Isoniazid 50mg/2ml solution for injection ampoules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Isoniazid

Saatavilla:

Alliance Pharmaceuticals Ltd

ATC-koodi:

J04AC01

INN (Kansainvälinen yleisnimi):

Isoniazid

Annos:

25mg/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous; Intrathecal; Intrapleural; Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010900; GTIN: 5024403000158

Pakkausseloste

Isoniazid Ampoules PIL UK 005
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISONIAZID 50 MG/2 ML SOLUTION FOR INJECTION
Isoniazid
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 further questions, ask your doctor or pharmacist.

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 Isoniazid is and what it is used for
2.
What you need to know before you use Isoniazid
3.
How to use Isoniazid
4.
Possible side effects
5.
How to store Isoniazid
6.
Contents of the pack and other information
1.
WHAT ISONIAZID IS AND WHAT IT IS USED FOR
Isoniazid 50 mg/2 ml Solution for Injection contains Isoniazid.
Isoniazid belongs to a group
of medicines called antibacterials, which work by killing the bacteria
that cause tuberculosis
(also known as TB).
Isoniazid is used to treat tuberculosis inside the lungs (pulmonary
TB) and outside the lungs
(extra-pulmonary TB).
You will receive your doses of Isoniazid by injections given to you by
a doctor or nurse.
Tuberculosis is a serious disease. It is important that you receive
effective treatment for this
condition as it can be passed on to other people and, if left
untreated, it can be fatal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ISONIAZID
DO NOT USE ISONIAZID IF YOU

are allergic to Isoniazid, or any of the other ingredients of this
medicine (listed in
Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine if you:

have kidney problems or have been told by your doctor that you have a
slow
acetylator status. Your doctor may wish to change your dose.

have liver problems including hepatitis.

are alcohol dependent or drink excessively. You may be more likely to
suffer from
fits or mental disturbances if you regularly drink alcohol whilst
taking this medicine.

have

Valmisteyhteenveto

OBJECT 1
ISONIAZID AMPOULES 50 MG/2 ML.
Summary of Product Characteristics Updated 14-Sep-2015 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Isoniazid 50 mg/2 ml Solution for Injection.
2. Qualitative and quantitative composition
Each ampoule contains 50 mg Isoniazid in 2 ml of solution.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
4. Clinical particulars
4.1 Therapeutic indications
For all forms of pulmonary and extra-pulmonary tuberculosis.
4.2 Posology and method of administration
Isoniazid 50 mg/2 ml Solution for Injection is for intramuscular,
intravenous, intrapleural, or intrathecal
injection.
Adults and children
The usual intramuscular or intravenous dose for adults is 200 to 300
mg as a single daily dose, for
children 100 to 300 mg daily (10 - 20 mg/kg), but doses much larger
than these are sometimes given,
especially in conditions such as tuberculous meningitis. It is
recommended to give an intravenous dose
slowly as an undiluted bolus injection, although other methods may be
employed.
Neonates
The recommended intravenous or intramuscular dose for neonates is 3-5
mg/kg with a maximum of 10
mg/kg daily. Isoniazid may be present in the milk of lactating mothers
(see section 4.6).
The elderly
No dosage reduction is necessary in the elderly.
Intrapleural use
50 to 250 mg may be instilled intrapleurally after aspiration of pus,
the dosage of oral isoniazid on that
day being correspondingly reduced. The ampoule solution is also used
for the local treatment of
tuberculous ulcers, for irrigation of fistulae, etc.
Intrathecal use:
It should be noted that CSF concentrations of isoniazid are
approximately 90% of plasma concentrations.
Where intrathecal use is required, 25 - 50 mg daily has been given to
adults and 10 - 20 mg daily for
children, according to age.
It is usual to give Isoniazid together with other antituberculous
therapy, as determined by current practice
and/or sensitivity testing.
It is recommended that pyridoxine be given during Iso