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

bausch health us, llc - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride 5 mg - librax is indicated to control emotional and somatic factors in gastrointestinal disorders. librax may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. librax is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. controlled substance librax contains chlordiazepoxide hydrochloride, a schedule iv controlled substance and clidinium bromide, which is not a controlled substance. librax is exempted from schedule iv and is not controlled under the controlled substances act. abuse chlordiazepoxide hydrochloride, a component of librax, is a cns depressant with a potential for abuse and addiction. abuse is the

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - emicizumab, quantity: 30 mg - injection, solution - excipient ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - emicizumab, quantity: 150 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - emicizumab, quantity: 105 mg - injection, solution - excipient ingredients: arginine; poloxamer; aspartic acid; histidine; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

genentech, inc. - emicizumab (unii: 7nl2e3f6k3) (emicizumab - unii:7nl2e3f6k3) - hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors. none. risk summary there are no available data on hemlibra use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with emicizumab-kxwh. it is not known whether hemlibra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. risk summary there is no information regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production. human igg is known to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hemlibra and any potential adverse effects on the breastfed child from hemlibra or from the underlying maternal condition. contraception women of childbearing potential should use contraception while receiving hemlibra. the safety and efficacy of hemlibra have been established in pediatric patients. use of hemlibra in pediatric patients with hemophilia a is supported by two randomized trials (haven 1 and haven 3) and two single-arm trials (haven 2 and haven 4). all clinical trials included pediatric patients in the following age group: 47 adolescents (12 years up to less than 18 years). only haven 2 included pediatric patients in the following age groups: 55 children (2 years up to less than 12 years) and five infants (1 month up to less than 2 years). no differences in efficacy were observed between the different age groups [see clinical studies (14)] . the steady-state plasma trough concentrations of emicizumab-kxwh were comparable in adult and pediatric patients older than 6 months at equivalent weight-based doses. lower concentrations of emicizumab-kxwh were predicted in pediatric patients less than 6 months old [see clinical pharmacology (12.3)] . in general, the adverse reactions in hemlibra-treated pediatric patients were similar in type to those seen in adult patients with hemophilia a [see adverse reactions (6.1)] . clinical studies of hemlibra did not include a sufficient number 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. be sure that you read, understand, and follow this instructions for use before injecting hemlibra. your healthcare provider should show you or your caregiver how to prepare, measure, and inject hemlibra properly before you use it for the first time. ask your healthcare provider if you have any questions. important information: - do not inject yourself or someone else unless you have been shown how to by your healthcare provider. - make sure the name hemlibra appears on the box and vial label. - before opening the vial, read the vial label to make sure you have the medicine strength(s) needed to give the dose prescribed by your healthcare provider. - your healthcare provider will determine your dose in milliliters (ml) that you will need to give based on your body weight. - hemlibra comes in multiple strengths. depending on your dose, you may need to use more than one vial to give your total prescribed dose. do not combine hemlibra vials of different concentrations in one injection to give the prescribed dose. - check the expiration date on the box and vial label. do not use if the expiration date has passed. - only use the vial one time. after you inject your dose, dispose of (throw away) any unused hemlibra left in the vial. do not save unused hemlibra in the vial for later use. - only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes. - only use the syringes, transfer needles and injection needles one time. dispose of (throw away) any used syringes and needles in a sharps disposal container. - if your prescribed dose is more than 2 ml, you will need to give more than one injection of hemlibra. storing hemlibra: - store hemlibra in the refrigerator at 36°f to 46°f (2°c to 8°c). do not freeze. - store hemlibra in the original carton to protect the vials from light. - do not shake hemlibra. - take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature before preparing an injection. - before giving the injection, unopened vials of hemlibra may be stored out of the refrigerator and then returned to the refrigerator. hemlibra should not be stored out of the refrigerator: for more than a total of 7 days or at a temperature greater than 86°f (30°c). - for more than a total of 7 days or - at a temperature greater than 86°f (30°c). keep hemlibra and all medicines out of the reach of children. inspecting the hemlibra vial and your supplies: - collect all supplies listed below to prepare and give your injection. - check the expiration date on the box, on the vial label, and on the supplies listed below. do not use if the expiration date has passed. - inspect the supplies for damage. do not use if they appear damaged or if they have been dropped. - place the supplies on a clean, well-lit flat work surface. hemlibra is colorless to slightly yellow in color. do not use the vial if: - the medicine is cloudy, hazy, or colored. - the medicine contains particles. - the cap covering the stopper is missing. - vial containing hemlibra - hemlibra instructions for use - alcohol wipes note: if you need to use more than one vial to inject your prescribed dose, you must use a new alcohol wipe for each vial. - gauze - cotton ball - syringe note: for injection amount up to 1 ml, use a 1 ml syringe. for injection amount between 1 ml and 2 ml, use a 2 ml or 3 ml syringe. - 18 gauge transfer needle with 5 micrometer filter. note: if you need to use more than one vial to inject your prescribed dose, you must use a new transfer needle for each vial. do not use the transfer needle to inject hemlibra. - injection needle with safety shield. you may use a 25, 26 or 27 gauge needle. do not use the injection needle to withdraw hemlibra from vial. - sharps disposal container - before use, allow the vial(s) to warm up to room temperature for about 15 minutes on a clean flat surface away from direct sunlight. - do not try to warm the vial by any other way. - wash your hands well with soap and water. - clean the chosen injection site area using an alcohol wipe. - let the skin dry for about 10 seconds. do not touch, fan, or blow on the cleaned area before your injection. - you can use your: thigh (front and middle). stomach area (abdomen), except for 2 inches around the navel (belly button). outer area of the upper arm (only if a caregiver is giving the injection). - thigh (front and middle). - stomach area (abdomen), except for 2 inches around the navel (belly button). - outer area of the upper arm (only if a caregiver is giving the injection). - you should use a different injection site each time you give an injection, at least 1 inch away from the area you used for your previous injection. - do not inject into areas that could be irritated by a belt or waistband. do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or the skin is broken. preparing the syringe for injection: - hemlibra must not be stored in the syringe . - hemlibra in the syringe must be injected under the skin (subcutaneous injection) immediately. - dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes in a sharps disposal container. important information after the injection: - do not rub the injection site after an injection. - if you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped. - if you have bruising (small area of bleeding under the skin), an ice pack can also be applied with gentle pressure to the site. if bleeding does not stop, please contact your healthcare provider. disposing of used hemlibra vial(s), needles, and syringes: - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not dispose of (throw away) any loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of 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. properly labeled to warn of hazardous waste inside the container. - made of 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. - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of (throw away) any used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of reach of children. 1. preparation - take the cap off the vial(s). - clean the top of the vial(s) stopper with an alcohol wipe. - dispose of (throw away) the vial cap(s) into the sharps disposal container. - push and twist the transfer needle with filter clockwise on to the syringe until it is fully attached. - slowly pull back on the plunger and draw air into the syringe that is the same amount for your prescribed dose. - hold the syringe by the barrel with the transfer needle pointing up. - carefully pull the transfer needle cap straight off and away from your body. do not throw the cap away. place the transfer needle cap down on a clean flat surface. you will need to recap the transfer needle after transferring the medicine. - do not touch the needle tip or place it on a surface after the needle cap has been removed. - keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the center of the vial stopper. - keep the needle in the vial and turn the vial upside down. - with the needle pointing upwards, push on the plunger to inject the air from the syringe above the medicine. - keep your finger pressed down on the syringe plunger. - do not inject air into the medicine as this could create air bubbles or foam in the medicine. - slide the tip of the needle down so that it is within the medicine. - slowly pull back the plunger to prevent air bubbles/foam. fill the syringe with more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. - keep the needle in the vial and check the syringe for larger air bubbles. too large an air bubble can reduce the dose you receive. - remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. move the tip of the needle above the medicine and slowly push the plunger up to push the air bubbles out of the syringe. - if the amount of hemlibra in the syringe is now at or below your prescribed dose, move the tip of the needle to within the medicine and slowly pull back the plunger until you have more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. - repeat the steps above until you have removed the larger air bubbles. do not use the transfer needle to inject hemlibra as this may cause harm such as pain and bleeding. 2. injection - remove the syringe and transfer needle from the vial. - using one hand, slide the transfer needle into the cap and scoop upwards to cover the needle. - once the needle is covered, push the transfer needle cap towards the syringe to fully attach it with one hand to prevent accidentally sticking yourself with the needle. - select and clean your injection site with an alcohol wipe. - let the skin dry for about 10 seconds. do not touch, fan, or blow on the cleaned area before your injection. - remove the transfer needle from the syringe by twisting counter-clockwise and gently pulling. - dispose of (throw away) the used transfer needle into a sharps disposal container. - push and twist the injection needle clockwise on to the syringe until it is fully attached. - move the safety shield away from the needle and towards the syringe barrel. - carefully pull the injection needle cap away from the syringe. - dispose of (throw away) the cap into a sharps disposal container. - do not touch the needle tip or allow it to touch any surface. - after the injection needle cap has been removed, hemlibra in the syringe must be injected right away. - slowly push the plunger to your prescribed dose. - ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose. - pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action. do not hold or push on the plunger while inserting the needle. - hold the position of the syringe and let go of the pinched injection site. - slowly inject all of hemlibra by gently pushing the plunger all the way down. - remove the needle and syringe from the injection site at the same angle as inserted. 3. disposal - move the safety shield forward 90°, away from the syringe barrel. - holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a "click". - if you do not hear a click, look to see that the needle is fully covered by the safety shield. - keep your fingers behind the safety shield and away from the needle at all times. - do not remove the injection needle from the syringe. - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. for further information, refer to the section "disposing of used hemlibra vial(s), needles, and syringes" above. - do not try to remove the used injection needle from the used syringe. - do not recap the injection needle with the cap. - important: always keep the sharps disposal container out of reach of children. - dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes in a sharps disposal container. if you need to use more than one vial to get to your total prescribed dose, follow these steps after you have drawn up hemlibra from the first vial: - remove the syringe and transfer needle from the first vial. - using one hand , slide the transfer needle into the cap and scoop upwards to cover the needle. - once the needle is covered, push the transfer needle cap toward the syringe to fully attach it with one hand to prevent accidentally sticking yourself with the needle. - remove the transfer needle from the syringe by twisting counter- clockwise and gently pulling. - dispose of (throw away) the used transfer needle into a sharps disposal container. - push and twist a new transfer needle clockwise on to the syringe until it is fully attached. - slowly pull back the plunger and draw some air into the syringe. - hold the syringe by the barrel with the transfer needle cap pointing up. - carefully pull the transfer needle cap straight off and away from your body. do not throw the cap away. you will need to recap the transfer needle after drawing up the medicine. - do not touch the needle tip. - with the new vial on the flat working surface, insert the new transfer needle and syringe, straight down into the center of the vial stopper. - keep the transfer needle in the vial and turn the vial upside down. - with the needle pointing upwards, inject the air from the syringe above the medicine. - keep your finger pressed down on the syringe plunger. - do not inject air into the medicine as this could create air bubbles or foam in the medicine. - slide the tip of the needle down so that it is within the medicine. - slowly pull back the plunger to prevent air bubbles/foam. fill the syringe barrel with more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. do not use the transfer needle to inject hemlibra as this may cause harm such as pain and bleeding. for more information, go to www.hemlibra.com or call 1-866-hemlibra. hemlibra® [emicizumab-kxwh] manufactured by: genentech, inc . a member of the roche group 1 dna way south san francisco, ca 94080-4990 hemlibra® is a registered trademark of chugai pharmaceutical co., ltd., tokyo, japan ©2023 genentech, inc. all rights reserved. u.s. license no. 1048 this instructions for use has been approved by the u.s. food and drug administration. revised: 07/2023

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

afaxys pharma, llc - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.250 mg - vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . vylibra is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see  warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabet

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

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . vylibra is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see  warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabet

European Union - English - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemophilia a - antihemorrhagics - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype.hemlibra can be used in all age groups.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - emicizumab 150 mg/ml - solution for injection - 150 mg/ml - active: emicizumab 150 mg/ml excipient: arginine aspartic acid histidine poloxamer 188 water for injection - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.