Paracetamol/Ibuprofen Vale 10 mg/ml+3 mg/ml Infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

ibuprofennatriumdihydrat; paracetamol

Tillgänglig från:

Vale Pharmaceuticals Ltd

ATC-kod:

N02BE51

INN (International namn):

ibuprofennatriumdihydrat; paracetamol

Dos:

10 mg/ml+3 mg/ml

Läkemedelsform:

Infusionsvätska, lösning

Sammansättning:

paracetamol 10 mg Aktiv substans; ibuprofennatriumdihydrat 3,85 mg Aktiv substans; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Injektionsflaska, 10 x 100 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2020-07-30

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL/IBUPROFEN VALE 10 MG/ML + 3 MG/ML SOLUTION FOR INFUSION
paracetamol/ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You should not use this medicine for longer than 2 days.
WHAT IS IN THIS LEAFLET
1.
What /.../
is and what it is used for
2.
What you need to know before you are given /.../
3.
How you are given /.../
4.
Possible side effects
5.
How to store /.../
6.
Contents of the pack and other information
1.
WHAT /.../ IS AND WHAT IT IS USED FOR
/.../
contains the active substances paracetamol and ibuprofen. Ibuprofen
belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (or NSAIDs).
Paracetamol works in a
different way to ibuprofen, but both substances work together to
reduce pain.
/.../ is used in adults for the short-term symptomatic treatment of
acute moderate pain, where an
intravenous route of administration is necessary and/or when other
routes of administration are not
possible.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN /.../
YOU SHOULD NOT BE GIVEN /.../:
•
if you are allergic to the active substances, other NSAIDs, or any of
the other ingredients of this
medicine (listed in section 6);
•
if you have severe heart failure, liver failure or kidney failure;
•
if you regularly drink large quantities of alcohol;
•
if you have asthma, urticaria or allergic-type reactions after taking
acetylsalicylic acid or other
NSAIDs;
•
if you have a history with gastrointestinal bleeding or perforation
related to previous NSAID t

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol/Ibuprofen Vale 10 mg/ml + 3 mg/ml solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol and ibuprofen sodium dihydrate
corresponding to 3 mg ibuprofen.
Excipient with known effect:
Sodium 35 mg per 100 ml (0.35 mg/ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution, free from visible particles, with a pH of
6.3-7.3 and an osmolality of 285-
320 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ is indicated in adults for the short-term symptomatic treatment
of acute moderate pain, where an
intravenous route of administration is considered clinically necessary
and/or when other routes of
administration are not possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For intravenous administration and short term use only for a maximum
of two days. Undesirable effects
may be minimised by using the lowest effective dose for the shortest
duration necessary to control
symptoms (see section 4.4).
_ADULTS (WEIGHING >50 KG)_
Administer one vial (100 ml) /.../ as a 15-minute infusion every 6
hours, as necessary. Do not exceed a
total daily dose of four vials (400 ml), which equates to 4000 mg (4
g) paracetamol and 1200 mg
ibuprofen.
_ADULTS (WEIGHING ≤50 KG)_
Adults weighing 50 kg or under should be dosed according to their
weight, at a dosage of 1.5 ml/kg, as
a 15-minute infusion every 6 hours, as necessary. This equates to a
maximum single dose of 75 ml
(discard remaining medicine in vial), and a total daily dose of 3000
mg (3 g) paracetamol and 900 mg
ibuprofen.
3
_PAEDIATRIC POPULATION_
/…/ is contraindicated in patients under the age of 18 years (see
section 4.3).
_SPECIAL POPULATIONS_
_Elderly_
Dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and