Stesolid Rectal Tubes

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diazepam 2 mg/mL

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Diazepam 2 mg/mL

Dosage:

5mg/2.5mL

Pharmaceutical form:

Enema

Composition:

Active: Diazepam 2 mg/mL Excipient: Benzoic acid Benzyl alcohol Ethanol Propylene glycol Purified water Sodium benzoate

Units in package:

Tube, plastic, 2.5mL, 5 dose units

Class:

Class C5 Controlled Drug

Prescription type:

Class C5 Controlled Drug

Manufactured by:

F.I.S. Fabbrica Italiana Sintetici SpA

Therapeutic indications:

For the treatment of febrile and childhood convulsions, where rapid onset of anticonvulsant therapy is imperative.

Product summary:

Package - Contents - Shelf Life: Tube, plastic, 2.5mL - 5 dose units - 30 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1981-08-10

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
STESOLID
®
DIAZEPAM
_(pronounced die-az-e-pam)_
_RECTAL TUBES CONTAINING 5MG OR 10MG DIAZEPAM _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about Stesolid
®
.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your
taking Stesolid
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT STESOLID
® IS USED FOR
Stesolid
®
rectal tubes contain a medicine called diazepam (die-az-e-pam) and are
used
for the treatment of fits or seizures caused by fever (called febrile
convulsions).
Your doctor may have prescribed Stesolid
®
for another reason. Ask your doctor or
pharmacist if you have any questions about why Stesolid
®
has been prescribed for
you.
BEFORE YOU USE STESOLID
®
_WHEN YOU MUST NOT USE IT _
•
If you are sensitive (allergic) to diazepam (or the group of medicines
to which
it belongs, called benzodiazepines) or any of the ingredients of
Stesolid
®
(listed at the end of this leaflet).
•
If you have severe breathing problems or have difficulty breathing.
•
If you have a condition called myasthenia gravis which causes muscle
weakness.
•
If you have a condition called sleep apnoea where you stop breathing
temporarily whilst asleep.
•
If you are breast feeding.
•
If you have severe liver problems.
•
If the packaging is torn or shows signs of tampering.
_BEFORE YOU START TO USE IT _
Tell your doctor or pharmacist if:
•
you are pregnant or plan on becoming pregnant. Your doctor will
discuss the
risks and benefits of using Stesolid
®
with you.
•
you suffer from anxiety or depression
•
you are using any other medicines, including any that you buy without
a
prescription from your pharmacy, supermarket or health food shop.
MANY
MED

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Stesolid® Rectal Tubes
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tube contains 5 mg diazepam in 2.5 mL or 10 mg diazepam in 2.5 mL
solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Stesolid
®
is a clear colourless-to-slightly-yellowish aqueous liquid, in a
yellow polyethylene tube.
Stesolid
®
is available in a 5mg/2.5mL tube or 10mg/2.5mL tube, for rectal
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of febrile and childhood convulsions, where rapid
onset of anticonvulsant activity is
imperative.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
AGE GROUP
DOSAGE IN MG
NUMBER OF
5MG/2.5ML TUBES
OR
NUMBER OF
10MG/2.5ML TUBES
Adults
10 to 20 mg
2 to 4
1 to 2
Children (7-12 years)
10 mg
2
1
Children (1-6 years)
5 mg
1
Not applicable
If necessary, these doses may be repeated once only, after five
minutes
A maximum dose of 30 mg is recommended, unless adequate medical
supervision and monitoring are
available.
METHOD OF ADMINISTRATION
For rectal administration only.
1.
Position the patient with the buttocks raised. If a child, place the
child across your knee.
2.
Remove the tube cap and coat the opening of the nozzle with a little
Vaseline.
3.
Insert the
ENTIRE
length of the nozzle (about 5cm) into the anus.
In children less than three years of age, insert the nozzle
HALFWAY
only.
4.
IMPORTANT: In order to empty the tube, the nozzle must point
downwards.
5.
When the tube feels empty, keep squeezing it, while simultaneously
withdrawing the nozzle.
6.
Keep the patient in the same position and press the buttocks together
for a few minutes, to avoid
seepage.
4.3
CONTRAINDICATIONS
Hypersensitivity to diazepam or to benzodiazepines, or to any of the
excipients listed in this data sheet
(see Section 6.1 List of excipients).
Version 1.0
2
Myasthenia
gravis,
severe
respiratory
insufficiency,
sleep
apnoea
syndrome,
severe
hepatic
insufficiency.
Not for IV, IM or oral administration.
4.4
SPECIAL WARNINGS