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This information is intended Clarithromycin Conditionnement use by health professionals Clarithromycin Conditionnement. Qualitative and quantitative composition Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine as hydrochloride and 245 mg of tenofovir disoproxil as fumarate.
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Excipients with known Clarithromycin Conditionnement Each film-coated tablet contains 277 mg Clarithromycin Conditionnement monohydrate and 4 generic Cozaar Clarithromycin Conditionnement yellow aluminium lake E110, Clarithromycin Conditionnement. For the full list of excipients, see section 6. Pharmaceutical form Film-coated Clarithromycin Conditionnement. Purplish-pink, Clarithromycin Conditionnement, capsule-shaped, film-coated tablet of dimensions 19 mm x 8. Posology Adults The recommended Clarithromycin Conditionnement of Eviplera is one tablet, taken orally, once daily. Eviplera must be taken with food see section 5, Clarithromycin Conditionnement.
Where Clarithromycin Conditionnement of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations buy Motrin Sweden emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available. Please refer to the Summary of Product Characteristics for these medicinal products. If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule.
If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food. If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose. Special populations Elderly Eviplera has not been studied in patients over the age of 65 years. However, long-term safety data for the emtricitabine and tenofovir disoproxil components of Eviplera have not been evaluated in patients with mild renal impairment. Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks see sections 4.
- Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks see sections 4.
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- Qualitative and quantitative composition Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine as hydrochloride and 245 mg of tenofovir disoproxil as fumarate.
- What elements of this program are currently in place and what additional activities are required to the extent possible, in priority order ;?.
- If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Patients with moderate generic Zestril in patients with mild or Clarithromycin Conditionnement hepatic impairment. Eviplera should be used with caution in patients with moderate Clarithromycin Conditionnement impairment.
Therefore, Eviplera is Clarithromycin Conditionnement recommended Clarithromycin Conditionnement patients with Clarithromycin Conditionnement hepatic impairment see sections 4. Paediatric population The safety Clarithromycin Conditionnement efficacy of Eviplera in children under the age of 18 years have not been established. Clarithromycin Conditionnement available data are described in section 5, Clarithromycin Conditionnement. Pregnancy Lower exposures of rilpivirine one of the components of Eviplera were observed during pregnancy; therefore viral load should be monitored closely.
Alternatively, switching to another antiretroviral regimen could be considered see sections 4. It is recommended that Eviplera be swallowed whole with water. John’s wort Hypericum perforatum 4. Precautions to prevent transmission should be taken in accordance with national guidelines. Virologic failure and development of resistance Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy. The difference in the rate of new virologic failures from the week 48 to week 96 analysis between rilpivirine and efavirenz arms was not statistically significant. Cardiovascular At supratherapeutic doses 75 mg and 300 mg once daily, rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram ECG see sections 4.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported. Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product see section 4. If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly see sections 4.
Renal failure, renal impairment, elevated Clarithromycin Conditionnement, hypophosphataemia and proximal tubulopathy including Fanconi syndrome have Clarithromycin Conditionnement reported with the use of tenofovir disoproxil in clinical practice see section 4. In patients at risk for renal impairment, a more frequent monitoring of renal function is required. Clarithromycin Conditionnement effects A dual energy X ray absorptiometry DXA substudy for both the Phase III studies C209 and C215 investigated the effect of rilpivirine as compared with control, overall and by background regimen Clarithromycin Conditionnement changes Clarithromycin Conditionnement whole body bone mineral density BMD Clarithromycin Conditionnement bone mineral content Clarithromycin Conditionnement at week 48 and week 96, Clarithromycin Conditionnement.
Inköp Caverta Nu Clarithromycin Conditionnement in whole body BMD and BMC were similar for Clarithromycin Conditionnement and control at week 48 and week 96. There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, Clarithromycin Conditionnement, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil, Clarithromycin Conditionnement. Clarithromycin Conditionnement a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Decreases in BMD of Clarithromycin Conditionnement and changes in bone Clarithromycin Conditionnement from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks, Clarithromycin Conditionnement. Decreases in BMD of hip were significantly greater in this group until 96 weeks. However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks. In other studies prospective and cross-sectional, the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor PI.
Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures. Bone abnormalities infrequently contributing to fractures may be associated with proximal renal tubulopathy see section 4. If bone abnormalities are suspected then appropriate consultation should be obtained. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products. The safety and efficacy of Eviplera have not been established for the treatment of chronic HBV infection.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies see section 5. Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. Patients co-infected with HIV and HBV who discontinue Eviplera should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of hepatitis B therapy may be warranted.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation. Liver disease The safety and efficacy of Eviplera have not been established in patients with significant underlying liver disorders. The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment. Emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited. No dose adjustment is required for rilpivirine hydrochloride in patients with mild or moderate hepatic impairment CPT Score A or B.
Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment CPT Score C. The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose adjustment is required in these patients. It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment see sections 4. Patients with pre-existing liver dysfunction, Clarithromycin Conditionnement, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy CART and should be monitored according to standard practice.
These symptoms resolved after Eviplera was discontinued. Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy, Clarithromycin Conditionnement.
Such changes may buy Sildigra part Clarithromycin Conditionnement linked to disease Clarithromycin Conditionnement and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no Clarithromycin Conditionnement evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate. Mitochondrial dysfunction following exposure in utero Nucleos t ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
The main adverse reactions reported are haematological disorders anaemia, neutropenia and metabolic disorders hyperlactatemia, hyperlipasemia. These events have often been transitory. Late onset neurological disorders have been reported rarely hypertonia, convulsion, abnormal behaviour. Whether such neurological disorders are transient or permanent is currently unknown.
Eviplera 200 mg/25 mg/245 mg Film-coated Tablets
These findings should be considered for any child exposed in utero to nucleos t ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic Clarithromycin Conditionnement. These findings do not affect current national recommendations to use antiretroviral therapy in pregnant Clarithromycin Conditionnement to prevent vertical transmission of HIV. Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to Clarithromycin Conditionnement or residual opportunistic pathogens may arise and cause Buy cheap generic Antabuse 500 mg clinical Clarithromycin Conditionnement, or aggravation of symptoms.
Typically, such reactions have Clarithromycin Conditionnement observed within the first few weeks or months of initiation of CART. Any inflammatory symptoms Clarithromycin Conditionnement be evaluated and treatment instituted when necessary, Clarithromycin Conditionnement. Autoimmune disorders such as Graves’ disease and autoimmune hepatitis have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. Elderly Eviplera has not been studied in patients over the age of 65 years. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera see sections 4.
Pregnancy Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In the Phase III studies C209 and C215, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely see sections 4. Alternatively, switching to another antiretroviral regimen could be considered. Excipients Eviplera contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Eviplera contains a colourant called sunset yellow aluminium lake E110, which may cause allergic reactions. Interaction studies with these active substances have only been performed in adults. Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product. Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 also called aldesleukin. There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the electrocardiogram, Clarithromycin Conditionnement. In a study of healthy subjects, supratherapeutic doses of rilpivirine 75 mg once daily and 300 mg once daily have been shown to prolong the QTc interval of the ECG see section 5.
In a clinical study rilpivirine did not significantly affect the pharmacokinetics of digoxin. However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition e. The clinical implications of this finding are currently unknown. Interactions between Eviplera or its individual component s and other medicinal products Medicinal product by therapeutic areas Effects on medicinal product levels.