United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 4 mg in 1 ml - - intravenous or intramuscular administration. when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: endocrine disorders. primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 4.4 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection - excipient ingredients: sodium citrate; creatinine; water for injections - replacement therapy:,adrenocortical insufficiency - dexamethasone has predominantly glucocorticoid activity and, therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in the following: ? acute adrenocortical insufficiency - addison's disease; bilateral adrenalectomy ? relative adrenocortical insufficiency prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should, therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns or severe infections where specific antibiotic therapy is available. ? primary and secondary adrenocortical insufficiency.,disease therapy: dexamethasone is indicated for therapy of the following diseases - 1. collagen diseases. systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis -during an exacerbation or as maintenance therapy. 2. pulmonary disorders. status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. blood disorders. leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. rheumatic diseases. rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. skin diseases. psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. gastrointestinal disorders. ulcerative colitis, regional enteritis. 7. oedema. cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. eye disorders. allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. neoplastic states. cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. endocrine disorders. adrenal insufficiency.,preoperative and postoperative support: dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery.,shock: dexamethasone may be used as an adjunct in the treatment of shock. refer to section 4.2 dose and method of administration. dexamethasone should not be used as a substitute for normal shock therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 8.8 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection - excipient ingredients: water for injections; sodium citrate; creatinine - replacement therapy:,adrenocortical insufficiency - dexamethasone has predominantly glucocorticoid activity and, therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in the following: ? acute adrenocortical insufficiency - addison's disease; bilateral adrenalectomy ? relative adrenocortical insufficiency prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should, therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns or severe infections where specific antibiotic therapy is available. ? primary and secondary adrenocortical insufficiency.,disease therapy: dexamethasone is indicated for therapy of the following diseases - 1. collagen diseases. systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis -during an exacerbation or as maintenance therapy. 2. pulmonary disorders. status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. blood disorders. leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. rheumatic diseases. rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. skin diseases. psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. gastrointestinal disorders. ulcerative colitis, regional enteritis. 7. oedema. cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. eye disorders. allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. neoplastic states. cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. endocrine disorders. adrenal insufficiency.,preoperative and postoperative support: dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery.,shock: dexamethasone may be used as an adjunct in the treatment of shock. refer to section 4.2 dose and method of administration. dexamethasone should not be used as a substitute for normal shock therapy.

United States - English - NLM (National Library of Medicine)

mylan institutional llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - dexamethasone phosphate 4 mg in 1 ml - a. by intravenous or intramuscular injection when oral therapy is not feasible: 1. endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. congenital adrenal hyperplasia. nonsuppurative thyroiditis. hypercalcemia associated with cancer. 2. rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode o

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: sucrose; monobasic sodium phosphate dihydrate; sodium chloride; water for injections; dibasic sodium phosphate dihydrate; arginine hydrochloride - enbrel is indicated for the treatment of: adults rheumatoid arthritis active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). enbrel can be used in combination with methotrexate. severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. psoriatic arthritis the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. enbrel has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. plaque psoriasis adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. ankylosing spondylitis the signs and symptoms of active ankylosing spondylitis in adults. non-radiographic axial spondyloarthritis treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids . * active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of greater than or equal to 4.,children and adolescents juvenile idiopathic arthritis active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards. active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. enbrel has not been studied in children aged less than 2 years. paediatric plaque psoriasis chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant pasi response is not achieved.

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - dexamethasone phosphate 4 mg in 1 ml - a. intravenous or intramuscular administration. when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used) preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis 4. dermatologic diseases pemphigus severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema (epinephrine is the drug of first choice) 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus iritis, iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy) regional enteritis (systemic therapy) 8. respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy loeffler's syndrome not manageable by other means aspiration pneumonitis 9. hematologic disorders acquired (autoimmune) hemolytic anemia idiopathic thrombocytopenic purpura in adults (i.v. only; i.m. administration is contraindicated) secondary thrombocytopenia in adults erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia 10. neoplastic diseases for palliative management of: leukemias and lymphomas in adults acute leukemia of childhood 11. edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 12. nervous system acute exacerbations of multiple sclerosis 13. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. b. intra-articular or soft tissue administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post-traumatic osteoarthritis c. intralesional administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for: keloids localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis) discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon (ganglia). systemic fungal infections.

United States - English - NLM (National Library of Medicine)

winthrop u.s, a business of sanofi-aventis u.s. llc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 30 mg in 0.3 ml - enoxaparin sodium is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium enoxaparin sodium is indicated for the prophylaxis of ischemic complications of unstable angina and non–q-wave myocardial infarction, when concurrently administered with aspirin. enoxaparin sodium, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute st-segment elevation myocardial infarction (stemi) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (pci). enoxaparin sodium is contraindicated in patients with: - active major bleeding - history of immune-mediated heparin-induced thrombocytopenia (hit) within the past 100 days or in the presence of circulating antibodies [see warnings and precautions (5.4)] - known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [see adverse reactions (6.2)] - known hypersensitivity to heparin or pork products - known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of enoxaparin sodium) [see warnings and precautions (5.8)] risk summary placental transfer of enoxaparin was observed in the animal studies. human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities (see data) . based on animal data, enoxaparin is not predicted to increase the risk of major developmental abnormalities (see data) . adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions. while not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [see warnings and precautions (5.7)and use in specific populations (8.6)] . pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used. all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. pregnant women receiving enoxaparin should be carefully monitored for evidence of bleeding or excessive anticoagulation. consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see boxed warning] . hemorrhage can occur at any site and may lead to death of mother and/or fetus. pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin is administered during pregnancy. it is not known if monitoring of anti-factor xa activity and dose adjustment (by weight or anti-factor xa activity) of enoxaparin sodium affect the safety and the efficacy of the drug during pregnancy. cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99–405 mg/kg/day). the multiple-dose vial of enoxaparin sodium contains 15 mg benzyl alcohol per 1 ml as a preservative [see warnings and precautions (5.8)] . data human data there are no adequate and well-controlled studies in pregnant women. a retrospective study reviewed the records of 604 women who used enoxaparin during pregnancy. a total of 624 pregnancies resulted in 693 live births. there were 72 hemorrhagic events (11 serious) in 63 women. there were 14 cases of neonatal hemorrhage. major congenital anomalies in live births occurred at rates (2.5%) similar to background rates. there have been postmarketing reports of fetal death when pregnant women received enoxaparin sodium. causality for these cases has not been determined. insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases. a clinical study using enoxaparin in pregnant women with mechanical prosthetic heart valves has been conducted [see warnings and precautions (5.7)] . animal data teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 15 times the recommended human dose (by comparison with 2 mg/kg as the maximum recommended daily dose). there was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. risk summary it is unknown whether enoxaparin sodium is excreted in human milk. in lactating rats, the passage of enoxaparin or its metabolites in the milk is very limited. there is no information available on the effect of enoxaparin or its metabolites on the breastfed child, or on the milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for enoxaparin sodium and any potential adverse effects on the breastfed child from enoxaparin sodium or from the underlying maternal condition. safety and effectiveness of enoxaparin sodium in pediatric patients have not been established. enoxaparin sodium is not approved for use in neonates or infants. serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and low-birth-weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth-weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. enoxaparin sodium multiple-dose vials contain 15 mg/ml of benzyl alcohol (at the dose of 1.5 mg/kg twice a day, benzyl alcohol exposure in patients is 0.45 mg/kg daily) [see warnings and precautions (5.8)] . prevention of deep vein thrombosis in hip, knee and abdominal surgery; treatment of deep vein thrombosis, prevention of ischemic complications of unstable angina and non–q-wave myocardial infarction over 2800 patients, 65 years and older, have received enoxaparin sodium in clinical trials. the efficacy of enoxaparin sodium in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years). the incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of enoxaparin sodium were employed. the incidence of bleeding complications was higher in geriatric patients as compared to younger patients when enoxaparin sodium was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours. the risk of enoxaparin sodium–associated bleeding increased with age. serious adverse events increased with age for patients receiving enoxaparin sodium. other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of enoxaparin sodium between geriatric and younger patients. careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. enoxaparin sodium should be used with care in geriatric patients who may show delayed elimination of enoxaparin. monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered [see warnings and precautions (2.6)and clinical pharmacology (12.3)] . treatment of acute st-segment elevation myocardial infarction in the clinical study for treatment of acute st-segment elevation myocardial infarction, there was no evidence of difference in efficacy between patients ≥75 years of age (n=1241) and patients less than 75 years of age (n=9015). patients ≥75 years of age did not receive a 30 mg intravenous bolus prior to the normal dosage regimen and had their subcutaneous dose adjusted to 0.75 mg/kg every 12 hours [see dosage and administration (2.4)] . the incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years). the use of enoxaparin sodium has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves and has not been adequately studied for long-term use in this patient population. isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin for thromboprophylaxis. some of these cases were pregnant women in whom thrombosis led to maternal and fetal deaths. insufficient data, the underlying disease and the possibility of inadequate anticoagulation complicate the evaluation of these cases. pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism [see warnings and precautions (5.7)] . in patients with renal impairment, there is an increase in exposure of enoxaparin sodium. all such patients should be observed carefully for signs and symptoms of bleeding. because exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 ml/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. no dosage adjustment is recommended in patients with creatinine clearance 30 to <50 ml/min and creatinine clearance 50 to 80 ml/min [see dosage and administration (2.3)and clinical pharmacology (12.3)] . in patients with renal failure, treatment with enoxaparin has been associated with the development of hyperkalemia [see adverse reactions (6.2)]. an increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg). observe low-weight patients frequently for signs and symptoms of bleeding [see clinical pharmacology (12.3)] . obese patients are at higher risk for thromboembolism. the safety and efficacy of prophylactic doses of enoxaparin sodium in obese patients (bmi >30 kg/m 2 ) has not been fully determined and there is no consensus for dose adjustment. observe these patients carefully for signs and symptoms of thromboembolism. enoxaparin sodium injection for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to prepare and inject enoxaparin sodium prefilled syringe. read this instructions for use before using the enoxaparin sodium prefilled syringe and each time you get a new prescription. there may be new information. do not inject yourself or someone else until you have been shown how to inject enoxaparin sodium. your healthcare provider can show you or your caregiver how to prepare and inject a dose of enoxaparin sodium. call your healthcare provider if you have any questions. important information: - your healthcare provider will tell you the prescribed dose that you should take and how often you will need to inject enoxaparin sodium. if your dose is based on your body weight, your dose of enoxaparin sodium might be less than what is in the prefilled syringe. - enoxaparin sodium is injected as a subcutaneous (under the skin) injection only. do not inject enoxaparin sodium into muscle. - do not use the enoxaparin sodium prefilled syringe if the needle cap is missing or not securely attached. - do not remove the needle cap until just before you give the injection. - do not touch the syringe plunger rod until you are ready to inject. do not pull back on the plunger rod at any time. - do not get rid of any air bubble(s) in the enoxaparin sodium prefilled syringe. this can lead to a loss of the medicine. - to avoid bruising, do not rub the injection site after you have injected yourself. - to protect from needle-stick injuries, each prefilled syringe has a safety system that covers the needle after injection. - throw away (dispose of) the used enoxaparin sodium prefilled syringe and needle cap right away after use, even if there is medicine left in the prefilled syringe. see " step 13: dispose of used enoxaparin sodium prefilled syringes and needle caps " below. - enoxaparin sodium injection is for one time use only. do not reuse an enoxaparin sodium prefilled syringe. storing enoxaparin sodium prefilled syringes: - store enoxaparin sodium prefilled syringes at 77°f (25°c). - store enoxaparin sodium prefilled syringes in the original carton or packaging until ready to use. - keep enoxaparin sodium injection and all medicines out of the reach of children. parts of enoxaparin sodium prefilled syringe: preparing to inject enoxaparin sodium: step 1: gather the following supplies for your injection (see figure a) : - 1 enoxaparin sodium prefilled syringe - 1 alcohol wipe 1 - 1 cotton ball or gauze 1 - a small adhesive bandage, if needed 1 - a sharps disposal container 1(see step 13) figure a step 2: wash your hands well with soap and water. step 3: preparing a dose of enoxaparin sodium injection take the prefilled syringe out of the package. open the packaging by peeling the lid at the arrow as directed. take the prefilled syringe out of the plastic container by holding the middle of the syringe body (see figure b). - do not remove the prefilled syringe by pulling on the plunger rod or the needle cap as this may damage the syringe. - do not pull off the needle cap until you are ready to inject. - do not use the enoxaparin sodium prefilled syringe if it has been dropped on a hard surface or damaged. figure b step 4: check the enoxaparin sodium prefilled syringe - when you receive your enoxaparin sodium syringes, always check to see that: you have the correct medicine and dose. the expiration date on the prefilled syringe has not passed (see figure c). - you have the correct medicine and dose. - the expiration date on the prefilled syringe has not passed (see figure c). - do not use the enoxaparin sodium prefilled syringe if the expiration date has passed. figure c step 5: check the medicine - look at the medicine inside the enoxaparin sodium prefilled syringe: the liquid should be clear and colorless to pale yellow (see figure d). note: you may see air bubble(s), this is normal. do not try to remove any air bubbles. - the liquid should be clear and colorless to pale yellow (see figure d). - note: you may see air bubble(s), this is normal. do not try to remove any air bubbles. - do not use the enoxaparin sodium prefilled syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles. figure d step 6: choose your injection site - you can inject into either the right or left side of your stomach area (abdomen), at least 2 inches away from your belly button and out towards your side (see figure e). - you should alternate between the left or right side of your stomach each time you give yourself an injection. - do not inject into skin that has bruises or scars. - do not inject through clothes. figure e step 7: clean the injection site clean the injection site with an alcohol wipe (see figure f). let your skin dry before injecting. figure f step 8: remove the needle cap hold the prefilled syringe in the middle of the body with the needle pointing away from you. remove the needle cap by pulling it straight off the syringe (see figure g). - do not twist the needle cap to avoid bending the needle. - do not put the needle cap back on. - do not touch the needle. figure g step 9: injecting a dose that is less than the full amount in the prefilled syringe. if your prescribed dose is the same as the amount in the prefilled syringe, go to step 10. if your dose is based on your bodyweight, your healthcare provider may prescribe less than the full amount in the syringe. you will have to get rid of (discard) some of the medicine from the prefilled syringe before you inject enoxaparin sodium. to measure your prescribed dose, hold the prefilled syringe with the needle pointing down. carefully watch the numbers on the syringe as you push the plunger down until the amount left in the syringe is the same as your prescribed dose. the tip of the plunger should line up with the number for your prescribed dose (see figure h). figure h step 10: injecting enoxaparin sodium hold the prefilled syringe like a pencil in your hand with the needle pointing down. with your other hand, pinch the cleaned stomach (abdomen) area between your forefinger and thumb to make a fold in the skin (see figure i). make sure you hold the skin fold during the entire injection. figure i insert the full length of the needle straight into the skin fold at about a 90° angle (see figure j). figure j push the plunger rod down slowly and steadily with your thumb until the enoxaparin sodium prefilled syringe is empty (see figure k). figure k step 11: remove the needle remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger rod (see figure l). - do not put the needle cap back on. - do not rub your skin after the injection. figure l step 12: activate the safety system point the needle away from yourself and other people, and firmly push the plunger rod again to activate the safety system. the protective sleeve will automatically come down and cover the needle. you will hear a "click" when the protective sleeve is released (see figure m). - you will feel some resistance. this is normal. keep pushing until you hear the "click." - the safety system can only be activated after the syringe has been emptied. - only activate the safety system after you have removed the needle from your skin. - activation of the safety system may cause a small amount of liquid to leak out of the syringe. activate the system while facing the syringe away from yourself and other people. figure m step 13: dispose of used enoxaparin sodium prefilled syringes and needle caps put the used enoxaparin sodium prefilled syringe and needle cap in an fda-cleared sharps disposal container right away after use (see figure n). do not dispose of enoxaparin sodium prefilled syringes or needle caps in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at http://www.fda.gov/safesharpsdisposal. figure n winthrop u.s. a business of sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company ©2021 sanofi-aventis u.s. llc this instructions for use has been approved by the u.s. food and drug administration. issued: december 2021

Australia - English - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards. psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; arginine hydrochloride; sucrose - enbrel is indicated for the treatment of: adults rheumatoid arthritis active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). enbrel can be used in combination with methotrexate. severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. psoriatic arthritis the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. enbrel has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. plaque psoriasis adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. ankylosing spondylitis the signs and symptoms of active ankylosing spondylitis in adults. non-radiographic axial spondyloarthritis treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids . * active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of greater than or equal to 4.,children and adolescents juvenile idiopathic arthritis active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards. active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. enbrel has not been studied in children aged less than 2 years. paediatric plaque psoriasis chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant pasi response is not achieved.

United States - English - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 0.05 mg in 1 ml - sufentanil citrate injection is indicated for intravenous administration in adults and pediatric patients: - as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. - as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. sufentanil citrate injection is indicated for epidural administration: - as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. sufentanil citrate injection is contraindicated in patients with: - hypersensitivity to sufentanil (e.g., anaphylaxis) [see adverse reactions (6.2)] risk summary prolonged use of opioid analgesic