Oxycodone Hydrochloride solution for injection infusion

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

oxycodone (oxycodone hydrochloride)

Предлага се от:

Kalceks JSC

АТС код:

N02AA05

INN (Международно Name):

oxycodone (oxycodone hydrochloride)

дозиране:

50mg/ml

Лекарствена форма:

solution for injection infusion

Броя в опаковка:

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

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2021-04-21

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION/INFUSION
OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION/INFUSION
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

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxycodone Hydrochloride 10 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride
(equivalent to 9 mg of oxycodone).
Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride
(equivalent to 18 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 w