Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Somatuline LA is indicated for the treatment of acromegaly when the circulating levels of growth hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy.
Somatuline LA is indicated for the treatment of thyrotropic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy.
Somatuline LA is indicated for the relief of symptoms associated with neuroendocrine (particularly carcinoid) tumours.
Initially, one intramuscular injection should be given every 14 days. The frequency of subsequent injections may be varied in accordance with the individual patient’s response (as judged by a reduction in symptoms and/or a reduction in GH and/or IGF-1 levels) such that injections can be given every 7 to 10 days as necessary.
Treatment should only be initiated and maintained by physicians experienced in the management of this condition.
Initially, one intramuscular injection should be given every 14 days. In the case of an insufficient response, as judged by the levels of thyroid hormone and TSH, the frequency of injection may be increased to one every 10 days. Continued treatment should be guided by periodic measurement of thyroid hormone and TSH.
In elderly patients, no dosage adjustment is necessary due to the wide therapeutic window of Somatuline LA (see section 5.2).
Somatuline LA 30 mg is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
In patients with impaired renal or hepatic function, no dosage adjustment is necessary due to the wide therapeutic window of lanreotide (see section 5.2).
If overdose occurs, symptomatic management is indicated.
Shelf life: 2 years.
After reconstitution, the suspension should be used immediately.
Store in a refrigerator (2°C to 8°C) in the original package.
For storage conditions of reconstituted medicinal product, see section 6.3.
Powder in a vial (type I glass), with a rubber stopper (halogenobutyl) and cap (aluminium) and 2 mL solvent in an ampoule (type I glass).
Box of 1 vial, 1 ampoule, 1 syringe and 2 needles.
Box of 2 vials, 2 ampoules, 2 syringes and 4 needles.
Box of 6 vials, 6 ampoules, 6 syringes and 12 needles.
Not all pack sizes may be marketed.
The powder should be reconstituted with the solvent immediately before injection. Keeping the vial upright, shake from side to side until a homogenous suspension is formed.
It is important that injection of this product is performed according to the instructions in the package leaflet.
For single use only.
Do not use if the kit is damaged or opened.
Any unused product or waste material should be disposed of in a sharps bin.
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