Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires thea - tropicamide; phenylephrine hydrochloride; lidocaine hydrochloride monohydrate - solution for injection - 0.2 mg/ml + 3.1 mg/ml + 10 milligram(s)/millilitre - anticholinergics; tropicamide, combinations

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

thea pharmaceuticals ltd - tropicamide; phenylephrine hydrochloride; lidocaine hydrochloride - solution for injection - 200microgram/1ml ; 3.1mg/1ml ; 10mg/1ml

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires théa - tropicamide 0,2 mg/ml; phenylephrine hydrochloride 3,1 mg/ml; lidocaine hydrochloride 10 mg/ml - solution for injection - 0,2 mg/ml - 3,1 mg/ml - 10 mg/ml - tropicamide 0.2 mg/ml; phenylephrine hydrochloride 3.1 mg/ml; lidocaine hydrochloride 10 mg/ml - tropicamide, combinations

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

akorn - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride 25 mg in 1 ml - phenylephrine hydrochloride ophthalmic solution, usp 2.5% and 10%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)] . animal reproduction studies have not been conducted with topical phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [see contraindications (4.2) ]. no overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

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

boucher & muir pty ltd - phenylephrine hydrochloride, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia. it is also employed to overcome paroxysmal supraventricular tachycardia.

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

eyenovia, inc. - tropicamide (unii: n0a3z5xtc6) (tropicamide - unii:n0a3z5xtc6), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. contraindicated in persons showing known hypersensitivity to any component of the formulation. risk summary there are no available data on mydcombi use in pregnant women or animals to inform any drug-associated risks. it is also not known whether tropicamide or phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. mydcombi should be given to a pregnant woman only if clearly needed. risk summary there are no data on the presence of tropicamide or phenylephrine in human milk from the administration of mydcombi, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mydcombi and any potential adverse effects on the breastfed

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires théa - phenylephrine hydrochloride 5,376 mg; tropicamide 0,28 mg - ophthalmic insert - 0,28 mg - 5,40 mg - phenylephrine hydrochloride 5.38 mg; tropicamide 0.28 mg - tropicamide, combinations

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

thea pharmaceuticals ltd - tropicamide; phenylephrine hydrochloride - ophthalmic insert - .28mg ; 5.4mg

Malta - English - Medicines Authority

laboratoire aguettant 1 rue alexander fleming, 69007 lyon, france - phenylephrine hydrochloride - solution for injection in a pre-filled syringe - phenylephrine hydrochloride 50 µg/ml - cardiac therapy

Israel - English - Ministry of Health

cts ltd - phenylephrine hydrochloride - solution for injection / infusion - phenylephrine hydrochloride 10 mg / 1 ml - phenylephrine - for the treatment of hypotensive states, e.g. septic shock, circulatory failure, during spinal anaesthesia or drug-induced hypotension.