Jigsimur Natural Herbal Drink (1 BOTTLE (750ML)

ANSM - Updated on: 08/30/2019

1. NAME OF THE MEDICINAL PRODUCT

IMUREL 50 mg, powder for solution for injection (IV)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Azathioprine .................................................. .................................................. .................... 50.0 mg

For a bottle

Excipient(s) with known effect: The sodium content of the injectable formulation is 4.5 mg (0.2 mEq).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for solution for injection

4. CLINICAL DATA

4.1. Therapeutic indications

· Organ transplantation: prevention of graft rejection in combination with corticosteroids or other immunosuppressive agents.

· Dysimmune diseases:

o Treatment of systemic lupus erythematosus, severe rheumatoid arthritis, autoimmune hepatitis, (excluding viral diseases), idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, dermatomyositis, polymyositis, systemic vasculitis (except viral diseases), pemphigus. IMUREL is indicated in severe forms of these diseases, in patients intolerant to corticosteroids or corticosteroid dependent or whose therapeutic response is insufficient despite high doses of corticosteroids when it is not possible to use the oral route.

o Treatment of moderate to severe chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) in patients for whom corticosteroid therapy is necessary when it is not possible to use the oral route.

4.2. Dosage and method of administration

Azathioprine Injection should ONLY be used when the oral route is unusable, and should be discontinued as soon as the oral route is tolerated.

Dosage

Organ transplantation – Adults:

The dosage is 1 to 3 mg/kg/day (generally not exceeding 150 mg/day) and must be adapted according to the clinical response and hematological tolerance. You should wait at least 2 weeks between each dosage change.

Immune system disorders – Adults:

· Dysimmune diseases apart from chronic inflammatory bowel diseases: The dosage is 1 to 3 mg/kg/day (without exceeding 150 mg/day) depending on the current clinical condition and the individual response of the patient , and hematological tolerance.

· The maintenance dosage will be reduced to the minimum compatible with maintaining effectiveness. If no improvement in the patient's condition occurs within 6 months, discontinuation of treatment should be considered.

· Chronic inflammatory bowel diseases: The recommended dose is 2 to 2.5 mg/kg/day. The time for the appearance of the clinical response is on average 2 to 3 months but can be up to 6 months.

Pediatric population

Dosages are similar to adult dosages.

Overweight pediatric population

Children considered overweight may require doses at the high end of the dosage range; close monitoring of response to treatment is therefore recommended (see section 5.2).

The elderly

Experience with the administration of azathioprine to elderly people is limited. Although available data do not show a higher incidence of adverse reactions in elderly patients compared to other patients treated with azathioprine, it is advisable to closely monitor hepatic and renal function, and consider a dosage reduction. in the event of liver or kidney damage (see section 4.2).

Renal failure

A dose reduction should be considered in patients with renal impairment (see sections 4.4 and 5.2).

Hepatic insufficiency

A dose reduction should be considered in patients with hepatic impairment (see sections 4.4 and 5.2).

Drugs interactions

The combination of azathioprine with xanthine oxidase inhibitors such as allopurinol is strictly contraindicated. (see section 4.3).

Patients with TPMT deficiency (see section 4.4)

• In patients with partial genetic TPMT deficiency (intermediate enzyme activity or heterozygous genotype), the initial dosage of azathioprine should be reduced to 30-70% of the standard dosage, i.e. an initial dosage of 1-1.5 mg /kg/d. The dosage must then be adapted according to the clinical response and hematological tolerance. You should wait between 2 and 4 weeks between each dosage change.

• In patients with complete genetic TPMT deficiency (undetectable enzyme activity or homozygous mutated/composite heterozygous genotypes), another non-thiopurin treatment should be preferred. If azathioprine should be used in these patients, the initial dosage should be reduced to 10% of the standard dosage, 3 times per week. It is advisable to wait