ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Rotavirus G2 human-bovine reassortant, Quantity: 1400000 Infectious unit/mL; Rotavirus G3 human-bovine reassortant, Quantity: 1100000 Infectious unit/mL; Rotavirus G1 human-bovine reassortant, Quantity: 1100000 Infectious unit/mL; Rotavirus G4 human-bovine reassortant, Quantity: 1000000 Infectious unit/mL; Rotavirus P1 [8] human-bovine reassortant, Quantity: 1150000 Infectious unit/mL

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Rotavirus G1 human-bovine reassortant,Rotavirus G2 human-bovine reassortant,Rotavirus G3 human-bovine reassortant,Rotavirus G4 h

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; monobasic sodium phosphate; glucose monohydrate; sodium ascorbate; sodium chloride; ammonium metavanadate; calcium chloride dihydrate; cupric sulfate pentahydrate; ferric nitrate nonahydrate; ferrous sulfate heptahydrate; magnesium chloride hexahydrate; dried magnesium sulfate; manganese sulfate tetrahydrate; ammonium molybdate; potassium chloride; sodium acetate; sodium bicarbonate; dibasic sodium phosphate; zinc sulfate heptahydrate; alanine; arginine hydrochloride; asparagine; aspartic acid; cysteine hydrochloride; cystine dihydrochloride; glutamic acid; glycine; histidine hydrochloride monohydrate; hydroxyproline; isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine disodium; valine; Biotin; ergocalciferol; choline chloride; folic acid; inositol; menadione; nicotinamide; nicotinic acid; aminobenzoic acid; calcium pantothenate; pyridoxal hydrochloride; pyridoxine hydrochloride; retinol acetate; riboflavine; dl-alpha-tocopheryl phosphate disodium; thiamine hydrochloride; cyanocobalamin; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine monophosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride; sodium hypoxanthine; linoleic acid; alpha lipoic acid; phenolsulfonphthalein; putrescine dihydrochloride; sodium pyruvate; ribose; thymidine; thymine; uracil; sodium xanthine; monoethanolamine; 2-mercaptoethanol; adenosine; uridine; cytidine; guanosine; dexamethasone; Epidermal growth factor; hydrocortisone; insulin; alprostadil; liothyronine; ascorbic acid; magnesium sulfate heptahydrate; monobasic sodium phosphate monohydrate; zinc sulfate; arginine; cysteine; cystine; histidine; lysine; tyrosine; adenosine triphosphate; guanine; putrescine

Administration route:

Oral

Units in package:

SINGLE UNIT-DOSE PACK, 10 UNIT-DOSE PACK

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RotaTeq is indicated for the prevention of rotavirus gastroenteritis (see Clinical Trials).

Product summary:

Visual Identification: Pale yellow, pink tint clear liquid.; Container Type: Tube; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-05-11

Patient Information leaflet

ROTATEQ
®
_Rotavirus vaccine, live, oral, pentavalent_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RotaTeq.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of your child
taking RotaTeq against the benefits
they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ROTATEQ IS USED
FOR
RotaTeq is a viral vaccine that helps
protect your child against
gastroenteritis (diarrhoea and
vomiting) caused by rotavirus
infection.
Rotavirus gastroenteritis may cause
fever, vomiting, and diarrhoea. These
symptoms can lead to the loss of
body fluids (dehydration) and even
death.
Rotavirus is the chief cause of severe
dehydrating diarrhoea among infants
and young children around the world.
Before the vaccine was used, the
virus was the cause for about 25
million physician visits per year. It
also accounted for 2.1 million
hospital admissions, and 352,000 to
592,000 deaths per year worldwide.
Rotavirus infects the small intestine
and usually starts with fever and
vomiting, followed by diarrhoea. The
diarrhoea can be mild to severe and
generally lasts 3-9 days. Severe
vomiting and diarrhoea (more than 5
times each day) lasts an average of
3-6 days. Nearly all children are
infected with rotavirus by the time
they are 5 years old. This is true even
where standards of hygiene are high.
_HOW IT WORKS_
RotaTeq works by causing your body
to produce its own protection
(antibodies) against the most
common types or "strains" of
rotavirus.
As with other vaccines, RotaTeq may
not fully protect all those who get it.
Some children may already have the
virus but not yet show signs of being
sick. In those cases, the vaccine may
not be able to prevent the illness.
RotaTeq helps protect against
diarrhoea and vomiting only i

Summary of Product characteristics

RotaTeq
®
WPC-V260-OS-082016
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
ROTATEQ
®
(ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT)
1
NAME OF THE MEDICINE
Rotavirus G1 human-bovine reassortant
Rotavirus G2 human-bovine reassortant
Rotavirus G3 human-bovine reassortant
Rotavirus G4 human-bovine reassortant
Rotavirus P1 [8] human-bovine reassortant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RotaTeq is a live, oral pentavalent reassortant vaccine for use in the
prevention of rotavirus
gastroenteritis.
Each 2 mL dose of RotaTeq contains the following rotavirus
reassortants: G1, G2, G3, G4,
and P1A[8] derived from rotaviruses infecting human and bovine
species. The minimum dose
levels of the reassortants are as follows:
G1
2.2 X 10
6
infectious units
G2
2.8 X 10
6
infectious units
G3
2.2 X 10
6
infectious units
G4
2.0 X 10
6
infectious units
P1A[8] 2.3 X 10
6
infectious units
The reassortants are propagated in Vero cells using standard tissue
culture techniques in the
absence of antifungal agents.
The reassortants are suspended in a buffered stabilizer solution.
List of excipients with known effect: sucrose, sugars, benzoates,
phenylalanine
For the full list of Excipients, see Section 6.1 List of Excipients.
The manufacture of this product includes exposure to bovine derived
material. No evidence
exists that any case of vCJD (considered to be the human form of
bovine spongiform
encephalopathy) has resulted from the administration of any vaccine
product.
DNA fragments from porcine circoviruses (PCV) 1 and 2 have been
detected in RotaTeq. The
source is porcine-derived material used in the manufacture of the
vaccine. PCV-1 and PCV-2
are not known to cause disease in humans.
3
PHARMACEUTICAL FORM
RotaTeq is a pale yellow clear liquid that may have a pink tint.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RotaTeq
is
indicated
for
the
prevention
of
rotavirus
gastroenteritis
(see
Section
5.1
Pharmacodynamic Properties, Clinical trials).
RotaTeq
®
WPC-V260-OS-082016
Page 2 of 16
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR