Bula do remedy Copaxone

the package insert of the medicine Copaxone.

what For?

it Is indicated to reduce the frequency of relapses in patients with multiple sclerosis cross-relapsing.

Contraindications

When should I not use?

The product is contraindicated to patients with known hypersensitivity to acetate glatirâmer or mannitol.

Dosage

How to use?

The recommended dose for adults of Copaxone for the treatment of multiple sclerosis cross-relapsing is 20 mg/day injected subcutaneously. Copaxone should be applied at the same time, every day. The locations indicated for self-injection are the arms, abdomen, hips and thighs. You should use a different location for the application each day, suggesting that-if you follow the clockwise or anti-clockwise, in order to reduce the propensity to irritation or local pain resulting from the injection. The drug was designed for long-term treatment and its use should not be stopped, unless directed by a physician. – Incompatibilities: Copaxone should not be mixed or co-administered with other products in addition to Water for Injection for reconstitution before use. – Use in pediatrics: safety and effectiveness of Copaxone have not been established for individuals younger than 18 years of age. – Use in geriatrics: Copaxone has not been specifically studied with the elderly. – Use in patients with renal insufficiency: the pharmacokinetics of Copaxone in patients with renal failure has not yet been established. – Overdose: daily doses up to 30 mg in humans have not been associated with other side effects, in addition to those mentioned previously. There is no experience with doses higher. There is no reported superdose with Copaxone. There is no specific antidote. The treatment consists of the discontinuation of the use of Copaxone, while the patient is monitored for at least ten hours and is therapy support appropriate to the symptoms.

Side Effects

What are the evils that can cause me?

In controlled clinical trials, the adverse reactions most commonly observed were: reactions at the application site, vasodilation, chest pain, asthenia, infection, pain, nausea, arthralgia, anxiety and hypertonia, depression, dyspnea, urticaria, tachycardia, vertigo and tremor. Immediate reactions after injection: flushing, chest pain, palpitations, anxiety, dyspnea, sensation of throat closing and hives. The symptoms, invariably, were transient and autolimitados, not requiring specific treatment. In general, these symptoms have their onset several months after the beginning of treatment, although they may occur early in the course of the treatment and certain patients may exhibit one or several of these symptoms. Not sure if all of these symptoms gets to be a syndrome, whether these episodes are mediated by an immunological mechanism or not, or whether several similar episodes seen in a given patient have mechanisms identical or not. Chest pain: some of these episodes occurred in the context of the immediate reactions after the injection, as described above; some have occurred at other times. The temporal relationship of the chest pain with the injection of the acetate of glatirâmer has not been established, although the pain was transient (usually lasting only a few minutes) and are often not related to the other symptoms, apparently without clinical consequences. There was no monitoring of the ECG during these episodes. You do not know the pathogenesis of the symptom of.

Warnings and Precautions

what should I know before using?

Administration exclusively by the subcutaneous route. Copaxone should not be administered intravenously. General: patients should be instructed about techniques of self-administration of injection of Copaxone to ensure the security of the administration. Based on the current data, there is no need for special precaution for the patients involved in activities requiring mental alertness such as driving vehicle or operating machinery. There is no evidence or experiences that suggest that the therapy with Copaxone may cause abuse or dependence; however, the risk of dependence has not been systematically evaluated. Considerations involving the use of a product capable of modifying immune response: such as the acetate glatirâmer can modify the immune response, one should consider the possibility that it can interfere with immune function. For example, the treatment with acetate of glatirâmer could, in theory, interfere with the recognition of the antigens strangers in a way that would prevent the body’s defenses against infections and tumour development. There is no evidence that this happens, but there are still no assessments of systemic risk. Due to the fact of the acetate glatirâmer be a material antigenic, it is possible that its use could lead to the induction of groups of unwanted responses. Although there is no evidence of this occurring in humans, one should not rule out a systematic surveillance of such effects. – Pregnancy and lactation: Copaxone is not recommended for use during pregnancy. Use during lactation: it is not known the extent of the excretion of acetate glatirâmer or its metabolites through breast milk. How many drugs are excreted through breast milk, you should have caution when administering Copaxone to a patient in the stage of breastfeeding. Should be taken into consideration the risks and benefits for the mother and for the child. – Drug interactions: the results of clinical trials do not suggest that there are significant interactions between Copaxone and the therapies commonly used for patients with multiple sclerosis (MS), including the use of concomitant corticosteroids for more than 28 days. Copaxone has not been formally evaluated in combination with interferon-beta.