Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

almirall, llc - tirbanibulin (unii: 4v9848rs5g) (tirbanibulin - unii:4v9848rs5g) - klisyri is indicated for the topical treatment of actinic keratosis on the face or scalp. none. risk summary there are no available data with klisyri use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of tirbanibulin to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal deaths and malformations at a systemic exposure that was at least 74 times the exposure associated with the maximum recommended human dose (mrhd). oral administration of tirbanibulin to pregnant rabbits during the period of organogenesis resulted in reduced mean fetal weight and size at a systemic exposure that was 159 times the exposure associated with the mrhd (see data ). the 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data tirbanibulin induced fetal deaths and external, visceral, and skeletal malformations when administered orally to pregnant rats during the period of organogenesis at doses greater than or equal to 1.25 mg/kg/day, which resulted in systemic exposures at least 74 times the exposure associated with the mrhd on an area under the curve (auc) comparison basis. tirbanibulin had no apparent effects on fetal development in rats at a dose of 0.5 mg/kg/day, which resulted in systemic exposures 18 times the exposure associated with the mrhd. tirbanibulin reduced mean fetal weight and size (crown-rump length) when administered orally to pregnant rabbits during the period of organogenesis at a dose of 3 mg/kg/day, which resulted in a systemic exposure 159 times the exposure associated with the mrhd on an auc comparison basis. tirbanibulin had no apparent effects on fetal development in rabbits at a dose of 1 mg/kg/day, which resulted in systemic exposures 53 times the exposure associated with the mrhd. tirbanibulin was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages up to 1.25 mg/kg/day. these dosages resulted in systemic exposures up to 74 times the exposure associated with the mrhd on an auc comparison basis. no adverse effects on maternal function or developmental, neurobehavioral, or reproductive performance of offspring were observed. risk summary there are no data on lactational transfer of klisyri to human or animal milk. the effects of klisyri on the breastfed infant, or its effects on milk production, are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for klisyri and any potential adverse effects on the breastfed child from tirbanibulin or from the underlying maternal condition. the safety and effectiveness of klisyri for actinic keratosis in subjects less than 18 years of age have not been established. actinic keratosis is not a condition generally seen within the pediatric population. of the 353 subjects with ak treated with klisyri in the 2 controlled phase 3 trials, 246 (70%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Vereinigte Staaten - Englisch - 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.

Kenia - Englisch - Pharmacy and Poisons Board

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

Kenia - Englisch - Pharmacy and Poisons Board

almirall, s.a. ctra. nacional ii, km 593, 08740, sant andreu de - almagate - powder for oral suspension - almagate 1.5g/15ml - almagate

Kenia - Englisch - Pharmacy and Poisons Board

almirall, s.a. general mitre, 151 08022 barcelona (spain) - almagate - oral drops, suspension - almagate 1 g/7.5 ml - almagate

Kenia - Englisch - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - atenolol - tablet - 100 mg /tablet - beta blocking agents: selective beta blocking

Kenia - Englisch - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - atenolol - tablet - 50 mg / tablet - beta blocking agents: selective beta blocking

Kenia - Englisch - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - atenolol + chlortalidone - tablet - 100 mg atenolol + 25 mg chlortalidone / tablet - beta blocking agents and other diuretics: beta

Kenia - Englisch - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - ebastine - film-coated tablet - 10 mg / tablet - other antihistamines for systemic use