Forvel 0.4mg/ml solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NALOXONE HYDROCHLORIDE, DIHYDRATE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

V03AB15

INN (International Name):

NALOXONE HYDROCHLORIDE DIHYDRATE 0.4 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

NALOXONE HYDROCHLORIDE DIHYDRATE 0.4 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2017-07-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FORVEL 0.4MG/ML SOLUTION FOR INJECTION/INFUSION
Naloxone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS
ADMINISTERED TO YOU 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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Forvel is and what it is used for
2.
What you need to know before Forvel is administered to you
3.
How Forvel is administered
4.
Possible side effects
5.
How to store Forvel
6.
Contents of the pack and other information
1.
WHAT FORVEL IS AND WHAT IT IS USED FOR
Forvel is a drug used to counter the effects of opioid overdose, for
example morphine overdose.
Forvel is used for reversal of unwanted effects of opioids for
countering life-threatening depression of
the central nervous system and respiratory system (breathing
difficulties).
Forvel is also used to diagnose an acute opioid overdose or
intoxication.
If a woman was given analgetic drugs during labour, a newborn child
can be treated with Forvel for
reversal of unwanted effects of opioids, e.g. if he/she suffers from
breathing problems or depression of
central nervous system.
2.
WHAT YOU NEED TO KNOW BEFORE FORVEL IS ADMINISTERED TO YOU
DO NOT USE FORVEL:
-
if you are
ALLERGIC
to naloxone hydrochoride or any of the other ingredients of this
medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before Forvel is administered to
you.
Special care will be taken
-
If you are
PHYSICALLY DEPENDENT TO OPIOIDS
(for example morphine) or have received high doses
of these drugs (you may get strong withdrawal symptoms after receiving
Forvel because o

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FORVEL 0.4mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1ml contains 0.4mg of naloxone hydrochloride (as
naloxone hydrochloride
dihydrate).
Excipient(s) with known effect: 1 ml of solution for
injection/infusion contains 3.38 mg
(0.15mmol) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless or almost colourless solution.
pH: 3.0 – 4.0
Osmolality: 270 – 310mOsMol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Complete or partial reversal of CNS and especially respiratory
depression, caused by
natural or synthetic opioids.
-
Diagnosis of suspected acute opioid overdose or intoxication.
-
Complete or partial reversal of respiratory and other CNS depression
in the neonate whose
mothers have received opioids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
COMPLETE OR PARTIAL REVERSAL OF CNS AND ESPECIALLY RESPIRATORY
DEPRESSION, CAUSED BY
NATURAL OR SYNTHETIC OPIOIDS
_Adults _
Dosage is determined for each patient in order to obtain optimum
respiratory response while
maintaining adequate analgesia. An i.v. injection of 0.1 to 0.2 mg
naloxone hydrochloride
(approx. 1.5-3 μg/kg) is usually sufficient. If necessary, additional
i.v. injections of 0.1 mg
can be administered at 2 minute intervals until satisfactory
respiration and consciousness are
obtained. An additional injection can again be necessary within 1 to 2
hours, depending on the
type of active substance to be antagonised (short-term effect or slow
release), the amount
administered
and
time
and
mode
of
administration.
Naloxone
can
alternatively
be
administered as an i.v. infusion.
Infusion:
The duration of action for some opioids is longer than that of the
naloxone hydrochloride i.v.
bolus. Therefore, in situations where depression is known to be
induced by such substances or
there is a reason to suspect this, naloxone hydrochloride