Ireland - English - HPRA (Health Products Regulatory Authority)

tolmar gmbh - doxycycline - powder and solvent for gingival gel - 44 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

tolmar gmbh - doxycycline - powder and solvent for gingival gel - 44 milligram

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

tolmar inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - fensolvi® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (cpp). - hypersensitivity to gnrh, gnrh agonists or any of the components of fensolvi. anaphylactic reactions to synthetic gnrh or gnrh agonists have been reported [see adverse reactions (6.2)] . - pregnancy: fensolvi may cause fetal harm [see use in specific populations (8.1)] . risk summary fensolvi is contraindicated in pregnancy [see contraindications (4)] . fensolvi may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)]. the available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications,

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

tolmar inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - fensolvi is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (cpp). - hypersensitivity to gnrh, gnrh agonists or any of the components of fensolvi. anaphylactic reactions to synthetic gnrh or gnrh agonists have been reported [see adverse reactions (6.2)] . - pregnancy: fensolvi may cause fetal harm [see use in specific populations (8.1)] . risk summary fensolvi is contraindicated in pregnancy [see contraindications (4)] . fensolvi may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)]. the available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. in animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. a similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. data animal data when administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. similar studies in rats failed to demonstrate an increase in fetal malformations. there was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats. risk summary there are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fensolvi and any potential adverse effects on the breastfed infant from fensolvi or from the underlying maternal condition. pregnancy testing exclude pregnancy in women of reproductive potential prior to initiating fensolvi if clinically indicated [see use in specific populations (8.1) ] . contraception females fensolvi may cause embryo-fetal harm when administered during pregnancy. fensolvi is not a contraceptive. if contraception is indicated, advise females of reproductive potential to use a non-hormonal method of contraception during treatment with fensolvi [see use in specific populations (8.1)] . infertility based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased while on treatment with fensolvi. clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks [see clinical pharmacology (12.1)] . there is no evidence that pregnancy rates are affected following discontinuation of fensolvi. animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other gnrh analogs have shown functional recovery of fertility suppression. the safety and effectiveness of fensolvi for the treatment of cpp has been established in pediatric patients 2 years of age and older. use of fensolvi for this indication is supported by evidence from an adequate and uncontrolled open-label, single-arm study of 64 pediatric patients with cpp with an age range of 4 to 9 years [see clinical studies (14)] . the safety and effectiveness of fensolvi have not been established in pediatric patients less than 2 years old.

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

tolmar inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - jatenzo (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of jatenzo in males less than 18 years old have not been established [see u

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

tolmar inc. - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - acyclovir 50 mg in 1 g - acyclovir ointment, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. acyclovir ointment, 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

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

tolmar inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate topical solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age. clobetasol propionate topical solution, 0.05% is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

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

tolmar inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by pityrosporum orbiculare (also known as malassezia furfur  or  m. orbiculare ). note: tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in normalization of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

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

tolmar inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m), calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology ( 12.3 )] . observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see data). advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see data). oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see data). the available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate topical suspension. the estimated background risk of major birth defects and miscarriage of 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. data human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or super potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. animal data embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). there were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. the incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. the incidence of major malformations among fetuses was not affected. an increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits. pregnant mice were administered doses of 0, 156, 625, or 2500 mcg/kg/day (0, 468, 1875, and 7500 mcg/m2 /day, respectively) on days 7 through 13 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, malformations (increased incidence of the cleft palate and crooked or short tail), and minor skeletal abnormalities (delayed ossification of vertebra and sternebrae). fetal toxicity was observed at the lowest exposure that was evaluated (156 mcg/kg/day). pregnant rabbits were injected subcutaneously at dosages of 0, 0.625, 2.5, and 10 mcg/kg/day (0, 7.5, 30, and 120 mcg/m2 /day, respectively) on days 6 through 18 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, external malformations (including malformed ears, cleft palate, umbilical hernia, kinked tail, club foot, and club hand), and skeletal malformations (including absence of phalanges of the first digit and cranial dysplasia) at dosages of 2.5 mcg/kg/day and above. calcipotriene was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 6, 18 or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) from gestation day 15 through day 20 postpartum. no remarkable effects were observed on any parameter, including survival, behavior, body weight, litter parameters, or the ability to nurse or rear pups. betamethasone dipropionate was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 100, 300, and 1000 mcg/kg/day (0, 600, 1800, and 6000 mcg/m2 /day, respectively) from gestation day 6 through day 20 postpartum. mean maternal body weight was significantly reduced on gestation day 20 in animals dosed at 300 and 1000 mcg/kg/day. the mean duration of gestation was slightly, but statistically significantly, increased at 100, 300, and 1000 mcg/kg/day. the mean percentage of pups that survived to day 4 was reduced in relation to dosage. on lactation day 5, the percentage of pups with a reflex to right themselves when placed on their back was significantly reduced at 1000 mcg/kg/day. no effects on the ability of pups to learn were observed, and the ability of the offspring of treated rats to reproduce was not affected. risk summary there is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production. concentrations of calcipotriene in plasma are low after topical administration, and therefore, concentrations in human milk are likely to be low [see clinical pharmacology ( 12.3 )]. it is not known whether topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcipotriene and betamethasone dipropionate topical suspension and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate topical suspension or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate topical suspension directly to the nipple and areola to avoid direct infant exposure [see use in specific populations ( 8.4 )] . the safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension for the treatment of plaque psoriasis of the scalp has been established in pediatric patients age 12 to 17 years. the use of calcipotriene and betamethasone dipropionate topical suspension for this indication is supported by evidence from adequate and well-controlled trials in adults and from uncontrolled trials in pediatric subjects that enrolled 109 adolescents with moderate psoriasis of the scalp. after 4 weeks of once daily treatment with calcipotriene and betamethasone dipropionate topical suspension, hpa axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. [see warnings and precautions ( 5.2 ), adverse reactions ( 6.1 ), and clinical pharmacology ( 12.2 )]. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical corticosteroids. pediatric patients are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency with the use of topical corticosteroids including calcipotriene and betamethasone dipropionate topical suspension [see clinical pharmacology (12.2)] . rare systemic toxicities such as cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. the safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension in pediatric patients less than 12 years of age have not been established. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of calcipotriene and betamethasone dipropionate topical suspension in plaque psoriasis on non-scalp areas included 124 subjects who were 65 years of age or older, and 36 were 75 years of age or older. clinical studies of calcipotriene and betamethasone dipropionate topical suspension in subjects with psoriasis of the scalp included 334 subjects who were 65 years or older and 84 subjects who were 75 years or older. no overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate topical suspension were observed between these subjects and younger subjects, and other reported clinical experience has not identified any differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. calcipotriene and betamethasone dipropionate topical suspension (kal si poe trye’ een and bay’’ ta meth’ a sone dye proe’ pee oh nate) important: calcipotriene and betamethasone dipropionate topical suspension is for use on skin only (topical). do not get calcipotriene and betamethasone dipropionate topical suspension near or in your mouth, eyes, or vagina. read this instructions for use before you start using calcipotriene and betamethasone dipropionate topical suspension  and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. how to apply calcipotriene and betamethasone dipropionate topical suspension to your body: follow your healthcare provider’s instructions of how much calcipotriene and betamethasone dipropionate topical suspension to use and where to use it. apply calcipotriene and betamethasone dipropionate topical suspension directly to areas affected by plaque psoriasis and gently rub in. wash your hands after applying calcipotriene and betamethasone dipropionate topical suspension, unless you are treating areas on your hands. how to apply calcipotriene and betamethasone dipropionate topical suspension to your scalp: you do not need to wash your hair before you apply calcipotriene and betamethasone dipropionate topical suspension. diagram of instructions for use how should i store calcipotriene and betamethasone dipropionate topical suspension? - store the calcipotriene and betamethasone dipropionate topical suspension at room temperature between 68°f to 77°f (20°c to 25°c). - do not refrigerate calcipotriene and betamethasone dipropionate topical suspension. - keep bottle in the carton when not in use. - discard unused calcipotriene and betamethasone dipropionate topical suspension 6 months after it has been opened.   keep calcipotriene and betamethasone dipropionate topical suspension and all medicines out of reach of children.   this instructions for use has been approved by the u.s. food and drug administration. manufactured and distributed by: tolmar, inc. fort collins, co 80526 04006030 rev. 0 12/19

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

tolmar inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - eligard is indicated for the treatment of advanced prostate cancer. hypersensitivity eligard is contraindicated in patients with hypersensitivity to gnrh, gnrh agonist analogs or any of the components of eligard.  anaphylactic reactions to synthetic gnrh or gnrh agonist analogs have been reported in the literature. risk summary based on findings in animal studies and mechanism of action, eligard may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. expected hormonal changes that occur with eligard treatment increase the risk for pregnancy loss. in animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. advise pregnant patients and females of reproductive potential of the potential risk to the fetus (see data) . data animal data in animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation.  there were increased fetal mortality and decreased fetal weights in rats and rabbits.  the effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. the safety and efficacy of eligard have not been established in females. there is no information regarding the presence of eligard in human milk, the effects on the breastfed child, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from eligard, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. infertility males based on mechanism of action, eligard may impair fertility in males of reproductive potential [see clinical pharmacology (12.1)] . the safety and effectiveness of eligard in pediatric patients have not been established. the majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older.  clinical studies of eligard did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients. follow the detailed instructions below to ensure correct preparation of eligard prior to administration: step 1 use aseptic technique throughout the procedure.  gloves are recommended during mixing and administration. allow the product to reach room temperature before mixing.  once mixed, the product must be administered within 30 minutes or it should be discarded. on a clean field open the tray by tearing off the foil from the corner and remove the contents. discard the desiccant pack. remove the pre-connected syringe system from the tray. open the sterile safety needle package by peeling back the paper tab. note: syringe a and syringe b should not be lined-up yet. the product should only be administered with the co-packaged, sterile safety needle. grasp the latching button on the coupling device with your finger and thumb and press until you hear a snapping sound. the two syringes will be aligned. step 3 holding the syringes in a horizontal position, transfer the liquid contents of syringe a into the leuprolide acetate powder contained in syringe b. thoroughly mix the product for 60 cycles by pushing the contents back and forth between both syringes to obtain a uniform suspension. - a cycle is one push of the syringe a plunger and one push of the syringe b plunger. - when thoroughly mixed, the suspension will appear light tan to tan (eligard 7.5 mg) or colorless to pale yellow (eligard 22.5 mg, 30 mg, and 45 mg). step 4 step 5 while ensuring the syringe a plunger is fully pushed down, hold the coupling device and unscrew syringe b. this will disconnect syringe b from the coupling device. syringe a will remain attached to the coupling device. note:  small air bubbles will remain in the formulation – this is acceptable. step 6 continue to hold syringe b upright with the open end at the top. hold back the white plunger on syringe b to prevent loss of the product and attach the safety needle and cap. gently screw clockwise with approximately a three-quarter turn until the safety needle and cap are secure. do not overtighten, as the needle hub may become damaged which could result in leakage of the product during injection. the safety shield may also be damaged if the safety needle and cap are screwed with too much force. step 7 move the safety shield away from the needle and towards the syringe. note: should the needle hub appear to be damaged, or leak, the product should not be used. the damaged safety needle and cap should not be replaced and the product should not be injected. in the event of damage to the needle hub, use a new replacement eligard carton. follow the detailed instructions below to ensure correct administration of eligard: 1. select an injection site on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and hasn’t recently been used. 2. cleanse the injection-site area with an alcohol swab (not enclosed). 3. using the thumb and forefinger, grab and bunch the area of skin around the injection site. 5. inject the drug using a slow, steady push and press down on the plunger until the syringe is empty. make sure all the drug has been injected before removing the needle. 6. withdraw the needle quickly at the same 90° angle used for insertion. 7. immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place. 8. an audible and tactile “click” verifies a locked position. 9. check to confirm the safety shield is fully engaged. discard all components safely in an appropriate biohazard container. ©2024 tolmar manufactured by: tolmar, fort collins, co 80526     04006512 rev. 3 01/2024