forteo delivery device user manual
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forteo delivery device user manualFor more information about Lilly’s privacy practice and to manage third-party preferences, click here.We’re here to help. We’re here to help. Do not use FORTEO if it has been frozen. FORTEO should look clear and colorless. Do not use FORTEO if it has particles in it, or if it is cloudy or colored. After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away. Talk to a healthcare provider about how to rotate injection sites. To help you remember to take FORTEO, take it at about the same time each day. Do not take more than one injection in the same day. It is set to give a 20-microgram dose of medicine each day. Do not inject all the medicine in the FORTEO delivery device at any one time. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness. This can result in taking the wrong dose of FORTEO. Pack the needles you'll need for your trip. Keep FORTEO with you when traveling to prevent it from being damaged, lost, or exposed to extreme temperatures. Do not put FORTEO in the trunk of a car or in checked baggage. Refrigerate FORTEO as soon as you arrive at your destination. Remember, you have the right to bring medically necessary supplies on board a plane. Just follow these steps: You may be asked to verify that the FORTEO delivery device and needles belong to you. Always bring it with you onto the airplane as a carry-on, as the temperature in the checked luggage area is not always controlled and may become too hot or cold. Visit the TSA Website or call the TSA Contact Center toll free at 1-866-289-9673. FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones, or fractures. FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.http://eczanemuhendisleri.com/userfiles/fordson-model-f-manual.xml
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During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy. Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported. Before you take FORTEO, you should also tell your healthcare provider if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. You should also tell your healthcare provider if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking FORTEO. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood. Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO.It is set to give a 20-microgram dose of medicine each day.http://cpils.com/userfiles/fordson-n-tractor-workshop-manual.xml Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO delivery device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO delivery device at any one time. Do not transfer the medicine from the FORTEO delivery device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO delivery device after 28 days even if it has medicine in it (see the User Manual ). See Full User Manual that accompanies the delivery device. Please confirm below. Please confirm below. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit. Then your card will be ready to be shared with your specialty pharmacy. Examples include Medicaid, Medicare, Medicare Part D, and others. See full prescribing information for FORTEO. FORTEO (teriparatide injection) for subcutaneous use Initial U.S. Approval: 1987Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.8, 7.1, 12.3 )The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose.There are no data available on the safety or efficacy of intravenous or intramuscular injection of FORTEO.FORTEO is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.http://stroyzona.com.ua/companynews/eeoc-compliance-manual-religious-discriminationConsequently, use of the drug for more than 2 years during a patient's lifetime is not recommended.Unexplained elevations of alkaline phosphatase may indicate Paget's disease of bone.Consequently, use of the drug for more than 2 years during a patients' lifetime is not recommended.These patients should not be treated with FORTEO because of the possibility of exacerbating hypercalcemia. Patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, should not be treated with FORTEO.However, FORTEO has not been studied in patients with active urolithiasis. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered. FORTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.In short-term clinical pharmacology studies with teriparatide, transient episodes of symptomatic orthostatic hypotension were observed in 5 of patients. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, it was relieved by placing the person in a reclining position, and it did not preclude continued treatment.The median durations of the trials were 11 months for men and 19 months for women, with 691 patients exposed to FORTEO and 691 patients to placebo. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day.The incidence of serious adverse events was 16 in FORTEO patients and 19 in placebo patients. Early discontinuation due to adverse events occurred in 7 of FORTEO patients and 6 of placebo patients.There was no evidence of hypersensitivity reactions or allergic reactions among these patients. Antibody formation did not appear to have effects on serum calcium, or on bone mineral density (BMD) response.Serum calcium measured at least 16 hours post-dose was not different from pretreatment levels. In clinical trials, the frequency of at least 1 episode of transient hypercalcemia in the 4 to 6 hours after FORTEO administration was increased from 2 of women and none of the men treated with placebo to 11 of women and 6 of men treated with FORTEO. The number of patients treated with FORTEO whose transient hypercalcemia was verified on consecutive measurements was 3 of women and 1 of men.In clinical trials, 3 of FORTEO patients had serum uric acid concentrations above the upper limit of normal compared with 1 of placebo patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.Assessments included creatinine clearance; measurements of blood urea nitrogen (BUN), creatinine, and electrolytes in serum; urine specific gravity and pH; and examination of urine sediment.The duration of the trial was 18 months with 214 patients exposed to FORTEO and 214 patients exposed to oral daily bisphosphonate (active control). All patients received 1000 mg of calcium plus 800 IU of vitamin D supplementation per day.The incidence of serious adverse events was 21 in FORTEO patients and 18 in active control patients, and included pneumonia (3 FORTEO, 1 active control). Early discontinuation because of adverse events occurred in 15 of FORTEO patients and 12 of active control patients, and included dizziness (2 FORTEO, 0 active control).Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.The causality to FORTEO use is unclear.Consider discontinuing FORTEO when pregnancy is recognized.The background risk in the US general population of major birth defects is 2 to 4 and of miscarriage is 15 to 20 of clinically recognized pregnancies.When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings.There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.FORTEO should not be prescribed in patients at an increased baseline risk of osteosarcoma which include pediatric and young adult patients with open epiphyses.Of the patients receiving FORTEO in the osteoporosis trial of 437 men, 39 were 65 years of age and over and 13 were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.The effects of overdose that might be expected include a delayed hypercalcemic effect and risk of orthostatic hypotension. Nausea, vomiting, dizziness, and headache might also occur.In some cases, no adverse events occurred as a result of the overdose. No fatalities associated with overdose have been reported.Treatment of suspected overdose should include discontinuation of FORTEO, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.FORTEO is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection.Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues.In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.The timing of these dose reductions was at the discretion of the investigator. FORTEO dose adjustments were made at varying intervals after the first observation of increased serum calcium (median 21 weeks). During these intervals, there was no evidence of progressive increases in serum calcium.Sustained hypercalcemia was not observed.However, hypophosphatemia ( In the placebo group, this concentration decreased by 2 in women and increased by 5 in men. The median serum 25-hydroxyvitamin D concentration at 12 months was decreased by 19 in women and 10 in men compared with baseline. In the placebo group, this concentration was unchanged in women and increased by 1 in men.Data on biochemical markers of bone turnover were available for the first 12 months of treatment. Peak concentrations of PICP at 1 month of treatment were approximately 41 above baseline, followed by a decline to near-baseline values by 12 months. BSAP concentrations increased by 1 month of treatment and continued to rise more slowly from 6 through 12 months. The maximum increases of BSAP were 45 above baseline in women and 23 in men. After discontinuation of therapy, BSAP concentrations returned toward baseline. The increases in formation markers were accompanied by secondary increases in the markers of bone resorption: urinary N-telopeptide (NTX) and urinary deoxypyridinoline (DPD), consistent with the physiological coupling of bone formation and resorption in skeletal remodeling. Changes in BSAP, NTX, and DPD were lower in men than in women, possibly because of lower systemic exposure to teriparatide in men.The rates of absorption and elimination are rapid. The peptide reaches peak serum concentrations about 30 minutes after subcutaneous injection of a 20-mcg dose and declines to non-quantifiable concentrations within 3 hours.The longer half-life following subcutaneous administration reflects the time required for absorption from the injection site.However, the mechanisms of metabolism and elimination of PTH(1-34) and intact PTH have been extensively described in published literature. Peripheral metabolism of PTH is believed to occur by non-specific enzymatic mechanisms in the liver followed by excretion via the kidneys.However, sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity.The 24-hour urine excretion of calcium was reduced by a clinically unimportant amount (15).These doses resulted in systemic exposures that were, respectively, 3, 20, and 60 times higher than the systemic exposure observed in humans following a subcutaneous dose of 20 mcg (based on AUC comparison). Teriparatide treatment resulted in a marked dose-related increase in the incidence of osteosarcoma, a rare malignant bone tumor, in both male and female rats. Osteosarcomas were observed at all doses and the incidence reached 40 to 50 in the high-dose groups. Teriparatide also caused a dose-related increase in osteoblastoma and osteoma in both sexes. No osteosarcomas, osteoblastomas or osteomas were observed in untreated control rats. The bone tumors in rats occurred in association with a large increase in bone mass and focal osteoblast hyperplasia.The study showed that the occurrence of osteosarcoma, osteoblastoma and osteoma was dependent upon dose and duration of exposure. The results did not demonstrate a difference in susceptibility to bone tumor formation, associated with teriparatide treatment, between mature and immature rats.Bone tumors were not detected by radiographic or histologic evaluation in any monkey in the study.Baseline and endpoint spinal radiographs were evaluated using the semiquantitative scoring. Ninety percent of the women in the study had 1 or more radiographically diagnosed vertebral fractures at baseline. The primary efficacy endpoint was the occurrence of new radiographically diagnosed vertebral fractures defined as changes in the height of previously undeformed vertebrae. Such fractures are not necessarily symptomatic.This difference was statistically significant (p seeStatistically significant increases were seen at 3 months and continued throughout the treatment period. Postmenopausal women with osteoporosis who were treated with FORTEO had statistically significant increases in BMD from baseline to endpoint at the lumbar spine, femoral neck, total hip, and total body ( seeSeventy-two percent of patients treated with FORTEO achieved at least a 5 increase in spine BMD, and 44 gained 10 or more.The mean decreases were 3.61 and 2.81 mm in the placebo and FORTEO groups, respectively.The new bone formed with teriparatide was of normal quality (as evidenced by the absence of woven bone and marrow fibrosis).The primary efficacy endpoint was change in lumbar spine BMD.Statistically significant increases were seen at 3 months and continued throughout the treatment period. FORTEO was effective in increasing lumbar spine BMD regardless of age, baseline rate of bone turnover, and baseline BMD. The effects of FORTEO at additional skeletal sites are shown in Table 4.Fifty-three percent of patients treated with FORTEO achieved at least a 5 increase in spine BMD, and 14 gained 10 or more.A total of 30 of patients had prevalent vertebral fracture(s) and 43 had prior non-vertebral fracture(s). The patients had chronic rheumatologic, respiratory or other diseases that required sustained glucocorticoid therapy. All patients received 1000 mg of calcium plus 800 IU of vitamin D supplementation per day.In patients treated with FORTEO, the mean percent change in BMD from baseline to endpoint was 7.2 at the lumbar spine, 3.6 at the total hip, and 3.7 at the femoral neck (p Patients should be instructed that if they feel lightheaded or have palpitations after the injection, they should sit or lie down until the symptoms resolve.The contents of the delivery device should NOT be transferred to a syringe.After the 28-day use period, discard the FORTEO delivery device, even if it still contains some unused solution.Patients need to understand and follow the instructions in the FORTEO delivery device User Manual. Failure to do so may result in inaccurate dosing.Also, read the User Manual that comes with the FORTEO delivery device (pen) for information on how to use the device to inject your medicine the right way. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.FORTEO may help to form new bone, increase bone mineral density and bone strength.FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who can not use other osteoporosis treatments.These include men and women with either a history of broken bones, who have several risk factors for fracture, or who can not use other osteoporosis treatments.See the end of this Medication Guide for a complete list of the ingredients in FORTEO.It is not known if FORTEO will harm your unborn baby.You should not breast-feed while taking FORTEO.Your healthcare provider needs this information to help keep you from taking FORTEO with other medicines that may harm you.Talk to a healthcare provider about how to rotate injection sites.It is set to give a 20 microgram dose of medicine each day. Do not inject all the medicine in the FORTEO delivery device at any one time.This can result in taking the wrong dose of FORTEO. If you do not have pen needles to use with your FORTEO delivery device, talk with your healthcare provider.Do not use FORTEO if it has particles in it, or if it is cloudy or colored.To help you remember to take FORTEO, take it at about the same time each day.Do not take more than one injection in the same day.If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take FORTEO.Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider.Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.Also, your healthcare provider may ask you to have follow-up tests of bone mineral density.For more information, ask your doctor or pharmacist.You may report side effects to FDA at 1-800-FDA-1088.Do not use FORTEO if it has been frozen.Do not use FORTEO for a condition for which it was not prescribed. Do not give FORTEO to other people, even if they have the same condition you have.If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FORTEO that is written for healthcare professionals. For more information, go to www.FORTEO.com or call Lilly at 1-866-436-7836.Osteoporosis usually causes no symptoms until a fracture happens. The most common fractures are in the spine (backbone). They can shorten height, even without causing pain. Over time, the spine can become curved or deformed and the body bent over. Fractures from osteoporosis can also happen in almost any bone in the body, for example, the wrist, rib, or hip. Once you have had a fracture, the chance for more fractures greatly increases.Follow the directions carefully when using the FORTEO delivery device. Throw away the FORTEO delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of FORTEO in the same day. Prepare the injection site as your healthcare provider instructed. Do not use if the FORTEO delivery device looks damaged, if the medicine in the cartridge is not clear and colorless, or if it has particles in it.Hold it in and count to 5 Then pull the needle from skin.Check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have finished the injection steps the right way.If you do and have already injected the medicine, do not inject yourself a second time on the same day. Instead, you MUST reset the FORTEO delivery device (see Troubleshooting, Problem A, on back page).Do not try to put the needle cover back on with your hands.Right after use, place FORTEO delivery device in the refrigerator. How do I reset my FORTEO delivery device? Check to make sure the red stripe shows.Push in the black injection button until it stops. Hold it in and slowly count to five. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in. Unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. Pull off the covered needle and throw away as instructed by your healthcare provider. Push the white cap back on, and put your FORTEO delivery device in the refrigerator. You can continue to take your dose as usual.You may still see some medicine left in the cartridge.Read and follow the instructions in the Medication Guide section “ How should I store FORTEO? ”.Doing this may cause air bubbles to form in the medicine cartridge.If the FORTEO delivery device has been frozen, throw the device away and use a new FORTEO delivery device.Place the delivery device back in the refrigerator and call Eli Lilly and Company at 1-866-4FORTEO (1-866-436-7836). This may result in you taking the wrong dose of medicine.Look at the FORTEO medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Eli Lilly and Company if you notice any of these (see Contact Information ).For more information about FORTEO, go to www.FORTEO.com. All rights reserved. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Also, read the User Manual that comes with the FORTEO delivery device (pen) for information on how to use the device to inject your medicine the right way. Once you have had a fracture, the chance for more fractures greatly increases. Read this Medication Guide before you start taking FORTEO and each time you get a refill. Before you use FORTEO Your health care professional should teach you how to use the FORTEO pen. Please refer to the User Manual for instructions for the pen. Before you use your new pen, please read the section Instructions for use completely. There may be new information. This site provides a FORTEO Delivery Device User Manual and a FORTEO Delivery Device Demonstration Video, which show you how to use your FORTEO Delivery Device to give yourself injections (or how a caregiver can do them for you). Pen Features. Also read the package leaflet provided. ? Check the FORTEO delivery device label to make sure you have the right medicine and that it has not expired. When to use it. Important Safety Information about FORTEO. The FORTEO delivery device has enough medicine for forteo delivery device user manual 28 days. Do not use the FORTEO delivery device if it looks damaged. Do not use FORTEO if it has been frozen.Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual). Pam Flores Nov 18, if you weren't constantly following the user manual. Do not use if solid particles appear or if the solution is cloudy or coloured. FORTEO should be administered initially under informatiion where the patient can sit or lie down if symptoms forteo delivery device user manual of orthostatic hypotension occur. Call FORTEO () if you need help on how to use your delivery device. You can take FORTEO with or without food or drink. Do not use FORTEO if it has forteo delivery device user manual been frozen. Nonclinical Toxicology. Throw away the Forteo delivery device after 28 days even if it has medicine in it (see the User Manual). Your healthcare professional (doctor or nurse) should teach you how to use the FORTEO pen (multidose prefilled delivery device). The FORTEO delivery device has enough medicine for 28 days. If your FORTEO delivery device isn’t working as it should, please forteo delivery device user manual review the troubleshooting guide. ? Do not use the FORTEO delivery device if it looks damaged. Keep FORTEO and all medicines out of the reach of children. Read and follow the instructions in theUser Manual so that you use your FORTEO delivery device the right way. Patients need to understand and follow the instructions in the FORTEO delivery device User Manual. 4. It is a good idea to refer to the user manual each time you inject. Do not use Forteo after the expiration date printed on the delivery device and packaging. aschindler. Also, read the User Manual that comes with the FORTEO delivery device (pen) for information on how to use the device to inject your medicine the right way. Also, read the User Manual that comes with the FORTEO forteo delivery device user manual delivery device (pen) for information on how to use the device to inject your medicine the right way. For instructions on how to use your FORTEO delivery device, refer to the User Manual. Find patient medical information for Forteo Subcutaneous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Do not use Forteo after the expiration date printed on the delivery device and packaging. Important Safety Information about FORTEO. Patients must be educated to use the proper injection techniques. Read the user manual and package delivery device). After the day use period, discard the Forteo pen, even if it still contains some unused solution. Throw away the FORTEO delivery device after 28 days even if it has medicine in it (see the User Manual). Most people tire of reading the user manual everyday, because it Author: Pam Flores. Do not use FORTEO if. For more safety information, please see Medication Guide and Full Prescribing Informationincluding Boxed Warning regarding osteosarcoma. Do not use FORTEO if it has been frozen. Failure to do so may result in inaccurate dosing. It is set to give a microgram dose of medicine each day. Advise patient to administer medication at same time each day. Pharmacology. Pen Features.