Israel - English - Ministry of Health

salomon,levin & elstein ltd - indomethacin - drops - indomethacin 0.1 % - indometacin - indometacin - inhibition of myosis during surgery. prevention of inflammation subsequent to cataract surgery or surgery of the anterior chamber of the eye. treatment of ocular pain following photorefractive keratectomy for the first few days after surgery.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires chauvin - indometacin - eye drops pdr & solv for soln - 0.1 %w/v

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires chauvin - indometacin - eye drops pdr & solv for soln - 0.1 %w/v

New Zealand - English - Medsafe (Medicines Safety Authority)

miro healthcare limited - metformin hydrochloride 500mg - film coated tablet - 500 mg - active: metformin hydrochloride 500mg excipient: colloidal silicon dioxide hypromellose e-15 macrogol 6000 magnesium stearate maize starch povidone propylene glycol purified talc purified water   sodium starch glycolate titanium dioxide - to control hyperglycaemia in metformin responsive, stable, mild, non-ketosis prone, maturity onset type of diabetes (type ii) which cannot be controlled by proper dietary management, exercise and weight reduction or when insulin therapy is not appropriate. it may be used alone or in combination with sulphonylurea therapy. metformin can be of value for the treatment of obese diabetics. it may also be used as adjuvant therapy in insulin-dependent diabetics especially if they are overweight.

New Zealand - English - Medsafe (Medicines Safety Authority)

miro healthcare limited - metformin hydrochloride 850mg - film coated tablet - 850 mg - active: metformin hydrochloride 850mg excipient: colloidal silicon dioxide hypromellose e-15 macrogol 6000 magnesium stearate maize starch povidone propylene glycol purified talc purified water   sodium starch glycolate titanium dioxide - to control hyperglycaemia in metformin responsive, stable, mild, non-ketosis prone, maturity onset type of diabetes (type ii) which cannot be controlled by proper dietary management, exercise and weight reduction or when insulin therapy is not appropriate. it may be used alone or in combination with sulphonylurea therapy. metformin can be of value for the treatment of obese diabetics. it may also be used as adjuvant therapy in insulin-dependent diabetics especially if they are overweight.

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

indoco remedies limited - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies (14.1)]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)]. monotherapy — oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients

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

indoco remedies limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.   pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary   there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. devel

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

indoco remedies limited - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. it is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see warnings ). the risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. the risk is dependent on the extent and location of the injury. the precise time of onset and the duration of the risk period are not known.

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

indoco remedies limited - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. apixaban tablets are indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. apixaban tablets are indicated for the treatment of dvt. apixaban tablets are indicated for the treatment of pe. apixaban tablets are indicated to reduce the risk of recurrent dvt and pe following initial therapy. apixaban tablets are contraindicated in patients with the following conditions: • active pathological bleeding [see warnings and precautions (5.2) and adverse  reactions(6.1)] • severe  hypersensitivity  reaction  to  apixaban (e.g.,  anaphylactic  reactions)  [see  adverse reactions (6.1)] risk summary the limited available data on apixaban tablets  use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental

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

indoco remedies limited - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate injection is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of dr