Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylprednisolone hydrogen succinate ph. eur.

Available from:

Pfizer Healthcare Ireland

ATC code:

H02AB; H02AB04

INN (International Name):

Methylprednisolone hydrogen succinate ph. eur.

Dosage:

1000 milligram/vial

Pharmaceutical form:

Powder and solvent for solution for injection/infusion

Prescription type:

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

Therapeutic area:

Glucocorticoids; methylprednisolone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

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

Summary of Product characteristics

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 1000 mg/vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains methylprednisolone sodium succinate equivalent to
1000 mg of methylprednisolone (62.5 mg/ml following
reconstitution as directed).
Excipients with known effect
Solu-Medrone 1000 mg contains 116.8 mg of sodium in each vial.
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 sterile water
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.
Health Products Regulatory Authority
14 November 2023
CRN00DX02
Page 2 of 16
13. The treatment of acute exacerbations of multiple sclerosis
superimposed on either a relapsing-remitting or chronic
progressive background.
4.2 POSOLOGY AND METHOD OF ADMIN