United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

aguettant ltd - atropine sulfate - solution for injection - 100microgram/1ml

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

medical purchasing solutions, llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 0.1 mg in 1 ml - atropine sulfate injection, usp, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. it may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery. the antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. for ureteral and biliary colic, atropine concomitantly with morphine may be indicated. atropine relaxes the upper gi tract and colon during hypotonic radiography. in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. it is also used as an antidote for mushroom poisoning due to muscarine in certain species such as amanita muscaria . atr

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

fresenius kabi usa, llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 0.4 mg in 1 ml - atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. none. risk summary limited available data with atropine sulfate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes (see data).  there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations).   animal reproduction studies have not been conducted with atropine sulfate injection. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies

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

wockhardt bio pty ltd - apomorphine hydrochloride hemihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections - apowok solution for injection or infusion is indicated to reduce the number and severity of ?off? phases in patients with parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. conventional therapy should be continued during ?on? phases.

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

wockhardt bio pty ltd - apomorphine hydrochloride hemihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections - apomorphine wockhardt solution for injection or infusion is indicated to reduce the number and severity of ?off? phases in patients with parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. conventional therapy should be continued during ?on? phases.

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

cardinal health - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp is indicated (1) as an antisialogogue for preanesthetic medication to prevent or reduce secretions of the respiratory tract, (2) to restore cardiac rate and arterial pressure during anesthesia when vagal stimulation produced by intra-abdominal surgical traction causes a sudden decrease in pulse rate and cardiac action, (3) to lessen the degree of atrioventricular (a-v) heart block when increased vagal tone is a major factor in the conduction defect as in some cases due to digitalis, (4) to overcome severe bradycardia and syncope due to a hyperactive carotid sinus reflex, (5) as an antidote (with external cardiac massage) for cardiovascular collapse from the injudicious use of a choline ester (cholinergic) drug, (6) in the treatment of anticholinesterase poisoning from organophosphorus insecticides, and (7) as an antidote for the “rapid” type of mushroom poisoning due to the presence of the alkaloid, muscarine, in certain species of fungus such as amanita muscaria . atropine ge

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

remedyrepack inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. trace amounts of atropine was found in breast milk. the clinical impact of this is not known. recommendations for use in pediatric patients are not based on clinical trials. an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disea

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

umsebe healthcare - injection - see ingredients - each 1,0 ml solution contains phenylephrine hydrochloride 0,1 mg

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

amneal pharmaceuticals ny llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate ophthalmic solution, 1% is indicated for: atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. pregnancy category c: there are no adequate and well-controlled studies of atropine sulfate in pregnant women. animal development and reproduction studies have not been conducted with atropine sulfate. since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. traces of atropine have been found in human milk following administration of atropine solution for injection. because some systemic absorption occurs from topical administration, caution should be exercised when atropine sulfate ophthalmic solution, 1% is administered to a nursing woman. due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution, 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. no overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

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

medefil, inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. these highlights do not include all the information needed to use atropine sulfate injection safely and effectively. see full prescribing information for atropine sulfate injection. atropine sulfate injection, for intravenous use initial u.s. approval: 1960 none. 8.1 pregnancy animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. 8.3 nursing mothers trace amounts of atropine was found in breast milk. the clinical impact of this is not known. 8.4 pediatric use recommendations for use in pediatric patients are not based on clinical trials. 8.5 geriatric use an evaluation of current literature revealed