Oxycodone Hydrochloride solution for injection infusion

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

oxycodone (oxycodone hydrochloride)

Saadav alates:

Kalceks JSC

ATC kood:

N02AA05

INN (Rahvusvaheline Nimetus):

oxycodone (oxycodone hydrochloride)

Annus:

50mg/ml

Ravimvorm:

solution for injection infusion

Ühikuid pakis:

(5/1x5/) ampoules 1ml in plastic liner, (10/2x5/) ampoules 1ml in plastic liner

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2022-12-08

Infovoldik

OXYCODONE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION/INFUSION
OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION/INFUSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone hydrochloride
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 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Oxycodone is and what it is used for
2. What you need to know before you use
Oxycodone
3. How to use Oxycodone
4. Possible side effects
5. How to store Oxycodone
6. Contents of the pack and other information
1. WHAT OXYCODONE
IS AND WHAT IT IS USED FOR
This injection has been prescribed for you by your
doctor to relieve moderate to severe pain. It contains
the active ingredient oxycodone which belongs to
a group of medicines called strong analgesics or
‘painkillers’.
Oxycodone is indicated in adults only.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
OXYCODONE
DO NOT USE OXYCODONE:
-
if you are allergic to oxycodone or any of the
other ingredients of this medicine (listed in
section 6);
-
if you have known sensitivity to morphine or
other opioids;
-
have breathing problems, such as severe chronic
obstructive lung disease, severe bronchial asthma
or severe respiratory depression. Your doctor will
have told you if you have any of these conditions.
Symptoms may include breathlessness, coughing
or breathing more slowly or weakly than expected;
-
have a heart problem after long‑term lung disease
(cor pulmonale);
-
have a condition where the small bowel does not
work properly (paralytic ileus) or you have severe
pain in your abdomen;
-
have ongoing problems

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxycodone hydrochloride 50 mg/ml solution for injection/infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 50 mg of oxycodone hydrochloride
(equivalent to 45 mg of oxycodone).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution, free from visible particles.
pH of solution is 4.5-5.5.
Osmolality is approximately 285 mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of moderate to severe pain in patients with cancer
and postoperative pain.
For the treatment of severe pain requiring the use of a strong opioid.
Oxycodone is indicated in adults only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted according to the severity of pain, the
total condition of the patient and
previous or concurrent medication.
_Adults over 18 years: _
The following starting doses are recommended. A gradual increase in
dose may be required if
analgesia is inadequate or if pain severity increases.
IV (Bolus): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%)
solution for injection, 50 mg/ml
(5%) dextrose or water for injections. Administer a bolus dose of 1 to
10 mg slowly over 1-2 minutes.
Doses should not be administered more frequently than every 4 hours.
IV (Infusion): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%)
solution for injection, 50 mg/ml
(5%) dextrose or water for injections.
A starting dose of 2 mg/hour is recommended.
IV (PCA): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution
for injection, 50 mg/ml (5%)
dextrose or water for injections.
Bolus doses of 0.03 mg/kg should be administered with a minimum
lock-out time of 5 minutes.
SC (Bolus): Use as 10 mg/ml concentration. Oxycodone 50 mg/ml dilute
in sodium chloride 9 mg/ml
(0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for
injections. A starting dose of 5 mg
is recommended, repeated at 4-hourly intervals as requ