Novator 500 ATRA treatment of anemia (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Deferiprone

Ingredient

Composition information	Content
Deferiprone	500mg

Uses

indications

Novator 500 drugs are indicated in the following cases:

Deferiprone is indicated for an iron overdose mainly in Thalassaemia patients (anemia) when treated with deferoxamine is contraindicated or insufficient.

Pharmacokic

The active ingredient is Deferiprone (3-Hydroxy-1,2-Dimethylpyridin-4-One), a chemical complex that binds to iron in a ratio of 3: 1.

Clinical research has shown that Deferiprone is effective in eliminating iron, a dose of 25 mg/kg 3 times/day can prevent iron accumulation assessed by serum ferritin for thalassaemia patients depending on blood transfusion. However, chelate therapy may not be necessary to protect against the destruction of the agency caused by iron.

Dynamic pharmacokinetics

absorption: Deferiprone is quickly absorbed from the upper part of the stomach line. The peak concentration of serum is reported from 45 to 60 minutes after a single -dose in patients fasting. Peak concentration in serum can be achieved after 2 hours in patients with full food. After taking the dose of 25 mg/kg, the peak concentration in the serum was detected in patients under the conditions of eating (85 umol/l) lower than the fasting conditions (126 mmol/l), although there was no reduction in the amount of Deferiprone absorbed when taken with food.

Metabolism: Deferiprone is metabolized mainly in conjugated with glucuronic acid. This metabolic product lacks the ability to combine with iron due to deferiprone 3-hydroxy group activity. The peak concentration of the form of glucuronic acid in serum is 2-3 hours after using Deferiprone.

Elimination: In humans, Deferiprone is eliminated mainly through the kidneys; 75% to 90% of oral doses are reported in urine detected in the first 24 hours, in the form of free deferiprone, combined with glucuronic acid and Iron-Deferiprone complex. A change in the change is reported. The sale time in most patients is 2 to 3 hours.

Before taking Novator 500 ATRA treatment of anemia (5 blisters x 10 tablets)

How to use

Take oral use.

Dosage

Deferiprone treatment should be started and maintained by a doctor with experience in thalassaemia patients.

Deferiprone is usually taken orally at 25 mg/kg body weight, 3 times/day for a daily daily dose of 75 mg/kg body in the body.

Note: The physician needs to choose a tablet with a suitable amount for the patient, because the Novator 500 tablet does not do the dose.

The dose of over 100 mg/kg/day is not recommended because the risk of increasing the risk of side effects used for longer than 2.5 times the largest recommended dose is related to neurological disorders. Because of the serious properties of grain leukemia, it can occur with the use of Deferiprone, all patients need to be monitored specially. Be cautious when the number of absolute neutrophils of the patient is low, as well as when treating patients with renal failure or liver failure.

Serum ferritin levels are recommended to check every 2 to 3 months to evaluate the effectiveness of iron control in the body. The dose should be adjusted based on the response of the patient and the purpose of treatment (maintaining and reducing the iron burden on the body). Temporarily stop treating deferiprone if the amount of ferritin in the serum is below 500 mcg/l.

Use for children: Clinical data of deferiprone use in children from 6 to 10 years old, and no data used in children under 6 years old.

Used for the elderly: Safety and efficiency when used for the elderly has not been set up. Caution should be careful when choosing the dose for elderly patients, usually starting with the lower limit within the prescribed dose, because the elderly often has a greater frequency than the impaired liver, kidney, heart, other diseases and the use of other drugs.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Novator 500 you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Digestive system: Nausea, vomiting, abdominal pain.

Kidney and urinary system: The ureter.

Common, ADR> 1/100

Liver: Increased liver enzyme.

Blood and lymphatic system: neutrophilia, grain leukocytes.

Nervous system: headache.

Digestive system: diarrhea.

Muscle and connective tissue system: joint pain.

Metabolic and nutrition disorders: Increase appetite.

general disorder: fatigue.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindications:

Novator 500 drugs contraindicated in the following cases:

Hypersensitivity to active ingredients or any excipients.

History of neutropenia recurrence.

History of grain leukemia.

Pregnant or lactating women.

Deferiprone's mechanism causes neutropenia, the patient must not use drugs that are related to neutropenia or drugs that may cause granulocytes.

Precautions when using

neutrophils/grain leukemia

Deferiprone shows neutropenia, including granulocytes. Neutral leukemia of the patient must be monitored every week.

In clinical trials, checking the weekly neutrophils, it has shown cases of neutropenia and a grain leukemia. Neutral leukopenia and loss of bodia are recovered once at treatment. If the patient develops an infection while using Deferiprone, the treatment should be stopped and neutral leukemia should be checked more often. It is recommended that patients report to their doctor immediately any signs that show infections such as fever, sore throat and symptoms like the flu.

The manager is proposed in the case of neutropenia summary below. The manager report is recommended before treating Deferiprone for any patient.

Do not start treatment with deferiprone in neutrophils patients. The risk of granulocytes and neutropenia is higher if the total neutropenia is absolutely less than 1.5x10^9/l.

In case of neutropenia (absolute number of neutrophils 0.5x 109/l):

Instructions for patients to stop immediately deferiprone and all other drugs are likely to cause neutropenia. Patients should limit contact with others to reduce the risk of infection. Immediately counting the number of total blood cells, the number of white blood cells is repaired by the presence of personal red blood cells, the number of neutral leukocytes and the amount of bridge pepper based on side effects and then repeat daily. It is recommended that after neutropenia is recovered, continue to count the whole blood cells weekly, the amount of leukocytes, neutrophils and platelets for 3 consecutive weeks to ensure the patient recovers completely. Any evidence that the development of infection occurs simultaneously with neutropenia, the appropriate bacterial transplant method and diagnosis should be done with an appropriate therapeutic regime.

In case of neutrophils or grain leukemia (absolute neutrophils

Perform the above guidelines and perform appropriate therapy as a agent stimulating granulocytic colonies, starting as soon as the above cases are determined; Use daily until restored. Protective isolation and if clinical indications, specialized patients to the hospital. Limit information about the medication again. Therefore, in case of neutropenia, it is not recommended to reuse drugs. In the case of grain leukemia, contraindicated use of drugs.

The ability to cause cancer/ mutations/ affect fertility.

Because of the ability to cause cancer, the gene toxicity of Deferiprone cannot be excluded. There is no animal research to assess the ability of Deferiprone to be reported on the report.

Plasma Zn ++ concentration

Monitor Zn ++ concentration in plasma and additional recommendations in the case of lack.

positive HIV or other immunominals

There is no appropriate data on the use of deferiprone in patients with HIV positive or other immune system damage. Based on Deferiprone related to neutropenia and grain leukemia, it is not advisable to treat patients with immune system damage unless the benefits exceed the potential risk.

kidney failure or liver failure and liver fibrosis

There is no appropriate data on the use of deferiprone in patients with liver or kidney failure. Because Deferiprone is mainly eliminated through the kidney, it is likely that the risk of complications in patients with renal impairment. Similarly, because Deferiprone is metabolized through the liver, caution in patients with impaired liver function. Liver and kidney function should be monitored in this patient while treating with Deferiprone. If there is an increase in alanine aminotransferase (ALT) in prolonged serum, stop treatment of deferiprone should be considered.

In patients with sea anemia, there is an association between liver fibrosis and excess iron and/or hepatitis C. Special care should be done to ensure the best chelate chelate in patients with hepatitis C is the best. Should carefully monitor liver tissue in these patients.

Starting urine

Patients should be informed that their urine can turn color into red/brown slightly due to the iron-deceriprone excretion.

Chronic overdose and neurological disorders

Neurological disorders have been observed in children treated at 2.5 to 3 times the recommended dose within a few years. The prescription should be reminded that the dose of over 100 mg/kg/day is not recommended.

The ability to drive and operate machinery

There is no research that affects the ability to drive and operate machinery.

Pregnancy

There is no adequate data on the use of Deferiprone in pregnant women. Animal research shows toxicity on fertility. The potential risk for unknown people, women who have the ability to reproduce to avoid pregnancy due to the ability to cause teratogenic and genetic changes of this drug. These women should be recommended to use contraception and must stop taking the drug immediately if pregnant or intended to get pregnant.

The period of breastfeeding

It is unknown whether the deferiprone is excreted in human milk. There is no reproductive ability before and after birth is conducted in animals. Deferiprone is not used for nursing women. If treatment is required, stop breastfeeding.

Interactive drug

interact between deferiprone and other drugs that have not been reported. However, due to Deferiprone associated with metal cations, there is the ability to exist interactive between DeferiProne and Ba chemotherapy cations such as Aluminum -based antacids. Therefore, it is not recommended to simultaneously use deferiprone and antacids of Aluminum -based aluminum.

Safety for simultaneous use of Deferiprone and Vitamin C has not been officially studied. Based on harmful interactions, the report may occur between Deferoxamine and Vitamin C, cautious when using sim sim sim Deferiprone and Vitamin C.Deferiprone's unknown disruption causes neutropenia, patients should not be with medications that cause neutropenia or granulocytes.

Storage

Store in a cool dry place at a temperature of less than 30 ° C. Avoid light.

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