Haloperidol 5mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Haloperidol

Available from:

Advanz Pharma

ATC code:

N05AD01

INN (International Name):

Haloperidol

Dosage:

5mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5099602317017

Patient Information leaflet

8899/98765432/0000
L12___200x670mm.indd 1
15.02.12 14:39
Package leaflet: Information for the patient
HALOPERIDOL 5MG/ML SOLUTION FOR INJECTION
Haloperidol
Package leaflet: Information for
the patient
HALOPERIDOL
5MG/ML
SOLUTION FOR INJECTION
Haloperidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
The product is known by the name above but will be referred
to as Haloperidol Injection throughout the rest of this leaflet.
WHAT IS IN THIS LEAFLET
1. What Haloperidol Injection is and what it is used for
2. What you need to know before you are given Haloperidol
Injection
3. How you will be given Haloperidol Injection
4. Possible side effects
5. How to store Haloperidol Injection
6. Contents of the pack and other information
1. WHAT HALOPERIDOL INJECTION IS AND WHAT IT IS
USED FOR
Haloperidol Injection contains the active substance haloperidol.
This belongs to a group of medicines called ‘antipsychotics’.
Haloperidol Injection is used in adults for illnesses affecting the
way you think, feel or behave. These include mental health
problems (such as schizophrenia and bipolar disorder) and
behavioural problems.
These illnesses may make you:
•
Feel confused (delirium)
•
See, hear, feel or smell things that are not there
(hallucinations)
•
Believe things that are not true (delusions)
•
Feel unusually suspicious (paranoia)
•
Feel very excited, agitated, enthusiastic, impulsive or
hyperactive
•
Feel very aggressive, hostile or violent.
Haloperidol Injection is also used in adults:
•
To help control movements in Huntington’s disease
•
To prevent or treat nausea and vomiting (feeling and being
sick) after surgery.
Haloperidol Injection may be used on its own or with other
medi

Summary of Product characteristics

OBJECT 1
HALOPERIDOL INJECTION BP 5MG/ML
Summary of Product Characteristics Updated 11-Sep-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Haloperidol 5mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ml of solution contains Haloperidol 5mg.
Excipient with known effect
Contains sodium less than 1mmol per dose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
Clear, colourless sterile solution
4. Clinical particulars
4.1 Therapeutic indications
Haloperidol solution for injection is indicated in adult patients for:
• Rapid control of severe acute psychomotor agitation associated
with psychotic disorder or manic
episodes of bipolar I disorder when oral therapy is not appropriate.
• Acute treatment of delirium when non-pharmacological treatments
have failed.
• Treatment of mild to moderate chorea in Huntington's disease, when
other medicinal products are
ineffective or not tolerated, and oral therapy is not appropriate.
• Single or combination prophylaxis in patients at moderate to high
risk of postoperative nausea and
vomiting, when other medicinal products are ineffective or not
tolerated.
• Combination treatment of postoperative nausea and vomiting when
other medicinal products are
ineffective or not tolerated.
4.2 Posology and method of administration
Posology
Adults
A low initial dose is recommended and this must be adjusted according
to the patient's response in order
to determine the minimal effective dose (see section 5.2).
The dose recommendations for Haloperidol solution for injection are
presented in Table 1.
TABLE 1: HALOPERIDOL DOSE RECOMMENDATIONS FOR ADULTS AGED 18 YEARS AND
ABOVE
RAPID CONTROL OF SEVERE ACUTE PSYCHOMOTOR AGITATION ASSOCIATED WITH
PSYCHOTIC DISORDER OR MANIC
EPISODES OF BIPOLAR I DISORDER WHEN ORAL THERAPY IS NOT APPROPRIATE
• 5 mg intramuscularly.
• May be repeated hourly until sufficient symptom control is
achieved.
• In the majority of patients, doses of up to