Procomvax - Patient leaflet, side effects, dosage

6. PHARMACEUTICAL PARTICULARS6.1 List of excipientsFormulation contains amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride.6.2 IncompatibilitiesIn the absence of compatibility studies, this vaccine must not be mixed with other vaccines or othermedicinal products in the same syringe.6.3 Shelf life3 years6.4 Special precautions for storageStore in a refrigerator (2 °C - 8 °C). Do not freeze.6.5 Nature and contents of container0.5 ml suspension in vial (type I flint glass).6.6 Instructions for use and handlingThe vaccine should be used as supplied; no reconstitution is neAfter thorough agitation, PROCOMVAX is a slightly opa products should be inspected visually for extraneous parti administration whenever solution and container permit.ite suspension. Parenteral medicinal matter and discoloration prior toShake well before withdrawal and use. Thorough agitation is necessary to achieve suspension of the vaccine.Sanofi Pasteur MSD S.N.C.8, rue Jonas Salk F - 69007 LYON7. MARKETING AUTHORHOLDER8. MAG AUTHORISATION NUMBER(S)EU/1/99/104/0019ATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATIONate of first authorisation: 07/05/1999Date of latest renewal: 02/08/200410. DATE OF REVISION OF THE TEXTANNEX II

A. MANUFACTURING AUTHORISATION HOLDE RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACT SUBSTANCES

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

PROCOMVAX – single dose in vial – Pack of 1

• 1. NAME OF THE MEDICINAL PRODUCT

PROCOMVAX suspension for injection

Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant

• 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains :

7.5 ^g of PRP from Haemophilus influenzae type b as PRP-OMPC

125 ^g of Neisseria meningitidis OMPC

5.0 ^g of hepatitis B surface antigen produced in recombinant yeas

Excipients: Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9 % sodium chloride

8. EXPIRY DATE

EXP:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

1. NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION

PROCOMVAX

Intramuscular use

Shake well before use

EXP:

Batch

1 dose = 0.5 ml

SANOFI PASTEUR MSD SNC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

5. CONTENTS BY WEIGHT, BY VO

BY UNIT

PACKAGE LEAFLET

Read all of this leaflet carefully before your child is vaccinated.

• – Keep this leaflet. You may need to read it again.

• – If you have further questions, please ask your doctor or your pharmacist.

• – This vaccine has been prescribed for your child and you should not pass it on to others.

  In this leaflet :

  
  

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  • 6.

anofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon rp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

COMVAX IS AND WHAT IT IS USED FOR

is an injectable vaccine in a 0.5ml single dose vial.

AX is indicated to help protect your child against invasive disease caused by Haemophilus ae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against ion of the liver caused by all known subtypes of hepatitis B virus. The vaccine can be inistered in most infants 6 weeks to 15 months of age.

BEFORE YOU USE PROCOMVAX

Do not use PROCOMVAX:

• – if your child is allergic to any component of the vaccine.

• – in infants younger than 6 weeks of age

• – if your child has fever (vaccination should be delayed).

• – in infants born to HBsAg positive mothers.

Take special care with PROCOMVAX:

if your child has bleeding disorders such as haemophilia or thrombocytopenia , special

precautions should be taken against the risk of haematoma following injection.

if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series. The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.

as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine.

because hepatitis B infection can go undetected for a long period of time, it is possible that individual may already be infected at the time the vaccine is given. The vaccine may not prevent hepatitis B in these individuals.

Using other vaccines

PROCOMVAX can be administered simultaneously with the primary seri pertussis vaccine (DTP) and oral polio vaccine (OPV). At 12 to 15 mo may be given simultaneously with Merck MMR (Measles, Mum or OPV or with a booster dose of diphtheria, tetanus, acellular pe of age in children who received the primary series of DTP.

PROCOMVAX has been administered simultaneously with the primary series of DTaP and enhanced inactivated poliovirus vaccine (IPV) to a limited number of infants. No serious vaccine-related side effects were reported. Immune response data are satisfactory for PROCOMVAX but are currently unavailable for DTaP.

3. HOW TO USE PROCOMVA

s should be vaccinated with three 0.5 ml doses of

–15 months of age. If the recommended schedule cannot be een the first two doses should be approximately two months and the third dose should be as close as possible to eight to eleven months.

nistered to complete the vaccination regimen.

Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered PROCOMV the schedule of 2, 4, and 12 –15 months of age.

inated according to recommended schedule

schedules for children not vaccinated according to the recommended schedule should be ed on an individual basis.

OCOMVAX must be injected into the muscle of the thigh. Do not inject intravenously, intradermally, or subcutaneously

If you forget to take PROCOMVAX:

Your doctor will decide when to give the missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PROCOMVAX can have side effects. PROCOMVAX has been generally well tolerated in clinical trials. Side effects include injection-site reactions such as pain, soreness, redness, and swelling. Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying. Other side effects that may occur rarely and be serious include seizure, febrile seizure, allergic reactions, allergic swelling (angioedema) and certain severe types of rash, injection site nodule.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

In addition, tell your doctor if your child experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• 5. STORING PROCOMVAX

Keep out of the reach and sight of children.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Do not use after the expiry date stated on the label.

• 6. FURTHER INFORMATION

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