Octreotide Depot

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Octreotide acetate 22.4mg equivalent to octreotide 20 mg;  

Available from:

Teva Pharma (New Zealand) Limited

Dosage:

20 mg

Pharmaceutical form:

Powder for injection with diluent

Composition:

Active: Octreotide acetate 22.4mg equivalent to octreotide 20 mg   Excipient: Mannitol Polyglactin Carmellose sodium Mannitol Poloxamer 188 Water for injection

Prescription type:

Prescription

Therapeutic indications:

Treatment of patients with acromegaly; in whom surgery or radiotherapy is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective. Treatment of patients with symptoms associated with functional gastro-enteropancreatic endocrine tumours: - Carcinoid tumours with features of the carcinoid syndrome - VIPomas - Glucagonomas - Gastrinomas/Zollinger-Ellison syndrome - Insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy - GRFomas Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

Product summary:

Package - Contents - Shelf Life: Combination pack, Drug product powder packaged in glass vial; diluent packaged in prefilled syringe - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Diluent: Prefilled syringe closed with tip cap and plunger - 1 dose units -   - Vial, glass, Powder: Glass vial closed with rubber stopper - 1 dose units -  

Authorization date:

2019-06-14

Patient Information leaflet

OCTREOTIDE DEPOT (TEVA) V2
1
OCTREOTIDE DEPOT (TEVA)
_Octreotide 10 mg, 20 mg, 30 mg Injection _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Octreotide
Depot (Teva).
This leaflet answers some common
questions about Octreotide Depot
(Teva). It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Octreotide
Depot (Teva) against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OCTREOTIDE
DEPOT (TEVA) IS USED
FOR
Octreotide Depot (Teva) is a long
acting form of octreotide acetate
injection. It is injected into the
buttocks once every 4 weeks, instead
of having frequent injections of the
short-acting octreotide acetate under
the skin.
Octreotide Depot (Teva) contains
octreotide, a man-made medicine
derived from somatostatin.
Somatostatin is a substance found in
the human body which controls the
effects of certain hormones such as
insulin and growth hormone.
Octreotide Depot (Teva) is used
instead of somatostatin because its
effects are stronger and last longer.

Octreotide Depot (Teva) is used
to treat acromegaly.
In people with acromegaly the
body makes too much growth
hormone which controls the
growth of tissues, organs and
bones. Too much growth
hormone leads to enlargement
of the bones, especially of the
hands and feet. In most cases,
the overproduction of growth
hormone is caused by an
enlargement in the pituitary
gland (a benign pituitary
adenoma). Other symptoms
include headaches, increased
sweating, tiredness, numbness
of the hands and feet, pain and
stiffness in the joints and loss of
sexual function. By blocking
the excess growth hormone,
Octreotide Depot (Teva) can
relieve many of these
symptoms.

Octreotide Depot (Teva) is u

Summary of Product characteristics

Version 2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Octreotide Depot, 10 mg, Powder for Suspension for Injection (Teva)
Octreotide Depot, 20 mg, Powder for Suspension for Injection (Teva)
Octreotide Depot, 30 mg, Powder for Suspension for Injection (Teva)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10 mg, 20 mg or 30 mg octreotide (as octreotide
acetate).
Upon reconstitution of the vial with the 2 mL diluent, prefilled
syringe results in the suspension for
injection corresponding to the following concentrations:

Octreotide Depot, 10 mg: Each vial contains 10 mg octreotide
corresponding to 5 mg
octreotide per mL.

Octreotide Depot, 20 mg: Each vial contains 20 mg octreotide
corresponding to 10 mg
octreotide per mL.

Octreotide Depot, 30 mg: Each vial contains 30 mg octreotide
corresponding to 15 mg
octreotide per mL.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Powder for Suspension for Injection and diluent.

Powder: White to off-white powder for suspension for injection.

Diluent: Clear colourless solution.
Octreotide Depot is a long-acting depot injection form of octreotide.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults

Treatment of patients with acromegaly:
o
in whom surgery or radiotherapy is inappropriate or ineffective, or in
the interim
period until radiotherapy becomes fully effective.

Treatment of patients with symptoms associated with functional
gastro-entero-pancreatic
endocrine tumours:
o
Carcinoid tumours with features of the carcinoid syndrome.
o
VIPomas.
o
Glucagonomas.
o
Gastrinomas/Zollinger-Ellison syndrome.
o
Insulinomas, for pre-operative control of hypoglycaemia and for
maintenance
therapy.
o
GRFomas.
Version 2
2

Treatment of patients with progression of well-differentiated,
advanced neuroendocrine
tumours of the midgut or suspected midgut origin.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
ACROMEGALY
It is recommended to start treatment with the administration of 20 mg
Octreotide Depot at 4-week
intervals f