Malta - enska - Medicines Authority

sanofi s.r.l viale l. bodio, 37/b 20158, milan, italy - carbocisteine - syrup - carbocisteine 20 mg/ml - cough and cold preparations

Malta - enska - Medicines Authority

sanofi s.r.l viale l. bodio, 37/b 20158, milan, italy - carbocisteine - syrup - carbocisteine 50 mg/ml - cough and cold preparations

Malta - enska - Medicines Authority

sanofi s.r.l viale l. bodio, 37/b 20158, milan, italy - carbocisteine, promethazine hydrochloride - syrup - carbocisteine 2 g/100ml promethazine hydrochloride 0.05 g/100ml - antihistamines for systemic use

Bandaríkin - enska - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - sildenafil (unii: 3m7ob98y7h) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)] . pediatric use information is approved for viatris specialty llc’s, revatio (sildenafil) oral suspension. however, due to viatris specialty llc’s marketing exclusivity rights, this drug product is not labeled with that information. sildenafil for oral suspension is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)] . - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the oral suspension. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (see data) . 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 is 2% to 4% and 15% to 20%, respectively. disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. animal data no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2  basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m2  basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil has not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc’s, revatio (sildenafil) oral suspension. however, due to viatris specialty llc’s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology (12.3)] . no dose adjustment is required (including severe impairment clcr < 30 ml/min) [see clinical pharmacology (12.3)] . sildenafil  (sil den’ a fil) for oral suspension read this instructions for use before you start taking sildenafil for oral suspension and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil for oral suspension. - your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - always use the oral dosing syringe that comes with sildenafil for oral suspension. if your carton does not come with an oral dosing syringe, contact your pharmacist. - do not take or give sildenafil for oral suspension if the bottle adaptor is not in the bottle. if the bottle adaptor is not in the bottle, contact your pharmacist. - sildenafil for oral suspension should not be mixed with any other medicine or flavoring. supplies you will need to take or give a dose of sildenafil for oral suspension (see figure a): - 1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton) step 1. shake the bottle of sildenafil for oral suspension for 10 seconds before each use. (see figure b)     step 2. remove the cap. open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (see figure c)   step 3. fully push down (depress) the plunger of the oral dosing syringe. then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (see figure d)   step 4. turn the bottle upside down while holding the oral dosing syringe in place. slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the ml marking on the syringe for your prescribed dose. (see figure e)   if your dose of sildenafil oral suspension is more than 2 ml (20 mg), you will need to divide the dose. follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. if you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat step 4.      step 5. turn the bottle back upright with the oral dosing syringe still in place. place the bottle on a flat surface. remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (see figure f) do not press on the plunger of the oral dosing syringe at this time.    step 6. put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. do not squirt the medicine out quickly. (see figure g) if you are giving sildenafil for oral suspension, make sure they are in an upright position before giving the medicine.                                  figure g   step 7. replace the cap on the bottle, leaving the bottle adaptor in place. turn the cap in the direction of the arrow (clockwise) to close the bottle. (see figure h)   step 8. wash the oral dosing syringe after each use. pull the plunger out of the barrel and rinse both parts with water. (see figure i)     step 9. dry all parts with a clean paper towel. push the plunger back into the barrel. store the oral dosing syringe with the sildenafil for oral suspension bottle. how should i store sildenafil for oral suspension? - store mixed (reconstituted) sildenafil for oral suspension below 30°c (86°f) or in a refrigerator between 2°c to 8°c (36°f to 46°f). - do not freeze mixed sildenafil for oral suspension. - throw away (discard) any remaining sildenafil for oral suspension 60 days after mixed by the pharmacist. see the “discard after” date written on the bottle label. keep sildenafil for oral suspension and all medicines out of the reach of children. pediatric use information is approved for viatris specialty llc’s, revatio (sildenafil) oral suspension. however, due to viatris specialty llc’s marketing exclusivity rights, this drug product is not labeled with that information. this instruction for use has been approved by the u.s. food and drug administration. this product’s label may have been updated. for current full prescribing information, please contact amneal pharmaceuticals at 1-877-835-5472 or visit www.amneal.com. distributed by: amneal pharmaceuticals llc bridgewater, nj  08807 rev. 11-2023-04

Bandaríkin - enska - NLM (National Library of Medicine)

tomlyn products, a divison of vetoquinol usa, inc. - lysine hydrochloride (unii: jnj23q2com) (lysine - unii:k3z4f929h6) - veterinarian formulated powder that helps support a healthy immune and respiratory system, while supporting normal eye health. with fish and chicken flavoring, your cat or kitten will love this great tasting supplement! for use in cats only. recommended for immune system support and conditions responsive to l-lysine.

Bandaríkin - enska - NLM (National Library of Medicine)

tomlyn products, a divison of vetoquinol usa, inc. - lysine hydrochloride (unii: jnj23q2com) (lysine - unii:k3z4f929h6) - veterinarian formulated gel that helps support a healthy immune system, normal eye function and health. with maple flavoring, your cat or kitten will love this great tasting gel. recommended for immune system support and conditions responsive to l-lysine.

Ísrael - enska - Ministry of Health

abic marketing ltd, israel - dipyrone - drops - dipyrone 500 mg / 1 ml - metamizole sodium - relief of moderate to severe pain as in headache, toothache, dysmenorrhea and for high fever that does not respond to other measures.

Bandaríkin - enska - NLM (National Library of Medicine)

oceanside pharmaceuticals - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol-3350, electrolytes, and ascorbate for oral solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. polyethylene glycol-3350, electrolytes, and ascorbate for oral solution is contraindicated in the following conditions: risk summary there are no available data on polyethylene glycol-3350, electrolytes, and ascorbate for oral solution in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with polyethylene glycol-3350, electrolytes, and ascorbate for oral solution. 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 is 2% to 4% and 15% to 20%, respectively. risk summary the

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

quanstar biotech sdn bhd - thuja occidentalis; echinacea pallida; echinacea purpurea; baptisia tinctoria -

Armenía - enska - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

allegiant health 75 north industry court - acetylsalicylic acid - chewable tablets - 81mg