IMITREX INJECTION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SUMATRIPTAN AS SUCCINATE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

N02CC01

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

SUMATRIPTAN AS SUCCINATE 6 MG / 0.5 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO OPERATIONS (UK) LIMITED

المجموعة العلاجية:

SUMATRIPTAN

المجال العلاجي:

SUMATRIPTAN

الخصائص العلاجية:

Subcutaneous Injection is indicated for the acute relief of migraine attacks, with or without aura, and for the acute treatment of cluster headache.Imitrex should only be used where there is a clear diagnosis of migraine or cluster headache.

تاريخ الترخيص:

2022-02-28

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
IMITREX INJECTION
Solution For Injection 6 mg/0.5 ml
Each 0.5 ml pre-filled syringe contains:
SUMATRIPTAN (AS SUCCINATE) 6 MG
For the list of inactive and allergenic ingredients in the
preparation, see section 6
“Additional information”
and in section 2 “Important information about some of the
ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any other
questions, refer to the
physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imitrex Subcutaneous Injection is indicated for the acute relief of
migraine attacks,
with or without aura, and for the acute treatment of cluster headache.
Imitrex
Injection should only be used where there is a clear diagnosis of
migraine or cluster
headache.
Migraine and cluster headache symptoms may be caused by the temporary
widening
of blood vessels in the head. Imitrex Injection is believed to reduce
the widening of
these blood vessels. This in turn helps to take away the headache and
relieve other
symptoms such as nausea or vomiting and sensitivity to light and
sound.
THERAPEUTIC GROUP
Analgesics: triptans - selective 5-HT
1
receptor agonists.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• IF YOU ARE SENSITIVE (ALLERGIC) to sumatriptan, or to any of the
additional
ingredients contained in the medicine (listed in section 6).
• IF YOU HAVE A HEART PROBLEM such as narrowing of the arteries
(ischaemic heart
disease)
or chest pains
(angina)
, or have already had a heart attack.
• IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp-like
pains
when you walk
(peripheral vascular disease)
.
• IF YOU HAVE HAD A STROKE or a

خصائص المنتج

Page
1
of
11
IMITREX INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
IMITREX INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 6 mg of sumatriptan base, as the
succinate
salt, in an isotonic solution of 0.5 ml.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Pre-filled syringes for use in conjunction with an auto injector for
subcutaneous injection.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Subcutaneous Injection is indicated for the acute relief of migraine
attacks,
with or without aura, and for the acute treatment of cluster
headache.Imitrex
should only be used where there is a clear diagnosis of migraine or
cluster
headache.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Imitrex Injection should not be used prophylactically.
The recommended dose of
Imitrex
should not be exceeded.
It is recommended to start the treatment at the first sign of a
migraine
headache or associated symptoms such as nausea, vomiting or
photophobia. It
is equally effective at whatever stage of the attack it is
administered.
The efficacy of sumatriptan is independent of the duration of the
attack when
starting treatment. Administration during a migraine aura prior to
other
symptoms occurring may not prevent the development of a headache.
Imitrex Injection should be injected subcutaneously using an
auto-injector.
Patients should be advised to observe strictly the instruction leaflet
for the
Imitrex auto-injector especially regarding the safe disposal of
syringes and
needles.
MIGRAINE:
Page
2
of
11
ADULT_: _
The recommended adult dose of Imitrex is a single 6mg subcutaneous
injection.
If a patient does not respond to the first dose of sumatriptan, a
second dose
should not be taken for the same attack. In these cases the attack can
be treated
with paracetamol, acetylsalicylic acid, or non-steroidal
anti-inflammatory
drugs. Sumatriptan injection may be taken for subsequent attacks.
If the patient has responded to the first dose, but the sympto