Kemadrin 10mg/2ml solution for injection ampoules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Beli Sekarang

Unduh Selebaran informasi (PIL)
07-06-2018
Unduh Karakteristik produk (SPC)
07-06-2018

Bahan aktif:

Procyclidine hydrochloride

Tersedia dari:

Auden McKenzie (Pharma Division) Ltd

Kode ATC:

N04AA04

INN (Nama Internasional):

Procyclidine hydrochloride

Dosis:

5mg/1ml

Bentuk farmasi:

Solution for injection

Rute administrasi :

Intravenous; Intramuscular

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04090200; GTIN: 5060032240596

Selebaran informasi

                                1.
What is KEMADRIN Injection and what is it
used for?
What is KEMADRIN Injection?
KEMADRIN Injection belongs to a group of medicines
called anticholinergics. Anticholinergics block the
effects of a substance called acetylcholine in your
body.
What is KEMADRIN Injection used for?
KEMADRIN Injection is used to treat and relieve
the symptoms of Parkinson’s disease such as stiff
muscles, paralysis, tremor, difficulties with speech,
writing and walking, overproduction of saliva and
dribbling, sweating, uncontrolled eye movements
and depression.
Some tranquillisers have side-effects like the
symptoms of Parkinson’s disease and they can also
cause restlessness and abnormal head and body
movements. KEMADRIN Injection is also sometimes
used to control these side effects.
2. Before you are given KEMADRIN Injection
Do not use KEMADRIN Injection:
Your doctor may decide that you should not be given
KEMADRIN Injection if any of the points listed below
applies to you:
•
Have you ever had an allergy (rash, itching, and
shortness of breath) to KEMADRIN, procyclidine
or lactic acid?
Special precautions to be taken:
Your doctor may decide to take special precautions
when giving you KEMADRIN Injection if any of the
points listed below applies to you:
•
Do you experience uncontrolled movements of the
face and tongue (tardive dyskinesis)?
•
Do you suffer from glaucoma (eye disease caused
by too much pressure within the eye)?
•
If you are a man, do you suffer from an enlarged
prostate gland?
•
Do you often suffer from stomach cramps,
abdominal pains or constipation?
•
Do you suffer from kidney or liver disease?
If any of the above applies to you talk to your doctor
or pharmacist.
Taking other medicines
Always tell your doctor if you are taking any other
medicines because taking some medicines together
can be harmful. Remember that the doctor at the
hospital may not have been informed if you have
recently begun a course of treatment for another
illness.
Are you taking any of the following drugs?
•
Tranquillisers (e.g.
                                
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Karakteristik produk

                                OBJECT 1
KEMADRIN 5MG/ML SOLUTION FOR INJECTION
(PROCYCLIDINE HYDROCHLORIDE)
Summary of Product Characteristics Updated 20-Jan-2017 | Auden
Mckenzie (Pharma Division) Ltd (a
subsidiary of Actavis PLC)
1. Name of the medicinal product
Kemadrin 5mg/ml Solution for injection
Procyclidine Hydrochloride 5mg/ml, Solution for Injection
2. Qualitative and quantitative composition
Procyclidine Hydrochloride BP 5mg per ml (10mg in each 2m1 ampoule)
3. Pharmaceutical form
Solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Procyclidine is indicated for the treatment and symptomatic relief of
all forms of Parkinson's disease e.g.
idiopathic (paralysis agitans), postencephalitic and arteriosclerotic
disease.
Procyclidine is also used to control troublesome extra-pyramidal
symptoms induced by neuroleptic drugs
including Pseudo-Parkinsonism, acute dystonic reactions and akathisia.
4.2 Posology and method of administration
The variation in optimum dosage from one patient to another should be
taken into consideration by the
physician.
Dosage in adults:-
Parkinson's disease:-
Treatment is usually started at 2.5mg three times per day, increasing
by 2.5 to 5mg daily at intervals of
two or three days until the optimum clinical response is achieved.
The usual maintenance dose to achieve optimal response is 15 to 30mg
procyclidine per day.
Addition of a fourth dose before retiring has been seen to be
beneficial in some patients. Doses up to
60mg procyclidine have been well tolerated, and at the discretion of
the attending physician dosing to this
level may be appropriate.
In general younger patients or those with postencephalitic
parkinsonism may require higher doses for a
therapeutic response than older patients and those with
arteriosclerotic parkinsonism.
Procyclidine may be combined with levodopa or amantadine in patients
who are inadequately controlled
on a single agent.
Neuroleptic-induced extrapyramidal symptoms:-
Treatment is usually initiated at 2.5mg procyclidine three times per
day increasing by 2.5 mg
                                
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