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

mylan pharmaceuticals inc. - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 20 mg in 1 ml - glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. there are no adequate and well-controlled studies of glatiramer acetate injection in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2  basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. risk summary there are no data on the presence of glatiramer acetate in human milk. based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see clinical pharmacology (12.3)] . there are no data on the effects of glatiramer acetate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. the safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. glatiramer acetate injection has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined. glatiramer acetate injection (gla tir′ a mer as′ e tate) 20 mg/ml for subcutaneous use for subcutaneous injection only. do not inject glatiramer acetate injection in your veins (intravenously). do not re-use your glatiramer acetate prefilled syringes. do not share your glatiramer acetate prefilled syringes with another person. you may give another person an infection or get an infection from them. you should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. this might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections. glatiramer acetate injection comes in a 20 mg prefilled syringe with needle attached. how often a dose is given depends on the product strength that is prescribed. your healthcare provider will prescribe the correct dose for you. if you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. if you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine. instructions for using your glatiramer acetate 20 mg prefilled syringe: how do i inject glatiramer acetate injection? step 1 : gather the supplies you will need to inject glatiramer acetate injection. see figure a. step 2 : remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. see figure b. step 3 : look closely at your glatiramer acetate prefilled syringe. step 4 : choose your injection area. see figure c. see the injection areas you should use on your body. talk with your healthcare provider about the injection areas that are best for you. step 5 : prepare to give your injection. step 6 : clean your injection site. step 7 : pick up the syringe with 1 hand and hold it like a pencil. remove the needle cover with your other hand and set it aside. see figure e. step 8 : pinch about a 2 inch fold of skin between your thumb and index finger. see figure f. step 9 : giving your injection. step 10 : give your glatiramer acetate injection. to inject the medicine, hold the syringe steady and slowly push down the plunger. see figure i. step 11 : remove the needle. after you have injected all of the medicine, pull the needle straight out. see figure j. step 12 : use a clean, dry cotton ball to gently press on the injection site for a few seconds. do not rub the injection site or re-use the needle or syringe. see figure k. step 13 : dispose of your needles and syringes. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured by: gland pharma ltd hyderabad 500 043 india code no.: ap/drugs/10/2012 revised: 1/2024 gl:glatij:rx2

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

mylan pharmaceuticals inc. - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 40 mg in 1 ml - glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. there are no adequate and well-controlled studies of glatiramer acetate injection in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. there are no data on the presence of glatiramer acetate in human milk. based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see clinical pharmacology (12.3)] . there are no data on the effects of glatiramer acetate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. the safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. glatiramer acetate injection has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined. glatiramer acetate injection (gla tir′ a mer as′ e tate) 40 mg/ml for subcutaneous use for subcutaneous injection only. do not inject glatiramer acetate injection in your veins (intravenously). do not re-use your glatiramer acetate prefilled syringes. do not share your glatiramer acetate prefilled syringes with another person. you may give another person an infection or get an infection from them. you should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. this might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections. glatiramer acetate injection comes in a 40 mg prefilled syringe with needle attached. how often a dose is given depends on the product strength that is prescribed. your healthcare provider will prescribe the correct dose for you. if you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. if you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine. instructions for using your glatiramer acetate 40 mg prefilled syringe: how do i inject glatiramer acetate injection? step 1 : gather the supplies you will need to inject glatiramer acetate injection. see figure a. step 2: remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. see figure b . step 3: look closely at your glatiramer acetate prefilled syringe. step 4: choose your injection area. see figure c . see the injection areas you should use on your body. talk with your healthcare provider about the injection areas that are best for you. step 5: prepare to give your injection. step 6: clean your injection site. step 7: pick up the syringe with 1 hand and hold it like a pencil. remove the needle cover with your other hand and set it aside. see figure e . step 8: pinch about a 2 inch fold of skin between your thumb and index finger. see figure f . step 9: giving your injection. step 10: give your glatiramer acetate injection. to inject the medicine, hold the syringe steady and slowly push down the plunger. see figure i. step 11: remove the needle. after you have injected all of the medicine, pull the needle straight out. see figure j. step 12: use a clean, dry cotton ball to gently press on the injection site for a few seconds. do not rub the injection site or re-use the needle or syringe. see figure k . step 13: dispose of your needles and syringes. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland revised: 1/2024 mi:glat40:rx1

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - glatiramer acetate is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

sandoz inc - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 20 mg in 1 ml - glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. data human data there are no adequate and well-controlled studies of glatiramer acetate injection in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. animal data in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. risk summary there are no data on the presence of glatiramer acetate in human milk. based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see clinical pharmacology (12.3)] . there are no data on the effects of glatiramer acetate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. the safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. glatiramer acetate injection has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.

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

teva neuroscience, inc. - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatiramer acetate 20 mg in 1 ml - copaxone is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. copaxone is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. risk summary available human data on the use of copaxone in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. data human data there are no adequate and well-controlled stu

Israel - English - Ministry of Health

teva israel ltd - glatiramer acetate - solution for injection - glatiramer acetate 20 mg/ml - glatiramer acetate - glatiramer acetate - for reducing the frequency of relapses in pateints with relapsing-remitting multiple sclerosis. copaxone is indicated for the treatment of patients who have experienced a well defined first clinical episode and are determined to be at high risk of developing clinically definite multiple sclerosis (cdms). these patients should have mri findings which are compatible with the diagnosis of multiple sclerosis.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - glatiramer acetate - solution for injection - glatiramer acetate 20 mg/dose - glatiramer acetate - glatiramer acetate - for reducing the frequency of relapses in pateints with relapsing-remitting multiple sclerosis. copaxone is indicated for the treatment of patients who have experienced a well defined first clinical episode and are determined to be at high risk of developing clinically definite multiple sclerosis (cdms). these patients should have mri findings which are compatible with the diagnosis of multiple sclerosis.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - copaxone is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

amgrow pty ltd - piperonyl butoxide; deltamethrin; d-tetramethrin 20:80 - suspension concentrate - piperonyl butoxide benzodioxole active 80.0 g/l; deltamethrin pyrethroid active 10.0 g/l; d-tetramethrin 20:80 pyrethroid active 10.0 g/l - insecticide - canteen and/or bakery and/or restaurant | commercial premises - general | factory | felled log, post and pole | flat | hospital - ant | bed bug | bird mite | carpet beetle | clothes moth | cockroach | family: anobiidae | family: bostrychidae | family: lyctidae | five-spined bark beetle | flea | house fly | mosquito | silverfish | spider | adult mosquitoes | argentine ant | auger beetles | bedbug | beetle family anobiidae | beetle family bostrychidae | beetle family lyctidae | ctenocephalides spp. | ground fleas | large cockroach | niditinea spp. | pharaoh ant | powderpost beetles | small cockroach | tinea spp. | tineola spp.

Canada - English - Health Canada

teva canada limited - glatiramer acetate - solution - 20mg - glatiramer acetate 20mg - immunomodulatory agents