HAEMOROL oily phenol 250mg/5mL Injection vial

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

phenol, Quantity: 250 mg

Dostupné s:

Phebra Pty Ltd

INN (Mezinárodní Name):

Phenol

Léková forma:

Injection, solution

Složení:

Excipient Ingredients: Almond oil

Podání:

Submucosal

Jednotky v balení:

5x250mg/5mL

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Haemorol is indicated for the treatment of symptomatic haemorrhoids in patients with an inadequate response to conservative therapy such as dietary manipulation. It must only be injected submucosally and its use is usually confined to first degree or second degree haemorrhoids.

Přehled produktů:

Visual Identification: a clear, yellowish solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2009-09-04

Informace pro uživatele

Haemorol (Oily Phenol Injection)
Page 1 of 3
_Version 05-1 _
HAEMOROL™
OILY PHENOL INJECTION (PHENOL)
EACH 5 ML CONTAINS PHENOL 250 MG IN ALMOND OIL
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Haemorol. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Haemorol against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT HAEMOROL
IS USED
FOR
Haemorol is used to treat haemorrhoids
when other methods of treatment, such
as changes in diet, have not worked.
Haemorrhoids occur when small veins
near the anus become swollen.
Haemorol works by attaching the veins
to the tissue around them, preventing
them from swelling.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS MEDICINE WHICH
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
HAEMOROL
_WHEN YOU MUST NOT BE GIVEN _
_IT _
Y
OU SHOULD NOT BE GIVEN HAEMOROL IF
YOU HAVE AN ALLERGY TO ANY MEDICINE
CONTAINING PHENOL OR ALMOND OIL.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
THIS MEDICINE SHOULD NOT BE GIVEN TO
INFANTS OR CHILDREN.
Safety in infants and children has not
been established.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF
THE SOLUTION IS
DISCOLOURED, CLOUDY, TURBID, OR A
PRECIPITATE OR PARTICLES ARE PRESENT.
The solution is normally clear,
yellowish and viscous.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE AFTER THE EXPIRY DATE
PRINTED ON THE PACK, OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If you are given this
medicine after the expiry date has
passed, it may not work as well.
IF YOU ARE NOT

Charakteristika produktu

PRODUCT INFORMATION
Australian Product Information – Haemorol Oily Phenol Injection
Page 1 of 8
Version 05-1
HAEMOROL™ OILY PHENOL INJECTION
(PHENOL)
1
NAME OF THE MEDICINE
Phenol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Haemorol is a solution containing 250 mg phenol in almond oil to 5 mL
(phenol 5% w/v).
Excipients of known effect: tree nuts.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Haemorol is a clear, yellowish solution, free from visible particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Haemorol is indicated for the treatment of symptomatic haemorrhoids in
patients with an inadequate response to
conservative therapy such as dietary manipulation. It must only be
injected submucosally and its use is usually
confined to first degree or second degree haemorrhoids.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Haemorol is for submucosal injection only (i.e. local administration);
personnel administering this treatment should
be trained in the correct placement of submucosal injections. Haemorol
is not to be administered intrathecally, or
injected into a blood vessel or into deep tissues (see Section 4.4
Special Warnings and Precautions for Use).
Haemorol is administered by submucosal injection of 2 to 5 mL. It may
be injected into the submucosal space
above each of the three principle haemorrhoids. The total maximum
volume that may be injected in any one
treatment is 10 mL. It is preferable that only sterile glass syringes
be used for injecting this product, to minimise
the possibility of absorption or extraction from plastic syringe
components. However, plastic syringes with needles
with plastic hubs may be used if the injection is to be administered
immediately.
4.3
C
ONTRAINDICATIONS
Haemorol is contraindicated in patients hypersensitive to phenol or
almond oil, in neonates and children (see
Section 4.4 Special Warnings and Precautions for Use), and for use
over large areas, since sufficient amounts
may be absorbed to give rise to toxic symptoms.
4.