SANDOSTATIN LAR Powder and solvent for suspension for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Sandostatin LAR 10 mg, 20mg or 30mg powder and solvent for suspension for injection.
Qualitative and quantitative composition
One vial contains 10 mg, 20mg or 30mg octreotide (as octreotide acetate). Excipients with known effect: Contains less than 1 mmol (23 mg) sodium per dose, i.e is essentially sodium-free. For the full list ...
Pharmaceutical form
Powder and solvent for suspension for injection. Powder: White to white with yellowish tint. Solvent: Clear, colourless to slightly yellow or brown solution.
Therapeutic indications
Treatment of patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective (see section 4.2). Treatment of patients with ...
Posology and method of administration
Posology Acromegaly It is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals for 3 months. Patients on treatment with s.c. Sandostatin can start treatment ...
Contraindications
Known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General As GH-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour ...
Interaction with other medicinal products and other forms of interaction
Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may be necessary when Sandostatin LAR is administered concomitantly ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of octreotide in pregnant women, and in approximately one third of the cases the pregnancy outcomes are unknown. ...
Effects on ability to drive and use machines
Sandostatin LAR has no or negligible influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines if they experience dizziness, asthenia/fatigue, ...
Undesirable effects
Summary of the safety profile The most frequent adverse reactions reported during octreotide therapy include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism ...
Overdose
A limited number of accidental overdoses of Sandostatin LAR have been reported. The doses ranged from 100 mg to 163 mg/month of Sandostatin LAR. The only adverse event reported was hot flushes. Cancer ...
Pharmacodynamic properties
Pharmacotherapeutic group: Somatostatin and analogues ATC code: H01CB02 Octreotide is a synthetic octapeptide derivative of naturally occurring somatostatin with similar pharmacological effects, but with ...
Pharmacokinetic properties
After single i.m. injections of Sandostatin LAR, the serum octreotide concentration reaches a transient initial peak within 1 hour after administration, followed by a progressive decrease to a low undetectable ...
Preclinical safety data
Acute and repeated dose toxicology, genotoxicity, carcinogenicity and reproductive toxicology studies in animals revealed no specific safety concerns for humans. Reproduction studies in animals revealed ...
List of excipients
<u>Powder (Vial):</u> Poly (DL-lactide-co-glycolide) Mannitol (E421) <u>Solvent (Prefilled syringe):</u> Carmellose sodium Mannitol (E421) Poloxamer 188 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. The product must not be stored after reconstitution (must be used immediately).
Special precautions for storage
Store in the original package in order to protect from light. Store in a refrigerator (2°C to 8°C). Do not freeze. Sandostatin LAR may be stored below 25°C on the day of the injection. For storage conditions ...
Nature and contents of container
Unit packs containing one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Instructions for preparation and intramuscular injection for Sandostatin LAR FOR DEEP INTRAMUSCULAR ...
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Marketing authorization number(s)
Sandostatin LAR 10mg: PL 00101/0511 Sandostatin LAR 20mg: PL 00101/0512 Sandostatin LAR 30mg: PL 00101/0513
Date of first authorization / renewal of the authorization
29 April 1998
Date of revision of the text
06 March 2018
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