SANDOSTATIN Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Sandostatin 50 microgram/1 ml, solution for injection/infusion. Sandostatin 100 microgram/1 ml, solution for injection/infusion. Sandostatin 500 microgram/1 ml, solution for injection/infusion. Octreotide ...
Qualitative and quantitative composition
S*andostatin 50 microgram/1 ml, solution for injection/infusion:* One ampoule of 1 ml contains 50 microgram octreotide (as octreotide acetate) Sandostatin 100 microgram/1 ml, solution for injection/infusion: ...
Pharmaceutical form
Solution for injection/infusion. Clear, colourless solution.
Therapeutic indications
Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin is also indicated for ...
Posology and method of administration
Posology Acromegaly Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; ...
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 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 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 in adults and children have been reported. In adults, the doses ranged from 2,400-6,000 micrograms/day administered by continuous infusion (100-250 ...
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
Absorption After s.c. injection, Sandostatin is rapidly and completely absorbed. Peak plasma concentrations are reached within 30 minutes. Distribution The volume of distribution is 0.27 L/kg and the total ...
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
Lactic acid Mannitol (E421) Sodium hydrogen carbonate Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Octreotide acetate is not stable in Total Parenteral Nutrition (TPN) solutions.
Shelf life
3 years. The product should be used immediately after opening. Diluted solutions should be used immediately after preparation.
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. The ampoules may be stored below 30°C for up to two weeks. For storage conditions after ...
Nature and contents of container
One-point-cut colourless, type I glass ampoule with two colour code rings containing clear colourless solution. Sandostatin 50 microgram/1 ml: one blue and one yellow. Sandostatin 100 microgram/1 ml: one ...
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 use and handling Ampoule is intended for single use only; it should be opened ...
Marketing authorization holder
NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Marketing authorization number(s)
Sandostatin 50 microgram/1 ml PL 00101/0212 Sandostatin 100 microgram/1 ml PL 00101/0213 Sandostatin 500 microgram/1 ml PL 00101/0214
Date of first authorization / renewal of the authorization
03 April 1989 / 07 June 2007
Date of revision of the text
29 May 2019
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