SOMATULINE LA Powder for suspension for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Somatuline LA 30 mg, powder for suspension for injection.
Qualitative and quantitative composition
Each vial contains 30 mg of lanreotide, presented as lanreotide acetate. After reconstitution with the solvent, 1 mL of suspension contains 15 mg lanreotide as lanreotide acetate. Each vial contains 2.64 ...
Pharmaceutical form
Powder for suspension for injection. Powder: a practically white lyophilisate with the presence of bubbles at the top.
Therapeutic indications
Acromegaly 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 ...
Posology and method of administration
Acromegaly and Neuroendocrine 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 ...
Contraindications
Hypersensitivity to lanreotide or related peptides or any of the excipients.
Special warnings and precautions for use
Somatuline LA 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 ...
Interaction with other medicinal products and other forms of interaction
The pharmacological gastrointestinal effects of lanreotide may reduce the intestinal absorption of co-administered drugs including ciclosporin. Concomitant administration of ciclosporin with lanreotide ...
Fertility, pregnancy and lactation
Pregnancy Non-clinical data Studies in animals showed no evidence of teratogenic effects following treatment with Somatuline LA. Clinical data Data on a limited number of exposed pregnancies indicate no ...
Effects on ability to drive and use machines
While no effect on the ability to drive and use machines has been established, dizziness has been reported with Somatuline LA. If a patient is affected, he/she should not drive or operate machinery.
Undesirable effects
Undesirable effects reported by patients suffering from acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs) treated with lanreotide in clinical trials are listed under the corresponding ...
Overdose
If overdose occurs, symptomatic management is indicated.
Pharmacodynamic properties
Pharmacotherapeutic group: Antigrowth hormones ATC code: H01CB03 Lanreotide is an octapeptide analogue of natural somatostatin. Like somatostatin, Lanreotide is an inhibitor of various endocrine, neuroendocrine, ...
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
In carcinogenic bioassays studies conducted in rats and mice, no systemic neoplastic changes were observed at doses in excess of those achieved in humans at therapeutic doses. Increased incidence of subcutaneous ...
List of excipients
Lactide glycolide copolymer Lactic glycolic copolymer Mannitol (E421) Carmellose sodium (E466) Polysorbate 80 (E433)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 2 years. After reconstitution, the suspension should be used immediately.
Special precautions for storage
Store in a refrigerator (2°C to 8°C) in the original package. For storage conditions of reconstituted medicinal product, see section 6.3.
Nature and contents of container
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, ...
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
Marketing authorization number(s)
PL 34926/0004
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 January 1998 Date of latest renewal: 20 May 2004
Date of revision of the text
10 December 2019
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