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

phytopia co., ltd. - eucalyptol (unii: rv6j6604tk) (eucalyptol - unii:rv6j6604tk), balsam peru oil (unii: dik0395679) (balsam peru oil - unii:dik0395679) - eucalyptol 1.3 mg in 50 mg - use helps relieve the condition of pain and stiffness. directions apply on skin and gentle massage around painful area.

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

pfizer australia pty ltd - methylprednisolone acetate, quantity: 40 mg/ml - injection, suspension - excipient ingredients: hydrochloric acid; macrogol 3350; miripirium chloride; sodium chloride; sodium hydroxide - indications as at 17 november 2004: a.for 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, the intramuscular use of depo-nisolone is indicated as follows: 1. endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone acetate is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. congenital adrenal hyperplasia. hypercalcaemia associated with cancer. non-suppurative thyroiditis. 2. rheumatic disorders. as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis. epicondylitis. synovitis of osteoarthritis. acute non-specific tenosynovitis. rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). acute gouty arthritis. psoriatic arthritis. ankylosing spondylitis. acute and subacute bursitis. 3. collagen diseases. during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus. acute rheumatic carditis. systemic dermatomyositis (polymyositis). 4. dermatological diseases. pemphigus. bullous dermatitis herpetiformis. severe erythema multiforme (stevens-johnson syndrome). severe seborrhoeic dermatitis. exfoliative 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. drug hypersensitivity reactions. contact dermatitis.urticarial transfusion reactions. atopic dermatitis. acute non-infectious laryngeal oedema (adrenaline is the drug of first choice). serum sickness. 6. ophthalmic diseases. severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus. sympathetic ophthalmia. iritis, iridocyclitis. anterior segment inflammation. chorioretinitis. allergic conjunctivitis. diffuse posterior uveitis. allergic corneal marginal ulcers. optic neuritis. 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-tuberculous chemotherapy. aspiration pneumonitis. loeffler's syndrome not manageable by other means. 9. haematological disorders. acquired (autoimmune) haemolytic anaemia. erythroblastopenia (rbc anaemia). secondary thrombocytopenia in adults. congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases. for palliative management of: leukaemias and lymphomas in adults. acute leukaemia in childhood. 11. oedematous states. to induce diuresis or remission of proteinuria in the nephrotic syndrome without uraemia of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous. tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy. trichinosis with neurological or myocardial involvement. b. for intra-articular or soft tissue administration depo-nisolone is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis. epicondylitis. rheumatoid arthritis. acute non-specific tenosynovitis. acute and subacute bursitis. post-traumatic osteoarthritis. acute gouty arthritis. c. for intralesional administration. depo-nisolone is indicated for intralesional use in the following conditions: keloids.discoid lupus erythematosus. necrobiosis lipoidica diabeticorum. alopecia areata. localised hypertrophic, infiltrated inflammatory lesions of licen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis). depo-nisolone may also be useful in cystic tumours of an aponeurosis or tendon (ganglia).

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

aspen pharma pty ltd - triamcinolone acetonide, quantity: 10 mg/ml - injection, suspension - excipient ingredients: carmellose sodium; polysorbate 80; benzyl alcohol; sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - intra-articular: kenacort-a 10 injection (sterile triamcinolone acetonide suspension usp) is indicated for intra-articular or intrasynovial administration, and for injections into tendon sheaths, 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 non-specific tenosynovitis, post-traumatic osteoarthritis. intradermal: intralesional administration of kenacort-a 10 injection is indicated for the treatment of keloids, discoid lupus erythermatous, necrobiosis lipoidica diabeticorum, alopecia areata and localised hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus ( neurodermatitis), kenacort-a 10 injection also may be useful in cystic tumours of an aponeurosis or tendon ( ganglia).

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

organon pharma pty ltd - betamethasone acetate, quantity: 3 mg/ml (equivalent: betamethasone, qty 5.7 mg/ml); betamethasone sodium phosphate, quantity: 3.9 mg/ml - injection, suspension - excipient ingredients: disodium edetate; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; benzalkonium chloride - celestone chronodose is indicated in the treatment of both severe and moderate conditions in acute and chronic self-limiting diseases responsive to systemic corticosteroid therapy and is especially useful in patients for whom treatment with oral corticosteroid medication is not feasible. representative conditions: rheumatic disorders: rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, myositis, fibrositis, tendonitis, psoriatic arthritis. collagen diseases: systemic lupus erythematosus, scleroderma, dermatomyositis. allergic states: status asthmaticus, chronic bronchial asthma, seasonal or perennial allergic rhinitis, severe allergic bronchitis, contact dermatitis, atopic dermatitis, hypersensitivity reactions to drug and insect bites. dermatologic conditions: localised, hypertrophic infiltrated lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus(neurodermatitis). keloids, discoid lupus erythematosus, necrobiosis lipoidi

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

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

rising pharma holdings, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the ef

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

aurobindo pharma limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the ef

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

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

remedyrepack inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. the efficacy of venlafaxine tablets, usp in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see clinical trials ). nevertheless, the physician who elects to use venlafaxine tablets, usp/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. the use of maois intended to treat psychiatric disorders with venlafaxine tablets or within 7 days of stopping treatment with venlafaxine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see  warnings and  dosage and administration ). starting venlafaxine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings  and  dosage and administration ). venlafaxine hydrochloride is not a controlled substance. in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine (see dosage and administration ). while venlafaxine hydrochloride has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine hydrochloride (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

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

remedyrepack inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. the efficacy of venlafaxine tablets, usp in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see clinical trials ). nevertheless, the physician who elects to use venlafaxine tablets, usp/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. the use of maois intended to treat psychiatric disorders with venlafaxine tablets or within 7 days of stopping treatment with venlafaxine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see  warnings and  dosage and administration ). starting venlafaxine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings  and  dosage and administration ). venlafaxine hydrochloride is not a controlled substance. in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine (see dosage and administration ). while venlafaxine hydrochloride has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine hydrochloride (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).