Valoid 50 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyclizine

Available from:

Amdipharm Limited

ATC code:

R06AE; R06AE03

INN (International Name):

Cyclizine

Dosage:

50/1 Base mg/ml

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Piperazine derivatives; cyclizine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALOID
®
50 MG/1 ML SOLUTION FOR INJECTION
(Cyclizine lactate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 name of your medicine is Valoid 50 mg/1 ml Solution for Injection.
It will be referred to
Valoid Injection for ease hereafter.
WHAT IS IN THIS LEAFLET
1.
What Valoid Injection is and what it is used for
2.
What you need to know before you are given Valoid Injection
3.
How Valoid Injection will be given to you
4.
Possible side effects
5.
How to store Valoid Injection
6.
Contents of the pack and other information
1.
WHAT VALOID INJECTION IS AND WHAT IT IS USED FOR
Each 1 ml injection ampoule contains 50 mg of the active ingredient,
cyclizine lactate.
Valoid Injection belongs to a group of medicines called
antihistamines. It is used in adults to
block the effects of substances called histamine and acetylcholine in
your body, which can make
you feel sick (nausea) or actually vomit. Valoid Injection is used for
travel or motion sickness,
and nausea which can be caused by radiotherapy of some medicines.
Some ear disorders, for example Menière’s disease, can cause loss
of balance. Valoid Injection is
used to treat the dizziness and vomiting which can come with this.
Valoid injection is used to prevent and treat nausea and vomiting
caused by certain painkillers
(narcotic analgesics) and general anaesthetics following surgery.
Valoid Injection may be given before emergency surgery to stop this
happening during the
operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VALOID INJECTION
DO NOT USE VALOID INJECTION IF YOU:

are allergic to cyclizine lactate or any of the other ingredients of
this medicine
(listed in section 6).

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valoid 50 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 50mg cyclizine lactate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Valoid is indicated in adults for the prevention and treatment of
nausea and vomiting, including:-
Motion sickness, when the oral route cannot be used.
Nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in the post-operative period.
Vomiting associated with radiotherapy, especially for breast cancer
since cyclizine does not elevate prolactin
levels.
Valoid Injection, by the intravenous route, is also indicated
pre-operatively in patients undergoing emergency
surgery in order to reduce the hazard of regurgitation and aspiration
of gastric content during induction of general
anaesthesia.
Valoid may be of value in relieving vomiting and attacks of vertigo
associated with Menière's disease and other forms
of vestibular disturbance when the oral route cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For the prevention of postoperative nausea and vomiting, administer
the first dose by slow intravenous injection 20
minutes before the anticipated end of surgery.
Adults
50 mg intramuscularly or intravenously up to three times daily.
When used intravenously, Valoid Injection should be injected slowly
into the bloodstream, with only minimal
withdrawal of blood into the syringe.
Cyclizine given intravenously, in half the recommended dose, increases
the lower oesophageal sphincter tone and
thereby reduces the hazard of regurgitation and aspiration of gastric
contents if given to patients, undergoing
emergency surgery, before induction of general anaesthesia.
Posology
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