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SOMATULINE AUTOGEL Solution for injection in a pre-filled syringe (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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

Somatuline Autogel should not be prescribed to patients with hypersensitivity to the active substance, somatostatin or related peptides or 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 Studies in animals showed no evidence of teratogenic effects associated with lanreotide during organogenesis. Data on a limited number of pregnant women exposed to lanreotide indicate no adverse ...

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

10 December 2019

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