STESOLID 5 Milligram Rectal Solution

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

DIAZEPAM

Mevcut itibaren:

Actavis Group PTC ehf

ATC kodu:

N05BA01

INN (International Adı):

DIAZEPAM

Doz:

5 Milligram

Farmasötik formu:

Rectal Solution

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

Benzodiazepine derivatives

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2008-02-18

Bilgilendirme broşürü

V013 - ADR update to section 4 
STESOLID® RECTAL SOLUTION 
5 MG AND 10 MG 
diazepam 

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 of the 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 STESOLID IS AND WHAT IT IS USED FOR 
2. WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID 
3. HOW TO USE STESOLID 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE STESOLID 
6. CONTENTS OF THE PACK AND OTHER INFORMATION 

1. WHAT STESOLID IS AND WHAT IT IS USED FOR 
Stesolid rectal solution contains diazepam which
belongs to a group of medicines called 
benzodiazepines. Diazepam is used to treat: 
• severe anxiety and agitation 
• epilepsy or febrile convulsions 
• tetanus 

Stesolid rectal solution may also be used to cause
relaxation and sleepiness before an 
operation or dental procedure, or in
other circumstances where a rapid effect is required but 
where intravenous injection is impracticable or undesirable. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID 
DO
NOT USE Stesolid rectal tubes and TELL your doctor if you: 
• are ALLERGIC to diazepam, to other benzodiazepine or to
any of the other ingredients of this 
medicine (listed in section 6) 
• HAVE SEVERE
BREATHING PROBLEMS OR HAVE DIFFICULTY BREATHING 
• SUFFER FROM DEPRESSION (with
or without anxiety) or 

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stesolid rectal solution 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 2 mg/ml
Each tube contains 5 mg of diazepam
Excipients with known effect: Benzoic acid 1 mg/ml and Propylene
Glycol 400 mg/ml
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Rectal Solution.
Clear, colourless to yellowish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stesolid rectal tubes 5 mg may be used in acute severe anxiety and
agitation, epileptic and febrile convulsions, tetanus,
as a sedative in minor surgical and dental procedures, or in other
circumstances in which a rapid effect is required but
where intravenous injection is impracticable or undesirable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage depends on age, weight, individual reactions, the
indications and the severity of the conditions.
If the patient does not respond within 5 minutes, the dose may be
repeated. Further doses of Stesolid rectal tubes should
be administered only after consultation with a physician. If
convulsions have not been brought adequately under control
with diazepam, other measures should be instituted.
4.3 CONTRAINDICATIONS
Stesolid is contraindicated for patients with:
Hypersensitivity to benzodiazepines or to one or more of the
excipients (see section 6.1)
Myasthenia gravis
Sleep apnoea syndrome
Severe respiratory insufficiency
Severe hepatic insufficiency
Children 1 to 3 years of age:
5
mg
Children above 3 years of age:
10
mg
Adults:
10
mg
Elderly patients:
5
mg
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