Rhophylac 1,500units/2ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anti-D (RHO) immunoglobulin

Available from:

CSL Behring UK Ltd

ATC code:

J06BB01

INN (International Name):

Anti-D (RHO) immunoglobulin

Dosage:

750unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 14050300; GTIN: 5028360000534

Patient Information leaflet

1
CSL BEHRING
PACKAGE LEAFLET: INFORMATION FOR THE USER
RHOPHYLAC
® 300 MICROGRAMS / 2 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Human anti-D immunoglobulin
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or healthcare
professional.
- If you get any side effects, talk to your doctor or healthcare
professional. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Rhophylac is and what it is used for
2. What you need to know before you are given Rhophylac.
3. How to use Rhophylac
4. Possible side effects
5. How to store Rhophylac
6. Contents of the pack and other information
1. WHAT RHOPHYLAC IS AND WHAT IT IS USED FOR
WHAT RHOPHYLAC IS
This medicine is a ready-to-use solution for injection, which comes in
a pre-filled syringe. The
solution contains special proteins, isolated from human blood plasma.
These proteins belong to the
class of "immunoglobulins", also called antibodies. The active
ingredient of Rhophylac is a specific
antibody called "anti-D (Rh) immunoglobulin". This antibody works
against Rhesus factor type D.
WHAT RHESUS FACTOR TYPE D IS
Rhesus factors are special characteristics of human red blood cells.
About 85% of the population carry
the so called Rhesus factor type D (abbreviated "Rh(D)"). These people
are called _Rh(D) positive_.
People who do not carry Rhesus factor type D are called _Rh(D)
negative_.
WHAT ANTI-D (RH) IMMUNOGLOBULIN IS
Anti-D (Rh) immunoglobulin is an antibody, which works against Rhesus
factor type D and is
produced by the human immune system. When a Rh(D) negative person
receives Rh(D) positive
blood, their immune system will recognise the Rh(D) positive red blood
cells as "foreign" to their
body, and will attempt to destroy them. For this purpose, the immune
system will build specific
antibodies against Rhesus factor typ

Summary of Product characteristics

OBJECT 1
RHOPHYLAC 300 (1500 IU)
Summary of Product Characteristics Updated 23-Aug-2016 | CSL Behring
UK Limited
1. Name of the medicinal product
Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
Each pre-filled syringe contains 1500 IU (300 micrograms) human anti-D
immunoglobulin*.
One ml contains 750 IU (150 micrograms) human anti-D immunoglobulin.
The product contains a maximum of 30 mg/ml of human plasma proteins of
which 10 mg/ml is human
albumin as stabiliser. At least 95 % of the other plasma proteins are
IgG.
Distribution of the IgG subclasses (approximate values):
IgG
1
84.1 %
IgG
2
7.6 %
IgG
3
8.1 %
IgG
4
1.0%
The content of immunoglobin A (IgA) is not more than 5 micrograms/ml.
*Produced from the plasma of human donors.
Excipient with known effect:
The maximal sodium content is 11.5 mg (0.5 mmol) per syringe.
Rhophylac contains no preservatives
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
The solution is clear or slightly opalescent and colourless or pale
yellow.
Rhophylac has an osmolality of at least 240 mosmol/kg.
4. Clinical particulars
4.1 Therapeutic indications
Prevention of Rh(D) isoimmunisation in Rh(D) negative women
• Antepartum prophylaxis
- Planned antepartum prophylaxis
- Antepartum prophylaxis following complications of pregnancy
including:
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole,
intrauterine foetal death,
transplacental haemorrhage resulting from antepartum haemorrhage,
amniocentesis, chorionic biopsy,
obstetric manipulative procedures e.g. external version, invasive
interventions, cordocentesis, blunt
abdominal trauma or foetal therapeutic intervention.
• Postpartum prophylaxis
- Delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
An Rh(D) incompatible pregnancy is assumed if the foetus/baby is
either Rh(D) positive or Rh(D)
unknown or if the father is either Rh(D) positive or Rh(D) unknown.
Treatment of Rh(D) negative adul