Where is depo provera manufacturer

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Regina's Rock Station, WOW XMFM Country! The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. Although Depo-Provera CI should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy.

Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development. A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. The use of Depo-Provera CI may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the Warnings and Precautions section 5 :. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two clinical trials with Depo-Provera CI, over 3, women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Depo-Provera CI. The patients received mg Depo-Provera CI every 3-months 90 days. The median study duration was 13 months with a range of 1—84 months. The following adverse reactions have been identified during post approval use of Depo-Provera CI. 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.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Depo-Provera CI.

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives.

Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:. HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes increase or decrease in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors.

Significant changes increase or decrease in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors. Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

The pathologist should be advised of progestin therapy when relevant specimens are submitted. Depo-Provera CI should not be administered during pregnancy. Depo-Provera CI is not indicated before menarche. It is unknown if use of Depo-Provera CI by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

This product has not been studied in post-menopausal women and is not indicated in this population. The effect of renal impairment on Depo-Provera CI pharmacokinetics has not been studied. The effect of hepatic impairment on Depo-Provera CI pharmacokinetics has not been studied. Depo-Provera CI should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. Depo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient.

Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. Depo-Provera CI medroxyprogesterone acetate [MPA] inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

MPA binding occurs primarily to serum albumin. MPA is extensively metabolized in the liver by P enzymes. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Depo-Provera CI is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

In five clinical studies using Depo-Provera CI, the month failure rate for the group of women treated with Depo-Provera CI was zero no pregnancies reported to 0. The effectiveness of Depo-Provera CI is dependent on the patient returning every 3 months 13 weeks for reinjection.

The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years. Mean changes in lumbar spine BMD of Mean decreases in BMD of the total hip and femoral neck were similar.

Longer duration of treatment was associated with less complete recovery during this 2-year period following the last injection. Table 4 shows the change in BMD in women after 5 years of treatment with Depo-Provera CI and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2-year post treatment data were available.

The impact of Depo-Provera CI mg use for up to weeks 4. Partway through the trial, drug administration was stopped at weeks. The mean number of injections per Depo-Provera CI user was 9.

Table 5 summarizes the study findings. The decline in BMD at total hip and femoral neck was greater with longer duration of use. The mean decrease in BMD at weeks was more pronounced at total hip Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche. However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.

Table 6 shows the extent of recovery of BMD up to 60 months post-treatment for adolescents who received Depo-Provera CI for two years or less compared to more than two years. Post-treatment follow-up showed that, in women treated for more than two years, only lumbar spine BMD recovered to baseline levels after treatment was discontinued. Adolescents treated with Depo-Provera CI for more than two years did not recover to their baseline BMD level at femoral neck and total hip even up to 60 months post-treatment.

Adolescents in the untreated cohort gained BMD throughout the trial period data not shown [see Warnings and Precautions 5. A retrospective cohort study to assess the association between Depo-Provera CI injection and the incidence of bone fractures was conducted in , female contraceptive users in the UK. It is not known if this is due to Depo-Provera CI use or to other related lifestyle factors that have a bearing on fracture rate. In the study, when cumulative exposure to Depo-Provera CI was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections.

However, it is not clear that cumulative exposure, which may include periods of intermittent use separated by periods of non-use, is a useful measure of risk, as compared to exposure measures based on continuous use.

There were very few osteoporotic fractures fracture sites known to be related to low BMD in the study overall, and the incidence of osteoporotic fractures was not found to be higher in Depo-Provera CI users compared to non-users. Importantly, this study could not determine whether use of Depo-Provera CI has an effect on fracture rate later in life.

This product's labeling may have been updated. For the most recent prescribing information, please visit www. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women's health.

If you have any questions about Depo-Provera CI, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you. Depo-Provera CI is intended to prevent pregnancy. Depo-Provera CI is a progestin hormone birth control method that is given by injection a shot to prevent pregnancy.

Your chance of getting pregnant depends on how well you follow the directions for taking your Depo-Provera CI. The more carefully you follow the directions such as returning every 3 months for your next injection , the less chance you have of getting pregnant.

In clinical studies, about 1 out of women got pregnant during the first year that they used Depo-Provera CI. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

If you are breastfeeding or plan to breastfeed, Depo-Provera CI can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Depo-Provera CI. Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Depo-Provera CI and certain other medicines may affect each other, causing serious side effects. Sometimes the doses of other medicines may need to be changed while you are taking Depo-Provera CI.

Some medicines may make Depo-Provera CI less effective at preventing pregnancy, including those listed below. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider or pharmacist before you first start taking Depo-Provera CI or when you get a new medicine. Follow your healthcare provider's instructions about using a back-up method of birth control if you are taking medicines that may make Depo-Provera CI less effective.

What are the possible side effects of Depo-Provera CI? If you need a birth control method for more than 2 years, your healthcare provider may switch you to another birth control method instead of using Depo-Provera CI. If you continue using Depo-Provera CI, your healthcare provider may ask you to have a bone test, especially if you have other risks for weak bones.

When Depo-Provera CI is stopped, your bones may start to regain calcium. However, in a study of teenage girls who used Depo-Provera CI for more than 2 years, their hip bones did not completely recover by 5 years after they stopped using Depo-Provera CI. Taking calcium and Vitamin D and exercising daily may lessen the loss of calcium from your bones.

These are not all the possible side effects of Depo-Provera CI. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. Unusually heavy or continuous bleeding is not a usual effect of Depo-Provera CI and if this happens you should see your healthcare provider right away. With continued use of Depo-Provera CI, bleeding usually decreases and many women stop having periods completely.

When you stop using Depo-Provera CI your menstrual period will usually, in time, return to its normal cycle. Because Depo-Provera CI is a long-acting birth control method, it takes some time after your last shot for its effect to wear off. Most women who try to get pregnant after using Depo-Provera CI get pregnant within 18 months after their last shot.

The length of time you use Depo-Provera CI has no effect on how long it takes you to become pregnant after you stop using it. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about Depo-Provera CI. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about Depo-Provera CI that is written for healthcare providers.

Inactive ingredients: polyethylene glycol , polysorbate 80, sodium chloride, methylparaben, propylparaben, and water for injection.