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

thea pharma inc. - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - zioptan ® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on c max . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on c max . at the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/ml). in a pre- and postnatal development study in rats, increased mortality of newborns, decreased body weights and delayed pinna unfolding were observed in offsprings. the no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison. there are no adequate and well-controlled studies in pregnant woman. although animal reproduction studies are not always predictive of human response, zioptan ® should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. women of childbearing age/potential should have adequate contraceptive measures in place. a study in lactating rats demonstrated that radio-labeled tafluprost and/or its metabolites were excreted in milk. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when zioptan ® is administered to a nursing woman. use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. read these instructions for use before using your zioptan ® and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your doctor about your medical condition or your treatment. important: - zioptan ® is for the eye only. do not swallow zioptan ® . - zioptan ® single-use containers are packaged in a foil pouch. - do not use the zioptan ® single-use containers if the foil pouch is opened. - write down the date you open the foil pouch in the space provided on the pouch. every time you use zioptan ® : - if your doctor has told you to use zioptan ® drops in both eyes, repeat steps 7 to 10 for your other eye. - there is enough zioptan ® in one single-use container for both of your eyes. - throw away the opened single-use container with any remaining zioptan ® right away. this patient information and instructions for use have been approved by the u.s. food and drug administration. rx only manufactured for : thea pharma inc. waltham, ma 02451 made in france © 2023. thea pharma inc. all rights reserved the zioptan trademark is owned by merck sharp & dohme corp. and is used under license. revised: 05/2023 n10260u30usa/0423 revised: 3/2024 thea pharma inc.

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

thea pharma inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - cosopt ® is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of cosopt administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14)] . cosopt is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)] . cosopt is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see warnings and precautions (5.2)] . cosopt is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.3)] . teratogenic effects. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (37 times the recommended human ophthalmic dose) revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day (15 times the recommended human ophthalmic dose). teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women. cosopt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether dorzolamide is excreted in human milk. timolol maleate has been detected in human milk following oral and ophthalmic drug administration. because of the potential for serious adverse reactions from cosopt in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. safety and efficacy in pediatric patients below the age of 2 years have not be established. no overall differences in safety or effectiveness have been observed between elderly and younger patients. what is cosopt? cosopt is a prescription eye drop solution that contains two medicines, dorzolamide hydrochloride called an ophthalmic carbonic anhydrase and timolol maleate called a beta-blocker. cosopt is used to lower high pressure in the eye in people with open-angle glaucoma or ocular hypertension when a beta-blocking medicine alone does not work to control the eye pressure. it is not known if cosopt is safe and effective in children 2 years of age and younger. do not use cosopt if you: - have or have had asthma. - have chronic obstructive pulmonary disease (copd) which emphysema, chronic bronchitis or both. - have heart problems including a slow heartbeat, heart block, heart failure, or your heart muscle suddenly becomes weak due to a severe heart attack or other heart problem that caused heart damage (cardiogenic shock). - are allergic to any of the ingredients in cosopt. see the end of this patient information leaflet for a complete list of ingredients in cosopt. before using cosopt, tell your healthcare provider about all your medical conditions, including if you: - have or have had allergies to sulfa drugs - have a history of anaphylactic reactions to allergens - have atopy (genetic disposition to develop allergic reactions) - have or have had muscle weakness or myasthenia gravis - have diabetes - have thyroid disease - have or have had kidney or liver problems - plan to have any type of surgery - wear contact lenses - are using any other eye drops - have an eye infection or eye trauma - are pregnant or plan to become pregnant. it is not know if cosopt will harm your unborn baby. tell your healthcare provider right away if you become pregnant while using cosopt. you and your healthcare provider will decide if you should use cosopt while you are pregnant. - are breastfeeding or plan to breastfeed. it is not known if cosopt passes into breastmilk. talk to your healthcare provider about the best way to feed your baby while using cosopt. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. cosopt may affect the way medicines work, and other medicines may affect how cosopt works. do not start a new medicine without first talking to your healthcare provider. ask your healthcare provider or pharmacist for a list of medicines you are using, if you are not sure. know the medicines you take. keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. how should i use cosopt? - see the complete instructions for use at the end of this patient information leaflet for detailed instructions about the right way to use cosopt. - use cosopt exactly as your healthcare provider tells you. - use 1 drop of cosopt in the affected eye or both eyes if needed, 2 times each day. 1 drop in the morning and 1 drop in the evening. - if you are using cosopt with another eyedrop, wait at least 5 minutes before or after using cosopt. - if you have eye surgery or have any problems with your eye such as trauma or an infection, talk to your healthcare provider about continuing to use the bottle (multidose) that contains cosopt. - cosopt contains a preservative called benzalkonium chloride. the preservative may be absorbed by soft contact lenses. if you wear contact lenses, remove them before using cosopt. the lenses can be placed back into your eyes 15 minutes after using cosopt. - do not touch your eye or eyelid with the dropper tip. eye medicines, not handled the right way, can become contaminated by bacteria that can cause eye infections. serious damage to the eye and followed by loss of vision may happen from using contaminated eye medicines. if you think your cosopt medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of cosopt. - if you use too much cosopt you may have dizziness, headaches, shortness of breath, slow heartbeats, or problems breathing. if you have any of these symptoms call your healthcare provider or go to the nearest hospital emergency room right away. what are the possible side effects of cosopt? cosopt may cause serious side effects, including: - severe breathing problems. these breathing problems can happen in people who have asthma, chronic obstructive pulmonary disease, or heart failure and can cause death. tell your healthcare provider right away if you have breathing problems while using cosopt. - heart failure. this can happen in people who already have heart failure and in people who have never had heart failure before. tell your healthcare provider right away if you get any of these symptoms of heart failure while taking cosopt: shortness of breath irregular heartbeat (palpitations) swelling of your ankles or feet sudden weight gain - shortness of breath - irregular heartbeat (palpitations) - swelling of your ankles or feet - sudden weight gain - serious sulfa (sulfonamide) reactions. serious reactions including death can happen in people who are allergic to sulfonamide medicines like one of the medicines in cosopt. other serious reactions can include: severe skin reactions liver problems blood problems stop using cosopt and call your healthcare provider or get emergency help right away if you get any of these symptoms of an allergic reaction: swelling of your face, lips, mouth, or tongue trouble breathing wheezing severe itching skin rash, redness, or swelling dizziness or fainting fast heartbeat or pounding in your chest sweating - severe skin reactions - liver problems - blood problems - swelling of your face, lips, mouth, or tongue - trouble breathing - wheezing - severe itching - skin rash, redness, or swelling - dizziness or fainting - fast heartbeat or pounding in your chest - sweating - increased allergic reactions. people who have a genetic history of developing allergies (atopy) or who have a history of severe anaphylactic reactions from different allergens may have increased allergic reactions while taking beta-blockers, like one of the medicines in cosopt. your usual dose of epinephrine used to treat your anaphylactic reactions may not work as well. stop using cosopt and call your healthcare provider or get emergency help right away if you get any of these symptoms of an allergic reaction: swelling of your face, lips, mouth or tongue trouble breathing wheezing severe itching skin rash, redness, or swelling dizziness or fainting fast heartbeat or pounding in your chest sweating - swelling of your face, lips, mouth or tongue - trouble breathing - wheezing - severe itching - skin rash, redness, or swelling - dizziness or fainting - fast heartbeat or pounding in your chest - sweating - worsening muscle weakness. muscle weakness symptoms including double vision or drooping eyelids can happen while using cosopt. muscle weakness can get worse in people who already have problems with muscle weakness like myasthenia gravis. - swelling of eye. some people with low counts of certain types of cells in the eye have developed corneal edema when using cosopt. call your healthcare provider if you have swelling in your eyes. the most common side effects of cosopt include: - eye burning - eye stinging - eye redness - blurred vision - eye tearing - eye itching - a bitter, sour, or unusual taste after putting in your eyedrops these are not all the possible side effects of cosopt. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store cosopt? - store at 68° to 77°f (20° to 25°c). - protect from light. - do not use cosopt after the expiration date on the bottle. keep cosopt and all medicines out of the reach of children. general information about the safe and effective use of cosopt. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use cosopt for a condition for which it was not prescribed. do not give cosopt to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about cosopt that is written for health professionals. what are the ingredients in cosopt? active ingredients: dorzolamide hydrochloride and timolol maleate inactive ingredients: sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, water for injection and benzalkonium chloride added as a preservative. this patient package information has been approved by the u.s. food and drug administration | 11/2020 read this instructions for use before you start using cosopt and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - cosopt is for use in the eye. - if you are using cosopt with another eyedrop, wait at least 5 minutes before or after using cosopt. - if you wear contact lenses, remove them before using cosopt. the lenses can be placed back into your eyes 15 minutes after using cosopt. - do not touch your eye or eyelid with the dropper tip. eye medicines, not handled the right way, can become contaminated by bacteria that can cause eye infections. serious damage to the eye and followed by loss of vision may happen from using contaminated eye medicines. if you think your cosopt medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of cosopt. - wash your hands before each use to make sure you do not infect your eyes while using cosopt. - before using the eyedrops for the first time, be sure the safety seal around the cap is not broken. if the safety seal is broken, call your pharmacist to get a new bottle of cosopt. - the dropper tip is made to give a single drop of cosopt. do not enlarge the hole of the dropper tip. - after you have used all of your doses of cosopt, there will be some cosopt left in the bottle. - there is an extra amount of cosopt that has been added to the bottle. you will get the full amount of cosopt that your doctor prescribed. - do not try to remove the extra cosopt medicine from the bottle. this instructions for use has been approved by the u.s. food and drug administration | 11/2020 manufactured for: thea pharma inc. waltham, ma 02451 made in switzerland © 2023. thea pharma inc. all rights reserved the cosopt trademarks are owned by merck sharp & dohme corp. and are being used with permission. rev. 05/2023 revised: 5/2023 thea pharma inc.

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

thea pharma inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - cosopt® pf is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of cosopt® administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14.1)]. cosopt pf is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)]. cosopt pf is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see warnings and precautions (5.2)]. cosopt pf is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.3)]. teratogenic effects . pregnancy category c. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (31 times the recommended human ophthalmic dose) revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day (13 times the recommended human ophthalmic dose). teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women. cosopt pf should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether dorzolamide is excreted in human milk. timolol maleate has been detected in human milk following oral and ophthalmic drug administration. because of the potential for serious adverse reactions from cosopt pf in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. safety and efficacy in pediatric patients below the age of 2 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients. read these instructions before using your cosopt pf and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your doctor about your medical condition or your treatment. important: - cosopt pf is for the eye only. do not swallow cosopt pf. - cosopt pf single-use containers are packaged in a foil pouch. - write down the date you open the foil pouch in the space provided on the pouch. every time you use cosopt pf: step 1. wash your hands. step 2. take the strip of single-use containers from the pouch. step 3. pull off 1 single-use container from the strip. step 4. put the remaining strip of single-use containers back in the pouch and fold the edge to close the pouch. (figure a) (figure b) (figure c) (figure d) - if your doctor has told you to use drops in both eyes, repeat steps 7 to 11 for your other eye. - there is enough cosopt pf in 1 single-use container for 1 or both of your eyes. - throw away the opened single-use container with any remaining cosopt pf right away. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured for: thea pharma inc. lexington, ma 02420 the cosopt trademark is owned by merck sharp & dohme corp. and is used under license. © 2022. thea pharma inc. all rights reserved rev. 05/22

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

meitheal pharmaceuticals inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer patients, because of the lon

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

meitheal pharmaceuticals inc. - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli ,* klebsiella spp .* (including k. pneumoniae*), proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp. ,* and acinetobacter calcoaceticus .* note: for information on use in pediatric patients (see precautions-pediatric use and clinical studies sections). intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp . (including k. pneumoniae *), bacteroides spp . (including b. fragilis ), and enterobacter spp .* gynecological infections caused by beta-lactamase producing strains of escherichia coli ,* and bacteroides spp.* (including b. fragilis *). * efficacy for this organism in this organ system was studied in fewer than 10 infections. while a

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

meitheal pharmaceuticals inc. - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus ,  escherichia coli ,* klebsiella spp.* (including k. pneumoniae *),  proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp.,* and acinetobacter calcoaceticus .* note: for information on use in pediatric patients see precautions-pediatric use and clinical studies sections. intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp . (including k. pneumoniae *), bacteroides spp. (including b. fragilis ), and enterobacter  spp. * gynecological infections caused by beta-lactamase producing strains of escherichia coli ,* and bacteroides spp.* (including b. fragilis *). * efficacy for this organism in this organ system was studied in fewer than 10 infections. while ampicil

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

meitheal pharmaceuticals inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5)] . zoledronic acid is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2)] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3)] . - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see adverse reactions (6.2)] . risk summary available data on the use of zoledronic acid in pregnant

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

prime pharmaceutical sdn. bhd. - thea sinensis; sepia esculentae; nelumbo nucifera/folium nelumbinis; crataegus cuneata fructus; alisma plantago aquatica -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

p.t mustika ratu (m) sdn. bhd. - thea sinensis l.; parameria laevigata (juss.) moldenke; mel depuratum (madu); guazuma ulmifolia lamk. var. tomentosa schum.; foeniculum vulgare l.; curcuma xanthorrhiza; citrus aurantifolia (lime) fruit extract -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

tanzania engineering and manufacturing design organization (temdo), tanzania - trolley wheels -