ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

boehringer ingelheim (malaysia) sdn. bhd. - dabigatran etexilate mesilate -

إسرائيل - الإنجليزية - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 20 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

إسرائيل - الإنجليزية - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 30 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

إسرائيل - الإنجليزية - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 40 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

إسرائيل - الإنجليزية - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 50 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

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

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - amlodipine besilate 13.870mg eqv amlodipine; telmisartan - tablet - 10mg - amlodipine besilate 13.870mg eqv amlodipine 10mg; telmisartan 40mg

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - amlodipine besilate 6.935 mg eqv amlodipine; telmisartan - tablet - 5mg - amlodipine besilate 6.935 mg eqv amlodipine 5mg; telmisartan 40mg

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - amlodipine besilate 13.870mg eqv amlodipine; telmisartan - tablet - 10 mg - amlodipine besilate 13.870mg eqv amlodipine 10 mg; telmisartan 80.000mg

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - amlodipine besilate 6.935mg eqv amlodipine; telmisartan - tablet - 5 mg - amlodipine besilate 6.935mg eqv amlodipine 5 mg; telmisartan 80.000 mg