Palladone 50mg/1ml solution for injection ampoules

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Hydromorphone hydrochloride

Предлага се от:

Napp Pharmaceuticals Ltd

АТС код:

N02AA03

INN (Международно Name):

Hydromorphone hydrochloride

дозиране:

50mg/1ml

Лекарствена форма:

Solution for injection

Начин на приложение:

Subcutaneous; Intravenous

Клас:

Schedule 2 (CD)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04070200; GTIN: 05012854079366

Листовка

1 /8
PACKAGE LEAFLET: INFORMATION FOR THE USER
_PALLADONE_
® 2 MG/ML, 10 MG/ML, 20 MG/ML AND 50 MG/ML SOLUTION FOR INJECTION OR
INFUSION
Hydromorphone 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, pharmacist or
nurse.

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 _PALLADONE_ injection is and what it is used for
2.
What you need to know before you use _PALLADONE_ injection
3.
How to use _PALLADONE_ injection
4.
Possible side effects
5.
How to store _PALLADONE_ injection
6.
Contents of the pack and other information
1.
WHAT _PALLADONE_ INJECTION IS AND WHAT IT IS USED FOR
You have been prescribed _PALLADONE_ injection to relieve severe pain.
It contains the active substance hydromorphone hydrochloride, which is
a potent analgesic (strong
“painkiller”) of the opioid group.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE _PALLADONE_ INJECTION
DO NOT USE _PALLADONE_ INJECTION IF YOU:

are allergic to hydromorphone or to any of the other ingredients of
this medicine (listed in section
6);

have breathing problems (respiratory depression);

suffer from a severe lung disease associated with obstruction of the
airways (severe chronic
obstructive pulmonary disease or severe COPD);

have a heart problem after long-term lung disease (cor pulmonale);

have severe pain in your abdomen;

have a condition where the small bowel does not work properly
(paralytic ileus);

are taking a type of medicine known as a monoamine oxidase inhibitor
(examples include
tranylcypromine, phenelzine, isocarboxazid, moclobemide and
line

Данни за продукта

OBJECT 1
PALLADONE 2 MG/ML SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 22-Mar-2017 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
_PALLADONE_ 2 mg/ml solution for injection or infusion
_PALLADONE_ 10 mg/ml solution for injection or infusion
_PALLADONE_ 20 mg/ml solution for injection or infusion
_PALLADONE_ 50 mg/ml solution for injection or infusion
2. Qualitative and quantitative composition
_PALLADONE_ 2 mg/ml_: _
1 ampoule contains 2 mg hydromorphone hydrochloride (corresponding to
1.77 mg hydromorphone) in 1
ml solution.
_PALLADONE_ 10 mg/ml_:_
1 ampoule contains 10 mg hydromorphone hydrochloride (corresponding to
8.87 mg hydromorphone) in
1 ml solution.
_PALLADONE_ 20 mg/ml_:_
1 ampoule contains 20 mg hydromorphone hydrochloride (corresponding to
17.73 mg hydromorphone) in
1 ml solution.
_PALLADONE_ 50 mg/ml_:_
1 ampoule contains 50 mg hydromorphone hydrochloride (corresponding to
44.33 mg hydromorphone) in
1 ml solution.
Excipient(s) with known effect:
_PALLADONE_ 2 mg/ml_: _
1 ml contains 0.153 mmol of sodium (3.52 mg/ml of sodium)
_PALLADONE_ 10 mg/ml_:_
1 ml contains 0.128 mmol of sodium (2.94 mg/ml of sodium)
_PALLADONE_ 20 mg/ml_:_
1 ml contains 0.105 mmol of sodium (2.41 mg/ml of sodium)
_PALLADONE_ 50 mg/ml:
1 ml contains 0.040 mmol of sodium (0.92 mg/ml of sodium)
This medicinal product contains less than 1 mmol sodium (23 mg) per
ml, i.e. essentially 'sodium- free'.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
Clear, colourless to pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain in cancer.
_PALLADONE_ injection is indicated in adults and adolescents aged >12
years.
4.2 Posology and method of administration
Method of administration
Intravenous injection or infusion
Subcutaneous injection or infusion
The medicinal product is to be visually inspected prior to use. Only
clear solutions free from particles
should be used.
After opening,