Shortec 50mg/1ml solution for injection ampoules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Oxycodone hydrochloride

Dostopno od:

Qdem Pharmaceuticals Ltd

Koda artikla:

N02AA05

INN (mednarodno ime):

Oxycodone hydrochloride

Odmerek:

50mg/1ml

Farmacevtska oblika:

Solution for injection

Pot uporabe:

Subcutaneous; Intravenous

Razred:

Schedule 2 (CD)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070200; GTIN: 5060307920161

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
_SHORTEC_
_®_
50 MG/ML, SOLUTION FOR INJECTION OR INFUSION
Oxycodone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What
_SHORTEC _
injection is and what it is used for
2.
What you need to know before you use
_SHORTEC _
injection
3.
How to use
_ SHORTEC _
injection
4.
Possible side effects
5.
How to store
_SHORTEC _
injection
6.
Contents of the pack and other information
1.
WHAT _SHORTEC _INJECTION 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’. The other ingredients are listed in section 6 of
this leaflet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE_ SHORTEC _INJECTION
DO NOT USE_ SHORTEC _INJECTION IF YOU:

are allergic to oxycodone, or any of the other ingredients of
_SHORTEC_
injection (listed in section 6);

have breathing problems, such as severe 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 condition where the small bowel does not work properly
(paralytic ileus) or you have severe
pain in your abdomen;

have a heart problem after long-term lung disease (cor pulmonale);

have moderate to severe liver problems. If you have o

Lastnosti izdelka

OBJECT 1
SHORTEC 50 MG/ML, SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 07-Feb-2017 | Qdem
Pharmaceuticals Limited
1. Name of the medicinal product
_SHORTEC_ 50 mg/ml, solution for injection or infusion
2. Qualitative and quantitative composition
Oxycodone hydrochloride 50 mg/ml (equivalent to 45 mg/ml oxycodone).
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer
and post-operative pain. For the
treatment of severe pain requiring the use of a strong opioid.
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.
i.v. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. Administer a bolus dose of 1 to 10
mg slowly over 1-2 minutes in opioid naïve patients.
Doses should not be administered more frequently than every 4 hours.
i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is
recommended for opioid naïve patients.
.
i.v. (PCA): Dilute in 0.9% saline, 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 for opioid
naïve patients.
s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 5 mg is
recommended, repeated at 4-hourly intervals as required for opioid
naïve patients.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections if required. A starting dose of
7.5 mg/day is recommended in opioid naïve patients, titrating
gradually according to symptom control.
Cancer patients transferring from oral ox