SOMATULINE AUTOGEL Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Somatuline Autogel 60 mg, solution for injection in a pre-filled syringe. Somatuline Autogel 90 mg, solution for injection in a pre-filled syringe. Somatuline Autogel 120 mg, solution for injection in ...
Qualitative and quantitative composition
Lanreotide (I.N.N.), 60 mg, 90 mg or 120 mg (as acetate). Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg lanreotide base/mg of solution, which ...
Pharmaceutical form
Solution for injection in a pre-filled syringe. White to pale yellow semi-solid formulation.
Therapeutic indications
Somatuline Autogel is indicated for: The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery ...
Posology and method of administration
Posology Acromegaly The recommended starting dose is 60 mg to 120 mg administered every 28 days. The dose should be individualised according to the response of the patient (as judged by a reduction in ...
Contraindications
Hypersensitivity to the active substance, somatostatin or related peptides or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore, patients may need to be monitored periodically. There have been post-marketing reports of gallstones resulting in ...
Interaction with other medicinal products and other forms of interaction
The pharmacological gastrointestinal effects of lanreotide may result in the reduction of the intestinal absorption of co-administered drugs including ciclosporin. Concomitant administration of ciclosporin ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of lanreotide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...
Effects on ability to drive and use machines
Somatuline Autogel has minor or moderate influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed. However, dizziness has ...
Undesirable effects
Undesirable effects reported by patients suffering from acromegaly and GEP-NETs treated with lanreotide in clinical trials are listed under the corresponding body organ systems according to the following ...
Overdose
If overdose occurs, symptomatic management is indicated.
Pharmacodynamic properties
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues; Somatostatin and analogues ATC code: H01CB03 Mechanism of action Lanreotide is an octapeptide analogue of natural somatostatin. ...
Pharmacokinetic properties
Intrinsic pharmacokinetic parameters of lanreotide after intravenous administration in healthy volunteers indicated limited extravascular distribution, with a steady-state volume of distribution of 16.1 ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. In carcinogenic bioassay studies ...
List of excipients
Water for injection Glacial acetic acid (for pH adjustment)
Incompatibilities
Not applicable.
Shelf life
2 years. After opening the protective laminated pack, the product should be administered immediately.
Special precautions for storage
Store in a refrigerator between 2°C-8°C. Store in the original package in order to protect from light. Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator ...
Nature and contents of container
Somatuline Autogel is supplied in a pre-filled syringe (polypropylene) fitted with an automatic safety system with a plunger stopper (bromobutyl rubber) and a needle (stainless steel) covered by a plastic ...
Special precautions for disposal and other handling
The solution for injection in a pre-filled syringe is ready for use. For immediate and single use following first opening. It is important that the injection of the product is performed exactly according ...
Marketing authorization holder
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Marketing authorization number(s)
PL 34926/0005 (Somatuline Autogel 60 mg) PL 34926/0006 (Somatuline Autogel 90 mg) PL 34926/0007 (Somatuline Autogel 120 mg)
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 October 2001 Date of latest renewal: 07 April 2009
Date of revision of the text
18 May 2022
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