Sumatriptan 6mg0.5ml solution for injection pre-filled pen

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Sumatriptan succinate

Disponível em:

Sun Pharmaceutical Industries Europe B.V.

Código ATC:

N02CC01

DCI (Denominação Comum Internacional):

Sumatriptan succinate

Dosagem:

12mg/1ml

Forma farmacêutica:

Solution for injection

Via de administração:

Subcutaneous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: ; GTIN: 8718104058323

Folheto informativo - Bula

V019
1
SUMATRIPTAN 6 MG/0.5 ML
NL/H/1375/001/DC
PACKAGE LEAFLET
V019
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUMATRIPTAN 6 MG/0.5 ML SOLUTION FOR INJECTION
Sumatriptan
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sumatriptan Injection is and what it is used for
2.
What you need to know before you use Sumatriptan Injection
3.
How to use Sumatriptan Injection
4.
Possible side effects
5.
How to store Sumatriptan Injection
6.
Contents of the pack and other information
1.
WHAT SUMATRIPTAN INJECTION IS AND WHAT IT IS USED FOR
The active substance in Sumatriptan Injection is Sumatriptan. It is
one of a group of medicines called 5HT
1
receptor agonists.
Sumatriptan Injection is used to treat migraine headache and a rare
condition called cluster headache. The
symptoms of migraine may due to temporary swelling of blood vessels in
the head. Sumatriptan is believed
to work by reducing the size of these blood vessels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SUMATRIPTAN INJECTION
DO NOT USE SUMATRIPTAN INJECTION
-
If you are allergic to sumatriptan or any of the other ingredients of
this medicine (listed in Section 6).
-
If you have heart problems or you already had a heart attack
-
If you have circulation problems in your arms and legs
-
If you have had a stroke or a mini-stroke (also called a transient
ischaemic attack or TIA)
-
If you have serious liver disease
-
If you have severe or uncontrolled high blood pressure.
-
With other migraine medicines containing ergotamine, or similar
medicines like

Características técnicas

OBJECT 1
SUMATRIPTAN 6 MG/0.5 ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 09-Apr-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Sumatriptan 6 mg/0.5 ml Solution for Injection
2. Qualitative and quantitative composition
Each pre-filled pen contains 6 mg of sumatriptan, as sumatriptan
succinate.
Excipient with known effect:
Sodium 1.3 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
Clear, colourless to pale yellow solution.
The pH is between 4.2 and 5.3. The osmolarity is between 260 to 340
mOsmols.
4. Clinical particulars
4.1 Therapeutic indications
Subcutaneous injection of Sumatriptan is indicated for the acute
relief of migraine attacks, with or
without aura, and for the acute treatment of cluster headache.
Sumatriptan Injection should only be used
where there is a clear diagnosis of migraine or cluster headache.
4.2 Posology and method of administration
Sumatriptan Injection should not be used prophylactically.
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.
Posology
_Adults_
Migraine and cluster headache:
It is recommended to start the treatment at the first sign of a
migraine headache, cluster headache or
associated symptoms such as nausea, vomiting or photophobia. It is
equally effective at whatever stage of
the attack it is administered.
Migraine:
The recommended adult dose of Sumatriptan is a single 6 mg
subcutaneous injection. Patients who do not
respond to this dose should not take a second dose of Sumatriptan for
the same attack. Sumatriptan may
be taken for subsequent attacks. Patients who respond initially but
whose migraine returns may take a
further dose at any time in the next 24 hours provided that one hour
has elapsed since the first dose.
The maximum dose in 24 hours is two 6 mg injections (12 mg).
Sumatriptan i