Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1.NAME OF THE MEDICINAL PRODUCT
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension
Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.2 ml) contains:
Reassortant influenza virus* (live attenuated) of the following strain**:
A/Vietnam/1203/2004 (H5N1) strain | 107.0±0.5 FFU*** |
(A/Vietnam/1203/2004, MEDI 0141000136) |
*propagated in fertilised hens’ eggs from healthy chicken flocks.
**produced in VERO cells by reverse genetic technology. This product contains a genetically modified organism (GMO).
***fluorescent focus units
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml).
For the full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Nasal spray, suspension
The suspension is colourless to pale yellow, clear to opalescent. Small white particles may be present.
4.CLINICAL PARTICULARS
4.1Therapeutic indications
Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.
Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance.
4.2Posology and method of administration
Posology
Children and adolescents from 12 months to less than 18 years of age
0.2 ml (administered as 0.1 ml per nostril).
Two doses are recommended for all children and adolescents. The second dose should be administered after an interval of at least 4 weeks.
Children less than 12 months
Pandemic influenza vaccine H5N1 AstraZeneca should not be used in infants below 12 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8).
Method of administration
Immunisation must be carried out by nasal administration.
Do not inject Pandemic influenza vaccine H5N1 AstraZeneca.
Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils. After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter. The patient can breathe normally while the vaccine is being administered – there is no need to actively inhale or sniff.
See section 6.6 for administration instructions.
4.3Contraindications
History of an anaphylactic (i.e.
4.4Special warnings and precautions for use
Caution is needed when administering this vaccine to individuals with a known hypersensitivity (other than anaphylactic reaction) to the active substance, or to any of the excipients listed in section 6.1, or to trace residues (gentamicin, eggs or egg proteins, ovalbumin). Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event or hypersensitivity event following administration of the vaccine.
There are no data with Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents younger than 18 years of age receiving salicylate therapy. Due to the association of Reye’s syndrome with salicylates and
Immune response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
No data are available for individuals with significant clinical immunodeficiency. In a pandemic situation, healthcare providers need to assess the potential benefits, alternatives, and risks of administering the vaccine to children and adolescents with significant clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and
The safety of seasonal live attenuated influenza vaccine (LAIV) in children with severe asthma and active wheezing has not been adequately studied. Healthcare providers need to assess the benefits and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to these individuals.
In a study with the seasonal trivalent live attenuated influenza vaccine (T/LAIV), an increased incidence of medically significant wheezing was seen in children
Vaccine recipients should be informed that Pandemic influenza vaccine H5N1 AstraZeneca is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely
immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation)
for
Vaccine recipients under treatment with influenza antiviral agents should not receive Pandemic influenza vaccine H5N1 AstraZeneca until 48 hours after the cessation of influenza antiviral therapy.
No data exist regarding the safety of intranasal administration of Pandemic influenza vaccine H5N1 AstraZeneca in children with unrepaired craniofacial malformations.
4.5Interaction with other medicinal products and other forms of interaction
Children and adolescents under 18 years of age receiving salicylate therapy should avoid vaccination with Pandemic influenza vaccine H5N1 AstraZeneca (see section 4.4). Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye’s syndrome has been reported following the use of salicylates during
The
Data regarding
- Pandemic influenza vaccine h5n1 medimmune - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain
Prescription drugs listed. Substance: "Reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain"
Based upon the potential for influenza antiviral agents to reduce the effectiveness of Pandemic influenza vaccine H5N1 AstraZeneca, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy. Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
If influenza antiviral agents and Pandemic influenza vaccine H5N1 AstraZeneca are administered concomitantly, timing and the need for revaccination should be considered based on clinical judgement.
4.6Fertility, pregnancy and lactation
Pregnancy
There are no data available on the use of Pandemic influenza vaccine H5N1 AstraZeneca in pregnant women.
Limited data are available from the use of T/LAIV and the seasonal Fluenz Tetra vaccine in pregnant women. There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving the seasonal T/LAIV vaccine in a
Animal developmental toxicity studies conducted with T/LAIV and Fluenz Tetra do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Healthcare providers need to assess the benefit and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to pregnant women.
It is not known whether Pandemic influenza vaccine H5N1 AstraZeneca is excreted in human milk. Therefore, as some viruses are excreted in human milk, the vaccine should not be used during breast- feeding.
Fertility
No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 AstraZeneca on male and female fertility.
4.7Effects on ability to drive and use machines
Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible influence on the ability to drive and use machines.
4.8Undesirable effects
Summary of the safety profile
The assessment of the safety profile for Pandemic influenza vaccine H5N1 AstraZeneca is based on a limited number of adult subjects.
In clinical studies, the safety profile of Pandemic influenza vaccine H5N1 AstraZeneca was comparable to the safety profile of the seasonal vaccines T/LAIV and Fluenz Tetra (see section 5.1 for more information).
Clinical studies have evaluated the incidence of adverse reactions in 59 adults from 18 to 49 years of age receiving at least one dose of Pandemic influenza vaccine H5N1 AstraZeneca. Additional data are provided from 289 adults enrolled in studies of vaccine candidates for an additional 7 influenza subtypes and from 240 adults and 259 children enrolled in studies of the monovalent 2009 H1N1 pandemic vaccine.
The most common adverse reactions observed in clinical studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in healthy adults was headache (25.4%) and upper respiratory infection (10.2%).
Paediatric population
List of adverse reactions
From clinical studies and
Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
Immune system disorders
Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Metabolism and nutrition disorders
Very common: Decreased appetite
Nervous system disorders
Very common: Headache
Respiratory, thoracic and mediastinal disorders
Very common: Nasal congestion/rhinorrhoea
Uncommon: Epistaxis
Skin and subcutaneous tissue disorders
Uncommon: Rash
Musculoskeletal and connective tissue disorders
Common: Myalgia
General disorders and administration site conditions
Very common: Malaise
Common: Pyrexia
Description of selected adverse reactions
Children less than 12 months of age
Pandemic influenza vaccine H5N1 AstraZeneca is not indicated for use in infants younger
than 12 months of age (see section 4.2). The safety and efficacy of the vaccine in this population has not been established. No data are available.
In an
T/LAIV versus 2.6% injectable influenza vaccine). Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. The rate of hospitalisations was not increased in T/LAIV recipients 12 months and older and the rates for infants and toddlers
Wheezing in children below 24 months of age
In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers
recipients 24 months of age and older.
Chronic conditions
- Lynparza - AstraZeneca AB
- Bydureon - AstraZeneca AB
- Ebymect - AstraZeneca AB
- Byetta - AstraZeneca AB
- Libertek - AstraZeneca AB
Prescription drugs listed. Manufacturer: "AstraZeneca AB"
Although safety in children and adolescents with mild to moderate asthma has been established for T/LAIV, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
In a study
In a study (AV010) of children and adolescents 9 to 17 years of age with moderate to severe asthma (seasonal T/LAIV: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
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Other special populations:
Immunocompromised
Overall, the safety profile of T/LAIV in a limited number of subjects with mildly to moderately non- HIV related compromised immune function, asymptomatic or mildly symptomatic HIV infection, or cancer (solid tumors and haematological malignancies) was comparable to that in healthy individuals and does not indicate any untoward effect. No data are available for individuals with severe immunosuppression (see section 4.4). In a pandemic situation, the use of Pandemic influenza vaccine H5N1 AstraZeneca in mildly to moderately inmmunosupppressed individuals may be considered after weighing the anticipated benefits against the potential risks for the individual.
Very rare reports of
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9Overdose
There have been reports of administration of twice the recommended dose of the seasonal vaccine Fluenz Tetra and the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) in the
5.PHARMACOLOGICAL PROPERTIES
5.1Pharmacodynamic properties
Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
The influenza virus strain in Pandemic influenza vaccine H5N1 AstraZeneca is (a)
(b)
Clinical studies
This section describes the clinical experience observed in three pivotal studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in adults. In addition, studies conducted with AstraZeneca’s 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Paediatric studies
H1N1 pandemic LAIV vaccine in children aged 2 to 17 years
In clinical study
For children regardless of baseline serostatus, seroresponse rates after receipt of monovalent vaccine were 7.8% and 11.1% for Days 15 and 29, respectively, and 32.0% on Day 57. For placebo recipients regardless of baseline serostatus, seroresponse rate was 6.3% on Days 15 and 29 and 14.5% on Day 57. Seroresponse rates were slightly higher among subjects who were seronegative at baseline. In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6, 96.2).
T/LAIV efficacy
T/LAIV’s efficacy data in the paediatric population consist of 9 controlled studies comprising
over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons. Four
Table 1 T/LAIV efficacy in placebo controlled paediatric studies
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| Number of | Influenza | Efficacy | (95% CI)c | |
Region | Age rangea | study | (95% CI)c | all strains | |||
number |
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| participantsb | season | matched strains | regardless | |
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| of match | |
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| 1,616 | 85.4% | 85.9% | ||
Europe | 6 to 35 M | (74.3, 92.2) | (76.3, 92.0) | ||||
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1,090 | 88.7% | 85.8% | |||||
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| (82.0, 93.2) | (78.6, 90.9) | |||
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| Africa, |
| 1,886 | 73.5% | 72.0% | ||
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| (63.6, 81.0)d | (61.9, 79.8)d | ||||
Latin | 6 to 35 M |
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| 73.6% | 46.6% | ||||
| America |
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| (33.3, 91.2) | (14.9, 67.2) | ||||
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Asia/ | 6 to 35 M | 1,041 | 62.2% | 48.6% | |||
Oceania | (43.6, 75.2) | (28.8, 63.3) | |||||
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| Europe, |
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| Asia/ |
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| 78.4% | 63.8% | |
Oceania, | 11 to 24 M | 1,150 | |||||
(50.9, 91.3) | (36.2, 79.8) | ||||||
| Latin |
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| America |
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| 2,764 | 72.9% | 70.1% | ||
Asia/ | 12 to 35 M | (62.8, 80.5) | (60.9, 77.3) | ||||
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Oceania | 1,265 | 84.3% | 64.2% | ||||
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| (70.1, 92.4)e | (44.2, 77.3)e | |||
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| 1,259 | 93.4% | 93.4% | ||
AV006 | USA | 15 to 71 M | (87.5, 96.5) | (87.5, 96.5) | |||
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1.358 | 100% | 87.1% | |||||
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| (63.1, 100) | (77.7, 92.6)f |
aM = months
bNumber of study participants for year 1 or year 2 primary efficacy analysis. cReduction in
dData presented for clinical trial
eIn study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) against matched strains and 44.8% (95% CI: 18.2, 62.9) against all strains regardless of match, respectively, in
fThe primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Table 2 | T/LAIV relative efficacy in |
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| Improved | |
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| Improved efficacy | efficacy | b |
| Study |
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| number |
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| range | participants | season | matched strains | all strains | |
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| regardless | |||
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| 44.5% | 54.9% |
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| 6 to 59 M | 7,852 | (22.4, 60.6) | (45.4, 62.9)c | ||||
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| Europe, | fewer cases than | fewer cases than | |||||
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| injectable | injectable | ||
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| 52.7% | 52.4% |
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| Europe | 6 to 71 M | 2,085 | (21.6, 72.2) | (24.6, 70.5)d | ||||
| fewer cases than | fewer cases than | |||||||
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| injectable | injectable | |
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| 34.7% | 31.9% |
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| Europe | 6 to 17 Y | 2,211 | (3.9, 56.0) | (1.1, 53.5) | ||||
| fewer cases than | fewer cases than | |||||||
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| injectable | injectable |
aM = months. Y = years. Age range as described in the protocol for the study. bReduction in
cT/LAIV demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 infants and toddlers
P/LAIV H5N1 vaccine
The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemic influenza vaccine H5N1 AstraZeneca in one or more subsets of the paediatric population in prevention of influenza infection. See 4.2 for information on paediatric use.
This medicinal product has been authorised under a
Adult studies
Adults aged 18 to 49 years
In clinical study CIR 217 the safety, infectivity, and immunogenicity of a live attenuated, vaccine derived from A/Vietnam/1203/2004 (H5N1) influenza isolate were evaluated in 21 subjects who received one 106.7 median tissue culture infectious dose (TCID50) , with 18 of those subjects receiving a second dose
In clinical study CIR 239 the safety, infectivity, and immunogenicity of a live attenuated vaccine derived from A/Hong Kong/213/2003 (H5N1) influenza isolate were evaluated in 17 subjects who received one dose of 107.5 TCID50 of the vaccine intranasally in isolation, with 16 of those subjects receiving a second dose
Adults aged 22 to 54 years
Clinical study CIR 277 assessed whether prior recipients of pandemic live attenuated influenza H5N1 vaccines were primed or established
P/LAIV
Table 3 Serum microneutralization (MN) and haemagglutination inhibition (HAI) assay antibody responses on Days 28 and 56 following administration of an inactivated H5N1 vaccine
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| P/LAIV | Vietnam | Number | Geometric | Geometric | |||||||
Study | mean titer | antibody rise | mean titer | antibody rise | ||||||||
group | priming | inactivat | of |
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| dose | ed | subjects |
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| MN | HAI | MN | HAI | MN | HAI | MN | HAI | |
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None | ||||||||||||
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None | 20c |
Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
aDays are counted relative to the only P/IIV dose for Groups
bSerological response defined as a
cSerum samples were available from 7 subjects in Group 3 on Day 28 and from 18 subjects in Group 5 on Day 56.
- Fluenz - J07BB03
- Pandemic influenza vaccine h5n1 medimmune - J07BB03
- Fluenz tetra - J07BB03
Prescription drugs listed. ATC Code: "J07BB03"
Antibody response developed rapidly in P/LAIV
subjects developed antibody responses that neutralized 2 or more clades of H5N1 viruses from the A/Goose/Guangdong/1996 H5N1 lineage, whereas few subjects even in the
Similar responses were seen with P/LAIV H7N7- and
5.2Pharmacokinetic properties
Not applicable.
5.3Preclinical safety data
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Sucrose
Dibasic potassium phosphate
Monobasic potassium phosphate
Gelatin (porcine, Type A)
Arginine hydrochloride
Monosodium glutamate monohydrate
Water for injections
6.2Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3Shelf life
18 weeks.
6.4Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the nasal applicator in the outer carton in order to protect from light.
/img_1/en_GB/xen_GB12x1.jpg.pagespeed.ic.VZv3FVGEKR.jpg)
Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this
6.5Nature and contents of container
Pandemic influenza vaccine H5N1 AstraZeneca is supplied as a 0.2 ml suspension in a
Pack size of 10.
6.6Special precautions for disposal and other handling
Administration
Pandemic influenza vaccine H5N1 AstraZeneca IS FOR NASAL USE ONLY.
DO NOT USE WITH A NEEDLE. Do not inject.
Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiry date has passed or if the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils.
After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
The patient can breathe normally while the vaccine is being administered – there is no need to actively inhale or sniff.
Refer to the Pandemic influenza vaccine H5N1 AstraZeneca administration diagram (Figure 1) for
/img_1/en_GB/xen_GB13x1.jpg.pagespeed.ic.FAfkQgM0By.jpg)
Figure 1 Pandemic influenza vaccine H5N1 AstraZeneca Administration
Check expiry date | Prepare the applicator | Position the applicator |
Product must be used | Remove rubber tip | With the patient in an |
before date on | protector. Do not remove | upright position, place |
applicator label. | the tip just inside the | |
| other end of the | nostril to ensure |
| applicator. | Pandemic influenza |
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| vaccine H5N1 |
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| AstraZeneca is delivered |
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| into the nose. |
Depress the plunger | Remove | Spray in other nostril |
With a single motion, | clip | Place the tip just inside |
depress plunger as | For administration in the | the other nostril and |
rapidly as possible | other nostril, pinch and | with a single motion, |
until the | remove the | depress plunger as |
clip prevents you from | clip from plunger. | rapidly as possible to |
going further. |
| deliver remaining |
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| vaccine. |
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.
7.MARKETING AUTHORISATION HOLDER
AstraZeneca AB
Sweden
8.MARKETING AUTHORISATION NUMBER(S)
EU/1/16/1089/001
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20 May 2016
Date of latest renewal: 20 April 2017
10.DATE OF REVISION OF THE TEXT
- Kinzalkomb
- Zimulti
- Imnovid (pomalidomide celgene)
- Irbesartan hydrochlorothiazide bms
- Evarrest
- Unituxin
Prescription drugs listed:
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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