for facile injection through conventional needle to reduce patient trauma and pain No local anaesthetic required while delivering the drug Closed semi-automatic process to give kilogram scale, reproducible, consistent and ...
a guide to managing adverse reactions - NINLARO
a guide to managing adverse reactions - NINLARO

... placebo regimens, respectively). count) of NINLARO. Women using hormonal contraceptives should Peripheral motor neuropathy was not commonly reported also use a barrier method of contraception. in either regimen (< 1%). Peripheral neuropathy resulted in Absolute neutrophil count less than • Withhold ...
Biotechnology and Drug Discovery: From Bench to Bedside
Biotechnology and Drug Discovery: From Bench to Bedside

... process-for instance, growth factors and their receptors, which are frequently overexpressed in carcinomas. 3 A case in point is the epidermal growth factor (EGF) receptor family, which is the most studied growth factor receptor system. These receptors are composed of an extracellular binding domain ...
Presentation
Presentation

... human variability in toxicokinetics (3.16) would not cater for these interactions •Results variable ; detailed analysis to classify interaction according to constant of inhibition (Ki) • In vivo database on therapeutic doses much higher than pesticide levels but only in vivo data quantifying human v ...
Research and Development at Sun Pharma
Research and Development at Sun Pharma

...  Key Features of technology developed Can produce controlled particle size for facile injection through conventional needle to reduce patient trauma and pain No local anaesthetic required while delivering the drug Closed semi-automatic process to give kilogram scale, reproducible, consistent and ...
this PDF file - International Journal of Ayurvedic Medicine
this PDF file - International Journal of Ayurvedic Medicine

... features of Parinama Shoola (acid peptic disorder) were enrolled and were randomly divided in two groups- 12 patients were enrolled in group A and were given trial drug Shatavari mandoor,19 patients were enrolled in group B and were given trial drug Pippali ghrita. Duration of study was 3 months. Re ...
gamunex - Grifols
gamunex - Grifols

... be adequately hydrated before administration. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia / markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. Patients at risk ...
SMA-compass web version
SMA-compass web version

... attention to weight gain, might have had a more favorable result. However, the use of VPA and L-Carnitine cannot be recommended at this time based upon this trial. While the study did not demonstrate functional improvement after a six month treatment with VPA and L-Carnitine, it did yield critically ...
Animal Use Protocol – Hazardous Agent Addendum (Chemicals
Animal Use Protocol – Hazardous Agent Addendum (Chemicals

... c. Indicate the route of administration (include range of needle gauge if applicable): Click here to enter text. d. Indicate the frequency of administration: Click here to enter text. e. Indicate the maximum duration of exposure: Click here to enter text. f. Identify the location (Building / Room) w ...
5 6 4  ‘00  OCT pz 3
5 6 4 ‘00 OCT pz 3

... has mass, occupies space, and can be perceived. ” “Dietary substance,” therefore, means anything commonly perceived as part of man’s usual food or drink. Selegiline is the active ingredient in an approved NDA, specifically, Eldepryl. It is not a part of man’s usual food or drink. Indeed, this substa ...
excipient-related adverse drug reactions: a clinical approach
excipient-related adverse drug reactions: a clinical approach

... our assessment and interpretation of the patient’s adverse drug reaction.11 Table II indicates the common ADR experienced with popular preservatives used in pharmaceutical preparations as well as in food products. There is controversy as to whether colouring agents and dyes cause hyperactivity in ch ...
Day 120 LoQ template
Day 120 LoQ template

... Twenty six healthy volunteers completed the study. The wash out period was 14 days. Blood samples were taken before administration and up to 132 hours post dose (acceptable since AUCt / AUCinf > 0.8). The protocol defines acceptance criteria of 0.8 – 1.25 for AUC and 70 143% for Cmax. This is satisf ...
DPP-4 INHIBITOR LINAGLIPTIN: A NEW ANTI-DIABETIC DRUG IN THE TREATMENT OF TYPE-2 DIABETES  Review Article
DPP-4 INHIBITOR LINAGLIPTIN: A NEW ANTI-DIABETIC DRUG IN THE TREATMENT OF TYPE-2 DIABETES Review Article

... patients with type-2 diabetes (T2DM). The efficacy and safety of linagliptin has seen when used as monotherapy or in combination with other oral antidiabetic drugs. Linagliptin was associated with significant improvements in glycosylated hemoglobin, fasting plasma glucose and postprandial glucose, a ...
Spiriva Respimat [product monograph].
Spiriva Respimat [product monograph].

... Nursing Women: Clinical data from nursing women exposed to tiotropium are not available. Based on lactating rodent studies, a small amount of tiotropium is excreted into breast milk. Therefore, SPIRIVA RESPIMAT should not be used in nursing women unless the expected benefit outweighs any possible ri ...
Safety Evaluation of a Combination, Defined Extract of
Safety Evaluation of a Combination, Defined Extract of

... chrysin and oroxylin were identified. Using 13C NMR, two structures were identified from the A. catechu standardized extract as catechin and epicatechin (Table 1). Three different extractions and preparations of the S. baicalensis and A. catechu varied by no more than 10% for each component. A stand ...
Investigator`s brochure
Investigator`s brochure

... Briefly state the investigational product (IP) chemical name, generic name (if approved) and trade name (if approved). List the active ingredients and confirm which pharmacological class the IP is in. Briefly discuss its expected position within this class (i.e., the advantages it is expected to hav ...
Intranasal midazolam delivery procedure
Intranasal midazolam delivery procedure

... o Be aware that midazolam causes some nasal burning for 30-45 seconds when administered. o In small children you should administer lidocaine 2% or 4% - 0.2 ml per nostril 5 minutes prior to the midazolam to stop the burning. o Sufentanil will also cause deeper sedation and in doses over 1.5 mcg/kg h ...
SOMATROPIN for growth hormone deficiencies of
SOMATROPIN for growth hormone deficiencies of

...  To confirm patient/carer understanding and consent to treatment.  To advise the patient/carer on potential side effects (particularly severe or recurrent headache, visual problems, nausea and/or vomiting) and the action to be taken should they occur.  To initiate treatment with somatropin and pr ...
Dosing Guide
Dosing Guide

... Continuous infusions of ULTIVA should be administered only by an infusion device. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Discontinuation of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. IV tubing must be cleared to remove re ...
Guidelines for medicines optimisation in patients
Guidelines for medicines optimisation in patients

... risks: seek specialist advice Low doses e.g. 500mcg bd or tds are effective. Do not use NSAIDs for Diarrhoea / vomiting causing Exacerbates hypoperfusion gout; if Colchicine causes hypovolaemia if also taking a NSAID unacceptable adverse effects, consider a short course of corticosteroids May accumu ...
Diapositive 1 - Moodle Lille 2
Diapositive 1 - Moodle Lille 2

... Campath independent from gene TP 53 17th chromosome ...
Print / Save PDF - Pennsylvania Patient Safety Authority
Print / Save PDF - Pennsylvania Patient Safety Authority

... of the terms for the many different kinds of longacting formulations. As a result, there are many inconsistencies, allowing different suffixes to be used for an identical formulation by two different manufacturers or even similar suffixes for dissimilar formulations. In short, the nomenclature used ...
Your Medication Reference Guide
Your Medication Reference Guide

... Your Medication Reference Guide The purpose of this tool is to ensure maximum safety and benefit from the medications prescribed for you. ...
Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug
Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug

... BE of the T and R products. For example, in the generic drug applications approved by the FDA, BE of solid oral dosage forms intended for systemic delivery is based on in vivo PK studies supported by comparative in vitro dissolution data. This approach has been successfully applied to a large number ...
Sandostatin - Novartis Pharmaceuticals Corporation
Sandostatin - Novartis Pharmaceuticals Corporation

... After subcutaneous injection, octreotide is absorbed rapidly and completely from the injection site. Peak concentrations of 5.2 ng/mL (100-mcg dose) were reached 0.4 hours after dosing. Using a specific radioimmunoassay, intravenous and subcutaneous doses were found to be bioequivalent. Peak concent ...
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