Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 125 mg/vial

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Methylprednisolone

Tilgængelig fra:

Pfizer Healthcare Ireland

ATC-kode:

H02AB; H02AB04

INN (International Name):

Methylprednisolone

Dosering:

125 milligram/vial

Lægemiddelform:

Powder and solvent for solution for injection/infusion

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Glucocorticoids; methylprednisolone

Autorisation status:

Marketed

Autorisation dato:

1978-04-01

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLU-MEDRONE
® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR CONCENTRATE FOR
SOLUTION FOR
INFUSION 40 MG/VIAL, 125 MG/VIAL, 500 MG/VIAL, 1000 MG/VIAL
methylprednisolone (as sodium succinate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

SOLU-MEDRONE IS A STEROID MEDICINE, prescribed for many different
conditions,
including serious illnesses.

YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.

DON’T STOP TAKING THIS MEDICINE without talking to your doctor –
you may need
to reduce the dose gradually.

SOLU-MEDRONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4.
Possible
side effects). Some problems such as mood changes (feeling depressed,
or
“high”), or stomach problems can happen straight away. If you feel
unwell in any
way, keep taking Solu-Medrone, but SEE YOUR DOCTOR STRAIGHT AWAY.

SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include
weakness
of arms and legs, or developing a round face (read section 4. Possible
side effects
for more information).

IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE “STEROID
CARD”:
always keep it with you and show it to any doctor or nurse treating
you.

KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX OR SHINGLES, if you have
never
had them. They could affect you severely. If you do come into contact
with
chicken-pox or shingles, SEE YOUR DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET. It includes other important
information on the safe
and effective use of this medicine that might be especially important
for you.

Keep this leaflet. You may need to read it again

If you have any further questions please ask your doctor, pharmacist
or nurse.

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.
WHAT IS IN THIS LEAFLET
1.
WHAT SOLU-MEDRONE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEE

Produktets egenskaber

Health Products Regulatory Authority
14 November 2023
CRN00DX02
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solu-Medrone powder and solvent for solution for injection or
concentrate for solution for infusion 125 mg/vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Act-o-Vial contains methylprednisolone sodium succinate
equivalent to 125 mg of methylprednisolone (62.5 mg/ml
following reconstitution).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection or concentrate for
solution for infusion.
A white to off-white lyophilised powder, supplied with a clear,
colourless solution for reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solu‑Medrone is indicated for any condition in which rapid and
intense corticosteroid effect is required such as:
1. Allergic states, for example:
bronchial asthma, angioneurotic oedema, anaphylaxis.
2. Dermatological conditions
severe erythema multiforme (for example: Stevens‑Johnson syndrome).
3. Acute adrenal insufficiency with supplemental salt and/or
desoxycorticosterone. Solu-Medrone is not first line treatment for
acute adrenal insufficiency because it does not possess sufficient
mineralocorticoid properties.
4. Acute systemic lupus erythematosus.
5. Acute rheumatic carditis.
6. Suppression of graft rejection reactions following transplantation.
7. Cerebral oedema secondary to cerebral tumour.
8. The prevention of nausea and vomiting associated with cancer
chemotherapy.
9. Ulcerative colitis.
10. Crohn's disease.
11. Aspiration of gastric contents.
12. Acute spinal cord injury. Treatment should begin within eight
hours of injury.
13. The treatment of acute exacerbations of multiple sclerosis
superimposed on either a relapsing-remitting or chronic
progressive background.
Health Products Regulatory Authority
14 November 2023
CRN00DX02
Page 2 of 16
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Solu‑Medrone may be administered intravenously (injection or
infusion) o