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OCTREOTIDE 500 MICROGRAMS/1 ML SOLUTION FOR INJECTION

Active substance(s): OCTREOTIDE ACETATE

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C00P1406 / V-05

Package leaflet: Information for the user
Octreotide 50 micrograms/1 ml solution for injection
Octreotide 100 micrograms/1 ml solution for injection
Octreotide 200 micrograms/ml solution for injection
Octreotide 500 micrograms/1 ml solution for injection
Octreotide acetate
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Octreotide is and what it is used for
2. What you need to know before you use Octreotide
3. How to use Octreotide
4. Possible side effects
5. How to store Octreotide
6. Contents of the pack and other information

1. What Octreotide is and what it is used for
Octreotide is a synthetic version of a hormone that occurs naturally in the body, called
somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones
and secretions.
Octreotide is used:
• To treat the symptoms that occurs with hormone producing gastrointestinal tumours.
These symptoms are associated with the over-production of some of the body’s
natural substances which may result in an imbalance of your natural hormone levels.
This imbalance may cause a variety of symptoms in the stomach, pancreas or
intestines (gut).
• To reduce the levels of growth hormone and Insulin-like growth factor number 1 (IGF-1)
if you have acromegaly and to improve symptoms that you may have due to
over‑production of these hormones.
• Prior to having an operation on the pancreas, to prevent further complications.

2. What you need to know before you use Octreotide
Do not use octreotide:
• If you are allergic to octreotide or any of the ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using octreotide.

Special care will be taken:
• as octreotide may affect your blood sugar levels. You or your doctor should closely
monitor your blood sugar levels.
• if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor
should closely monitor your blood sugar levels.
• if you have any thyroid problems
• if you have gallstones (gallstones can occur sometimes without symptoms. This is
the reason why your doctor may perform ultrasonic examinations before and after
treatment with octreotide)

• if you have liver disease
• if you are pregnant or planning to become pregnant. If you do become pregnant, tell
your doctor immediately.
• if you are breast-feeding
• if you are younger than 18 years old

The following information is intended for
healthcare professionals only:

Other medicines and octreotide:

This is an extract from the SmPC to
help you with the administration of
Octreotide Solution for Injection.

Tell your doctor if you are using any of the following medicines;
• ciclosporin (a drug used after a transplant)
• cimetidine (a drug used to reduce stomach acid)
• bromocriptine (a drug used in Parkinson’s disease or in acromegaly or to suppress
breast milk)
• terfenadine (to relieve allergic symptoms)
• carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia
and neuropathy)
• digoxin (medicine for certain heart problems)
• warfarin (a drug used to thin the blood)
Other medicines that are metabolised by the liver can also be affected, so tell your doctor
or pharmacist if you are using any other medicines.

Pregnancy, breast-feeding and fertility
There is no data regarding treatment with octreotide and its effects on fertility.
Women of child bearing potential must use an effective contraceptive method during
treatment with octreotide.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine. Octreotide
should not be used if you are pregnant or breast-feeding unless the benefits to the mother
outweigh the risk to the baby.

3. How to use Octreotide
Always use this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
A doctor or nurse will usually give you this medicine.
The medicine will be given to your either as a subcutaneous injection (underneath the
skin) or as a slow intravenous injection (via a drip into the vein).
The recommended dosages are given below; however your doctor will decide what
dosage to give to you, as this depends on the nature of your treatment, your age and your
medical condition:
• To treat the symptoms that occur with hormone producing gastrointestinal tumours:
0.05 mg each 24 hours or each 12 hours, depending on your response, the dose may
be increased to 0.1-0.2 mg every 8 hours. The usual recommended maximum daily
dosage is 0.6 mg.
• If you have acromegaly: initial doses of 0.05-0.1 mg, every 8 hours. For most patients
the dosage is 0.2-0.3 mg per day and the maximum daily dosage is 1.5 mg.
• Prior to having an operation on the pancreas: 0.1 mg every 8 hours for 7 days, starting
on the day of the operation.
Your injection should be given between meals or at bedtime in order to reduce stomach
and intestinal (gut) side effects.
To reduce discomfort, Octreotide solution for injection should reach room temperature
before administration. Multiple subcutaneous injections at short intervals at the same
administration site should be avoided.
If you use more octreotide than you should: this medicine is given to you by healthcare
professionals, and so it is unlikely that you will receive any overdose. However, if you think
you have had too much octreotide, tell your doctor or nurse immediately.

4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody
gets them.

If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling
of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in
swallowing or breathing).

Octreotide solution for
injection

For parenteral use only:
Subcutaneously (SC) or
Intravenously (IV)
Storage
Store in a refrigerator (2°C - 8°C). Do not
freeze. Store the vial in the outer carton in
order to protect the product from light.
Shelf-life after first opening: The product
must be used immediately and any
unused drug-product must be discarded.
The multidose vials of Octreotide
200 micrograms/ml solution for injection
for daily use may be stored for two weeks
below 25°C.
The multidose vials can be stored for
2 weeks at room conditions for daily use,
however to prevent contamination, it is
recommended to puncture the cap of the
vial no more than 10 times (Multidose
vials only).
Chemical and physical stability of
diluted solution has been demonstrated
for 7 days below 25°C when stored in
PVC bags or polypropylene syringes
and diluted in sodium chloride 0.9%
solution. From a microbiological point
of view, the product should be used
immediately. If not used immediately,
in-use storage times and conditions
prior to use are the responsibility of
the user and would normally not be
longer than 24 hours at 2 to 8°C, unless
dilution has taken place in controlled and
validated aseptic conditions.

Use
Octreotide is an injection, so it must
be handled with particular caution. The
dilution must be done under aseptic
conditions, by trained staff and in a
specific area. The contact of octreotide
with skin and membranes should be
avoided. If the injection comes into contact
with skin: wash with water and soap. If it
comes into contact with membranes, wash
(irrigate) the affected area with water.
To reduce local discomfort, let the solution
reach room temperature before injection.
Avoid multiple injections at short intervals
at the same site.
Prior to administration the solution should
be inspected visually for changes of colour
or presence of particles.
It is not recommended to mix or dilute the
octreotide solutions for injection except
with 0.9% Sodium Chloride solution.

Q79776

Component Specification

Requester

Item number:

Q79776

Request number:

AS5638

Country:

UK & Ireland

OI template:
Amalia version:

OMI001
7

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

360 x 305 mm
1 ml & 5 ml vials
Omega
N/A
72 x 39 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A

Colours
Black:

C00P1406 / V-05

Previous Item Number: Q73783

Signed:
Date:

Version 1
Technician: JE
Date: 06/Nov/15

Version 2
Technician: XX
Date: dd/mmm/yy

Version 3
Technician: XX
Date: dd/mmm/yy

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

C00P1406 / V-05

Disposal
Any solution or item used (or that has
been in contact) with Octreotide solution
for injection must be discarded according
to local recommendations for injections.

Administration:
The recommended route of administration
is subcutaneous, however, in instances
where a rapid response is required, e.g.
carcinoid crises, the initial recommended
dose of Octreotide may be administered
by the intravenous route, diluted and given
as a bolus, whilst monitoring the cardiac
rhythm through ECG.

Subcutaneous injection:
Octreotide Vials and Multidose Vials are
recommended to be given subcutaneously
without reconstitution.

Intravenous infusion:
GEP tumours where a rapid response
is required (IV bolus administration):
Octreotide Vials and Multidose Vials
should be diluted with 0.9% Sodium
Chloride w/v solution to a ratio of no
more than 1:100. Dilution with Glucose
is not recommended. Where a rapid
response is required 0.05 mg is given
as a slow bolus intravenous dose and
thereafter 0.02-0.05 mg/hour as an
intravenous dose.

• pancreatitis – this may give you sudden severe pains in your abdomen. It may occur in
the first few hours or days of treatment.
• intestinal obstruction – you may experience constipation and abdominal pains.

Octreotide, diluted in 0.9% sodium chloride would not normally be stored for longer than
24 hours in a refrigerator.

These are very serious side effects. You may need urgent medical attention. These side
effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Do not use this medicine after the expiry date which is stated on the carton and label.

Tell your doctor as soon as possible if you notice any of the following side effects:
Very common (occurs in more than 1 in 10 patients):
• gallstones that could give gallbladder pain
• increases in blood sugar levels (hyperglycaemia)
• headache
• stomach ache, diarrhoea, constipation, nausea (feeling sick) and wind (these may be
less if you inject between meals or before going to bed)
• pain where the injection is given
Common (occurs in less than 1 in 10 patients but more than 1 in 100):
• changes in activity of the thyroid gland (hypothyroidism)
• changes in blood sugar levels (low levels may occur - hypoglycaemia)
• impaired glucose tolerance
• anorexia
• dizziness
• slow heart beat
• stomach discomfort after a meal
• bloated stomach
• loose stools
• vomiting
• fatty material in the faeces (steatorrhea)
• discolouration of faeces
• itching
• rash
• hair loss
• shortness of breath
• inflammation of the gallbladder
• biliary sludge
• yellow skin and eyes (jaundice)
• gallstone
• abnormal liver function test results

Keep this medicine out of the sight and reach of children.
The injection should only be used if it is clear and free of particles.
Do not throw away any medicines via wastewater or household waste. These measures
will help protect the environment.

6. Contents of the pack and other information
What Octreotide Solution for Injection contains
• The active substance is octreotide;
• The other excipients are glacial acetic acid, sodium acetate trihydrate, sodium
chloride and water for injections. The multi-dose vials additionally contain phenol
(a preservative).
This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially
sodium free) per ml of solution.

What Octreotide Solution for Injection looks like and contents of the pack
Octreotide Solution for Injection is available as vials containing a clear, colourless solution
for injection.

Octreotide Solution for Injection is available in the following pack sizes:
Octreotide solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)
The vials may be overwrapped with a protective plastic to minimise the risk of spillage if
the vials break; these vials are referred to as ONCO-TAIN™.

Marketing authorisation holder and manufacturer:
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom

Component Specification

Requester

Item number:

Q79776

Request number:

AS5638

Country:

UK & Ireland

OI template:
Amalia version:

OMI001
7

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

360 x 305 mm
1 ml & 5 ml vials
Omega
N/A
72 x 39 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A

Previous Item Number: Q73783

Signed:
Date:

Version 1
Technician: JE
Date: 06/Nov/15

Version 2
Technician: XX
Date: dd/mmm/yy

Version 3
Technician: XX
Date: dd/mmm/yy

Version 4
Technician: XX
Date: dd/mmm/yy

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):
• fast heart beat
• dehydration
• liver problems

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):
• pancreas inflammation (acute pancreatitis)
• ileus-like conditions (your gut may not work properly)
• severe epigastric pain (pain in upper part of stomach)
• allergic skin reactions (hypersensitivity)

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

Colours
Black:

This leaflet was last revised in 11/2015

Your doctor will take blood tests to check for changes in liver and thyroid function, which is
a side effect of treatment with octreotide.
If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes
any side effects not listed in this leaflet.

5. How to store Octreotide
Keep the vial in the outer carton in order to protect the product from light.
Medicinal product as packaged for sale: Store in a refrigerator (2°C-8°C). Do not freeze.
Shelf-life after first opening: The product must be used immediately and any unused
drug‑product must be discarded.
The multidose vials of Octreotide 200 micrograms/ml solution for injection for daily use
may be stored for two weeks below 25°C.
Q79776

C00P1406 / V-05

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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