Source: Marketing Authorisation Holder Revision Year: 2019
Intramuscular and subcutaneous use.
Use in adults and children.
Lectrum 3.75 mg; Lectrum 7.5 mg; Lectrum 11.25 mg are indicated in the palliative treatment of advanced prostate cancer, especially as an alternative to orchiectomy or oestrogen therapy and the treatment of high risk locally prostate cancer and hormone depending locally advanced prostate cancer in combination with radiotherapy.
Lectrum 3.75 for preoperative management of uterine fibroids to reduce their size and associated bleeding.
Lectrum 3.75 mg; Lectrum 11.25 mg are indicated in the management of endometriosis including pain relief and reduction of endometriotic lesions. Lectrum 3.75 mg is indicated for endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection.
Lectrum 3.75 mg; Lectrum 11.25 mg are indicated for the treatment of central precocious puberty for girls under 9 years of age and boys under 10 years of age. Premature puberty is caused by a release of certain hormones from the pituitary gland (central precocious puberty).
Selection of children should be made using the following criteria:
Children should be selected using the following criteria:
1. Clinical diagnosis of CPP (idiopathic or neurogenic) with onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males.
2. Clinical diagnosis should be confirmed prior to initiation of therapy:
3. Baseline evaluation should also include:
The doctor or nurse will give you an injection of Lectrum. The injection will normally be given in your arm, thigh, or abdomen. The injection site should be varied at regular intervals.
If you think that Lectrum is too strong or too weak, please contact to your doctor immediately.
The treatment of children with Lectrum should be under the overall supervision of the paediatric endocrinologist. The dosing scheme needs to be adapted individually. The recommended starting dose is dependent on the body weight:
Unless prescribed otherwise, subcutaneous use, the recommended dose is 1 mL of Lectrum 3.75 mg as a single injection every month or 1 mL Lectrum 11.25 mg as a single injection every three months.
In these rare cases the following dose should be administered according to the clinical activity of the central precocious puberty:
Unless prescribed otherwise, subcutaneous use, the recommended dose is 0.5 mL (1.88mg) of Lectrum 3.75 mg as a single injection every month or 0.5 mL (5.625 mg) of Lectrum 11.25 mg as a single injection every three months.
Depending on the central precocious puberty activity, your doctor may increase the dosage in the presence of inadequate suppression (e.g. vaginal bleeding). Your doctor will determine the minimal effective dose with the help of a blood test.
The duration of treatment depends on the clinical signs at the start of treatment or during the course of treatment and is decided by your doctor together with the legal guardian and, if appropriate, the treated child. Your doctor will determine the bone age of the child in regular intervals.
In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years your doctor will consider discontinuing the treatment, depending on the clinical effects in your child.
In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, please talk to your doctor.
The therapy is a long-term treatment, adjusted individually. Please arrange with your doctor that Lectrum is administered as precisely as possible in regular 1-Month or 3-monthly periods. An exceptional delay of the injection date for a few days (30 ± 2 // 90 ± 2 days) does not influence the result of the therapy.
Lectrum suspension for injection 3.75 mg and 7.5 mg is provided in vials containing lyophilised microcapsules for monthly administration by single intramuscular or subcutaneous injection. Lectrum suspension for injection 11.25mg is provided in vials containing lyophilised microcapsules for every three months administration by single intramuscular or subcutaneous injection. The product must first be reconstituted by adding the diluent. The recommendations for the reconstitution of Lectrum are as follows:
There is no experience of overdose in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in dyspnoea, decreased activity, and excessive scratching. In early clinical trials with daily subcutaneous Lectrum, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
In cases of overdose, the patients should be monitored closely and management should be symptomatic and supportive.
Store below 30ºC. Protect from light. Do not freeze.
Keep out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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