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

king bio inc. - official hpus, ammonium phosphoricum, belladonna, colchicum autumnale, formicum acidum, fraxinus excelsior, ledum palustre, natrum carbonicum, nux vomica, and urtica urens., reference image gout.jpg - for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains. reference image gout.jpg uses for temporary relief of pain in the foot, heel, toes and joints including: - swelling - burning - itching - tingling - tearing pains - throbbing - cramps - shooting pains

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

king bio inc. - amanita muscaria fruiting body (unii: dif093i037) (amanita muscaria fruiting body - unii:dif093i037), clematis vitalba flower (unii: 7scp4n87ci) (clematis vitalba flower - unii:7scp4n87ci), lachesis muta venom (unii: vsw71ss07i) (lachesis muta venom - unii:vsw71ss07i), lathyrus sativas seed (unii: 8vp54wot4i) (lathyrus sativas seed - unii:8vp54wot4i), lonicera caprifolium flowering top (unii: 1x0t378sxy) (lonicera caprifolium flowering top - unii:1x0t378sxy), achillea millefolium (unii: 2fxj6sw4pk) (a - uses ​ for temporary relief of: gossip, incessant talking, hastiness, indiscretion, meddling, uneasy feeling during silence. uses for temporary relief of: - gossip - incessant talking - hastiness - indiscretion - meddling - uneasy feeling during silence

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

king bio inc. - aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), gold tribromide (unii: 4pjv3vh75y) (gold tribromide - unii:4pjv3vh75y), oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), artemisia cina pre-flowering top (unii: 28m1820act) (artemisia cina flower - unii:28m1820act), strychnos ignatii seed (unii: 1nm3m2487k) (strychnos ignatii seed - - uses ​ a natural aid for: frightening dreams, night terrors, crying, talking or screaming in sleep, restless tossing, anxiety, jerking, twitching, waking up terrified, general fears day or night, phobias. uses ​a natural aid for: - frightening dreams - night terrors - crying, talking or screaming in sleep - restless tossing - anxiety, jerking, twitching, waking up terrified - general fears day or night - phobias

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

king bio inc. - ammonium phosphate, dibasic (unii: 10lge70fsu) (phosphate ion - unii:nk08v8k8hr), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), colchicum autumnale bulb (unii: 993qhl78e6) (colchicum autumnale bulb - unii:993qhl78e6), formic acid (unii: 0yiw783rg1) (formic acid - unii:0yiw783rg1), fraxinus excelsior bark (unii: r6kcx5h8i2) (fraxinus excelsior bark - unii:r6kcx5h8i2), fraxinus excelsior leaf (unii: rc38362q7m) (fraxinus excelsior leaf - unii:rc38362q7m), ledum palustre twi - uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains. uses  ​for temporary relief of pain in the foot, heel, toes and joints including: - swelling - burning - itching - tingling - tearing pains - throbbing - cramps - shooting pains

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

king bio inc. - arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw) - uses temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. product "uses" have not been evaluated by the fda. product has not been clinically tested. drug facts ____________________________________________________________________________________________________________________ active ingredients                                   purpose† arnica montana.......................................swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion. *hpus indicates inclusion in the official homeopathic pharmacopoeia of the united states.

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

king bio inc. - equal volumes of each hpus ingredient in 10x, 30x, and 1lm potencies., allium cepa, ambrosia artemisiaefolia, arsenicum album, arum triphyllum, arundo mauritanica, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, kali bichromicum, naphthalinum, natrum muriaticum, sabadilla, solidago virgaurea, sticta pulmonaria,  wyethia helenioides., hpus” indicates the active ingredients are in the official homeopathic pharmacopeia of the united states., reference image: allergies.jpg - for temporary relief of allergies in general including hay fever symptoms:  nasal and sinus congestion  runny nose sneezing  coughing  watery eyes  as per various homeopathic materia medicas. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by the fda, and product has not been clinically tested. reference image: allergies.jpg equal volumes of each hpus ingredient in 10x, 30x, and 1lm potencies. allium cepa............. runny nose; itchy eyes, ears, nose or throat ambrosia artemisiaefolia..................nasal and sinus congestion arsenicum album ...................................... exhaustion, hay fever arum triphyllum .......................swollen glands, nasal congestion arundo mauritanica ......................... itching and burning in nose, ears, or roof of mouth euphrasia officinalis.........................sinus irritation and pressure galphimia glauca..........................................excessive sneezing histamin

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

king bio inc. - equal volumes of each hpus ingredient in 10x, 30x, and 1lm potencies., adrenalinum, adrenocorticotrophin (30x), agrimonia eupatoria, flos, anacardium orientale, antimonium crudum, calcarea carbonica,  castanea sativa, flos, cortisone aceticum, fucus vesiculosus, hypothalamus, kali bichromicum, oleander, pituitarum posterium, sabadilla, staphysagria, thyroidinum., **“hpus” indicates the active ingredients are in the official homeopathic pharmacopeia of the united states., reference image:appetite and weight. - temporarily relieves symptoms contributing to:  excessive appetite  constitutional tendency to gain fat cravings for sweets and starches  water retention overeating  ravenous hunger  excess weight abdominal fat as per various homeopathic materia medicas. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by the fda, and product has not been clinically tested. reference image:appetite and weight.jpg  equal volumes of each hpus ingredient in 10x, 30x, and 1lm potencies. adrenalinum ................................increased appetite, indigestion adrenocorticotrophin (30x) ............. fat face, neck, and shoulders agrimonia eupatoria, flos .............................................cravings anacardium orientale ........................... empty feeling in stomach antimonium crudum ...........tendency to grow fat, constant hunger calcarea carbonica ......................ravenous hunger, abdominal fat castanea sativa, flos .............

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

king bio inc. - cairina moschata heart/liver autolysate (unii: rn2hc612gy) (cairina moschata heart/liver autolysate - unii:rn2hc612gy) - cairina moschata heart/liver autolysate 200 [hp_c] in 1 g - uses: temporarily relieves flu-like symptoms, such as: •fever •chills •fatigue •body aches and pains.  † as per various materia medicas product "uses" have not been evaluated by the fda. product has not been clinically tested. ​drug facts ___________________________________________________________________________________________________________________ ​ ​hpus active ingredients                                                               purpose † anas barbariae hepatis et cordis extractum 200 ck.................to reduce the duration and severity of flu-like symptoms the letters hpus indicate that this ingredient is officially included in the homeopathic pharmacopoeia of the united states.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

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

ipsen biopharmaceuticals, inc. - mecasermin (unii: 7gr9i2683o) (mecasermin - unii:7gr9i2683o) - mecasermin 40 mg in 4 ml - severe primary igf-1 deficiency (primary igfd) increlex is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: - severe primary igf-1 deficiency or - growth hormone (gh) gene deletion who have developed neutralizing antibodies to gh. severe primary igf-1 deficiency (igfd) is defined by: - height standard deviation score ≤ –3.0 and - basal igf-1 standard deviation score ≤ –3.0 and - normal or elevated growth hormone (gh). limitations of use: increlex is not a substitute to gh for approved gh indications. increlex is not indicated for use in patients with secondary forms of igf-1 deficiency, such as gh deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids. - known hypersensitivity increlex should not be used by patients who are allergic to mecasermin (rhigf-1) or any of the inactive ingredients in increlex, or who have experienced a severe hypersensitivity to increlex [see warnings and precautions (5.2) and adverse reactions (6.3)]. - closed epiphyses increlex should not be used for growth promotion in patients with closed epiphyses. - malignant neoplasia increlex is contraindicated in pediatric patients with malignant neoplasia or a history of malignancy [see warnings and precautions (5.7) and adverse reactions (6.3)]. risk summary there are no available data on increlex use in pregnant women. exposure to increlex during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure. in animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration of increlex to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times the maximum recommended human dose (mrhd) of 0.24 mg/kg/day based on body surface area (bsa), respectively (see data) . the estimated background risk of 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 animal data studies to assess embryo-fetal toxicity evaluated the effects of increlex during organogenesis in sprague dawley rats given 1, 4, and 16 mg/kg/day and in new zealand white rabbits given 0.125, 0.5, and 2 mg/kg/day, administered intravenously. there were no observed embryo-fetal developmental abnormalities in rats given up to 16 mg/kg/day (11 times the mrhd based on bsa comparison). in the rabbit study, the noael for fetal toxicity was 0.5 mg/kg/day (approximately equivalent to the mrhd based on bsa) due to an increase in fetal death at 2 mg/kg. increlex displayed no teratogenicity or maternal toxicity in rabbits given up to 2 mg/kg (3 times the mrhd based on bsa). risk summary there is no information available on the presence of mecasermin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for increlex and any potential adverse effects on the breast-fed child from increlex or from the underlying maternal condition. toxicity (gasping syndrome) with benzyl alcohol serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/l to 1.378 mmol/l). increlex contains 9 mg/ml benzyl alcohol as a preservative. additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. use of increlex in infants is not recommended [see warnings and precautions (5.8)] . safety and effectiveness in pediatric patients below the age of 2 years of age have not been established. the safety and effectiveness of increlex in patients aged 65 and over has not been established. instructions for use increlex® (eenk-ruh-lex) (mecasermin) injection for subcutaneous use read this instructions for use before you start using increlex and each time you get a refill. there may be new information. this information does not take the place of talking to your child's doctor about your child's medical condition or treatment. do not share your child's needles and syringes with another person. your child may give another person an infection or your child could get an infection from them. important : - inject increlex exactly as your child's doctor or nurse has shown you. - follow your doctor's instructions for the type of syringe and needle to use to prepare and inject your child's dose of increlex . - always use a new, unopened needle and syringe for each injection. - only use single-use, disposable needles and syringes. never reuse disposable needles and syringes. - throw away used needles and syringes in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. supplies needed to give the injection: - 1 vial of increlex - 1 alcohol swab - 1 gauze or cotton ball - alcohol (to clean the skin at the injection site) - 1 sharps container for throwing away (disposing of) used needles and syringes. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. preparing the dose: - wash your hands before getting increlex ready for your child's injection. - check the liquid to make sure it is clear and colorless. do not use if it is cloudy or if you see particles. - check the expiration date printed on the label of the vial. do not use increlex if the expiration date has passed. - if you are using a new vial, remove the protective cap. do not remove the rubber top (see figure 1). figure 1: remove the protective cap - wipe the rubber top on the vial with an alcohol swab (see figure 2). figure 2: wipe rubber top with alcohol swab - before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the increlex dose. put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see figure 3). figure 3: inject air into vial - leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly (see figure 4). figure 4: prepare to withdraw liquid - make sure the tip of the needle is in the liquid (see figure 5). pull the plunger to withdraw the correct dose into the syringe (see figure 6). figure 5: tip in liquidfigure 6: withdraw correct dose - before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see figure 7). figure 7: remove air bubbles and refill syringe - remove the needle from the vial. do not let the needle touch anything. you are now ready to inject (see figure 8). figure 8: ready to inject injecting the dose: inject increlex exactly as your child's doctor or nurse has shown you. do not give the increlex injection if your child is unable to eat within 20 minutes before or after the injection . - put used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - do not try to touch the needle. - 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. - 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 to throw away 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. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol swabs, cotton balls, and gauze may be placed in your household trash. - do not 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. - always keep the sharps disposal container out of the reach of children. how should i store increlex? - before opening : store new, unopened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c). - after opening : store opened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c) for 30 days after you start using the vial. throw away any unused increlex after 30 days. - do not freeze increlex. if a vial freezes, throw it away. - keep increlex out of direct light. - do not use increlex after the expiration date printed on the label. keep increlex and all medicines out of reach of children. this instructions for use has been approved by the u.s. food and drug administration. for additional information, call 855-463-5127. manufactured by: ipsen biopharmaceuticals, inc. cambridge, ma 02142 usa u.s. license no. 2194 www.ipsenus.com revised: october 2023