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

almirall, llc - sarecycline hydrochloride (unii: 36718856jr) (sarecycline - unii:94o110cx2e) - seysara® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. limitations of use efficacy of seysara beyond 12 weeks and safety beyond 12 months have not been established. seysara has not been evaluated in the treatment of infections [see clinical studies (14)] . to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, seysara should be used only as indicated [see warnings and precautions (5.6)] . seysara is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. risk summary seysara, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see warnings and precautions (5.1) and use in specific populations (8.4)] . the limited available human data are not sufficient to inform a drug-associated

Ireland - English - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - tablets - 10 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - tablets - 20mg milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

almirall, s.a. - almotriptan - film-coated tablet - 12.5 milligram(s) - selective serotonin (5ht1) agonists; almotriptan

Ireland - English - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - tablets - 10 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - tablets - 20mg milligram

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

almirall, llc - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazorac® (tazarotene) gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. tazorac (tazarotene) gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. the efficacy of tazorac gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. the safety of tazorac gel use on more than 20% body surface area has not been established in psoriasis or acne [see warnings and precautions ( 5.1 ) and use in specific populations ( 8.1 )]. tazorac gel is contraindicated in:  - pregnancy. retinoids may cause fetal harm when administered to a pregnant female [see warnings and precautions ( 5.1 ), use in specific populations ( 8.1 , 8.3 )]. - individuals who have known hypersensitivity to any of its components [see warnings and precautions ( 5.2 )]. risk summary based on data from animal reproduction studies, ret

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

almirall, llc - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - aczone® gel, 5%, is indicated for the topical treatment of acne vulgaris. none risk summary there are no available data on aczone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. these dosages resulted in systemic exposures that represented approximately 956 times [rats] and 289 times [rabbits] the systemic exposure observed in human females as a result of use of the mrhd of aczone gel, 5%, based on auc comparisons. these effects were probably secondary to maternal toxicity. dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 382 times the systemic exposure that is associated with the mrhd of aczone gel, 5%, based on auc comparisons). no effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. risk summary there is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant, or the effects on milk production. orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with g6pd deficiency. systemic absorption of dapsone following topical application is minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone. safety and efficacy was evaluated in 1169 children aged 12-17 years old treated with aczone gel, 5%, in the clinical trials. the adverse event rate for aczone gel, 5%, was similar to the vehicle control group. safety and efficacy was not studied in pediatric patients less than 12 years of age, therefore aczone gel, 5%, is not recommended for use in this age group. clinical trials of aczone gel, 5%, did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. aczone gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical trial of 64 subjects with g6pd deficiency and acne vulgaris. subjects were black (88%), asian (6%), hispanic (2%) or of other racial origin (5%). blood samples were taken at baseline, week 2, and week 12 during both vehicle and aczone gel, 5% treatment periods. there were 56 out of 64 subjects who had a week 2 blood draw and applied at least 50% of treatment applications. table 3 contains results from testing of relevant hematology parameters for these two treatment periods. aczone gel was associated with a 0.32 g/dl drop in hemoglobin after two weeks of treatment, but hemoglobin levels generally returned to baseline levels at week 12. there were no changes from baseline in haptoglobin or lactate dehydrogenase during aczone or vehicle treatment at either the 2-week or 12-week time point. the proportion of subjects who experienced decreases in hemoglobin ≥1 g/dl was similar between aczone gel, 5% and vehicle treatment (8 of 58 subjects had such decreases during aczone treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). subgroups based on gender, race, or g6pd enzyme activity did not display any differences in laboratory results from the overall study group. there was no evidence of clinically significant hemolytic anemia in this study. some of these subjects developed laboratory changes suggestive of hemolysis.

Kenya - English - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - aceclofenac - film-coated tablet - 100 mg /tablet - non-steroidal