bhpardo/ema_en · Datasets at Hugging Face

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A slower injection is preferable in patients who react to the treatment with “ flu-like” symptoms.
3.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/ dl.
Cervarix is a turbid white suspension.
This also applies to any unknown or emerging viruses or other types of infections.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
PHARMACEUTICAL FORM
The mean Cmax of paclitaxel, which occurred at the end of the infusion, was 18.7 µg/ ml.
Vial (glass)
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Uncommon
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
180
Oral use Oral use
Bondronat should not be used in children.
EU/ 1/ 01/ 185/ 042
73 B.
3.
EXPIRY DATE
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
What is the risk associated with Aloxi?
Post-hoc analysis where patients who failed virologically or discontinued for adverse events were treated as failures; for other drop-outs, the LOCF (last observation carried forward) method was applied
120 ml
250 micrograms
178 Danmark BRISTOL-MYERS SQUIBB Tlf: + 45 45 93 05 06
See the package leaflet for further information.
Slovenská republika BRISTOL-MYERS SQUIBB SPOL.
Read the package leaflet before use.
1.
Store in the original carton.
Psychiatric disorders Nervous system disorders
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Date of first authorisation:
For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ ml by PCR at end of dosing.
In clinical trials with AMMONAPS, 56% of the patients experienced at least one adverse event and 78% of these adverse events were considered as not related to AMMONAPS.
4.6 Pregnancy and lactation
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
150 µg
Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly may be converted to once every other week Aranesp.
Your ability to concentrate or to react will be less during a hypo.
EU/ 1/ 07/ 410/ 015
dose of Agenerase capsules is 600 mg twice daily with ritonavir 100 mg twice daily, in combination with other antiretroviral medicinal products.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
EU/ 1/ 03/ 258/ 018, 56 tablets, component of a 168 tablet multipack.
What benefit has Arixtra shown during the studies?
Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).
3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).
It is not known whether Interferon beta-1b passes into human breast milk.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
4.
Hepatobiliary disorders
12.8%
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.
The maximum daily dose should not exceed 30 mg.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined (see section 4.5).
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
Patients had a BMI ≥ 30 kg/ m² or BMI > 27 kg/ m² with hypertension and/ or dyslipidemia at inclusion.
=
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
e EU/ 1/ 06/ 344/ 009
TRAY LID
6.
Actrapid must be protected from excessive heat and sunlight.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
4.3 Contraindications
- beta-blockers (used to treat high blood pressure),
• if you have/ your child has previously had any allergic reaction to Ambirix, or any ingredient contained in this vaccine including neomycin (antibiotic).
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Open a new sachet and squeeze some cream onto your fingertip.
their symptoms are the same as yours.
AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the
dysmenorrhoea and uterine bleeding
4.
The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
0 800 222 555 Appel depuis l’ étranger: +33 1 57 63 23 23
In addition, other causes of anaemia, such as vitamin B12 or folate deficiency, should be excluded before instituting therapy with epoetin alfa.
13.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Favourable response rates in neutropaenic patients were 7/ 14 (50%) in the caspofungin group and 4/ 10 (40%) in the amphotericin B group.
Fosamprenavir/ ritonavir
EXP.:
Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
80
© European Medicines Agency, 2008.
10 mg retapamulin (1% w/w)
weight increased, blood creatine phosphokinase increased
Film-coated tablet
Interferon beta-1a
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
Tel: +356 21493022
An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.

A slower injection is preferable in patients who react to the treatment with “ flu-like” symptoms.

3.

The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/ dl.

Cervarix is a turbid white suspension.

This also applies to any unknown or emerging viruses or other types of infections.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

PHARMACEUTICAL FORM

The mean Cmax of paclitaxel, which occurred at the end of the infusion, was 18.7 µg/ ml.

Vial (glass)

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.

Uncommon

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections

Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).

180

Oral use Oral use

Bondronat should not be used in children.

EU/ 1/ 01/ 185/ 042

73 B.

3.

EXPIRY DATE

Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).

What is the risk associated with Aloxi?

Post-hoc analysis where patients who failed virologically or discontinued for adverse events were treated as failures; for other drop-outs, the LOCF (last observation carried forward) method was applied

120 ml

250 micrograms

178 Danmark BRISTOL-MYERS SQUIBB Tlf: + 45 45 93 05 06

See the package leaflet for further information.

Slovenská republika BRISTOL-MYERS SQUIBB SPOL.

Read the package leaflet before use.

1.

Store in the original carton.

Psychiatric disorders Nervous system disorders

The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.

Date of first authorisation:

For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ ml by PCR at end of dosing.

In clinical trials with AMMONAPS, 56% of the patients experienced at least one adverse event and 78% of these adverse events were considered as not related to AMMONAPS.

4.6 Pregnancy and lactation

Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

150 µg

Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing

For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly may be converted to once every other week Aranesp.

Your ability to concentrate or to react will be less during a hypo.

EU/ 1/ 07/ 410/ 015

dose of Agenerase capsules is 600 mg twice daily with ritonavir 100 mg twice daily, in combination with other antiretroviral medicinal products.

Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.

EU/ 1/ 03/ 258/ 018, 56 tablets, component of a 168 tablet multipack.

What benefit has Arixtra shown during the studies?

Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.

In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).

3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).

It is not known whether Interferon beta-1b passes into human breast milk.

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.

from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

4.

Hepatobiliary disorders

12.8%

Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.

AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.

An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.

The maximum daily dose should not exceed 30 mg.

It may occur if the insulin dose is too high in relation to the insulin requirement.

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined (see section 4.5).

The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).

Patients had a BMI ≥ 30 kg/ m² or BMI > 27 kg/ m² with hypertension and/ or dyslipidemia at inclusion.

=

Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.

e EU/ 1/ 06/ 344/ 009

TRAY LID

6.

Actrapid must be protected from excessive heat and sunlight.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.

4.3 Contraindications

- beta-blockers (used to treat high blood pressure),

• if you have/ your child has previously had any allergic reaction to Ambirix, or any ingredient contained in this vaccine including neomycin (antibiotic).

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.

Open a new sachet and squeeze some cream onto your fingertip.

their symptoms are the same as yours.

AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the

dysmenorrhoea and uterine bleeding

4.

The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.

0 800 222 555 Appel depuis l’ étranger: +33 1 57 63 23 23

In addition, other causes of anaemia, such as vitamin B12 or folate deficiency, should be excluded before instituting therapy with epoetin alfa.

13.

If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.

Favourable response rates in neutropaenic patients were 7/ 14 (50%) in the caspofungin group and 4/ 10 (40%) in the amphotericin B group.

Fosamprenavir/ ritonavir

EXP.:

Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00

80

10 mg retapamulin (1% w/w)

weight increased, blood creatine phosphokinase increased

Film-coated tablet

Interferon beta-1a

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.

Tel: +356 21493022

An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.