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nucare pharmaceuticals, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 30 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ).  a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.  the effectiveness of mirtazapine tablets i

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

nucare pharmaceuticals,inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 30 mg - mirtazapine tablets, usp are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders -3 rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.   the effectiveness of mirtazap

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

nucare pharmaceuticals,inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets, usp are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders -3 rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.   the effectiveness of mirtazap

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

preferred pharmaceuticals inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ).  a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.  the effectiveness of mirtazapine tablets in

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

twi pharmaceuticals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - warning: secondary exposure to testosterone see full prescribing information for complete boxed warning. - virilization has been reported in children who were secondarily exposed to testosterone gel (5.2, 6.2). - children should avoid contact with unwashed or unclothed application sites in men using testosterone gel (2.2, 5.2). - healthcare providers should advise patients to strictly adhere to recommended instructions for use (2.2, 5.2, 17). - testosterone gel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions (5.1) and adverse reactions (6.1)]. - testosterone gel 1.62% is contraindicated in women who are pregnant. testosterone gel 1.62% can cause virilization of the female fetus when administered to a pregnant woman. pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1.62%. if a pregnant woman is exposed to testosterone gel 1.62%, she should be apprised of the potential hazard to the fetus [see warnings and precautions (5.2) and use in specific populations (8.1)] . risk summary testosterone gel 1.62% is contraindicated in pregnant women. testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see contraindications (4) and clinical pharmacology (12.1)] . exposure of a female fetus to androgens may result in varying degrees of virilization. in animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. these studies did not meet current standards for nonclinical development toxicity studies. data animal data in developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. risk summary androgel 1.62% is not indicated for use in women. infertility testis disorder, testicular atrophy, and oligospermia have been identified during use of androgel 1.62% [see adverse reactions (6.1, 6.2)] . during treatment with large doses of exogenous androgens, including androgel 1.62%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions (5.8)] . reduced fertility is observed in some men taking testosterone replacement therapy. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see drug abuse and dependence (9.2)] . with either type of use, the impact on fertility may be irreversible. the safety and effectiveness of testosterone gel 1.62% in pediatric patients less than 18 years old has not been established. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. of the 234 patients enrolled in the clinical trial utilizing testosterone gel 1.62%, 21 were over 65 years of age. additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph. no studies were conducted involving patients with renal impairment. no studies were conducted in patients with hepatic impairment. testosterone gel 1.62% contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. instruction for use testosterone (tes-tos-ter-one) gel ciii 1.62% for topical use read this instructions for use for testosterone gel 1.62% before you start using it and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. applying testosterone gel 1.62%: - testosterone gel 1.62% comes in a pump. - before applying testosterone gel 1.62% make sure that your shoulders and upper arms are clean, dry, and that there is no broken skin. - testosterone gel 1.62% is to be applied to the area of your shoulders and upper arms that will be covered by a short sleeve t-shirt (see figure a). do not apply testosterone gel 1.62% to any other parts of your body such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees. (figure a) if you are using testosterone gel 1.62% pump: - before using a new bottle of testosterone gel 1.62 % for the first time, you will need to remove the cap and then prime the pump. to prime the testosterone gel 1.62% pump, slowly push the pump all the way down 3 times, over the sink drain. do not use any testosterone gel 1.62% that came out while priming. wash it down the sink to avoid accidental exposure to others. your testosterone gel 1.62% pump is now ready to use. - remove the cap from the pump. then, put the spout opening at the top of the pump where the medicine comes out over the palm of your hand and slowly push the pump all the way down. apply testosterone gel 1.62% to the application site. you may also apply testosterone gel 1.62% directly to the application site. your healthcare provider will tell you the number of times to press the pump for each dose. - wash your hands with soap and water right away. find your dose as prescribed by your healthcare provider how should i store testosterone gel 1.62%? - store testosterone gel 1.62% at room temperature between 59ºf to 86ºf (15ºc to 30ºc). - when it is time to throw away the pump, safely throw away used testosterone gel 1.62% in household trash. be careful to prevent accidental exposure of children or pets. - keep testosterone gel 1.62% away from fire. keep testosterone gel 1.62% and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration manufactured for: twi pharmaceuticals usa, inc. paramus, nj 07652 manufactured by: twi pharmaceuticals, inc. taoyuan city, 32063, taiwan revised: 07/22

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nucare pharmaceuticals,inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. drug interactions coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to s

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

eton pharmaceuticals, inc. - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - alkindi sprinkle is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. alkindi sprinkle is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in alkindi sprinkle. anaphylactic reactions have occurred in patients receiving corticosteroids [see adverse reactions (6.2)] . risk summary untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. the use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is 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 human data available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. however, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications. in addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. animal data corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring. risk summary cortisol is present in human milk. the use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. there are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alkindi sprinkle and any potential adverse effects on the breastfed infant from alkindi sprinkle or from the underlying maternal condition. the safety and effectiveness of alkindi sprinkle have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. use of alkindi sprinkle in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. no new adverse reactions were identified [see adverse reactions (6) and clinical pharmacology (12.3)] . alkindi sprinkle are oral granules contained within capsules that must be opened and not swallowed whole to administer the granules. additionally, alkindi sprinkle granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage [see dosage and administration (2.2)] . instructions for use alkindi® sprinkle(ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules read this instructions for use before you start using alkindi sprinkle, 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 child's medical condition or treatment. important information you need to know before giving alkindi sprinkle - alkindi sprinkle comes in a capsule that must be opened before use. - do not let your child swallow the capsule. small children may choke. - do not let your child chew or crush the granules in the capsule. - do not let the capsules get wet as this may make some of the granules stick to the capsule. - your healthcare provider will decide the right dose of alkindi sprinkle for your child. follow your healthcare provider's instructions for the dose of alkindi sprinkle to give your child. - ask your healthcare provider or pharmacist if you are not sure how to prepare or give the prescribed dose of alkindi sprinkle to your child. - call your healthcare provider if granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing alkindi sprinkle. your child may not have received the full dose of alkindi sprinkle and another dose of alkindi sprinkle may be needed. - your child may sometimes pass the alkindi sprinkle granules in their stools (bowel movement). it does not mean that alkindi sprinkle is not working. do not give your child another dose of alkindi sprinkle. supplies needed to give alkindi sprinkle: - alkindi sprinkle capsule(s) for prescribed dose - 1 spoon - soft food such as yogurt or pureed fruit or sip of fluids such as water, milk, breastmilk or formula preparing and giving alkindi sprinkle: step 1: check the expiration date on the alkindi sprinkle bottle. do not use alkindi sprinkle after the expiration date on the bottle has passed. step 2: remove the prescribed dose of alkindi sprinkle capsules from the bottle. step 6: giving alkindi sprinkle alkindi sprinkle can be given (a) with food onto a spoon, (b) without food onto a spoon, or (c) directly into the child's mouth. do not add the granules to a fluid before giving alkindi sprinkle because it can result in less than the full dose given and it may leave a bitter taste in the mouth. (c) directly onto the child's tongue. pour all granules that make up the prescribed dose directly onto the child's tongue. tap the capsule to make sure all granules are removed. the alkindi sprinkle granules should be given and swallowed within 5 minutes to avoid a bitter taste. step 7: give fluids after giving alkindi sprinkle, give a sip of fluids such as water, milk, breastmilk or formula right away to make sure all granules are swallowed. throwing away (disposal of) alkindi sprinkle: ask your pharmacist how to throw away medicines you no longer use. how should i store alkindi sprinkle? - store alkindi sprinkle at room temperature between 68°f to 77°f (20°c to 25°c). - store in the original bottle to protect from light. - after the bottle has been opened, use the alkindi sprinkle capsules within 60 days. keep alkindi sprinkle and all medicines out of the reach of children. alkindi sprinkle is manufactured for eton pharmaceuticals, inc. by glatt pharmaceutical services gmbh & co. kg werner-glatt-strasse 1, binzen, baden-wuerttemberg, 79589, germany alkindi® is a registered trademark of diurnal limited. alkindi is covered by the following us patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. for more information, go to www.alkindisprinkle.com or call 1-833-343-2500. this instructions for use has been approved by the u.s. food and drug administration. revised: 12/2022

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camber pharmaceuticals, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate tablets is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate tablets, are metabolized to 5-hydroxymethyl tolterodine.

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boehringer ingelheim pharmaceuticals, inc. - spesolimab (unii: 5ib2j79mcx) (spesolimab - unii:5ib2j79mcx) - spevigo is indicated for the treatment of generalized pustular psoriasis (gpp) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. spevigo is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in spevigo. reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (dress) [see warnings and precautions (5.3) and adverse reactions (6.1)] . risk summary the limited data on the use of spevigo in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. human igg is known to cross the placental barrier; therefore, spevigo may be transmitted from the mother to the developing fetus. in an animal reproduction study, intravenous administration of a surrogate antibody against il36r in mice during the period of organogenesis did not elicit any reproductive toxicity (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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data embryo-fetal development and pre- and postnatal development toxicity studies were performed in mice using a surrogate mouse specific il36r antagonist monoclonal antibody. in the embryo-fetal development study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly during the period of organogenesis. the surrogate was not associated with embryo-fetal lethality or fetal malformations. in the pre- and postnatal development toxicity study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly from gestation day 6 through lactation day 18. there were no maternal effects observed. there were no treatment-related effects observed on postnatal developmental, neurobehavioral, or reproductive performance of offspring. risk summary there are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for spevigo and any potential adverse effects on the breastfed infant from spevigo or from the underlying maternal condition. the safety and effectiveness of spevigo for the treatment of gpp have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. use of spevigo for this indication is supported by data from a randomized, placebo-controlled study which included 6 pediatric subjects 14 to 17 years of age with a history of gpp treated with subcutaneous spevigo (study effisayil-2) and evidence from an adequate and well-controlled study of intravenous spevigo in adults with gpp (study effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of spevigo in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established. there were 2 (6%) intravenous spevigo-treated subjects 65 to 74 years of age and no subjects 75 years of age or older in study effisayil-1. there were 6 (7%) subcutaneous spevigo-treated subjects 65 to 74 years of age and 1 (1%) subject 75 years of age in study effisayil-2. clinical studies of spevigo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. this instructions for use contains information on how to inject spevigo. read both sides of this instructions for use before you use spevigo for the first time 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 or your child's medical condition or treatment. your healthcare provider should show you or your child the right way to inject spevigo before you try to inject yourself or your child for the first time. in children 12 to 17 years of age, spevigo should be given under supervision of an adult. spevigo comes in a prefilled syringe with a safety cover. spevigo is for one-time use only. do not reuse the prefilled syringes. your healthcare provider has prescribed a dose of spevigo for you or your child that requires 2 injections (2 prefilled syringes) to deliver a complete dose. you must inject the contents of both spevigo prefilled syringes that come in the carton to deliver the complete dose. getting to know spevigo: spevigo comes in a prefilled syringe with a safety cover. the needle is pulled back into the safety cover after injection. guide to parts: the figure below shows spevigo before use, and after use with the activated safety cover. important information you need to know before injecting spevigo: - you must inject the contents of both spevigo prefilled syringes to deliver a complete dose. - inspect the spevigo carton to be sure that you have the correct medicine, 2 prefilled syringes for your or your child's prescribed dose, for any damage, and the expiration date. - do not use spevigo if the liquid is cloudy or contains flakes or large or colored particles. - do not use spevigo if the expiration date (exp) has passed. - do not use spevigo if the prefilled syringe has been dropped. - do not remove the cap until you are ready to inject. - inject spevigo under the skin (subcutaneous injection) in either the upper thighs or stomach-area (abdomen). do not inject spevigo into any other area of the body. storing spevigo: - store spevigo prefilled syringes in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze spevigo. do not use spevigo if frozen, even if it has been thawed. - store spevigo in the original carton until use to protect from light. keep spevigo and all medicines out of the reach of children. - take the spevigo carton out of the refrigerator and remove the prefilled syringes from the carton. - gather supplies listed above and place them on a clean, flat work surface in a well-lit area. - if you do not have all the supplies listed above, contact your pharmacist. - see step 10: "disposing of the used spevigo prefilled syringes and caps." - wait 15 to 30 minutes to allow the medicine to reach room temperature to avoid discomfort during injection. do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water. - do not leave the prefilled syringes in direct sunlight. - do not remove the needle cap until you are ready to inject. - wash your hands well with soap and water and dry them. - check to make sure the medicine name spevigo and dose on your prefilled syringes match your or your child's prescribed dose. - check the expiration date on both prefilled syringes. do not use if the expiration date has passed. - check both prefilled syringes for damage, cracks, and leakage. do not use if any part of the prefilled syringes appear cracked, broken, or are leaking. - make sure the medicine in both prefilled syringes is clear and colorless to slightly brownish-yellow. it may contain tiny white or clear particles. do not use if the medicine is cloudy or has flakes or large or colored particles in it. - it is normal to see air bubbles, they do not need to be removed. - do not use if the spevigo prefilled syringes have been dropped. - you may use an area on your: upper thighs or stomach-area (abdomen) , except for an area 2 inches around your navel (belly button). - upper thighs or - stomach-area (abdomen) , except for an area 2 inches around your navel (belly button). - choose a different injection site each time you inject, at least 1 inch away from the last injection site. alternate between upper thigh or stomach-area for each complete dose. - do not inject an area near your waistline or belly button. - do not inject into areas that are tender, bruised, red, hard, or scarred. - do not inject through clothes. - clean the injection site with an alcohol wipe and let air dry. - do not touch this area again before injecting. - do not fan or blow on the clean area. - hold the prefilled syringe by the finger grip with one hand. with the other hand, pull the cap straight off. do not pull on or hold the plunger rod. do not twist the cap. twisting the cap could damage the needle. do not use the prefilled syringe if the needle is bent or damaged. if you accidentally bend the needle, do not attempt to straighten it. - do not pull on or hold the plunger rod. - do not twist the cap. twisting the cap could damage the needle. - do not use the prefilled syringe if the needle is bent or damaged. if you accidentally bend the needle, do not attempt to straighten it. - throw away the cap. see step 10: "disposing of the used spevigo prefilled syringes and caps. - inject spevigo right away after removing the cap. do not try to recap the needle. re-capping can lead to needle-stick injury. do not touch the needle or let the needle touch anything before injecting. - do not try to recap the needle. re-capping can lead to needle-stick injury. - do not touch the needle or let the needle touch anything before injecting. - gently pinch the area of cleaned skin around your injection site and hold it firmly. - keep the skin pinched during the entire injection. you will inject into the pinched skin. - do not let go until you have removed the needle from your skin at end of the injection. - hold the prefilled syringe by the blue finger grip. avoid touching the blue thumb pad. - using a quick, "dart-like" motion, insert the needle into the pinched skin at about a 45-degree angle . - do not move the needle while inserting or during the injection. - use your thumb to slowly press down on the blue thumb pad to push the plunger rod down inside the syringe body. - continue pressing on the blue thumb pad until the plunger rod has moved all the way down. - make sure that the blue thumb pad cannot be pressed any further so that the built-in safety cover can be activated. - slowly remove your thumb from the blue thumb pad, to move the needle out of your skin and up into the safety cover. check that the thumb pad springs back and that the needle is inside the safety cover. if the needle is not inside the safety cover call your healthcare provider. you may not have received a full dose. - check that the thumb pad springs back and that the needle is inside the safety cover. - if the needle is not inside the safety cover call your healthcare provider. you may not have received a full dose. - if there is bleeding, press a cotton ball or gauze on the site for a few seconds. - do not rub the injection site. - apply an adhesive bandage if needed. - choose a different injection site. the new injection site should be at least 1 inch away from last injection site. alternate between upper thigh or stomach-area for each complete dose. - get second prefilled syringe. - repeat steps 4 through 8 right away. - then continue to step 10. - put the used prefilled syringes and caps in an fda-cleared sharps disposal container right away after use. - do not throw away (dispose of) the prefilled syringes and caps in the household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak resistant, and - properly labeled to warn of hazardous waste inside the container. - do not reuse the prefilled syringes. - do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container. manufactured by: boehringer ingelheim pharmaceuticals, inc., ridgefield, ct 06877 usa us license number 2006 licensed from: boehringer ingelheim international gmbh, ingelheim, germany spevigo is a registered trademark of and used under license from boehringer ingelheim international gmbh. copyright © 2024 boehringer ingelheim international gmbh all rights reserved col12534ac152024 for more information about spevigo, including current prescribing information and medication guide, go to www.spevigo.com , scan the code below, or call boehringer ingelheim pharmaceuticals, inc. at 1-800-542-6257. this instructions for use has been approved by the u.s. food and drug administration. approved: 03/2024

Philippines - English - FDA (Food And Drug Administration)

international apex pharmaceuticals inc.; distributor: international apex pharmaceuticals inc. - human normal immunoglobulin (igiv) - solution for injection (iv infusion) - 50mg/ml