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If peripheral neuropathy improves cheap sulfasalazine 500 mg line pain burns treatment, zalcitabine may be readministered at 50% of the initial dose buy discount sulfasalazine 500mg on line severe back pain treatment vitamins. The prescribing physician should be cognizant of these toxic effects and should advise the patient to discon- tinue the drug should they occur discount sulfasalazine 500mg free shipping pain treatment center hartford ct. Toxic effects include peripheral neuropathy (potentially reversible) sulfasalazine 500mg discount wnc pain treatment center arden nc, pancreatitis (1. Food: Should be taken 30 minutes before or 1 hour after meal with a glass of water. Advice to patients • Take only prescribed dose and do not discontinue without consulting the treating physician. Clinically important drug interactions • Zidovudine increases effects/toxicity of dapsone, gancyclovir, vincristine, vinblastine, flucytosine, adriamycin, doxorubicin. If this occurs, it may be necessary to reduce the dosage or stop drug administration. Produces cranial vasoconstriction and decreased release of inflammatory neuropeptides. Editorial comments • Zolmitriptan, a new agent for acute treatment of migraine headaches, is very similar to sumatriptan. Adverse reactions • Common: headache, drowsiness, dizziness, diarrhea, drugged sensation, dry mouth. Editorial comments • Patient should be reevaluated if zolpidem is taken longer than 2–3 weeks. Controlled studies performed in pregnant women do not demonstrate a risk to the fetus during the first trimester of pregnancy with no evidence of risk in the second or third trimesters. Either studies in reproducing animals do not demonstrate a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown adverse effects (other than a decrease in fertility) that were not confirmed in controlled studies in pregnant women in the first trimester and there is no evidence of a risk in later trimesters. Either study in animals has demonstrated adverse effects on the fetus (teratogenic, embryocidal, or other effects) and there are no controlled studies in women, or studies in women and animals are not available. These drugs should be given only if the potential benefits of the drug justify the potential or unknown risk to the fetus. There is positive evidence of human fetal risk, but the ben- efits from administration in pregnant women may be acceptable despite the risk. For example, if the drug is needed in a life-threatening situation or for a serious dis- ease for which safer drugs cannot be used or are ineffective, administration may be indicated. Animals or human studies have demonstrated fetal abnor- malities or there is evidence of risk to the fetus based on human experience, or both. The risk of the use of the drug in pregnant women clearly outweighs any possible bene- fit. The applicant identity, strength, quality, purity, or potency of a product should submit this change in a Prior Approval Supplement as these factors may relate to the safety or effectiveness of 6 Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products the product is considered to be independent of the type of products include modified-release solid oral drug product dosage form or specific type of operation dosage forms, transdermal systems, liposomal being performed. Therefore, the recommended reporting products, depot products, oral and nasal metered- category for any one of these manufacturing site changes dose inhalers, dry powder inhalers, and nasal will be the same for all types of drug products and opera- spray pumps tions. Transfer of manufacturing of an aseptically cess drug products, in-process materials, drug substances, processed sterile drug substance or aseptically or drug substance intermediates or perform primary pack- processed sterile drug product to a newly con- aging operations, the potential for adverse effect and, con- structed or refurbished aseptic processing facil- sequently, the recommended reporting category depend on ity or area or to an existing aseptic processing various factors such as the type of product and operation facility or area that does not manufacture sim- being performed. For this reason, recommended reporting ilar (including container types and sizes) categories may differ depending on the type of drug prod- approved products; for example, transferring uct and operations. A move to a different manufacturing site, to have a moderate potential to have an adverse effect on except one used to manufacture or process a the identity, strength, quality, purity, or potency of a prod- drug substance intermediate, when the new uct as these factors may relate to the safety or effectiveness manufacturing site has never been inspected by of the product. A move to a different manufacturing site for the (1) the manufacture, processing, or primary manufacture or processing of any drug product, packaging of drug products when the primary in-process material, or drug substance that is packaging components control the dose deliv- not otherwise provided for in this guidance ered to the patient or when the formulation b. A move to a different manufacturing site for quality, purity, or potency of a drug product as these fac- testing whether (1) the test procedures tors may relate to the safety or effectiveness of the product approved in the application or procedures that depends on the type of manufacturing process and the have been implemented via an annual report changes being instituted for the drug substance or drug are used, (2) all postapproval commitments product. In some cases there may be a substantial potential made by the applicant relating to the test pro- for adverse effect, regardless of direct testing of the drug cedures have been fulfilled (e. When there is a substantial poten- testing facility has the capability to perform tial for adverse effects, a change should be filed in a Prior the intended testing Approval Supplement. A move to a different manufacturing site for The following are examples of changes that are considered the manufacture or processing of the final to have a substantial potential to have an adverse effect intermediate on the identity, strength, quality, purity, or potency of a product as these factors may relate to the safety or effec- D. Changes that may affect the controlled (or mod- to have a minimal potential to have an adverse effect on ified) release, metering, or other characteristics the identity, strength, quality, purity, or potency of a prod- (e. A move to a different manufacturing site for from sterile filtered or aseptic processing to secondary packaging terminal sterilization, or vice versa 2. A move to a different manufacturing site for Addition, deletion, or substitution of steriliza- labeling tion steps or procedures for handling sterile 3. A move to a different manufacturing site for the materials in an aseptic processing operation manufacture or processing of drug substance Replacing sterilizers that operate by one set of intermediates, other than the final intermediate principles with sterilizers that operate by 4. A transfer of the manufacture of a finished plastics) that will come in contact with ster- product sterilized by terminal processes to a ilized bulk solution or sterile drug compo- newly constructed building or existing building nents, or deletion of equipment from an at the same manufacturing site aseptic processing line 6. Establishing a new procedure for reprocessing Effected in 30 Days a batch of drug substance or drug product that Replacement or addition of lyophilization fails to meet the approved specification equipment of a different size that uses dif- ferent operating parameters or lengthens the C. Supplement—Changes Being Effected approved application in 30 Days Changes in sterilizer load configurations that are outside the range of previously validated a. For drug products, any change in the process, loads process parameters, or equipment, except as Changes in materials or pore-size rating of fil- otherwise provided for in this guidance ters used in aseptic processing b. The following changes for a natural product: process parameters, except as otherwise pro- Changes in the virus or adventitious agent vided for in this guidance removal or inactivation methods; this is appli- c. For natural protein drug substances and drug cable to any material for which such proce- products: dures are necessary, including drug substance, Any change in the process, process parameters, drug product, reagents, and excipients or equipment, except as otherwise provided For drug substance and drug product, changes for in this guidance in the source material (e. Any fundamental change in the manufacturing but not identical, design and operating prin- process or technology from that currently used ciple that does not affect the process method- by the applicant, for example: ology or process operating parameters a. For sterile products, drug substances, and com- Dry to wet granulation, or vice versa ponents, as appropriate: Change from one type of drying process Changes in dry heat depyrogenation processes to another (e. Drug substance cesses or aseptic processing Filtration to centrifugation, or vice versa Changes to filtration parameters for aseptic pro- Change in the route of synthesis of a drug cessing (including flow rate, pressure, time, substance or volume but not filter materials or pore size 5. The following changes for drug substance: rating) that require additional validation Any process change made after the final inter- studies for the new parameters mediate processing step in drug substance Filtration process changes that provide for a manufacture change from single to dual product steriliz- Changes in the synthesis or manufacture of the ing filters in series, or for repeated filtration drug substance that may affect its impurity of a bulk profile or the physical, chemical, or biolog- Changes from one qualified sterilization cham- ical properties ber to another for in-process or terminal ster- 6. For drug substances, redefinition of an interme- plement unless otherwise exempted by regulation or guid- diate, excluding the final intermediate, as a start- ance (506A(c)(2)(A)). Supplement—Changes Being Effected an approved application to confirm the quality of drug a. A change in methods or controls that provides substances, drug products, intermediates, raw materials, increased assurance that the drug substance or reagents, and other components, including container and drug product will have the characteristics of closure systems and in-process materials. For the purpose identity, strength, purity, or potency that it pur- of defining specifications, acceptance criteria are numer- ports to or is represented to possess ical limits, ranges, or other criteria for the tests described. For sterile drug products, elimination of in-pro- Examples of a test, an analytical procedure, and accep- cess filtration performed as part of the manu- tance criteria are an assay, a specific fully described high- facture of a terminally sterilized product pressure liquid chromatography procedure, and 98.

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Mechanism of action: Reduces intraocular fluid buy 500 mg sulfasalazine free shipping pain solutions treatment center hiram ga, contracts sphinc- ter muscle of iris producing myosis discount 500mg sulfasalazine with mastercard chronic pain treatment center venice fl, stimulates muscarinic recep- tors in eye purchase sulfasalazine 500mg visa georgia pain treatment center canton. Contraindications: Acute iritis cheap 500mg sulfasalazine with mastercard pain treatment program johns hopkins, secondary glaucoma, acute inflam- matory disease of the anterior chamber, acute or anterior uveitis, hypersensitivity to carbachol. Clinically important drug interactions: Cholinergic blocking agents, ophthalmic atropine-like compounds decrease effects/ toxicity of carbachol. Also has anticholinergic, antidiuretic, antiarrythmic, muscle relaxant properties. Adjustment of dosage • Kidney disease: creatinine clearance <10 mL/min: 75% of standard dose. Warnings/precautions • Use with caution in patient with the following conditions: mixed type seizures, liver and cardiac disease. Advice to patient • To minimize possible photosensitivity reaction, apply adequate sunscreen and use proper covering when exposed to strong sunlight. Adverse reactions • Common: drowsiness, dizziness, ataxia, confusion, nausea, vom- iting, rash, blurred vision, nystagmus. Clinically important drug interactions • Drugs that increase effects/toxicity of carbamazepine: isoni- azid, cimetidine, diltiazem, verapamil, erythromycin, propoxy- phene, danazol. Editorial comments • Carbamazepine has not been shown to be efficacious for the treatment of myoclonic, akinetic, or absence seizures. Exacer- bation of mixed type seizures with this agent has been seen in pediatric patients. Susceptible organisms in vivo: Staphylococci, Streptococcus pneumoniae, beta-hemolytic streptococci, Escherichia coli, Proteus mirabilis, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Enterobacter sp, Pseudomonas aeruginosa. Adjustment of dosage • Kidney disease: creatinine clearance 10–20 mL/min: dosage adjustment may be necessary, exact guidelines are not avail- able; creatinine clearance <10 mL/min: therapeutic urine levels will not be achieved. Editorial comments: This was the first penicillin with activity against Pseudomonas aeruginosa. In general, carbenicillin is not used in patients with kidney disease because of the requirement for large doses, increased toxicity, and the availability of better alternatives. In combi- 2 nation with cyclophosphamide: 300 mg/m q4wk + 600 2 mg/m cyclophosphamide. Intermittent courses generally 3 repeated after neutrophil count ≥2000 mm , platelet count 3 ≥100,000 mm. Contraindications: History of hypersensitivity to mannitol, car- boplatin, or related compounds, severe bone marrow depression, acute bleeding. Warnings/precautions • Use with caution in patients with the following conditions: kidney disease, prior chemotherapy. Advice to patient • Use two forms of birth control including hormonal and barrier methods. Adverse reactions • Common: nausea (10–18%), vomiting (65–80%), electrolyte abnormalities (see below), bone marrow depression (see below). Clinically important drug interactions: Nephrotoxic agents, eg, aminoglycosides, aluminum increase effects/toxicity of carbo- platin. Parameters to monitor • Serum electrolytes including calcium, magnesium, sodium, and potassium. Treat with peroxide, tea, topical anesthetics such as benzocaine, lidocaine, or antifungal drug. Editorial comments • It is recommended that this drug be administered only by physicians who are well versed in the use of alkylating agents of this type. Mechanism of action: Oxytocic: stimulates uterine contraction by altering calcium transport. Warnings/precautions • Use with caution in patients with the following conditions: asthma, hypotension, renal or hepatic disease, diabetes, epilepsy, cardiac or adrenal disease. Advice to patient: Use two forms of birth control including hor- monal and barrier methods. Clinically important drug interactions: Carboprost increases effects/toxicity of oxytocin and other oxytocic drugs. Mechanism of action: Blocks interneuronal activity in spinal cord, and reticular formation, causing muscle relaxation (animal data). Onset of Action Duration 30 min 4–6 h Food: Administer with food if gastric upset occurs. Contraindications: Hypersensitivity to carisoprodol, aspirin, or related compounds, eg, meprobamate; acute intermittant por- phyria, bleeding disorders. Warnings/precautions • Use with caution in patients with the following conditions: kidney or liver disease, history of drug abuse. This is characterized by weakness, quadriple- gia, visual disturbance, confusion, dysarthria. Advice to patient • This drug may cause dizziness and faintness especially at the beginning of use. Adjustment of dosage 3 3 • Leukocyte nadir 2000–3000 m , platelets 25,000–75,000 mm : reduce dose to 70% of standard; leukocytes <2000: reduce dose to 50% of standard. Contraindications: Hypersensitivity to carmustine, bone marrow depression from various causes including previous chemother- apy, previous resistance to the drug. Warnings/precautions • Use with caution in patients with the following conditions: his- tory of seizures, head trauma, potential epileptogenic drugs, renal or hepatic disease, bone marrow depression. Advice to patient • Use two forms of birth control including hormonal and barrier methods. Adverse reactions • Common: nausea, vomiting, pain at infusion site, dizziness, ataxia, alopecia, flushing. Clinically important drug interactions: Cimetidine, etoposide increase effects/toxicity of carmustine. Editorial comments • It is essential to perform a complete hematologic evaluation every 2 weeks for patients on this drug. Clinicians should con- sult published protocols for current dosages of this and other chemotherapeutic agents as well as the method and sequence of drug administration. Mechanism of action: Competitive blocker of β-adrenergic receptors in heart and blood vessels. Adjustment of dosage • Kidney disease: creatinine clearance >60 mL/min: dose q24h; creatinine clearance >20–60 mL/min: dose q48h; creatinine clearance <20 mL/min: dose q72h. Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo: Comparable to cefuroxime axetil, but less active against Hemophilus influenzae and Moraxella catarrhalis. Extended-release tablets: all uses • Acute exacerbations (bacterial), chronic bronchitis, secondary bacterial infections of acute bronchitis Ð Adults: 500 mg q12h, 10 days.

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Additional information can also be found in specifc drug information sheets in the Web Annex at www sulfasalazine 500 mg mastercard pain treatment and research. Antiretroviral drugs and formulations are available from several companies cheap sulfasalazine 500 mg fast delivery pain treatment center hazard ky, and the dose strengths of tablets buy sulfasalazine 500 mg low cost pain medication for dogs teeth, capsules and liquid formulations may vary from the information given here effective sulfasalazine 500mg pain spine treatment center. In addition, the listing of a formulation in this annex does not equate to quality assurance of that formulation. National programme managers should ensure that any product procured for use is approved and of appropriate quality and stability. For the current list of antiretroviral drugs approved and tentatively approved by the United States Food and Drug Administration, see www. Developing dosing guidance for new and upcoming formulations of paediatric antiretrovirals in line with Treatment 2. Meeting report, Paediatric Antiretroviral Working Group, Geneva, Switzerland, 25–26 October 2011. Oral liquid or syrup formulations should be avoided where possible, especially if volumes are large – such as above 10 ml. Dispersible tablets (or tablets for oral solution) are the preferred solid oral dosage forms, since each dispersible tablet can be made into liquid at the point of use. In general, young children should be switched to available solid oral dosage forms as soon as they are tolerated. Where children have to use adult formulations, care must be taken to avoid underdosing. Different dosing between morning and evening doses should be avoided where possible. Children have to be weighed at each clinic visit, and dose changes are required as children grow and/or gain weight. Annexes 245 246 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing hiv infection 12. Annexes 247 248 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing hiv infection 12. However, the Paediatric Antiretroviral Working Group recognized that, although a child-specifc formulation may be ideal, a scored adult formulation may be easier to develop as a frst step. As more data are obtained to inform the best use of this drug in young children, sprinkles formulation should be made available in resource limited settings. Going from evidence to recommendations: the significance and presentation of recommendations. Achieving universal access for human immunodeficiency virus and tuberculosis: potential prevention impact of an integrated multi-disease prevention campaign in Kenya. Evaluation of a home-based voluntary counselling and testing intervention in rural Uganda. Responding to intimate partner violence and sexual violence against women: clinical and policy guidelines. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. European Journal of Clinical Microbiology and Infectious Diseases, 2012, 31:919–927. Scaling up antiretroviral therapy in resource-limited settings: adapting guidance and meet the challenges. Initiating highly active antiretroviral therapy in sub-Saharan Africa: an assessment of the revised World Health Organization scaling-up guidelines. Immunodeficiency at start of combination antiretroviral therapy in low, middle and high income countries. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Proceedings of the National Academy of Sciences of the United States of America, 2010, 107:19485–19489. Antiretroviral Pregnancy Registry international interim report for 1 January 1989 through 31 July 2012. Liver-related deaths in persons infected with the human immunodeficiency virus: the D: A:D study. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Impact of human immunodeficiency virus infection on the course of hepatitis C virus infection: a meta- analysis. Minneaolis, Clinical and Translational Science Institute, University of Minnesota, 2012 (http://apps. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high- income countries: a systematic review and meta-analysis. Cross Continents Collaboration for Kids (3Cs4kids) Analysis and Writing Committee. Pretoria, Republic of South Africa National Department of Health 2013 (http://www. Adverse events associated with nevirapine and efavirenz-based first-line antiretroviral therapy: a systematic review and meta-analysis. Safety of efavirenz in the first trimester of pregnancy: an updated systematic review and meta- analysis. Technical update on treatment optimization: pharmacological equivalence and clinical interchangeability between lamivudine and emtricitabine, a review of current literature. Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial. Kaletra (lopinavir/ritonavir): label change – serious health problems in premature babies. Reverse transcriptase genotypes in pediatric patients failing initial antiretroviral therapy in Gaborone, Botswana. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-lamivudine: a randomized, 96-week trial. Conservation of first-line antiretroviral treatment regimen where therapeutic options are limited. Validating clinical and immunological definitions of antiretroviral treatment failure in Malawi. Evaluation of World Health Organization criteria for antiretroviral treatment failure in resource-limited settings. Evaluating patients for second-line antiretroviral therapy in India: the role of targeted viral load testing.

In some cases the dose for a component in a particular weight band may be somewhat above or below the target dose recommended by the manufacturer generic sulfasalazine 500 mg otc pain treatment peptic ulcer. This is inevitable given the limitations imposed by a fxed-dose combination sulfasalazine 500mg line pain medication for dogs on prednisone, but care was taken to ensure that in no case would a child receive more than 25% above the maximum target dose or more than 5% below the minimum target dose discount sulfasalazine 500 mg pain treatment center suny upstate. For simplifcation 500mg sulfasalazine sale treatment for pain for dogs, Antiretroviral drugs that are no longer considered preferred or alternative options for children such as didanosine and saquinavir are no longer included in the dosing guidance. This dosing annex and the simplifed dosing schedule will be regularly reviewed and updated as further data or newer formulations become available, but national programmes are advised to consider the most recent product labelling for up-to-date information. Additional information can also be found in specifc drug information sheets in the Web Annex at www. Antiretroviral drugs and formulations are available from several companies, and the dose strengths of tablets, capsules and liquid formulations may vary from the information given here. In addition, the listing of a formulation in this annex does not equate to quality assurance of that formulation. National programme managers should ensure that any product procured for use is approved and of appropriate quality and stability. For the current list of antiretroviral drugs approved and tentatively approved by the United States Food and Drug Administration, see www. Developing dosing guidance for new and upcoming formulations of paediatric antiretrovirals in line with Treatment 2. Meeting report, Paediatric Antiretroviral Working Group, Geneva, Switzerland, 25–26 October 2011. Oral liquid or syrup formulations should be avoided where possible, especially if volumes are large – such as above 10 ml. Dispersible tablets (or tablets for oral solution) are the preferred solid oral dosage forms, since each dispersible tablet can be made into liquid at the point of use. In general, young children should be switched to available solid oral dosage forms as soon as they are tolerated. Where children have to use adult formulations, care must be taken to avoid underdosing. Different dosing between morning and evening doses should be avoided where possible. Children have to be weighed at each clinic visit, and dose changes are required as children grow and/or gain weight. Annexes 245 246 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing hiv infection 12. Annexes 247 248 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing hiv infection 12. However, the Paediatric Antiretroviral Working Group recognized that, although a child-specifc formulation may be ideal, a scored adult formulation may be easier to develop as a frst step. As more data are obtained to inform the best use of this drug in young children, sprinkles formulation should be made available in resource limited settings. Going from evidence to recommendations: the significance and presentation of recommendations. Achieving universal access for human immunodeficiency virus and tuberculosis: potential prevention impact of an integrated multi-disease prevention campaign in Kenya. Evaluation of a home-based voluntary counselling and testing intervention in rural Uganda. Responding to intimate partner violence and sexual violence against women: clinical and policy guidelines. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. European Journal of Clinical Microbiology and Infectious Diseases, 2012, 31:919–927. Scaling up antiretroviral therapy in resource-limited settings: adapting guidance and meet the challenges. Initiating highly active antiretroviral therapy in sub-Saharan Africa: an assessment of the revised World Health Organization scaling-up guidelines. Immunodeficiency at start of combination antiretroviral therapy in low, middle and high income countries. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Proceedings of the National Academy of Sciences of the United States of America, 2010, 107:19485–19489. Antiretroviral Pregnancy Registry international interim report for 1 January 1989 through 31 July 2012. Liver-related deaths in persons infected with the human immunodeficiency virus: the D: A:D study. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Impact of human immunodeficiency virus infection on the course of hepatitis C virus infection: a meta- analysis. Minneaolis, Clinical and Translational Science Institute, University of Minnesota, 2012 (http://apps. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high- income countries: a systematic review and meta-analysis. Cross Continents Collaboration for Kids (3Cs4kids) Analysis and Writing Committee. Pretoria, Republic of South Africa National Department of Health 2013 (http://www. Adverse events associated with nevirapine and efavirenz-based first-line antiretroviral therapy: a systematic review and meta-analysis. Safety of efavirenz in the first trimester of pregnancy: an updated systematic review and meta- analysis. Technical update on treatment optimization: pharmacological equivalence and clinical interchangeability between lamivudine and emtricitabine, a review of current literature. Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial. Kaletra (lopinavir/ritonavir): label change – serious health problems in premature babies. Reverse transcriptase genotypes in pediatric patients failing initial antiretroviral therapy in Gaborone, Botswana. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-lamivudine: a randomized, 96-week trial.

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