sanofi cardiovascular products

There are an estimated 7.1 million Australians living with hypercholesterolaemia. Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Clinically significant hypotension due to amlodipine overdose requires active cardiovascular support including limb elevation and monitoring of circulating volume and urinary output. Based on the experience with the use of other medications that affect the renin-angiotensin system, the concomitant use of Irbesartan with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other medications that may increase kalaemia with irbesartan can cause an increase in serum potassium, sometimes severe, and requires close monitoring of serum potassium. irbesartan and hydrochlorothiazide) may be recommended. General disorders and conditions of the administration site: Peripheral edema, edema A vasoconstrictor can help restore vascular tone and blood pressure, when there is no contraindication to its use. Hepatic impairment: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. . The antihypertensive effect of angiotensin II receptor antagonists can be attenuated by NSAIDs including selective COX-2 inhibitors. Get a 360 view and stay up-to-date on cardiovascular disease with content selected for you, Get inspired and stay at the forefront of innovation with the following resources. ALDURAZYME must not be administered with other medicinal products in the same infusion. In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel. PRODUCTS PRODUCTS Amaryl Apidra Aprovasc Aprovel Aubagio . No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is 30 ml/min (see sections 4.3 and 4.4). Excipient qs: 1tab 1tab 1tab 1tab. Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. Irbesartan: 150mg 150mg 300mg 300mg. Yellowish to yellow oblong tablet with score line, upper stamp 2.5 and company logo, lower stamp HMR and 2.5. Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2). You are about to visit another Sanofi website that is not governed by Australia & New Zealand regulatory. Intravenous calcium gluconate may be of benefit in reversing the effects of calcium channel blockade. Suggested measures include gastric lavage. Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. Close monitoring of serum potassium in patients at risk is recommended (see section 4.5). The safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction. ESH - ISH 2021/ Sanofi Hypertension Symposium - Case Based Scenarios. Skip to main content. Therefore, the use of Aprovel is not recommended. In particular, they appeared less favourable in women and non-white subjects (see section 5.1). Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular). Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made. Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Please note: Sanofi provides these links as a service to its website visitors and users; however, Sanofi takes no responsibility for the information on any website but their own. The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. ESH - ISH 2021/ Sanofi Hypertension Symposium - Case Based Scenarios ESH - ISH 2021/ Sanofi Hypertension Symposium - Case Study . Lithium: the combination of lithium and Aprovel is not recommended (see section 4.5). No specific information is available on the treatment of overdose with Aprovel. The tablet can be divided into equal halve. Animal studies have shown excretion of clopidogrel in breast milk. Date of SmPC text revision: 11 April 2019; Loop diuretics are preferred to thiazides in this population. Cardiac disorders: Palpitations It is recommended that Tritace is taken each day at the same time of the day. Stay up to date and register for the latest events and view webinar recordings. This website is restricted to healthcare professionals in Nigeria only. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4). When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.; CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. The concomitant use of Tritace with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see sections 4.5 and 5.1). Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). The use of Factor IX products has been associated with the development of thromboembolic complications. This website uses cookies to track its audience and improve its content. As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2). Sanofi is a diversified global healthcare leader, focused on developing products that meet the health needs of people. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. As a health journey partner, we at Sanofi focus on improving quality . Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure. In patients insufficiently controlled with 150 mg once daily, the dose of Aprovel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). While this is not documented with Aprovel, a similar effect should be anticipated with angiotensin-II receptor antagonists. For uncommon, rare and very rare side effects see full prescribing information. Pale red oblong tablet with score line, upper stamp 5 and company logo, lower stamp HMP and 5. In a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss. Starting dose: Tritace should be started gradually with an initial recommended dose of 2.5mg daily. For Pharmacovigilance (reporting adverse events), please contact: ng-gh.pv@sanofi.com. Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. New CEO Paul Hudson has indicated he . Sanofi engages in the research, production, and distribution of pharmaceutical products. Even as therapeutic solutions become more effective, we recognize that the management of these diseases is a 24/7 job. This website is intended exclusively for healthcare professionals residing and/or working in the UAE. In patients with diabetes and at least one cardiovascular risk: Titration and maintenance dose: Depending on the patients tolerability to the active substance, the dose is subsequently increased. More detailed Information on request:Refer to Summary of Product Characteristics or Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (hypertensive patients with stenosis of the renal artery of one or both kidneys, or patients with severe congestive heart failure), treatment with other drugs that affect this system has been associated with oliguria and/or progressive azotemia elevation and rarely with acute renal failure and/or death. Sanofi Australia & New Zealand has no control over the contents of these sites or resources, and accepts no liability or responsibility for them or for any loss or damage that may arise from your use of them. It operates through the following business segments: Pharmaceuticals, . Cyclosporine: Pharmacokinetic studies with cyclosporine have shown that amlodipine does not significantly modify its pharmacokinetics. The combination should be administered with caution, especially in the elderly. Doubling the once daily dose to 2.5mg after two weeks and then to 5mg after a further two weeks is recommended. Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Doubling the daily dose to 5mg Tritace after one or two weeks and then to 10mg Tritace after a further two or three weeks is recommended. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). Clinical and economic value of SOLIQUA - Pharmacist perspective. For uncommon, rare and very rare side effects see full prescribing information. Jul 27, 2022. As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4). Products Our Products Clexane LEARN MORE . Titration and maintenance dose. Hepatic impairment: CoAprovel is not indicated in patients with severe hepatic impairment. Acquired haemophilia has been reported following use of clopidogrel. Nervous system disorders: dizziness, orthostatic dizziness* Our people are passionate and committed to continue working together with health partners through disease awareness initiatives and healthcare solutions that can make a difference in the lives of people living with cardiovascular diseases. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3). We're determined to find answers for patients, and to develop medicines and vaccines with the potential to improve people's lives. Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4). No dosage adjustment is necessary in patients with impaired renal function. Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel. 35 Patrice Lumumba Road, Airport Residential Area, Accra. 14.6 ELIXA Cardiovascular Outcome Study 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Vascular disorders: Orthostatic hypotension Aprovel 300MG TABLETS SANOFI, Level 3, One JLT, Jumeirah Lake Towers (JLT), DMCC, PO Box 53899, Dubai, UAE | Tel. Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Pharmacotherapeutic group: platelet aggregation inhibitors excl. Sanofi continues streamlining of established products with sale of dental care brands to Septodont . Changes in the renal function of susceptible individuals can be expected as a consequence of the inhibition of the renin-angiotensin-aldosterone system. This includes those individuals with measured high total cholesterol and those that self-reported as having high cholesterol. Although Sanofi has a top-selling insulin product on the market, overall its diabetes business -- and cardiovascular too -- has contributed noticeably declining percentages to the company's revenues in recent years. : +971 4 550 3600 | Fax: +971 4 5521050 . The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). Tel: +233 302 734772; This website is restricted to healthcare professionals of Nigeria. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised. Therefore clopidogrel should be used with caution in these patients (see section 4.2). Tritace is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Antacids did not modify the extent of clopidogrel absorption. Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started >48hours following acute myocardial infarction. However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs. White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side. Tests are available to identify a patient's CYP2C19 genotype. FORMULA Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Tel: +234 1 2710135/2800994; Therefore, Aprovasc should be administered with caution in these patients. hypersensitivity to dihydropyridines For oral administration. Dr. Nurudeen Olowopopo Avenue, Ikeja Central Business District, Agidingbi, Lagos, Nigeria. In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered. Such conditions should be corrected before the administration of Aprovel. Randys Story: Ill never forget hearing my doctor say, We need to talk about your cholesterol.. Date of last abbreviation of prescribing information: November 2020. If the combination proves necessary, careful monitoring of serum lithium levels is recommended. In patients with diabetes and microalbuminuria: Starting dose: The recommended initial dose is 1.25mg of Tritace once daily. Sanofi, Japaul House, Plot 8, Amlodipine has been safely administered concomitantly with thiazide diuretics, beta blockers, alpha blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, non-steroidal anti-inflammatory drugs, and oral hypoglycemic drugs. Refractory hypokalaemia, hypercalcaemia Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, Tritace is not recommended during the first trimester of Pregnancy and is contraindicated during the second and third trimesters of pregnancy. discover events and innovations in the changing world of cardiovascular disease. In elderly patients, with volume depletion (including those on therapy with diuretics), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, can cause a deterioration of renal function, including a possible acute renal failure. Amlodipine is a calcium dihydropyridine antagonist. Tel: +233 302 734772; No_ 6 Goerge Walker Bush Highway Dzorwulu, Accra. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4). Renal impairment: Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. : +971 4 550 3600 | Fax: +971 4 5521050, please contact: +971 565776791 or Email: medical-information.gulf@sanofi.com, please call: +971 561747001 or Email: Gulf.pharmacovigilance@sanofi.com, To report any product technical complaints, kindly contact: Email: quality.greatergulf@sanofi.com. If you wish to access one of our Group website from another country, click Proceed. The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1). Tritace may be used in monotherapy or in combination with other classes of antihypertensive medicinal products (see sections 4.3, 4.4, 4.5 and 5.1). Based on in vitro information, no interactions are expected with drugs whose metabolism is dependent on CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1, or CYP3A4 cytochrome isoenzymes. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. The concomitant use of angiotensin II receptor blockers and calcium channel blockers may reduce renal lithium clearance and the increase of serum levels that may reach toxic levels. The concomitant use of CoAprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m) (see sections 4.5 and 5.1). Tritace has to be swallowed with liquid. ATC code: C09C A04. Therefore, this combination is not recommended (see section 4.4). Due to the presence of both, Irbesartan and amlodipine, Aprovasc is contraindicated in: hypersensitivity to the active substances or to any formulation component Secondary prevention after acute myocardial infarction and with heart failure: Starting dose: After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5mg twice daily for three days. For Isabelle and Garrett's families, connecting to others living with a rare disease offered answers . Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8). Plavix 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg. Sanofi and the Heart Foundation are looking at why people with CVD appear to be more vulnerable to severe outcomes, and how we can better treat the cardiac complications of COVID-19. Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. Pharmacotherapeutic group: ACE Inhibitors, plain. For uncommon, rare and very rare side effects see full prescribing information. In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. If the initial 2.5mg dose is not tolerated a dose of 1.25mg twice a day should be given for two days before increasing to 2.5mg and 5mg twice a day. CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers. General disorders and administration site conditions: fatigue patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5). Gastrointestinal disorders: nausea/vomiting This website is intended exclusively for healthcare professionals residing and/or working in the KSA. The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8). Apidra. This website is intended exclusively for healthcare professionals residing and/or working in Oman. To report any product technical complaints, kindly contact: By clicking on this link, you will be leaving Campus Sanofi website and going to another, entirely independent website. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken. For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose. Some of these are new molecular entities while others are existing products with potential new indications, or different formulations. Aprovel 150MG TABLETS The optimal duration of treatment has not been formally established. Tritace tablets 10mg Renal function should be monitored periodically in patients receiving periodic treatment with Irbesartan and NSAIDs. Aprovel is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Close monitoring of serum potassium in patients at risk is . Musculoskeletal and connective tissue disorders: musculoskeletal pain* . The administration of activated carbon to healthy individuals immediately or up to two hours after the ingestion of 10 mg of amlodipine has shown a significant decrease in the absorption of amlodipine. Sanofi's molecular oncology teams are investigating potential therapeutics that aim to suppress hormone-driven cancers, and antibody-drug conjugates that harness antibodies to deliver anticancer payloads to tumors, minimizing collateral damage to normal tissues. Find Sanofi US corporate information, pharmaceutical products, news, career opportunities and health resources. In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials. please contact: +971 565776791 or Email: medical-information.gulf@sanofi.com. mTOR inhibitors or vildagliptin: An increased risk of angioedema is possible in patients taking concomitant medications such as mTOR inhibitors (e.g. In hypertensive patients in whom the diuretic is not discontinued, therapy with Tritace should be initiated with a 1.25mg dose. Sanofi Office, 2nd Floor Yekeima Square, Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Digoxin: Simultaneous administration of amlodipine with digoxin did not modify serum concentrations of digoxin or its renal clearance in healthy volunteers. At Sanofi, industry-leading technology platforms are giving our R&D teams the tools they need to design pioneering therapeutics that would have been unimaginable just a few years ago. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Sanofi Biosurgery's products include: Synvisc , Synvisc-One (hylan G-F 20), Carticel (autologous cultured chondrocytes), MACI (Matrix-induced Autologous Chondrocyte Implantation . Amaryl M Forte. Appropriate therapy should be considered if bleedings are observed. Renal and urinary disorders: Proteinuria Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. Activated charcoal may be useful in the treatment of overdose. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. If a dose is missed: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time. Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. White to almost white oblong tablet with score line, upper stamp HMO/HMO. The compatibility of ALDURAZYME in solution with other products has not been evaluated. Doubling the once daily dose to 2.5mg after two weeks and then to 5mg after a further two weeks is recommended. Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

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